Additional  copies  are  available  from: 
Office  of  Nutrition,  Labeling,  and  Dietary  Supplements 
HFS-800 
Center  for  Food  Safety  and  Applied  Nutrition 
Food  and  Drug  Administration 
5100  Paint  Branch  Parkway 
College  Park,  MD  20740 
(Tel)  240-402-2373 
www.fda.gov/FoodLabelingGuide  T C
ABLE OF  ONTENTS
 
1.	  INTRODUCTION  4 
Contains  Nonbinding  
Recommendations  2.	  BACKGROUND  4 
3.	  GENERAL FOOD LABELING REQUIREMENTS  5 
Guidance  for  Industry 
A  Food  Labeling  Guide  4.	  NAME OF FOOD  7 
Juices 
This  guidance  represents  the 
Food  and  Drug  5.	  NET QUANTITY OF CONTENTS STATEMENTS  14 
Administration's  (FDA's)  6.	  INGREDIENT LISTS  17 
current  thinking  on  this  Colors
 
topic.  It  does  not  create  or  Food  Allergen  Labeling
 
confer  any  rights  for  or  on 
any  person  and  does  not  7.	  NUTRITION LABELING  25 
General 
operate  to  bind  FDA  or  the 
Nutrient  Declaration 
public.  You  can  use  an  
Products  with  Separately  Packaged  Ingredients/Assortments  of  Foods 
alternative  approach  if  the  
Label  Formats/Graphics 
approach  satisfies  the 
General 
requirements  of  the 
Specific  Label  Formats 
applicable  statutes  and 
Trans  Fat  Labeling 
regulations.  If  you  want  to 
Miscellaneous 
discuss  an  alternative 
Serving  Size 
approach,  contact  the  FDA 
Exemptions/Special  Labeling  Provisions 
staff  responsible  for 
implementing  this  guidance.  8.	  CLAIMS  72 
If  you  cannot  identify  the  Nutrient  Content  Claims
 
appropriate  FDA  staff,  call  Health  Claims
 
the  appropriate  telephone  Qualified  Health  Claims
 
number  listed  on  the  title  Structure/Function  Claims
 
page  of  this  guidance. 
9.	  APPENDIX A:  DEFINITIONS OF NUTRIENT CONTENT CLAIMS  87 
10.	  APPENDIX B:  ADDITIONAL REQUIREMENTS FOR NUTRIENT 
CONTENT CLAIMS  91 
11.	  APPENDIX C:  HEALTH CLAIMS  95 
12.	  APPENDIX D:  QUALIFIED HEALTH CLAIMS  105 
13.	  APPENDIX E:  ADDITIONAL FDA  RESOURCES  126 
14.	  APPENDIX F:  CALCULATE THE PERCENT DAILY VALUE (DV)  
FOR THE APPROPRIATE NUTRIENTS  127 
15.	  APPENDIX G:  DAILY VALUES FOR INFANTS,  CHILDREN LESS 
THAN 4  YEARS OF AGE,  AND PREGNANT AND LACTATING WOMEN  128 
16.	  APPENDIX H:  ROUNDING THE VALUES ACCORDING TO THE 
FDA  ROUNDING RULES  129  I
1.  NTRODUCTION 
In  a  guide  such  as  this,  it  is  impractical  to  attempt  to  answer  every  food 
labeling  question  that  might  arise.  The  most  frequently  raised  questions  have 
been  addressed  using  a  question  and  answer  format.  We  believe  the  vast 
majority  of  food  labeling  questions  are  answered.  They  are  grouped  by  the 
food  labeling  area  of  interest.  The  Table  of  Contents  will  help  you  locate  your 
food  labeling  area  of  interest. 
Under  FDA's  laws  and  regulations,  FDA  does  not  pre-approve  labels  for  food 
products.  Questions  concerning  the  labeling  of  food  products  may  be  directed 
to  the  Food  Labeling  and  Standards  Staff  (HFS-820),  Office  of  Nutrition, 
Labeling,  and  Dietary  Supplements,  Center  for  Food  Safety  and  Applied 
Nutrition,  Food  and Drug  Administration,  5100  Paint  Branch  Parkway, 
College  Park,  MD  20740-3835,  Telephone:  (240)  402-2371. 
B
2.  ACKGROUND 
The  Food  and  Drug  Administration  (FDA)  is  responsible  for  assuring  that 
foods  sold  in  the  United  States  are  safe,  wholesome  and  properly  labeled.  This 
applies  to  foods  produced  domestically,  as  well  as  foods  from  foreign  countries. 
The  Federal  Food,  Drug,  and  Cosmetic  Act  (FD&C  Act)  and  the  Fair 
Packaging  and  Labeling  Act  are  the  Federal  laws  governing  food  products 
under  FDA's  jurisdiction. 
The  FDA  receives  many  questions  from  manufacturers,  distributors,  and 
importers  about  the  proper  labeling  of  their  food  products.  This  guidance  is  a 
summary  of  the  required  statements  that  must  appear  on  food  labels  under 
these  laws  and  their  regulations.  To  help  minimize  legal  action  and  delays,  it  is 
recommended  that  manufacturers  and  importers  become  fully  informed  about 
the  applicable  laws  and  regulations  before  offering  foods  for  distribution  in  the 
United  States. 
The  Nutrition  Labeling  and  Education  Act  (NLEA),  which  amended  the 
FD&C  Act  requires  most  foods  to  bear  nutrition  labeling  and  requires  food 
labels  that  bear  nutrient  content  claims  and  certain  health  messages  to  comply 
with  specific  requirements.  Although  final  regulations  have  been  established 
and  are  reflected  in  this  guidance,  regulations  are  frequently  changed.  It  is  the 
responsibility  for  the  food  industry  to  remain  current  with  the  legal 
requirements  for  food  labeling.  All  new  regulations  are  published  in  the 
Federal  Register  (FR)  prior  to  their  effective  date  and  compiled  annually  in 
Title  21  of  the  Code  of  Federal  Regulations  (CFR). 
This  guidance  has  been  prepared  by  the  Office  of  Nutrition,  Labeling,  and  
Dietary  Supplements  in  the  Center  for  Food  Safety  and  Applied  Nutrition  at 
the  U.S.  Food  and  Drug  Administration. 
This  document  supercedes  the  previous  version  issued  in  October  2009. 
4 G U I D A N C E  F O R  I N D U S T R Y  G F L R
3.  ENERAL  OOD  ABELING  EQUIREMENTS 
1.  Where  should  label  statements  be  placed  on  containers  and  packages? 
Answer: There  are  two  ways  to  label  packages  and  containers: 
a. 
Place  all  required  label  statements  on  the  front  label  panel  (the  principal  
display  panel  or  PDP),  or, 
b.  STATEMENT  OF  IDENTITY 
Place  certain  specified  label  statements  on  the  PDP  and  other  labeling  on 
the  information  panel  (the  label  panel  immediately  to  the  right  of  the  PDP,  as 
seen  by  the  consumer  facing  the  product). 
21  CFR  101.1,  21  CFR  101.2,  21  CFR  101.3,  21  CFR  101.4,  21  CFR 
101.5,  21  CFR  101.9,  and  21  CFR  101.105 
2.   What  are  the  PDP  and  the  alternate  PDP? 
Answer: The  PDP,  is  that  portion  of  the  package  label  that  is  most  likely  to  be 
seen  by  the  consumer  at  the  time  of  purchase.  Many  containers  are  designed 
with  two  or  more  different  surfaces  that  are  suitable  for  display  as  the  PDP. 
21  CFR  101.1 
These  are  alternate  PDPs.  
3.   What  label  statements  must  appear  on  the  PDP? 
Answer: Place  the  statement  of  identity,  or  name  of  the  food,  and  the  net 
quantity statement,  or  amount  of  product,  on  the  PDP  and  on  the  alternate 
PDP.  The   required  type  size  and  prominence  are  discussed  in  sections  4  and  PDP 
21  CFR  101.3(a)  and  21  CFR  101.105(a) 
5  of  this  guidance.  
4.   Which  label  panel  is  the  information  panel? 
Answer: The  information  panel  is  the  label  panel  immediately  to  the  right  of 
the  PDP,  as  displayed  to  the  consumer.  If  this  panel  is  not  usable,  due  to 
package  design  and  construction,  (e.g.,  folded  f laps),  then  the  information 
21  CFR  101.2(a) 
panel  is  the  next  label  panel  immediately  to  the  right.  
NET  QUANTITY  STATE
MENT 
A  F O O D  L A B E L I N G  G U I D E   5  5.   What  is  information  panel  labeling? 
Answer: The  phrase  information  panel  labeling  refers  to  the  label 
statements  that  are  generally  required  to  be  placed  together,  without  any 
intervening  material,  on  the  information  panel,  if  such  labeling  does  not 
appear  on  the  PDP.  These  label  statements  include  the  name  and  address  of 
the  manufacturer,  packer  or  distributor,  the  ingredient  list,  nutrition  labeling 
21  CFR  101.2(b)  and  (d),  Section  403(w) 
and  any  required  allergy  labeling.  
of  the  FD&C  Act 
6.   What  type  size,  prominence  and  conspicuousness  is  required? 
Answer: For  information  panel  labeling,  use  a  print  or  type  size  that  is 
prominent,  conspicuous  and  easy  to  read.  Use  letters  that  are  at  least  one-
sixteenth  (1/16)  inch  in  height  based  on  the  lower  case  letter  o.  The  letters 
must  not  be  more  than  three  times  as  high  as  they  are  wide,  and  the  lettering 
must  contrast  sufficiently  with  the  background  so  as  to  be  easy  to  read.  Do  not 
crowd  required  labeling  with  artwork  or  non-required  labeling. 
PDP  INFORMATION  PANEL 
Smaller  type  sizes  may  be  used  for  information  panel  labeling  on  very  small 
21  CFR  101.2(c)  & (f). 
food  packages  as  discussed  in 
Different  type  sizes  are  specified  for  the  Nutrition  Facts  label.  (see  section  7) 
The  type  size  requirements  for  the  statement  of  identity  and  the  net  quantity 
statement  are  discussed  in  sections  4  and  5  of  this  guidance. 
21  CFR  101.2(c) 
7.   What  is  the  prohibition  against  intervening  material? 
Answer: 
Information  that  is  not  required  by  FDA  is  considered  intervening 
material  and  is  not  permitted  to  be  placed  between  the  required  labeling  on 
the  information  panel  (e.g.,  the  UPC  bar  code  is  not  FDA  required  labeling).  
21  CFR  101.2(e) 
8.   What  name  and  address  must  be  listed  on  the  label? 
Answer: Food  labels  must  list: 
a. 
Name  and  address  of  the  manufacturer,  packer  or  distributor.  Unless  the 
name  given  is  the  actual  manufacturer,  it  must  be  accompanied  by  a  qualifying 
phrase  which  states  the  firm's  relation  to  the  product  (e.g.,  manufactured  for 
or  distributed  by); 
b. 
Street  address  if  the  firm  name  and  address  are  not  listed  in  a  current  city  
directory  or  telephone  book; 
c. 
City  or  town; 
d. 
State  (or  country,  if  outside  the  United  States);  and 
e. 
ZIP  code  (or  mailing  code  used  in  countries  other  than  the  United  States). 
21  CFR  101. 5 
INTERVENING   MATERIAL  USUALLY  INFORMATION  PANEL 
 
6 G U I D A N C E  F O R  I N D U S T R Y  N O F
4.  AME  F  OOD
 
1. 	  What  is  the  name  of  the  food  statement  called  and  where  must  it  
be  placed? 
Answer: The  statement  of  identity  is  the  name  of  the  food.  It  must  appear  on  
21  CFR  101.3 
the  front  label,  or  PDP  as  well  as  any  alternate  PDP.  
2. 	  Should  the  statement  of  identity  stand  out? 
Answer: Use  prominent  print  or  type  for  the  statement  of  identity.  It  shall  be  
in  bold  type.  The  type  size  must  be  reasonably  related  to  the  most  prominent 
printed  matter  on  the  front  panel  and  should  be  one  of  the  most  important 
features  on  the  PDP.  Generally,  this  is  considered  to  be  at  least  1/2  the  size  of 
21  CFR  101.3(d) 
the  largest  print  on  the  label.  
3. 	  What  name  should  be  used  as  the  statement  of  identity? 
Answer: The  name  established  by  law  or  regulation,  or  in  the  absence  thereof, 
the  common  or  usual  name  of  the  food,  if  the  food  has  one,  should  be  used  as 
the  statement  of  identity.  If  there  is  none,  then  an  appropriate  descriptive 
name,  that  is  not  misleading,  should  be  used.  Brand  names  are  not  considered 
to  be  statements  of  identity  and  should  not  be  unduly  prominent  campared  to 
21  CFR  101.3(b)  & (d)  STATEMENT  OF  IDENTITY 
the  statement  of  identity.  
4. 	  Where  should  the  statement  of  identity  be  placed  on  the  label? 
Answer:  
Place  the  statement  of  identity  on  the  PDP  in  lines  generally  parallel 
21  CFR  101.3(d) 
to  the  base  of  the  package.  
5.   When  are  fanciful  names  permitted  as  the  statement  of  identity? 
Answer: When  the  nature  of  the  food  is  obvious,  a  fanciful  name  commonly 
21  CFR  101.3(b)(3) 
used  and  understood  by  the  public  may  be  used.  
6.   Is  it  necessary  to  use  the  common  or  usual  name  instead  of  a  new  
name? 
Answer: The  common  or  usual  name  must  be  used  for  a  food  if  it  has  one.  It 
would  be  considered  misleading  to  label  a  food  that  has  an  established  name 
with  a  new  name.  If  the  food  is  subject  to  a  standard  of  identity  it  must  bear 
21  CFR  101.3(b)(2) 
the  name  specified  in  the  standard.  
7.   Should  modified  statements  of  identity  be  used  for  sliced  and  
unsliced  versions  of  a  food? 
Answer: Labels  must  describe  the  form  of  the  food  in  the  package  if  the  food 
is  sold  in  different  optional  forms  such  as  sliced  and  unsliced,  whole  or  halves, 
21  CFR  101.3(c) 
etc.  
8.   What  food  must  be  labeled  as  an  imitation? 
Answer: Generally  a  new  food  that  resembles  a  traditional  food  and  is  a 
substitute  for  the  traditional  food  must  be  labeled  as  an  imitation  if  the  new 
food  contains  less  protein  or  a  lesser  amount  of  any  essential  vitamin  or 
21  CFR  101.3(e) 
mineral.  
A  F O O D  L A B E L I N G  G U I D E   7  9. 	  What  type  size  and  degree  of  prominence  is  required  for  the  word  
imitation  in  the  product  name? 
Answer: Use  the  same  type  size  and  prominence  for  the  word  imitation  as  is 
21  CFR  101.3(e) 
used  for  the  name  of  the  product  imitated.  
10. 	  Are  there  restrictions  on  label  artwork? 
Answer: Do  not  use  artwork  that  hides  or  detracts  from  the  prominence  
and  visibility  of  required  label  statements  or  that  misrepresents  the  food.  
21  CFR  1.21(a)(1),  21  CFR  101.3(a),  21  CFR  101.105(h) 
11. 	  Where  should  the  country  of  origin  be  declared  on  an  imported  food? 
Answer: The  country  of  origin  statement  must  be  conspicuous.  If  a  domestic 
firm's  name  and  address  is  declared  as  the  firm  responsible  for  distributing  the 
product,  then  the  country  of  origin  statement  must  appear  in  close  proximity 
to  the  name  and  address  and  be  at  least  comparable  in  size  of  lettering. 
(FDA/CBP  (Customs  and  Border  Protection) 
Guidance  and  Customs 
19  CFR  134) 
regulation  
12.  Are  foreign  language  labels  permitted? 
Answer: If  a  foreign  language  is  used  anywhere  on  the  label,  all  required  label 
statements  must  appear  both  in  English  and  in  the  foreign  language.  
21  CFR  101.15(c)(2) 
Juices 
J1.  What  causes  a  juice  beverage  label  to  be  required  to  have  a  % 
juice  declaration? 
Answer: Beverages  that  purport  to  contain  juice  (fruit  or  vegetable  juice)  must 
declare  the  %  of  juice.  Included  are  beverages  that  purport  to  contain  juice  by 
way  of  label  statements,  by  pictures  of  fruits  or  vegetables  on  the  label,  or  by 
taste  and  appearance  causing  the  consumer  to  expect  juice  in  the  beverage. 
This  includes  non-carbonated  and  carbonated  beverages,  full-strength  (100%) 
juices,  concentrated  juices,  diluted  juices,  and  beverages  that  purport  to 
21  CFR  101.30(a) 
contain  juice  but  contain  no  juice.  
J2. 	  Where  and  how  is  %  juice  declared? 
Answer: The  %  juice  must  be  on  the  information  panel  (for  packages  with 
information  panels),  near  the  top.  Only  the  brand  name,  product  name,  logo, 
or  universal  product  code  may  be  placed  above  it.  Use  easily  legible  boldface 
print  or  type  that  distinctly  contrasts  with  the  other  printed  or  graphic 
material.  The  type  size  for  the  %  juice  declaration  must  be  not  less  than  the 
largest  type  on  the  information  panel,  except  that  used  for  the  brand  name, 
product  name,  logo,  universal  product  code,  or  the  title  phrase  Nutrition 
Facts.  The  percentage  juice  declaration  may  be  either  contains^^^^%  juice 
or  ^^^^%  juice.  The  name  of  the  fruit  or  vegetable  may  also  be  included 
(e.g.,  100%  Apple  Juice).  If  the  package  does  not  contain  an  information 
panel,  the  percent  juice  must  be  placed  on  the  PDP  in  a  type  size  not  less  than 
that  required  for  the  net  contents  declaration  and  placed  near  the  name  of  the 
food.  21  CFR  101.30(e);  21  CFR  101.30(g) 
8 G U I D A N C E  F O R  I N D U S T R Y  J3.  Are  there  any  exceptions  from  the  %  juice  requirement? 
Answer: 
An  exception  is  that  beverages  containing  minor  amounts  of  juice 
for  flavoring  are  not  required  to  bear  a  %  juice  declaration  provided  that:  (a) 
the  product  is  described  using  the  term  flavor  or  flavored,  (b)  the  term 
juice  is  not  used  other  than  in  the  ingredient  list,  and  (c)  the  beverages  do 
not  otherwise  give  the  impression  they  contain  juice  such  as  with  the  use  of 
explicit  vig nettes  on  the  label  or  physical  resemblance  of  the  beverage  to  juice 
such  as  pulp.  21  CFR  101.30(c) 
J4. 	  How  is  the  %  juice  calculated? 
Answer: For  juice  expressed  directly  from  fruit  or  vegetables:  Compute  on  a  
volume/volume  basis. 
For  juice  made  by  adding  water  to  concentrate:  Calculate  using  values  from  
21  CFR  101.30(h)(1) 
the  Brix  table  in   as  the  basis  for  100%  juice.  
21  CFR  101.30(j),  21  CFR  101.30(h) 
J5. 	  Should  my  product  be  labeled  as  a  drink  or  a  beverage? 
Answer: Beverages  that  are  100%  juice  may  be  called  juice.  However, 
beverages  that  are  diluted  to  less  than  100%  juice  must  have  the  word  juice 
qualified  with  a  term  such  as  beverage,  drink,  or  cocktail.  Alternatively, 
the  product  may  be  labeled  with  a  name  using  the  form  diluted  ^^^  juice, 
21  CFR  102.33(a) 
(e.g.  diluted  apple  juice).  
J6. 	  Is  it  necessary  to  use  the  term  concentrate  on  the  label? 
Answer: Juices  made  from  concentrate  must  be  labeled  with  terms  such  as 
from  concentrate,  or  reconstituted  as  part  of  the  name  wherever  it  appears 
on  the  label.  An  exception  is  that,  in  the  ingredient  statement,  the  juice  is 
declared  as  concentrated  ^^^^  juice  and  water  or  water  and  concentrated 
21  CFR  102.33(g) 
^^^^  juice,  as  appropriate.  
J7. 	  What  statement  of  identity  is  used  on  a  mixed  fruit  or  vegetable  juice  
beverage? 
Answer: When  stated,  names  of  juices  must  be  in  descending  order  of 
predominance  by  volume,  unless  the  label  indicates  that  the  named  juice  is 
used  as  a  flavor.  Examples: 
 Apple,  Pear  and  Raspberry  Juice  Drink 
 Raspberry-Flavored  Apple  and  Pear  Juice  Drink 
If  the  label  represents  one  or  more  but  not  all  the  juices  (except  in  the  ingredient 
list),  then  the  name  must  indicate  that  more  juices  are  present.  Examples: 
 Apple  Juice  Blend 
 Apple  Juice  in  a  Blend  of  Two  Other  Fruit  Juices 
When  one  or  more,  but  not  all,  juices  are  named  and  the  named  juice  is  not 
the  predominant  juice,  the  name  of  the  beverage  must  either  state  that  the 
beverage  is  flavored  with  the  named  juice  or  declare  the  amount  of  the  named 
juice  in  a  5%  range.  Examples  (for  a  raspcranberry  beverage  that  is  primarily 
white  grape  juice  with  raspberry  and  cranberry  juices  added): 
 Raspcranberry  Raspberry  and  Cranberry  flavored  Juice  Drink 
 Raspcranberry  Cranberry  and  Raspberry  Juice  Beverage 
 10-15%  Cranberry  Juice  and  3-8%  Raspberry  Juice 
21  CFR  102.33(b),  21  CFR  102.33(c),  21  CFR  102.33(d) 
A  F O O D  L A B E L I N G  G U I D E   9  J8.  What  type  sizes  must  be  used  in  naming  juices? 
Answer: 
The  term  from  concentrate  or  reconstituted  must  be  no  smaller  
than  one-half  the  height  of  the  letters  in  the  name  of  the  juice.  The  5%  range  
information  generally  should  be  not  less  than  one-half  the  height  of  the  largest 
type  appearing  in  the  common  or  usual  name  (may  not  be  less  than  1/16th 
inch  in  height  on  packages  with  5  sq.  in.  or  less  area  on  the  PDP,  and  not  less 
than  1/8  inch  in  height  on  packages  with  a  PDP  greater  than  5  sq.  in.).  
21  CFR  102.5(b)(2),  21  CFR  102.33(d),  21  CFR  102.33(g) 
J9.  When  does  a  beverage  purport  to  contain  a  fruit  or  vegetable  juice? 
Answer: 
Under  21  CFR  101.30(a),  a  beverage  purports  to  contain  fruit  or 
vegetable  juice  if  the  product's  advertising,  label,  or  labeling,  bears  the  name 
of,  or  makes  any  other  direct  or  indirect  representation  with  respect  to  any 
fruit  or  vegetable  juice,  or  the  label  or  labeling  bears  any  vignette  (i.e., 
depiction  of  a  fruit  or  vegetable)  or  another  pictorial  representation  of  any 
fruit  or  vegetable,  or  product  contains  color  and  f lavor  that  gives  the 
appearance  and  taste  of  a  fruit  or  vegetable  juice.  The  beverages  may  be 
carbonated  or  noncarbonated,  full  strength,  diluted,  or  contain  no  juice. 
J10. Are  bar  mixes  required  to  bear  percent  juice  declarations  under  21  
CFR  101.30? 
Answer: 
Bar  mixes  are  subject  to  the  same  requirements  as  other  beverage 
products.  Thus,  a  percent  juice  declaration  would  be  required  on  labels  of  bar 
mixes  that  meet  the  definition  set  out  in  21  CFR  101.30(a). 
J11. Is  a  whiskey  sour  mix  that  contains  lemon  juice  from  concentrate  as  the  
only  juice  component  and  a  number  of  juice  flavors  and  other  ingredients, 
and  that  makes  no  claim  or  bears  no  pictures  of  fruits/fruit  juices  on  the  
label  required  to  bear  a  percent  juice  declaration? 
Answer: 
No.  A  percent  juice  declaration  would  not  be  required  on  the 
whiskey  sour  mix  if  the  only  reference  to  the  lemon  juice  is  in  the  ingredient 
statement  and  no  pictures  of  fruits/fruit  juice  appear  on  the  label  or  in  its 
labeling. 
J12.  Would  a  strawberry  daiquiri  mix  have  to  bear  a  percent  juice  
declaration? 
Answer: 
A  strawberry  daiquiri  mix  would  purport  to  contain  strawberries  
or  strawberry  juice  because  the  term  strawberry  appears  in  the  identity 
statement.  Also,  there  is  no  indication  that  the  strawberry  is  present  only  as  
a  flavor  or  flavoring.  If  its  label  or  labeling  also  includes  pictures  of  the  juice 
dripping  from  strawberries  or  if  the  product  looks  and  tastes  like  it  contains 
strawberry  juice  or  strawberry  pulp,  the  product  would  have  to  bear  a 
declaration  of  the  percent  of  juice  or  the  absence  of  such  juice  on  the 
information  panel  of  the  label.  However,  if  the  product  were  labeled 
Strawberry  flavored  daiquiri  mix  and  did  not  otherwise  purport  to  
contain  strawberry  juice,  it  would  not  need  a  percent  juice  declaration. 
J13.  Must  bloody  mary  mix  bear  a  percent  juice  declaration? 
Answer: Bloody  mary  mix,  by  appearance  and  taste,  purports  to  contain 
tomato  juice  and  thus  would  be  required  to  bear  a  statement  as  to  the 
percentage  of  juice  contained  in  the  product. 
10 G U I D A N C E  F O R  I N D U S T R Y  J14. Would  a  beverage  that  is  made  by  reconstituting  a  blend  of  dehydrated  
fruits  or  vegetables  be  required  to  bear  a  percent  juice  declaration?  If  so,  
how  is  the  percentage  determined? 
Answer: 
The  declaration  is  required  if  the  product  purports  to  contain  juice. 
However,  because  FDA  has  not  established  specific  procedures  for  calculating 
the  percentage  of  juice  when  beverages  are  prepared  by  rehydrating  juice  solids, 
it  will  evaluate  labels  of  products  made  by  this  process  on  a  case  by  case  basis. 
Brix  values,  where  provided  in  21  CFR  101.30(h),  may  be  used  as  guidelines  in 
calculating  the  level  of  total  juice  solids  necessary  to  prepare  full  strength  juices, 
provided  the  beverage  does  not  contain  other  non-juice  ingredients. 
J15. Do  lemon  and  lime  juices,  used  for  mixed  drinks,  have  to  bear  a  percent  
juice  declaration? 
Answer: Yes.  The  percentage  juice  declaration  would  be  based  on  the  anhydrous 
citric  acid  content  of  the  lemon  juice  or  lime  juice,  listed  in  
21  CFR  101.30(h)(1). 
J16. Is  apple  cider  required  to  bear  a  percent  juice  declaration? 
Answer: Apple  cider  is  juice  that  is  expressed  from  apples  and  must  bear  a 
declaration  of  the  percent  of  juice. 
J17. Does  apple  cider  vinegar  have  to  bear  a  percent  juice  declaration? 
Answer: No.  Apple  cider  vinegar  does  not  purport  to  be  a  beverage  and  thus  is 
not  required  to  bear  a  percent  juice  declaration.  Although  the  product  is  made 
from  apple  juice,  it  is  not  considered  to  be  a  juice  beverage. 
J18. Must  concentrated  juices  bear  percent  declarations?  If  so  what  
percentage  is  to  be  declared? 
Answer: Concentrated  juice  products  must  bear  a  percentage  juice  declaration 
and  that  declaration  may  not  be  greater  than  100  percent.  The  label  may  explain 
that  when  the  product  is  diluted  according  to  label  directions,  the  product 
yields  a  ^^^percent  juice  from  concentrate,  with  the  blank  being  filled  in  with 
21  CFR 
the  correct  percentage  based  on  the  Brix  values  set  out  in  
101.30(h)(1), 
as  applicable. 
J19. Is  there  an  exemption  from  the  requirement  that  the  percent  juice  
declaration  be  on  the  information  panel  for  multiunit  packages  that  are  
packed  in  a  secure  shrink  wrap  and  are  not  for  sale  by  individual  unit,  and  
the  percentage  of  juice  is  declared  on  the  outer  shrink  wrap? 
Answer: No,  there  is  no  specific  exemption  from  the  requirement  that  the 
percent  juice  declaration  be  on  the  information  panel  of  individual  juice 
packages  packed  in  a  multi-unit  shrink  wrap  pack. 
J20. Must  the  entire  common  or  usual  name  of  a  juice  beverage  be  in  one  
place  and  in  a  single  type  size?  Some  juice  beverages  will  have  very  
complex  common  or  usual  names,  like  cranberryraspberry  flavored  
juice  drink  in  a  blend  of  three  other  juices  from  concentrate. 
Answer: The  entire  common  or  usual  name  must  be  in  one  place.  If  some  or  all 
of  the  juices  listed  in  the  name  are  from  concentrate,  the  term  from 
concentrate  must  follow  the  names  and  may  be  in  a  smaller  type  size,  but  not 
less  than  one  half  the  height  of  the  letters  in  the  other  part  of  the  common  or 
usual  name. 
21  CFR  102.33 
A  F O O D  L A B E L I N G  G U I D E   11  J 21 . R e ga  r d in  g    vi g  n  e   t te   s  on    ju  i c e    la  b  e   ls  ,  d o  t h e  pi c t  ur e s  h av e    to    be   
proportional  to  the  fruits  in  the  juice?  Does  any  fruit  that  is  present  at  
a  level  of  less  than  2  percent  by  volume  have  to  be  depicted  in  the  
vignette? 
Answer: FDA  has  not  established  specific  requirements  for  vignettes  on  labels 
of  juice  beverages.  FDA  urges  manufacturers  to  use  vignettes  that  accurately 
depict  each  fruit  or  vegetable  contained  in  the  multiple  juice  products. 
However,  a  vignette  depicting  only  some  of  the  fruits  or  vegetables  may  not  be 
considered  misleading,  if  the  name  of  the  food  adequately  and  appropriately 
describes  the  contribution  of  the  pictured  juice.  For  example,  a  100  percent 
juice  consisting  of  apple,  grape  and  raspberry  juices,  in  which  raspberry  juice 
provides  the  characterizing  flavor,  and  bears  a  vignette  that  only  depicts 
raspberries,  would  not  necessarily  be  misleading  if  the  identity  statement  were 
raspberry  juice  blended  with  apple  and  grape  juices.  Alternatively,  the 
statement  of  identity  may  be  raspberry  f lavored  fruit  juice  blend  or 
raspberry  juice  in  a  blend  of  two  other  juices,  3  to  8  percent  raspberry  juice 
(58  FR  2897  at  2921). 
J22. Do  I  make  any  adjustments  to  the  analytical  Brix  value  in  declaring  the  
percentage  of  juice  when  tomato  juice  contains  added  salt  or  other  dry  
ingredients  (e.g.,  spices)? 
Answer: 
Yes.  The  soluble  solids  content  for  tomato  juice  must  be  determined 
before  addition  of  any  spices.  The  soluble  solids  for  tomato  juice,  determined 
by  refractometer,  should  be  corrected  for  salt  content  as  prescribed  in  21  CFR 
156.3(b)  and  (c). 
J23. I  have  a  100%  juice  drink  and  add  a  non  juice  ingredient.  May  I  still  call  it  
100%  juice? 
Answer: If  the  added  ingredient  does  not  dilute  the  juice  or,  for  an  expressed 
juice,  change  its  volume,  you  may  continue  to  call  it  100%  juice  but  the 
percent  juice  statement  must  identify  the  added  ingredient,  e.g.,  100%  juice 
21  CFR  101.30(b)(3)  and  101.54(e) 
with  added  preservative.  
J24. What  if  the  added  substance  is  also  a  nutrient  such  as  Vitamin  C  
(ascorbic  acid)? 
Answer: 
If  ascorbic  acid  is  added  at  levels  consistent  with  fortification  of  the 
juice,  a  declaration  as  part  of  the  percent  juice  statement  would  constitute  a 
nutrient  content  claim  which  would  trigger  compliance  with  more  claims 
including  the  required  accompanying  information.  If  it  were  added  at  the  level 
used  as  a  preservative,  then  a  statement  such  as  100%  juice  with  preservative 
could  be  used.  In  this  case  it  would  be  listed  in  the  ingredient  statement  as  a 
preservative  in  accordance  with  101.22(j). 
J25. Do  I  have  to  say  fruit  punch  from  concentrate  or  lemonade  from  
concentrate? 
Answer: 
No.  Section  102.33(g)  states  that  if  one  or  more  of  the  juices  in  a 
juice  beverage  is  made  from  concentrate,  then  the  name  of  the  juice  must 
include  the  term  from  concentrate  or  reconstituted.  Because  the  names 
fruit  punch  and  lemonade  do  not  include  the  name  of  a  specific  juice, 
these  names  do  not  have  to  contain  the  term  from  concentrate  or 
reconstituted. 
12 G U I D A N C E  F O R  I N D U S T R Y  J26. Is  the  declaration  on  a  lemonade  made  in  terms  of  the  lemon  juice  only,  
exclusive  of  sugar? 
Answer: 
Yes,  before  adding  sugar. 
J27. We  have  a  juice  product  for  food  service  only,  and  we  are  exempt  from  
nutrition  labeling  for  this  product  (we  know  that  is  never  goes  to  club  
stores).  Are  we  also  exempt  from  percent  juice  declarations? 
Answer: 
No.  There  are  no  exemptions  from  the  requirement  for  label 
declaration  of  the  percentage  of  juice  on  food  service  containers  of  juices. 
J28. Is  the  common  or  usual  name  regulation  in  21  CFR  102.33  applicable  to  
100  percent  juices  or  only  to  diluted  juices? 
Answer: 
The  regulation  is  applicable  to  both. 
J29. We  have  very  small  labels,  about  7  square  inches.  How  do  you  name  a  
citrus  punch  which  contains  five  juices  in  which  three  are  from  
concentrate and  two  are  expressed  juices,  and  the  expressed  juices  are 
not  citrus  juices  nor  do  their  flavors  characterize  the  beverage?  Also,  
what  if  one  of  the  citrus  juices  is  an  expressed  juice  and  is  present  only  
in  a  minor  amount,  must  it  be  identified  by  name? 
Answer: 
There  are  several  alternatives.  In  the  first  case,  the  common  or  usual 
name  may  be  a  blend  of  3  citrus  juices  from  concentrate  with  ^^^^^^  and 
^^^^  juices,  the  blanks  filled  in  with  names  of  the  expressed  juices.  In  the 
second  case,  the  citrus  juice  that  is  not  from  concentrate  should  be  listed  as  in 
the  example  given  above  in  order  of  predominance,  i.e.,  a  blend  of  2  citrus 
juices  from  concentrate  with  ^^^^^,  ^^^^^^,  and  ^^^^^^  juices,  with  the 
third  citrus  juice  listed  in  one  of  the  blanks,  along  with  the  other  expressed 
juices.  Alternatively,  a  name  such  as  citrus  punch  or  citrus  flavored  punch 
may  be  used  as  the  statement  of  identity  without  further  identification  of  the 
component  juices. 
J30. Is  it  necessary  to  state  that  juices  are  from  concentrate  when  they  are  
contained  in  a  beverage  such  as  punch? 
Answer: Yes,  sometimes.  If  the  juices  are  specifically  named  in  the  statement 
of  identity,  and  the  juices  are  from  concentrate,  their  names  must  be  followed 
21  CFR  102.33(g). 
by  the  term  from  concentrate  in  accordance  with   If  no 
reference  is  made  to  specific  juices  in  the  name  of  a  punch  that  is  made  from 
concentrated  juices,  the  statement  of  identity  does  not  have  to  include  the 
term  from  concentrate.  However,  each  of  the  concentrated  juices  used  in  the 
punch  must  be  declared  in  order  of  predominance  in  the  ingredient  statement 
of  the  label. 
J31. Does  a  punch  have  to  be  made  from  fruit  juice? 
Answer: No.  FDA  does  not  have  a  specific  definition  or  standard  of  identity 
for  punch,  or  any  other  requirement  that  a  punch  contain  fruit  juice.  A  punch 
may  be  an  artificially  f lavored  beverage,  with  or  without  natural  flavorings,  or 
it  may  be  made  from  tea  and  other  ingredients,  exclusive  of  fruit  juice.  Such 
products  must  be  clearly  distinguished  from  products  which  are  made  from 
fruit  juices  or  fruit  concentrates  or  purees.  Products  containing  artificial  or 
natural  flavors  must  be  labeled  in  accordance  with  21  CFR  101.22. 
J32. In  the  case  of  a  vegetable  juice  cocktail  that  is  100  percent  juice,  can  the  
name  include  the  term  cocktail? 
Answer: Yes. 
A  F O O D  L A B E L I N G  G U I D E   13  N Q O C S
5.  ET  UANTITY  F  ONTENTS  TATEMENTS 
1.   What  is  the  net  quantity  of  contents  and  how  is  it  expressed? 
Answer: The  net  quantity  of  contents  (net  quantity  statement)  is  the  statement 
on  the  label  which  provides  the  amount  of  food  in  the  container  or  package.  It 
must  be  expressed  in  weight,  measure  or  numeric  count.  Generally,  if  the  food 
is  solid,  semisolid  or  viscous,  it  should  be  expressed  in  terms  of  weight.  If  the 
food  is  a  liquid  it  should  be  expressed  in  fluid  measure  (e.g.,  fl  oz).  
21  CFR  101.105(a)(b)(c) 
2.   Where  is  the  net  quantity  of  contents  statement  placed  on  the  label? 
Answer: The  net  quantity  statement  (net  quantity  of  contents)  is  placed  as  a  
distinct  item  in  the  bottom  30  percent  of  the  principal  display  panel,  in  lines  
generally  parallel  with  the  base  of  the  container.  21  CFR  101.105(e); 
21  CFR  101.105(f) 
3.   Should  the  net  quantity  of  contents  be  stated  in  both  grams  and  ounces? 
NET  QUAMNETNITTY   STATE Answer: Food  labels  printed  must  show  the  net  contents  in  both  metric 
(grams,  kilograms,  milliliters,  liters)  and  U.S.  Customary  System  (ounces, 
pounds,  f luid  ounces)  terms.  The  metric  statement  may  be  placed  either 
before  or  after  the  U.  S.  Customary  statement,  or  above  or  below  it.  Each  of 
the  following  examples  is  correct  (additional  examples  appear  in  the 
regulations): 
 Net  wt  1  lb  8  oz  (680g) 
 Net  wt  1  lb  8  oz  680  g 
 500  ml  (1  pt  0.9  fl  oz) 
 Net  contents  1  gal  (3.79  L) 
21  CFR  101.105 
P.L.  102-329,  August  3,  1992;  
4.   Why  is  it  necessary  to  calculate  the  area  of  the  PDP? 
Answer: The  area  of  the  PDP  (calculated  in  square  inches  or  square 
centimeters)  determines  the  minimum  type  size  that  is  permitted  for  the  net 
quantity  statement  (see  next  question). 
Calculate  the  area  of  the  PDP  as  follows.  The  area  of  a  rectangular  or  square  
PDP  on  a  carton  is  the  height  multiplied  by  the  width  (both  in  inches  or  both 
in  centimeters). 
To  calculate  the  area  of  the  PDP  for  a  cylindrical  container,  use  40%  of  the 
product  of  the  height  by  the  circumference.  21  CFR  101.1 
5.   What  is  the  minimum  type  size? 
Answer: For  the  net  quantity  statements,  the  minimum  type  size  is  the 
smallest  type  size  that  is  permitted  based  on  the  space  available  for  labeling  on 
10"  X  2"  =  20  SQ.  IN. 
the  PDP.  Determine  the  height  of  the  type  by  measuring  the  height  of  the 
AREA  OF  PDP  =  20  SQ.  IN.  X  40% 
lower  case  letter  "o"  or  its  equivalent  when  mixed  upper  and  lower  case  letters 
=  8  SQ.  IN. 
are  used,  or  the  height  of  the  upper  case  letters  when  only  upper  case  letters 
are  used. 
14 G U I D A N C E  F O R  I N D U S T R Y  Minimum  Type  Size  Area  of  Principal  Display  Panel 
1/16  in.  (1.6  mm)  5  sq.  in.  (32  sq.  cm.)  or  less 
1/8  in.  (3.2  mm)  More  than  5  sq.  in.  (32  sq.  cm.)  but  not  more  than  
25  sq.  in.  (161  sq.  cm.) 
3/16  in.  (4.8  mm)  More  than  25  sq.  in.  (161  sq.  cm.)  but  not  more  than 
100  sq.  in.  (645  sq.  cm.) 
1/4  in.  (6.4  mm)  More  than  100  sq.  in.  (645  sq.  cm.)  but  not  more  than 
400  sq.  in.  (2580  sq.  cm.) 
1/2  in.  (12.7  mm)  Over  400  sq.  in.  (2580  sq.  cm.) 
21  CFR  101.105(h)  and  (i) 
6. 	  What  are  the  conspicuousness  and  prominence  requirements  for  net  
quantity  statements? 
Answer: Choose  a  print  style  that  is  prominent,  conspicuous  and  easy  to  read. 
NET  QUANTITY  STATEMENT 
The  letters  must  not  be  more  than  three  times  as  high  as  they  are  wide,  and 
lettering  must  contrast  sufficiently  with  the  background  to  be  easy  to  read.  Do 
not  crowd  the  net  quantity  statement  with  artwork  or  other  labeling 
(minimum  separation  requirements  are  specified  in  the  regulation).  21  CFR 
101.105  and  101.15 
7. 	  What  is  included  in  the  net  quantity  of  contents  statement? 
Answer: Only  the  quantity  of  food  in  the  container  or  package  is  stated  in  the 
net  quantity  statement.  Do  not  include  the  weight  of  the  container,  or 
wrappers  and  packing  materials.  To  determine  the  net  weight,  subtract  the 
average  weight  of  the  empty  container,  lid  and  any  wrappers  and  packing 
materials  from  the  average  weight  of  the  container  when  filled  with  food. 
Filled  container  weighs  18  oz. 
Empty  container  weighs  2  oz. 
	
Wrapper  weighs 1  oz. 
Net  Weight	  15  oz.  (425  g) 
21  CFR  101.105(g) 
8. 	  Is  water  or  other  packing  medium  included  in  determining  the  net  
quantity  of  contents  in  a  food  container? 
Answer: The  water  or  other  liquid  added  to  food  in  a  container  is  usually 
included  in  the  net  quantity  declared  on  a  label. 


Beans  weigh  9  oz.


Water  weighs  4  oz.


Sugar  weighs  1  oz.
Net  Weight	  14  oz.  (396  g) 
In  some  cases  where  the  packing  medium  is  normally  discarded,  the  drained 
weight  is  given  (e.g.,  olives  and  mushrooms). 
21  CFR  101.105(a) 
A  F O O D  L A B E L I N G  G U I D E   15  9. 	  What  is  the  net  quantity  of  contents  for  a  pressurized  can? 
Answer: The  net  quantity  is  the  weight  or  volume  of  the  product  that  will  be 
delivered  from  the  pressurized  container  together  with  the  weight  or  volume  of 
the  propellant. 
	
Whipped  cream 11.95  oz. 
	
Propellant .05  oz. 
Net  Weight	  12  oz.  (340  g) 
21  CFR  101.105(g) 
10.	   What  is  the  policy  on  using  qualifying  phrases  in  net  quantity  
statements? 
Answer: Do  not  use  qualifying  phrases  or  terms  that  exaggerate  the  amount  of 
21  CFR  101.105(o) 
food.  
16 G U I D A N C E  F O R  I N D U S T R Y  I L
6.  NGREDIENT  ISTS 
1.	  What is the ingredient list? 
Answer: The ingredient list on a food label is the listing of each ingredient in 
descending order of predominance. 
INGREDIENTS: Pinto Beans, Water, and Salt 
21 CFR 101.4(a) 
2.	  What is meant by the requirement to list ingredients in descending 
order of predominance by weight? 
Answer: Listing ingredients in descending order of predominance by weight 
means that the ingredient that weighs the most is listed first, and the 
ingredient that weighs the least is listed last (see illustration for question 3 
21 CFR 101.4(a) 
below). 
3.	  Where is the ingredient list placed on the label? 
Answer: The ingredient list is placed on the same label panel as the name and 
address of the manufacturer, packer or distributor. This may be either the 
information panel or the PDP. It may be before or after the nutrition label and 
the name and address of the manufacturer, packer or distributor. 
21 CFR 101.4 
See also section 3, question 7 of this guidance for information on intervening 
material on the information panel. 
4. What type size is required for ingredient lists? 
Answer: Use a type size that is at least 1/16 inch in height (based on the lower 
case o) and that is prominent, conspicuous, and easy to read. See the type 
size, prominence, and clarity requirements for information panel labeling 
21 CFR 101.2(c) 
discussed in section 3, question 6 of this guidance. 
5. Should water be listed as an ingredient? 
Answer: Water added in making a food is considered to be an ingredient. The 
added water must be identified in the list of ingredients and listed in its 
descending order of predominance by weight. If all water added during 
processing is subsequently removed by baking or some other means during 
processing, water need not be declared as an ingredient. 
INGREDIENTS: Water, Navy Beans, and Salt 
21 CFR 101.4(a); 21 CFR 101.4(c); Compliance Policy Guide 555.875 
6. Should the common or usual name always be used for ingredients? 
Answer: Always list the common or usual name for ingredients unless there is 
a regulation that provides for a different term. For instance, use the term 
sugar instead of the scientific name sucrose. 
INGREDIENTS: Apples, Sugar, Water, and Spices 
21 CFR 101.4(a) 
See also section 4 question 3. 
A  F O O D  L A B E L I N G  G U I D E  17  7.   Is  it  necessary  to  declare  ingredients  in  trace,  i.e.,  incidental  amounts? 
Can  sulfites  be  considered  incidental  additives? 
Answer: FDA  does  not  define  trace  amounts,  however,  there  are  some 
exemptions  for  declaring  ingredients  present  in  incidental  amounts  in  a  finished 
food.  If  an  ingredient  is  present  at  an  incidental  level  and  has  no  functional  or 
technical  effect  in  the  finished  product,  then  it  need  not  be  declared  on  the  label. 
An  incidental  additive  is  usually  present  because  it  is  an  ingredient  of  another 
ingredient.  Note  that  major  food  allergens  (as  discussed  on  pages  20-24),  regardless 
of  whether  they  are  present  in  the  food  in  trace  amounts,  must  be  declared. 
Sulfites  added  to  any  food  or  to  any  ingredient  in  any  food  and  that  has  no 
technical  effect  in  that  food  are  considered  to  be  incidental  only  if  present  at 
21  CFR  101.100(a)(3)  &  (4) 
less  than  10  ppm.  
8. 	  What  foods  may  list  alternative  fat  and  oil  ingredients? 
Answer: Listing  alternative  fat  and  oil  ingredients  (and/or  labeling)  in 
parentheses  following  the  declaration  of  fat  and  oil  blends  is  permitted  only  in  the 
case  of  foods  in  which  added  fats  or  oils  are  not  the  predominant  ingredient  and 
only  if  the  manufacturer  is  unable  to  predict  which  fat  or  oil  ingredient  will  be  used. 
INGREDIENTS:  .  .  .  Vegetable  Oil  (contains  one  or  more  of  the  
following:  Corn  Oil,  Soybean  Oil,  or  Safflower  Oil)  .  .  .  . 
21  CFR  101.4(b)(14) 
9. 	  What  ingredient  listing  is  necessary  for  chemical  preservatives? 
Answer: When  an  approved  chemical  preservative  is  added  to  a  food,  the 
ingredient  list  must  include  both  the  common  or  usual  name  of  the 
preservative  and  the  function  of  the  preservative  by  including  terms,  such  as 
preservative,  to  retard  spoilage,  a  mold  inhibitor,  to  help  protect 
flavor,  or  to  promote  color  retention. 
INGREDIENTS:  Dried  Bananas,  Sugar,  Salt,  and  Ascorbic  Acid  to  
Promote  Color  Retention 
21  CFR  101.22(j) 
10. 	  How  are  spices,  natural  flavors  or  artificial  flavors  declared  in  
ingredient  lists? 
Answer: These  may  be  declared  in  ingredient  lists  by  using  either  specific 
common  or  usual  names  or  by  using  the  declarations  spices,  flavor  or 
natural  flavor,  or  artificial  flavor. 
INGREDIENTS:  Apple  Slices,  Water,  Cane  Syrup,  Corn  Syrup,  Modified 
Corn  Starch,  Spices,  Salt,  Natural  Flavor  and  Artificial  Flavor 
However,  products  that  are  spices  or  spice  blends,  flavors  or  colors  must  list 
FD&C  Act  403(i)(2)  and 21  CFR  101.22(h)(1) 
each  ingredient  by  name.  
11. 	  If  fruit  is  canned  in  juice  from  concentrate,  does  the  water  used  to  
reconstitute  the  juice  have  to  be  declared? 
Answer: Yes.  The  reconstituted  juice  in  which  the  fruit  is  canned  is  prepared 
from  juice  concentrate  and  water,  thus  both  ingredients  have  to  be  declared.  
21  CFR  101.4(a) 
12. 	  Can  juice  concentrates  be  grouped  in  the  ingredient  statement  
(e.g.,  Fruit  Juice  Concentrates  (grape,  apple,  cherry)? 
Answer: No.  Fruit  juice  concentrates  is  not  established  as  a  common  or 
usual  name,  nor  is  it  established  as  an  appropriate  collective  name  for  a  variety 
of  different  concentrated  fruit  juices. 
18 G U I D A N C E  F O R  I N D U S T R Y  13. 	  When  do  you  declare  water  as  an  ingredient  in  tomato  concentrate? 
Answer: Water  that  is  added  to  adjust  the  Brix  level  of  the  standardized  food 
within  the  permitted  range  of  soluble  solids  (e.g.,  water  used  to  adjust  a  Brix  
of  28  to  24  in  tomato  paste,  or  to  adjust  a  Brix  of  16  to  10  in  tomato  puree) 
does  not  have  to  be  declared.  However,  water  added  to  tomato  paste  (Brix  of  24  ) 
to  make  a  product  with  a  Brix  of  16  (tomato  puree)  would  have  to  be  declared. 
21  CFR  155.191(a)(3)(iv) 
14. 	  Can  tomato  paste,  tomato  puree,  and  tomato  concentrate  be  used  
interchangeably  in  the  ingredient  statement? 
Answer: Tomato  paste  and  tomato  puree  are  different  foods  based  on  the 
amount  of  soluble  solids  present  in  the  product,  and  thus,  the  names  can  not 
be  used  interchangeably  in  the  ingredient  statement.  However,  the  term 
tomato  concentrate  may  be  used  in  lieu  of  tomato  paste,  tomato  pulp,  or 
tomato  puree  when  the  concentrate  complies  with  the  requirements  of  such 
foods  and  the  statement  for  remanufacturing  purposes  only  appears  on  the 
label  of  packages  equal  to  or  less  than  3.1  kilograms  or  109  oz.  Further,  tomato 
concentrate  may  be  used  in  lieu  of  tomato  paste,  tomato  pulp,  or  tomato 
21  CFR  155.191(a)(3)(i),  21  CFR 
puree  in  the  ingredient  labeling  of  catsup.  
155.194(a)(3)(ii)(b) 
15. 	  How  do  you  declare  the  ingredients  in  a  food  when  the  food  itself  is 
made  from  other  foods  containing  multiple  ingredients? 
Answer: The  sub  ingredients  of  a  food  that  is  an  ingredient  in  another  food 
may  be  declared  parenthetically  following  the  name  of  the  ingredient  or  may 
be  declared  by  dispersing  each  ingredient  in  its  order  of  predominance  in  the 
21  CFR 
ingredient  statement  without  naming  the  original  ingredient.  
101.4(b)(2) 
16. 	  Do  you  have  to  parenthetically  declare  all  of  the  ingredients  in  flavors  
that  conform  to  a  standard  of  identity? 
Answer: If  the  flavor  is  declared  by  the  standardized  name  (eg.  vanilla  extract), 
each  ingredient  must  also  be  declared  parenthetically  following  the  standardized 
name.  However,  the  standardized  flavor  may  simply  be  declared  as  f lavoring, 
21  CFR  101.22(i)  and  21 
natural  flavoring,  artificial  flavoring,  as  appropriate.  
CFR  169 
17.	   How  do  you  declare  protein  hydrolysates  that  are  made  of  blends  
of  proteins? 
Answer: For  proteins  that  are  blended  prior  to  being  hydrolyzed  an  appropriate 
name  for  the  hydrolyzed  protein  product  must  be  sufficiently  descriptive  of  the 
protein  product  and  must  include  all  of  the  various  proteins  that  were  used  to 
make  the  hydrolyzed  protein.  For  example  a  hydrolyzed  protein  made  from  a 
blend  of  corn  and  soy  protein  would  be  hydrolyzed  corn  and  soy  protein. 
However,  if  the  proteins  are  hydrolyzed  prior  to  blending,  then  the  common 
or  usual  name  must  be  specific  to  each  individual  hydrolyzed  protein  (e.g., 
hydrolyzed  corn  protein  and  hydrolyzed  soy  protein),  and  the  ingredients 
must  be  declared  in  their  order  of  predominance.  In  addition,  any  other 
ingredients  that  are  blended  with  the  hydrolyzed  protein  products  must  also  be 
declared  by  their  common  or  usual  names  in  the  ingredient  statement  in  order 
21  CFR  101.22(h)(7) 
of  predominance.  
A  F O O D  L A B E L I N G  G U I D E   19  Colors 
C1. 	  What  ingredient  listing  is  used  for  vegetable  powder? 
Answer: Vegetable  powders  must  be  declared  by  common  or  usual  name,  such 
21  CFR  101.22(h)(3) 
as  celery  powder.  
C2. 	  What  listing  is  used  for  a  spice  that  is  also  a  coloring? 
Answer: Spices,  such  as  paprika,  turmeric,  saffron  and  others  that  are  also 
colorings  must  be  declared  either  by  the  term  spice  and  coloring  or  by  the 
21  CFR  101.22(a)(2) 
actual  (common  or  usual)  names,  such  as  paprika.  
C3. 	  What  ingredient  listing  is  used  for  artificial  colors? 
Answer: It  depends  on  whether  the  artificial  color  is  a  certified  color: 
Certified  colors: 
List  by  specific  or  abbreviated  name  such  as  FD&C  Red  No. 
40  or  Red  40. 
Noncertified  colors: 
List  as  artificial  color,  artificial  coloring,  or  by  their 
specific  common  or  usual  names  such  as  caramel  coloring  and  colored  with 
beet  juice. 
21  CFR  101.22(k)(1)  and  (2),  21  CFR  74 
C4. 	  Do  certified  color  additive  lakes  have  to  be  declared  separately  from  the  
certified  color  in  the  ingredient  statement? 
Answer: Yes.  Certified  color  additives  and  their  lakes  are  separate  ingredients 
21  CFR 
and,  thus,  must  be  declared  separately  in  the  ingredient  statement.  
101.22  (k)(1) 
Food  Allergen  Labeling 
General  Information 
F1. 	  What  is  the  Food  Allergen  Labeling  and  Consumer  Protection  Act  of  
2004? 
Answer: The  Food  Allergen  Labeling  and  Consumer  Protection  Act  of  2004 
(FALCPA)  (or  Title  II  of  Public  Law  108-282)  is  a  law  that  was  enacted  in  August 
2004.  Among  other  issues,  FALCPA  addresses  the  labeling  of  all  packaged 
foods  regulated  by  the  FDA.  We  recommend  that  producers  of  meat  products, 
poultry  products,  and  egg  products,  which  are  regulated  by  the  U.S.  Department 
of  Agriculture  (USDA),  contact  appropriate  USDA  agency  staff  regarding  the 
labeling  of  such  products.  Also  see  Information  about  Food  Allergens  for  more 
information  about  the  agency's  food  allergen  activities  and  related  guidance 
documents  that  address  additional  FALCPA  questions  and  answers. 
http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/default.htm 
F2. 	  What  is  a  major  food  allergen? 
Answer:  Under  FALCPA,  a  major  food  allergen  is  an  ingredient  that  is  one 
of  the  following  eight  foods  or  food  groups  or  an  ingredient  that  contains 
protein  derived  from  one  of  them: 
a.  milk 
b.  egg 
c.  fish 
d.  Crustacean  shellfish 
20 G U I D A N C E  F O R  I N D U S T R Y  e.  tree  nuts 
f.  wheat 
g.  peanuts 
h.  soybeans 
Although  more  than  160  foods  have  been  identified  to  cause  food  allergies  in 
sensitive  individuals,  the  major  food  allergens  account  for  90  percent  of  all 
food  allergies.  Allergens  other  than  the  major  food  allergens  are  not  subject  to 
FALCPA  labeling  requirements. 
F3. 	  When  did  the  labeling  requirements  of  the  FALCPA  become  effective  for  
packaged  foods  sold  in  the  United  States? 
Answer: All  packaged  foods  regulated  by  FDA  under  the  FD&C  Act  that  are 
labeled  on  or  after  January  1,  2006,  must  comply  with  FALCPA's  food  allergen 
labeling  requirements. 
F4. 	  Are  flavors,  colors,  and  incidental  additives  subject  to  FALCPA  labeling  
requirements? 
Answer: Yes.  FALCPA  labeling  requirements  apply  to  foods  that  are  made 
with  any  ingredient,  including  flavorings,  colorings,  or  incidental  additives 
(e.g.,  processing  aids),  that  is  or  contains  a  major  food  allergen. 
F5. 	  Do  retail  and  foodservice  establishments  have  to  comply  with  FALCPA's  
labeling  requirements? 
Answer: FALCPA's  labeling  requirements  extend  to  foods  packaged  by  a  retail 
or  foodservice  establishment  that  are  offered  for  human  consumption. 
However,  FALCPA's  labeling  requirements  do  not  apply  to  foods  provided  by  a 
retail  food  establishment  that  are  placed  in  a  wrapper  or  container  in  response 
to  a  consumer's  order  - such  as  the  paper  or  box  used  to  convey  a  sandwich 
that  has  been  prepared  in  response  to  a  consumer's  order. 
Foods  Not  Subject  To  FALCPA 
F6. 	  Are  there  any  foods  exempt  from  FALCPA  labeling  requirements? 
Answer: Yes.  Under  FALCPA,  raw  agricultural  commodities  (generally  fresh 
fruits  and  vegetables)  are  exempt  as  are  highly  refined  oils  derived  from  one  of 
the  eight  major  food  allergens  and  any  ingredient  derived  from  such  highly 
refined  oil.  In  addition,  FALCPA  provides  mechanisms  by  which  a 
manufacturer  may  request  that  a  food  ingredient  may  be  exempt  from 
FALCPA's  labeling  requirements.  See  FALCPA  Section  203  for  details  on  how 
to  request  allergen  labeling  exemptions. 
http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/Guidance 
ComplianceRegulatoryInformation/ucm106187.htm 
F7. 	  Are  molluscan  shellfish  considered  a  major  food  allergen  under 
FALCPA? 
Answer: No.  Under  FALCPA,  molluscan  shellfish  (e.g.,  such  as  oysters,  clams, 
mussels,  or  scallops)  are  not  major  food  allergens.  However,  Crustacean 
shellfish  (e.g.,  crab,  lobster,  or  shrimp),  and  ingredients  that  contain  protein 
derived  from  Crustacean  shellfish,  are  major  food  allergens. 
A  F O O D  L A B E L I N G  G U I D E   21  Major  Food  Allergens  (food  source  names  and  examples) 
F8. 	  Does  FALCPA  provide  any  specific  direction  for  declaring  the  presence  
of  ingredients  from  the  three  food  groups  that  are  designated  as  major  
food  allergens  (i.e.,  tree  nuts,  fish,  and  Crustacean  shellfish)? 
Answer: Yes.  FALCPA  requires  that  in  the  case  of  tree  nuts,  the  specific  type  of 
nut  must  be  declared  (e.g.,  almonds,  pecans,  or  walnuts).  The  species  must  be 
declared  for  fish  (e.g.,  bass,  flounder,  or  cod)  and  Crustacean  shellfish  (crab, 
lobster,  or  shrimp). 
F9. 	  Under  section  403(w)(1)  of  the  FD&C  Act,  a  major  food  allergen  must  be  
declared  using  the  name  of  the  food  source  from  which  the  major  food  
allergen  is  derived.  Section  403(w)(2)  of  the  FD&C  Act  provides  that,  in  
the  case  of  fish  or  Crustacean  shellfish,  the  term  name  of  the  food  
source  from  which  the  major  food  allergen  is  derived  means  the  
species  of  fish  or  Crustacean  shellfish.  What  is  the  species  of  fish  
or  Crustacean  shellfish  for  purposes  of  section  403(w)(2)? 
Answer: A  declaration  of  the  species  of  fish  or  Crustacean  shellfish  for 
purposes  of  complying  with  Section  403(w)(2)  should  be  made  using  the 
acceptable  market  name  provided  in  FDA's  The  Seafood  List.  The  Seafood  List 
is  a  compilation  of  existing  acceptable  market  names  for  imported  and 
domestically  available  seafood.  We  note,  however,  that  if  a  Contains 
statement  is  used  to  declare  the  source  of  the  fish  or  Crustacean  shellfish,  we 
would  not  object  to  just  the  type  of  fish  or  Crustacean  shellfish  being  used, 
e.g.,  Contains  salmon  or  Contains  trout. 
F10. Section  201(qq)  of  the  FD&C  Act  defines  the  term  major  food  allergen  
to  include  tree  nuts.  In  addition  to  the  three  examples  provided  in  
section  201(qq)  (almonds,  pecans,  and  walnuts),  what  nuts  are  
considered  tree  nuts? 
Answer: The  following  are  considered  tree  nuts  for  purposes  of  section 
201(qq).  The  name  listed  as  common  or  usual  name  should  be  used  to 
declare  the  specific  type  of  nut  as  required  by  section  403(w)(2). 
Common  or  usual  name  Scientific  name 
Almond  Prunus  dulcis  (Rosaceae) 
Beech  nut  Fagus  spp.  (Fagaceae) 
Brazil  nut  Bertholletia  excelsa  (Lecythidaceae) 
Butternut  Juglans  cinerea  (Juglandaceae) 
Cashew  Anacardium  occidentale  (Anacardiaceae) 
Chestnut  (Chinese,  American,  
European,  Seguin)  Castanea  spp.  (Fagaceae) 
Chinquapin  Castanea  pumila  (Fagaceae) 
Coconut  Cocos  nucifera  L.  (Arecaceae  (alt.  Palmae) 
Filbert/hazelnut  Corylus  spp.  (Betulaceae) 
Ginko  nut  Ginkgo  biloba  L.  (Ginkgoaceae) 
Hickory  nut  Carya  spp.  (Juglandaceae) 
Lichee  nut  Litchi  chinensis  Sonn.  (Sapindaceae) 
Macadamia  nut/Bush  nut  Macadamia  spp.  (Proteaceae) 
Pecan  Carya  illinoensis  (Juglandaceae) 
22 G U I D A N C E  F O R  I N D U S T R Y  Pine  nut/Pinon  nut  Pinus  spp.  (Pineaceae) 
Pistachio  Pistacia  vera  L.  (Anacardiaceae) 
Sheanut   Vitellaria  paradoxa  C.F.  Gaertn.  (Sapotaceae) 
Walnut  (English,  Persian,  Black,  
Japanese,  California),  Heartnut  Juglans  spp.  (Juglandaceae) 
The  foregoing  list  reflects  FDA's  current  best  judgment  as  to  those  nuts  that 
are  tree  nuts  within  the  meaning  of  Section  201(qq).  In  order  to  be 
comprehensive,  this  list  employs  broad  scientific  categories  that  may  include  a 
species  that  currently  has  no  food  use.  The  fact  that  a  species  falls  within  a 
scientific  category  on  this  list  does  not  mean  that  the  species  is  appropriate  for 
food  use.  FDA  further  advises  that,  as  with  any  guidance,  the  list  may  be 
revised  consistent  with  the  process  for  revising  guidance  documents  in  our 
21  CFR  10.115
regulation  on  good  guidance  practices  in   . 
F11.  Section  201(qq)  of  the  FD&C  Act  includes  wheat  in  the  definition  of  
major  food  allergen.  What  is  considered  wheat  for  purposes  of  
Section  201(qq)? 
Answer: The  term  wheat  in  Section  201(qq)  means  any  species  in  the  genus  1.  Include  the  name  of  the  food  source  in 
parenthesis  following  the  common  or 
Triticum.  Thus,  for  the  purposes  of  Section  201(qq),  wheat  would  include 
usual  name  of  the  major  food  allergen  in 
grains  such  as  common  wheat  (Triticum  aestivum  L.),  durum  wheat  (Triticum  the  list  of  ingredients  in  instances  when 
the  name  of  the  food  source  of  the  major 
durum  Desf.),  club  wheat  (Triticum  compactum  Host.),  spelt  (Triticum  spelta  food  allergen  does  not  appear  elsewhere 
L.),  semolina  (Triticum  durum  Desf.),  Einkorn  (Triticum  monococcum  L.  in  the  ingredient  statement  for  another 
allergenic  ingredient. 
subsp.  Monococcum),  emmer  (Triticum  turgidumL.  subsp.  dicoccon  (Schrank) 
Thell.),  kamut  (Triticum  polonicum  L.),  and  triticale  (x  Triticosecale  ssp.  OR 
Wittm.). 
F12. May  singular  terms  be  substituted  for  the  plural  terms  peanuts,  2.  Place  the  word  Contains,  followed  
by  the  name  of  the  food  source  from 
soybeans  and  the  different  types  of  tree  nuts  (e.g.,  almonds,  pecans, 
which  the  major  food  allergen  is  derived, 
or  walnuts),  and  may  synonyms  for  the  term  soybean  be  used  to  immediately  after  or  adjacent  to  the  list 
satisfy  the  labeling  requirements  of  FALCPA?  of  ingredients,  in  a  type  size  that  is  no 
smaller  than  that  used  for  the  ingredient 
Answer: Yes.  FDA  believes  that  the  singular  terms  peanut,  and  soybean,  as  list. 
well  as  the  singular  terms  (e.g.,  almond,  pecan,  or  walnut)  for  the  different 
types  of  tree  nuts  are  acceptable  substitutes  for  the  plural  terms  for  these  major 
food  allergens  for  the  purpose  of  satisfying  the  FALCPA  labeling  requirements. 
Also,  the  terms  soybean,  soy,  and  soya  are  reasonable  synonyms  for  the 
common  or  usual  name  soybeans,  and  any  one  of  these  terms  may  be  used 
to  identify  the  food  source  of  the  major  food  allergen  soybeans.  However, 
packaged  foods  that  are  made  using  soybeans  as  an  ingredient  or  as  a 
component  of  a  multi-component  ingredient  (e.g.,  soy  sauce  or  tofu)  should 
continue  to  use  the  word  soybeans  as  the  appropriate  common  or  usual 
name  for  this  ingredient  to  identify  properly  the  ingredient  (e.g.,  soy  sauce 
(water,  wheat,  soybeans,  salt)). 
FALCPA Labeling (provisions and examples) 
F13. How must major food allergens be declared on food labels to comply 
with FALCPA? 
Answer: FALCPA requires food manufacturers to label food products that are 
made with an ingredient that is a major food allergen in one of the ways 
shown at right. 
A  F O O D  L A B E L I N G  G U I D E  23  F14. Are  single  ingredient  foods  that  are  major  food  allergens  required  to 
comply  with  FALCPA? 
Answer: Yes.  Single  ingredient  foods  must  comply  with  the  allergen 
declaration  requirements  in  Section  403(w)(1).  A  single  ingredient  food  that 
is,  or  contains  protein  derived  from  milk,  egg,  fish,  Crustacean  shellfish,  tree 
nuts,  wheat,  peanuts,  or  soybeans,  may  identify  the  food  source  in  the  name  of 
the  food  (e.g.,  all-purpose  wheat  flour)  or  use  the  Contains  statement 
format.  FDA  recommends  that  if  a  Contains  statement  format  is  used,  the 
statement  be  placed  immediately  above  the  manufacturer,  packer,  or 
distributor  statement.  For  single  ingredient  foods  intended  for  further 
manufacturing  where  the  Contains  statement  format  is  used,  the  statement 
should  be  placed  on  the  PDP  of  the  food. 
F15. May  a  Contains  statement  on  a  food  label  provided  in  accordance  with  
FALCPA  list  only  the  names  of  the  food  sources  of  the  major  food 
allergens  that  are  not  already  identified  in  the  ingredient  list  for  a 
packaged  food? 
Answer: No.  If  a  Contains  statement  is  used  on  a  food  label,  the  statement 
must  include  the  names  of  the  food  sources  of  all  major  food  allergens  used  as 
ingredients  in  the  packaged  food.  For  example,  if  sodium  caseinate,  whey, 
egg  yolks,  and  natural  peanut  flavor  are  declared  in  a  product's  ingredients 
list,  any  Contains  statement  appearing  on  the  label  immediately  after  or 
adjacent  to  that  statement  is  required  to  identify  all  three  sources  of  the  major 
food  allergens  present  (e.g.,  Contains  milk,  egg,  peanuts)  in  the  same  type 
(i.e.,  print  or  font)  size  as  that  used  for  the  ingredient  list. 
F16. Is  there  more  than  one  way  to  word  a  Contains  statement  used  to  
declare  the  major  food  allergens  in  a  packaged  food? 
Answer: Yes.  The  wording  for  a  Contains  statement  may  be  limited  to  just 
stating  the  word  Contains  followed  by  the  names  of  the  food  sources  of  all 
major  food  allergens  that  either  are  or  are  contained  in  ingredients  used  to 
make  the  packaged  product.  Alternatively,  additional  wording  may  be  used  for 
a  Contains  statement  to  more  accurately  describe  the  presence  of  any  major 
food  allergens,  provided  that  the  following  three  conditions  are  met: 
 The  word  Contains  with  a  capital  C  must  be  the  first  word  used  to  
begin  a  Contains  statement.  (The  use  of  bolded  text  and  punctuation  
within  a  Contains  statement  is  optional.) 
 The  names  of  the  food  sources  of  the  major  food  allergens  declared  on  
the  food  label  must  be  the  same  as  those  specified  in  the  FALCPA,  
except  that  the  names  of  food  sources  may  be  expressed  using  singular  
terms  versus  plural  terms  (e.g.,  walnut  versus  walnuts)  and  the  synonyms  
soy  and  soya  may  be  substituted  for  the  food  source  name  
soybeans. 
 If  included  on  a  food  label,  the  Contains  statement  must  
identify  the  names  of  the  food  sources  for  all  major  food  allergens  that  
either  are  in  the  food  or  are  contained  in  ingredients  of  the  food. 
24 G U I D A N C E  F O R  I N D U S T R Y  N L
7.  UTRITION  ABELING 
General 
G1. 	  Where  should  the  Nutrition  Facts  label  be  placed  on  food  packages? 
Answer: The  Nutrition  Facts  label  may  be  placed  together  with  the  ingredient 
list  and  the  name  and  address  (name  and  address  of  the  manufacturer,  packer, 
or  distributor)  on  the  PDP.  These  three  label  statements  also  may  be  placed  on 
the  information  panel  (the  label  panel  adjacent  and  to  the  right  of  the  PDP, 
or,  if  there  is  insufficient  space  on  the  adjacent  panel,  on  the  next  adjacent 
panel  to  the  right).  On  packages  with  insufficient  area  on  the  PDP  and 
information  panel,  the  Nutrition  Facts  label  may  be  placed  on  any  alternate 
21  CFR  101.2(b)  &  (e)  &  101.9(i) 
panel  that  can  be  seen  by  the  consumer.  
G2. 	  Is  it  necessary  to  use  a  nutrition  display  with  a  box  shape  on  a  
round package? 
Answer: Yes.  Even  when  using  the  tabular  display,  the  nutrition  information 
21  CFR  101.9(d)(1)(i) 
must  be  set  off  in  a  box.  
G3. 	  Can  the  product  name  be  placed  within  the  Nutrition  Facts  label? 
Answer: No.  The  name  may  be  placed  above  the  box  that  encloses  the 
21  CFR  101.9(c)  & (d) 
nutrition  information.  
G4. 	  Can  the  Nutrition  Facts  label  be  oriented  perpendicularly  as  opposed  to  
parallel,  to  the  base  of  the  package? 
Answer: Yes.  There  is  no  requirement  that  any  information,  other  than  the 
net  quantity  of  contents  and  statement  of  identity,  be  printed  parallel  to  the 
base  of  the  package.  However,  FDA  urges  manufacturers  to  strive  for 
consistency  of  presentation  of  nutrition  information  in  the  market  and  to   
place  the  Nutrition  Facts  label  so  that  it  is  readily  observable  and  legible  to  the 
consumer  at  the  point  of  purchase. 
G5. 	  Is  a  break  in  the  vertical  alignment  allowed  with  the  standard  format? 
Answer: Yes.  The  vertical  format  may  be  broken  in  either  of  the  following 
ways:  (1)  placement  of  the  footnote  to  the  right  of  the  panel  as  shown  in  the 
21  CFR  101.9(d)(11)  (2) 
example  in   or   all  vitamins  and  minerals  that  are 
listed  voluntarily  (i.e.,  after  iron)  may  be  moved  to  the  top  right  of  the  panel 
21  CFR  101.9(d)(11) 
along  with  the  footnote.  
Nutrient  Declaration 
N1. 	 Are  Nutrition  Facts  labels  required  on  all  foods? 
Answer: The  Nutrition  Facts  label  (an  example  is  illustrated  in  section  7  L2)  is  
required  on  most  food  packages  labeled.  The  illustration  indicates  FDA's 
typeface  and  style  to  help  assure  readability  and  conspicuousness.  Not  all  of 
these  type  specifications  are  required.  The  mandatory  type  specifications  are 
21  CFR  101.9(d). 
listed  in   Unlike  the  illustrative  examples  in  this  guidance, 
(1)  Any  legible  type  style  may  be  used,  not  just  Helvetica,  (2)  The  heading 
Nutrition  Facts  must  be  the  largest  type  size  in  the  nutrition  label  (i.e.,  it  must 
be  larger  than  8-point,  but  does  not  need  to  be  13-point)  and  should  extend 
the  width  of  the  Nutrition  Facts  box,  and  (3)  There  is  no  specific  thickness 
A  F O O D  L A B E L I N G  G U I D E   25  

required  for  the  three  bars  that  separate  the  central  sections  of  the  nutrition
21  CFR  101.9(a)  21  CFR  101.9(a)(1)
 
label.   and  


Below  are  listed  categories  providing  exemptions  or  special  provisions  for


nutrition  labeling.  Generally,  a  food  package  loses  those  exemptions,  if  a


nutrition  claim  is  made  or  nutrition  information  is  provided:
Summary  of  Exemption  Regulation  # 
21  CFR  101.9(j)(1) 
Manufactured  by  small  businesses  and 
101.9(j)(18) 


Food  served  in  restaurants,  etc.  or  delivered
21  CFR  101.9(j)(2)
 
to  homes  ready  for  immediate  consumption 
Delicatessen-type  food,  bakery  products  
and  confections  that  are  sold  directly  to  
21  CFR  101.9(j)(3) 
consumers  from  the  location  where  prepared 
Foods  that  provide  no  significant  nutrition  
such  as  instant  coffee  (plain,  unsweetened)  
21  CFR  101.9(j)(4) 
and  most  spices 
Infant  formula,  and  infant  and  junior  foods  
21  CFR  101.9(j)(5) 
for  children  up  to  4  years  of  age  (modified   and 
101.9(j)(7) 
label  provisions  for  these  categories) 


Dietary  supplements  (must  comply 
21  CFR  101.36 21  CFR  101.9(j)(6)
 
with   ) 
21  CFR  101.9(j)(8) 
Medical  foods 


Bulk  foods  shipped  for  further  processing 
21  CFR  101.9(j)(9)
 
or  packaging  before  retail  sale 
Fresh  produce  and  seafood  (a  voluntary  
nutrition  labeling  program  covers  these  foods 
21  CFR  101.9(j)(10) 
through  the  use  of  the  appropriate  means   and 
101.45 
such  as  shelf  labels,  signs,  and  posters) 
Packaged  single-ingredient  fish  or  game  
meat  may  be  labeled  on  basis  of  3-ounce  
cooked  portion  (as  prepared).  Custom-
processed  fish  and  game  are  exempt  from  
21  CFR  101.9(j)(11) 
nutrition  labeling. 
Certain  egg  cartons  (nutrition  information  
21  CFR  101.9(j)(14) 
inside  lid  or  on  insert  in  carton) 
Packages  labeled  This  unit  not  labeled  for  
retail  sale  within  multiunit  package,  and  outer 
21  CFR  101.9(j)(15) 
wrapper  bears  all  required  label  statements 
Self-service  bulk  foods--nutrition  labeling  
21  CFR  101.9(a)(2) 
by  placard,  or  on  original  container   and 
101.9(j)(16) 
displayed  clearly  in  view 
Donated  food  that  is  given  free   You  are  not  required  to  put 
(not  sold)  to  the  consumer.  Nutrition  Facts  labels  on  
donated  food  unless  the  
donated  food  is  later  placed  
on  sale  (the  law  applies  only  to 
food  that  is  offered  for  sale)  
21  CFR  101.9(a) 
 
Game  meats  may  provide  required  
nutrition  information  on  labeling  in  
21  CFR  101.9(a)(2) 
accordance  with  
21  CFR  101.9(j)(12) 
(eg.  counter  cards) 
26 G U I D A N C E  F O R  I N D U S T R Y  N2.	 Are  nutrition  designations  permitted  on  food  package  labels? 
Answer: FDA  considers  information  that  is  required  or  permitted  in  the 
Nutrition  Facts  label  that  is  on  the  front  label  or  elsewhere  on  the  package 
outside  the  Nutrition  Facts  label  to  be  a  Nutrient  Content  Claim  (NCC).  In 
such  cases,  the  package  label  must  comply  with  the  regulations  for  nutrient 
content  claims.  See  the  NCC  section  and  Appendices  A  and  B  of  this 
21  CFR  101.13(c) 
document  for  more  information. 
N3.	 What  other  nutrients  can  be  declared  on  the  Nutrition  Facts  label? 
Answer: In  addition  to  the  nutrients  shown  on  the  label  in  section  7  L2 
manufacturers  may  add  calories  from  saturated  fat,  polyunsaturated  fat, 
monounsaturated  fat,  potassium,  soluble  and  insoluble  fiber,  sugar  alcohol, 
other  carbohydrate,  vitamins  and  minerals  for  which  Reference  Daily  Intake 
(RDI's)  have  been  established,  or  the  percent  of  vitamin  A  that  is  present  as 
21  CFR  101.9(c) 
beta-carotene.  
N4. 	 Is  there  a  restriction  against  certain  nutrients  in  the  Nutrition  
Facts  label? 
Answer: Only  those  nutrients  listed  in  FDA's  nutrition  regulations,  as 
mandatory  or  voluntary  components  of  the  nutrition  label,  may  be  included 
21  CFR  101.9(c) 
in  the  Nutrition  Facts  label.  
N5. 	 When  must  voluntary  nutrients  be  listed? 
Answer: In  addition  to  the  nutrients  shown  on  the  sample  labels  in  this 
guidance,  other  nutrients  (listed  in  FDA's  regulations,  e.g.,  thiamin)  must  be 
included  in  a  food's  Nutrition  Facts  label  if  the  nutrients  are  added  as  a 
nutrient  supplement  to  the  food,  if  the  label  makes  a  nutrition  claim  (such  as  a 
NCC)  about  them,  or  if  advertising  or  product  literature  provides  information 
21  CFR  101.9(a),  21  CFR  101.9(c), 
connecting  the  nutrients  to  the  food.  
21  CFR  101.9(c)(8)(ii) 
N6.	 When  should  the  vitamins  and  minerals  in  flour  be  listed  on  the 
Nutrition  Facts  label? 
Answer: Generally,  FDA  only  requires  that  the  label  declare  the  vitamins  A 
and  C,  and  the  minerals  calcium  and  iron.  The  other  enrichment  vitamins 
and  minerals  must  be  declared  when  they  are  added  directly  to  the  packaged 
food  (e.g.,  enriched  bread),  but  not  when  the  enriched  product  is  added  as  an 
ingredient  to  another  food.  NOTE:  It  is  necessary  to  declare  the  other 
vitamins  and  minerals  in  the  ingredient  list.  However,  if  unenriched  flour  is 
used,  and  the  enrichment  nutrients  are  added  separately,  those  nutrients  (i.e., 
thiamin,  ribof lavin,  niacin,  and  folic  acid)  would  have  to  be  declared  on  the 
21  CFR  101.9(c)(8)(ii)(A)(B)  and  21  CFR 
Nutrition  Facts  label.  
101.9(c)(8)(iv) 
N7. 	 When  the  caloric  value  for  a  serving  of  a  food  is  less  than  5  calories,  can  
the  actual  caloric  value  be  declared? 
Answer: The  caloric  value  of  a  product  containing  less  than  5  calories  may  be 
expressed  as  zero  or  to  the  nearest  5  calorie  increment  (i.e.,  zero  or  5 
depending  on  the  level).  Foods  with  less  than  5  calories  meet  the  definition  
of  calorie  free  and  any  differences  are  dietarily  insignificant. 
21  CFR  101.9(c)(1) 
A  F O O D  L A B E L I N G  G U I D E   27  N8.  Should  a  value  of  47  calories  be  rounded  up  to  50  calories  or  rounded  
down  to  45  calories? 
Answer:	  Calories  must  be  shown  as  follows: 
50  calories  or  less--Round  to  nearest  5-calorie  increment: 
Example:  Round  47  calories  to  45  calories 
Above  50  calories--Round  to  nearest  10-calorie  increment: 
Example:  Round  96  calories  to  100  calories 
21  CFR  101.9(c)(1) 
Also  see  Appendix  H  for  rounding  guidelines. 
N9.   How  are  calories  from  alcohol  to  be  calculated? 
Answer: Calories  from  alcohol  may  be  calculated  using  specific  Atwater 
factors  as  provided  for  in  21  CFR  101.9(c)(1)(i)(A).  USDA  Handbook  No.  74 
provides  a  specific  food  factor  of  7.07  calories  per  gram  of  alcohol. 
N10. What  is  total  fat? 
Answer: To  determine  the  total  fat  content  of  a  food,  add  the  weight  in  grams 
of  all  lipid  fatty  acids  in  the  food  (e.g.,  lauric,  palmitic,  stearic  fatty  acids)  and 
express  as  triglycerides.  Total  fat  =  Weight  of  all  individual  fatty  acids  +  weight 
21  CFR  101.9(c)(2) 
of  one  unit  of  glycerol  for  each  three  fatty  acids.  
N11.  Does  total  fat,  which  is  defined  as  total  lipid  fatty  acid  expressed  as  
triglycerides,  include  cholesterol? 
Answer: No. 
N12.  The  total  fat  content  for  a  serving  of  my  product  is  0.1  g.  How  should  I  
declare  fat  and  calories  from  fat? 
Answer: Because  it  is  present  at  a  level  below  0.5  g,  the  level  of  fat  is  expressed 
as  0  g.  Calories  from  fat  would  also  be  expressed  as  zero.  
21  CFR  101.9(c)(1)(i),  21  CFR  101.9(c)(2) 
N13.  What  fractions  are  used  for  total  fat  on  the  Nutrition  Facts  label? 
Answer: Below  0.5  grams  total  fat  per  serving:  Use  the  declaration  0  grams  for 
total  fat.  0.5  grams  to  5  grams  total  fat:  Use  0.5  gram  increments  rounded  to 
the  nearest  1/2  gram. 
Examples:  

0.5  g,  1  g,  1.5  g,  2  g,  2.5  g,  3  g,  3.5  g,  4  g,  4.5  g,  5  g


Above  5  grams:  Use  1  gram  increments  rounded  to  the  nearest  1  gram  (do 


not  use  fractions  above  5  grams).
Examples:  

5  g,  6  g,  7  g,  etc.
21  CFR  101.9(c)(2)  
Also  see  Appendix  H  for  rounding  guidelines. 
N14. What  values  are  used  for  calculating  Daily  Values  for  the  
nutrition  label? 
Answer: See  Appendix  F:  Calculate  the  percent  daily  value  (DV)  for  the 
appropriate  nutrients  and  Appendix  G:  Daily  Values  for  Infants,  Children 
Less  Than  4  Years  of  Age,  and  Pregnant  and  Lactating  Women.  
21  CFR  101.9(c)(8)(iv)  &  (c)(9) 
28 G U I D A N C E  F O R  I N D U S T R Y  N15.  When  less  than  0.5  grams  of  dietary  fiber  or  saturated  fat  is  present  in  
a  serving  of  a  product,  the  amounts  would  be  shown  as  zero  on  the  
label.  However,  when  the  %  DV  is  calculated  based  on  an  actual  
unrounded  fiber  or  saturated  fat  content  of  0.2  grams  per  serving,  the  
calculation  yields  1  percent.  To  avoid  consumer  confusion  can  the  %  DV  
be  expressed  as  zero  in  these  cases? 
Answer: Yes.  Section  101.9(d)(7)(ii) permits  the  percent  Daily  Value  to  be 
calculated  by  dividing  either  the  amount  declared  on  the  label  for  each 
nutrient  or  the  actual  amount  of  each  nutrient  (i.e.,  before  rounding)  by  the 
Daily  Reference  Value  (DRV)  for  that  nutrient  except  that  the  percent  for 
21  CFR  101.9(c)(7)(ii)
protein  must  be  calculated  as  specified  in   .  As  a  result 
of  this  change,  whenever  a  declared  quantitative  amount  is  zero,  the  declared 
percent  Daily  Value  will  also  be  zero. 
N16.  How  is  total  carbohydrate  calculated? 
Answer: Total  carbohydrate  is  calculated  by  subtracting  the  weight  of  crude 
protein,  total  fat,  moisture,  and  ash  from  the  total  weight  of  the  sample  of 
21  CFR  101.9(c)(6) 
food.  
N17.  Does  total  carbohydrate  include  dietary  fiber? 
Answer: Yes.  Dietary  fiber  must  be  listed  as  a  subcomponent  under  total 
21  CFR  101.9(c)(6) 
carbohydrate.  
N18.  What  is  meant  by  sugars  on  the  Nutrition  Facts  label? 
Answer: To  calculate  sugars  for  the  Nutrition  Facts  label,  determine  the 
weight  in  grams  of  all  free  monosaccharides  and  disaccharides  in  the  sample 
21  CFR  101.9(c)(6)(ii) 
of  food.  
N19.  I  have  0.8  grams  of  fiber  in  a  serving  of  food.  Can  I  round  this  up  to  1  g,  
or  must  I  use  the  statement  less  than  1  g?  Can  I  do  the  same  thing  
for  protein? 
Answer: Since  this  serving  contains  less  than  1  gram  of  dietary  fiber  per 
serving,  fiber  is  to  be  expressed  as  Less  than  1  gram  or  Contains  less  than  1 
gram,  or  the  manufacturer  has  the  option  to  not  list  dietary  fiber  and  include 
the  following  statement  at  the  bottom  of  the  table  of  nutrients:  Not  a 
significant  source  of  dietary  fiber.  Protein  can  be  expressed  to  the  nearest 
whole  gram  (i.e.,  1  g);  or  the  label  can  state  less  than  1  gram  or  Contains 
less  than  1  gram.  The  <  symbol  may  be  used  in  place  of  the  words  less 
(21  CFR  101.9(d)(7)(i)).  21  CFR  101.9(c)(6)(i),  21  CFR 
than  
101.9(c)(7) 
N20.  Under  what  circumstances  is  the  listing  of  sugar  alcohol  required? 
Answer: When  a  claim  is  made  on  the  label  or  in  labeling  about  sugar  alcohol 
21  CFR  101.9(c)(6)(iii) 
or  sugars  when  sugar  alcohols  are  present  in  the  food.  
N21.  What  DRV's  and  RDI's  are  established  for  protein  for  the  purpose  of  
listing  protein  as  a  percent  of  Daily  Value  (%  DV)? 
Answer: The  DRV  for  protein  for  adults  and  children  4  or  more  years  of  age 
is  50  grams.  The  RDIs  for  protein  for  children  less  than  4  years  of  age,  infants, 
pregnant  women,  and  lactating  women  are  established  at  16  grams,  14  grams, 
21  CFR  101.9(c)(7)(iii) 
60  grams,  and  65  grams  respectively.  
A  F O O D  L A B E L I N G  G U I D E   29  N22. Why  is  the  declaration  of  the  DRV  for  protein  not  mandatory? 
Answer: The  percent  of  the  DRV  is  required  if  a  protein  claim  is  made  for  the 
product  or  if  the  product  is  represented  or  purported  to  be  for  use  by  infants 
or  children  under  4  years  of  age.  Based  on  current  scientific  evidence  that 
protein  intake  is  not  a  public  health  concern  for  adults  and  children  over  4 
years  of  age,  and  because  of  the  costs  associated  with  a  determination  of  the 
Protein  Digestibility  Corrected  Amino  Acid  Score  (PDCAAS),  FDA  has 
determined  that  declaration  of  the  percent  of  the  DRV  for  protein  need  not 
be  provided  when  a  claim  is  not  made. 
N23.  How  should  the  %  DV  for  protein  be  expressed  when  it  is  provided  on  
labeling  of  foods  for  adults  and  children  over  four? 
Answer: When  protein  is  listed  as  a  percent  of  the  50  gram  DRV  and 
expressed  as  %  DV,  the  %  DV  is  calculated  by  correcting  the  actual  amount  of 
protein  in  grams  per  serving  by  multiplying  the  amount  by  its  amino  acid 
score  corrected  for  protein  digestibility,  dividing  by  50  grams,  and  converting 
21  CFR  101.9(c)(7)(ii) 
to  percent.  
N24.  When  %  DV's  for  protein  and  potassium  are  included  on  the  Nutrition  
Facts  label  on  foods  for  adults  and  children  over  4  years,  where  in  the  
footnote  is  the  DRV  information  to  be  placed? 
Answer: Protein  should  be  listed  in  the  footnote  under  dietary  fiber  with  the 
DRV  inserted  on  the  same  line  in  the  numeric  columns.  The  DRV  for 
protein  is  based  on  10  percent  of  calories  as  protein,  which  equates  to  50 
grams  for  a  2,000  calorie  diet  and  65  grams  (62.5  rounded  up  to  65)  for  a 
2,500  calorie  diet.  Similarly,  potassium  would  be  listed  in  the  footnote  under 
sodium.  The  DRV  for  potassium  is  3,500  milligrams  for  both  the  2,000  and 
21  CFR  101.9(d)(9) 
2,500  calorie  diets.  
N25.  How  do  I  determine  what  values  to  declare  on  the  Nutrition  
Facts  label? 
Answer: The  nutrient  values  declared  on  the  Nutrition  Facts  label  are  based 
on  the  nutrient  profile  of  the  product,  as  packaged,  rounded  as  required  by 
21  CFR  101.9(c) 
regulation.  Rounding  rules  are  provided  in   and 
summarized  in  Appendix  H. 
N26. How  should  vitamins  and  minerals  that  are  permitted  to  be  
listed  voluntarily  be  listed? 
Answer: If  potassium  is  listed,  it  should  be  listed  in  bold  type  directly  under 
sodium.  Voluntary  vitamins  and  minerals  (i.e.,  those  other  than  vitamin  A,  
vitamin  C,  calcium,  and  iron),  should  be  declared  horizontally  or  vertically  
following  the  required  vitamins  and  minerals  in  the  order  listed  in  
21  CFR  101.9(c)(8)(iv),  21  CFR  101.9(c)(5)  and  21  CFR  101.9(d)(8) 
N27.  Is  it  legal  to  declare  400%  of  the  Daily  Value  for  a  vitamin? 
Answer: Yes.  The  percent  Daily  Value  is  based  on  the  amount  of  the  nutrient 
present  in  the  product. 
N28.  Can  information  about  nutrients  that  do  not  have  an  RDI/DRV  such  as  
boron  and  omega3  fatty  acids  be  provided  on  the  food  label? 
Answer: Yes,  provided  that  the  information  is  truthful  and  not  misleading 
and  is  provided  outside  the  Nutrition  Facts  label.  Such  information  is  limited 
to  statements  of  amount  or  percent  of  a  nutrient  (eg.  300  mg  omega  3)  and 
may  not  characterize  the  level  of  the  nutrient  (you  may  not  state  High  in 
21  CFR  101.13(i)(3) 
Omega-3).  
30 G U I D A N C E  F O R  I N D U S T R Y  N29. Would  a  dry  mix  product  such  as  flavored  rice  be  required  to  provide  
nutrition  information  for  both  the  product  as  packaged  and  
as  prepared? 
Answer: Only  the  nutritional  properties  of  the  product  as  packaged  is 
required.  However,  nutritional  information  may  be  voluntarily  presented  as 
21  CFR  101.9(h)(4).  21  CFR  101.9(e) 
prepared  as  provided  for  in  
N30.  Can  I  use  average  values  derived  from  data  bases  to  determine  the  
nutrient  content  of  my  product? 
Answer: FDA  has  not  stated  how  a  company  should  determine  the  nutrient 
content  of  their  product  for  labeling  purposes.  Therefore,  there  is  no 
prohibition from  using  average  values  for  its  product  derived  from  data 
bases  if  a  manufacturer  is  confident  that  the  values  obtained  meet  FDA's 
compliance  criteria.  Regardless  of  its  source,  a  company  is  responsible  for  the 
accuracy  and  the  comp liance  of  the  information  presented  on  the  label.  Use 
of  a  data  base  that  has  been  accepted  by  FDA  affords  a  firm  some  measure  of 
security  in  that  the  agency  has  stated  that  it  will  work  with  industry  to  resolve 
any  compliance  problems  that  might  arise  for  food  labeled  on  the  basis  of  a 
FDA  Nutrition 
data  base  that  the  agency  has  accepted.  A  manual  entitled  
Labeling  Manual:  A  Guide  for  Developing  and  Using  Databases 
is  available 
online. 
N31.  How  many  samples  of  each  product  should  we  analyze  for  nutrition  
labeling? 
Answer: FDA  has  not  defined  the  number  of  samples  that  must  be  analyzed. 
It  is  the  responsibility  of  the  manufacturer/packer/distributor  to  determine 
the  variability  of  their  product(s)  and  the  number  of  samples  needed  to 
FDA  Nutrition  Labeling  Manual:  A 
provide  accurate  nutrient  data.  The  
Guide  for  Developing  and  Using  Databases, 
available  from  FDA,  may  be  of 
assistance  in  this  area.  FDA  will  use  a  composite  of  12  units  when  performing 
21  CFR  101.9(g) 
enforcement  analyses.  
N32.  May  I  copy  my  competitor's  label? 
Answer: Firms  are  responsible  for  the  accuracy  of  the  Nutrition  Facts  label 
and  there  is  no  assurance  that  the  data  from  a  competitor's  product  is  valid 
for  another  product.  Products  of  a  similar  nature  are  not  necessarily 
equivalent  in  ingredients  and  nutrient  value.  If  FDA  found  a  product  to  be 
out  of  compliance  because  a  firm  merely  copied  its  competitor's  label,  the  firm 
would  be  hard  pressed  to  prove  that  they  labeled  the  product  in  good  faith. 
N33.  Will  FDA  analyze  my  products  and  send  me  a  report  to  use  for  
my  nutrition  label? 
Answer: No.  FDA  does  not  have  the  resources  to  analyze  products  upon 
request.  However,  FDA  will  collect  surveillance  samples  to  monitor  the 
accuracy  of  nutrition  information.  The  manufacturer,  packer  or  distributor 
would  be  advised  of  any  analytical  results  that  are  not  in  compliance. 
Additionally,  depending  on  circumstances,  FDA  may  initiate  regulatory 
action. 
N34.  Does  FDA  provide  data  base  information  to  industry? 
Answer: No.  FDA  will  review  and  accept  industry  data  bases  which  remain 
the  property  of  the  organization  that  developed  and  submitted  the  data. 
A  F O O D  L A B E L I N G  G U I D E   31  N35.  Can  FDA  recommend  an  analytical  laboratory  and  must  a  laboratory  
be  approved  to  perform  nutrient  analysis? 
Answer: FDA  does  not  approve,  and  is  not  in  a  position  to  endorse  or 
recommend,  specific  laboratories.  Assistance  may  be  available  through  the 
following  sources:  trade  and  professional  associations,  trade  publications, 
colleges  and  universities,  and  by  looking  in  local  phone  books  under  testing 
or  analytical  laboratories.  For  compliance  purposes  for  nutrient  analysis,  FDA 
uses  appropriate  methods  published  by  the  Association  of  Analytical  Chemists 
Official  Methods  of  Analysis  of  the  AOAC  International 
(AOAC)  in   (the  most 
current  edition  unless  otherwise  stated  in  the  CFR)  or  other  methods  as 
needed.  You  may  wish  to  ascertain  if  the  laboratory  is  familiar  with  these 
methodologies  when  selecting  a  laboratory. 
N36. How  many  samples  must  be  analyzed  to  determine  the  nutrient  levels  
for  a  product? 
Answer: The  number  of  samples  to  analyze  for  each  nutrient  is  determined  by 
the  variability  of  each  nutrient  in  a  food.  Fewer  analytical  samples  are  generally 
required  for  nutrients  that  are  less  variable.  The  variables  that  affect  nutrient 
levels  should  be  determined,  and  a  sampling  plan  should  be  developed  to 
encompass  these  variables. 
N37.  Is  there  a  problem  with  using  ingredient  composition  data  bases  to  
calculate  the  values  for  nutrition  labeling? 
Answer: If  manufacturers  choose  to  use  ingredient  data  bases,  they  should  be 
assured  of  the  accuracy  of  the  databases  and  validate  the  resulting  calculations 
by  comparing  them  with  values  for  the  same  foods  obtained  from  laboratory 
analyses.  Manufacturers  are  responsible  for  the  accuracy  of  the  nutrition 
labeling  values  on  their  products.  Although  FDA  specifies  the  laboratory 
methods  that  will  be  used  to  evaluate  the  accuracy  of  the  labeled  products, 
FDA  does  not  specify  acceptable  sources  for  the  labeled  values. 
Products  with  Separately  Packaged  
Ingredients/Assortments  of  Foods/Gift  Packages 
P1.	  Can  the  Nutrition  Facts  label  on  a  box  containing  dry  noodles  and  a  
seasoning  packet  list  the  nutrients  in  the  noodles  separately  from  the  
seasoning  packet?  If  so,  must  a  column  be  included  that  gives  the  total  
nutrients  for  the  noodles  and  the  seasoning  packet? 
Answer: Section  101.9(h)(1) provides  the  option  of  listing  nutrition 
information  per  serving  for  each  component  or  as  a  composite  value.  The 
decision  is  up  to  the  manufacturer.  A  column  of  total  values  is  not  required. 
P2. 	  What  are  the  labeling  options  for  products  packed  in  an  assortment  that 
are  intended  to  be  eaten  at  the  same  time?  Can  the  nutrient  analysis  for 
a  product  containing  a  mixture  of  nuts  or  different  types  of  dried  fruit  be 
based  on  a  composite  of  the  mixture  blended  together? 
Answer: Section  101.9(h)(1) allows  the  nutrition  information  for 
assortments  of  the  same  type  of  food  (e.g.,  mixed  nuts  or  mixed  fruits)  that  are 
intended  to  be  consumed  at  the  same  time  to  be  specified  for  each 
component  or  as  a  composite  value.  Therefore,  if  it  is  reasonable  to  assume 
that  a  consumer  would  eat  an  assortment  of  the  nuts  or  fruits  offered,  a  single 
composite  analysis  may  be  used  to  determine  the  nutrient  composition. 
32 G U I D A N C E  F O R  I N D U S T R Y  P3.	  What  is  the  correct  way  to  label  a  gift  basket  that  contains  a  variety  of  
foods,  candies,  and  liquors  of  various  sizes?  Does  nutrition  labeling  
have  to  be  provided  for  each  individually  wrapped  product,  and  are  such 
packages  considered  multipacks? 
Answer: Nutrition  labeling  of  gift  food  packages  is  addressed  in  21  CFR 
101.9(h)(3) 
which: 
1.	 
allows  nutrition  information  to  be  placed  on  the  label  of  the  outer  package 
or  in  labeling  within  or  attached  to  the  outer  package, 
2.	 
provides  for  standardized  serving  sizes  when  there  is  no  RACC  appropriate 
for  the  variety  of  foods  in  the  gift  pack, 
3.	 
allows  number  of  servings  per  container  to  be  listed  as  varied, 
4.	 
allows  nutrition  information  to  be  given  as  a  composite  for  categories  of  
foods  in  the  gift  pack  that  have  similar  dietary  uses  and  similar  nutritional  
characteristics  (e.g.,  assorted  chocolate  candies,  assorted  cheeses),  and 
5.	 
does  not  require  declaration  of  nutrients  in  free  promotional  items  or  
items  used  in  small  quantities  to  enhance  the  appearance  of  the  gift  
package. 
The  required  nutrition  information  for  different  foods  may  be  put  
21  
on  a  brochure  or  package  insert  using  the  aggregate  display  illustrated  in  
CFR  101.9(d)(13)(ii)
.  Listing  the  servings  per  container  as  varied  allows  
use  of  the  same  nutrition  label  on  packages  of  varied  sizes. 
If  some  individually  wrapped  food  items  in  the  gift  pack  bear  nutrition 
labeling,  that  information  need  not  be  repeated  with  the  nutrition 
information  provided  for  the  unlabeled  foods  (e.g.,  on  the  outside  of  the  gift 
pack  or  on  a  package  insert).  Further,  the  labeling  of  all  malt  beverages, 
regardless  of  alcohol  content,  and  of  liquors  and  wines  containing  7  percent 
or  more  by  volume  of  alcohol  is  regulated  by  the  Alcohol  and  Tobacco  Tax 
and  Trade  Bureau  (TTB).  TTB  does  not  require  that  the  products  it  regulates 
bear  nutrition  labeling. 
P4. 	  A  retailer  assembles  gift  packages  containing  a  mixture  of  prep  ackaged  
and  prelabeled  foods  from  the  following  categories:  (1)  Food  items  in  
packages  that  bear  Nutrition  Facts  in  accordance  with  21  CFR  101.9,  (2)  
packages  with  less  than  12  square  inches  of  available  label  space  that  
may  be  obtained.  What  are  the  nutrition  labeling  requirements  for  gift  
packages  containing  these  foods? 
Answer: Gift  packages  are  required  to  bear  nutrition  labeling  in  accordance 
with  current  labeling  regulations.  The  following  rules  apply  to  the  above 
categories: 
1.	 
When  individual  food  packages  within  a  gift  package  bear  complete  
nutrition  labeling,  the  nutrition  information  need  not  be  repeated  on  the  
outer  wrapper  or  in  a  package  insert,  even  when  such  means  are  used  to  
convey  nutrition  information  on  other  products  within  the  gift  package. 
2.	 
Available  label  space  is  not  an  issue  for  most  gift  packages  since  the  
required  information  may  be  placed  on  the  larger  outer  wrapper  or  in  a  
package  insert.  Therefore,  when  packages  with  less  than  12  square  inches  
of  available  label  space  are  added  to  a  gift  package,  the  nutrition  
information  should  be  obtained  from  the  manufacturer  and  placed  on  or  
within  the  gift  package.  Free  promotional  items  and  items  used  in  small  
quantities  to  enhance  the  appearance  of  the  gift  package  are  excused  from  
this  requirement  (21  CFR  101.9(h)(3)(v)). 
A  F O O D  L A B E L I N G  G U I D E   33  3.	 
Nutrition  labeling  must  be  placed  on  the  outer  wrapper  or  on  a  package  
insert  for  all  foods  in  a  gift  package  (except  free  promotional  items  and  
items  used  in  small  quantities  to  enhance  the  appearance  of  the  gift  
package)  that  do  not  bear  the  required  nutrition  information  on  the  
package  label. 
P5.	  Must  inserts  for  gift  packages  follow  the  standard  format?  May  other  
displays  such  as  the  tabular  display  be  used  on  the  insert? 
Answer: The  full  format  must  be  used  because  the  space  available  is  not 
limited  by  the  size  of  the  label. 
P6.	  Is  nutrition  labeling  required  for  fresh  fruit  included  in  a  gift  package? 
Answer: Nutrition  labeling  is  not  required  when  the  entire  package  is  made 
up  of  fresh  fruits  (which  fall  under  the  voluntary  nutrition  labeling  program) 
or  when  the  fruit  is  packed  with  other  processed  foods  that  are  intended  to  be 
eaten  separately.  However,  if  the  fruit  is  included  as  one  part  of  a  kit  with 
more  than  one  ingredient,  and  some  of  the  other  ingredients  are  not  subject 
to  the  voluntary  labeling  exemption,  nutrition  labeling  is  required  (e.g.,  apples 
and  caramel  sauce). 
P7. 	  When  cello  pack  labeling  of  fresh  fruits  or  vegetables  includes  a  claim,  
must  nutrition  information  be  provided  on  the  label? 
Answer: Claims  subject  the  food  to  nutrition  labeling  in  accordance  with  
21  CFR  101.45
,  which  means  that  nutrition  information  will  have  to  be 
available  at  point  of  purchase  although  not  necessarily  on  the  package. 
P8.	  I  assemble  gift  packs  using  prepackaged  foods  manufactured  by  other  
companies.  Labeling  on  my  part  is  limited  to  adding  a  Contents  List  
which  includes  my  company  name  and  address.  The  gift  pack  is  featured 
in  the  same  manner  in  my  catalogue.  While  some  of  these  products  have 
nutrition  labeling,  some  do  not  because  the  manufacturers  have  a  small  
business  exemption  and  no  claims  are  made.  Am  I  responsible  for  
providing  nutrition  labeling  for  the  items  that  do  not  carry  nutrition  
information? 
Answer: Nutrition  labeling  must  be  made  available  for  all  foods  in  a  gift  pack  
unless  the  individual  food  product  qualifies  for  a  small  business  exemption. 
Section  101.9(h)(3)(i) allows  for  the  added  nutrition  information  to  be 
placed  on  an  insert  in  the  gift  pack  rather  than  on  each  package  label. 
Label  Formats/Graphic  Requirements 
General 
L1. 	  How  large  must  the  Nutrition  Facts  label  be? 
Answer: There  are  no  specific  size  requirements  for  the  nutrition  label. 
However,  the  Nutrition  Facts  heading  must  be  in  a  type  size  larger  than  all 
other  print  size  in  the  nutrition  label  and  generally  set  the  full  width  of  the 
(21  CFR  101.9(d)(2))
nutrition  facts  label   .  Minimum  type  sizes  of  6  point 
(21 
and  8  point  are  required  for  the  other  information  in  the  nutrition  label  
CFR  101.9(d)(1)(iii))
,  and  there  are  minimum  spacing  requirements 
(21  CFR  101.9(d)(1)(ii)(C))
between  lines  of  text   . 
34 G U I D A N C E  F O R  I N D U S T R Y  L2. 	  What  are  the  minimum  type  sizes  and  other  format  requirements  for  
the  Nutrition  Facts  label? 
Answer: Format  requirements  are  specified  in  21  CFR  101.9(d).  For 
example,  the  nutrition  information  must  be  set  off  in  a  box  by  use  of 
hairlines  and  must  be  all  black  or  one  color  type,  printed  on  a  white  or  other 
21  CFR  101.9(d)(1)(i) 
neutral  contrasting  background  whenever  practical.  
FDA  urges  that  the  nutrition  information  be  presented  using  the  graphic
specifications  set  forth  in  appendix  B  to  part  101  (see  below).  
Example  of  Graphic  Enhancements  used  by  FDA 
A  F O O D  L A B E L I N G  G U I D E   35  Typeface  and  Size 
1.	 
The  Nutrition  Facts  label  uses  6  point  or  larger  Helvetica  Black  and/or  
Helvetica  Regular  type.  In  order  to  fit  some  formats  the  typography  may  be  
kerned  as  much  as  -4  (tighter  kerning  reduces  legibility). 
2.	 
Key  nutrients  &  their  %  Daily  Value  are  set  in  8  point  Helvetica  Black  (but 
%  is  set  in  Helvetica  Regular). 
3.	 
Nutrition  Facts  is  set  in  either  Franklin  Gothic  Heavy  or  Helvetica  Black  to 
fit  the  width  of  the  label  flush  left  and  f lush  right. 
4.	 
Serving  Size  and  Servings  per  container  are  set  in  8  point  Helvetica  
Regular  with  1  point  of  leading. 
5.	 
The  table  labels  (for  example,  Amount  per  Serving)  are  set  in  6  point  
Helvetica  Black. 
6.	 
Absolute  measures  of  nutrient  content  (for  example,  1g)  and  nutrient  
subgroups  are  set  in  8  point  Helvetica  Regular  with  4  points  of  leading. 
7.	 
Vitamins  and  minerals  are  set  in  8  point  Helvetica  Regular,  with  4  points  
of  leading,  separated  by  10  point  bullets. 
8.	 
All  type  that  appears  under  vitamins  and  minerals  is  set  in  6  point  
Helvetica  Regular  with  1  point  of  leading. 
Rules 
1.	 
A  7  point  rule  separates  large  groupings  as  shown  in  the  example.  A  3  
point  rule  separates  calorie  information  from  the  nutrient  information. 
2.	 
A  hairline  rule  or  1/4  point  rule  separates  individual  nutrients,  as  shown  
in  the  example.  The  top  half  of  the  label  (nutrient  information)  has  2  
points  of  leading  between  the  type  and  the  rules,  the  bottom  half  of  the  
label  (footnotes)  has  1  point  of  leading  between  the  type  and  the  rules. 
Box 
All  labels  are  enclosed  by    point  box  rule  within  3  points  of  text  measure. 
L3. 	  Must  all  of  the  type  specifications  shown  with  the  nutrition  format  
example  of  section  7  L2  (above)  be  followed? 
Answer: No.  The  mandatory  type  specifications  are  listed  in  21  CFR 
101.9(d)
.  Unlike  the  illustrative  example  of  section  7  L2  (above): 
1.	 
Any  legible  type  style  may  be  used,  not  just  Helvetica. 
2.	 
The  heading  Nutrition  Facts  must  be  the  largest  type  size  in  the  nutrition  
label  (i.e.,  it  must  be  larger  than  8-point,  but  does  not  need  to  be  13-point). 
3.	 
There  is  no  specific  thickness  required  for  the  three  bars  that  separate  the  
central  sections  of  the  nutrition  label. 
L4.	  Can  I  use  type  sizes  larger  than  8  point  and  6  point? 
Answer: The  requirement  for  6  and  8  point  type  sizes  are  minimum 
requirements.  Larger  type  sizes  may  be  used. 
L5. 	  Where  should  the  Nutrition  Facts  appear  on  the  food  label? 
Answer: Under  21  CFR  101.9(j)(13)(ii)(D) the  Nutrition  Facts  may  be 
presented  on  any  label  panel  when  the  total  surface  available  for  labeling  is  40 
or  less  square  inches.  Packages  with  more  than  40  square  inches  of  available 
space  must  place  the  nutrition  information  on  either  the  PDP  or  information 
21  CFR  101.2  unless  there  is  insufficient  space 
panel  as  defined  in  
(excluding  vignettes,  etc.),  in  which  case  the  Nutrition  Facts  may  be 
placed  on  any  panel  that  may  be  seen  readily  by  consumers.  21  CFR 
101.9(j)(17) 
36 G U I D A N C E  F O R  I N D U S T R Y  L6.   Can  print  be  condensed? 
Answer: Yes,  however,  if  condensing  results  in  a  label  that  does  not  meet 
minimum  type  size  requirements,  FDA  would  consider  the  label  misleading. 
21  CFR  101.9(d)(1)(iii) 
L7.   What  can  be  done  if  the  regular  Nutrition  Facts  label  (i.e.,  the  vertical 
format)  does  not  fit  the  package? 
Answer: On  packages  with  more  than  40  square  inches  available  to  bear 
labeling,  the  side-by-side  format  may  be  used  if  the  regular  Nutrition  Facts 
label  does  not  fit.  In  this  format,  the  bottom  part  of  the  Nutrition  Facts  label 
(following  the  vitamin  and  mineral  information)  is  placed  immediately  to  the 
right  and  separated  with  a  line.  If  additional  vitamins  and  minerals  are  listed 
after  iron  and  the  space  under  iron  is  inadequate,  they  may  also  be  listed  to 
the  right  with  a  line  that  sets  them  apart  from  the  footnotes. 
Also,  if  the  package  has  insufficient  continuous  vertical  space  (i.e.,  about  3  inches) 
to  accommodate  the  above  format,  the  nutrition  label  may  be  presented  in  a  tabular 
21  CFR  101.9(d)(11) 
(i.e.,  horizontal)  display.   
A  F O O D  L A B E L I N G  G U I D E   37  L8. 	  Are  cellophane  windows  on  bags  or  boxes  considered  as  space  available 
to  bear  labeling? 
Answer: If  the  window  is  used  for  any  labeling,  including  promotional 
stickers,  the  window  is  considered  to  be  available  labeling  space.  However,  if 
no  labeling  is  present  it  is  not  considered  to  be  available  space. 
L9. 	  If  a  straw  is  placed  over  the  back  of  a  juice  carton,  must  that  panel  be  
considered  space  available  to  bear  labeling? 
Answer: Yes,  however,  required  label  information  must  be  presented  in  a 
manner  so  that  it  is  not  obscured.  Firms  having  difficulties  in  presenting 
nutrition  information  on  such  packages  may  wish  to  request  a  special 
21  CFR  101.9(g)(9) 
allowance  pursuant  to   by  writing  to  the  Office  of 
Nutrition,  Labeling,  and  Dietary  Supplements,  HFS-800,  5100  Paint  Branch 
Pkwy.,  College  Park  MD  20740. 
L10. If  the  nutrients  that  are  required  to  be  included  on  the  Nutrition  Facts  
label  are  present  at  0  grams  per  serving,  when  can  they  be  summarized  
in  a  sentence?  Can  more  than  one  nutrient  be  included  in  the  sentence? 
Answer: The  nutrients  listed  below  may  be  omitted  from  the  list  of  nutrients 
and  included  in  a  single  sentence  when  present  at  zero  levels  in  a  food.  This 
is  done  by  putting  the  label  statement  (Not  a  significant  source  of  ^^^^^^^^^) 
immediately  below  the  listing  of  vitamins  A  and  C,  calcium,  and  iron.  When 
the  statement  Not  a  significant  source  of^^^^^^^^^^^^^  is  used  for  more 
than  one  nutrient,  nutrients  must  be  listed  in  the  order  in  which  they  would 
have  been  listed  in  the  regular  format  (e.g.,  Not  a  significant  source  of  calories 
from  fat,  saturated  fat,  trans  fat,  cholesterol,  dietary  fiber,  sugars,  vitamin  A, 
vitamin  C,  calcium  and  iron).  The  footnote  can  be  used,  with  any  format,  to 
(21  CFR  101.9(c)) 
list  one  or  more  of  the  following  nutrients:  
Nutrient	  Level  per  serving  Label  statement 
Calories  from  fat  Less  than  0.5  g   Not  a  significant  source  
21  CFR  101.9(c)(1)(ii) 
fat  of  calories  from  fat 
Saturated  fat  Less  than  0.5  g   Not  a  significant  source 
(1) Saturated  fat  content  information 
21  CFR101.9(c)(2)(i) 
is  required  if  claims  are  made  about  of  total  fat(1)  of  saturated  fat 
fat,  fatty  acid,  or  cholesterol  content 
or  if  calories  from  saturated  fat   Trans  fat  Less  than  0.5  g   Not  a  significant  source
is  declared.  21  CFR  101.9(c)(2)(ii) 
of  total  fat(2)  of  trans  fat 
(2) Trans  fat  information  is  required  
if  claims  are  made  about  fat,  fatty   Cholesterol  Less  than  2  mg(3)  Not  a  significant  source  
acid  or  cholesterol  content.  21  CFR  101.9(c)(3) 
of  cholesterol 
(3) Cholesterol  content  is  required  if  
claims  are  made  about  fat,  fatty   Dietary  fiber  Less  than  1  g  Not  a  significant  source
acids  or  cholesterol  content.   21  CFR  101.9(c)(6)(i) 
of  dietary  fiber 
(4) Sugars  content  information  is  
required  if  claims  are  made  about  Sugars  Less  than  0.5  g(4)  Not  a  significant  source  
sweeteners,  sugars  or  sugar  alcohols.  21  CFR  101.9(c)(6)(ii) 
of  sugars 
Vitamins  A  and  C,   Less  than  2%   Not  a  significant  source 
calcium,  and  iron   of  RDI  of  ^^^^^^^^^  (listing  the  
21  CFR  101.9(c)(8)(iii) 
vitamins  or  minerals  omitted) 
38 G U I D A N C E  F O R  I N D U S T R Y  L11. A  package  design  firm  asked  about  the  option  of  reversing  the  Nutrition  
Facts  label  copy  as  white  type  out  of  a  dark  colored  background  on  the  
grounds  that  reverse  copy,  with  the  appropriate  size  and  color  contrast,  
can  be  as  readable  as  positive  type. 
Answer: Part  101.9(d)(1)(i)  states  that  the  nutrition  information  shall  be  all  black 
or  one  color  type,  printed  on  a  white  or  other  neutral  contrasting  background 
whenever  practical.  This  does  not  prohibit  reverse  print  or  use  of  other  colors. 
However,  if  reverse  type  is  used,  FDA  expects  that  any  impairment in  readability 
resulting  from  such  a  technique  will  be  compensated  for  by  use  of  other 
graphic  techniques  to  improve  readability,  such  as  increased  type  size.  Reverse 
21  CFR  101.9(d)(1)(iv) 
printing  is  not  permitted  as  a  form  of  highlighting  under  
because  it  would  interfere  with  the  consistent  look  of  the  label. 
L12. Is  it  necessary  to  include  a  calorie  conversion  footnote  which  states  that  
fat,  carbohydrate,  and  protein  furnish  9,  4,  and  4  calories  per  gram, 
respectively? 
Answer: No,  the  use  of  that  footnote  is  optional.  21  CFR  101.9(d)(10) 
L13. Do  the  values  under  %  Daily  Value  need  to  be  aligned  under  the  heading  
as  specified  in  21  CFR  101.9(d)(7)(ii)  or  aligned  to  the  far  right  side  of  the  
column  (i.e.,  right  justified)  as  shown  in  the  format  examples? 
Answer: The  listing  of  percent  of  the  Daily  Values  needs  to  be  in  a  column 
aligned  under  the  heading  and  can  be  either  centered  or  right  justified. 
L14. We  make  bean  curd  (tofu)  hot  dogs  that  are  packaged  in  a  film  that  
conforms  to  the  shape  of  the  product.  Can  I  place  nutrition  labeling  on  
the  film,  or  must  I  use  a  paper  strip  label? 
Answer: The  Nutrition  Facts  label  can  be  placed  on  the  film  package  provided 
that  the  color  contrast  of  the  print  and  the  indentations  made  by  the  product 
do  not  prevent  consumers  from  being  able  to  read  the  information  at  the 
point  of  purchase. 
L15. Can  we  use  a  continuous  print  label  that  would  result  in  the  Nutrition  
Facts  label  being  cut  off  at  an  odd  spot,  with  the  bottom  of  the  label  at  
the  top  of  the  package,  and  the  top  of  the  label  near  the  bottom? 
Answer: No.  However,  if  a  continuous  print  label  includes  one  uncut 
Nutrition  Facts  label  it  would  be  acceptable. 
L16. Can  the  Nutrition  Facts  label  be  printed  on  a  sticker  and  affixed  to  a  
package? 
Answer: Yes,  as  long  as  the  sticker  adheres  to  the  product  under  the  intended 
storage  conditions.  Some  companies  use  generic  cartons  or  bags  and  affix 
product  specific  labeling. 
A  F O O D  L A B E L I N G  G U I D E   39  Specific  Label  Formats 
Bilingual  Format 
L17. On  labels  that  have  two  languages,  may  nutrition  information  be  
provided  in  one  bilingual  Nutrition  Facts  label? 
Answer: When  nutrition  labeling  must  be  presented  in  a  second  language,  the 
nutrition  information  may  be  presented  in  separate  nutrition  labels  for  each 
language  or  in  one  label  with  the  second  language,  translating  all  required 
information,  following  that  in  English.  Numeric  characters  that  are  identical 
in  both  languages  need  not  be  repeated.  
21  CFR  101.9(d)(14) 
40 G U I D A N C E  F O R  I N D U S T R Y  L18. I  call  my  product  Frijoles  Pintos.  Is  bilingual  labeling  required?  What  
about  salsa? 
Answer: 
When  an  accepted  common  or  usual  name  for  a  food  is  in  a 
language other  than  English  (e.g.,  salsa,  chili  con  carne,  croissants,  rigatoni), 
use  of  this  common  or  usual  name  does  not  necessitate  dual  language 
declaration.  However,  if  the  name  of  the  food  is  intended  to  bring  the  article 
to  the  attention  of  a  person  who  does  not  speak  English  (e.g.,  Frijoles  Pintos),  
all  required  information  must  be  presented  in  the  foreign  language.   
21  CFR  101.15(c) 
Variety Packs/Aggregate Format 
L19. How should variety packs (e.g., breakfast cereals) display the nutrition 
information? 
Answer: When a package contains two or more packaged foods that are 
intended to be eaten individually, such as a variety pack of breakfast cereals or 
when packages may be used interchangeably for the same type of food, such as 
round ice cream containers, the manufacturer may choose to include separate 
Nutrition Facts labels for each food product, or may use an aggregate 
21 CFR 101.9(d)(13)(i) & (ii) 
Nutrition Facts label. 
A  F O O D  L A B E L I N G  G U I D E  41  L20. We  produce  a  cookie  assortment  containing  various  percentages  of  6  
different  cookies.  What  nutrition  format  should  be  used? 
Answer: The  manufacturer  may  choose  to  use:  (1)  a  separate  Nutrition  Facts 
label  for  each  variety  of  cookie  in  the  package,  (2)  an  aggregate  label  (i.e.,  a 
single  Nutrition  Facts  label  including  nutrient  content  information  and  % 
DVs  in  separate  columns  for  each  variety),  or,  (3)  if  it  is  likely  that  one  person 
would  eat  an  assortment  of  the  cookies  at  the  same  time,  a  composite  label 
that  provides  one  set  of  nutrition  information  based  on  a  weighted  average  of 
all  of  the  cookies  in  the  assortment.  21  CFR  101.9(h),  21  CFR  101.9(d)(13) 
L21. I  use  a  single  box  to  package  a  variety  of  different  products  (e.g.,  cherry  
pie,  apple  pie  or  cheese  cake,  etc.).  The  box  is  partially  prelabeled  (i.e.,  
it  bears  nutrition  labeling  in  the  aggregate  format  for  all  possible  
products).  When  the  product  is  packaged,  I  print  the  identity  statement  
for  the  food  on  the  PDP.  Must  the  Nutrition  Facts  label  be  marked  or  
highlighted  at  the  time  of  packaging  to  indicate  which  product  is  in  the  
package? 
Answer: No,  the  statement  of  identity  on  the  PDP  along  with  the  statement  of 
identity  above  each  column  of  nutrient  values  in  the  aggregate  Nutrition  Facts 
label  will  provide  adequate  information  for  the  consumer  to  determine  which 
nutritional  values  in  the  aggregate  label  apply  to  the  contents  of  the  package. 
21  CFR  101.9(d)(13)(i) 
As  Packaged/As  Prepared/Dual  Column  Format 
L22. What  are  the  definitions  of  as  packaged  and  as  prepared? 
Answer: As  packaged  refers  to  the  state  of  the  product  as  it  is  marketed  for 
purchase.  As  prepared  refers  to  the  product  after  it  has  been  made  ready  for 
consumption  (e.g.,  ingredients  added  per  instructions  and  cooked  such  as  a 
cake  mix  that  has  been  prepared  and  baked  or  a  condensed  or  dry  soup  that 
has  been  reconstituted). 
L23.  If  a  manufacturer  chooses  to  do  so,  how  may  a  food  be  labeled  if  the 
labeled  food  is  commonly  combined  with  another  food  before  eating? 
Answer: The  Nutrition  Facts  label  must  state  the  nutrients  in  the  food  as 
packaged  (i.e.,  before  consumer  preparation).  However,  manufacturers  are 
encouraged  to  add  a  second  column  of  nutrition  information  showing 
calories,  calories  from  fat  and  the  %  DV  for  the  combination  of  foods  eaten. 
Quantitative  amounts  (i.e.,  g/mg)  need  only  be  given  for  the  packaged  food. 
However,  as  shown  in  this  example,  a  footnote  can  be  added  to  indicate  the 
amount  of  nutrients  in  the  added  food.  Alternatively,  the  quantitative 
amounts  of  the  prepared  food  may  be  included  immediately  adjacent  to  those 
21  CFR  101.9(e) 
for  the  packaged  food  (e.g.,  Sodium  200  mg,  265  mg).  
L24. When  a  second  column  of  nutrient  information  is  provided,  is  it  
necessary  to  repeat  the  serving  size  and  servings  per  container? 
Answer: The  dual  listing  of  serving  size  and  servings  per  container  is  not 
required  when  providing  a  second  column  of  nutrient  information.  The  only 
requirement  is  to  list  the  serving  size  and  servings  per  container  that  are  based 
on  the  Reference  Amounts  Customarily  Consumed  (RACC)  for  the  product. 
21  CFR  101.9(b)(9)  and  21  CFR  101.9(e) 
42 G U I D A N C E  F O R  I N D U S T R Y  L25. I  have  a  recipe  on  my  package  which  calls  for  250%  of  the  RACC  of  my  
product  for  each  serving  of  the  food  created  using  the  recipe.  Must  I  use  
dual  declaration  for  the  nutrition  label? 
Answer: Yes.  Section  101.9(b)(11) states  that  if  the  product  is  promoted  on 
the  label  or  labeling  for  a  use  that  differs  in  quantity  from  the  RACC  by  200% 
or  greater,  dual  declaration  would  be  required.  FDA  considers  recipes  on  the 
(21  CFR  101.9(b)(11)) 
label  as  promoting  a  use  of  the  food.  The  regulations  
specifically  exempt  bulk  products  used  primarily  as  ingredients  (e.g.,  f lour, 
sugar,  oils)  or  traditionally  used  for  multi-purposes  (e.g.,  eggs,  butter)  from 
dual  declaration  requirements. 
L26. We  want  to  use  dual  declaration  for  cereals.  Do  we  have  to  include  the  
240  mL  RACC,  a  one  cup  serving,  for  the  added  milk,  or  can  we  use  1/2  
or  1/4  cup? 
Answer: Such  a  label  would  have  two  columns  with  a  heading  Cereal  and  
Cereal  with  1/2  cup  (or  1/4  cup)  ^^^^^  milk  where  the  blank  is  filled  in 
21  CFR  101.9(e)  (See  figure  on  page  42) 
with  the  type  of  milk.  
L27. We  have  a  condensed  cream  of  ___  soup.  Should  we  do  dual  
declaration? 
Answer: Dual  declaration  is  optional.  21  CFR  101.9(e) 
L28. If  a  recipe  is  placed  on  the  label  of  a  product,  does  the  nutrient  profile  of  
the  recipe  have  to  be  included  on  the  label? 
Answer: Only  if  the  recipe  calls  for  200%  or  more  of  the  RACC  of  the 
product  for  each  serving  of  the  food  created  by  the  recipe.  When  the  recipe 
calls  for  an  amount  less  than  200%  of  the  RACC,  such  information  could  be 
voluntarily  listed.  However,  nutrition  information  for  a  specific  recipe  may  be 
21  CFR  101.9(b)(11) 
presented  outside  of  the  Nutrition  Facts  label.  
L29. If  a  manufacturer  chooses  to  do  so,  what  is  an  example  of  the  Nutrition  
Facts  label  for  a  food  requiring  further  preparation  by  the  consumer? 
Answer: See  example  to  right.  However,  when  the  nutrient  values  in  the 
column  for  the  product  prepared  according  to  package  directions  would  be 
identical  to  the  column  for  the  product  as  packaged  (e.g.,  the  only  ingredients 
added  during  preparation  are  ingredients  such  as  water),  manufacturers  may 
omit  the  second  column  and  include  the  amount  made  as  part  of  the  serving 
size  declaration.  For  example,  a  dry  beverage  mix  could  declare:  Serving  Size: 
1  tsp.  dry  powder  (4  g)(makes  1  cup  prepared). 
21  CFR  101.9(b)(7)(v),  21  CFR  101.9(e)(5) 
Simplified  Format 
L30. Is  there  a  Nutrition  Facts  format  for  a  food  in  which  most  nutrients  are  
present  in  insignificant  amounts? 
Answer: A  simplified  Nutrition  Facts  label  may  be  used  if  at  least  eight  of  the 
following  nutrients  are  present  in  insignificant  amounts:  Calories,  total  fat, 
saturated  fat,  trans  fat,  cholesterol,  sodium,  total  carbohydrate,  dietary  fiber, 
sugars,  protein,  vitamin  A,  vitamin  C,  calcium  and  iron  (slightly  different  rules 
for  labeling  foods  intended  for  children  less  than  2  years).  The  five  core 
nutrients,  shown  in  bold  in  the  adjoining  example,  must  always  appear  on  all 
Nutrition  Facts  labels  regardless  of  amounts  present  in  the  food.  In  addition, 
A  F O O D  L A B E L I N G  G U I D E   43  any  of  the  nutrients  required  on  the  full  Nutrition  Facts  label  that  are 
naturally  present  or  are  added  to  the  food  must  be  declared  on  the 
simplified  Nutrition Facts  label. 
21  CFR  101.9(f)  101.9(f)(1) 
- List  of  nutrients;    Insignificant  defined; 
101.9(c) 
 Insignificant  levels  listed  for  nutrients 
L31. What  are  insignificant  amounts  of  nutrients?
Answer: These  are  the  amounts  that  are  permitted  to  be  shown  as  zero  on  the 
Nutrition  Facts  label  (e.g.,  less  than  5  calories  may  be  expressed  as  0  calories) 
except  that  for  total  carbohydrate,  dietary  fiber,  and  protein,  it  is  the  amount 
21  CFR 
that  can  be  declared  as  less  than  1  g  on  the  Nutrition  Facts  label.  
101.9(c) 
L32. When  I  use  the  simplified  format,  when  is  the  statement  Not  a  
significant  source  of_____________  required? 
Answer: This  statement,  which  must  list  all  nutrients  required  by  the  full 
format  that  are  present  at  insignificant  amounts,  must  be  included  when:  (1) 
nutrition  claims  are  made;  or  (2)  vitamins  and  minerals  are  added;  or  (3) 
naturally  occurring  nutrients  that  are  not  required  on  the  full  format  (e.g., 
21  CFR  101.9(f)(4) 
potassium)  are  voluntarily  declared.  
L33. If  a  product  qualifies  for  the  simplified  format,  but  the  company  wants  to 
make  a  claim  about  a  required  or  voluntary  nutrient,  can  it  still  use  the  
simplified  format? 
Answer: Yes.  However,  as  noted  in  the  previous  question  and  answer,  when  a 
claim  is  made,  the  statement  Not  a  significant  source  of  ^^^^^^^^^^^^^ 
21 
(with  the  blank  filled  in  with  the  name(s)  of  any  nutrient(s)  identified  in  
CFR  101.9(f) 
and  calories  from  fat  that  are  present  in  insignificant  amounts) 
21  CFR  101.9(f)(4) 
must  be  included  at  the  bottom  of  the  nutrition  label.  
L34. When  should  a  statement  be  used  on  simplified  format  labels  to  list  
nutrients  present  at  insignificant  amounts? 
Answer: A  simplified  format  label  must  include  a  statement  listing  zero 
level  nutrients  when  nutrients  are  added  to  the  food  or  voluntarily  declared 
on  the  Nutrition  Facts  label,  and  when  claims  are  made  on  the  label.  In  this 
example,  the  manufacturer  voluntarily  lists  polyunsaturated  and 
monounsaturated  fat,  and  therefore  must  add  the  statement  Not  a 
significant  source  of  ^^^^^^^^^  with  the  blank  filled  in  by  the  names  of 
21  CFR  101.9(f)(4) 
nutrients  present  at  insignificant  levels.  
L35. When  the  simplified  format  is  used,  can  nutrients  that  are  not  required  
to  be  listed  and  that  are  present  at  insignificant  amounts  be  listed  
voluntarily  (e.g.,  calories  from  fat,  saturated  fat,  trans  fat,  cholesterol,  
dietary  fiber,  sugars,  vitamin  A,  vitamin  C,  calcium  and  iron)? 
Answer: The  intent  of  the  simplified  format  was  to  minimize  the  amount  of 
information  required  to  be  on  the  label.  While  the  agency  discourages  the 
listing  of  optional  nutrients,  present  at  insignificant  amounts,  in  the  simplified 
format,  the  regulations  do  not  prohibit  such  listing.  When  non  required 
nutrients  (e.g.,  calories  from  fat,  saturated  fat,  trans  fat,  cholesterol,  dietary 
fiber,  sugars,  vitamin  A,  vitamin  C,  calcium  or  iron)  are  voluntarily  listed  as 
21  CFR  101.9(f)(4) 
zero,  the  footnote  required  by   is  not  required. 
44 G U I D A N C E  F O R  I N D U S T R Y  L36. If  a  product  qualifies  to  use  the  simplified  format  but  the  manufacturer  
elects  to  use  the  full  format  and  list  the  insignificant  level  of  nutrient(s)  
as  zero,  can  the  footnote  still  be  shortened? 
Answer: No,  since  use  of  the  simplified  format  is  optional  all  required 
21  CFR 
information  must  be  presented  when  the  full  format  is  used.  
101.9(d)(9) 
L37. How  do  I  use  the  Not  a  significant  source  of  ____________  in  
the  tabular  format? 
Answer: When  the  full  format  is  presented  in  a  tabular  display,  the  statement 
Not  a  significant  source  of  ^^^^^^^^^^^^  should  be  placed  beneath  the 
vitamins  and  minerals  and  be  separated  by  a  hairline.  When  the  simplified 
format  is  presented  in  a  tabular  display,  the  statement  should  be  separated  by  a 
bar  under  the  nutrients  declared. 
L38. What  is  the  correct  type  size  for  the  Not  a  significant  source  of  
____________  statement? 
Answer: 6  point 
L39. Can  the  simplified  format  be  used  regardless  of  the  amount  of  available  
label  space? 
Answer: Yes.  The  nutrient  content  of  the  food,  not  available  label  space,  is  the  
21  CFR  101.9(f) 
determining  factor.  
L40. When  the  simplified  format  is  used,  what  is  the  required  type  size? 
Answer: The  type  size  and  layout  requirements  are  the  same  as  that  required 
21  CFR  101.9(f)(5) 
for  the  full  format.  
L41. Is  the  entire  footnote  used  with  the  standard  format,  which  lists  DVs  for  
2,000  and  2,500  calorie  diets,  required  to  be  used  on  the  simplified  
format  for  intermediate  sized  packages  with  40  or  less  square  inches  of  
available  space? 
Answer: No.  The  simplified  format  only  requires  the  statement  Percent  Daily 
Values  are  based  on  a  2,000  calorie  diet  regardless  of  the  size  of  the  package. 
If  the  term  Daily  Value  is  abbreviated  in  the  heading  as  DV,  the  statement 
must  indicate  that  DV  means  Daily  Value  (e.g.,  Percent  Daily  Values  (DV) 
21  CFR  101.9(f)(5) 
are  based  on  a  2,000  calorie  diet).  
Trans Fat  Labeling 
L42. Why  is  FDA  requiring  that  trans  fatty  acids  be  listed  in  nutrition 
labeling? 
Answer: FDA  is  requiring  that  trans  fatty  acids  be  listed  in  nutrition  labeling 
in  response  to  a  petition  from  the  Center  for  Science  in  the  Public  Interest 
and  to  published  human  studies  that  show  that  intake  of  trans  fatty  acids, 
similar  to  the  intake  of  saturated  fatty  acids,  increases  low  density  lipoprotein-
cholesterol  (LDL -C)  (bad  cholesterol)  in  the  blood.  An  elevated  LDL -C 
increases  the  risk  of  developing  coronary  heart  disease.  Reports  published  by 
the  Institute  of  Medicine  of  the  National  Academy  of  Sciences  (IOM/NAS) 
and  the  Federal  government  have  recommended  that  Americans  limit  their 
intake  of  trans  fat  and  other  cholesterol-raising  fats  while  consuming  a 
A  F O O D  L A B E L I N G  G U I D E   45  nutritionally  adequate  diet.  For  Americans  to  follow  these  recommendations, 
they  must  know  the  amount  of  trans  fatty  acids  in  the  individual  foods  that 
they  eat.  Therefore,  FDA  is  requiring  that  this  information  be  provided  in 
nutrition  labeling  to  assist  consumers  in  maintaining  healthy  dietary  practices. 
(68  FR  41434,  July  11,  2003) 
L43. How  is  trans  fat  defined  for  labeling  purposes? 
Answer: The  Agency's  regulatory  chemical  definition  of  trans  fatty  acids  is 
all  unsaturated  fatty  acids  that  contain  one  or  more  isolated  double  bonds 
(i.e.  non  conjugated)  in  a  trans  configuration.  Trans  vaccenic  acid,  a  trans 
fatty  acid  with  a  single  double  bond,  and  other  trans  fatty  acids  of  ruminant 
origin  with  either  a  single  double  bond  or  nonconjugated  double  bonds  are 
included  in  this  definition.  Trans  fatty  acids  with  conjugated  bonds  are  not 
included  because  they  do  not  meet  the  Agency's  definition.  Thus,  trans  fatty 
acids,  regardless  of  origin,  that  meet  the  above  definition  are  to  be  included 
in  the  label  declaration  of  trans  fat.  Further,  using  FDA's  regulatory 
chemical  definition,  the  categories  trans  fatty  acids  and  conjugated  fatty 
acids  are  mutually  exclusive.  The  definition  of  trans  fatty  acids,  excluding 
fatty  acids  with  conjugated  double  bonds,  is  consistent  with  the  way  that  cis 
(68  FR  41434  at  41461, 
isomers  of  polyunsaturated  fatty  acids  are  defined.  
July  11,  2003.) 
L44. Do  trans  fatty  acids  need  to  be  listed  when  mono and  polyunsaturated  
fatty  acids  are  not  listed? 
Answer: Yes.  The  listing  of  trans  fatty  acids  is  mandatory  even  when  mono-
1  CFR  101.9(c),  (c)(2)(ii), 
and  polyunsaturated  fatty  acids  are  not  listed.  2
(c)(2)(iii),  (c)(2)(iv). 
and  
L45. How  should  trans  fatty  acids  be  listed? 
Answer: Trans  fatty  acids  should  be  listed  as  Trans  fat  or  Trans  on  a 
separate  line  under  the  listing  of  saturated  fat  in  the  Nutrition  Facts  label  (see 
figure).  The  word  trans  may  be  italicized  to  indicate  its  Latin  origin.  Trans 
fat  content  must  be  expressed  as  grams  per  serving  to  the  nearest  0.5-gram 
increment  below  5  grams  and  to  the  nearest  gram  above  5  grams.  If  a  serving 
contains  less  than  0.5  gram,  the  content,  when  declared,  must  be  expressed  as 
(21  CFR  101.9(c)(2)(ii)). 
0  g.  
L46. If  a  serving  contains  less  than  0.5  gram  of  trans  fat,  when  would  0  g  of  
trans  fat  not  have  to  be  declared? 
Answer: For  conventional  food  products  (those  food  products  other  than 
dietary  supplements),  declaration  of  0  g  of  trans  fat  is  not  required  for  such 
products  that  contain  less  than  0.5  g  of  total  fat  in  a  serving  and  no  claims  are 
made  about  fat,  fatty  acid  or  cholesterol  content.  If  trans  fat  is  not  listed,  the 
statement  Not  a  significant  source  of  trans  fat  may  be  placed  at  the  bottom 
of  the  table  of  nutrient  values  in  lieu  of  declaring  0  g  of  trans  fat.  If  these 
claims  are  present,  then  the  statement  Not  a  significant  source  of  trans  fat  is 
21  CFR 
not  an  option  and  the  declaration  of  0  g  of  trans  fat  is  required. 
101.9(c)(2)(ii) 
46 G U I D A N C E  F O R  I N D U S T R Y  L47. Why  is  there  no  %  DV  for  trans  fat? 
Answer: Although  the  updated  Nutrition  Facts  label  will  now  list  the  amount 
of  trans  fat  in  a  product,  there  is  no  %  DV  for  trans  fat.  While  scientific 
reports  have  confirmed  the  relationship  between  trans  fat  and  an  increased 
risk  of  CHD,  none  has  recommended  an  amount  of  trans  fat  that  FDA  could 
use  to  establish  a  DV.  Without  a  DV,  a  %  DV  cannot  be  calculated.  As  a 
1  CFR 
result,  trans  fat  will  be  listed  with  only  a  gram  amount.  2
101.9(d)(7)(ii) 
L48. Is  it  possible  for  a  food  product  to  list  the  amount  of  trans  fat  as  0  g  on  
the  Nutrition  Facts  label  if  the  ingredient  list  indicates  that  it  contains  
partially  hydrogenated  vegetable  oil? 
Answer: Yes.  Food  manufacturers  are  allowed  to  list  amounts  of  trans  fat  with  
less  than  0.5  gram  (  g)  as  0  (zero)  on  the  Nutrition  Facts  label.  As  a  result, 
consumers  may  see  a  few  products  that  list  0  gram  trans  fat  on  the  label,  while 
the  ingredient  list  will  have  shortening  or  partially  hydrogenated  vegetable 
oil  on  it.  This  means  the  food  contains  very  small  amounts  (less  than  0.5  g)  of 
trans  fat  per  serving. 
L49. What  about  nutrient  content  claims  for  trans  fat? 
Answer: Nutrient  content  claims  are  statements  that  are  made  on  the  food 
label  package  that  indicate  that  the  product  contains  a  range  from  free  to  high 
of  the  amount  of  a  specific  nutrient.  Examples:  Low  Fat  and  High  in 
Fiber.  At  this  time,  FDA  has  insufficient  scientific  information  to  establish 
NCCs  for  trans  fat.  Such  claims  are  permitted,  however,  for  saturated  fat  and 
cholesterol. 
L50. What  other  regulations  about  nutrition  labeling  of  trans  fatty  acids  is  
FDA  considering? 
Answer: The  Food  and  Drug  Administration  (FDA)  issued  an  advance  notice 
of  proposed  rulemaking  (ANPRM)  in  the  Federal  Register  (Food  Labeling: 
Trans  Fatty  acids  in  Nutrition  Labeling;  Consumer  Research  to  Consider 
Nutrient  Content  and  Health  Claims  and  Possible  Footnote  or  Disclosure 
Statements;  68  FR  41507;  July  11,  2003)  to  solicit  information  and  data  that 
potentially  could  be  used  to  establish  new  NCCs  about  trans  fat,  to  establish 
qualifying  criteria  for  trans  fat  in  current  NCCs  for  saturated  fat  and 
cholesterol,  lean  and  extra  lean  claims,  and  health  claims  that  contain  a 
message  about  cholesterol  raising  fats,  and,  in  addition,  as  disclosure  and 
disqualifying  criteria  to  help  consumers  make  heart-healthy  food  choices.  The 
agency  also  requested  comments  on  whether  to  consider  statements  about 
trans  fat,  either  alone  or  in  combination  with  saturated  fat  and  cholesterol, 
as  a  footnote  in  the  Nutrition  Facts  label  or  as  a  disclosure  statement  in 
conjunction  with  claims  to  enhance  consumers'  understanding  about  such 
cholesterol-raising  lipids  and  how  to  use  the  information  to  make  healthy  food 
choices.  Information  and  data  obtained  from  comments  and  from  consumer 
studies  conducted  by  FDA  may  be  used  to  help  draft  a  proposed  rule  that 
would  establish  criteria  for  certain  nutrient  content  or  health  claims  or  require 
the  use  of  a  footnote,  or  other  labeling  approach,  about  one  or  more 
cholesterol-raising  lipids  in  the  Nutrition  Facts  label  to  assist  consumers  in 
maintaining  healthy  dietary  practices. 
A  F O O D  L A B E L I N G  G U I D E   47  Miscellaneous 
L51. If  we  nutrition  label  in  good  faith,  will  FDA  take  legal  action  involving  
small  mistakes? 
Answer: FDA  is  unlikely  to  take  regulatory  action  for  minor  errors.  However, 
such  errors  should  be  corrected  during  the  next  printing  of  labels. 
L52. When  are  pointofpurchase  materials  considered  labeling? 
Answer: Always. 
L53.I  have  tried  all  the  available  format  options,  but  without  some 
modification  I  can  not  make  them  work  on  my  label,  what  can  I  do? 
Answer: Under  21  CFR  101.9(g)(9), FDA  may  permit  alternative  means  of 
compliance  or  additional  exemptions  to  deal  with  special  situations.  Firms  in 
need  of  special  allowances  should  make  their  request  in  writing  to  the  Office 
of  Nutrition,  Labeling,  and  Dietary  Supplements,  HFS-800,  5100  Paint 
Branch  Pkwy.,  College  Park,  MD  20740.  The  letter  should:  (1)  specify  that  you 
21  CFR  101.9(g)(9)
are  requesting  an  exemption  or  special  provision  under   , 
(2)  identify  the  particular  product(s)  that  are  the  subject  of  the  request,  (3) 
state  the  reason(s)  why  it  is  technologically  infeasible  or  impracticable  to 
adhere  to  the  regulations  for  such  products,  and  (4)  identify  the  proposed 
alternative  procedure.  If  possible,  include  an  example  of  the  proposed  label(s). 
L54. Are  mail  order  sales  covered  by  the  food  labeling  laws? 
Answer: The  same  labeling  laws  apply  to  all  categories  of  retail  sale,  including 
mail  orders.  Foods  sold  by  mail  order  must  be  fully  labeled. 
L55. Is  it  permissible  to  use  stickers  to  make  changes  in  labeling? 
Answer: Correcting  label  mistakes  in  any  manner  is  acceptable  if  the  final 
label  is  correct  and  complies  with  all  regulations  at  the  time  of  retail  sale.  The 
stickers  should  not  cover  other  mandatory  labeling,  and  should  adhere  tightly. 
L56. Does  FDA  approve  labels  before  printing? 
Answer: No,  it  is  the  responsibility  of  the  manufacturer  or  importer  of  a  food 
to  comply  with  current  food  labeling  regulations. 
Serving  Size 
Serving  Size/Reference  Amounts  Customarily  Consumed  (RACCs)  
and  Food  Categories 
L57. I  am  trying  to  determine  the  appropriate  serving  size  and  number  of  
servings  to  list  on  the  label  of  my  food  product.  How  do  I  start,  and  what  
steps  should  I  follow? 
Answer: Manufacturers  must  use  the  information  provided  in  the  regulation 
to  determine  a  specific  serving  size  for  their  products.  The  process  consists  of 
three  steps: 
1.	 
Locate  the  appropriate  food  category  and  Reference  Amount  
Customarily  Consumed  (RACC)  for  your  product  in  the  two  tables  in  
101.12(b) 
Section   of  the  food  labeling  regulations.  Table  1  is  for  infant  
and  toddler  foods.  Table  2  is  foods  for  the  general  population.  FDA  
48 G U I D A N C E  F O R  I N D U S T R Y  established  RACCs  for  139  food  product  categories,  and  these  values  
represent  the  amount  of  food  customarily  consumed  at  one  eating  
occasion.  Most  of  the  RACCs  are  for  foods  in  a  ready-to-eat  form.  If  your  
product  in  the  form  in  which  it  is  sold  (i.e.,  as  packaged),  does  not  have  a 
RACC  in  the  tables,  then  you  must  generate  an  appropriate  RACC  for  
21  CFR  101.12(c) 
your  product  using   for  products  that  require  further  
preparation,  (d)  for  imitation  foods,  (e)  for  aerated  foods,  and  (f)  for  
products  that  represent  two  or  more  foods  packaged  and  presented  to  be  
consumed  together. 
The  first  important  step  in  establishing  an  appropriate  serving  size  is  to  
determine  if  your  product  is  in  a  single  serving  container.  Products  
packaged  and  sold  in  small  units  are  required  to  be  labeled  as  single-serving 
21  CFR  
containers;  the  specifications  for  these  products  are  described  in  
101.9(b)(6)
.  If  your  product  is  a  single  serving,  it  must  be  labeled  in  
accordance  with  the  labeling  requirements  for  single-serving  containers  in  
21  CFR  101.9(b)(6
). 
2.	 
Determine  the  serving  size  for  your  multi-serving  product  using  the  
RACC  for  the  product  (21  CFR  101.9(b)(2),(3),  and  (4)). 
The  serving  size  is  expressed  as  a  common  household  measure  followed  by  
the  equivalent  metric  quantity  in  parenthesis  (e.g.,  1/2  cup  (112  g)).  
21 
Acceptable  household  measures  are  listed  in  order  of  appropriate  use  in  
CFR  101.9(b)(5)
.  Rounding  rules  for  metric  quantities  and  a  few  
21  CFR  101.9(b)(7)
additional  format  options  are  included  in   . 
3. 
Use  the  information  in  21  CFR  101.9(b)(8)  to  determine  the  number  of  
servings  and  the  appropriate  rounding  rules  for  numbers  of  servings. 
L58. The  RACC  for  a  food  product  is  50  grams,  but  a  single  serving  of  the  
product  weighs  54  grams.  Is  the  nutrition  information  based  on  the  50  
gram  RACC  or  the  actual  metric  unit? 
Answer: The  nutrition  information  on  the  label  is  based  on  the  household 
unit  closest  to  the  RACC.  In  this  case  it  would  be  based  on  54  grams,  which 
would  be  declared  as  the  weight  of  the  label  serving  size.  The  RACC  is  used  as 
the  starting  point  to  determine  the  serving  size  for  the  foods  in  each  product 
category  and  to  govern  claims. 
L59. What  is  the  RACC  for  partially  cooked,  packaged  pasta  products?  Table  2 
only  gives  RACCs  for  prepared  and  dry  pasta. 
Answer: The  RACC  for  a  partially  cooked  pasta  product  is  the  amount  of 
21 
partially  cooked  pasta  that  makes  one  RACC  of  cooked  pasta  (140  grams).  
CFR  101.12(c) 
L60. To  what  category  do  pickled  vegetables  belong? 
Answer: Pickled  vegetables  are  categorized  with  pickles,  all  types  with  a 
21  CFR  101.12(b) 
RACC  of  30  grams.  
L61.What  if  my  product  does  not  have  an  appropriate  food  category  
listing  or  RACC? 
Answer: The  agency  realizes  that  the  categories  in  Table  2  Reference 
Amounts  Customarily  Consumed  may  not  include  all  foods  marketed  in  the 
U.S.  Therefore,  in  order  to  allow  manufacturers  to  provide  nutrition 
information  on  currently  marketed  product  labels,  the  manufacturer  should 
write  the  agency  and  send  in  information  regarding  the  primary  usage, 
A  F O O D  L A B E L I N G  G U I D E   49  amount  customarily  consumed,  and  any  other  information  as  requested  for  a 
2 1  CF R  10 1 .12 (h) . 
petition  as  discussed  in  section   FDA  will  provide  a 
suggested  RACC  for  the  product  that  may  be  used  to  meet  the  manufacturer's 
immediate  needs  to  nutrition  label  its  products.  While  the  agency  will  provide 
a  suggested  RACC  so  as  to  allow  the  manufacturer  to  nutrition  label  its 
products  at  this  time,  FDA  believes  that  it  will  be  necessary  at  a  later  date  to 
undertake  notice  and  comment  rulemaking  to  formally  establish  a  RACC. 
Alternatively,  the  manufacturer  or  any  other  interested  party  may  petition 
21  CFR  101.12(h). 
FDA  at  any  time  to  establish  a  RACC  as  specified  in  
L62. What  suggested  RACCs  have  been  provided  to  date? 
Answer: The  suggested  RACCs  to  date  are  shown  below.  The  labeled 
serving  size  for  these  products  would  be  expressed  in  a  household  unit 
followed  by  the  metric  equivalent  in  parentheses. 
	
Powdered,  flavored  candy 15  g 
	 

Colored,  flavored  syrup-filled  wax  candy 15  mL
	 

Ice 4  ounces
	 

Dried  tomatoes  (halved,  sliced,  minced,  bits) 5  g
	 

Dried  tomatoes  in  oil  (halved,  sliced,  minced,  bits) 10  g


Wrappers  for  eggrolls,  dumplings,  wontons  or  potstickers  60  g
	 

Egg  whites  (fresh,  frozen,  dried) about  1  large  egg
	 

Sugared  eggs,  sugared  egg  yolks about  1  large  egg
	 

Flavoring  oils 1  t
	 

Fruit  chutney 1  T
	 

Dried  yeast 0.5  g
	 

Baking  cocoa,  carob  powder 2  T
	 

Coconut  milk 1/3  cup


Dried,  e.g.,  sun-dried  tomatoes,  dried  mushrooms,  dried  seaweed  10  g
	 

Dried  seaweed  sheets 3  g
	 

Vegetable  spreads  (eggplant  caponata,  olive  spread) 2  T
	 

Sprouts 10  g
Hors  doeuvres,  mini  eggrolls,  mini  pizza  rolls  and  bagel  pizzas  85  g 
L63. What  terms  must  be  used  for  the  serving  size? 
Answer:  The  serving  size  declaration  is  made  up  of  two  parts:  a  household 
measure  term  followed  by  its  metric  equivalent  in  grams  (g).  For  beverages, 
the  household  measures  may  be  declared  as  either  f luid  ounces,  cups,  or 
fractions  of  a  cup  with  the  metric  equivalent  in  milliliters  (mL).  The  examples 
below  show  permitted  declarations. 
	
Food Examples 
	 

Cookies 1  cookie  (28  g)  or  1  cookie  (28  g/1  oz)
	
Milk,  juices,  soft  drinks 8  fl  oz  (240  mL),  or  1  cup  (240  mL)  
for  multiserving  containers,  or  the  container  
(e.g.,  1  can)  for  single  serving  containers 


Grated  cheese  1  tablespoon  (5  g)  or  1  tablespoon  (5  g/0.2  oz)
21  CFR  101.9(b)(2),  21  CFR  101.9(b)(5),  21  CFR  101.9(b)(7),  
21  CFR  101.12(b) 
and 
50 G U I D A N C E  F O R  I N D U S T R Y  L64. Is  a  RACC  different  from  a  serving  size? 
Answer:  Yes,  the  RACC  is  used  to  derive  a  serving  size  for  a  particular  product. 
The  following  example  shows  how  to  use  the  RACC  to  determine  the  serving 
size  for  a  16  oz  (454g)  pizza: 
1. 1st  step: From  the  RACCs  table  (21  CFR  101.12(b)),  you  determine  that  the 
RACC  for  pizza  is  140g. 
2. 2nd  step: Calculate  the  fraction  of  the  pizza  that  is  closest  to  the  RACC  of 


140g  (calculations  shown  for  a  pie  of  net  weight  16oz/454g  pizza):


1/3  X  454g  =  151g


1/4  X  454g  =  113g
Note  that  151g  is  closer  than  113g  to  the  RACC  for  pizza  (140g) 
3. 3rd  step: The  serving  size  is  the  fraction  closest  to  the  RACC  together  with 
the  actual  gram  weight  for  that  fraction  of  the  pizza: 
Example:  Serving  Size  1/3  pie  (151g) 
Therefore,  the  serving  size  is    1/3  pizza  (151g)  for  this  example,  whereas  the 
RACC  is  140g  for  all  pizzas.  Note:  Sections  101.9(b)(2)(i)  (discrete  units),  21 
CFR  101.9.(b)(2)(ii)  (large  discrete  units),  and  21  CFR  101.9(b)(2)(iii)  (bulk 
products)  describe  how  to  use  the  RACC  to  derive  a  ser ving  size. 
21  CFR  101.12(b) 
L65.The  table  for  RACCs  in  the  regulation  contains  a  column  of  label  
statements.  What  are  these  and  must  I  use  them  in  declaring  a  
serving  size  for  my  food  product? 
Answer: FDA  added  a  label  statement  column  to  the  RACC  tables  to  provide 
manufacturers  with  examples  of  how  serving  sizes  could  appear  on  product 
labels.  Exact  values  were  initially  provided  as  part  of  these  statements,  but  have 
since  been  removed  because  some  manufacturers  incorrectly  believed  that  the 
exact  label  statements  were  required  even  if  the  values  were  inaccurate  for  their 
specific  products.  Manufacturers  should  realize  that  the  label  statement 
column  is  not  all  inclusive  and  merely  provides  a  few  examples  of  possible 
label  statements.  Manufacturers  should  use  an  appropriate  household  measure 
and  the  corresponding  metric  weight  or  volume  actually  measured  for  their 
21  CFR  101.12(b) 
specific  product.  
L66. If  the  number  of  units  closest  to  the  RACC  is  midway  between  two  
numbers,  which  should  be  chosen? 
Answer:  For  serving  sizes  halfway  between  two  numbers  of  units,  the  serving 
(21  CFR  101.9(b)(5)(ix))
size  should  be  rounded  up  to  the  higher  value   .  For 
example,  the  RACC  for  cookies  is  30  g.  If  the  product  is  a  bag  of  12  g  cookies, 
then  2  units  weigh  24  g,  and  3  units  weigh  36  g.  Thus,  2.5  cookies  would 
weigh  exactly  30  g,  and  the  serving  size  would  be  rounded  to  the  next 
incremental  value:  3  cookies  (36  g). 
L67. How  is  the  serving  size  calculated  for  the  Nutrition  Facts  label  on  a  
biscuit  mix  product? 
Answer: The  following  example  shows  how  to  calculate  the  serving  size  for  a 
biscuit  mix  product  and  similar  products  that  require  further  preparation: 
1. 1st  step: From  the  RACC  table  (21  CFR  101.12(b)),  determine  that  the  
RACC  for  biscuits  is  55g. 
2. 2nd  step: Determine  amount  of  mix  needed  to  make  a  55g  biscuit. 
A  F O O D  L A B E L I N G  G U I D E   51  3.	 3rd  step: Determine  closest  permitted  fraction  of  tablespoon  or  cup  that  
contains  the  amount  of  mix  closest  to  the  amount  determined  in  step  2. 
4. 4th  step: The  serving  size  is  the  fraction  of  a  tablespoon  or  cup  of  biscuit  
mix  determined  in  step  3  together  with  the  actual  gram  weight  of  that  
measure  of  biscuit  mix  as  the  serving  size. 
Use  the  form  Serving  Size  ^^  cup  (^^  g),  the  blanks  filled  in  with  
21  CFR  101.12(b)&(c) 
correct  values  for  the  product.  
L68. Is  it  necessary  to  reformulate  the  size  of  a  product  such  as  cookies  so  
that  the  serving  size  weighs  exactly  the  RACC  (i.e.,  30g)? 
Answer: It  is  not  necessary  to  adjust  the  size  of  your  cookies  to  fit  the  RACC. 
For  example,  if  four  cookies  weigh  28  grams  (and  five  cookies  weigh  35  grams), 
declare  the  number  of  cookies  nearest  the  RACC  and  label  with  the  exact 
weight  of  that  number  of  cookies  for  the  serving  size:  Serving  size  4  cookies 
21  CFR  101.12(b) 
(28g)  or  4  cookies  (28g/1  oz).  
L69. What  fractions  must  be  used  to  express  serving  sizes  in  common  
household  measures? 
Answer: For  cups,  these  fractions  of  a  cup  are  allowed  household  measures: 
1/4  cup,  1/3  cup,  1/2  cup,  2/3  cup,  3/4  cup,  1  cup,  1  1/4  cup,  etc.  If  serving 
sizes  are  declared  in  f luid  ounces,  declare  the  serving  size  in  whole  numbers 
(such  as  4  fl  oz,  5  fl  oz,  6  fl  oz,  etc).  For  tablespoons,  the  following  fractions  of 
a  tablespoon  are  allowed:  1,  1  1/3,  1  1/2,  1  2/3,  2,  and  3  tablespoons.  For 
teaspoons,  the  fractions  of  a  teaspoon  shall  be  expressed  as  1/8,  1/4,  1/2,  3/4, 
21  CFR  101.9(b)(5)(i) 
1,  or  2  teaspoons.  
L70. For  foods  that  are  usually  cut  into  pieces  before  serving,  what  fractions  
must  be  used  in  the  serving  size  declaration? 
Answer: These  fractions  must  be  used  in  serving  sizes  for  foods  such  as  cakes 
or  pies:  1/2,    1/3,  1/4,  1/5,  1/6,  1/8,  1/9,  1/10,  1/12  and 
smaller  fractions  that  can  be  arrived  at  by  further  division  by  2  or  3.  
21  CFR  101.9(b)(2)(ii) 
L71. For  a  multiserving  package,  what  is  the  serving  size  for  a  product  that  
is  sliced  thinner  or  thicker  than  the  RACC? 
Answer: The  slices  are  treated  as  discrete  units.  One  slice  is  a  single  serving 
if  it  weighs  from  67%  to  less  than  200%  of  the  RACC.  Larger  slices  (weighing 
more  than  200%  of  RACC)  may  be  declared  as  a  serving  if  the  whole  slice  can 
reasonably  be  eaten  at  a  single-eating  occasion.  For  slices  weighing  between 
50%-67%  of  the  RACC,  the  serving  size  may  be  declared  as  either  one  or  two 
slices.  For  slices  weighing  less  than  50%  of  the  RACC,  the  serving  size  is  the 
number  of  slices  closest  to  the  RACC.  
21  CFR  101.9(b)(2)(i)  and  21  CFR  101.12 
L72. Should  a  label  show  2  1/2  servings? 
Answer: For  packages  containing  from  two  to  five  servings,  round  the  number 
of  servings  to  the  nearest  0.5  serving.  Examples:  2  servings,  2.5  servings, 
3  servings,  3.5  servings,  4  servings,  4.5  servings,  and  5  servings.  For 
packages  containing  five  or  more  servings,  round  the  number  of  servings  to 
the  nearest  whole  serving.  Examples:  5  servings,  6  servings,  7  servings. 
Rounding  should  be  indicated  by  the  term  about  (e.g.,  about  6  servings). 
21  CFR  101.9(b)(8) 
52 G U I D A N C E  F O R  I N D U S T R Y  Serving  Size/As  Packaged/As  Prepared 
L73. My  dehydrated  mixed  dish  product  has  a  RACC  of  1  cup.  Do  I  declare  the  
serving  size  as  1  cup  or  the  amount  of  my  product  to  make  1  cup? 
Answer:  Although  the  RACC  for  mixed  dish  products  is  one  cup,  this 
amount  is  for  the  prepared  product.  The  serving  size,  however,  must  represent 
the  product  as  packaged.  This  will  be  the  amount  of  the  product,  expressed  in 
a  household  measure,  that  will  make  one  cup  when  prepared  according  to 
package  directions.  For  example,  the  serving  size  for  a  dry  seasoned  rice  mix 
will  be  less  than  one  cup  since  rice  expands  during  cooking.  The  gram  weight 
in  the  parenthetical  expression  will  be  the  weight  of  the  household  measure  of 
21  CFR  101.9(b)(9) 
dry  mix.  
L74.Should  the  serving  size  and  number  of  servings  per  container  
for  unpopped  popcorn  be  based  on  the  prepared  product? 
Answer: The  serving  size  and  servings  per  container  for  unpopped  popcorn  is 
based  on  the  amount  of  the  product  as  packaged  or  purchased  needed  to 
make  the  RACC  of  the  prepared  product.  A  second  column  of  nutrition 
21  CFR 
information  based  on  the  as  prepared  basis  may  also  be  presented.  
101.9(b)(10)(iii) 
Serving  Size/Separately  Packaged  Ingredients 
L75. What  about  the  use  of  fractions  of  a  package  to  declare  serving  sizes,  
such  as  a  1/8  package  of  dry  mix? 
Answer: Generally,  serving  sizes  cannot  be  declared  on  the  basis  of  fractions  of 
a  package.  The  exception  is  for  unprepared  products  where  the  entire  contents 
of  the  package  mix  is  used  to  prepare  one  large  discrete  unit  that  is  usually 
(21  CFR  101.9(b)(5)(v)). 
divided  for  consumption  (e.g.,  cake  mix,  pizza  kit) 
For  example,  a  mix  for  a  sheet  cake  may  declare:  1/12  package  (40  g/about 
1/3  cup  mix).  This  option  is  not  allowed  for  other  dry  mixes  or  other 
products.  However,  a  fraction  of  the  package  may  be  used  as  part  of  the  visual 
(21 
unit  of  measure  when  ounces  is  used  as  the  primary  household  measure  
CFR  101.9(b)(5)(iii)). 
For  example,  the  serving  size  listed  on  a  1  lb  (16  oz) 
box  of  spaghetti  could  be:  2  oz  (56  g/  1/8  box). 
L76.  Are  there  special  provisions  for  individually  packaged  products? 
Answer:  Single  serving  containers  and  individually  packaged  products  within 
multi-serving  containers  must  use  a  description  of  the  individual  container  or 
package  (21  CFR  101.9(b)(5)(iv)):  1  can  (360  mL)  or  2  boxes  (38  g),  and 
(21 
products  in  discrete  units  must  use  a  description  of  the  individual  unit 
CFR  101.9(b)(5)(iv)): 
2  candies  (22  g)  or  1  slice  (45  g). 
L77. What  are  the  options  for  products  consisting  of  several  inner  packaged  
components  and  intended  to  be  mixed  together? 
Answer: Products  consisting  of  two  or  more  distinct  ingredients  or 
components  packaged  and  presented  to  be  consumed  together  (e.g.,  dry 
macaroni  and  cheese  mix,  cake  and  muffin  mixes  with  separate  ingredient 
packages,  pancakes  and  syrup)  may  declare  serving  size  and  nutrition 
information  either:  (a)  for  each  component  or  (b)  as  a  composite.  For  products 
where  one  of  the  components  is  represented  as  the  main  ingredient,  there  are 
A  F O O D  L A B E L I N G  G U I D E   53  provisions  for  representing  the  amount  of  the  main  ingredient  and 
(21  CFR  101.9(b)  (5)(i)(iii),  CFR  21 
proportioned  minor  ingredients  
101.9(b)(2)(i)(H)): 
2  pancakes  with  syrup  (160  g)  or  alternatively  2 
pancakes  (110  g)  and  either  syrup  for  2  pancakes  (50  g)  or  2  tbsp  syrup  (50 
g)  if  50  g  of  syrup  makes  2  tbsp.  In  addition,  these  products  may  also  use 
(21  CFR  101.9(b)(5)(vii)): 
ounces   4  oz  (112  g/about  2/3  cup  macaroni  and 
2  tbsp  dry  cheese  mix)  or  alternatively  3  oz  dry  macaroni  (84  g/about  2/3 
cup)  and  1  oz  dry  cheese  mix  (28  g/about  2  tbsp). 
L78 How  do  we  state  the  serving  size  for  peanuts  with  shells? 
Answer:  The  RACC  for  nuts  is  30  grams  edible  portion.  The  serving  size  for 
peanuts  with  shells  would  be  the  household  measure  closest  to  30  grams  of 
nuts  without  shells.  In  order  to  reduce  consumer  confusion  regarding  the 
serving  size,  a  clarifying  statement  can  be  used.  For  example,  the  serving  size 
statement  for  your  product  might  read:  1/2  cup  nuts  without  shells  (30  g/ 
about  1  cup  nuts  with  shells  ). 
L79. Is  the  serving  size  for  all  pickled  vegetables  based  on  a  drained  weight  
basis?  Is  it  the  same  for  canned  vegetables? 
Answer: The  serving  size  for  pickled  vegetables  is  based  on  the  drained  weight 
of  the  product  because  the  liquid  is  not  usually  consumed  with  these  type 
products.  For  canned  vegetables,  the  liquid  is  included  in  the  determination  of 
21  CFR  101.9(b)(8)(ii),  21  CFR  101.9(b)(9) 
serving  size.  
Serving  Size/Dual  Column  Allowances 
L80. If  a  product  is  sold  both  in  the  U.S.  and  exported,  can  the  nutrition  
information  also  be  declared  per  100  grams  or  per  100  mL  in  order  
to  meet  certain  international  requirements? 
Answer: Yes.  Section  21  CFR  101.9(b)(10) permits  the  voluntary  listing  of 
nutrition  information  per  100  grams  or  100  mL  of  the  food  as  packaged  or 
purchased.  A  column  may  also  be  presented  with  nutrition  information  per  1 
oz  or  per  1  fl  oz  as  packaged  or  prepared. 
L81. Products  such  as  mini  egg  rolls,  pizza  rolls,  and  stuffed  pastry  are  
categorized  as  mixed  dishes.  However,  on  the  label  of  these  products,  
they  are  promoted  as  appetizers,  as  well  as  side  dishes.  How  can  the  
products  be  labeled  to  show  their  use  as  appetizers  with  a  smaller  
serving  size  than  as  a  side  dish? 
Answer: The  regulations  allow  a  second  column  of  nutrition  information  to 
be  declared  for  a  food  provided  that  it  is  not  misleading  to  consumers.  The 
serving  size  and  first  column  of  nutrition  information  for  these  products 
would  be  based  on  their  use  as  a  mixed  dish,  but  the  second  column  could  be 
21  CFR  101.9(b)(11),  21  CFR  101.9(e) 
based  on  their  use  as  an  appetizer.  
L82. Although  sauerkraut  and  pickled  beets  are  categorized  under  pickles,  
all  types  with  a  RACC  of  30  grams,  can  they  also  be  labeled  as  a  
vegetable  side  dish  with  a  RACC  of  130  grams? 
Answer: Yes,  manufacturers  may  use  a  second  column  to  declare  information 
based  on  a  different  serving  size.  The  first  column  under  the  Nutrition  Facts 
label  would  show  the  serving  size,  servings  per  container,  and  nutrition 
information  based  on  a  30  gram  RACC  for  the  pickled  vegetable  and  the 
second  column  could  show  nutrition  information  based  on  the  RACC  for  the 
21  CFR  101.9(b)(11)  and  21  CFR  101.9(e) 
product  used  as  a  vegetable  side  dish.  
54 G U I D A N C E  F O R  I N D U S T R Y  Serving  Size/Single  Serving  Containers 
L83. What  are  the  exemptions  for  singleserving  containers? 
Answer: Single  serving  containers  may  omit  the  servings  per  container 
declaration.  In  addition,  most  single  serving  containers  may  omit  the  metric 
equivalent  portion  of  the  serving  size  declaration.  However,  if  it  is  voluntarily 
included,  it  must  be  consistent  with  the  net  quantity  of  contents  value.  The 
serving  size  for  single-serving  containers  must  be  a  description  of  the  container 
such  as:  Serving  Size:  1  package  for  food  in  bags,  Serving  Size:  1  container 
for  foods  in  plastic  containers,  or  Serving  Size:  1  can  as  appropriate.  Only 
those  few  foods  that  are  required  to  declare  drained  weights  must  include  the 
metric  equivalent  as  part  of  the  serving  size  declaration  (e.g.,  Serving  size:  1 
21  CFR  101.9(b)(5)(iv),  21  CFR  101.9(b)(7)(i) 
can  drained  (^^g)).   and 
21  CFR  101.9(d)(3)(ii) 
L84. How  do  I  know  if  my  product  is  a  singleserving  container? 
Answer:  Single-serving  containers  are  discussed  in  21  CFR  101.9(b)(6). 
Products  that  are  packaged  and  sold  individually  are  considered  to  be  single 
servings  if  they  contain  less  than  200%  of  the  RACC  for  the  product  category. 
Above  200%  of  the  RACC,  it  is  the  manufacturer's  option  to  label  the 
product  as  a  multi-serving  container  or  as  a  single-serving  container  if  it  can 
reasonably  be  consumed  at  a  single  eating  occasion.  For  example,  the  RACC 
for  brownies  is  40  g.  All  brownies  that  are  packaged  and  sold  individually  and 
that  weigh  less  than  80  g  must  be  labeled  as  a  single  serving.  If  the 
manufacturer  believes  it  is  reasonable  for  an  individually  packaged  brownie 
that  weighs  more  than  80  g  to  be  consumed  at  one  time,  such  a  brownie  may 
also  be  labeled  as  one  serving. 
L85.What  about  singleserving  containers  for  products  that  have  larger 
RACCs,  such  as  soup? 
Answer: If  a  product  has  a  RACC  of  100  g  or  100  mL  or  larger  and  is 
packaged  and  sold  individually,  it  must  be  labeled  as  a  single-serving  if  it 
contains  150%  or  less  of  the  RACC.  However,  packages  for  such  products 
containing  between  150%  and  200%  of  the  RACC  may  be  labeled  as  one  or 
two  servings  at  the  manufacturer's  option. 
For  example,  the  RACC  for  potato  salad  is  140  g.  Containers  of  potato  salad 
that  are  packaged  and  sold  individually  and  that  weigh  210  g  or  less  must  be 
labeled  as  a  single  serving.  Containers  weighing  between  210  g  and  280  g  may 
be  labeled  as1  or  2  servings.  However,  the  serving  size  for  a  product  labeled  as 
two  servings  is  based  on  the  household  measure  and  not  on  the  weight  of  1/2 
21  CFR  101.9(b)(6) 
package.  
L86. What  are  the  differences  between  labeling  for  singleserving  containers 
and  multiserving  containers? 
Answer: The  serving  size  statement  for  multi-serving  containers  must  use  the 
(21  CFR  101.9(b)(5)(i)(iii)), 
hierarchy  of  common  household  measures 
whereas  single-serving  containers  are  required  to  use  a  description  of  the 
(21  CFR  101.9(b)(5)(iv)). 
individual  container  or  package   Multi-serving 
packages  must  list  the  metric  equivalent  to  the  household  measure  and  the 
number  of  servings  in  the  container;  however  this  is  optional  information  on 
single-serving  containers.  If  the  metric  equivalent  is  listed  on  single-serving 
containers,  it  must  match  the  net  contents  declaration  for  the  product. 
A  F O O D  L A B E L I N G  G U I D E   55  An example  of  a  single-serving  container  would  be  a  360  mL  can  of  soda  that 
is  packaged  and  sold  individually.  The  serving  size  for  this  product  would  be 
1  can  or  1  can  (360  mL),  and  the  number  of  servings  would  be  1  or  not 
listed  at  all.  By  contrast,  the  serving  size  for  a  one  liter  soda  bottle  (1000  mL) 
would  be  8  fl  oz  (240  mL)  or  1  cup  (240  mL),  and  the  number  of  servings 
would  be  listed  as  about  4. 
L87. Won't  the  serving  sizes  vary  for  products,  such  as  soft  drinks,  that  
are  packaged  in  different  size  singleserving  containers  and  in  
larger  bulk  containers? 
Answer: Yes.  The  serving  size  for  beverages  in  single-serving  containers  is  the 
total  contents  of  the  container.  Thus,  the  serving  size  would  be  listed  as  1 
bottle,  but  the  contents  could  vary  greatly  (e.g.,  8  f l  oz,  12  f l  oz,  16  fl  oz,  etc.). 
Since  the  RACC  for  beverages  is  240  mL,  the  serving  size  for  multi-serving 
beverage  containers  such  as  the  commonly  available  one-liter  bottle  would  be 
either  1  cup  (240  mL)  or  8  fl  oz  (240  mL). 
L88. The  RACC  for  muffins  is  55  grams.  If  a  single,  large  muffin  weighs  130  
grams,  can  it  be  labeled  as  one  serving? 
Answer: A  130  gram  muffin  weighs  236%  of  the  RACC  for  muffins.  Products 
that  weigh  more  than  200%  of  the  RACC  may  be  labeled  as  one  serving  if  the 
entire  contents  of  the  package  can  reasonably  be  consumed  at  a  single  eating 
occasion.  Therefore,  there  are  two  options  for  the  serving  size  declaration  for 
21  CFR 
this  large  muffin:  1  muffin  (130  g)  or  1/2  muffin  (65  g).  
101.9(b)(6) 
L89. Are  there  limits  on  the  size  of  a  package  that  may  be  labeled  as  a  
single  serving? 
Answer: Products  that  are  packaged  and  sold  individually  are  considered  to  be 
single  servings  if  they  contain  less  than  200%  of  the  RACC  shown  in  21  CFR 
101.12.  For  packages  that  contain  200%  or  more  of  the  RACC,  it  is  the 
manufacturer's  option  to  label  the  product  as  a  single  serving  if  the  entire 
21  CFR  101.9(b)(6) 
contents  can  reasonably  be  eaten  at  one  time.  
L90. What  is  the  smallest  amount  of  food  that  may  be  labeled  as  two  
servings? 
Answer: The  answer  depends  on  the  size  of  the  RACC.  For  foods  with  RACC 
less  than  100g  (solid  foods)  or  100mL  (liquids),  packages  must  contain  at  least 
200%  of  the  RACC  to  be  labeled  as  2  servings.  For  foods  with  RACCs  of  100g 
or  100mL  or  more,  you  may  choose  to  label  packages  containing  more  than 
21  CFR 
150%  but  less  than  200%  of  the  RACC  as  either  one  or  two  servings. 
101.9(b)(6)  21  CFR  101.12(b) 
and  
Serving  Size/Servings  Per  Container 
L91. Can  the  number  of  servings  be  listed  as  1.5  or  about  1.5? 
Answer: No.  Rounding  to  the  nearest  0.5  servings  is  allowed  between  2  and  5 
servings.  Below  2  servings,  the  number  of  servings  must  be  listed  as  1  or 
about  2.  For  example,  the  RACC  for  egg  rolls  is  140  g.  Since  the  RACC  is 
greater  than  100  g,  a  package  of  egg  rolls  containing  more  than  150%  but  less 
than  200%  of  the  RACC  can  be  labeled  as  1  or  2  servings.  For  example,  a 
56 G U I D A N C E  F O R  I N D U S T R Y  package  of  egg  rolls  weighs  225  g  and  contains  3  egg  rolls  (75  g  each).  The 
manufacturer  may  choose  to  label  the  product  as  1  serving  (3  egg  rolls  (225  g)). 
Alternatively,  if  the  manufacturer  chooses  to  label  the  product  as  more  than  1 
serving,  the  serving  size  would  be  2  egg  rolls  (150  g).  The  number  of 
servings,  determined  as  the  total  contents  divided  by  the  serving  size,  would  be 
21  CFR  101.9(b)(8) 
1.5  and  would  be  rounded  to  about  2.   
Serving  Size/Small  Discrete  Units 
L92. What  are  the  key  considerations  when  determining  a  serving  size  for  a  
product  that  consists  of  small  discrete  units? 
Answer: Serving  sizes  for  products  in  discrete  units  (e.g.,  muffins,  sliced  bread, 
and  individually-packaged  products  in  multi-serving  packages)  are  discussed  in 
21  CFR  101.9(b)(2)(i). 
The  serving  size  options  depend  on  the  RACC  for 
the  product  and  the  weight  of  a  single  discrete  unit. 
	
 If  a  single  unit  weighs  50%  or  less  of  the  RACC,  the  serving  size  will  be  the 
number  of  whole  units  closest  to  the  RACC.  For  example,  the  RACC  for  
hard  candy  is  15  g;  therefore,  50%  of  the  RACC  is  7.5  g.  For  a  bag  of  candy 
where  the  individual  candies  weigh  4  g  (less  than  7.5  g),  the  serving  size  
would  be  4  candies  (16  g). 
	
 If  a  single  unit  weighs  more  than  50%  but  less  than  67%  of  the  RACC,  
there  are  two  options  for  declaring  serving  size,  either  1  or  2  units.  For  
example,  the  RACC  for  snack  crackers  is  30  g;  thus  50%  of  the  RACC  is  
15  g,  and  67%  of  the  RACC  is  20.1  g.  For  a  box  of  crackers  where  the  
individual  crackers  weigh  17  g,  (15  g  <  17  g  <  20.1  g),  the  serving  size  would  
be  either  1  cracker  (17  g)  or  2  crackers  (34  g). 
	
 If  a  single  unit  weighs  67%  or  more  but  less  than  200%  of  the  RACC,  
then  the  serving  size  must  be  declared  as  1  unit.  For  example,  the  RACC  
for  bread  is  50  g;  therefore  67%  of  the  RACC  is  33.5  g,  and  200%  of  the  
RACC  is  100  g.  One  slice  of  bread  would  be  used  as  the  serving  size  for  
breads:  1  slice  (45  g).  However,  if  the  RACC  is  100  g,  or  100  mL  for  
liquids,  or  larger,  and  the  product  weighs  more  than  150%  but  less  than  
200%  of  the  RACC,  the  manufacturer  may  decide  whether  the  individual  
unit  is  1  or  2  servings  (also,  see  questions  for  single-serving  containers). 
	
 If  the  single  unit  weighs  200%  or  more  of  the  RACC,  there  are  two  
options.  The  serving  size  can  either  be  declared  as  one  unit  if  the  entire  
unit  can  reasonably  be  eaten  on  one  occasion  or  can  be  declared  as  a  
portion  of  the  unit.  For  example,  the  RACC  for  candy  bars  is  40  g,  and  
200%  of  the  RACC  is  80  g.  For  a  90  g  candy  bar,  the  serving  size  could  be  
either  1  candy  bar  (90  g)  or    candy  bar  (45  g). 
FDA  also  provides  additional  specific  provisions  for  (1)  products  (such  as 
21  CFR  101.9(b)(8)(ii)
pickles)  that  naturally  vary  in  size   ;  (2)  products  made 
21 
up  of  two  or  more  foods,  packaged  and  intended  to  be  consumed  together  
CFR  101.9(b)(5)(vii)
;  and  (3)  products  containing  several,  fully  labeled, 
21  CFR  101.9(b)(5)(iv) 
single  serving  units.  
A  F O O D  L A B E L I N G  G U I D E   57  L93. The  RACC  for  beverages  is  240  mL  (8  fl  oz).  If  a  product  is  packaged  as  a  
group  of  6  fl  oz  bottles  (discrete  units),  should  the  serving  size  for  this  
product  be  declared  as  8  fl  oz  (240  mL)? 
Answer: For  products  with  RACCs  of  100  mL  or  larger,  the  serving  size  for 
discrete units  that  contain  67%  or  more  but  less  than  or  equal  to  150%  of  the 
RACC  is  1  unit.  For  beverages,  this  range  is  160.8  mL  to  360  mL.  Thus,  1  bottle 
would  be  the  serving  size  for  beverages  packaged  in  6  fl  oz  (180  mL)  bottles. 
L94. The  RACC  for  cakes,  heavy  weight  is  125  grams.  If  the  individual  
portions  of  a  presliced  cake  weigh  55  grams,  what  would  be  the  serving 
size  declaration? 
Answer: The  pre-portioned  slices  are  treated  like  all  other  discrete  units.  The 
55  g  piece  of  cake  is  less  than  50%  of  the  RACC  for  heavy  weight  cakes  (50% 
of  125  g  =  62.5  g);  therefore  the  serving  size  will  be  the  number  of  units  closest 
to  the  RACC.  Two  pieces  weigh  110  g,  and  3  pieces  weigh  165  g;  therefore,  the 
21  CFR  101.9(b)(2)(i)(A) 
serving  size  would  be  2  pieces  (110  g).  
Serving  Size/Large  Discrete  Units 
L95. What  are  the  steps  for  determining  a  serving  size  for  a  product  that  is  a  
large  discrete  unit? 
Answer: Serving  sizes  for  products  in  large  discrete  units  usually  divided  for 
21  CFR 
consumption  (e.g.,  cake,  pie,  pizza,  melon,  cabbage)  are  discussed  in  
101.9(b)(2)(ii). 
The  serving  size  depends  on  the  RACC  for  the  product  and 
on  the  fraction  of  the  large  discrete  unit.  The  serving  size  is  expressed  using 
the  allowed  fraction  (friendly  fraction)  that  is  closest  to  the  RACC. 
For  example,  the  RACC  for  pizza  is  140  g.  A  16  oz  (454  g)  pizza  can  be  divided  in 
half  (one  piece  =  227  g),  thirds  (one  piece  =  151  g),  fourths  (one  piece  =  113  g),  etc. 
The  closest  fraction  is  1/3;  therefore  the  serving  size  would  be    1/3  pizza  (151  g). 
Allowable  fractions  include  1/2,  1/3,  1/4,  1/5,  1/6,  or  smaller  fractions  that 
can  be  generated  by  further  division  by  2  or  3.  An  additional  example  would 
be:  1/8  (i.e.,  1/4  divided  by  2).  Thus,  fractions  such  as  1/7,  1/11,  1/13,  and 
1/14  are  not  allowed. 
Serving  Size/Bulk  Products 
L96. I  have  several  products  that  are  bulk  products  and  I  want  to  know  the  
appropriate  serving  size  to  list  on  the  label.  How  do  I  start,  and  what  
steps  should  I  follow? 
Answer: Serving  sizes  for  non-discrete  bulk  products  (e.g.,  breakfast  cereal, 
flour,  sugar,  dry  mixes,  concentrates,  pancake  mixes,  macaroni  and  cheese  kits) 
21  CFR  101.9(b)(2)(iii). 
are  discussed  in   The  serving  size  depends  on  the 
RACC  for  the  product  and  on  the  household  measure.  The  serving  size  is 
expressed  using  the  allowed  household  measure  that  is  closest  to  the  RACC. 
For  example,  the  RACC  for  snacks  is  30  g.  If  a  bag  contains  a  mixture  of  nuts 
and  caramel  popcorn  that  weighs  23  g  per  cup,  then  1  1/4  cup  weighs  28.75  g 
and  1  1/3  cup  weighs  30.7  g.  The  closest  household  measure  is  1  1/3  cup; 
therefore  the  serving  size  would  be  1  1/3  cup  (31  g). 
Allowable  household  measures  include  (a)  cups  as  1/4,  1/3,  1/2,  2/3,  3/4,  1,  
58 G U I D A N C E  F O R  I N D U S T R Y  1  1/4,  1  1/3,  etc,  (b)  tablespoons  as  1,  1  1/3,  1  1/2,  1  2/3,  2,  and  3,  and  (c) 
teaspoons  as  1/8,  1/4,  1/2,  3/4,  1,  and  2.  In  addition,  piece,  slice,  tray,  jar, 
fraction,  and  ounce  may  be  used  in  accordance  with  the  provisions  of  
21  CFR  101.9(b)(5). 
L97. What  if  the  dehydrated  mixed  dish  product  contains  several  inner  
packages  of  ingredients  intended  to  be  mixed  together  to  prepare  a  bulk 
product,  such  as  macaroni  and  cheese? 
Answer: In  these  cases,  manufacturers  may  use  an  ounce  declaration  (21  CFR 
101.9(b)(5)(vii)).  For  example,  the  RACC  for  prepared  macaroni  and  cheese  is 
1  cup.  If  a  12  oz  package  (9  oz  dry  macaroni  and  3  oz  dry  cheese  mix)  makes  3 
cups  of  prepared  macaroni  and  cheese,  then  the  serving  size  for  the  composite 
product  could  be  expressed  as  4  oz  (112  g/about  2/3  cup  macaroni  and  2 
tbsp  dry  cheese  mix).  Alternatively,  the  manufacturer  may  provide  nutrition 
information  separately  for  each  component.  Thus,  the  serving  size  could  also 
be  expressed  as  3  oz  dry  macaroni  (84  g/about  2/3  cup)  and  1  oz  dry 
cheese  mix  (28  g/about  2  tbsp). 
L98. What  is  the  serving  size  for  products  such  as  a  cake  mix? 
Answer: For  products  that  require  further  preparation,  where  the  entire 
contents  of  the  package  are  used  to  prepare  a  large  discrete  unit  usually 
divided  for  consumption,  the  serving  size  is  the  amount  of  the  unprepared 
product  used  to  make  one  RACC  for  the  prepared  product.  The  RACC  for 
the  unprepared  product  is  the  amount  of  the  unprepared  product  that  is 
required  to  make  the  fraction  of  the  prepared  product  closest  to  the  RACC  of 
the  prepared  product.  For  example,  a  prepared  medium-weight  cake  has  a 
RACC  of  80  grams.  If  480  grams  of  cake  mix  makes  900  grams  of  prepared 
cake,  then  1/12  of  the  prepared  cake  (75  g)  is  the  closest  fraction  to  the  80 
gram  RACC  for  medium  weight  cakes.  Therefore,  the  RACC  for  the 
unprepared  cake  is  1/12  of  480  g,  or  40  g.  The  serving  size  could  be  listed  as 
1/12  package  (40  g/about  1/3  cup  mix). 
Serving  Sizes/Common  Household  Measures  
L99. How  do  I  choose  appropriate  household  measures  for  declaring  the  
serving  sizes  for  products? 
Answer:  Common  household  measures  are  discussed  in  21  CFR  101.9(b)(5). 
Manufacturers  must  first  try  to  express  serving  sizes  for  their  products  using 
(21  CFR  101.9(b)(5)(i)). 
cups,  tablespoons,  or  teaspoons  Second,  if  cups, 
tablespoons,  and  teaspoons  are  not  appropriate,  then  whole  units  and 
fractions  of  large  whole  units  must  be  used  (if  appropriate),  such  as  pieces, 
(21  CFR  101.9(b)(5)(ii)).  
slices,  tray,  or  jar  Finally,  if  other  options  fail 
(usually  because  the  product  size  naturally  varies  to  a  considerable  degree), 
(21 
manufacturers  must  use  ounces  with  an  appropriate  visual  unit  of  measure  
CFR  101.9(b)(5)(iii)). 
For  example,  small  pastas,  such  as  macaroni,  can  be  measured  by  cup:  ^^  cup 
(^^  g).  Larger  discrete  pastas,  such  as  lasagna,  can  be  measured  by  the  piece: 
^^  lasagna  noodles  (^^  g).  A  few  pastas,  such  as  spaghetti,  may  need  to  use 
ounces:  ^^  oz  (^^  g/visual  unit  of  measure).  Visual  units  of  measure  could 
include  descriptive  phrases  such  as  1/8  box  or  about  1  1/4-inch  circle  of 
spaghetti. 
A  F O O D  L A B E L I N G  G U I D E   59  Exemptions/Special  Labeling  Provisions 
General 
L100. If  a  manufacturer  chooses  to  nutrition  label  voluntarily  a  food  that  is  
otherwise  exempt,  must  the  manufacturer  follow  the  labeling 
regulations? 
Answer: Yes,  if  a  manufacturer,  packer,  distributor  or  retailer  chooses  to 
21  CFR  101.9(j), 
nutrition  label  a  product  that  is  exempt  under   all 
applicable  labeling  regulations  must  be  followed. 
L101. If  a  nutrient  content  claim  is  made  for  only  one  size  package,  are  
packages  that  do  not  include  the  claim,  and  that  are  otherwise  exempt,  
required  to  also  bear  nutrition  labeling? 
Answer: No,  only  the  package  that  bears  the  claim  is  required  to  provide 
nutrition  labeling. 
L102. If  a  product  is  produced  and  sold  in  the  same  state  (i.e.,  not  shipped  in  
interstate  commerce),  is  it  exempt  from  these  regulations? 
Answer: Generally  speaking,  a  food  that  involves  no  interstate  commerce 
(i.e.,  it  is  not  manufactured  from  ingredients  that  have  moved  in  interstate 
commerce  or  itself  is  not  distributed  in  interstate  commerce)  would  not  be 
subject  to  FDA  regulation.  However,  FDA  notes  that  interstate  commerce  is 
interpreted  very  broadly  and,  additionally,  many  states  model  their 
requirements  after  FDA's. 
L103. Is  nutrition  labeling  required  for  imported  products? 
Answer: All  imported  products  are  required  to  have  nutrition  labeling  unless 
21  CFR  101.9(j) 
the  product  qualifies  for  an  exemption.  
L104. Would  foods  that  are  exempt  from  nutrition  labeling  under  21  CFR  
101.9(j)  also  be  exempt  from  other  labeling  requirements? 
Answer: The  exemptions  in  21  CFR  101.9(j) apply  only  to  nutrition 
labeling  requirements  when  the  food  bears  no  claim  or  other  nutrition 
information. 
Small  Business 
L105. If  a  retail  establishment  produces  $51,000  worth  of  food,  but  had  a  
total  gross  sales  for  all  products,  food  and  nonfood,  of  $490,000,  do  
they  need  a  nutrition  label? 
Answer: No.  The  firm  is  exempt  provided  that  no  claims  are  made.  A  firm  
whose  total  gross  sales  for  all  products,  food  and  non-food,  is  $501,000,  with  
only  $49,000  of  this  figure  representing  sales  of  food,  is  also  exempt.  Under  the 
NLEA,  firms  who  have  an  annual  gross  sales  made  or  business  done  in  sales  to 
consumers  that  is  not  more  than  $500,000  or  have  annual  gross  sales  made  or 
business  done  in  sales  of  food  to  consumers  of  not  more  than  $50,000  are 
exempt  under  21  CFR  101.9(j)(1)(i).  
The  following  chart  illustrates  the  exemption: 
60 G U I D A N C E  F O R  I N D U S T R Y  Sales  in  Food  to  Consumers  Total  Sales  (Food  &  NonFood)  Status 
$50,000  or  less  $500,000  or  less  Exempt 
$50,000  or  less  $500,001  or  more  Exempt 
$50,001  or  more  $500,000  or  less  Exempt 
$50,001  or  more  $500,001  or  more  Not  Exempt 
L106. Company  X  is  a  multimillion  dollar  firm  that  produces  only  private  
label  products  for  other  companies  using  the  other  companies  trade  
name  and  logo.  Are  products  produced  by  company  X  required  to  
bear  nutrition  labeling? 
Answer: Products  manufactured  for  a  company  that  is  not  exempt  must  bear 
nutrition  labeling.  The  company  whose  name  appears  on  the  label  is 
responsible  for  providing  nutrition  information.  Company  X  is  not 
required  by  law  to  provide  the  nutrition  information  to  the  private  labeler. 
However,  company  X  may  wish  to  develop  nutrition  information  for  their 
product  line  and  provide  it  to  their  customers  for  use  on  the  label. 
L107. What  type  of  records  need  to  be  kept  to  substantiate  a  small  business  
exemption,  and  will  FDA  be  maintaining  copies  of  any  records  for  this  
exemption? 
Answer: It  is  up  to  each  company  to  maintain  records,  such  as  tax  returns,  to 
support  such  an  exemption.  FDA  will  not  maintain  such  records. 
L108. When  determining  whether  or  not  there  is  a  small  business  
exemption,  is  it  required  that  brokered  sales  of  foods  be  included  in  
determining  gross  sales  for  the  business? 
Answer: The  agency  defines  brokered  sales  as  the  sale  of  foods  shipped  in 
bulk  form  that  are  not  for  distribution  to  consumers  but  are  for  use  solely  in 
the  manufacture  of  other  foods  or  that  are  to  be  processed,  labeled,  or 
repackaged  at  a  site  other  than  where  originally  processed  or  packed. 
Accordingly,  any  brokered  sale  would  not  need  to  be  considered  in 
determining  eligibility  for  the  small  business  exemption. 
L109. A  manufacturer  who  qualifies  for  a  small  business  exemption  sells  his  
product  to  a  large  retailer  who  then  repacks  it  in  the  deli  and  places  it  
on  selfservice  shelves.  Is  the  product  exempt  from  nutrition  labeling  if 
the  retailer  puts  the  small  manufacturer's  name  on  the  product? 
Answer: Yes.  As  long  as  the  retailer  is  simply  repacking  the  food  into  smaller 
containers  and  placing  the  small  business's  name  and  address  on  the 
packaged  food  (i.e.,  the  package  label  bears  no  name  or  logo  that  would  tie 
the  product  to  the  larger  retailer),  the  food  would  retain  any  exemption  it  was 
21  CFR  101.9(j)(1)  or  (18). 
eligible  for  under  
L110. A  small  retailer  purchases  a  bulk  product  from  a  large  manufacturer  
and  repacks  the  product  for  retail  sale  using  the  retailer's  name  and  
logo.  Is  the  product  exempt  from  nutrition  labeling? 
Answer: If  the  retailer  is  eligible  for  the  exemption  in  21  CFR  101.9(j)(1) 
(based  on  gross  sales),  product  purchased  from  a  large  manufacturer  but 
repacked  by  the  retailer  would  be  exempt  from  nutrition  labeling,  as  long  as 
the  package  label  bears  no  name  or  logo  that  would  tie  the  product  to  the 
21  CFR 
manufacturer.  However,  to  be  eligible  for  the  exemption  in  
101.9(j)(18), 
the  product  must  meet  the  definition  of  low  volume  products 
(based  on  the  total  number  of  units  of  the  product  sold  by  the  large 
manufacturer  in  the  United  States). 
A  F O O D  L A B E L I N G  G U I D E   61  L111. What  are  the  requirements  for  the  exemption  from  nutrition  labeling  
for  a  low  volume  food  product? 
Answer: The  exemption  for  low  volume  food  products  is  based  on  the 
average  number  of  full  time  equivalent  employees  (FTE's)  and  the  number  of 
units  of  product  sold  in  the  United  States. 
L112. Do  all  firms  need  to  file  with  FDA  for  a  small  business  exemption? 
Answer: No.  Firms  eligible  for  the  exemption  based  on  gross  sales  and  firms 
with  less  than  10  FTE's  and  less  than  10,000  units  do  not  have  to  file  with 
the  FDA.  However,  such  firms  can  choose  to  do  so  voluntarily  in  order  to 
establish  a  record  that  they  are  claiming  an  exemption.  Also,  all  importers 
FD&C  Act  403(q)(5)(E)(iii),  21  U.S.C.  343(q)(5)(E))iii)  and 
must  file.  
21  CFR  101.9(j)(1)  & (j)(18) 
L113. Do  the  small  business  exemptions  apply  to  restaurants? 
Answer: There  is  a  separate  exemption  from  nutrition  labeling  for  foods  sold  
(21  CFR 
in  restaurants  of  any  size,  provided  the  food  does  not  bear  a  claim  
101.9(j)(2)). 
These  foods  do  not  need  the  small  business  exemptions. 
However,  to  the  extent  that  a  restaurant  distributes  food  products  for  sale 
outside  the  restaurant  (e.g.,  through  grocery  stores),  such  products  may  be 
eligible  for  an  exemption  from  nutrition  labeling  under  the  small  business 
exemptions. 
AwayFromHome  Foods 
L114. Is  a  manufacturer  that  produces  institutional  and  restaurant  foods  
required  to  provide  nutrition  information? 
Answer: Foods  which  are  served  or  sold  for  use  only  in  restaurants  and  other 
establishments  in  which  food  is  served  for  immediate  consumption  are 
exempt  from  nutrition  labeling.  However,  if  there  is  a  reasonable  possibility 
that  the  product  will  be  purchased  directly  by  consumers  (e.g.,  club  stores), 
21  CFR  101.9(j)(2)(iii)  21  CFR 
nutrition  information  is  required.   and  
101.9(j)(2)(v)(B) 
L115. Must  nutrition  information  be  presented  on  individual  packets  intended 
for  use  in  restaurants  and  institutions  (e.g.,  catsup,  mayonnaise,  soy  
sauce)  if  claims  are  made? 
Answer: Individual  serving  size  packages  that  are  served  to  consumers  and  make  a 
claim  are  required  to  have  nutrition  labeling  (e.g.,  light  salad  dressing). 
L116. Would  it  be  useful  for  labels  of  products  that  are  exempt  to  carry  
a  disclaimer  such  as  not  intended  for  retail  sale  or  for  further  
processing? 
Answer:  It  is  up  to  the  manufacturer  to  determine  its  own  exemption  status, 
and  such  a  statement  can  not  be  used  to  avoid  compliance  with  the  regulations. 
L117. Would  food  served  or  sold  in  carryout  boxes,  doggie  bags,  or  sanitary  
wrappers  be  considered  packaged  food? 
Answer: Food  sold  in  a  restaurant  or  other  retail  establishment  (e.g.,  a  bakery 
or  delicatessen)  that  is  sold  from  behind  a  counter  and  placed  in  a  wrapper, 
carry-out  box,  or  other  non-durable  container  whose  sole  purpose  is  to 
facilitate  handling  would  not  be  considered  packaged  food  and  would  not 
62 G U I D A N C E  F O R  I N D U S T R Y  need  to  bear  a  net  weight  statement,  ingredient  declaration,  or  the  other 
labeling  required  of  packaged  foods.  However,  if  consumers  make  their 
selections  based  on  the  food  in  its  packaged  form  (e.g.,  the  food  is  wrapped 
or  boxed  by  the  retailer  and  sold  from  a  self-service  case  in  a  corner  of  a 
restaurant,  or  across  the  aisle  from  an  in-store  deli),  the  food  must  bear  all 
required  information. 
L118. Could  FDA  provide  additional  guidance  on  what  foods  sold  in  delis  and  
bakeries  are  exempt? 
Answer: This  exemption  is  based  on  3  primary  criteria:  1)  when  the  food  is 
consumed,  2)  the  location  in  which  the  food  is  processed  and  prepared,  and 
3)  the  extent  to  which  the  food  is  processed  and  prepared  (i.e.,  must  be  ready-
to-eat  and  of  the  type  served  in  restaurants). 
Bakeries  and  delis  that  sell  foods  for  immediate  consumption  (e.g.,  where  the  deli 
or  bakery  has  facilities  for  customers  to  sit  and  consume  the  food  on  the  premises) 
are  considered  analogous  to  restaurants  and  all  foods  sold  in  such  establishments 
21  CFR  101.9(j)(2)   . 
are  exempt  under   provided  no  claims  are  made
When  foods  are  not  for  immediate  consumption,  they  may  be  exempt  if  they 
21  CFR  101.9(j)(3). 
meet  all  of  the  criteria  listed  in   That  is,  when  the  food 
is  ready-to-eat  and  is  processed  and  prepared  primarily  on  the  premises  of  the 
establishment  from  which  it  is  sold,  it  is  exempt  - regardless  of  how  it  is  sold 
(i.e.,  from  behind  a  counter  or  in  pre-portioned  packages  from  a  self-service 
shelf).  However,  if  the  food  is  not  primarily  processed  and  prepared  on-site, 
nutrition  labeling  is  required. 
To  meet  the  criteria  for  being  primarily  processed  and  prepared  on-site,  the 
food  must  be  augmented  on  site  in  a  manner  that  changes  the  nutrient 
profile  of  the  food  (i.e.,  filling,  icing,  enrobing).  Washing  and  garnishing  with 
nuts,  onions  or  seeds  would  fall  under  the  definition  of  primarily  processed 
and  prepared  if  the  added  foods  change  the  nutrition  profile  of  the  finished 
product.  Custom  cakes  are  exempt. 
If  pre-formed  dough,  pre  scaled/molded  and  par  baked  dough  are  merely 
proofed  and  baked  or  simply  thawed,  the  product  is  considered  to  be 
standardized  and  nutrition  labeling  is  required. 
Foods  which  are  not  prepared  on  premises  and  that  are  portioned  to 
consumer  specifications  on-site  are  not  required  to  have  nutrition  labeling 
(e.g.,  1  lb  of  potato  salad;  2  lb  cheese,  1  lb  assorted  cookies,  5  rolls).  However, 
if  these  items  are  packaged  and  offered  for  sale  in  another  section  of  the  store 
21 
(e.g.,  refrigerator  case;  self  service  bins),  nutrition  labeling  is  mandatory.  
CFR  101.9(j)(3)(iv) 
L119. I  manufacture  candy  for  sale  on  premises  and  at  my  two  satellite  
stores.  The  total  dollar  volume  of  my  firm  is  over  $500,000.  Am  I  
required  to  nutrition  label  my  products? 
Answer: Candy  sold  at  the  manufacturing  site  is  not  required  to  have 
nutrition  labeling.  Also,  individual  candies  offered  from  behind  a  counter 
for  consumer selection  (i.e.,  packaged  to  consumer  specification)  are  not 
required  to  have  nutrition  labeling.  However,  consumer  packages  of  candy 
offered  for  sale  at  the  satellite  stores  must  have  nutrition  labeling.  The  same 
applies  to  bakeries  that  sell  product  at  satellite  stores. 
A  F O O D  L A B E L I N G  G U I D E   63  Foods  of  No  Nutritional  Significance 
L120. Are  spices,  coffee,  and  tea  required  to  be  nutrition  labeled? 
Answer: The  regulations  provide  for  an  exemption  for  foods  that  contain 
21  CFR  101.9(j)(4), 
insignificant  amounts,  as  defined  in  of  all  of  the 
nutrients  and  food  components  required  to  be  included  in  the  nutrition 
FRUIT  DESSERT  FOR  CHILDREN 
 
LESS  THAN  2  YEARS  OLD
  label.  Exempted  foods  include  coffee  beans  (whole  or  ground),  tea  leaves, 
plain  instant  unsweetened  instant  coffee  and  tea,  condiment-type  dehydrated 
vegetables,  flavor  extracts,  and  food  colors.  Some  spices  contain  levels  of 
nutrients  that  would  not  meet  the  criteria  of  insignificant  and  would 
require  nutrition  labeling. 
L121. Must  aerosol  oil  sprays  have  nutrition  labeling?  The  serving  size  is  so  
small  and  all  nutrient  values  are  zero. 
Answer: A  product  would  be  exempt  from  nutrition  labeling  if  it 
contains  insignificant  amounts  of  all  the  nutrients  required  to  be  on  the 
label,  so  long  as  no  nutrient  content  or  health  claims  are  made  for  the 
product. 
L122. When  labeling  mineral  water,  is  nutrition  labeling  required  if  the  label  
does  not  reference  any  specific  minerals? 
Answer: Under  FDA  labeling  regulations  the  term  Mineral  Water  is  a 
statement  of  identity  and  does  not  trigger  mandatory  nutrition  labeling  if 
there  is  no  nutrient  content  claims  about  a  particular  mineral  and  if  all 
21  CFR  101.9(j)(5)(i)  required  nutrients  are  present  at  insignificant  levels. 
L123. Does  FDA  require  nutrition  labeling  if  minerals  are  declared  on  bottled  
water  to  meet  state  regulations? 
FRUIT  DESSERT  FOR  CHILDREN 
 
AGES  2  YEARS  TO  4  YEARS
  Answer: If  a  nutrient  for  which  there  is  an  RDI  or  DRV  is  referenced  on  the 
label,  nutrition  information  is  required.  However,  if  state  regulations  require 
declaration  of  nutrients  which  are  not  provided  for  on  the  nutrition  label 
(e.g.,  fluoride,  arsenic),  nutrition  labeling  cannot  accommodate  such 
nutrients  and  nutrition  labeling  is  therefore  not  required. 
Labels  for  Infants  and  Small  Children 
L124. What  are  the  special  aspects  of  the  Nutrition  Facts  labels  for  products 
intended  for  infants  and  small  children? 
Answer: Nutrition  Facts  labels  for  foods  specifically  for  children  less  than  4 
years  do  not  provide  %  Daily  Values  for  the  macronutrients  or  footnote 
21  CFR  101.9(d)(9). 
required  in   Also,  foods  specifically  for  children  less 
than  2  years  of  age  must  not  present  information  on  calories  from  fat  and 
calories  from  saturated  fat  and  quantitative  amounts  for  saturated  fat, 
polyunsaturated  fat,  monounsaturated  fat  and  cholesterol.  In  both  cases, 
% Daily  Value  is  declared  only  for  protein,  vitamins,  and  minerals. 
21  CFR  101.9(j)(5)(ii) 
64 G U I D A N C E  F O R  I N D U S T R Y  Small  Packages  and  IntermediateSized  Packages  
L125. What  are  the  special  labeling  provisions  for  small  and  intermediate
sized  packages? 
Answer:  Food  packages  with  a  surface  area  of  40  sq.  in.  or  less  available  for 
labeling  may  place  the  Nutrition  Facts  label  on  any  label  panel  (not  limited  to 
the  information  panel),  may  omit  the  footnote  required  in  21  CFR  101.9(d)(9) 
if  an  asterisk  is  placed  at  the  bottom  of  the  label  with  the  statement  Percent 
Daily  Values  are  based  on  a  2,000  calorie  diet,  and,  may  also  use  the  tabular 
display  label  format. 
21  CFR  101.9(j)(13)(ii)(A)(1) 
L126. Is  there  another  special  labeling  provision  if  the  tabular  display  label  
does  not  fit  on  small  and  intermediatesized  packages? 
Answer: A  linear  (string)  format  may  be  used  on  food  packages  with  40  sq. 
in.  or  less  total  surface  area  available  for  labeling  if  the  package  shape  or  size 
cannot  accommodate  the  nutrition  information  placed  in  columns  on  any 
label  panel. 
21  CFR  101.9(j)(13)(ii)(A)(2) 
A  F O O D  L A B E L I N G  G U I D E   65  L127. Are  abbreviations  permitted  in  Nutrition  Facts  labels  for  small  and  
intermediatesized  packages? 
Answer: Food  packages  with  a  surface  area  of  40  sq.  in.  or  less  available  for 
labeling  may  use  the  following  abbreviations  in  the  Nutrition  Facts  label: 
Label  Term  Abbreviation  Label  Term  Abbreviation 
Serving  size  Serv  size  Cholesterol  Cholest 
Servings  per  container  Servings  Total  carbohydrate  Total  carb 
Calories  from  fat  Fat  cal  Dietary  fiber  Fiber 
Calories  from  saturated  fat  Sat  fat  cal  Soluble  fiber  Sol  fiber 
Saturated  fat  Sat  fat  Insoluble  fiber  Insol  fiber 
Monounsaturated  fat  Monounsat  fat  Sugar  alcohol  Sugar  alc 
Polyunsaturated  fat  Polyunsat  fat  Other  carbohydrate  Other  carb 
21  CFR  101.9(j)(13)(ii)(B) 
L128. What  is  the  exemption  for  small  food  packages? 
Answer:  Small  packages  (less  than  12  sq.  in.  total  surface  area  available  to 
bear  labeling)  may  be  printed  with  a  telephone  number  or  an  address  to 
obtain  nutrition  information.  This  exemption  (using  a  telephone  number  or 
address  in  place  of  the  Nutrition  Facts  label)  is  permitted  only  if  there  are  no 
nutrient  content  claims  or  other  nutrition  information  on  the  product  label 
21  CFR  101.9(j)(13)(i) 
or  in  labeling  and  advertising.  
For  nutrition  information  call  1-800-123-4567 
Itty-Bitty Candies 
Net Wt. 1 oz. (28g) 
L129. What  is  the  minimum  type  size  for  the  Nutrition  Facts  label  on  small  
packages? 
Answer: Small  packages  (less  than  12  sq.  in.  total  surface  area  available  to  
bear  labeling)  may  use  type  sizes  no  smaller  than  6  point  or  all  uppercase  type  
21  CFR 
of  not  less  than  1/16  inch  for  all  required  nutrition  information.  
101.9(j)(13)(i)(B) 
L130. Is  it  acceptable  to  downsize  the  graphic  elements  of  the  Nutrition  
Facts  label  because  of  space  constraints  on  a  label? 
Answer: If  space  is  limited  on  the  label,  there  is  flexibility  to  adjust  non-required 
graphic  elements  to  help  fit  the  nutrition  label  to  the  available  space.  The 
21  CFR  101.9(d). 
required  graphic  elements  are  those  that  are  specified  in  
L131. How  is  total  space  available  to  bear  labeling  calculated? 
Answer: In  determining  the  total  surface  area  available  to  bear  labeling,  flanges 
and  ends  (tops  and  bottoms)  of  cans,  shoulders  and  necks  and  caps  of  bottles 
and  jars,  and  folded  flaps  and  other  unusable  area  may  be  excluded;  as 
21  CFR  101.1(c)  21  CFR  101.2(a)(1).  
provided  for  in   and   However, 
packages  that  provide  label  information  on  tops,  bottoms,  or  necks  should 
include  those  areas  when  calculating  available  label  space.  The  available  label 
space  includes  the  principal  display  panel  and  is  not  limited  to  currently 
labeled  areas. 
66 G U I D A N C E  F O R  I N D U S T R Y  L132. When  should  the  bottoms  of  packages  be  included  in  calculating  space  
available  to  bear  labeling? 
Answer:  When  normal  handling  by  the  consumer  would  result  in  the 
bottom  of  the  box  being  easily  seen,  such  as  frozen  food  boxes.  The  bottom 
of  boxes  stored  end  up  would  not  be  considered  available  to  bear  labeling 
since  consumers  do  not  look  at  these  areas  during  normal  handling. 
Likewise,  the  bottoms  of  cans  and  jars  are  not  normally  seen  and  would  not 
be  calculated  when  determining  space  available  to  bear  labeling. 
L133. Is  the  criteria  for  exemption  of  less  than  12  square  inches  applied  to  
the  total  labeling  area  or  only  to  the  principal  display  and  information  
panels? 
Answer: Section  101.9(j)(13)(i) states  clearly  that  the  area  available  for 
labeling  is  based  on  the  total  surface  area  available  to  bear  a  label. 
L134. Can  we  use  the  linear  display  on  a  small  package  that  does  not  have  
room  for  the  tabular  display  because  of  the  space  required  by  the  UPC  
code? 
Answer: No.  When  determining  what  format  is  required,  space  occupied  by 
vignettes,  design  and  other  non-mandatory  label  information  must  be 
21  CFR  101.9(j)(17) 
considered  as  available  label  space.  
L135. How  can  nutrition  labeling  be  put  on  novel  packages  such  as  a  jar  in  the 
shape  of  an  animal? 
Answer: If  the  package  has  less  than  12  square  inches  of  space  available  to 
bear  labeling  because  of  the  irregular  container  surface  and  no  claims  are 
made,  nutrition  labeling  requirements  may  be  met  by  providing  an  address  or 
21  CFR 
phone  number  where  consumers  could  obtain  the  information.  
101.9(13)(i) 
Bulk  Containers 
L136. How  should  nutrition  labeling  be  accomplished  for  foods  sold  from  
bulk  containers? 
Answer: Section  101.9(j)(16)  allows  foods  sold  from  bulk  containers  to 
display  the  required  nutrition  information  on  the  outside  of  the  container  or 
on  posters,  counter  cards,  tags,  or  similar  measures.  The  containers  these 
foods  are  put  into  when  sold  to  the  consumer  do  not  need  to  bear  nutrition 
labeling  as  long  as  the  required  nutrition  information  is  displayed  at  point-of-
purchase  (i.e.,  plainly  in  view  by  the  bulk  containers). 
L137. When  nutrition  information  is  provided  on  the  outside  of  bulk  
containers  in  grocery  stores,  must  the  information  be  presented  in  the  
format  specified  in  21  CFR  101.9(d)? 
Answer: Yes. 
L138. Is  the  inside  of  the  lid  an  acceptable  location  for  placing  nutrition  
labeling  on  bulk  containers? 
Answer: The  regulations  require  that  nutrition  information  be  displayed  to 
consumers  on  the  labeling  of  the  container  plainly  in  view.  Therefore,  this 
method  of  labeling  would  be  acceptable  if  the  underside  of  the  lid  were  displayed 
at  all  times  and  another  means  is  used  to  protect  the  contents  of  the  drum. 
A  F O O D  L A B E L I N G  G U I D E   67  L139. If  a  bulk  food  is  repacked  at  the  retail  level  and  sold  in  packaged  form  
instead  of  from  the  bulk  container,  do  the  individual  packages  have  to  
carry  nutrition  labeling? 
Answer: Yes.  When  foods  are  received  by  a  retail  store  in  bulk  form  and 
repacked  for  sale  to  consumers  as  a  packaged  food,  the  package  must  meet  all 
mandatory  labeling  requirements. 
L140. When  placing  nutrition  labeling  on  bulk  foods,  how  should  the  number  
of  servings  per  bulk  container  be  declared? 
Answer: The  number  of  servings  in  a  bulk  container  will  vary  according  to 
the  fill  of  the  container,  and  such  a  number  is  of  little  or  no  usefulness  to 
consumers.  FDA  would  be  unlikely  to  object  to  a  statement  that  the 
Servings  per  container  are  varied  on  bulk  food  containers  or  on  random 
weight  portions  of  foods  repackaged  by  the  retailer. 
L141. Who  is  responsible  for  providing  nutrition  information  for  bulk  foods? 
Answer:  The  retailer  is  responsible  for  displaying  the  nutrition  information 
in  the  required  format  on  or  adjacent  to  the  bulk  container.  The  information 
may  be  obtained/provided  by  either  the  supplier  or  retailer.  The  decision  as 
to  who  actually  develops  the  information  is  up  to  those  parties  involved. 
L142. If  a  coop  sells  bulk  foods  directly  to  consumers  or  consumer  groups,  
must  the  bulk  container  bear  nutrition  labeling? 
Answer: Yes.  Subject,  of  course,  to  the  exemptions  for  small  businesses. 
EXEMPTIONS 
Voluntary  Nutrition  Labeling  of  Raw  Fruits,  Vegetables  and  Fish 
L143. What  are  the  20  most  frequently  consumed  raw  fruits,  vegetables,  and  
fish?  Are  they  determined  on  a  regional  basis? 
Answer:  On  July  25,  2006  (71  FR  42031),  (corrected  August  17,  2006  (71 
FR  47439),  FDA  published  a  final  rule  to  update  the  names  and  nutrition 
values  of  the  top  20  raw  fruits,  vegetables,  and  fish.  The  20  foods  for  each 
21  CFR  101.44. 
group  are  identified  in   The  same  list  is  to  be  used 
nationwide.  The  20  most  frequently  consumed  raw  fruits  are:  Apple,  avocado 
(California),  banana,  cantaloupe,  grapefruit,  grapes,  honeydew  melon, 
kiwifruit,  lemon,  lime,  nectarine,  orange,  peach,  pear,  pineapple,  plums, 
strawberries,  sweet  cherries,  tangerine,  and  watermelon.  The  20  most 
frequently  consumed  raw  vegetables  are:  Asp  arag  us,  bell  pepper,  broccoli, 
carrot,  cauliflower,  celery,  cucumber,  green  (snap)  beans,  green  cabbage, 
green  onion,  iceberg  lettuce,  leaf  lettuce,  mushrooms,  onion,  potato,  radishes, 
summer  squash,  sweet  corn,  sweet  potato,  and  tomato.  The  20  most  frequently 
consumed  raw  fish  are:  Blue  crab,  catfish,  clams,  cod,  flounder/sole,  haddock, 
halibut,  lobster,  ocean  perch,  orange  roughy,  oysters,  pollock,  rainbow  trout, 
rockfish,  salmon  (Atlantic/coho/Chinook/sockeye,  chum/pink),  scallops, 
shrimp,  swordfish,  tilapia,  and  tuna. 
L144. Can  retailers  provide  nutrition  labeling  for  raw  fruit,  vegetables,  and  
fish  that  are  not  among  the  top  20  items? 
Answer: Yes.  The  names  and  descriptions  of  these  foods  should  clearly 
identify  them  as  distinct  from  the  foods  among  the  most  frequently 
68 G U I D A N C E  F O R  I N D U S T R Y  (21  CFR  101.45(c)(1)). 
consumed  list  for  which  FDA  has  provided  data  
Nutrition  labeling  values  for  foods  not  on  FDA's  lists  are  subject  to  the 
21  CFR  101.9(g). 
compliance  provisions  of  
L145. We  package  fresh  tomatoes  and  want  to  put  nutrition  labeling  on  the  
package.  Should  we  follow  the  guidelines  for  the  voluntary  program  
for  raw  fruit,  vegetables,  and  fish  (21  CFR  101.45)  or  the  nutrition  
labeling  format  required  by  21  CFR  101.9? 
Answer: When  providing  nutrition  information  on  the  package,  even  when  
nutrition  labeling  is  otherwise  voluntary,  the  information  must  be  presented 
21  CFR 
in  a  format  that  is  consistent  with  the  format  requirements  in  
101.9(d). 
L146. How  does  FDA  define  raw  fruit  and  vegetables  for  the  voluntary  
nutrition  labeling  program?  Are  fresh  herbs  and  nuts  included  under  
the  voluntary  nutrition  labeling  program  if  they  are  sold  in  the  produce  
section  of  retail  stores? 
Answer: The  NLEA  provides  for  voluntary  nutrition  labeling  of  raw 
agricultural  commodities  and  raw  fish.  The  FD&C  Act  defines  raw 
agricultural  commodities  as  any  food  in  its  raw  or  natural  state,  including  all 
fruits  that  are  washed,  colored,  or  otherwise  treated  in  their  unpeeled  natural 
form  prior  to  marketing.  Therefore,  fruit  and  vegetables  that  receive  little  or 
no  processing  and  no  heat  treatment,  regardless  of  whether  the  fruit  and 
vegetables  are  waxed,  are  subject  to  the  voluntary  program.  In  addition,  for 
ease  of  administration  the  agency  has  chosen  to  draw  a  practical  line  in  terms 
of  retail  selling  practices  and  program  implementation  by  including  raw  fruit 
and  vegetables  that  are  sold  in  the  produce  section  and  that  are  peeled, 
trimmed,  cut  and/or  packaged  with  no  added  ingredients  (e.g.,  carrot  sticks, 
mixed  salad  greens)  in  the  voluntary  program  when  no  claims  are  made  for 
the  product.  When  claims  are  made,  nutrition  labeling  is  required  on  the 
package  unless  the  required  nutrition  information  is  provided  on  a  poster  or 
21  CFR  101.45. 
other  means  as  specified  in  
Accordingly,  fresh  herbs  and  nuts  (e.g.,  walnuts,  peanuts)  that  have  no  added 
ingredients,  such  as  salt,  and  that  are  sold  in  the  produce  section  would  be 
exempt  from  nutrition  labeling  under  the  voluntary  program.  However,  when 
shelled  or  unshelled  nuts  or  produce  are  processed  in  a  manner  other  than 
mixing  with  other  raw  produce  items,  peeling,  trimming  ,  or  cutting,  (e.g., 
dried  fruit,  roasted  nuts,  frozen  melon  balls),  nutrition  labeling  is  required 
21  CFR  101.9. 
under  
L147. Is  nutrition  labeling  still  voluntary  on  packages  of  raw  vegetables  or  
fruits  when  processed  foods,  such  as  salad  dressings  and  croutons,  are 
added  to  the  package? 
Answer: When  processed  foods,  such  as  salad  dressings  or  croutons,  are 
added  to  packages  of  raw  vegetables  or  fruits,  the  product  is  considered  to  be 
a  multi-ingredient  processed  packaged  food  and  is  no  longer  part  of  the 
voluntary  program.  
Therefore,  nutrition  labeling  is  mandatory  for  the  entire  contents  of  the 
package.  (Subject,  of  course,  to  the  exemption  for  ready-to-eat  food  that  is 
primarily  processed  or  prepared  at  the  retail  location  and  the  small  business 
exemptions.) 
A  F O O D  L A B E L I N G  G U I D E   69  L148. Would  the  packaged  salad  with  dressing  be  considered  readytoeat  if  
consumers  have  to  open  the  package  of  dressing  and  add  it  to  the  salad 
greens  themselves? 
Answer:  Because  restaurant  salads  may  be  served  with  the  dressing  on  the 
side  or  the  croutons  in  a  side  package,  packages  of  salads  prepared  in  the 
retail  establishment  would  be  considered  ready-to-eat  when  the  only 
preparation  needed  by  the  consumer  is  adding  the  dressing  or  croutons.  In 
contrast,  products  that  require  a  significant  amount  of  assembly  or 
preparation  (e.g.,  a  pizza  kit)  would  generally  not  be  considered  ready-to-eat. 
L149. I  understand  that  adding  salad  dressing  to  a  package  of  greens  makes  
the  food  a  multiingredient  processed  food  and  nutrition  labeling  is  
required  for  the  entire  contents  of  the  package.  Does  the  requirement  
change  if  the  packaged  salad  contains  a  packet  of  salad  dressing  that  
already  bears  nutrition  labeling? 
Answer: No.  Nutrition  labeling  is  still  required  for  both  the  greens  and  the 
21  CFR  101.9(h)(1) 
salad  dressing.  However,   allows  separately  packaged 
ingredients  that  are  intended  to  be  eaten  at  the  same  time  to  be  labeled 
individually  or  with  a  composite  value.  Therefore,  the  greens  and  salad 
dressing  can  be  labeled  individually.  If  the  nutrition  label  on  the  packet  is 
visible  at  the  point  of  purchase,  the  information  on  the  dressing  need  not  be 
reprinted  on  the  outer  bag. 
L150. Is  nutrition  labeling  required  for  candied  or  caramel  apples  sold  in  the  
produce  department? 
Answer: Yes.  These  products  are  multi-ingredient  processed  food  products.  
Therefore,  nutrition  labeling  is  mandatory. 
L151. Is  nutrition  labeling  required  for  raw,  frozen  fish  that  are  packed  or  
repacked  by  the  retailer  and  sold  in  the  frozen  food  section  of  the  retail  
store? 
Answer: Raw  single-ingredient  fish  that  are  packaged  by  the  retailer,  whether 
fresh  or  frozen,  fall  under  the  voluntary  nutrition  labeling  program.  However,  
for  the  retail  store  to  be  in  compliance  with  the  voluntary  program,  the 
nutrition  labeling  information  must  be  available  at  point  of  purchase  (i.e.,  be 
displayed  in  close  proximity  to  the  product)  of  both  the  fresh  and  frozen  fish. 
It  may  be  necessary  for  some  retail  stores  to  display  signs/brochures  with  the 
nutrient  data  for  fish  in  the  frozen  food  section  as  well  as  the  fresh  fish 
21  CFR  101.45)  
section  of  the  store.  ( In  contrast,  raw  frozen  fish  that  are 
packaged  by  a  manufacturer  (e.g.,  packaged  in  a  box  with  a  printed  label  and 
brand  name)  come  under  the  mandatory  nutrition  labeling  program. 
L152. Is  nutrition  labeling  required  for  crab  meat  that  is  canned  and  
pasteurized,  but  not  shelfstable? 
Answer: Pasteurized  crab  meat  that  is  not  shelf-stable  and  is  sold  on  ice  or 
refrigerated  is  included  under  the  voluntary  nutrition  labeling  program, 
whereas  canned  crab  meat  that  is  shelf-stable  must  bear  nutrition  labeling. 
L153. Are  steamed  shrimp  exempt  from  nutrition  labeling  if  they  are  
purchased  from  a  manufacturer  and  repacked  in  the  retail  store  for  
sale  from  either  the  fresh  fish  or  deli  counters?  Would  it  make  a  
difference  if  the  retailer  adds  a  seasoning  mix  when  steaming  the  
shrimp  or  if  a  cocktail  sauce  is  added  to  the  package? 
70 G U I D A N C E  F O R  I N D U S T R Y  Answer: Plain,  thermally  processed  shelled  or  unshelled  lobster,  crab,  and 
shrimp  are  included  in  the  voluntary  nutrition  labeling  program  when  sold 
in  either  the  fresh  fish  or  deli  sections  of  the  store.  However,  consistent  with 
earlier  answers  for  fruit  and  vegetable  products,  when  a  food  is  composed  of 
more  than  one  ingredient,  some  of  which  are  not  included  in  the  voluntary 
program  (such  as  a  seasoning  mix  or  cocktail  sauce),  it  must  bear  nutrition 
labeling.  These  added  ingredients  would  generally  alter  the  nutrient  content 
of  the  product  so  that  the  nutrient  values  posted  for  the  voluntary  program 
would  no  longer  accurately  represent  the  finished  product.  However,  if  the 
finished  product  meets  the  criteria  for  a  ready-to-eat  food,  primarily  processed 
and  prepared  at  the  location  from  which  it  is  sold  (e.g.,  steamed,  spiced 
shrimp  prepared  in-house),  it  may  be  exempt  from  nutrition  labeling  under 
21  CFR101.9(j)(3). 
A  F O O D  L A B E L I N G  G U I D E   71  C
8.  LAIMS 
Nutrient  Content  Claims 
N1. What  is  a  nutrient  content  claim  (NCC)? 
Answer: It  is  a  claim  on  a  food  product  that  directly  or  by  implication 
characterizes  the  level  of  a  nutrient  in  the  food  (e.g.,  "low  fat,"  "high  in  oat 
21  CFR  101.13(b),  21  CFR  101.13(a) 
bran,"  or  "contains  100  calories").  
N2. What  nutrient  levels  must  be  present  in  a  food  to  use  NCCs  on  food 
labels? 
Answer: The  nutrient  levels  needed  to  use  NCCs  are  shown  in  Appendices  A 
and  B  of  this  guidance. 
N3. If  a  NCC  is  not  included  in  FDA's  regulations  can  it  be  used  on  a  label? 
Answer: No.  Only  those  claims,  or  their  synonyms,  that  are  specifically 
defined  in  the  regulations  may  be  used.  All  other  claims  are  prohibited.  21 
CFR  101.13(b) 
N4. Where  are  NCCs  specifically  defined  by  the  agency? 
Answer: In  21  CFR  101.13,  Subpart  D  of  part  101,  and  parts  105  and  107.  
21  CFR  101.13(b) 
N5. Are  there  any  requirements  for  NCCs  regarding  the  size  or  style  of  type? 
Answer: Yes.  A  NCC  may  be  no  more  than  twice  as  prominent  as  the 
statement  of  identity  (the  name  of  the  food).  Specifically,  the  type  size  of  the 
claim  may  be  no  more  than  two  times  the  type  size  of  the  statement  of 
identity.  If  the  style  of  the  type  makes  the  claim  unduly  prominent  compared 
to  the  statement  of  identity,  it  will  be  in  violation  of  the  regulations  (even  if 
21  CFR  101.13(f) 
the  size  of  the  type  is  appropriate).  
N6. Is  there  any  additional  information  that  is  required  when  a  claim  is  
made? 
Answer: Yes.  A  variety  of  information  is  required  depending  on  the  claim  and 
what  information  is  needed  to  prevent  the  claim  from  being  misleading. 
21  CFR  101.13(n) 
Nutrition  labeling  is  required  for  virtually  all  claims.  
N7. What  is  a  disclosure  statement? 
Answer: It  is  a  statement  that  calls  the  consumer's  attention  to  one  or  more 
nutrients  in  the  food  that  may  increase  the  risk  of  a  disease  or  health-related 
condition  that  is  diet  related.  The  disclosure  statement  is  required  when  a 
nutrient  content  claim  is  made  and  when  a  nutrient  in  that  food  exceeds 
certain  prescribed  levels.  The  disclosure  statement  identifies  that  nutrient  (e.g. 
21  CFR  101.13(h)(1) 
"See  nutrition  information  for  sodium  content").  
N8. When  is  a  disclosure  statement  required? 
Answer: It  is  a  requirement  when  a  NCC  is  made  and  the  food  contains  one 
or  more  of  the  following  nutrients  in  excess  of  the  levels  listed  below  per 
Reference  Amount  Customarily  Consumed  (RACC),  per  labeled  serving,  or, 
for  foods  with  small  serving  sizes,  per  50  grams.  
72 G U I D A N C E  F O R  I N D U S T R Y  (Different  levels  apply  to  main  dish  and  meal  products  (see  section  8  N18): 
Total  Fat  13.0  grams 
Saturated  Fat  4.0  grams 
Cholesterol  60  milligrams 
Sodium  480  milligrams 
21  CFR  101.13(h)(1) 
N9.  What  is  a  food  with  a  small  serving  size? 
Answer: It  is  a  food  with  a  RACC  of  30  g  or  less  or  2  tablespoons  or  less.  
21  CFR  101.13(h)(1) 
N10. How  must  the  disclosure  statement  be  presented  on  the  label? 
Answer: It  must  be  in  legible  boldface  type,  in  distinct  contrast  to  other 
printed  or  graphic  matter,  and  generally  in  a  type  size  at  least  as  large  as  the 
net  quantity  of  contents  declaration.  It  must  also  be  placed  immediately 
21  CFR  101.13(h)(4)(i)(ii) 
adjacent  to  the  claim.  
N11. What  is  meant  by  "immediately  adjacent  to"? 
Answer: "Immediately  adjacent  to"  means  just  that,  right  next  to  the  claim.  
There  may  be  no  intervening  material,  such  as  vignettes  or  other  art  work  or 
graphics.  However,  other  required  information  such  as  the  statement  of 
identity  (when  the  claim  is  part  of  the  statement  of  identity  such  as  "low  fat 
cheddar  cheese")  and  special  disclosure  statements  (those  required  by  section 
403(r)(2)(A)(iii)(v)), 
are  permitted  between  the  claim  and  the  disclosure  
21  CFR  101.13(h)(4)(ii) 
statement.  
N12. Could  a  statement  of  identity  ever  be  considered  intervening  material? 
Answer: Yes,  the  claim  and  the  statement  of  identity  can  be  separate  pieces  of 
information  on  the  label.  If  the  statement  of  identity  and  the  claim  were 
printed  in  noticeably  different  type  styles,  sizes,  colors  or  locations,  for 
example,  if  the  phrase  "low  fat"  were  in  a  star-burst,  the  claim  and  the 
statement  of  identity  would  be  considered  separate  pieces  of  information.  In 
such  cases  the  disclosure  statement  would  have  to  be  adjacent  to  the  claim, 
not  separated  from  it  by  the  statement  of  identity. 
N13. How  is  the  type  size  for  the  disclosure  statement  determined? 
Answer: The  type  size  for  the  disclosure  statement  is  the  same  as  that  required 
21  CFR  101.105(i);  
for  the  net  quantity  of  contents  statement  in   for 
example,  for  packages  with  a  PDP  of  five  square  inches  or  less,  the  disclosure 
statement  must  be  at  least  1/16  inch  in  height;  for  packages  with  a  PDP  of  5-
25  square  inches,  not  less  than  1/8  inch;  for  PDPs  25-100  square  inches,  not 
less  than  3/16  inch;  for  packages  with  a  PDP  greater  than  100  square  inches, 
21 
not  less  than  1/4  inch;  and  for  packages  1/2  inch  over  400  square  inches.  
CFR  101.13(h)(4)(i) 
N14. Are  there  any  exceptions  to  the  disclosure  statement  type  size  
requirements? 
Answer: Yes.  If  a  claim  is  less  than  two  times  the  required  size  of  the  net 
quantity  of  contents  statement,  the  disclosure  statement  may  be  half  the  size 
21  CFR  101.13(h)(4)(i) 
of  the  claim  but  not  less  than  1/16  inch.  
A  F O O D  L A B E L I N G  G U I D E   73  N15. What  are  the  disclosure  statement  type  size  requirements  for  
extremely  small  packages? 
Answer: If  a  package  has  three  square  inches  or  less  of  available  label  space 
and  is  an  individual  serving-size  package  served  with  meals  in  restaurants,  the 
21  CFR 
disclosure  statement  may  be  no  less  than  1/32  inch  in  height. 
101.13(h)(4)(i) 
N16. If  several  claims  are  made  on  one  panel,  is  a  disclosure  statement  
required  each  time  a  claim  is  made? 
Answer: No.  If  multiple  claims  are  made  on  a  panel,  only  one  disclosure 
statement  per  panel  is  required  and  it  must  be  adjacent  to  the  claim  printed 
21  CFR  101.13(h)(4)(iii) 
in  the  largest  type  on  that  panel.  
N17. If  two  claims  are  made  on  one  panel,  both  in  the  same  size  print,  where  
is  the  disclosure  statement  placed? 
Answer: The  disclosure  statement  may  be  next  to  either  claim. 
N18. When  are  disclosure  statements  required  on  mealtype  products? 
Answer: A  meal  product  (see  21  CFR  101.13(l)  for  definition  of  a  "meal 
product")  must  be  labeled  with  a  disclosure  statement  if  it  contains  (per 
labeled  serving)  more  than: 


26  g  of  fat,


8  g  of  saturated  fat,


120  mg  of  cholesterol,  or


960  mg  of  sodium
21  CFR  101.13(h)(2) 
Likewise,  a  main  dish  product  (see  21  CFR  101.13(m)  for  the  definition  of  a 
"main  dish  product")  must  be  labeled  with  a  disclosure  statement  if  it  contains 
(per  labeled  serving)  more  than: 
19.5  g  of  fat, 


6.0  g  of  saturated  fat,


90  mg  of  cholesterol,  or


720  mg  of  sodium
21  CFR  101.13(h)(3) 
N19. When  may  a  "high"  or  a  "good  source"  claim  be  made? 
Answer: A  "good  source"  claim  may  be  made  when  a  food  contains  10-19%  of 
the  RDI  or  DRV  (both  declared  on  the  label  as  the  %  Daily  Value  (%DV)).  A 
21 
"high"  claim  may  be  made  when  a  food  contains  at  least  20%  of  the  DV.  
CFR  101.54(b)(c) 
N20. May  a  "high"  or  a  "good  source"  claim  be  made  for  a  nutrient  that  does  
not  have  an  established  daily  value? 
Answer: No.  "High"  and  "good  source"  claims  are  defined  as  a  percentage  of  
the  DV.  Therefore,  nutrients  that  do  not  have  an  established  DV  are  not 
covered  by  the  definition  and  may  not  make  "high"  or  "good  source"  claims. 
21  CFR  101.54(a) 
N21. Is  there  any  way  that  a  manufacturer  can  let  consumers  know  that  a  
product  contains  nutrients  without  DVs,  such  as  omega3  fatty  acids? 
Answer: A  manufacturer  may  make  a  statement  about  a  nutrient  for  which 
there  is  no  established  daily  value  as  long  as  the  claim  specifies  only  the 
amount  of  the  nutrient  per  serving  and  does  not  implicitly  characterize  the 
74 G U I D A N C E  F O R  I N D U S T R Y  level  of  the  nutrient  in  the  product.  Such  a  claim  might  be  "x  grams  of  omega-
21  CFR 
3  fatty  acids."  Such  claims  must  be  outside  the  Nutrition  Facts  label.  
101.13(i)(3) 
N22. May  a  label  make  statements  using  the  words  "contains"  and  
"provides"  (e.g.,  "Contains  x  grams  of  omega3  fatty  acids")  for  
nutrients  without  DVs? 
Answer: To  use  the  words  "contains"  or  "provides"  for  nutrients  without  DVs,  
must 
the  specific  amount  of  the  nutrient   be  stated.  The  statements  "Contains 
x  grams  of  omega-3  fatty  acids  per  serving"  or  "Provides  x  g  of  omega-3  fatty 
acids"  are  permitted. 
However,  "Contains  omega-3  fatty  acids"  or  "Provides  omega-3  fatty  acids" 
(without  the  specific  amount  statement)  would  not  be  permitted.  Such  claims 
would  be  synonyms  for  a  "good  source"  claim  which  is  not  permitted  for 
21  CFR  101.54(c) 
nutrients  that  do  not  have  established  DVs.  
N23. Is  a  statement  that  describes  the  percentage  of  the  RDI  of  a  vitamin  or  
mineral  in  a  food  outside  the  nutrition  panel  a  NCC? 
Answer: Yes,  while  labels  bearing  these  claims  are  exempt  from  certain 
labeling  requirements,  they  are  not  exempt  from  bearing  a  disclosure 
21  CFR 
statement  when  required  and  nutrition  information.  
101.13(q)(3)(i),  21  CFR  101.13(n),  21  CFR  101.13(h) 
N24. May  a  food  that  is  normally  low  in  or  free  of  a  nutrient  bear  a  "Low"  or  
"Free"  claim  if  it  has  an  appropriate  disclaimer  (e.g.,  fat  free  broccoli)? 
Answer: No.  Only  foods  that  have  been  specially  processed,  altered, 
formulated,  or  reformulated  so  as  to  lower  the  amount  of  nutrient  in  the 
food,  remove  the  nutrient  from  the  food,  or  not  include  the  nutrient  in  the 
food  may  bear  such  a  claim  (e.g.,  "low  sodium  potato  chips").  Other  foods  may 
only  make  a  statement  that  refers  to  all  foods  of  that  type  (e.g.,  "corn  oil,  a 
21  CFR  101.13(e)(1)(2) 
sodium-free  food"  or  "broccoli,  a  fat-free  food").  
N25. When  is  a  formulated  food  considered  to  be  specially  processed  and  
permitted  to  bear  a  "low"  or  "free"  claim? 
Answer: If  a  similar  food  would  normally  be  expected  to  contain  a  nutrient, 
such  as  sodium  in  canned  peas,  and  the  labeled  food  is  made  in  such  a 
manner  that  it  has  little  or  none  of  the  nutrient,  then  the  food  is  considered 
21  CFR 
specially  processed  and  may  bear  a  "free"  or  a  "low"  claim. 
101.13(e)(1) 
N26. If  a  product  is  made  that  does  not  have  a  regular  version,  such  as  a  
spice  mix,  and  salt  is  not  included  in  it,  may  the  product  be  labeled  
"sodium  free?" 
Answer: Yes.  FDA  would  consider  that  the  food  was  formulated  so  as  not  to 
include  the  nutrient  in  the  food  and  therefore  it  would  be  eligible  to  bear  a 
"sodium  free"  claim  if  the  product  otherwise  meets  the  criteria  for  the  term 
"sodium  free." 
N27. May  a  "fat  free"  claim  be  made  even  though  the  product  is  essentially  
100%  fat,  for  example,  a  cooking  oil  spray  that  has  a  very  small  serving  
size? 
Answer: Although  the  food  has  less  than  0.5  grams  of  fat  per  RACC  and 
technically  qualifies  to  make  a  "fat  free"  claim,  such  a  claim  on  a  product  that 
A  F O O D  L A B E L I N G  G U I D E   75  403(a)(1)  and 
is  essentially  100%  fat  would  be  misleading.  Under  section  
201(n) 
of  the  FD&C  Act,  the  label  would  have  to  disclose  that  the  product  is 
100%  fat.  However,  the  terms  "fat  free"  and  "100%  fat"  or  "all  fat"  are 
contradictory  and  the  statement  seems  confusing.  FDA  believes  a  claim  such 
as  "for  fat  free  cooking"  is  more  appropriate,  so  long  as  it  was  not  made  in  a 
misleading  manner  and  the  words  "fat  free"  were  not  highlighted,  printed  in  a 
more  prominent  type,  or  otherwise  set  off  from  the  rest  of  the  statement. 
N28. What  is  meant  by  "product  category"  when  the  regulation  say  that  for  
"less,"  "fewer"  and  "more"  claims,  the  reference  food  may  be  a  
dissimilar  food  within  a  product  category  that  can  generally  be  
substituted  for  one  another  in  the  diet.  Are  these  product  category  the  
same  as  the  139  product  categories  used  to  describe  the  RACCs  for  
serving  sizes? 
Answer: These  are  not  the  same  as  the  product  categories  established  for 
serving  sizes.  The  agency  intentionally  did  not  define  "product  category"  in 
the  final  rule  in  order  to  allow  for  the  use  of  a  flexible  standard.  It  intended 
that  comparisons  be  made  for  foods  that  are  interchangeable  in  the  diet, 
recognizing  that  sometimes  these  foods  would  be  dissimilar,  for  example 
"apples  have  less  fat  than  potato  chips"). 
N29. When  would  such  a  claim  as  described  in  section  8  N28  (above)  be  
considered  misleading? 
Answer: A  claim  would  be  misleading  if  it  compared  two  foods  that  are  not 
reasonably  likely  to  be  used  as  alternative  food  choices  for  a  specified  eating 
occasion,  for  example,  "apples  have  less  fat  than  sour  cream." 
N30. May  a  "Less"  or  "Fewer"  claim  be  made  that  compares  readytoeat  
cereals  to  other  breakfast  options  such  as  sausages  or  Danish  pastries? 
Answer: The  agency  would  not  object  to  such  a  claim  if  it  were  properly 
framed  in  the  context  of  an  eating  occasion  such  as  "Try  a  change  for 
breakfast.  A  serving  of  this  cereal  has  ^^%  less  fat  than  a  serving  of  Danish 
21  CFR  101.13(j)(1)(i)(A) 
pastry".  
N31. Will  I  have  to  similarly  frame,  in  the  context  of  an  eating  occasion,  
comparisons  between  foods  that  are  normally  considered  to  be  
alternatives  for  one  another  such  as  pretzels  for  potato  chips  or  one  
cookie  for  another  cookie? 
Answer: No.  Such  substitutions  would  be  generally  understood  by  the 
consumer  and  would  not  have  to  be  specified. 
N32. What  is  an  appropriate  reference  food  for  a  food  bearing  a  "Light"  
claim? 
Answer:  The  reference  food  must  be  a  food  or  group  of  foods  that  are 
representative  of  the  same  type  as  the  food  bearing  the  claim.  For  example,  a 
chocolate  ice  cream  would  use  as  its  reference  food  other  chocolate  ice  creams.  
21  CFR  101.13(j)(1)(i)(B) 
The  nutrient  value  for  fat  or  calories  in  a  reference  food  that  is  used  as  a  basis 
for  a  "light"  claim  may  be  determined  in  several  ways.  It  may  be  a  value  in  a 
representative,  valid  data  base;  an  average  value  determined  from  the  top 
three  national  (or  regional)  brands  of  the  food,  a  market  basket  norm;  or 
where  its  nutrient  value  is  representative  of  the  food  type,  a  market  leader.  
21  CFR  101.13(j)(1)(ii)(A) 
76 G U I D A N C E  F O R  I N D U S T R Y  The  nutrient  value  used  as  a  basis  for  a  'light'  claim  should  be  similar  to  that 
calculated  by  averaging  the  nutrient  values  of  many  of  the  foods  of  the  type.  It 
should  not  be  the  value  of  a  single  food  or  group  of  foods  at  the  high  end  of 
the  range  of  nutrient  values  for  the  food.  When  compared  to  an  appropriate 
reference  food,  a  "light"  food  should  be  a  food  that  the  consumer  would 
generally  recognize  as  a  food  that  is  improved  in  its  nutrient  value  compared 
21  CFR  101.13(j)(1)(ii)(A) 
to  other  average  products  of  its  type.  
N33. What  is  considered  to  be  an  "average  nutrient  value"? 
Answer: It  might  be  a  value  in  a  data  base  that  is  appropriate  for  the  food,  or 
an  average  of  nutrient  levels  in  several  of  the  leading  brands  of  that  type  of 
food.  It  might  also  be  a  market  basket  norm.  In  determining  an  average 
nutrient  value  for  a  particular  type  of  food,  a  manufacturer  should  take  into 
21  CFR  101.13(j)(1)(i)(A) 
account  the  nutrient  variability  of  the  product.  
Some  types  of  products  are  fairly  uniform;  others,  such  as  chocolate  chip 
cookies,  are  not.  Obviously,  in  products  in  which  there  is  wide  variability 
among  different  versions  of  the  same  food  type,  more  products  should  be 
considered  in  arriving  at  an  accurate  nutrient  level. 
N34. How  will  anyone  know  what  the  reference  food  is  and  how  it  was  
derived? 
Answer: The  type  of  food  used  as  a  reference  food  must  be  identified  on  the 
label  as  part  of  the  accompanying  information.  
21  CFR  101.13(j)(2)(i) 
In  addition,  the  regulation  requires  that  manufacturers  using  calculated 
nutrient  values  (averages,  norms,  etc.)  as  the  basis  for  a  claim  be  able  to 
provide  specific  information  on  how  the  nutrient  values  were  derived.  This 
information  must  be  available  on  request  to  consumers  and  to  appropriate 
regulatory  officials.  
21  CFR  101.13(j)(1)(ii)(A) 
N35. How  would  a  label  state  the  identity  of  a  reference  food  when  the  
nutrient  value  used  as  a  reference  for  the  claim  was  from  a  data  base  or 
was  an  average  of  several  foods? 
Answer: The  label  might  state  50%  less  fat  than  regular  Italian  salad 
dressing  (on  a  light  Italian  dressing)  or  half  the  fat  of  the  average  creamy 
Italian  salad  dressing  (on  a  light  creamy  Italian  salad  dressing).  The  label  is 
21  CFR 
not  required  to  state  that  the  reference  value  came  from  a  data  base.  
101.13(j)(2)(i) 
N36. Can  a  reference  food  for  a  light  product  be  an  average  of  
regional  brands? 
Answer: Yes,  so  long  as  the  regional  brands  are  available  in  the  same  area  in 
which  the  light  product  is  sold. 
N37. Are  there  any  circumstances  in  which  the  reference  food  for  a  light  
claim  may  be  a  single  food? 
Answer: Yes.  The  agency  has  stated  that  if  the  nutrient  levels  in  a  food,  such 
as  the  leading  national  or  regional  brand,  were  accurately  reflective  of  the 
average  of  foods  of  that  type,  that  food  might  be  an  appropriate  reference  food 
for  a  light  product. 
A  F O O D  L A B E L I N G  G U I D E   77  N38. Is  a  market  leader  always  an  appropriate  reference  food? 
Answer: No.  For  example,  if  there  are  two  market  leaders  with  widely 
different  nutrient  profiles,  selecting  the  one  with  the  slightly  higher  market 
share  for  the  reference  food  could  be  misleading.  In  that  case  the  nutrient 
values  for  the  two  market  leaders  should  be  averaged  together  to  determine  a 
nutrient  value  for  the  basis  of  the  light  claim. 
N39. What  if  my  product  is  a  unique  product  and  the  only  one  of  its  kind  on  
the  market?  Can  I  make  a  light  version  using  the  regular  product  as  
the  reference  food? 
Answer: Products  that  are  truly  unique  may  make  the  light  comparisons  to 
the  regular  version  of  the  product. 
N40. What  happens  if  the  light  version  or  other  improved  versions  of  the  
product  become  so  popular  that  the  regular  version  is  no  longer  
marketed? 
Answer: The  agency  believes  that  it  would  be  misleading  for  comparisons  to  
be  made  to  products  that  are  no  longer  marketed.  Therefore,  especially  for 
products  that  are  nontraditional  or  unique,  the  agency  would  find  claims 
which  are  based  on  products  that  have  been  discontinued  for  more  than  6 
months  to  be  misleading. 
N41. What  if  the  product  is  not  discontinued  but  has  an  extremely  small  
market  share?  Would  those  products  still  be  considered  appropriate  
reference  foods  for  light  products? 
Answer: The  agency  would  not  consider  any  food  to  be  an  appropriate 
reference  food  for  any  relative  claim  if  it  did  not  have  a  significant  market 
share.  Just  as  it  does  not  want  foods  to  be  specially  created  to  be  reference 
foods  for  relative  claims,  neither  would  it  expect  foods  that  can  no  longer  be 
purchased  by  the  consumer  to  be  appropriate  reference  foods. 
N42. Is  this  always  the  case? 
Answer: There  are  conceivably  some  circumstances  in  which  a  traditional 
food  (hypothetically,  full-fat  yogurt)  might  no  longer  be  marketed  and  only  the 
nutritionally  improved  food  would  be  available.  The  agency  would  not 
generally  consider  comparisons  of  the  nutritionally  improved  food  to  the 
traditional  food  to  be  misleading,  as  long  as  consumers  are  likely  to  have 
knowledge  of  the  traditional  food  and  the  term  light  signals  that  the 
product  was  improved  relative  to  the  traditional  food. 
N43. Is  there  any  information  that  must  be  placed  on  the  label  when  making  
relative  claims  such  as  Light? 
Answer: When  making  light  claims,  as  with  other  relative  claims  such  as  
reduced,  less,  fewer,  more,  or  added,  the  label  must  state  each  of  the 
following  (these  are  called  accompanying  information): 
 The  percentage  or  fraction  by  which  the  food  has  been  modified, 
 The  reference  food,  and 
 The  amount  of  nutrient  (that  is  the  subject  of  the  claim)  that  is  
in  the  labeled  food  and  in  the  reference  food. 
Example: 1/3  fewer  calories  and  50%  less  fat  than  our  regular  cheese  cake. 
Lite  cheese  cake--200  calories,  4g  fat;  Regular  cheese  cake--300  calories,  8g  fat 
21  CFR  101.56(b)(3)(i)(ii)  and  21  CFR  101.13(j)(2) 
per  serving.  
78 G U I D A N C E  F O R  I N D U S T R Y  N44. Where  must  the  accompanying  information  be  placed? 
Answer:  The  percentage  or  fraction  by  which  the  food  is  modified  and  the 
identity  of  the  reference  food  must  be  immediately  adjacent  to  the  most 
21  CFR  101.13(j)(2)(ii) 
prominent  claim  on  the  label.   The  actual  amount 
of  the  nutrient  in  the  labeled  food  and  the  reference  food  may  be  adjacent  to 
21 
the  most  prominent  claim  or  on  the  same  panel  as  the  nutrition  label.  
CFR  101.13(j)(2)(iv)(B) 
N45. What  is  the  appropriate  reference  food  for  a  NCC  on  a  product  that  
substitutes  for  a  food  and  bears  a  name  that  is  significantly  different  
from  that  food? 
Answer: Examples  are  vegetable  oil  spreads  that  substitute  for  margarine  or 
butter,  and  mayonnaise  spreads  that  substitute  for  mayonnaise.  To  bear  a 
claim,  the  labeled  food,  for  example,  vegetable  oil  spread,  must  be  not 
nutritionally  inferior  to  the  food  that  it  resembles  and  for  which  it  substitutes 
(e.g.,  margarine).  The  reference  food  on  which  the  claim  is  based  should  be 
the  food  that  it  resembles  and  for  which  it  substitutes  (e.g.,  margarine). 
21  CFR  101.13(d) 
Definition  of  substitute  food  is  found  in  
N46. What  is  the  most  prominent  claim? 
Answer: In  order,  the  most  prominent  claims  are: 
1.  

A  claim  on  the  PDP  as  a  part  of  or  adjacent 


to  the  statement  of  identity;
2. 
A  claim  elsewhere  on  the  PDP; 
3. 
A  claim  on  the  information  panel; 
4. 
A  claim  elsewhere  on  the  label  or  in  labeling. 
21  CFR  101.13(j)(2)(iii) 
N47. How  large  must  the  accompanying  information  be? 
Answer: Generally  the  type  size  must  be  at  least  1/16  of  an  inch  in  height. 
However,  there  are  certain  exemptions  from  this  type  size  requirement  for 
packaged  foods  that  meet  certain  size  requirements.  Generally,  the  minimum 
type  size  is  1/32  inch  for  products  with  a  total  surface  area  available  to  bear 
21  CFR  101.2(c) 
labeling  of  less  than  12  square  inches.  
N48. Implied  NCCs  in  brand  names  have  to  be  authorized  by  the  FDA.  
Does  a  petition  have  to  be  submitted  before  a  claim  may  be  used  in 
any  brand  name? 
Answer:  No.  Implied  claims  that  are  specifically  identified  in  21  CFR  101.65 
may  be  used  in  a  brand  name  without  submission  of  a  petition  under 
21  CFR  101.69(o). 
N49. What  are  the  requirements  to  use  the  word  Healthy? 
Answer
:  You  may  use  the  term  healthy  or  related  terms  as  an  implied 
nutrient  content  claim  on  the  label  or  in  labeling  of  a  food  that  is  useful  in 
creating  a  diet  that  is  consistent  with  dietary  recommendations  if  the  food 
meets  the  conditions  for  total  fat,  saturated  fat,  cholesterol,  and  other 
nutrients  (See  table  in  Appendix  B  of  this  guidance).  In  addition,  the  food 
must  comply  with  definitions  and  declaration  requirements  for  any  specific 
21  CFR  101.65(d)(2) 
NCCs.  
A  F O O D  L A B E L I N G  G U I D E   79  N50. What  does  Fresh  mean? 
Answer:  When  used  in  a  manner  which  suggests  that  a  food  is  unprocessed, 
the  term  fresh  means  that  the  food  is  in  a  raw  state  and  has  not  been  frozen 
or  subjected  to  any  form  of  thermal  processing  or  preservation,  except: 
The  addition  of  approved  waxes  or  coatings; 
The  post-harvest  use  of  approved  pesticides; 
The  application  of  a  mild  chlorine  wash  or  mild  acid  wash  on  produce; 
or 
The  treatment  of  raw  foods  with  ionizing  radiation  not  to  exceed  the 
21  CFR  179.26,  
maximum  dose  of  1  kiloGray  in  accordance  with  
21  CFR  101.95(a)  and  21  CFR  101.95(c) 
N51. What  do  the  terms  Fresh  Frozen  and  Quickly  Frozen  mean? 
Answer: FDA's  regulation  specifies  that  fresh  frozen  or  frozen  fresh  means 
the  food  has  been  quickly  frozen  while  still  fresh  (i.e.,  recently  harvested  when 
frozen).  Appropriate  blanching  before  freezing  is  permitted.  Quickly  frozen 
means  freezing  using  a  system  such  as  blast-freezing  (i.e.,  sub-zero  Fahrenheit 
temperature  with  fast  moving  air  directed  at  the  food)  for  a  sufficient  length 
of  time  to  freeze  quickly  to  the  center  of  the  food  with  virtually  no 
21  CFR  101.95(b) 
deterioration.  
Health  Claims 
H1.   What  is  a  Health  Claim? 
Answer: Health  claim  means  any  claim  made  on  the  label  or  in  labeling  of  a 
food,  including  a  dietary  supplement,  that  expressly  or  by  implication, 
including  third  party  references,  written  statements  (e.g.,  a  brand  name 
including  a  term  such  as  heart),  symbols  (e.g.,  a  heart  symbol),  or  vignettes, 
characterizes  the  relationship  of  any  substance  to  a  disease  or  health-related 
condition.  Implied  health  claims  include  those  statements,  symbols,  vignettes, 
or  other  forms  of  communication  that  suggest,  within  the  context  in  which 
they  are  presented,  that  a  relationship  exists  between  the  presence  or  level  of  a 
21  CFR 
substance  in  the  food  and  a  disease  or  health-related  condition  (see  
101.14(a)(1)). 
Further,  health  claims  are  limited  to  claims  about  disease  risk  reduction,  and 
cannot  be  claims  about  the  diagnosis,  cure,  mitigation,  or  treatment  of 
disease.  Health  claims  are  required  to  be  reviewed  and  evaluated  by  FDA  prior 
to  use.  An  example  of  an  authorized  health  claim,  is:  Three  grams  of  soluble 
fiber  from  oatmeal  daily  in  a  diet  low  in  saturated  fat  and  cholesterol  may 
reduce  the  risk  of  heart  disease.  This  cereal  has  2  grams  per  serving. 
H2.  What  health  claims  are  permitted  on  food  labels? 
Answer: If  a  claim  is  provided  for  in  a  FDA  regulation,  then  it  may  be  used  
in  accordance  with  that  regulation.  A  firm  may  also  submit  a  health  claim 
notification  based  on  an  authoritative  statement  by  a  U.S.  government 
403(r)(3)(c)  
scientific  body  under  section   of  the  FD&C  Act.  The  criteria 
necessary  to  use  health  claims  provided  for  by  FDA  are  summarized  in 
21  CFR  101.9(k)(1),  101.14(c)(d)  &  
Appendix  C  of  this  guidance.  
21  CFR  101.70 
80 G U I D A N C E  F O R  I N D U S T R Y  H3.	  How  are  health  claims  different  from  structure/function  claims? 
Answer: Both  health  claims  that  meet  the  Significant  Scientific  Agreement 
(SSA)  standard  and  Qualified  Health  Claims  (QHCs)  characterize  the 
relationship  between  a  substance  to  a  disease  or  health-related  condition  (see 
21  CFR  101.14). 
Structure/function  (S/F)  claims  describe  the  effect  that  a 
substance  has  on  the  structure  or  function  of  the  body  and  do  not  make 
reference  to  a  disease.  Both  S/F  and  health  claims  can  be  used  on  the  label 
and  in  the  labeling  of  conventional  foods  and  dietary  supplements.  An 
example  of  a  S/F  claim  is  Calcium  builds  strong  bones.  S/F  claims  must  be 
truthful  and  not  misleading  and  are  not  pre-reviewed  or  authorized  by  FDA. 
21  U.S.C.  343(r)(6)  and  21  CFR  101.93 
H4.	 How  are  health  claims  different  from  statements  about  dietary  
guidance? 
Answer:  Both  health  claims  that  meet  the  SSA  standard  and  QHCs 
characterize  a  relationship  between  a  substance  and  a  disease  or  health-related 
21  CFR  101.14). 
condition  (see   Both  elements  of  1)  a  substance  and  2)  a 
disease  are  present  in  a  health  claim.  Dietary  guidance  does  not  contain  both 
elements  (and  therefore  does  not  constitute  a  health  claim,  but  may  contain 
one  element  or  another.  Typically,  dietary  guidance  statements  make  reference 
to  a  category  of  foods  (i.e.,  a  grouping  that  is  not  readily  characterized 
compositionally)  and  not  to  a  specific  substance.  The  following  illustrations 
may  be  helpful: 
Two  examples  of  an  authorized  health  claim,  which  by  definition  must 
contain  the  elements  of  a  substance  and  a  disease  or  health-related  condition, 
are:  Three  grams  of  soluble  fiber  from  oatmeal  daily  in  a  diet  low  in  saturated 
fat  and  cholesterol  may  reduce  the  risk  of  heart  disease.  This  cereal  has  2 
grams  per  serving.  and  Diets  low  in  saturated  fat  and  cholesterol  that 
include  25  grams  of  soy  protein  a  day  may  reduce  the  risk  of  heart  disease. 
An  example  of  dietary  guidance,  which  does  not  refer  to  a  specific  substance 
but  rather  refers  to  a  broad  class  of  foods  without  an  expressed  or  implied 
connection  to  a  specific  substance  that  is  present  the  class  of  foods  is: 
Consuming  at  least  3  or  more  ounce-equivalents  of  whole  grains  per  day  can 
reduce  the  risk  of  several  chronic  diseases.  One  element  is  present,  but  not 
both.  It  is  not  a  health  claim  because  it  cannot  reasonably  be  understood  to  be 
about  a  specific  substance. 
A  dietary  guidance  statement  that  refers  to  a  specific  food  or  food  component 
but  not  a  disease  or  health-related  condition  is:  Carrots  are  good  for  your 
health,  or  Calcium  is  good  for  you.  Again,  one  element  is  present,  but  not 
both. 
H5.	  How  is  dietary  guidance  provided  for  on  food  labels? 
Answer:  Truthful,  non-misleading  dietary  guidance  statements  may  be  used 
on  food  labels,  and  do  not  undergo  pre-review  by  FDA.  However,  once  the 
food  is  marketed  with  the  statement,  FDA  can  consider  whether  the 
statement meets  the  requirement  to  be  truthful  and  not  misleading.  
Section  403(a)  of  the  FD&C  Act 
FDA,  as  part  of  its  recent  Better  Nutrition  Information  for  Consumer  Health 
Initiative,  recognized  that  scientifically  sound  and  non-misleading  dietary 
guidance  statements  may  be  useful  to  consumers  when  placed  on  food  labels. 
A  F O O D  L A B E L I N G  G U I D E   81  H6.	  What  are  the  similarities  and  differences  between  health  claims  
established  under  the  1993  regulations  and  QHCs? 
Answer:  Both  types  of  health  claims  characterize  a  relationship  between  a 
substance  (specific  food  component  or  a  specific  food)  and  a  disease  (e.g.,  lung 
cancer  or  heart  disease)  or  health-related  condition  (e.g.,  high  blood  pressure), 
21  CFR  101.14).  
and  are  supported  by  scientific  evidence  (see   Health  claims 
generally  undergo  review  by  FDA  through  a  petition  process.  All  health  claims 
as  provided  for  by  Congress  in  1990  were  evaluated  under  the  SSA  standard. 
Past  court  decisions  resulting  in  QHCs  on  dietary  supplements  focused  on 
whether  a  manufacturer  could  make  statements  about  diet/disease 
relationships  when  the  science  supporting  the  claim  did  not  meet  the  SSA 
standard,  provided  that  the  claim  about  the  relationship  was  stated  or 
qualified  in  such  a  way  as  to  not  mislead  consumers.  Thus,  QHCs  differ 
from  health  claims  in  that  they  must  be  accompanied  by  a  disclaimer  or 
otherwise  qualified.  See  the  next  section  of  this  guidance  for  more 
information  on  QHCs. 
Qualified  Health  Claims 
Q1.	  Why  is  FDA  providing  for  qualified  health  claims  (QHCs)? 
Answer:  Through  the  Consumer  Health  Information  for  Better  Nutrition 
Initiative,  FDA  acknowledged  that  consumers  benefit  from  more  information 
on  food  labels  concerning  diet  and  health.  As  part  of  this  initiative,  the  agency 
established  interim  procedures  whereby  QHCs  can  be  made  not  only  for 
dietary  supplements  but  for  conventional  foods  as  well.  Moreover,  past  court 
decisions  have  clarified  the  need  to  provide  for  health  claims  based  on  less 
scientific  evidence  rather  than  just  on  the  standard  of  Significant  Scientific 
Agreement  (SSA)  as  long  as  the  claims  do  not  mislead  the  consumers.  FDA 
began  considering  QHCs  under  its  interim  procedures  on  September  1,  2003. 
Q2.	  Why  are  the  procedures  for  QHCs  interim? 
Answer:  FDA  believes  that  more  information  is  needed  before  the  agency  can 
establish  final  procedures  to  provide  for  QHCs,  and  therefore  issued  an 
Advanced  Notice  of  Proposed  Rulemaking  (ANPRM)  to  solicit  comments 
on  the  agency's  options.  FDA  has  and  continues  to  conduct  research  in 
order  to  obtain  information  about  appropriate  qualifying  language  for  use 
with  the  claims  and  the  extent  to  which  consumers  can  understand  different 
levels  of  supporting  science.  The  agency  is  also  interested  in  knowing  if  there 
are  better  formats  for  presenting  the  supporting  science  than  through  the 
use  of  words  alone. 
Q3.	  What  is  a  letter  of  enforcement  discretion  for  QHCs? 
Answer: A  letter  of  enforcement  discretion  is  a  letter  issued  by  FDA  to  the 
petitioner  specifying  the  nature  of  the  QHC  for  which  FDA  intends  to  consider 
the  exercise  of  its  enforcement  discretion.  If  a  letter  of  enforcement  discretion 
has  been  issued,  FDA  does  not  intend  to  object  to  the  use  of  the  claim  as  specified 
in  the  letter,  provided  that  the  products  that  bear  the  claim  are  consistent  with 
the  stated  criteria.  All  letters  of  enforcement  discretion  are  posted  on  the  Center 
for  Food  Safety  and  Applied  Nutrition's  website  so  manufacturers  know  how  the 
agency  intends  to  exercise  its  enforcement  discretion  on  the  use  of  the  QHC. 
82 G U I D A N C E  F O R  I N D U S T R Y  Q4.	 How  is  the  science  supporting  a  QHC  different  from  that  for  a  
health  claim? 
Answer:  Health  claims  require  Significant  Scientific  Agreement  (SSA)  based 
21  CFR  101.14). 
on  the  totality  of  publicly  available  scientific  evidence  (see  
QHCs  are  still  based  on  the  totality  of  publicly  available  evidence  but  the 
scientific  support  does  not  have  to  be  as  strong  as  that  for  SSA.  (See  also  H7) 
Q5.	 What  is  the  procedural  timeline  for  QHCs? 
Answer:  Within  15  days  of  receipt,  FDA  will  acknowledge  the  petition. 
Within  45  days  of  receipt,  FDA  will  file  the  petition  and  a  docket  number  will 
be  assigned.  Note:  Petitions  that  do  not  meet  content  requirements  as 
21  CFR  101.70 
specified  in   will  not  be  filed  and  will  be  returned  to  the 
petitioner.  At  the  time  of  filing,  FDA  will  post  the  petition  on  the  FDA 
webpage  for  a  60-day  public  comment  period.  During  this  time,  written 
comments  may  be  submitted  to  the  docket.  On  or  before  270  days  after  receipt 
of  the  petition,  a  final  decision  will  be  sent  to  the  petitioner  in  the  form  of  a 
letter  as  to  whether  FDA  intends  to  exercise  enforcement  discretion  with 
respect  to  a  QHC  or  deny  the  petition.  The  letter  will  be  posted  on  FDA's 
website.  Extensions  beyond  270  days  can  be  granted  upon  mutual  agreement 
between  the  petitioner  and  the  agency. 
Q6.	  How  will  FDA  know  that  I  wish  to  have  my  petition  reviewed  under  the  
standards  for  a  QHC  rather  than  those  for  an  SSA  health  claim  (i.e.,  
under  the  SSA  standard)? 
Answer: The  petitioner  may  indicate  within  the  petition's  cover  letter  that 
he/she  is  waiving  the  right  to  a  review  under  the  SSA  standard  and  request 
that  the  petition  be  reviewed  under  the  interim  procedures  for  a  QHC.  This 
request  will  result  in  FDA  proceeding  directly  to  the  QHC  procedures  and  its 
270-day  timeline  (see  next  question).  In  the  absence  of  such  a  request,  FDA 
contacts  the  petitioner  to  determine  if  they  are  petitioning  for  a  SSA  or  QHC. 
Q7.	  What  information  is  required  to  be  included  in  the  petition? 
Answer: The  requirements  of  21  CFR  101.70 apply.  A  general  summary  of 
these  requirements  follows. 
1.  21  CFR  101.70(f)(A))  
Preliminary  Requirements  (see   Explanation  of  how 
21  CFR  101.14(b): 
substance  conforms  to  the  requirements  of  
 Relationship  between  substance  and  disease  or  health-related  condition; 
 Substance  contributes  taste,  aroma,  nutritive  value,  or  a  technical  
21  CFR  170.3(o); 
effect  listed  in  
 Substance  is  a  food,  food  ingredient,  or  component  that  has  been  
shown  to  be  safe  and  lawful  at  levels  necessary  to  justify  a  claim  
101.14(b)(3)(ii)). 
(21  CFR  
2.  (see  21  CFR  101.70(f)(B)) 
Summary  of  Scientific  data  
3.  

Analytical  data  to  show  amount  of  substance  that  is  present  in 
(see  21  CFR  101.70(f)(C))
 
representative  foods  
4.  (see  21  CFR  101.70(f)(D)) 
Proposed  model  health  claim(s)  
5.  (see  21  CFR  101.70(f)(E)) 
Attachments  
 Scientific  data  supporting  a  claim: 
 Copies  of  computer  literature  searches; 
 Copy  of  all  research  articles  relied  upon  for  support  of  petition  -- 
English  only; 
A  F O O D  L A B E L I N G  G U I D E   83   Information  concerning  adverse  consequences  pertinent  to  any  
segment  of  the  U.S.  population. 
6.  2 1 
A  claim  for  categorical  exclusion  or  an  environmental  assessment  (see  
C FR    1 0 1 .7  0 ( f)  ( F)  ) 
NOTE:  FDA  encourages  petitioners  to  specify  whether  they  are  requesting 
that  their  petition  be  reviewed  as  a  QHC,  and  that  they  waive  review  under 
the  SSA  standard. 
Q8.  Where  should  I  send  the  petition? 
Answer: Mail  the  original  and  one  copy  of  the  petition  (or  a  computer 


readable  disk  containing  the  petition)  to  the  following  address:


Food  and  Drug  Administration


Office  of  Nutrition,  Labeling  and  Dietary  Supplements  (HFS-800)


5100  Paint  Branch  Parkway,  College  Park,  MD  20740
Q9.  Are  there  circumstances  when  FDA  will  not  file  a  petition? 
Answer: Yes,  if  the  petition  is  incomplete  in  that  it  does  not  provide  the 
required  information  that  is  summarized  above. 
Q10. How  can  I  find  out  what  letters  FDA  has  issued  for  QHC? 
Answer:  See  Qualified  Health  Claims:  Letters  of  Enforcement  Discretion  at 
www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims. 
Alternately,  you  can  go  to  Appendix  D  of  this  guidance  for  a  listing  of  the 
QHCs  available  at  the  time  this  guidance  was  issued. 
Structure/Function  Claims 
S1.  What  are  structure/function  (S/F)  claims? 
Answer:  The  Dietary  Supplement  Health  and  Education  Act  of  1994 
(DSHEA)  added  Section  403(r)(6)  to  the  FD&C  Act.  This  section  of  the  law 
states  that  a  dietary  supplement  may  bear  certain  statements  on  its  label  or  in 
its  labeling  if  the  claim  meets  certain  requirements.  Section  101.93(f)  simply 
restates  part  of  the  definition  of  the  types  of  claims  that  may  be  made  under 
4 0 3 ( r)  ( 6 )  1 0 1 .9  3 ( f)  
Section   of  the  FD&C  Act.  Section   reads: 
Pe r m  i t t e d   st r u c t u r e / f u n c t i o n   st a t e m  e n t s .  
(f)   Dietary  supplement  labels  or  labeling 
may,  subject  to  the  requirements  in  paragraphs  (a)  through  (e)  of  this  section, 
bear  statements  that  describe  the  role  of  a  nutrient  or  dietary  ingredient 
intended  to  affect  the  structure  or  function  in  humans  or  that  characterize  the 
documented  mechanism  by  which  a  nutrient  or  dietary  ingredient  acts  to 
maintain  such  structure  or  function,  provided  that  such  statements  are  not 
(2 1   CF R    10 1 . 9 3 ) .  
disease  claims  under  paragraph  (g)   If  the  label  or  labeling  of 
a  product  marketed  as  a  dietary  supplement  bears  a  disease  claim  as  defined  in 
paragraph  (g)  of  this  section,  the  product  will  be  subject  to  regulation  as  a  drug 
unless  the  claim  is  an  authorized  health  claim  for  which  the  product  qualifies. 
4 0 3 ( r)  ( 6 ) 
Section   of  the  FD&C  Act  does  not  apply  to  conventional  foods, 
however  structure/function  claims  may  be  made  on  a  conventional  food 
provided  the  effects  are  derived  from  the  nutritive  value  of  the  food. 
ht t p : / / w  w  w  . f d a . g o v / F o o d / L a b e l i n g N  u t r i t i o n / L a b e l C  l a i m  s / S t r u c t u r e F u n c t i o n C  l a i m  s /  
d e f a u l t . h t m  and h t t p : / / w w w.  f d a . g o v / F o o d / L a b e l i n g N u t r i t i o n / L a b e l C l a i m s / 
u c m 1 1 1 4 4 7. 
84 G U I D A N C E  F O R  I N D U S T R Y  S2.	  Are  there  other  claims  that  can  be  made  for  dietary  supplements  under  
this  section  of  the  law? 
Answer: Yes.  Section  403(r)(6)  also  states  that  dietary  supplements  can  use 
claims  about  nutrient  deficiency  diseases  (for  example,  vitamin  C  and  scurvy) 
or  that  describe  the  effect  of  the  dietary  supplement  on  general  well-being. 
S3.	  What  requirements  must  I  meet  to  make  any  of  these  types  of  claims  for 
my  dietary  supplement? 
Answer:  There  are  three  requirements  you  must  meet.  First,  the  law  says  you 
can  make  these  claims  if  you  have  substantiation  that  the  claims  are  truthful 
and  not  misleading.  You  must  have  this  substantiation  before  you  make  the 
claims.  Second,  you  must  notify  FDA  that  you  are  using  the  claim  within  30 
days  of  first  marketing  your  product.  Third,  the  claim  must  include  a 
mandatory  disclaimer  statement  that  is  provided  for  in  the  law.  Section 
403(r)(6) 
of  the  FD&C  Act. 
S4.	  Where  can  I  find  information  on  the  mandatory  disclaimer  and  the  
notification  I  need  to  send  in? 
Answer: We  have  published  regulations  that  describe  exactly  what  the 
disclaimer  must  say  and  what  you  must  include  in  your  notification  to  us  and 
(62  FR 
where  you  must  send  it  in  the  September  23,  1997  Federal  Register  
49859  49883,   21  CFR 
and   respectively).  These  requirements  can  be  found  in  
101.93(b)  through  (e)  21  CFR  101.93(a), 
and   respectively. 
S5.	  How  do  I  determine  if  a  claim  is  a  structure/function  claim  or  a  
disease  claim? 
Answer: It  may  not  be  possible  always  to  draw  a  bright  line  between  structure/ 
function  and  disease  claims.  You  should  look  at  the  objective  evidence  in  your  
labeling  to  assess  whether  a  claim  explicitly  or  implicitly  is  a  disease  claim.  For  
example,  a  statement  may  not  mention  a  disease  but  may  refer  to  identifiable 
characteristic  signs  or  symptoms  of  a  disease  such  that  the  intended  use  of  the 
product  to  treat  or  prevent  the  disease  may  be  inferred.  It  is  important  that 
you  keep  in  mind  two  things.  First,  the  context  of  the  statement,  decided  from 
information  on  the  label  and  in  other  labeling,  will  determine  if  the  statement 
is  considered  to  be  a  disease  claim.  Second,  foods  may  not  bear  disease  claims, 
explicit  or  implied,  unless  the  claim  has  undergone  premarket  review  by  FDA 
and  has  been  authorized  or  approved  under  the  rules  for  health  claims  or 
drugs,  as  appropriate.  To  assist  you  in  deciding  whether  a  claim  is  or  is  not  a 
disease  claim,  the  new  regulation  contains  a  definition  for  disease,  and  then 
includes  10  criteria  intended  to  help  clarify  the  types  of  claims  that  may  be 
made  for  dietary  supplements  without  prior  authorization  or  approval  by 
FDA.  We  are  providing  that  disease  definition  and  a  link  to  the  10  criteria  in 
S7  below. 
S6.	  What  is  the  definition  of  a  disease? 
Answer: Section  101.93(g) defines  disease  as: 
...damage  to  an  organ,  part,  structure,  or  system  of  the  body  such  that  it  does 
not  function  properly  (e.g.,  cardiovascular  disease),  or  a  state  of  health  leading 
to  such  dysfunctioning  (e.g.,  hypertension);  except  that  diseases  resulting  from 
essential  nutrient  deficiencies  (e.g.,  scurvy,  pellagra)  are  not  included  in  this 
definition. 
A  F O O D  L A B E L I N G  G U I D E   85  S7.  What  are  the  criteria  for  determining  if  a  statement  is  a  disease  claim? 
Answer: There  are  10  criteria  in  the  final  rule  entitled  Regulations  on 
Statements  Made  for  Dietary  Supplements  Concerning  the  Effect  of  the 
Product  on  the  Structure  or  Function  of  the  Body,  published  on  January  6, 
(65  FR  10001050)
2000  in  the  Federal  Register   ,  that  are  useful  in  determining 
if  a  statement  is  a  disease  claim.  These  10  criteria  can  be  found  in  the: 
Structure/Function  Claims  Small  Entity  Compliance  Guide: 
http://www.fda.gov/Food/Guidance  ComplianceRegulatoryInformation/Guidance 
Documents/DietarySupplements/ucm103340. 
86 G U I D A N C E  F O R  I N D U S T R Y  A A:  
9.  PPENDIX 
D N C C
EFINITIONS OF  UTRIENT  ONTENT  LAIMS 
Content  Claims  (Free,  Low,  Reduced/Less) 
Free  Low  Reduced/Less  Comments 
Synonyms  for  Synonyms  for  Synonyms  for  For  Free,  Very  Low,  or  Low, 
Free  Zero,  Low:   Reduced/Less:   must  indicate  if  food  meets  a 
No,Without,  Little,  (Few  Lower  definition  without  benefit  of  special 
Trivial  Source  for  Calories),  (Fewer  for   processing,  alteration,  formulation 
of,  Dietarily  Contains  a  Calories)  or  reformulation;  e.g.,  broccoli,  a 
Insignificant  Small  Amount  fat-free  food  or  celery,  a  low 
Source  of  of,  Low  Source  Modified  may  calorie  food 
of  be  used  
Definitions  for  in  statement  of 
Free  for  meals  identity 
and  main  dishes 
are  the  stated  Definitions  for 
values  per  meals  and  main 
labeled  serving  dishes  are  same 
but  are  not  as  for  individual 
defined  for  foods  on  a  per 
calories  100  g  basis 
Definitions  of  Nutrient  Content  Claims 
Nutrient  Free  Low  Reduced/Less  Comments 
Calories  Less  than  5  cal  40  cal  or  less  per  At  least  25%  Light  or  Lite:  if  50%  or  more  of 
per RACC  and  RACC  (and  per  fewer  calories  per  the  calories  are  from  fat,  fat  must  be 
21  CFR  101.60(b) 
per  labeled  50g  if  RACC  is  RACC  than  an  reduced  by  at  least  50%  per  RACC. 
(b)(1)  (b)(2) 
serving   small)   appropriate  If  less  than  50%  of  calories  are  from 
reference  food  fat,  fat  must  be  reduced  at  least  50% 
Meals  and  main 
(for  meals  and  or  calories  reduced  at  least  1/3  per 
dishes:  120  cal  or 
main  dishes,  at  RACC  21  CFR  101.56(b) 
less  per  100  g 
(b)(3)  least  25%  fewer 
calories  per  100  g) 
Light  or  Lite  meal  or  main  dish 
Reference  food 
product  meets  definition  for  Low 
may  not  be  Low 
Calorie  or  Low  Fat  meal  and  is 
Calorie  
labeled  to  indicate  which  definition  is 
21  CFR  101.56(d) 
Uses  term  met  
Fewer  rather
For  dietary  supplements:  Calorie 
than  Less 
(b)(4)   (5)  claims  can  only  be  made  when  the 
& 
reference  product  is  greater  than  40 
21  CFR 
calories  per  serving  
101.60(a)(4) 
A  F O O D  L A B E L I N G  G U I D E   87  Definitions  of  Nutrient  Content  Claims  continued 
Nutrient  Free  Low  Reduced/Less  Comments 
Total  Fat  Less  than  0.5  g  3  g  or  less  per  At  least  25%  less  ^^%  Fat  Free:  may  be  used  if  food 
21  CFR  101.62(b) 
RACC  and  per  RACC  (and  per  fat  per  RACC  meets  the  requirements  for  Low  Fat 
21  CFR  101.62(b)(6) 
labeled  serving  50  g  if  RACC  is  than  an 
(b)(2) 
(or  for  meals  and  small)   appropriate 
100%  Fat  Free:  food  must  be  Fat 
main  dishes,  less  reference  food  (b)(6)(iii) 
Meals  and  main  Free  
than  0.5  g  per  (or  for  meals  and 
dishes:  3  g  or  less 
labeled  serving)  main  dishes,  at  Lightsee  previous  Calorie 
(b)(1)  per  100  g  and  least  25%  less  fat  comments 
not  more  than  (b)(4) 
per  100  g)  
Contains  no  30%  of  calories  (5)  For  dietary  supplements:  total  fat 
(b)(3)  &  
ingredient  that  is  from  fat   claims  cannot  be  made  for  products 
fat  or  understood  Reference  food  that  are  40  calories  or  less  per  serving 
to  contain  fat,  may  not  be  Low  21  CFR  101.62(a)(4) 
except  noted  Fat 
below  (*). 
Nutrient  Free  Low  Reduced/Less  Comments 
Saturated  Fat  
Less  than  0.5  g  1  g  or  less  per  At  least  25%  less  Next  to  all  saturated  fat  claims,  must 
21  CFR  101.62(c) 
saturated  fat  and  RACC  and  15%  saturated  fat  per  declare  the  amount  of  cholesterol  if  2 
less  than  0.5  g  or  less  of  calories  RACC  than  an  mg  or  more  per  RACC;  and  the 
trans  fatty  acids  from  saturated  appropriate  amount  of  total  fat  if  more  than  3g 
(c)(2) 
per  RACC  and  fat   reference  food  per  RACC  (or  0.5  g  or  more  of  total 
main  dishes,  less  (or  for  meals  and  fat  per  RACC  for  Saturated  Fat 
Meals  and  main 
than  0.5  g  main  dishes,  at  Free)  (or  for  meals  and  main  dishes, 
dishes:  1  g  or  less 
saturated  fat  and  least  25%  less  per  labeled  serving)  
per  100g  and  less  21  CFR  101.62(c) 
trans  fatty  acids  saturated  fat  per 
than  10%  of  (c)(4) 
per  labeled  100  g)   & 
(c)(1)  calories  from  (5) 
serving)  
saturated  fat  For  dietary  supplements:  saturated  fat 
(c)(3)
Contains  no  t  Reference  food  claims  cannot  be  made  for  products 
ingredient  that  is  may  not  be  Low  that  are  40  calories  or  less  per  serving 
21  CFR  101.62(a)(4) 
understood  to  Saturated  Fat 
contain  saturated 
fat  except  as 
noted  below  (*) 
88 G U I D A N C E  F O R  I N D U S T R Y  Definitions  of  Nutrient  Content  Claims  continued 
Nutrient  Free  Low  Reduced/Less  Comments 
Cholesterol  
Less  than  2  mg  20  mg  or  less  per  At  least  25%  less  Cholesterol  claims  only  allowed 
21  CFR  101.62(d) 
per  RACC  and  RACC  (and  per  cholesterol  per  when  food  contains  2  g  or  less 
per  labeled  50  g  of  food  if  RACC  than  an  saturated  fat  per  RACC;  or  for  meals 
serving  (or  for  RACC  is  small)  appropriate  and  main  dish  products,  per  labeled 
(d)(2) 
meals  and  main  reference  food  serving  size  for  Free  claims  or  per 
dishes,  less  than  (or  for  meals  and  100  g  for  Low  and  Reduced/Less 
Meals  and  main 
2  mg  per  labeled  main  dishes,  at  claims 
dishes:  20  mg  or 
serving)  least  25%  less 
less  per  100  g  Must  declare  the  amount  of  total  fat 
(d)(3)  cholesterol  per 
Contains  no  next  to  cholesterol  claim  when  fat 
100  g)  (d)(4)  & 
ingredient  that  exceeds  13  g  per  RACC  and  labeled 
(5)) 
contains  serving  (or  per  50  g  of  food  if  RACC 
cholesterol  except Reference  food  is  small),  or  when  the  fat  exceeds 
as  noted  below  may  not  be  Low  19.5  g  per  labeled  serving  for  main 
(d)(1) 
(*)   Cholesterol  dishes  or  26g  for  meal  products 
For  dietary  supplements:  cholesterol 
claims  cannot  be  made  for  products 
that  are  40  calories  or  less  per  serving 
Nutrient  Free  Low  Reduced/Less  Comments 
Sodium  Less  than  5  mg  140  mg  or  less  At  least  25%  less  Light  (for  sodium  reduced  21  CFR 
21  CFR  101.61 
per  RACC  and  per  RACC  (and  sodium  per  products):  if  food  is  Low  Calorie 
per  labeled  per  50  g  if  RACC  RACC  than  an  and  Low  Fat  and  sodium  is  reduced 
(b)(4)  21  CFR  101.56(c)(1) 
serving  (or  for  is  small)   appropriate  by  at  least  50%.  
meals  and  main  reference  food 
Meals  and  main  Light  in  Sodium:  if  sodium  is 
dishes,  less  than  (or  for  meals  and 
dishes:  140  mg  or  reduced  by  at  least  50%  per  RACC. 
5  mg  per  labeled  main  dishes,  at  21  CFR  101.56(c)(2) 
(b)(1)  less  per  100g 
serving   (b)(5)  least  25%  less 
sodium  per  100  g)  For  meals  and  main  dishes,  Light  in 
Contains  no 
Very  Low  Sodium  meets  definition  for  Low  in 
ingredient  that  is Reference  food  21  CFR  101.56(d)(2) 
Sodium:  35  mg  Sodium  
sodium  chloride  may  not  be  Low 
or  less  per  RACC  (b)(6) 
or  generally  Sodium   No  Salt  Added  and  Unsalted 
(and  per  50  g  if  (7) 
understood  to  &   must  declare  This  is  Not  A  Sodium
RACC  is  small). 
contain  sodium  Free  Food  on  information  panel  if 
For  meals  and 
except  as  noted  food  is  not  Sodium  Free  
below  (*)  main  dishes:  21  CFR  101.61(c)(2) 
35  mg or  less  per 
(b)(2)  
Salt  Free  must  100  g   &  Lightly  Salted:  50%  less  sodium 
(3) 
meet  criterion  for  than  normally  added  to  reference 
Sodium  Free  food  and  if  not  Low  Sodium,  so 
(c)(1) 
labeled  on  information  panel  
21  CFR  101.56(g) 
A  F O O D  L A B E L I N G  G U I D E   89  Definitions  of  Nutrient  Content  Claims  continued 
Nutrient  Free  Low	  Reduced/Less  Comments 
Sugars 
Sugar  Free:  Not  Defined.  At  least  25%  less  No  Added  Sugars  and  Without 
21  CFR  101.60(c)	 
Less  than  0.5  g  sugars  per  RACC  Added  Sugars  are  allowed  if  no  sugar 
May  not  be  used 
sugars  per  RACC  than  an  or  sugar  containing  ingredient  is 
and  per  labeled  appropriate  added  during  processing.  State  if  food 
serving  (or  for  reference  food  is  not  Low  or  Reduced  Calorie 
(c)(2) 
meals  and  main  (or  for  meals  and 
dishes,  less  than  main  dishes,  at 
The  terms  Unsweetened  and  No 
0.5  g  per  labeled  least  25%  less 
(c)(1)  Added  Sweeteners  remain  as  factual 
serving)   sugar  per  100g)  (c)(3) 
statements  
Contains  no  May  not  use  this 
The  claim  does  not  refer  to  sugar 
ingredient  that  is  claim  on  dietary 
alcohols, which  may  be  present. 
a  sugar  or  supplements  of 
generally  vitamins  and  For  dietary  supplements:  Sugar 
understood  to  minerals  (c)(5)  Free  and  No  Added  Sugar  may  be 
contain  sugars  &  (6)  used  for  vitamins  and  minerals 
except  as  noted  intended  to  be  used  by  infants  and 
below  (*)  children  less  than  2  years  of  age. 
(c)(4) 
Disclose  calorie 
profile  (e.g., 
Low  Calorie) 
Notes: 
*  Except  if  the  ingredient  listed  in  the  ingredient  statement  has  an  asterisk  that  refers  to  footnote  
(e.g.,  *  adds  a  trivial  amount  of  fat). 
RACC  =  Reference  Amounts  Customarily  Consumed. 
Small  RACC  =  Reference  Amounts  Customarily  Consumed  of  30  g  or  less  or  2  tablespoons 
or  less  (for  dehydrated  foods  that  are  typically  consumed  when  rehydrated  with  water  or  a 
21  CFR  101.9(f)(1),  
diluent  containing  an  insignificant  amount,  as  defined  in   of  all  
nutrients  per  RACC,  the  per  50  g  criterion  refers  to  the  prepared  form  of  the  food). 
When  levels  exceed:  13  g  Total  Fat,  4  g  Saturated  Fat,  60  mg  Cholesterol,  and  480  mg  Sodium  per  
RACC,  per  labeled  serving  or,  for  foods  with  small  RACC,  per  50  g,  a  disclosure  statement  is  
required  as  part  of  claim  (e.g.,  See  nutrition  information  for^^^content  with  the  blank  filled  in  
with  nutrient(s)  that  exceed  the  prescribed  levels). 
The  term  light  may  be  used  to  describe  a  physical  or  organoleptic  attribute  of  the  food  if  it 
21  CFR  101.56(e) 
clearly  conveys  the  nature  of  the  product,  e.g.,  light  in  color,  light  in  texture.  
If  there  has  been  a  long  history  of  use  of  the  term  light  associated  with  a  product  it  may 

continue  to  be  used,  e.g.,  light  corn  syrup,  light  brown  sugar.  21  CFR  101.56(f) 
90 G U I D A N C E  F O R  I N D U S T R Y  A B:  
10.  PPENDIX 
A R
DDITIONAL  EQUIREMENTS 
N C C
FOR  UTRIENT  ONTENT  LAIMS 
Relative  Claims 
To  bear  a  relative  claim  about  the  level  of  a  nutrient,  the  amount  of  that  nutrient 
in  the  food  must  be  compared  to  an  amount  of  nutrient  in  an  appropriate 
(21  CFR  101.13(j)(1))
reference  food  as  specified  below   : 
	
Light (1)  A  food  representative  of  the  type  of  food  bearing  
the  claim  (e.g.,  average  value  of  top  three  brands  or  
representative  value  from  valid  data  base),  and  (2)  
Similar  food  (e.g.,  potato  chips  for  potato  chips) 


Reduced  and   (1)  An  established  regular  product  or  average


Added  (or  Extra, representative  product,  and  (2)  Similar  food.


Plus,  Fortified, 


and  Enriched)
More  and  Less (1)  An  established  regular  product  or  average 
(or  Fewer)  representative  product,  and  (2)  A  dissimilar  food  in  
the  same  product  category  which  may  be  generally  
substituted  for  the  labeled  food  (e.g.,  potato  chips  for 
pretzels)  or  a  similar  food. 
For  all  relative  claims,  the  percent  (or  fraction)  of  change  and  identity  of  reference 
food  must  be  declared  immediately  adjacent  to  the  most  prominent  claim.  
21  CFR  101.13(j)(2)(i)  21  CFR  101.13(j)(2)(ii) 
and  
Quantitative  comparison  of  the  amount  of  the  nutrient  in  the  product  per 
labeled  serving  with  that  in  the  reference  food  must  be  declared  either  adjacent  to 
21  CFR  101.13(j)(2)(iv)(A) 
the  claim  or  on  the  information  panel.  
A  relative  claim  for  decreased  levels  of  a  nutrient  may  not  be  made  if  the  nutrient 
content  of  the  reference  food  meets  the  requirement  for  a  low  claim  for  that 
21  CFR  101.13(j)(3) 
nutrient  (e.g.,  3  g  fat  or  less).  
Other  Nutrient  Content  Claims 
Claim	  Requirements 
High,  Rich  In,   Contains  20%  or  more  of  the  DV  per  RACC.  May  
or  Excellent  Source be  used  on  meals  or  main  dishes  to  indicate  that  the 
Of  product  contains  a  food  that  meets  the  definition,  but 
21  CFR  101.54(b) 
may  not  be  used  to  describe  the  meal.  
Good  Source,   10%-19%  of  the  DV  per  RACC.  These  terms  may  be 
Contains,  or   used  on  meals  or  main  dishes  to  indicate  that  the 
Provides  product  contains  a  food  that  meets  the  definition  but 
21  CFR  101.54(e) 
may  not  be  used  to  describe  the  meal.  
A  F O O D  L A B E L I N G  G U I D E   91  

More,  Fortified, 10%  or  more  of  the  DV  per  RACC  than  an  appropriate


Enriched,  Added, reference  food.  May  only  be  used  for  vitamins,  minerals,
21  CFR  101.54(e) 
Extra,  or  Plus  protein,  dietary  fiber,  and  potassium.  
Lean  On  seafood  or  game  meat  products  that  contain  less 
than  10  g  total  fat,  4.5  g  or  less  saturated  fat,  and  less 
than  95  mg  cholesterol  per  RACC  and  per  100g  (for 
meals  &  main  dishes,  meets  criteria  per  100g  and  per  
labeled  serving).  On  mixed  dishes  not  measurable  with 
21  CFR  101.12(b) 
a  cup  (as  defined  in   in  table  2)  that  
contain  less  than  8  g  total  fat,  3.5  g  or  less  saturated  fat 
and  less  than  80  mg  cholesterol  per  RACC. 
21  CFR  101.62(e)(1)(3) 
	
Extra  Lean On  seafood  or  game  meat  products  that  contains  less 
than  5  g  total  fat,  less  than  2  g  saturated  fat  and  less  than 
95  mg  cholesterol  per  RACC  and  per  100  g  (for  meals 
and  main  dishes,  meets  criteria  per  100  g  and  per  labeled 
21  CFR  101.62(e)(4)  & (5) 
serving).  
	
High  Potency  May  be  used  on  foods  to  describe  individual  vitamins  or 
minerals  that  are  present  at  100%  or  more  of  the  RDI 
per  RACC  or  on  a  multi-ingredient  food  product  that 
contains  100%  or  more  of  the  RDI  for  at  least  2/3  of 
the  vitamins  and  minerals  with  RDIs  and  that  are  
present  in  the  product  at  2%  or  more  of  the  RDI  
(e.g.,  High  potency  multivitamin,  multimineral  dietary 
21  CFR  101.54(f) 
supplement  tablets).  
Modified  May  be  used  in  statement  of  identity  of  a  food  that 
bears  a  relative  claim  (e.g.,  Modified  fat  cheesecake, 
contains  35%  less  fat  than  our  regular  cheesecake.) 
21  CFR  101.13(k) 
	
Fiber  Claims If  a  fiber  claim  is  made  and  the  food  is  not  low  in  total 
fat,  then  the  label  must  disclose  the  level  of  total  fat  per 
21  CFR  101.54(d)(1) 
labeled  serving.  
Claims  using  the   For  claims  characterizing  the  level  of  antioxidant  
term  antioxidant  nutrients  in  a  food: 
1. 
an  RDI  must  be  established  for  each  of  the  
nutrients  that  are  the  subject  of  the  claim; 
2.
each  nutrient  must  have  existing  scientific  
evidence  of  antioxidant  activity; 
3.
the  level  of  each  nutrient  must  be  sufficient  to 
meet  the  definition  for  high,  good  source,  
or  more;  
Beta-carotene  may  be  the  subject  of  an  antioxi-
dant  claim  when  the  level  of  vitamin  A  present  as  
beta-carotene  in  the  food  is  sufficient  to  qualify  
for  the  claim. 
4.
Name(s)  of  nutrient(s)  that  is  (are)  the  subject  of 
the  claim  is  (are)  included  as  part  of  the  claim. 
(e.g.,  high  in  antioxidant  vitamins  C  &  E)  
21  CFR  101.54(g) 
92 G U I D A N C E  F O R  I N D U S T R Y  Implied  Claims 
21  CFR  101.65 
 Claims  about  a  food  or  ingredient  or  method  of  preparation  that  suggests  that  
the  nutrient  or  ingredient  are  absent  or  present  in  a  certain  amount  or  claims  
about  a  food  that  suggests  a  food  may  be  useful  in  maintaining  healthy  dietary  
practices  and  which  are  made  with  an  explicit  claim  (e.g.  healthy,  contains  3  
grams  of  fat)  are  implied  claims. 
 Claims  that  a  food  contains  or  is  made  with  an  ingredient  that  is  known  to  
contain  a  particular  nutrient  may  be  made  if  product  is  Low  in  or  a  Good  
Source  of  the  nutrient  associated  with  the  claim  (e.g.  good  source  of  oat  
bran). 
 Equivalence  claims:  contains  as  much  [nutrient]  as  a  [food]  may  be  made  if  
both  reference  food  and  labeled  food  are  an  equivalent  Good  Source  of  a  
nutrient  on  a  per  serving  basis.  (e.g.  Contains  as  much  vitamin  C  as  an  8  
21  CFR  101.65(c)(2) 
ounce  glass  of  orange  juice).  
 The  following  label  statements  are  generally  not  considered  implied  claims  
unless  they  are  made  in  a  nutrition  context:  1)  avoidance  claims  for  religious,  
food  intolerance,  or  other  non-nutrition  related  reasons  (e.g.  100%  milk  
free);  2)  statements  about  non-nutritive  substances  (e.g.  no  artificial  colors);  
3)  added  value  statements  (e.g.  made  with  real  butter);  4)  statements  of  
identity  (e.g.  corn  oil  or  corn  oil  margarine);  and  5)  special  dietary  
statements  made  in  compliance  with  a  specific  Part  105  provision. 
 The  term  healthy  and  related  terms  (health,  healthful,  healthfully,  
healthfulness,  healthier,  healthiest,  healthily  and  healthiness)  may  be 
21  CFR  101.65(d)(2) 
used  if  the  food  meets  the  following  requirements:  
A  F O O D  L A B E L I N G  G U I D E   93  Conditions  for  the  Use  of  Healthy 
Individual  Food	  Seafood/Game  Meat  Meal/Main  Dish 
TOTAL  FAT  low  fat  <  5  g  fat  /RACC   low  fat 
&  /100g 
SATURATED  FAT  low  sat  fat  <  2  g  sat  fat  /RACC   low  sat  fat 
&  /100g 
SODIUM	    480  mg  /RACC  and  /    480  mg  /RACC    600  mg  /l.s. 
l.s.;  or  /50  g,  if  RACC  and  /l.s.;  or  /50  g, 
is  small  if  RACC  is  small 
CHOLESTEROL    disclosure  level  <  95  mg  /RACC  &  /    90  mg  /l.s. 
100  g 
BENEFICIAL  NUTRIENTS	  Contains  at  least  10%  of  DV  /  Contains  at  least   Contains  at  least 
RACC  for  vitamins  A,  C,   10%  of  DV  /RACC    10%  of  the  DV  /l.s. 
calcium,  iron,  protein,  or  fiber    for  vitamins  A,  C,  of  two  nutrients  (for 
except:  raw  fruits  and  vegetables;   calcium,  iron,  a  main  dish  product) 
or  a  single  ingredient  or  mixture  protein,  or  fiber  or  of  three  nutrients 
of  frozen  or  canned  fruits  and  (for  a  meal  product) 
vegetables  (may  include  ingred- of  vit.  A,  vit.  C, 
ients  whose  addition  does  not   calcium,  iron, 
change  the  nutrient  profile  of   protein,  or  fiber. 
the  fruit  or  vegetable);  enriched  
cereal-grain  products  that  
conform  to  a  standard  of  identity  
21  CFR  136,  137,  or  139. 
in  
FORTIFICATION	  Per  21  CFR  104.20  Per  21  CFR  104.20  Per  21  CFR  104.20 
Note: l.s.  =  labeled  serving;  RACC  =  Reference  Amount  Customarily  Consumed  per  Eating  Occasion;  small  RACC  =  30  g 
or  less,  or  2  tablespoons  or  less 
Claims  on  Foods  for  Infants  and  Children  Less  than  2  Years  of  Age 
Nutrient  content  claims  are  not  permitted  on  foods  intended  specifically  for  infants  and  children  less  than  2  years  of  age  except: 
1. 21  CFR  101.13(q)(3)(i)
 
Claims  describing  the  percentage  of  vitamins  and  minerals  in  a  food  in  relation  to  a  daily  value.  
2. 21  CFR  101.13(b)
 
Claims  on  infant  formulas  provided  for  in  Part  107.  
3. 21  CFR  101.60(c)(3)
 
The  terms  Unsweetened  and  Unsalted  as  taste  claims.  
4. 21  CFR  101.60(c)(4)
 
Sugar  Free  and  No  Added  Sugar  claims  on  dietary  supplements  only.  
94 G U I D A N C E  F O R  I N D U S T R Y  A C:  
11.  PPENDIX 
H C
EALTH  LAIMS 
Requirements  for  Health  Claims  Made  in  Labeling 
Approved   Requirements   Claim   Model  Claim  
Claims  for  the  Food  Requirements  Statements 
Calcium  and  For  calcium  and  The  claim  makes  clear  the  importance  Calcium  and  Osteoporosis:  Adequate 
Osteoporosis  osteoporosis  of  adequate  calcium  intake,  or  when  calcium  throughout  life,  as  part  of  a 
and  calcium,  claim  - high  in  appropriate,  adequate  calcium  and  well-balanced  diet,  may  reduce  the  risk 
vitamin  D,  and  calcium  vitamin  D  intake,  throughout  life,  in  a  of  osteoporosis. 
osteoporosis  healthful  diet,  are  essential  to  reduce 
For  calcium,  Calcium,  vitamin  D  and  osteoporosis: 
osteoporosis  risk.  The  claim  does  not 
(21  CFR  101.72)  vitamin  D  and Adequate  calcium  and  vitamin  D,  as 
imply  that  adequate  calcium  intake,  or 
osteoporosis  part  of  a  well  balanced  diet,  along  with 
when  appropriate,  adequate  calcium 
claim  - high  in physical  activity,  may  reduce  the  risk  of 
and  vitamin  D  intake,  is  the  only 
calcium  and  osteoporosis. 
recognized  risk  factor  for  the 
vitamin  D 
development  of  osteoporosis. 
- assimilable 
The  claim  does  not  attribute  any 
(Bioavailable) 
degree  of  reduction  in  risk  of 
Supplements  osteoporosis  to  maintaining  an 
must  disintegrate  adequate  dietary  calcium  intake,  or 
and  dissolve,  and  when  appropriate,  an  adequate  dietary 
calcium  and  vitamin  D  intake, 
Phosphorus 
throughout  life. 
content  cannot 
exceed  calcium 
content 
Dietary  Fat    Low  fat  Required  terms:  Development  of  cancer  depends  on 
and  Cancer  many  factors.  A  diet  low  in  total  fat 
(Fish  &  game  Total  fat  or  Fat  may  reduce  the  risk  of  some  cancers. 
(21  CFR  101.73) 
meats:  Extra 
lean)  Some  types  of  cancers  or  
Some  cancers 
Does  not  specify  types  of  fats  or  fatty  
acids  that  may  be  related  to  risk  of  cancer. 
A  F O O D  L A B E L I N G  G U I D E   95  Approved   Requirements   Claim   Model  Claim  
Claims  for  the  Food  Requirements  Statements 
Sodium  and   Low  sodium  Required  terms:  Diets  low  in  sodium  may  reduce  the 
Hypertension  risk  of  high  blood  pressure,  a  disease 
Sodium,  High  blood  pressure  associated  with  many  factors. 
(21  CFR  101.74) 
Includes  physician  statement 
(Individuals  with  high  blood  pressure 
should  consult  their  physicians)  if  
claim  defines  high  or  normal  blood  
pressure 
Dietary  Saturated  Low  saturated  fat,  Required  terms:  While  many  factors  affect  heart 
Fat  and   disease,  diets  low  in  saturated  fat  and 
Cholesterol  Low  cholesterol  Saturated  fat  and  cholesterol  cholesterol  may  reduce  the  risk  of 
and  risk  of  and  this  disease. 
Coronary  Heart  Coronary  heart  disease  
Disease  Low  fat  or  heart  disease 
(21  CFR  101.75)  Includes  physician  statement 
(individuals  with  elevated  blood 
totalor  LDLcholesterol  should 
consult  their  physicians)  if  claim 
defines  high  or  normal  blood  total 
and  LDLcholesterol. 
Fiber-Containing   A  grain  product,  Required  terms:  Low  fat  diets  rich  in  fiber-containing 
Grain  Products,   fruit,  or  vegetable grain  products,  fruits,  and  vegetables 
Fruits,  and   that  contains  Fiber,  Dietary  fiber,  or  Total  may  reduce  the  risk  of  some  types  of 
Vegetables  and   dietary  fiber;  dietary  fiber  cancer,  a  disease  associated  with 
Cancer  many  factors. 
Low  fat,  and  Some  types  of  cancer  or  Some 
(21  CFR  101.76) 
cancers 
Good  source  of 
dietary  fiber   Does  not  specify  types  of  dietary  fiber 
(without   that  may  be  related  to  risk  of  cancer. 
fortification) 
96 G U I D A N C E  F O R  I N D U S T R Y  Approved   Requirements   Claim   Model  Claim  
Claims  for  the  Food  Requirements  Statements 
Fruits,  Vegetables  A  fruit,  vegetable,   Required  terms:  Diets  low  in  saturated  fat  and 
and  Grain   or  grain  product   cholesterol  and  rich  in  fruits, 
Products  that   that  contains  Fiber,  Dietary  fiber,  Some  types  vegetables,  and  grain  products  that 
contain  Fiber,   fiber;  of  dietary  fiber,  Some  dietary  fibers,  contain  some  types  of  dietary  fiber, 
particularly   or  Some  fibers  particularly  soluble  fiber,  may  reduce
Soluble  Fiber,   Low  saturated  fat,  the  risk  of  heart  disease,  a  disease 
and  Risk  of   Saturated  fat  and  Cholesterol  associated  with  many  factors. 
Coronary  Heart  
Disease  Low  cholesterol,  Heart  disease  or  Coronary 
heart  disease 
(21  CFR  101.77) 
Low  fat, 
At  least  0.6  grams  
of  soluble  fiber  
per  RACC  
(without  
fortification),  
and, 
Soluble  fiber  
content  provided  
on  label 
Fruits  and   A  fruit  or  Required  terms:  Low  fat  diets  rich  in  fruits  and 
Vegetables   vegetable,  Fiber,  Dietary  fiber,  or  Total  vegetables  (foods  that  are  low  in  fat 
and  Cancer  dietary  fiber;  and  may  contain  dietary  fiber,  
Low  fat,  and  Vitamin  A,  or  Vitamin  C)  may  reduce 
(21  CFR  101.78) 
Total  fat  or  Fat,  the  risk  of  some  types  of  cancer,  a 
Good  source   disease  associated  with  many  factors. 
(without   Some  types  of  cancer  or  Some  Broccoli  is  high  in  vitamin  A  and  C, 
fortification)  of   cancers  and  it  is  a  good  source  of  dietary  fiber. 
at  least  one  of  the
following:  Characterizes  fruits  and  vegetables  as 
Vitamin  A,  Foods  that  are  low  in  fat  and  may 
Vitamin  C,  or  contain  Vitamin  A,  Vitamin  C,  and 
   Dietary  fiber  dietary  fiber. 
Characterizes  specific  food  as  a  Good  
source  of  one  or  more  of  the  following:  
Dietary  fiber,  Vitamin  A,  or  Vitamin  C. 
Does  not  specify  types  of  fats  or  fatty  
acids  or  types  of  dietary  fiber  that  may  
be  related  to  risk  of  cancer. 
A  F O O D  L A B E L I N G  G U I D E   97  Approved   Requirements   Claim   Model  Claim  
Claims  for  the  Food  Requirements  Statements 
Folate  and  Neural   Good  source  Required  terms:  Healthful  diets  with  adequate  folate 
Tube  Defects  of  folate  (at  least may  reduce  a  woman's  risk  of  having  
40  mcg  folate  Nutrient:  a  child  with  a  brain  or  spinal  cord  
(21  CFR  101.79) 
per  serving)  Folate,  folic  acid,  folacin,  folate,  defect. 
a  B  vitamin,  folic  acid,  a  B  vitamin, 
Dietary   folacin,  a  B  vitamin. 
supplements,  or  
foods  in   Condition: 
conventional  food   neural  tube  defects,  birth  defects,  
form  that  are   spinal  bifida,  or  anencephaly,  
naturally  good   birth  defects  of  the  brain  or  spinal  cord,  
sources  of  folate   anencephaly  or  spinal  bifida,  spinal   
(i.e.,  only  non- bifida  and  anencephaly,  birth  defects  of  
fortified  food  in   the  brain  or  spinal  cord; 
conventional  food   brain  or  spinal  cord  birth  defects. 
form) 
Must  also  include  information  on  the 
The  claim  shall  multifactorial  nature  of  neural  tube 
not  be  made  on   defects,  and  the  safe  upper  limit  of 
products  that   daily  intake. 
contain  more  
than  100%  of  the 
RDI  for  vitamin  
A  as  retinol  or  
preformed  
vitamin  A  or  
vitamin  D 
Dietary  
supplements  shall  
meet  USP  
standards  for  
disintegration  and  
dissolution  or  
otherwise  
bioavailable 
Amount  of  folate  
required  on 
Nutrition  Label 
98 G U I D A N C E  F O R  I N D U S T R Y  Approved   Requirements   Claim   Model  Claim  
Claims  for  the  Food  Requirements  Statements 
Dietary  Non- Sugar  free,  and  Required  terms:  Full  claim:  Frequent  between-meal 
cariogenic   consumption  of  foods  high  in  sugars 
Carbohydrate   When  a  fermen-       does  not  promote,  may  reduce  the  and  starches  promotes  tooth  decay. 
Sweeteners  and   table  carbohydrate  risk  of,  useful  [or  is  useful]  in  not  The  sugar  alcohols  in  [name  of  food]  
Dental  Caries  is  present,  the  promoting  or  expressly  [or  is  do  not  promote  tooth  decay. 
food  must  not  expressly]  for  not  promoting  dental 
(21  CFR  101.80)  lower  plaque  pH   caries;  Shortened  claim  (on  small  packages  
below  5.7.  only):  Does  not  promote  tooth  decay. 
dental  caries  or  tooth  decay. 
Eligible  substances 
sugar  alcohol  or  sugar  alcohols  
1)  The  following   or  the  name  or  names  of  the  sugar 
sugar  alcohols:  alcohols 
xylitol,  sorbitol,  
mannitol,  maltitol,   Note:  D-tagatose  may  be  identified 
isomalt,  lactitol,   as  tagatose 
hydrogenated  
starch  hydrolysates,   When  the  substance  that  is  the  subject 
hydrogenated   of  the  claim  is  a  noncariogenic  sugar 
glucose  syrups,   (i.e.,  D-tagatose)  the  claim  shall  identify 
erythritol,  or  a   the  substance  as  a  sugar  that,  unlike 
combination  of   other  sugars,  does  not  promote  the 
these.  development  of  dental  caries. 
2)  The  following   Includes  statement  that  frequent 
sugars:  between  meal  consumption  of  foods 
D-tagatose  and  high  in  sugars  and  starches  can 
isomaltulose  promote  tooth  decay. 
3)  The  following   Packages  with  less  than  15  square 
non-nutritive  inches  of  surface  area  available  for 
sweetener:  labeling  may  use  a  shortened  claim 
sucralose 
A  F O O D  L A B E L I N G  G U I D E   99  Approved   Requirements   Claim   Model  Claim 
 
Claims  for  the  Food  Requirements  Statements
 
Soluble  Fiber  Low  saturated  fat  Required  terms:  Soluble  fiber 
from  Certain  from  foods  such 
Foods  and  Risk  Low  cholesterol  Heart  disease  or  coronary  heart  as  [name  of 
of  Coronary  disease.  soluble  fiber 
Heart  Disease  Low  fat,  and  source,  and,  if 
(21  CFR  101.81) Saturated  fat  and  cholesterol.  desired,  name  of 
The  food  product  must  include  one  food  product],  
or  more  of  the  following  whole  oat  or  In  specifying  the  substance  the  claim  as  part  of  a  diet 
barley  foods:  1)  oat  bran,  2)  rolled  oats,   uses  the  term  soluble  fiber  qualified  low  in  saturated 
3)  whole  oat  f lour,  4)  whole  grain  by  the  name  of  the  eligible  source  of   fat  and 
barley  or  dry  milled  barley,  and  the  by  the  name  of  the  eligible  source  of  cholesterol,  may 
whole  oat  or  barley  foods  must  contain  the  soluble  fiber,  which  is  either  whole  reduce  the  risk 
at  least  0.75  g  of  soluble  fiber  per  oat  or  barley  or  psyllium  seed  husk.  heart  disease. 
RACC  of  the  food  product;  or  A  serving  of  
Claim  specifies  the  daily  dietary  [name  of  food 
Oatrim  that  contains  at  least  0.75  g  of  intake  of  the  soluble  fiber  source  product]  
beta--glucan  soluble  per  RACC  of  the  necessary  to  reduce  the  risk  of  CHD  supplies  ^  grams 
food  product;  or  of  the  [necessary 
Claim  specifies  the  amount  of  soluble  daily  dietary 
Psyllium  husk  that  contains  at  least   fiber  in  one  serving  of  the  product.  intake  for  the 
1.7  g  of  soluble  fiber  per  RACC  of  food  benefit]  soluble 
Additional  Required  Label  Statement 
product.  fiber  from 
[name  of  
Eligible  Sources  of  Soluble  Fiber  Foods  bearing  a  psyllium  seed  husk  soluble  fiber 
health  claim  must  also  bear  a  label  source]  necessary 
Beta-glucan  soluble  fiber  from  the  statement  concerning  the  need  to  per  day  to  have 
following  whole  oat  and  barley  sources:  consume  them  with  adequate  amounts  this  effect. 
1)Oat  bran  of  f luids;  e.g.,  NOTICE:  This  food  protein. 
2)  Rolled  Oats should  be  eaten  with  at  least  a  full 
3)Whole  Oat  Flour  glass  of  liquid.  Eating  this  product 
4)Oatrim without  enough  liquid  may  cause 
5)  Whole  Grain  Barley  and  Dry  choking.  Do  not  eat  this  product  if 
Milled  Barley  your  have  difficulty  in  swallowing. 
6)  Barley  Betafiber  
(21  CFR  101.17(f)) 
7)  Soluble  fiber  from  psyllium  husk
with  purity  of  no  less  than  95% 
The  amount  of  soluble  fiber  per 
RACC  must  be  declared  in  nutrition  
label. 
100 G U I D A N C E  F O R  I N D U S T R Y  Approved   Requirements   Claim   Model  Claim 
 
Claims  for  the  Food  Requirements  Statements
 
Soy  Protein  and  At  least  6.25  g  Required  terms:   (1)  25  grams  of  soy  protein  a  day,  as 
Risk  of  Coronary soy  protein  per  part  of  a  low  in  saturated  fat  and 
Heart  Disease  RACC  Heart  disease  or  coronary  heart  cholesterol,  may  reduce  the  risk  of 
disease  heart  disease.  A  serving  of  [name  of 
(21  CFR  101.82) 
Low  saturated  food]  supplies  ^^  grams  of  soy  protein. 
fat,  Soy  protein 
(2)  Diets  low  in  saturated  fat  and 
Low  cholesterol,  Saturated  fat  and  cholesterol  cholesterol  that  include  25  grams  of  
and  soy  protein  a  day  may  reduce  the  risk 
Claim  specifies  daily  dietary  intake  of  heart  disease.  One  serving  of  [name 
Low  fat  (except  levels  of  soy  protein  associated  with  of  food]  provides  ^^  grams  of  soy  
that  foods  made reduced  risk  protein. 
from  whole 
soybeans  that  Claim  specifies  amount  of  soy  protein 
contain  no  fat   in  a  serving  of  food 
in  addition  to 
that  inherent  in 
the  whole 
soybean  are 
exempt  from  the
low  fat  
requirement) 
A  F O O D  L A B E L I N G  G U I D E   101  Approved   Requirements   Claim   Model  Claim 
 
Claims  for  the  Food  Requirements  Statements
 
Required  terms: 
*Plant  Sterol/  At  least  0.65  g  (1)  Foods  containing  at  least  0.65 
stanol  esters  and  plant  sterol  esters  gram  per  of  vegetable  oil  sterol  esters, 
Risk  of  Coronary  per  RACC  of  May  or  might  reduce  the  risk  of  eaten  twice  a  day  with  meals  for  a 
Heart  Disease  spreads  and  salad  CHD  daily  total  intake  of  least  1.3  grams, 
dressings,  or  as  part  of  a  diet  low  in  saturated  fat 
(21  CFR  101.83)  Heart  disease  or  coronary  heart  and  cholesterol,  may  reduce  the  risk 
At  least  1.7  g  disease  of  heart  disease.  A  serving  of  [name 
plant  stanol  esters of  food]  supplies  ^^  grams  of 
per  RACC  of  Plant  sterol   esters  or  plant  stanol  vegetable  oil  sterol  esters. 
spreads,  salad  esters;  except  vegetable  oil  may 
dressings,  snack  replace  the  term  plant  if  vegetable  (2)  Diets  low  in  saturated  fat  and  
bars,  and  dietary  oil  is  the  sole  source  of  the  sterol/  cholesterol  that  include  two  servings 
supplements.  stanol  ester  of  foods  that  provide  a  daily  total  of  at 
least  3.4  grams  of  plant  stanol  esters 
Low  saturated  fat,  Claim  specifies  plant  stero/stanol  in  two  meals  may  reduce  the  risk  of 
esters  are  part  of  a  diet  low  in  saturated  heart  disease.  A  serving  of  [name  of 
Low  cholesterol,  fat  and  cholesterol.  food]  supplies  ^^  grams  of  plant  
and  stanol  esters 
Claim  does  not  attribute  any  degree 
Spreads  and  salad  of  CHD  risk  reduction. 
dressings  that 
exceed  13  g  fat  Claim  specifies  the  daily  dietary  intake 
per  50  g  must  of  plant  sterol  or  stanol  esters 
bear  the  statement  necessary  to  reduce  CHD  risk,  and 
see  nutrition  the  amount  provided  per  serving. 
information  for  Claim  specifies  that  plant  sterol  or 
fat  content  stanol  esters  should  be  consumed 
with  two  different  meals  each  a  day. 
Salad  dressings 
are  exempted  from 
the  minimum  
10%  DV  nutrient  
requirement 
* FDA  regulates  the  plant  sterol/stanol  esters  and  risk  of  coronary  heart  disease  health  claim  according  to  the  following  requirements: 
1)  An  interim  final  rule  for  the  health  claim  that  published  on  September  8,  2000  (65  FR  54686), 
2)  An  enforcement  discretion  letter  about  expanded  use  of  the  interim  final  rule  for  the  health  claim,  
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/HealthClaimsMeetingSignificantScientificAgreementSSA/ucm074779.htm?utm_campaign 
=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=phytosterols&utm_content=8 and 
3)  A  proposed  rule  for  the  health  claim  that  published  on  December  8,  2010  (75  FR  76526). 
102 G U I D A N C E  F O R  I N D U S T R Y  FDAMA  (FDA  Modernization  Act)  Health  Claims  (Health  Claims  Authorized  
Based  on  an  Authoritative  Statement  by  Federal  Scientific  Bodies) 
Approved  Food  Claim  Model  Claim 
 
Claims  Requirements  Requirement  Statements
 
Required  wording  of  the  claim: 
Whole  Grain  Contains  51  percent  or  more  whole  NA 
Foods  and  Risk  grain  ingredients  by  weight  per  RACC, 
Diets  rich  in  whole  grain  foods  and 
of  Heart  Disease  and 
other  plant  foods  and  low  in  total  fat, 
and  Certain 
Dietary  fiber  content  at  least:  saturated  fat,  and  cholesterol  may 
Cancers 
reduce  the  risk  of  heart  disease  and 
(Docket  No.  3.0  g  per  RACC  of  55  g   some  cancers. 
1999P2209)   2.8  g  per  RACC  of  50  g  
 2.5  g  per  RACC  of  45  g 
1.7  g  per  RACC  of  35  g 
Required  wording  of  the  claim: 
Whole  Grain  Contains  51  percent  or  more  whole  NA 
Foods  with  grain  ingredients  by  weight  per  RACC, 
Diets  rich  in  whole  grain  foods  and 
Moderate  Fat  and 
other  plant  foods,  and  low  in  total  fat, 
Content  and 
Dietary  fiber  content  at  least:  saturated  fat,  and  cholesterol  may  help 
Risk  of  Heart 
reduce  the  risk  of  heart  disease. 
Disease   3.0  g  per  RACC  of  55  g  
(Docket  No.   2.8  g  per  RACC  of  50  g  
03Q0547)   2.5  g  per  RACC  of  45  g 
1.7  g  per  RACC  of  35  g 
Required  wording  of  the  claim: 
Potassium  and  Good  source  of  potassium  NA 
the  Risk  of  High 
Low  sodium  Diets  containing  foods  that  are  a 
Blood  Pressure 
good  source  of  potassium  and  that  are 
and  Stroke  Low  total  fat  low  in  sodium  may  reduce  the  risk  of 
(Docket  No.  high  blood  pressure  and  stroke. 
Low  saturated  fat 
2000Q1582) 
Low  cholesterol 
Required  wording  of  the  claim: 
Fluoridated  Bottled  water  meeting  the  standards  of  NA 
Water  and  identity  and  quality  set  forth  in  
21  CFR  165.110  Drinking  f luoridated  water  may 
Reduced  Risk  of 
reduce  the  risk  of  [dental  caries  or
Dental  Carries 
tooth  decay]. 
Meet  all  general  requirements  for 
(Docket  No. 
health  claims  in  (21  CFR  101.14)  with 
2006Q0418) 
the  exception  of  the  minium  nutrient 
(21  CFR  101.14(e)(6)), 
contribution  
Total  Fluoride:  >0.6  to  1.0  mg/L 
Excluding  bottled  water  products 
specifically  marketed  for  use  by  infants 
A  F O O D  L A B E L I N G  G U I D E   103  Approved  Food  Claim  Model  Claim 
 
Claims  Requirements  Requirement  Statements
 
Required  wording  of  the  claim: 
Saturated  Fat,  Low  saturated  fat  NA 
Cholesterol,  and 
Low  cholesterol  Diets  low  in  saturated  fat  and 
Trans  Fat,  and 
cholesterol,  and  as  low  as  possible  in 
Reduced  Risk  of  Bear  quantitative  trans  fat  labeling  trans  fat,  may  reduce  the  risk  of  heart 
Heart  Disease 
disease. 
Contains  less  than  0.5  g  trans  fat  per 
(Docket  No. 
RACC 
2006Q0458) 
Contains  less  than  6.5  g  total  fat 
Required  wording  of  the  claim: 
Substitution  of  Low  fat  NA 
Saturated  Fat  in 
Replacing  saturated  fat  with  similar 
Low  cholesterol 
the  Diet  with 
amounts  of  unsaturated  fats  may 
Unsaturated 
Meets  all  general  requirements  for  reduce  the  risk  of  heart  disease.  To 
Fatty  Acids  and  health  claims  in  21  CFR  101.14  achieve  this  benefit,  total  daily  calories 
Reduced  Risk  of 
should  not  increase. 
Heart  Disease  
(Docket  No. 
2007Q0192) 
104 G U I D A N C E  F O R  I N D U S T R Y  A D:  
12.  PPENDIX 
Q H C
UALIFIED  EALTH  LAIMS 
21 
FDA  will  exercise  enforcement  discretion  for  qualified  health  claims  when  the  claim  meets  all  general  requirements  of  
CFR  101.14, 
except  for  the  requirements  that  the  claim  meet  the  significant  scientific  agreement  standard  and  that  the 
claim  be  made  in  accordance  with  an  authorizing  regulation.  Other  factors  that  FDA  will  consider  in  exercising  enforcement 
discretion  are  listed  in  the  following  qualified  health  claim  table. 
Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
0.8  mg  Folic  Acid  Dietary  The  disclaimer  (i.e.,  FDA  does  not  0.8  mg  folic  acid  in  a  dietary 
&  Neural  Tube  supplements  endorse  this  claim...)  is  placed  supplement  is  more  effective  in 
Birth  Defects  containing  immediately  adjacent  to  and  directly  reducing  the  risk  of  neural  tube 
folic  acid  beneath  the  claim  (i.e.,  0.8  mg  folic   defects  than  a  lower  amount  in  foods 
Docket  No.  
acid  ...),  with  no  intervening  material,   in  common  form.  FDA  does  not 
1991N100H  in 
the  same  size,  typeface,  and  contrast  endorse  this  claim.  Public  health 
as  the  claim.  authorities  recommend  that  women 
10/10/2000   consume  0.4  mg  folic  acid  daily  from 
enforcement   fortified  foods  or  dietary  supplements 
discretion  letter  or  both  to  reduce  the  risk  of  neural 
tube  defects. 
04/03/2001  
clarification  letter 
Note:  there  also  
is  a  folic  acid/ 
neural  tube  defect  
health  claim  
authorized  by  
regulation  (see  
21  CFR  101.79). 
A  F O O D  L A B E L I N G  G U I D E   105  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
B  Vitamins  &   Dietary  The  disclaimer  (i.e.,  FDA  evaluated  As  part  of  a  well-balanced  diet  that  is 
Vascular  Disease  supplements  the  above  claim...)  must  be  low  in  saturated  fat  and  cholesterol, 
containing  immediately  adjacent  to  and  directly  Folic  Acid,  Vitamin  B6  and  Vitamin 
Docket  No.  
vitamin  B6,  B12,  beneath  the  first  claim  (i.e.,  As  part  B12  may  reduce  the  risk  of  vascular 
1999P3029 
and/or  folic  acid  of  a  well-balanced  diet...)  with  no  disease.  FDA  evaluated  the  above  
intervening  material  that  separates  the  claim  and  found  that,  while  it  is 
11/28/2000   claim  from  the  disclaimer,  and  the  known  that  diets  low  in  saturated  fat 
enforcement   second  sentence  must  be  in  the  same  and  cholesterol  reduce  the  risk  of 
discretion  letter  size,  type  face  and  contrast  as  the  first  heart  disease  and  other  vascular 
sentence.  diseases,  the  evidence  in  support  of 
05/15/2001   the  above  claim  is  inconclusive. 
clarification  letter  Products  that  contain  more  than  100 
percent  of  the  Daily  Value  (DV)  of  
folic  acid  (400  micrograms),  when 
labeled  for  use  by  adults  and  children 
4  or  more  years  of  age,  must  identify  
the  safe  upper  limit  of  daily  intake  with  
respect  to  the  DV.  The  folic  acid  safe  
upper  limit  of  daily  intake  value  of  
1,000  micrograms  (1  mg)  may  be  
included  in  parentheses. 
The  claim  does  not  suggest  a  level  of  
vitamins  B6,  B12,  and/or  folic  acid  as  being 
useful  in  achieving  the  claimed  effect. 
Dietary  supplements  containing  folic  
acid  must  meet  the  United  States  
Pharmacopeia  (USP)  standards  for  
disintegration  and  dissolution,  except  
that  if  there  are  no  applicable  USP  
standards,  the  folate  in  the  dietary  
supplement  shall  be  shown  to  be  
bioavailable  under  the  conditions  of  
use  stated  on  the  product  label. 
106 G U I D A N C E  F O R  I N D U S T R Y  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Selenium  & 
Dietary  The  disclaimer  (i.e.,  Some  scientific  (1)  Selenium  may  reduce  the  risk  of 
Cancer 
supplements evidence  suggests...)  is  placed  certain  cancers.  Some  scientific 
containing  immediately  adjacent  to  and  directly  evidence  suggests  that  consumption 
Docket  No. 
selenium  beneath  the  claim  (i.e.,  Selenium  may  of  selenium  may  reduce  the  risk  of 
2002P0457
reduce  the  risk),  with  no  intervening  certain  forms  of  cancer.  However, 
material,  in  the  same  size,  typeface,  FDA  has  determined  that  this  evidence 
02/21/2003  and  contrast  as  the  claim  itself.  is  limited  and  not  conclusive.  or, 
enforcement 
discretion  letter   The  supplement  does  not  recommend (2)  Selenium  may  produce  anti-carcinogenic 
or  suggest  in  its  labeling,  or  under  effects  in  the  body.  Some  scientific 
04/28/2003  ordinary  conditions  of  use,  a  daily  evidence  suggests  that  consumption  of 
clarification  letter  intake  exceeding  the  Tolerable  Upper  selenium  may  produce  anticarcinogenic 
Intake  Level  established  by  the   effects  in  the  body.  However,  FDA  has 
National  Academy  of  Sciences/  determined  that  this  evidence  is 
Institute  of  Medicine  for  selenium  limited  and  not  conclusive. 
(400  micro-grams  per  day). 
Paragraph  101.14(d)(2)(vii)  requires 
that  the  dietary  supplement  bearing 
the  claim  meet  the  nutrient  content 
claim  definition  for  high  (i.e.,  20%  or 
more  of  the  daily  value  (DV)  per 
RACC).  20%  DV  for  selenium  is  14 
micrograms. 
A  F O O D  L A B E L I N G  G U I D E   107  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Antioxidant  Dietary  The  disclaimer  (i.e.,  ...evidence  is  (1)  Some  scientific  evidence  suggests 
Vitamins  &  supplements  limited  and  not  conclusive)  is  placed  that  consumption  of  antioxidant 
Cancer  containing  immediately  adjacent  to  and  below  the  vitamins  may  reduce  the  risk  of  
vitamin  E  and/  claim,  with  no  intervening  material,  certain  forms  of  cancer.  However, 
Docket  No. 
or  vitamin  C  in  the  same  size,  typeface,  and  contrast   FDA  has  determined  that  this 
1991N0101 
as  the  claim  itself.  evidence  is  limited  and  not  conclusive. 
or, 
04/01/2003   The  supplement  does  not  recommend 
enforcement   or  suggest  in  its  labeling,  or  under  (2)  Some  scientific  evidence  suggests 
discretion  letter  ordinary  conditions  of  use,  a  daily  that  consumption  of  antioxidant 
intake  exceeding  the  Tolerable  Upper   vitamins  may  reduce  the  risk  of 
Intake  Levels  established  by  the   certain  forms  of  cancer.  However, 
Institute  of  Medicine  for  vitamin  C   FDA  does  not  endorse  this  claim 
(2000  mg  per  day)  or  for  vitamin  E   because  this  evidence  is  limited  and 
(1000  mg  per  day).  not  conclusive.  or, 
Paragraph  101.14(d)(2)(vii)  requires   (3)  FDA  has  determined  that  although 
that  the  food  bearing  the  claim  meet   some  scientific  evidence  suggests  that 
the  nutrient  content  claim  definition   consumption  of  antioxidant  vitamins 
for  high  (i.e.,  20%  or  more  of  the  daily  may  reduce  the  risk  of  certain  forms 
value  (DV)  per  RACC).  20%  DV  for   of  cancer,  this  evidence  is  limited 
vitamin  C  is  12  mg;  20%  DV  for   and  not  conclusive. 
vitamin  E  is  6  IU. 
Phosphatidylserine  Dietary  The  disclaimer  (i.e.,  Very  limited  and  (1)  Consumption  of  phosphatidyl-
&  Cognitive  supplements  preliminary  scientific  research...)  is   serine  may  reduce  the  risk  of  
Dysfunction  and  containing  soy- placed  immediately  adjacent  to  and  dementia  in  the  elderly.  Very  limited  
Dementia  derived  phos- directly  beneath  the  claim  (i.e.,  Phos- and  preliminary  scientific  research 
phatidylserine  phatidylserine  may  reduce...),  with  no  suggests  that  phosphatidylserine  may 
Docket  No. 
intervening  material,  in  the  same  size,  reduce  the  risk  of  dementia  in  the 
2002P0413 
typeface,  and  contrast  as  the  claim  elderly.  FDA  concludes  that  there  is 
itself.  little  scientific  evidence  supporting 
02/24/2003   this  claim.  or, 
enforcement   The  claim  does  not  suggest  a  level  of 
discretion  letter  phosphatidylserine  as  being  useful  in  (2)  Consumption  of  phosphatidyl-
achieving  the  claimed  effect.  serine  may  reduce  the  risk  of  cognitive 
05/13/2003   dysfunction  in  the  elderly.  Very 
clarification  letter The  soy-derived  phosphatidylserine  limited  and  preliminary  scientific 
used  is  of  very  high  purity.  research  suggests  that  phosphatidyl-
11/24/2004   serine  may  reduce  the  risk  of  cognitive 
updated  letter  dysfunction  in  the  elderly.  FDA 
concludes  that  there  is  little  scientific  
evidence  supporting  this  claim. 
108 G U I D A N C E  F O R  I N D U S T R Y  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Nuts  &  Heart (1)  Whole  or  Whole  or  chopped  nuts  Scientific  evidence  suggests  but  does 
Disease  chopped  nuts  Whole  or  chopped  nuts  do  not  need  not  prove  that  eating  1.5  ounces  per 
listed  below  that  to  comply  with  the  total  fat  disquali- day  of  most  nuts  [such  as  name  of  
Docket  No. 
are  raw,  blanched, fying  level  in  21  CFR  101.14(a)(4).  specific  nut]  as  part  of  a  diet  low  in 
2002P0505
roasted,  salted,  saturated  fat  and  cholesterol  may 
and/or  lightly   Only  walnuts  do  not  need  to  comply  reduce  the  risk  of  heart  disease.  [See 
07/14/2003   coated  and/or  with  the  requirement  in    101.14(e)(6)  nutrition  information  for  fat  content.]
enforcement   flavored;  any  fat  that  the  food  contain  a  minimum  of  
discretion  letter or  carbohydrate  10  percent  of  the  Daily  Value  per  Note:  The  bracketed  phrase  naming  a 
added  in  the   RACC  of  vitamin  A,  vitamin  C,  iron,  specific  nut  is  optional.  The  bracketed
coating  or   calcium,  protein,  or  dietary  fiber.  fat  content  disclosure  statement  is 
flavoring  must   applicable  to  a  claim  made  for  whole 
meet  the  21   Where  the  claim  is  used  on  whole  or  or  chopped  nuts,  but  not  a  claim 
CFR  101.9(f)(1)   chopped  nuts,  the  disclosure  statement  made  for  nut-containing  products. 
definition  of  an   (see  nutrition  information...)  must  be 
insignificant   placed  immediately  adjacent  to  and 
amount.  directly  beneath  the  claim,  with  no 
intervening  material,  in  the  same  size, 
(2)  Nut-contain- typeface,  and  contrast  as  the  claim  itself. 
ing  products  
other  than  whole  Nuts  bearing  the  claim  must  comply 
or  chopped  nuts   with  the  21  CFR  101.14(a)(4)  
that  contain  at   saturated  fat  disqualifying  level  (4  g 
least  11  g  of  one   saturated  fat  per  50  g  nuts). 
or  more  of  the  
nuts  listed  below   Nutcontaining  products 
per  RACC.  Nut-containing  products  bearing  
the  claim  must  comply  with  all  the 
(3)  Types  of  nuts   21  CFR  101.14(a)(4)  disqualifying 
eligible  for  this   levels  which  are  13  g  total  fat,  4  g 
claim  are  restrict- saturated  fat,  60  mg  of  cholesterol, 
ed  to  almonds,   and  480  mg  of  sodium  per  RACC. 
hazelnuts,  pea-
nuts,  pecans,   The  claim  applies  only  to  types  of  
some  pine  nuts,   nuts  that  do  not  exceed  the 
pistachio  nuts,   21  CFR  101.14(a)(4)  disqualifying 
and  walnuts.   nutrient  level  for  saturated  fat  (4  g  
Types  of  nuts  on   saturated  fat  per  50  g  nuts). 
which  the  health  
claim  may  be   Nut-containing  products  bearing  the 
based  is  restricted  claim  must  comply  with  the  21  CFR 
to  those  nuts  that  101.62(c)(2)  definition  of  a  low 
were  specifically   saturated  fat  food  and  the  21  CFR 
included  in  the   101.62(d)(2)  definition  of  a  low  
health  claim   cholesterol  food. 
petition,  but  that  
do  not  exceed  4  g  Nut-containing  products  bearing  the 
saturated  fat  per   claim  must  comply  with  the  21  CFR  
50  g  of  nuts.  101.14(e)(6)  requirement  that  the  food  
contain  a  minimum  of  10  percent  of  the 
Daily  Value  per  RACC  of  vitamin  A, 
vitamin  C,  iron,  calcium,  protein,  or  
dietary  fiber  prior  to  any  nutrient  addition. 
A  F O O D  L A B E L I N G  G U I D E   109  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Walnuts  &   Whole  or  Walnuts  do  not  need  to  comply  with Supportive  but  not  conclusive  
Heart  Disease chopped  walnuts  the  total  fat  disqualifying  level  in  research  shows  that  eating  1.5  ounces 
21  CFR  101.14(a)(4).  per  day  of  walnuts,  as  part  of  a  low 
Docket  No.  
saturated  fat  and  low  cholesterol  diet 
2002P029 
Walnuts  do  not  need  to  comply  with  and  not  resulting  in  increased  caloric 
the  requirement  in    101.14(e)(6)  that  intake,  may  reduce  the  risk  of 
03/09/2004   the  food  contain  a  minimum  of  10  coronary  heart  disease.  See  nutrition 
enforcement   percent  of  the  Daily  Value  per  RACC  information  for  fat  [and  calorie] 
discretion  letter  of  vitamin  A,  vitamin  C,  iron,  calcium,  content. 
protein,  or  dietary  fiber. 
Notes:  The  bracketed  phrase  and 
The  disclosure  statement  about  total   calorie  is  optional  in  that  FDA  does 
fat  content  (i.e.,  See  nutrition   not  intend  for  the  presence  or  absence 
information  for  fat  content)  is  placed   of  such  phrase  to  be  a  factor  in 
immediately  following  the  claim,  with   whether  it  considers  enforcement 
no  intervening  material,  in  the  same   discretion  for  the  use  of  the  qualified 
size,  typeface,  and  contrast  as  the   health  claim.  FDA  considered  this 
claim  itself.  additional  information  beneficial  to  
consumers  to  heighten  their  awareness
of  the  caloric  contribution  from  
walnuts  and  encourages  companies  to 
include  it  in  product  labeling. 
110 G U I D A N C E  F O R  I N D U S T R Y  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Omega3  Fatty   Conventional  Dietary  supplements  should  not   Supportive  but  not  conclusive  
Acids  &  Coronary   foods  and  dietary   recommend  or  suggest  in  their  labeling  research  shows  that  consumption 
Heart  Disease  supplements  that  a  daily  intake  exceeding  2  grams  of   of  EPA  and  DHA  omega-3  fatty  acids  
contain  EPA  and  EPA  and  DHA  may  reduce  the  risk  of  coronary  heart  
Docket  No.  
DHA  omega-3  disease.  One  serving  of  [Name  of  the 
2003Q0401  fatty  acids.  Total  fat  content  food]  provides  [  ]  gram  of  EPA  and 
Dietary  supplements  that  weigh  5  g  or  DHA  omega-3  fatty  acids.  [See 
09/08/2004   less  per  RACC  (RACC  for  dietary   nutrition  information  for  total  fat, 
enforcement   supplement  is  labeled  serving  size)   saturated  fat,  and  cholesterol  content.] 
discretion  letter  -  are  exempted  from  the  total  fat 
Wellness  Petition  disqualifying  level,  but  if  dietary   Note:  Dietary  supplements  may 
supplements  that  weigh  5  g  or  less   declare  the  amount  of  EPA  and  DHA  
09/08/2004   per  RACC  exceed  the  total  fat  dis- per  serving  in  Supplement  Facts, 
enforcement   qualifying  level  (13.0  g  per  50  g)  the  instead  of  making  the  declaration  in 
discretion  letter  -  disclosure  statement  (i.e.,  See  nutrition  the  claim. 
Martek  Petition  information  for  total  fat  content)  must  
be  placed  immediately  adjacent  to  the  
health  claim.  Dietary  supplements  that  
weigh  more  than  5  g  per  RACC  must  
not  exceed  the  total  fat  disqualifying  
level  (13.0  g  per  RACC  and  per  50  g  
if  RACC  is    30  g  or    2  tbsp).  (See  
Qualified  Health  Claims  Subject  to  
Enforcement  Discretion,  Omega3  
Fatty  Acids  and  Coronary  Heart  
Disease  and  the  enforcement  dis
cretion  letter  for  Omega3  Fatty  
Acids  and  Coronary  Heart  Disease) 
Fish  (i.e.,  products  that  are  essentially  
all  fish)  may  not  exceed  16.0  g  total  
fat  per  RACC.  Fish  with  a  total  fat  
content  greater  than  13.0  g  per  RACC  
must  include  See  nutrition  informa-
tion  for  total  fat  content  with  the  
health  claim.  The  products  that  are  
essentially  all  fish  include  fish  without  
any  added  ingredients  and  fish  with  
a  small  amount  of  added  fat  or  carbo-
hydrate  that  meets  the  definition  of  an  
21  CFR  101. 
insignificant  amount  in  
9(f)(1
).  Examples  of  these  products  are  
raw  fish,  boiled  fish,  and  broiled  fish. 
(Continued) 
A  F O O D  L A B E L I N G  G U I D E   111  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Conventional  foods other  than  fish  may  
not  exceed  the  total  fat  disqualifying  
levels.  For  individual  foods,  the  total  
fat  disqualifying  level  is  13.0  g  per  
RACC  and  per  50  g  if  RACC  is    30  g  
or    2  tbsp.  The  total  fat  disqualifying  
level  is  26.0  g  per  label  serving  size  for  
meal  products  and  19.5  g  per  label  
serving  size  for  main  dish  products. 
Saturated  fat  content 
Dietary  supplements  must  meet  the  
criterion  for  low  saturated  fat  with  
regard  to  the  saturated  fat  content  
(  1  g  per  RACC)  but  not  with  regard  
to  the  no  more  than  15  percent  calories  
from  saturated  fat  criterion. 
Fish  may  not  exceed  the  saturated  fat  
disqualifying  level  of  4.0  g  per  RACC  
(or  4.0  g  per  50  g  if  RACC  is    30  g  
or    2  tbsp). 
Conventional  foods  other  than  fish  
must  meet  the  criteria  for  low  saturated  
fat  (  1  g  per  RACC  and  no  more  than  
15  percent  of  calories  from  saturated  
fat  for  individual  foods,    1  g  per  100  g  
and  less  than  10  percent  calories  from  
saturated  fat  for  meal  products  and  
main  dish  products).  There  is  an  error 
in  the  enforcement  discretion  letters  in  
the  section  of  low  saturated  fat,  
stating  that  meal  products  and  main  
dishes  meet  all  criteria  specified  for  the  
(21  CFR  
low  saturated  fat  criteria  
101.62(c)(2)). 
The  CFR  number  
(21  CFR  101.62(c)(3)). 
should  be 
Cholesterol  content 
Dietary  supplements  that  weigh  5  g  or 
less  per  RACC  are  exempt  from  the  
cholesterol  disqualifying  level  (60  mg  
per  50  g),  but  those  that  exceed  the  
cholesterol  disqualifying  level  must  
include  See  nutrition  information  for  
cholesterol  content  with  the  qualified  
health  claim.  Dietary  supplements  that  
weigh  more  than  5  g  per  RACC  must  
meet  the  criterion  for  low  cholesterol  
(  20  mg  per  50g). 
(Continued) 
112 G U I D A N C E  F O R  I N D U S T R Y  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Fish  must  meet  the  extra  lean  criterion  
with  regard  to  cholesterol  content  
(<  95  mg  per  RACC  and  per  100  g,  
whichever  is  greatest),  but  not  with  
regard  to  saturated  fat  content.  Fish  
with  cholesterol  content  greater  than  
60  mg  per  RACC  must  include  See  
nutrition  information  for  cholesterol  
content  with  the  qualified  health  
claim. 
Conventional  foods other  than  fish  
must  meet  the  low  cholesterol  criterion  
(21  CFR  101.62(d)(2)).  21  CFR  
See  
101.62(d)(2) 
for  the  low  cholesterol  
criterion  specific  for  individual  foods,  
meal  products,  and  main  dish  products. 
Sodium 
All  conventional  foods  and  dietary  
supplements  must  meet  the  sodium  
disqualifying  level  (  480  mg  per  
RACC  and  per  50  g  if  RACC  is    30  g  
or    2  tbsp  for  individual  foods,    960  
mg  per  label  serving  size  for  meal  
products,    720  mg  per  label  serving  
size  for  main  dish  products). 
The  10  percent  minimum   
nutrient  requirement 
All  conventional  foods  must  meet  
the  10  percent  minimum  nutrient  
requirement  (Vitamin  A  500  IU,  
Vitamin  C  6  mg,  Iron  1.8  mg,  Calcium  
100  mg,  Protein  5  g,  Fiber  2.5  g  per  
RACC),  prior  to  any  nutrient  addition.  
The  10  percent  minimum  nutrient  
requirement  does  not  apply  to  dietary  
CFR  101.14(e)(6)). 
supplements  (21  
A  F O O D  L A B E L I N G  G U I D E   113  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Monounsaturated   All  products  that  Olive  oil,  vegetable  oil  spreads,  Limited  and  not  conclusive  scientific 
Fatty  Acids  From   are  essentially  dressings  for  salads,  shortenings  and  evidence  suggests  that  eating  about 
Olive  Oil  and   pure  olive  oil  and  olive-oil  containing  foods  do  not  need  2  tablespoons  (23  grams)  of  olive  oil 
Coronary  Heart   labeled  as  such  to  comply  with  the  total  fat  disquali- daily  may  reduce  the  risk  of  coronary  
Disease  (see  *  for  fying  level  in  21  CFR  101.14(a)(4).  heart  disease  due  to  the  monounsatu-
definitions)  rated  fat  in  olive  oil.  To  achieve  this 
Docket  No.  
The  requirement  that  the  food  comply  possible  benefit,  olive  oil  is  to  replace 
2003Q0559 
Dressings  for  with  the  50  gram-criterion  of  the  a  similar  amount  of  saturated  fat  and 
(21 
salads  (i.e.  salad  saturated  fat  disqualifying  level  not  increase  the  total  number  of 
CFR  101.14(e)(3))  
11/01/2004   dressings)  that  does  not  apply  to  calories  you  eat  in  a  day.  One  serving 
enforcement   contain  6  g  or  olive  oil,  vegetable  oil  spreads,  and  of  this  product  contains  [x]  grams  of 
discretion  letter  more  olive  oil  per   shortenings.  olive  oil. 
Reference  Amount 
Customarily   The  requirement  that  the  food  contain Note:  The  last  sentence  of  the  claim 
Consumed   a  minimum  of  10  percent  of  the  Daily  One  serving  of  this  product  contains 
(RACC),  are  low   Value  per  RACC  of  at  one  of  the  [x]  grams  of  olive  oil.  is  optional 
(21  
in  cholesterol   following:  vitamin  A,  vitamin  C,  iron, when  the  claim  is  used  on  the  label  or 
CFR  101.62(d) 
calcium,  protein,  or  dietary  fiber  per  in  the  labeling  of  olive  oil. 
(2)), 
and  do  not   RACC  (21  CFR  101.14(e)(6))  does  not 
contain  more   apply  to  olive  oil,  dressings  for  salads,  *(1)  Olive  oil  means  virgin  olive  oil,  or 
than  4  g  of   and  shortenings.  blends  of  virgin  olive  oil  and  refined 
saturated  fat  per   olive  oil;  where  virgin  olive  oil  is  the 
50  g.  When  the  total  fat  disqualifying  level   oil  resulting  from  the  first  pressing  of  
is  exceeded  in  vegetable  oil  spreads,  olives  and  is  suitable  for  human  con-
Vegetable  oil   dressings  for  salads,  shortenings,  or  sumption  without  further  processing 
spreads  that  con- olive-oil  containing  foods  the  disclosure  and  refined  olive  oil  is  the  oil  ob-
tain  6  g  or  more   statement  (i.e.,  See  nutrition  informa- tained  from  subsequent  pressings  and 
olive  oil  per   tion  for  saturated  fat  content)  must  be  which  is  suitable  for  human  consump-
RACC,  are  low   placed  immediately  following  the  claim,  tion  by  refining  processes  which  neut-
(21  
in  cholesterol   with  no  intervening  material,  in  the  ralize  the  acidity  or  remove  particulate 
CFR  101.62(d) 
same  size,  typeface,  and  contrast  as  the  matter. 
(2))
and  do  not   claim  itself. 
contain  more   (2)  Vegetable  oil  spread  means 
(21  CFR  166.110) 
than  4  g  of  sat- When  the  food  does  not  meet  the  margarine  and 
(21 
urated  fat  per   definition  of  low  saturated  fat   margarine-like  products. 
CFR  101.62(c)(2)) 
RACC.  the  disclosure  
statement  (i.e.,  See  nutrition  informa- (3)  dressings  for  salads  means 
Olive  oil-contain- tion  for  saturated  fat  content)  must  be  dressings  for  salads  formulated  to 
ing  foods  that   placed  immediately  following  the  contain  olive  oil. 
contain  6  g  or   claim,  with  no  intervening  material,  in 
more  olive  oil  per   the  same  size,  typeface,  and  contrast  as  (4)  shortenings  means  vegetable  oil 
RACC,  are  low  in   the  claim  itself.  shortenings,  formulated  to  contain 
(21  
cholesterol   olive  oil. 
CFR  101.62(d) 
If  both  of  the  above  two  conditions  are 
(2)), 
contain  at   met  the  disclosure  statements  for  total  (5)  Olive  oil-containing  foods  means 
least  10%  of  either   fat  and  saturated  fat  can  be  combined  foods,  such  as  sauces  or  baked  goods, 
vitamin  A,   (i.e.,  See  nutrition  information  for  excluding  olive  oil,  vegetable  oil 
vitamin  C,  iron,   total  and  saturated  fat  content).  spreads,  dressings  for  salads,  and 
calcium,  protein   shortenings. 
or  dietary  fiber.  
(Continued) 
114 G U I D A N C E  F O R  I N D U S T R Y  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
If  the  RACC  of  
the  olive  oil-con-
taining  food  is  
greater  than  30  g  
the  food  cannot  
contain  more  
than  4  g  of  sat-
urated  fat  per  
RACC  and  if  the  
RACC  of  the  olive  
oil-containing  
food  is  30  g  or  less  
the  food  cannot  
contain  more  than  
4  g  of  saturated  
fat  per  50  g. 
Shortenings  that  
contain  6  g  or  
more  olive  oil  per  
RACC  and  are  
low  in  cholesterol  
(21  CFR  101.62 
(d)(2))  
and  do  
not  contain  more  
than  4  g  of  satur-
ated  fat  per  
RACC. 
Meal  products  
(21  CFR  101.13 
(l)) 
or  Main  dish  
(21  CFR  
products  
101.13(m)) 
are  
not  eligible  for  the  
claim. 
A  F O O D  L A B E L I N G  G U I D E   115  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Green  Tea  &   Green  tea  and  Green  tea  does  not  exceed  the  disqual- ((11))   GTwreoe nst  utedaie  ms dayo   rneodtu scheo  twh et  hraistk  of 
Cancer  conventional  ifying  nutrient  levels  for  total  fat,  bdrreinaskti  nogr   gprreoesnta tteea  c raendcuecre  as ltthheo urigshk   othfe 
foods  and  dietary  saturated  fat,  cholesterol,  and  sodium  FbDreAas  th caasn  ccoenr cinlu wdeodm  tehna,t   btuhte roen  ies  very 
Docket  No.   21  CFR  101.14(a)(4). 
supplements  that  specified  in   lwitetalek  esrc,i emnotirfei cl  iemviidteedn scteu  fdoyr   stuhgigs  ecsltasim. 
FDA2004
contain  green  tea 
Q0427 
FDA  intends  to  consider  the  exercise  (t2h)i  s  Grisrkee. nB  atesead  m oany   trheedsuec set  uthdiee  sr,isk  of 
02/24/2011   of  its  enforcement  discretion  for  bFrDeaAs tc  oonr  cplruodsetsa tteh  acat nitc iesr .h  FigDhAly   hunas- 
enforcement   qualified  health  claims  for  green  tea  clioknelcyl uthdaetd g  trheaetn   ttheear ree  idsu  vceersy t  lhitet lrei sk
discretion  letter  and  breast  cancer  and  for  green  tea   socfi ebnretiafsitc   ceavnidceern. coer  ,for  this  claim. 
and  prostate  cancer  to  be  used  on  the  
label  or  in  the  labeling  of  green  tea-
containing  foods  when  the  food  does  
not  exceed  any  of  the  disqualifying  
nutrient  levels  for  fat,  saturated  fat,  
cholesterol,  and  sodium. 
FDA  intends  to  consider  the  exercise  
of  its  enforcement  discretion  for  green  
tea  that  does  not  meet  the  10%  mini-
mum  nutrient  content  requirement  in  
21  CFR  101.14(e)(6). 
FDA  does  not  intend  to  consider  the
exercise  of  its  enforcement  discretion
for  green  tea-containing  foods  that  
do  not  meet  the  requirements  of  
21  CFR  101.14(e)(6). 
Chromium   Dietary  Dietary  supplement  containing  One  small  study  suggests  that 
Picolinate  &   supplements  chromium  must  meet  or  exceed  the  chromium  picolinate  may  reduce  the 
Diabetes  containing  requirement  for  a  high  level  of  risk  of  insulin  resistance,  and  there-
21  CFR  fore  possibl
chromium  chromium  as  defined  in   y  may  reduce  the  risk 
Docket  No.  101.54(b) 
(i.e.,  24  mg  or  more  per  of  type  2  diabetes.  FDA  concludes, 
2004Q0144 
RACC  under  the  current  regulation)  however,  that  the  existence  of  such  a 
for  FDA  to  exercise  enforcement  relationship  between  chromium  pico-
08/25/2005   discretion.  linate  and  either  insulin  resistance  or 
enforcement   type  2  diabetes  is  highly  uncertain. 
discretion  letter 
116 G U I D A N C E  F O R  I N D U S T R Y  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Calcium  and  Colon/Rectal  Cancer: 
Dietary  The  dietary  supplement  must  meet  or 
Colon/Rectal 
supplements  exceed  the  requirement  for  a  high  Some  evidence  suggests  that  calcium 
Cancer  &  containing  level  of  calcium  as  defined  in  21  CFR  supplements  may  reduce  the  risk  of  
Calcium  and   calcium  101.54(b) (i.e.,  200  mg  or  more  colon/rectal  cancer,  however,  FDA 
Recurrent  Colon/ 
calcium  per  RACC)  has  determined  that  this  evidence  is 
Rectal  Polyps 
limited  and  not  conclusive. 
The  calcium  content  of  the  dietary 
Docket  No.  Recurrent  Colon  Polyps: 
supplement  must  be  assimilable  (i.e., 
2004Q0097  bioavailable) (21  CFR  101.72(c)  Very  limited  and  preliminary  evidence
(ii)(B)), and  meet  the  United  States  suggests  that  calcium  supplements 
10/12/2005  Pharmacopeia  (U.S.P.)  standards  for  may  reduce  the  risk  of  colon/rectal 
enforcement  disintegration  and  dissolution  polyps.  FDA  concludes  that  there  is 
discretion  letter applicable  to  their  component  calcium  little  scientific  evidence  to  support 
salts.  For  dietary  supplements  for   this  claim. 
which  no  U.S.P.  standards  exist,  the  
dietary  supplement  must  exhibit 
appropriate  assimilability  under  the 
conditions  of  use  stated  on  the  product 
(21  CFR  101.72(c)(ii)(C)). 
label 
Calcium  &  Hypertension: 
Dietary  The  dietary  supplement  must  meet  or 
Hypertension,  supplements exceed  the  requirement  for  a  high  Some  scientific  evidence  suggests  that 
Pregnancy  containing  level  of  calcium  as  defined  in  21  CFR  calcium  supplements  may  reduce  the 
Induced  Hyper calcium  101.54(b) (i.e.,  200  mg  or  more  risk  of  hypertension.  However,  FDA 
tension,  and  calcium  per  RACC)  has  determined  that  the  evidence  is 
Preeclampsia   inconsistent  and  not  conclusive. 
The  calcium  content  of  the  dietary 
Docket  No.  PregnancyInduced  Hypertension: 
supplement  must  be  assimilable  (i.e., 
2004Q0098  bioavailable) (21  CFR  101.72(c)  Four  studies,  including  a  large  clini- 
(ii)(B)), and  meet  the  United  States  cal  trial,  do  not  show  that  calcium 
10/12/2005   Pharmacopeia  (U.S.P.)  standards  for  supplements  reduce  the  risk  of 
enforcement   disintegration  and  dissolution  pregnancy-induced  hypertension 
discretion  letter  applicable  to  their  component  calcium  during  pregnancy.  However,  three 
salts.  For  dietary  supplements  for   other  studies  suggest  that  calcium 
which  no  U.S.P.  standards  exist,  the  supplements  may  reduce  the  risk. 
dietary  supplement  must  exhibit  Based  on  these  studies,  FDA  con-
appropriate  assimilability  under  the  cludes  that  it  is  highly  unlikely  that  
conditions  of  use  stated  on  the  product  calcium  supplements  reduce  the  risk  
label (21  CFR  101.72(c)(ii)(C)).  of  pregnancy-induced  hypertension. 
Preeclampsia: 
Three  studies,  including  a  large  
clinical  trial,  do  not  show  that  calcium 
supplements  reduce  the  risk  of  pre-
eclampsia  during  pregnancy.  How-
ever,  two  other  studies  suggest  that  
calcium  supplements  may  reduce  the 
risk.  Based  on  these  studies,  FDA  
concludes  that  it  is  highly  unlikely 
that  calcium  supplements  reduce  the 
risk  of  preeclampsia. 
A  F O O D  L A B E L I N G  G U I D E   117  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Tomatoes  and/or  Tomatoes  and/or  Tomato  Sauce  and 
(1)  Cooked,  Raw, 
Tomato  Sauce  &  Prostate  Cancer: 
Dried,  or  Canned 
Prostate,  Ovarian, Very  limited  and  preliminary  scientific 
Tomatoes 
Gastric,  and  research  suggests  that  eating  one-half 
Pancreatic  to  one  cup  of  tomatoes  and/or 
(2)  Tomato  
Cancers  tomato  sauce  a  week  may  reduce  the 
Sauces  that  
risk  of  prostate  cancer.  FDA  concludes 
contain  at  least  
Docket  No. 
that  there  is  little  scientific  evidence 
8.37  percent  salt-
2004Q020
1  supporting  this  claim. 
free  tomato  solids 
11/08/2005  Tomato  Sauce  and  Ovarian  Cancer: 
enforcement  One  study  suggests  that  consumption 
discretion  letter  - of  tomato  sauce  two  times  per  week  
American  may  reduce  the  risk  of  ovarian 
Longevity  Petition  cancer;  while  this  same  study  shows 
that  consumption  of  tomatoes  or 
11/08/2005  tomato  juice  had  no  effect  on  ovarian 
enforcement  cancer  risk.  FDA  concludes  that  it  is 
discretion  letter  - highly  uncertain  that  tomato  sauce 
Lycopene  Heath  reduces  the  risk  of  ovarian  cancer. 
Claim  Coalition 
Petition  Tomatoes  and  Gastric  Cancer: 
Four  studies  did  not  show  that  tomato 
intake  reduces  the  risk  of  gastric  
cancer,  but  three  studies  suggest  that 
tomato  intake  may  reduce  this  risk. 
Based  on  these  studies,  FDA  con-
cludes  that  it  is  unlikely  that  tomatoes 
reduce  the  risk  of  gastric  cancer. 
Tomatoes  and  Pancreatic  Cancer: 
One  study  suggests  that  consuming 
tomatoes  does  not  reduce  the  risk  of 
pancreatic  cancer,  but  one  weaker, 
more  limited  study  suggests  that  con-
suming  tomatoes  may  reduce  this  risk. 
Based  on  these  studies,  FDA  con-
cludes  that  it  is  highly  unlikely  that 
tomatoes  reduce  the  risk  of  pancreatic 
cancer. 
118 G U I D A N C E  F O R  I N D U S T R Y  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Unsaturated  Fatty
Canola  oil  (see  *  Canola  oil,  vegetable  oil  spreads,  Limited  and  not  conclusive  scientific 
Acids  from  Canola
for  definitions)  dressings  for  salads,  shortenings  and  evidence  suggests  that  eating  about 
Oil  and  Reduced 
canola-oil  containing  foods  do  not  1  1/2  tablespoons  (19  grams)  of 
Risk  of  Coronary 
Vegetable  oil  need  to  comply  with  the  total  fat  canola  oil  daily  may  reduce  the  risk 
Heart  Disease  21  CFR  101. 
spreads,  dressings  disqualifying  level  in   of  coronary  heart  disease  due  to  the 
14(a)(4). 
for  salads,  unsaturated  fat  content  in  canola  oil. 
Docket  No. 
shortenings,  and  To  achieve  this  possible  benefit, 
2006Q0091 
canola  oil- The  requirement  that  the  food  contain  canola  oil  is  to  replace  a  similar 
containing  foods  a  minimum  of  10  percent  of  the  Daily  amount  of  saturated  fat  and  not 
10/06/2006  that  contain   Value  per  RACC  of  at  one  of  the  increase  the  total  number  of  calories 
enforcement  4.75  g  or  more   following:  vitamin  A,  vitamin  C,  iron,  you  eat  in  a  day.  One  serving  of  this 
discretion  letter  of  canola  oil  per  calcium,  protein,  or  dietary  fiber  per  product  contains  [x]  grams  of  canola 
RACC,  are  low  in  not  apply  to  canola  oil,  dressings  for  oil. 
(21 
saturated  fat  salads,  and  shortenings. 
CFR  101.62(c) 
For  purposes  of  this  qualified  health 
(2)), 
are  low  in  When  the  total  fat  disqualifying  level   claim: 
(21 
cholesterol  is  exceeded  in  vegetable  oil  spreads, 
CFR  101.62(d) 
dressings  for  salads,  shortenings,  or  (1)  Canola  oil  means  products  that 
(2)), 
and  meet  canola-oil  containing  foods,  the  dis- are  essentially  pure  canola  oil  and  are 
the  saturated  fat,  closure  statement  (i.e.,  See  nutrition  labeled  as  such. 
cholesterol,  and  information  for  total  fat  content)  must 
sodium  disquali- be  placed  immediately  following  the  (2)  Vegetable  oil  spread  means 
(21  (21  CFR  166.110)  
fying  levels   claim,  with  no  intervening  material,  in  margarine  and 
CFR  101.14(a) 
the  same  size,  typeface,  and  contrast   margarine-like  products,  formulated 
(4)). 
as  the  claim  itself.  to  contain  canola  oil. 
Vegetable  oil  (3)  Dressings  for  salads  means  
spreads  and  canola  dressings  for  salads  formulated  to 
oil-containing  contain  canola  oil. 
foods  must  also 
meet  the  10%  (4)  Shortenings  means  vegetable  oil 
minimum  shortenings,  formulated  to  contain 
nutrient  content  canola  oil. 
(21 
requirement  
CFR  101.14(e) 
(5)  Canola  oil-containing  foods 
(6)). 
means  all  other  foods,  such  as  sauces  
or  baked  goods,  formulated  to  contain 
canola  oil,  excluding  canola  oil,  veg-
etable  oil  spreads,  dressings  for  salads, 
and  shortenings. 
A  F O O D  L A B E L I N G  G U I D E   119  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Corn  Oil  and 
Corn  oil  (see  *  Corn  oil,  vegetable  oil  blends,  vegetable  Very  limited  and  preliminary  scientific 
Corn  Oil
for  definitions)  oil  spreads,  dressings  for  salads,  evidence  suggests  that  eating  about 
Containing 
shortenings  and  corn-oil  containing  1  tablespoon  (16  grams)  of  corn  oil 
Products  and  a 
for  definitions)  foods  do  not  need  to  comply  with  the  daily  may  reduce  the  risk  of  heart 
Reduced  Risk  of  21  CFR 
blends  and  total  fat  disqualifying  level  in   disease  due  to  the  unsaturated  fat 
Heart  Disease  101.14(a)(4). 
shortenings  that  content  in  corn  oil.  FDA  concludes 
Docket  No.  contain  4  g  or  that  there  is  little  scientific  evidence 
2006P0243  more  corn  oil  per  The  requirement  that  the  food  comply  supporting  this  claim.  To  achieve  this 
RACC,  are  low  in  with  the  50  gram-criterion  of  the  possible  benefit,  corn  oil  is  to  replace 
cholesterol  (21  saturated  fat  disqualifying  level (21  a  similar  amount  of  saturated  fat  and 
3/26/2007  CFR  101.62(d)  CFR  101.14(e)(3))  does  not  apply  to  not  increase  the  total  number  of  
enforcement  (2)), meet  the  corn  oil,  vegetable  oil  blends,  vegetable  calories  you  eat  in  a  day.  One  serving 
discretion  letter  cholesterol  and  oil  spreads,  and  shortenings.  of  this  product  contains  [x]  grams  of  
sodium  disquali- corn  oil. 
fying  levels (21  The  requirement  that  the  food  contain 
CFR  101.14(a)  a  minimum  of  10  percent  of  the  Daily  (1)  corn  oil  means  products  that  are 
(4)),  and  do  not  Value  per  RACC  of  at  one  of  the  essentially  pure  corn  oil  and  are 
contain  more  following:  vitamin  A,  vitamin  C,  iron,  labeled  as  such 
than  4  g  of  calcium,  protein,  or  dietary  fiber  per 
(21  CFR  101.14(e)(6)) 
saturated  fat  per  RACC   does  (2)  vegetable  oil  blends  means  a  
RACC.  not  apply  to  corn  oil,  vegetable  oil  blend  of  two  or  more  vegetable  oils 
blends,  dressings  for  salads,  and  formulated  to  contain  corn  oil 
Dressings  for  shortenings. 
salads  (i.e.  salad  (3)  vegetable  oil  spread  means 
(21  CFR  166.110)  
dressings)  that  When  the  total  fat  disqualifying  level  is  margarine  and  
contain  4  g  or  exceeded  in  vegetable  oil  spreads,  margarine-like  products  formulated 
more  corn  oil  per dressings  for  salads,  shortenings,  or  to  contain  corn  oil 
RACC,  are  low  corn-oil  containing  foods,  the  dis-
(21
in  cholesterol   closure  statement  (i.e.,  See  nutrition  (4)  dressings  for  salads  means 
CFR  101.62(d)  information  for  total  fat  content)  must  dressings  for  salads  formulated  to 
(2)), meet  the  be  placed  immediately  following  the  contain  corn  oil 
cholesterol  and  claim,  with  no  intervening  material,  
sodium  disquali- in  the  same  size,  typeface,  and  contrast   (5)  shortenings  means  vegetable  oil 
fying  levels  (21  as  the  claim  itself.  shortenings  formulated  to  contain 
CFR  101.14(a)  corn  oil 
(4)), and  do  not  When  the  food  does  not  meet  the 
(21  
contain  more  definition  of  low  saturated  fat   (6)  corn  oil-containing  foods  means 
CFR  101.62(c)(2)), 
than  4  g  of  the  disclosure  all  other  foods,  such  as  sauces  or 
saturated  fat  per  statement  (i.e.,  See  nutrition  informa- baked  goods,  formulated  to  contain 
50  g.  tion  for  saturated  fat  content)  must  be  corn  oil,  excluding  corn  oil,  vegetable 
placed  immediately  following  the   oil  blends,  vegetable  oil  spreads, 
Vegetable  oil  claim,  with  no  intervening  material,   dressings  for  salads,  and  shortenings. 
spreads  that  in  the  same  size,  typeface,  and  contrast 
contain  4  g  or  as  the  claim  itself. 
more  corn  oil  per 
RACC,  are  low  If  both  of  the  above  two  conditions  
in  cholesterol (21  are  met,  the  disclosure  statements  for
CFR  101.62(d)  total  fat  and  saturated  fat  can  be 
(2)), meet  the  combined  (i.e.,  See  nutrition  infor-
cholesterol  and  mation  for  total  and  saturated  fat 
sodium  disquali- content).  (Continued) 
(21 
fying  levels 
120 G U I D A N C E  F O R  I N D U S T R Y  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
CFR  101.14(a) 
(4)), 
contain  at  
least  10%  of  
either  vitamin  A,  
vitamin  C,  iron,  
calcium,  protein  
or  dietary  fiber,  
and  do  not  con-
tain  more  than  
4  g  of  saturated  
fat  per  RACC. 
Corn  oil-contain-
ing  foods  that  
contain  4  g  or  
more  corn  oil  per  
RACC,  are  low  
(21  
in  cholesterol  
CFR  101.62(d) 
(2)),  
meet  the  
cholesterol  and  
sodium  disquali-
(21  
fying  levels 
CFR  101.14(a) 
(4)), 
contain  at  
least  10%  of  
either  vitamin  A,  
vitamin  C,  iron,  
calcium,  protein  
or  dietary  fiber. 
If  the  RACC  of  
the  corn  oil-con-
taining  food  is  
greater  than  30  g,  
the  food  cannot  
contain  more  
than  4  g  of  
saturated  fat  per 
RACC, and  if  the 
RACC  of  the  corn 
oil-containing  food 
is  30  g  or  less,  the  
food  cannot  contain 
more  than  4  g  of 
saturated  fat  per 
50  g. 
A  F O O D  L A B E L I N G  G U I D E   121  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Selenium  &  Bladder  Cancer 
Dietary  The  qualified  health  claim  about 
Cancer  supplements  selenium  and  a  reduced  risk  of   One  study  suggests  that  selenium 
containing  bladder  cancer  can  only  be  used  on   intake  may  reduce  the  risk  of  bladder  
Docket  No. 
selenium  the  label  or  in  labeling  of  dietary  cancer  in  women.  However,  one 
FDA2008 
supplements  that  contain  any  form  of  smaller  study  showed  no  reduction  in 
Q-0323  selenium  other  than  selenium  sulfide.  risk.  Based  on  these  studies,  FDA 
concludes  that  it  is  highly  uncertain  
06/19/2009  The  qualified  health  claims  about  that  selenium  supplements  reduce  the 
enforcement  selenium  and  a  reduced  risk  of  prostate  risk  of  bladder  cancer  in  women. 
discretion  letter  cancer  or  thyroid  cancer  can  only  be  Colorectal  Cancers 
used  on  the  label  or  in  labeling  of 
Summary  of  "Selenium  may  reduce  the  risk  of 
dietary  supplement  that  contain 
settlement  in  colorectal  cancer.  Scientific  evidence 
selenomethionine. 
Alliance  for  concerning  this  claim  is  inconclusive. 
Natural  Health  101.14(d)(2)(vii)  Based  on  its  review,  FDA  does  not 
Paragraph   requires 
vs.  Sebelius  agree  that  selenium  may  reduce  the 
that  the  dietary  supplement  bearing 
risk  of  colorectal  cancer." 
claim  meet  the  nutrient  content  clai
definition  for  high  (i.e.,  20%  or   "Selenium  may  reduce  the  risk  of  colon 
more  of  the  daily  value  (DV)  per   and  rectal  cancer.  Scientific  evidence 
RACC).  20%  DV  for  selenium  is  14  concerning  this  claim  is  inconclusive. 
micrograms.  Based  on  its  review,  FDA  does  not 
agree  that  selenium  may  reduce  the 
risk  of  colon  and  rectal  cancer." 
Colon  Cancer 
"Selenium  may  reduce  the  risk  of 
colon  cancer.  Scientific  evidence 
concerning  this  claim  is  inconclusive. 
Based  on  its  review,  FDA  does  not 
agree  that  selenium  may  reduce  the 
risk  of  colon  cancer." 
Prostate  Cancer 
Two  weak  studies  suggest  that  selenium 
intake  may  reduce  the  risk  of  prostate 
cancer.  However,  four  stronger  studies 
and  three  weak  studies showed  no 
reduction  in  risk.  Based  on  these 
studies,  FDA  concludes that  it  is  highly 
unlikely  that  selenium  supplements 
reduce  the  risk  of  prostate  cancer. 
"Selenium  may  reduce  the  risk  of 
prostate  cancer.  Scientific  evidence 
concerning  this  claim  is  inconclusive. 
Based  on  its  review,  FDA  does  not 
agree  that  selenium  may  reduce  the 
risk  of  prostate  cancer." 
Several  Cancers 
"Selenium  may  reduce  the  risk  of 
bladder,  colon,  prostate,  rectal  and 
thyroid  cancers.  Based  on  its  review, 
FDA  does  not  agree  that  selenium  may 
reduce  the  risk  of  these  cancers." 
122 G U I D A N C E  F O R  I N D U S T R Y  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Thyroid  Cancer 
One  weak,  small  study  sugggests  that 
selenium  intake  may  reduce  the  risk 
of  thyroid  cancer.  Based  on  this  study, 
FDA  concludes  that  it  is  highly  un-
certain  that  selenium  supplements 
reduce  the  risk  of  thyroid  cancer. 
Antioxidant  Vitamin  C 
Dietary  The  supplement  does  not  recommend 
Vitamins  & 
supplements  or  suggest  in  its  labeling,  or  under 
Cancer  Gastric  (Stomach)  Cancer 
containing  ordinary  conditions  of  use,  a  daily 
vitamin  E  intake  of  vitamin  C  above  1000  mg   One  weak  study  and  one  study  with 
Docket  No.  and/or  per  day  or  above  670  mg  of  alpha- inconsistent  results  suggest  that  vitamin 
FDA2008
vitamin  C  tocopherol  per  day  for  vitamin  E.  C  supplements  may  reduce  the  risk  of 
Q-0299  gastric  cancer.  Based  on  these  studies, 
Paragraph  101.14(d)(2)(vii) requires  FDA  concludes  that  it  is  highly 
06/19/2009  that  the  food  bearing  the  claim  meet  uncertain  that  vitamin  C  supplements 
enforcement  the  nutrient  content  claim  definition  reduce  the  risk  of  gastric  cancer.  
discretion  letter  for  high  (i.e.,  20%  or  more  of  the  
Vitamin  C  may  reduce  the  risk  of 
daily  value  (DV)  per  RACC).  20%  DV 
Summary  of  gastric  cancer  although  the  FDA  has 
for  vitamin  C  is  12  mg;  20%  DV  for 
settlement  in  concluded  that  there  is  very  little 
vitamin  E  is  6  IU*. 
Alliance  for  scientific  evidence  for  this  claim. 
Natural  Health 
Vitamin  C  may  reduce  the  risk  of 
vs.  Sebelius 
gastric  cancer.  FDA  has  concluded  that 
there  is  very  little  scientific  evidence  for 
this  claim.  
Vitamin  E 
Bladder  Cancer 
One  small  study  suggests  that  vitamin 
E  supplements  may  reduce  the  risk  of 
bladder  cancer.  However,  two  small 
studies  showed  no  reduction  of  risk. 
Based  on  these  studies,  FDA  concludes 
that  it  is  highly  unlikely  that  vitamin  E 
supplements  reduce  the  risk  of  bladder 
cancer.  
Vitamin  E  may  reduce  the  risk  of 
bladder  cancer  although  the  FDA  has 
concluded  that  there  is  very  little 
scientific  evidence  for  this  claim.  
Vitamin  E  may  reduce  the  risk  of 
bladder  cancer.  FDA  has  concluded 
that  there  is  very  little  scientific 
evidence  for  this  claim.   
A  F O O D  L A B E L I N G  G U I D E   123  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims  Foods  Enforcement  Discretion  Statements 
Colorectal  Cancer 
Two  weak  studies  and  one  study  with 
inconsistent  results  suggest  that  vitamin 
E  supplements  may  reduce  the  risk  of 
colorectal  cancer.  However,  another 
limited  study  showed  no  reduction  of 
risk.  Based  on  these  studies,  FDA 
concludes  that  it  is  highly  unlikely  that 
vitamin  E  supplements  reduce  the  risk 
of  colorectal  cancer.  
Vitamin  E  may  reduce  the  risk  of 
colorectal  cancer  although  the  FDA  has 
concluded  that  there  is  very  little 
scientific  evidence  for  this  claim.  
Vitamin  E  may  reduce  the  risk  of 
colorectal  cancer.  FDA  has  concluded 
that  there  is  very  little  scientific  evidence 
for  this  claim. 
Renal  Cell  Cancer 
One  weak  and  limited  study  suggests 
that  vitamin  E  supplements  may  reduce 
the  risk  of  renal  cell  cancer.  FDA 
concludes  that  it  is  highly  uncertain 
that  vitamin  E  supplements  reduce  the 
risk  of  renal  cell  cancer.  
Vitamin  E  may  reduce  the  risk  of 
renal  cancer  although  the  FDA  has 
concluded  that  there  is  very  little 
scientific  evidence  for  this  claim.  
Vitamin  E  may  reduce  the  risk  of  renal 
cancer.  FDA  has  concluded  that  there  is 
very  little  scientific  evidence  for  this  claim. 
100%  Whey- 100%  Whey- The  following  language  is  placed  (1)  "Very  little  scientific  evidence 
Protein  Partially  Protein  Partially  immediately  adjacent  to  and  directly  suggests  that,  for  healthy  infants  who 
Hydrolyzed  Hydrolyzed   beneath  the  claim:  are  not  exclusively  breastfed  and  who 
Infant  Formula  Infant  Formula  have  a  family  history  of  allergy,  feeding 
"Partially  hydrolyzed  formulas  
&  Atopic  should  not  be  fed  to  infants  who  are   a  100  %  Whey-Protein  Partially 
Dermatitis  allergic  to  milk  or  to  infants  with  Hydrolyzed  infant  formula  from  birth 
existing  milk  allergy  symptoms.  up  to  4  months  of  age  instead  of  a 
Docket  No.  formula  containing  intact  cow's  milk 
If  you  suspect  your  baby  is  already  
FDA-2009-Q- proteins  may  reduce  the  risk  of 
allergic  to  milk,  or  if  your  baby  is  on  
0301  developing  atopic  dermatitis 
a  special  formula  for  the  treatment  of 
throughout  the  1st  year  of  life  and  up 
allergy,  your  baby's  care  and  feeding 
05/24/2011  to  3  years  of  age."  
choices  should  be  under  a  doctor's  
enforcement   (Continued) 
supervision." 
discretion  letter 
124 G U I D A N C E  F O R  I N D U S T R Y  Qualified   Eligible   Factors  for  Exercising   Claim  
Health  Claims Foods  Enforcement  Discretion  Statements 
(2)  "Little  scientific  evidence  suggests 
that,  for  healthy  infants  who  are  not 
exclusively  breastfed  and  who  have  a 
family  history  of  allergy,  feeding  a  100 
%  Whey-Protein  Partially  Hydrolyzed 
infant  formula  from  birth  up  to  4 
months  of  age  instead  of  a  formula 
containing  intact  cow's  milk  proteins 
may  reduce  the  risk  of  developing 
atopic  dermatitis  throughout  the  1st 
year  of  life."  
(3)  "For  healthy  infants  who  are  not 
exclusively  breastfed  and  who  have  a 
family  history  of  allergy,  feeding  a 
100%  Whey-Protein  Partially 
Hydrolyzed  infant  formula  from  birth
up  to  4  months  of  age  instead  of  a 
formula  containing  intact  cow's  milk 
proteins  may  reduce  the  risk  of 
developing  atopic  dermatitis 
throughout  the  1st  year  of  life  and  up 
to  3  years  of  age.  FDA  has  concluded 
that  the  relationship  between  100% 
Whey-Protein  Partially  Hydrolyzed 
infant  formulas  and  the  reduced  risk 
of  atopic  dermatitis  is  uncertain, 
because  there  is  very  little  scientific 
evidence  for  the  relationship." 
(4)  "For  healthy  infants  who  are  not 
exclusively  breastfed  and  who  have  a 
family  history  of  allergy,  feeding  a 
100%  Whey-Protein  Partially 
Hydrolyzed  infant  formula  from  birth 
up  to  4  months  of  age  instead  of  a 
formula  containing  intact  cow's  milk 
proteins  may  reduce  the  risk  of 
developing  atopic  dermatitis 
throughout  the  1st  year  of  life.  FDA 
has  concluded  that  the  relationship 
between  100%  Whey-Protein  Partially 
Hydrolyzed  infant  formulas  and  the 
reduced  risk  of  atopic  dermatitis  is 
uncertain,  because  there  is  little 
scientific  evidence  for  the  relationship." 
* Based  upon  conversion  factors  identified  in  the  2000  IOM  Report,  this  equates  to  about  1500  IU  of  natural  vitamin  E  or  about  2200  IU  of  synthetic  (all  
racemic)  vitamin  E.  The  conversion  factors  are  as  follows:  (mg  of  alphatocopherol  in  food,  fortified  food  or  multivitamin  =  0.67  X  IU  of  the  RRR 
a
tocopherol  or  =  0.45  X  IU  of  the  all  rac tocopherol)  (IOM,  2000,  Chapter  6). 
a
A  F O O D  L A B E L I N G  G U I D E   125  A E:  
13.  PPENDIX 
A FDA  R
DDITIONAL  ESOURCES 
The  following  titles  are  available  on  FDA's  web  site. 
A  Labeling  Guide  for  Restaurants  and  Other  Retail  Establishments  Selling  Away  FromHome  Foods 
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053455.htm 
FDA  Nutrition  Labeling  Manual:  A  Guide  for  Developing  and  Using  Databases 
Generic  instructions  for  developing  and  preparing  an  acceptable  database  when  valid  estimates  of  nutrient  content  
and  variation  are  not  available  for  the  food  (single  or  mixed  products)  to  be  labeled. 
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm063113.htm 
Small  Business  Nutrition  Labeling  Exemption 
Sample  exemption  application  form  and  related  information. 
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053857.htm 
The  following  titles  contain  more  information  about  Federal  food  laws  and  regulations.  They  can  be  obtained  from  the 
Government  Printing  Office. 
Food  and  Drug  Administration  Modernization  Act  of  1997,  Public  Law  105115  GPO  (Stock  #869033001169) 
Book.  Amends  the  Federal  Food,  Drug,  and  Cosmetic  Act  and  the  Public  Health  Service  Act  to  Improve  the  
Regulation  of  Food,  Drugs,  Devices,  and  Biological  Products. 
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstothe 
FDCAct/FDAMA/FullTextofFDAMAlaw/default.htm 
Compilation  of  Laws  Enforced  by  the  United  States  Food  and  Drug  Administration  and  Related  Statutes,  V.  1  (1996)  
GPO  (Stock  #017-012-00378-8)  Printed  in  1996,  this  looseleaf  (with  binder)  is  a  compilation  of  the  Federal  Food, 
Drug,  and  Cosmetic  Act;  Public  Health  Service  Act;  Fair  Packaging  and  Labeling  Act;  Miscellaneous  Provisions  
Relating  to  Orphan  Drugs;  Administrative  Procedures  Act;  Federal  Committee  Act;  and  Lead-Based  Paint  
Poisoning  Prevention  Act. 
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm  and 
http://www.fda.gov/RegulatoryInformation/Legislation/ucm153119.htm 
Title  21,  Code  of  Federal  Regulations 
GPO  (order  by  title  and  part)  Contains  regulations  which  FDA  enforces.  Those  applicable  to  the  food  industry  are: 
	
 Part  1  to  99:  General  regulations  for  the  enforcement  of  the  Federal  Food,  Drug,  and  Cosmetic  Act  and  the  
Fair  Packaging  and  Labeling  Act.  Color  Additives. 
	
 Part  100  to  169:  Food  labeling,  food  standards,  good  manufacturing  practices  for  foods,  low-acid  canned  foods, 
and  acidified  foods. 
	
 Part  170  to  199:  Food  additives. 
	
 Part  800  to  1299:  Regulations  under  Federal  Import  Milk  Act,  the  Federal  Tea  Importation  Act,  the  Federal 
Caustic  Poison  Act,  and  regulations  for  control  of  communicable  diseases  and  interstate  conveyance  sanitation. 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm 
For  price  and  ordering  information 
Superintendent  of  Documents 
Government  Printing  Office 
Washington,  DC.  20402 
Telephone:  (202)  512-1800 
(Check  the  telephone  book  for  GPO  branches  in  your  city) 
126 G U I D A N C E  F O R  I N D U S T R Y  A F:  
14.  PPENDIX 
C P D V
ALCULATE THE  ERCENT  AILY  ALUE 
A N
FOR THE  PPROPRIATE  UTRIENTS 
There  are  two  sets  of  reference  values  for  reporting  nutrients  in  nutrition  labeling:  1) 
Daily  Reference  Values  (DRVs)  and  2)  Reference  Daily  Intakes  (RDIs).  These  values 
assist  consumers  in  interpreting  information  about  the  amount  of  a  nutrient  that  is 
present  in  a  food  and  in  comparing  nutritional  values  of  food  products.  DRVs  are 
established  for  adults  and  children  four  or  more  years  of  age,  as  are  RDIs,  with  the 
exception  of  protein.  DRVs  are  provided  for  total  fat,  saturated  fat,  cholesterol,  total 
carbohydrate,  dietary  fiber,  sodium,  potassium,  and  protein.  RDIs  are  provided  for 
vitamins  and  minerals  and  for  protein  for  children  less  than  four  years  of  age  and  for 
pregnant  and  lactating  women.  In  order  to  limit  consumer  confusion,  however,  the 
label  includes  a  single  term  (i.e.,  Daily  Value  (DV)),  to  designate  both  the  DRVs  and 
RDIs.  Specifically,  the  label  includes  the  %  DV,  except  that  the  %  DV  for  protein  is  not 
required  unless  a  protein  claim  is  made  for  the  product  or  if  the  product  is  to  be  used 
by  infants  or  children  under  four  years  of  age.  The  following  table  lists  the  DVs  based 
on  a  caloric  intake  of  2,000  calories,  for  adults  and  children  four  or  more  years  of  age. 
Food  Component  DV  Food  Component  DV 


Total  Fat  65  grams  (g)  Niacin  20  mg


Saturated  Fat  20  g  Vitamin  B6  2  mg
Cholesterol  300  milligrams  (mg)  Folate  400  g

Sodium  2,400  mg  Vitamin  B12  6  g 
Potassium  3,500  mg 
Biotin  300  g 
Total  Carbohydrate  300  g 
Pantothenic  acid  10  mg 
Dietary  Fiber  25  g 
Phosphorus  1,000  mg 
Protein  50  g 
Iodine  150  g 
Vitamin  A  5,000  International  Units  (IU) 
Magnesium  400  mg 
Vitamin  C  60  mg 
Zinc  15  mg 
Calcium  1,000  mg 
Selenium  70  g 
Iron  18  mg 
Copper  2  mg 
Vitamin  D  400  IU 
Manganese  2  mg 
Vitamin  E  30  IU 


Vitamin  K  80  micrograms  (g)  Chromium  120  g


Thiamin  1.5  mg  Molybdenum  75  g


Riboflavin  1.7  mg  Chloride  3,400  mg
In  order  to  calculate  the  %  DV,  determine  the  ratio  between  the  amount  of  the  nutrient 
in  a  serving  of  food  and  the  DV  for  the  nutrient.  That  is,  divide  either  the  actual 
(unrounded)  quantitative  amount  or  the  declared  (rounded)  amount  (see  next  section) 
by  the  appropriate  DV.  When  deciding  whether  to  use  the  unrounded  or  rounded 
value,  consider  the  amount  that  will  provide  the  greatest  consistency  on  the  food  label 
and  prevent  unnecessary  consumer  confusion.  The  nutrients  in  the  table  above  are 
listed  in  the  order  in  which  they  are  required  to  appear  on  a  label  in  accordance  with 
21  CFR  101.9(c). 
This  list  includes  only  those  nutrients  for  which  a  DRV  has  been 
21  CFR  101.9(c)(9)   21  CFR  101.9(c)(8)(iv). 
established  in   or  a  RDI  in  
A  F O O D  L A B E L I N G  G U I D E   127  A G:  
15.  PPENDIX 
D V I ,  C
AILY  ALUES FOR  NFANTS HILDREN 
L T 4  Y A ,  
ESS  HAN  EARS OF  GE AND 
P L W
REGNANT AND  ACTATING  OMEN 
These  values  have  not  been  codified,  but  have  been  published  in  the  Federal 
Register  to  provide  guidance  to  manufacturers  for  the  nutrients  listed  (58  FR 
2206  at  2213;  January  6,  1993).  The  abbreviation  "IU"  is  used  for  International 
Units,  "mg"  for  milligrams,  and  "mcg"  for  micrograms.  The  abbreviation  "g"  may 
also  be  used  for  micrograms.  Also,  the  agency  has  modified  the  units  of  measure 
for  four  nutrients.  Calcium  and  phosphorus  values  are  expressed  in  mg  and 
(60  FR  67164  to  67174). 
biotin  and  folate  values  in  mcg  
Vitamin   Less  than   Pregnant  and   Units  of  
or  Mineral  Infants  4  Years  Lactating  Women  Measure 
Vitamin  A  1,500  2,500  8,000  IU 
Vitamin  C  35  40  60  mg 
Calcium  600  800  1,300  mg 
Iron  15  10  18  mg 
Vitamin  D  400  400  400  IU 
Vitamin  E  5  10  30  IU 
Thiamin  0.5  0.7  1.7  mg 
Riboflavin  0.6  0.8  2.0  mg 
Niacin  8  9  20  mg 
Vitamin  B6  0.4  0.7  2.5  mg 
Folate  100  200  800  mcg 
Vitamin  B12  2  3  8  mcg 
Biotin  50  150  300  mcg 
Pantothenic  acid  3  5  10  mg 
Phosphorus  500  800  1,300  mg 
Iodine  45  70  150  mcg 
Magnesium  70  200  450  mg 
Zinc  5  8  15  mg 
Copper  0.6  1.0  2.0  mg 
128 G U I D A N C E  F O R  I N D U S T R Y  A H:  
16.  PPENDIX 
R V A
OUNDING THE  ALUES  CCORDING 
FDA  R R
TO  OUNDING  ULES 
The  following  table  provides  rounding  rules  for  declaring  nutrients  on  the  nutrition  label  or  in  labeling: 
Increment   Insignificant 
Nutrient  Rounding  Amount 
(1) 
Calories   <  5  cal  - express  as  0  <  5  cal 
(1)(ii) 
Calories  from  Fat   50  cal  - express  to  nearest  5  cal  increment 
(1)(iii) 
Calories  from  Saturated  Fat   >  50  cal  - express  to  nearest  10  cal  increment 
(2) 
Total  Fat   <  .5  g  - express  as  0  <  .5  g 
(2)(i) 
Saturated  Fat   <  5  g  - express  to  nearest  .5g  increment 
(2)(ii) 
Trans  Fat   5  g  - express  to  nearest  1  g  increment 
(2)(iii) 
Polyunsaturated  Fat  
(2)(iv) 
Monounsaturated  Fat  
(3) 
Cholesterol   <  2  mg  - express  as  0  <  2  mg 
2  - 5  mg  - express  as  less  than  5  mg   
>  5  mg  - express  to  nearest  5  mg  increment 
(4) 
Sodium   <  5  mg  - express  as  0  <  5  mg 
(5) 
Potassium   5  - 140  mg  - express  to  nearest  5  mg  increment 
>  140  mg  - express  to  nearest  10  mg  increment 
(6) 
Total  Carbohydrate   <  .5  g  - express  as  0  <  1  g 
(6)(i) 
Dietary  Fiber   <  1  g  - express  as  Contains  less  than  1  g  or  less  than  1  g 
(6)(ii) 
Sugars   1  g  - express  to  nearest  1  g  increment 
Soluble  and  Insoluble  
(6)(i)(A)&(B)&(6)(ii) 
Fiber;  Sugars   <  .5  g  - express  as  0  <  .5  g 
(6)(iii) 
Sugar  Alcohol   <  1  g  - express  as   Contains  less  than  1  g    or  less  than  1  g 
(6)(iv) 
Other  Carbohydrate   1  g  - express  to  nearest  1  g  increment 
(7) 
Protein   <  .5  g  - express  as  0  <  1  g 
<  1  g  - express  as  Contains  less  than  1  g  or  
less  than  1  g  or  to  1  g  if  .5  g  to  <  1  g 
1  g  - express  to  nearest  1  g  increment 
When  declaring  nutrients  other  than   express  to  nearest  1%  DV  increment  <  1%  DV 
vitamins  and  minerals  that  have  RDIs  
(8)(iii) 
as  a  %  DV  
(Continued) 
A  F O O D  L A B E L I N G  G U I D E   129  Increment   Insignificant 
Nutrient  Rounding  Amount 
Vitamins  &  Minerals  <  2%  of  RDI  may  be  expressed  as:  <  2%  RDI 
(express  as  %  DV)  (1)  2%  DV  if  actual  amount  is  1%  or  more 
(2)  0 
(3)  an  asterisk  that  refers  to  statement 
Contains  less  than  2%  of  the  Daily  Value  of  
this  (these)  nutrient(s)   
(4)  for  Vit  A,  C,  calcium,  iron:  statement 
Not  a  significant  source  of  ^^^^^^^^^ 
(listing  the  vitamins  and  minerals  omitted) 
10%  of  RDI  - express  to  nearest  2%  DV  increment 
>  10%  - 50%  of  RDI  - express  to  nearest  5%  DV  increment 
>  50%  of  RDI  - express  to  nearest  10%  DV  increment 
Beta-Carotene  10%  of  RDI  for  vitamin  A- express  to  nearest  2%  DV  increment 
(express  as  %  DV)  >  10%  - 50%  of  RDI  for  vitamin  A- express  to  nearest  5%  DV  increment 
>  50%  of  RDI  for  vitamin  A- express  to  nearest  10%  DV  increment 
To  express  nutrient  values  to  the  nearest  1  g  increment,  for  amounts  falling  exactly  halfway  between  two  whole  numbers  or 
higher  (e.g.,  2.5  to  2.99  g),  round  up  (e.g.,  3  g).  For  amounts  less  than  halfway  between  two  whole  numbers  (e.g,  2.01  g  to 
2.49  g),  round  down  (e.g.,  2  g). 
When  rounding  %  DV  for  nutrients  other  than  vitamins  and  minerals,  when  the  %  DV  values  fall  exactly  halfway  between 
two  whole  numbers  or  higher  (e.g.,  2.5  to  2.99),  the  values  round  up  (e.g.,  3  %).  For  values  less  than  halfway  between  two 
whole  numbers  (e.g.,  2.01  to  2.49),  the  values  round  down  (e.g.,  2%). 
130 G U I D A N C E  F O R  I N D U S T R Y   Food  and  Drug  Administration
 
5100 Paint  Branch  Parkway
 
College  Park,  MD  20740
 
www.fda.gov/FoodLabelingGuide 
132 GUIDANCE FOR INDUSTRY