Nutrition Labeling and Education Act Amendments of 1993
PL 103-80 (H.R.2900), enacted 08/13/1993

PUBLIC LAW 103-80—AUG. 13, 1993 
107 STAT. 773 
Public Law 103-80 
103d Congress 
An Act 
To clarify and revise the small business exemption firom the nutrition labeling 
Aug. 13,1993 
requirements of the Federal Food, Drug, and Cosmetic Act, and for other purposes. 
[H.R. 2900] 
Be it enacted by the Senate and House of Representatives of 
the United States of 
America in Congress assembled, 
Nutrition 
Labeling and 
SECTION 1. SHORT TITLE. 
Education Act 
This Act may be cited as the **Nutrition Labeling and Education 1993" 
Act Amendments of 1993". 
21 use 301 note. 
SEC. 2. S
M
A
L
L BUSINESS EXEMPTION. 
21 U
S
C 343 note. 
(a) APPUCATION OF EXISTING EXEMPTION.— 
(1) BEFORE MAY S, 1995.—Before May 8,1995, the exemption 
provided by section 403(qX5XD) of the Federal Food, Drug, 
and Cosmetic Act shall be available in accordance with the 
regulations of the Secretary of Health and Human Services 
pubUshed at 21 C.F.R. 101.90X1X1X1993). 
(2) AFTER MAY 8, 1996.—AJfter May 8, 1995, the exemption 
provided by section 403(qX5XD) of uie Federal Food, Drug, 
and Cosmetic Act shall only be available with respect to food 
when it is sold to consumers. 
(b) NEW EXEMPTION.—Section 403(qX5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343(qX5)) is amended by 
redesignating clauses (E) and (F) as clauses (F) and (G), respec-
tively, and by adding after clause (D) the following: 
(EXi) 6uring the 12-month period for wmch an exemption 
from subparagraphs (1) and (2) is claimed pursuant to this 
subclause, the requirements of such subparagraphs shall not apply 
to any food product if— 
"(I) the labeling for such product does not provide nutrition 
information or make a claim subject to paragraph (r), 
"(11) the person who claims for such product an exemption 
from such subparagraphs employed fewer than an average of 
100 full-time equivcuent employees, 
"(III) such person provided the notice described in subclause 
(iii), and 
"(IV) in the case of a food product which was sold in 
the 12-month period preceding the period for which an exemp-
tion was claimed, fewer than 100,000 units of such product 
were sold in the United States during such preceding period, 
or in tiie case of a food product which was not sold in the 
12-month period preceding the period for which such exemption 
is claimed, fewer than 100,000 units of such product are reason-
ably anticipated to be sold in the United States during the 
period for which such exemption is claimed. 
107 STAT. 774 
PUBLIC LAW 103-80—AUG. 13,1993 
"(ii) During the 12-nioiith period after the applicable date 
referred to in this sentence, the requirements of subparagraphs 
(1) and (2) shall not apply to any food product which was first 
introduced into interstate commerce before May 8, 1994, if the 
labeling for such product does not provide nutrition information 
or make a claim subject to paragraph (r), if such person provided 
the notice described in subdause uii), and if— 
"(I) during the 12-month period preceding May 8, 1994, 
the person who claims for such product an exemption from 
such subparagraphs employed fewer than an average of 300 
full-time equivalent employees and fewer than 600,000 units 
of such product were sold in the United States, 
"(11) during the 12-month period preceding May 8, 1995, 
the person who claims for sudi product an exemption from 
such subparagraphs employed fewer than an average of 300 
full-time equivalent employees and fewer than 400,000 units 
of such product were sold in Ihe United States, or 
"(III) during the 12-month period preceding May 8, 1996, 
the person who claims for sucn product an exemption from 
such subparagraphs employed fewer than an average of 200 
full-time eauivalent employees and fewer than 200,000 units 
of such product were sold in the United States. 
"(iii) The notice referred to in subclauses (i) and (ii) shall 
be given to the Secretary prior to the beginning of the period 
during which the exemption under subclause (i) or (ii) is to be 
in effect, shall state that the person claiming such exemption for 
a food product has complied with the applicable requirements of 
subclause (i) or (ii), and snail— 
"(I) state the average number of full-time equivalent 
employees such person employed during the 12 months preced-
ing the date such person claims such exemption, 
"(II) state the approximate nimiber of units the person 
claiming the exemption sold in the United States, 
"(III) if the exemption is claimed for a food product which 
was sold in the 12-month period preceding the period for which 
the exemption was claimed, state the approximate number 
of units of such product which were sold in the United States 
during such preceding period, and, if the exemption is claimed 
for a 
rood 
product which was not sold in such preceding period, 
state the number of units of such product which such person 
reasonably anticipates will be sold in the United States during 
the period for which the exemption was claimed, and 
"(IV) contain such information as the Secretary may require 
to verify the information required by the preceding provisions 
of this subclause if the Secretary has questioned the validity 
of such information. 
If a person is not an importer, has fewer them 10 full-time equiva-
lent employees, and sells fewer than 10,000 units of any food 
product in any yecur, such person is not required to file a notice 
for such product under tliis subclause for such year. 
"(iv) In the case of a person who claimed an exemption under 
subclause (i) or (ii), if, during the period of such exemption, the 
number of full-time equivalent employees of such person exceeds 
the number in such subclause or if the number of food products 
sold in the United States exceeds tiie number in such subclause, 
such exemption shall extend to the expiration of 18 months after 
PUBLIC LAW 103-80—AUG. 13,1993 
107 STAT. 775 
the date the number of full-time equivalent employees or food 
products sold exceeded the applicable number. 
"(v) For any food product first introduccMl into interstate com-
merce after May 8, 2002, the Secretary may by regulation lower 
the employee or units of food products requirement of subclause 
(i) if the Secretary determines that the cost of compliance with 
such lower requirement will not place an undue burden on persons 
subject to such lower requirement. 
"(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v)— 
"(1) the term 'unit' means the packaging or, if there is 
no packaging, the form in which a food product is offered 
for sale to consumers, 
"(II) the term 'food product' means food in any sized pack-
age which is manufactured by a single mani:^acturer or which 
bears the same brand name, which bears the same statement 
of identity, and which has similar preparation methods, and 
"(III) the term 'person' in the case of a corporation includes 
all domestic and foreign afiEiliates of the corporation.". 
SEC. 3. TECHNICAL AMENDMENTS TO FEDERAL FOOD, DRUG, AND 
COSMETIC ACT. 
(a) REFERENCE.—Whenever in this section an amendment or 
repecd is expressed in terms of an amendment to, or repeal of, 
a section or other provision, the reference shall be considered to 
be made to a section or other provision of the Federal Food, Drug, 
and Cosmetic Act. 
(b) SECTION 201.—Paragraphs (w), (x), (y), (z), (aa), QyhX (cc), 
(dd), (ee), and (fiD of section 201 (21 U.S.C 321) are redesignated 
as paragraphs (v), (w), (x), (y), (z), (aa), (bb), (cc), (dd), and (ee) 
respectively. 
(c) SECTION 301.—Section 301 (21 U.S.C. 331) is amended— 
(1) in subsection (j), by striking out "721, or 708" and 
inserting in Heu thereof "708, or 721"; and 
(2) in subsection (s), by striking out "412(d)" and inserting 
in lieu thereof "412(e)". 
(d) SECTION 302.—Section 302 (21 U.S.C. 332) is amended— 
(1) in subsection (a), by striking out ", and subject to" 
and all that follows through "381),", and 
(2) in subsection (b), by strikhig out the second sentence. 
(e) SECTION 303.—Section 303 (21 U.S.C. 333) is amended by 
redesignating the second subsection (e) and subsection (f) as sub-
sections (f) and (g), respectively. 
(f) SECTION 304.—Section 304 (21 U.S.C. 334) is amended— 
(1) in subsection (aXD, by striking out": Provided, however. 
That no" and inserting in heu thereof a period and "No", 
and 
(2) in subsection (dXl)— 
(A) by striking out ": Provided, That after" and insert-
ing in lieu thereof a period and "After", 
(B) by striking out ": Provided, however. That the" 
and inserting in heu thereof a period and "The", 
(C) by striking out": And provided further. That where" 
and inserting in heu thereof a period and "Where", and 
(D) by striking out "the foregoing proviso" and inserting 
in Ueu thereof "the preceding sentence . 
69-194 O - 94 - 26 : QL. 3 Part 1 
107 STAT. 776 
PUBLIC LAW 103-80—AUG. 13, 1993 
21 use 335b. 
(g) SECJTION 307.—Section 307(bX3XA) (21 U.S.C. 337(bX3XA)) 
is amended by striking out "Act" and inserting in lieu thereof 
"section". 
(h) SECTION 401.—Section 401 (21 U.S.C. 341) is amended 
by striking out "and/or reasonable standards of fill of container: 
Provided, That no" and inserting in lieu thereof "or reasonable 
standardis of fill of container. No". 
(i) SECTION 402.—Section 402 (21 U.S.C. 342) is amended— 
(1) by striking out "; or" at the end of subparagraphs 
(1) and (2) of paragraph (a) and inserting in lieu thereof a 
period and by striking out "if it" at the beginning of subpara-
graph (3) of such paragraph and inserting in lieu thereof "If 
it", 
(2) in paragraph (dXD, by striking out ": Provided, That 
this clause" and inserting in lieu thereof ", except that this 
subparagraph", and 
(3) in paragraph (dX3), by striking out ": Provided, That 
this clause" and inserting in lieu thereof ", except that this 
subparagraph" and by striking out ": And provided further. 
That the Secretary may, for the purpose of avoiding or resolving 
uncertainty as to the application of this clause" and inserting 
in lieu thereof ", except that the Secretary may, for the purpose 
of avoiding or resolving uncertainty as to the application of 
this subparagraph". 
(j) SECTION 403.—Section 403 (21 U.S.C. 343) is amended— 
(1) in paragraph (e), by striking out ": Provided, That" 
and inserting in lieu thereof ", except that", 
(2) in paragraph (i), by striking out ", other than those 
sold as such" and inserting in lieu thereof "iinless sold as 
spices, flavorings, or such colors" and by striking out ": Pro-
vided, That, to the extent" and inserting in lieu thereof a 
period and "To the extent", 
(3) in paragraph (k), by striking out ": Provided, That" 
and inserting in lieu thereof", except mat", 
(4) in paragraph (1), by striking out ": Provided, however. 
That" and inserting in lieu thereof", except that", 
(5) in paragraph (rXlXB), by striking out "5(D)" and insert-
ing in lieu thereof "(5)(D)", and 
(6) in paragraph (r)(4XB), by striking out "subsection" and 
inserting in lieu thereof "paragraph". 
(k) SECTION 408.—Section 408 (21 U.S.C. 346a) is amended— 
(1) in subsection (aXD, by striking out "Secretanr of Health 
and Human Services" and inserting in lieu thereof "Adminis-
trator of the Environmental Protection Agency (hereinafter in 
this section referred to as the 'Administrator')", 
(2) in subsection (dX5), by striking out "section 7(c) of 
the Administrative Procedure Act (5 U.S.C, sec. 1006(c))" and 
inserting in lieu thereof "section 55i6(c) of title 5, United States 
Code", 
(3) in subsection (1), by striking out "It the event" and 
inserting in lieu thereof "In me event , 
(4) in subsection (n), by striking out "of the Federal Food, 
Drug, and Cosmetic Act", 
(5) in subsection (o), by striking out "Secretaiy of Health 
and Human Services" each place it occurs and inserting in 
lieu thereof "Administrator", and 
PUBLIC LAW 103-80—AUG. 13, 1993 
107 STAT. 777 
(6) by striking out "Secretary" each place it occurs except 
when followed by "of Agriculture" and inserting in lieu thereof 
"Administrator". 
(1) SECTION 412.—Section 412(h) (21 U.S.C. 350a(h)) is amended 
by striking out "(cXlXB)," and inserting in lieu thereof "(eXlXB)". 
(m) SECTION 502.—Section 502 (21 U.S.C. 352) is amended— 
(1) in paragraph (eX3), by striking out ": Provided fiirther. 
That" and inserting in lieu thereof", except that", 
(2) in paragraph (f), by string out ": Provided, That" 
and inserting in lieu thereof ", except that", 
(3) in paragraph (g), by striking out ": Provided^ That 
the method" and inserting in lieu thereof a period and "The 
method" and by striking out ": Provided further, That," and 
inserting in lieu thereof", except that", and 
(4) in paragraph (n), by striking out ": Provided, That" 
and inserting in lieu thereof", except that". 
(n) SECTION 505.—Section 505 (21 U.S.C. 355) is amended— 
(1) in subsection (jX6XA)— 
(A) by striking out "Secretry" in claiise (ii) and insert-
ing in lieu thereof "Secretar3r", and 
(B) by inserting a comma after "Secretary" the first 
time it appears in clause (iii). 
(2) in subsection (kXD, by striking out": Provided, however. 
That regulations" and inserting in Ueu thereof a period and 
"Regulations". 
(o) SECTION 506.—Section 506(a) (21 U.S.C. 356(a)) is amended 
by striking out "Federal Security Administrator" and "Adminis-
trator" each place it appears and inserting in lieu thereof "Sec-
retary". 
(p) SECTION 507.—Section 507 (21 U.S.C. 357) is amended— 
(1) in subsection (a), by striking out "Federal Security 
Administrator" and "Administrator" each place it appears and 
inserting in lieu thereof "Secretary", 
(2) in subsection (e)— 
(A) by striking out "section 507" each place it occurs 
and inserting in lieu thereof "this section", 
(B) by striking out "or 507" and inserting in lieu thereof 
"or this section", and 
(C) by strildng out ": Provided, That, for purposes" 
and inserting in lieu thereof a period and "For purposes", 
(3) in subsection (gXD, by striking out": Provided, however. 
That regulations" and inserting in lieu thereof a period and 
"Regulations", and 
(4) in subsection (h), by striking out "507". 
(q) SECTION 508.—Subsections (c) and (e) of section 508 (21 
U.S.C. 358) are each amended by striking out "section 4 of the 
Administrative Procedure Act (5 U.S.C. 1003)" and inserting in 
lieu thereof "section 553 of title 5, United States Code". 
(r) SECTION 512.—Section 512 (21 U.S.C. 360b) is amended— 
(1) in subsection (cX2XAXii), by inserting "in" after 'pro-
vided", 
(2) in subsection (cX2XFXi), by striking out "(CXiii)" and 
inserting in lieu thereof "(D)(iii)", 
(3) in subsection (cX2XH), by striking out "subclause" the 
first time it appears and inserting in lieu thereof "subclauses", 
107 STAT. 778 
PUBLIC LAW 103-80—AUG. 13, 1993 
(4) in subsection (dXD, by striking out "subparagraphs 
(A) through (G)" and inserting in lieu thereof "subparagraphs 
(A) throu^ (I)", and 
(5) in subsection (nXl)— 
(A) by striking out "201(wf in subparagraphs (BXiiXII). 
and (CXiiXD ana inserting in lieu thereof 20Kv)", and 
(B) by striking out in the last sentence "(H)" and 
inserting in lieu thereof "(I)". 
(s) SECTION 513.—Section 513(bX3) (21 U.S.C 360c(bX3)) is 
amended by striking out "
S
T
O
S
C
b
)
" and inserting in lieu thereof 
•'5703''. 
(t) SECTION 515.—Section 515(cX2XA) (21 U.S.C. 360e(cX2XA)) 
is amended by striking out "refer sudi application". 
(u) SECTION 519.—Section 519(a) (21 U.S.C. 360i(a)) is amended 
by striking out "paragraph (4)" and inserting in lieu thereof "para-
graph (7)". 
(v) SECTION 527.—Section 527(b) (21 U.S.C. 360cc(b)) is 
amended— 
(1) by striking out "507,," and inserting in lieu thereof 
"507,", and 
(2) in paragraph (1), by striking out "The" and inserting 
in lieu thereof "tne. 
(w) SECTION 534.—Section 534(fX2) (21 U.S.C. 360kk) is 
amended by striking out "this Act" and inserting in lieu thereof 
"the Public Health Service Act". 
(x) SECTION 601.—Section 601(a) (21 U.S.C. 361) is amended 
by striking out ": Provided, That this" and inserting in lieu thereof 
", except that this". 
(y) SECTION 701.—Section 701 (21 U.S.C. 371) is amended— 
(1) in subsection (eXl)> hy striking out the period after 
"Regulations)" the second time it occurs, and 
(2) in subsection (f)(4), by striking out "sections 239 and 
240 of the Judicial Code, as amended" and inserting in lieu 
thereof "section 1254 of title 28, United States Code". 
(z) SECTION 703.—Section 703 (21 U.S.C. 373) is amended— 
(1) by striking out ": Provided, That" and inserting in 
lieu thereof", except that", and 
(2) by striking out ": Provided further, That" and inserting 
in lieu thereof ", and except that". 
(aa) SECTION 704.—Section 704(aXl) (21 U.S.C. 374(aXl)) is 
amended— 
(1) by striking out the semicolon after "materials" and 
inserting in lieu thereof a comma, and 
(2) by striking out "(j)" the furst time it appears and insert-
ing in Ueu thereof 
"(k)". 
(bb) 
SECTION 
721.—Section 
721(bX5XD) 
(21 
U.S.C. 
379e(bX5XD)) is amended by striking out "5703(b)" and inserting 
in lieu thereof "5703". 
(cc) SECTION 801.—Section 801(b) (21 U.S.C. 381(b)) is 
amended— 
(1) by striking out "Administrator" the first time it occurs 
and inserting in lieu thereof "Secretary of Health and Human 
Services", 
(2) by striking out "Administrator" the second and third 
time it occurs and mserting in lieu thereof "Secretary", 
(3) by striking out "Administrator's" and inserting in Ueu 
thereof "Secretary^", and 
PUBLIC LAW 103-80—AUG. 13, 1993 
107 STAT. 779 
(4) bv striking out Tederal Security Agency" and inserting 
in lieu thereof "Department of Health and Human Services . 
rddl Af RTf 
TJLTITRl'' ^
— 
(1) Sections 201(c), 201(d), 701(b), and 801(a) (21 U.S.C. 
321(c), 321(d), 371(b), and 381(a) are each amended by striking 
out "A^culture" each place it appears and inserting in lieu 
thereof "Health and Human Services". 
/ 
(2) Sections 702(c) and 706 (21 U.S.C. 372(c) and 376) 
are each amended by striking out "of Agriculture" each place 
it appears. 
SEC. 4. TECHNICAL AMENDMENTS TO AMENDATORY ACTS. 
(a) SAFE MEDICAL DEVICES ACT OF 1990.— 
(1) Section 18(b) of the Safe Medical Devices Act of 1990 
(Public Law 101-629) is amended by striking out "(bX4XB)" 2iusc360d. 
and inserting in lieu thereof "(b)", and 
(2) Section 19(aX4) of the Safe Medical Devices Act of 
1990 (PubUc Law 101-629) is amended— 
Sohfaeoas-
(A) by striking out "as amended by paragraphs (1) 42 use 263b. 
and (2)" and inserting in lieu thereof "as amended by 
para^aphs (1), (2), ancr(3)", 
(B) by striking out "530" and inserting in lieu thereof 
"531", and 
(C) by striking out "354" and inserting in heu thereof 
"355". 
(b) M
E
D
I
C
A
L DEVICE AMENDMENTS OF 1992.—Section 6(a) of 
the Medical Device Amendments of 1992 (PubUc Law 102-300) 21USC321. 
is amended by inserting "wherever appearing" after " 'any of its 
principal'". 
(c) NUTRITION LABELING AND EDUCATION ACT OF 1990.—Section 
8 of l^e Nutrition Labeling and Education Act of 1990 is amended 21 use 371. 
by striking the period at the end and inserting close quotation 
marks and a period. 
Approved August 13, 1993. 
LEGISLATIVE HISTORY—H.R. 2900: 
CONGRESSIONAL RECORD, Vol. 139 (1993): 
Aug. 6, considered and passed House and Senate.