Nutrition Labeling and Education Act of 1990
PL 101-535 (H.R.3562), enacted 11/08/1990

PUBLIC LAW 101-535—NOV. 8, 1990 
104 STAT. 2353 
Public Law 101-535 
101st Congress 
An Act 
To amend the Federal Food, Drug, and Cosmetic Act to prescribe nutrition labeling 
Nov. 8, 1990 
for foods, and for other purposes. 
[H.R. 3562] 
Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled. 
Nutrition 
' 
° 
Labelmg and 
SECTION 1. SHORT TITLE, REFERENCE. 
Education Act of 
1990. 
(a) SHORT TITLE.—This Act may be cited as the "Nutrition Label- 
21 use 301 note, 
ing and Education Act of 1990". 
(b) REFERENCE.—Whenever in this Act an amendment or repeal 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. 
SEC. 2. NUTRITION LABELING. 
(a) NUTRITION INFORMATION.—Section 403 (21 U.S.C. 343) is 
amended by adding at the end the following new paragraph: 
"(qXD Except as provided in subparagraphs (3), (4), and (5), if it is 
a food intended for human consumption and is offered for sale, 
unless its label or labeling bears nutrition information that 
provides— 
"(AXi) the serving size which is an amount customarily 
consumed and which is expressed in a common household meas-
ure that is appropriate to the food, or 
"(ii) if the use of the food is not typically expressed in a 
serving size, the common household unit of measure that ex-
presses the serving size of the food, 
"(B) the number of servings or other units of measure per 
container, 
"(C) the total number of calories— 
"(i) derived from any source, and 
"(ii) derived from the total fat, 
in each serving size or other unit of measure of the food, 
"(D) the amount of the following nutrients: Total fat, satu-
rated fat, cholesterol, sodium, total carbohydrates, complex 
carbohydrates, sugars, dietary fiber, and total protein contained 
in each serving size or other unit of measure, 
"(E) any vitamin, mineral, or other nutrient required to be 
placed on the label and labeling of food under this Act before 
October 1, 1990, if the Secretary determines that such infor-
mation will assist consumers in maintaining healthy dietary 
practices. 
The Secretary may by regulation require any information required 
to be placed on the label or labeling by this subparagraph or 
subparagraph (2XA) to be highlighted on the label or labeling by 
larger type, bold type, or contrasting color if the Secretary deter-
mines that such highlighting will assist consumers in maintaining 
healthy dietary practices. 
49-139 O - 90 (535) 
104 STAT. 2354 
PUBLIC LAW 101-535—NOV. 8, 1990 
Regulations. 
Agricultural 
commodities. 
Seafood. 
Regulations. 
Reports. 
"(2)(A) If the Secretary determines that a nutrient other than a 
nutrient required by subparagraph (IXC), (1)(D), or (1)(E) should be 
included in the label or labeling of food subject to subparagraph (1) 
for purposes of providing information regarding the nutritional 
value of such food that will assist consumers in maintaining healthy 
dietary practices, the Secretary may by regulation require that 
information relating to such additional nutrient be included in the 
label or labeling of such food. 
"(B) If the Secretary determines that the information relating to a 
nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or clause 
(A) of this subparagraph to be included in the label or labeling of 
food is not necessary to assist consumers in maintaining healthy 
dietary practices, the Secretary may by regulation remove informa-
tion relating to such nutrient from such requirement. 
"(3) For food that is received in bulk containers at a retail 
establishment, the Secretary may, by regulation, provide that the 
nutrition information required by subparagraphs (1) and (2) be 
displayed at the location in the retail establishment at which the 
food is offered for sale. 
"(4)(A) The Secretary shall provide for furnishing the nutrition 
information required by subparagraphs (1) and (2) with respect to 
raw agricultural commodities and raw fish by issuing voluntary 
nutrition guidelines, as provided by clause (B) or by issuing regula-
tions that are mandatory as provided by clause (C). 
"(B)(i) Upon the expiration of 12 months after the date of the 
enactment of the Nutrition Labeling and Education Act of 1990, the 
Secretary, after providing an opportunity for comment, shall issue 
guidelines for food retailers offering raw agricultural commodities 
or raw fish to provide nutrition information specified in subpara-
graphs (1) and (2). Such guidelines shall take into account the 
actions taken by food retailers during such 12-month period to 
provide to consumers nutrition information on raw agricultural 
commodities and raw fish. Such guidelines shall only apply— 
"(I) in the case of raw agricultural commodities, to the 20 
varieties of vegetables most frequently consumed during a year 
and the 20 varieties of fruit most frequently consumed during a 
year, and 
"(II) to the 20 varieties of raw fish most frequently consumed 
during a year. 
The vegetables, fruits, and raw fish to which such guidelines apply 
shall be determined by the Secretary by regulation and the Sec-
retary may apply such guidelines regionally. 
"(ii) Upon the expiration of 12 months after the date of the 
enactment of the Nutrition Labeling and Education Act of 1990, the 
Secretary shall issue a final regulation defining the circumstances 
that constitute substantial compliance by food retailers with the 
guidelines issued under subclause (i). The regulation shall provide 
that there is not substantial compliance if a significant number of 
retailers have failed to comply with the guidelines. The size of the 
retailers and the portion of the market served by retailers in 
compliance with the guidelines shall be considered in determining 
whether the substantial-compliance standard has been met. 
"(C)(i) Upon the expiration of 30 months after the date of the 
enactment of the Nutrition Labeling and Education Act of 1990, the 
Secretary shall issue a report on actions taken by food retailers to 
provide consumers with nutrition information for raw agricultural 
commodities and raw fish under the guidelines issued under clause 
PUBLIC LAW 101-535—NOV. 8, 1990 
104 STAT. 2355 
(A). Such report shall include a determination of whether there is 
substantial compliance with the guidelines. 
"(ii) If the Secretary finds that there is substantial compliance 
with the guidelines, the Secretary shall issue a report and make a 
determination of the type required in subclause (i) every two years. 
"(D)(i) If the Secretary determines that there is not substantial 
compliance with the guidelines issued under clause (A), the Sec-
retary shall at the time such determination is made issue proposed 
regulations requiring that any person who offers raw agricultural 
commodities or raw fish to consumers to provide, in a manner pre-
scribed by regulations, the nutrition information required by sub-
paragraphs (1) and (2). The Secretary shall issue final regulations 
imposing such requirements 6 months after issuing the proposed 
regulations. The final regulations shall become effective 6 months 
after the date of their promulgation. 
"(ii) Regulations issued under subclause (i) may require that the 
nutrition information required by subparagraphs (1) and (2) be 
provided for more than 20 varieties of vegetables, 20 varieties of 
fruit, and 20 varieties of fish most frequently consumed during a 
year if the Secretary finds that a larger number of such products are 
frequently consumed. Such regulations shall permit such informa-
tion to be provided in a single location in each area in which raw 
agricultural commodities and raw fish are offered for sale. Such 
regulations may provide that information shall be expressed as an 
average or range per serving of the same type of raw agricultural 
commodity or raw fish. The Secretary shall develop and make 
available to the persons who offer such food to consumers the 
information required by subparagraphs (1) and (2). 
"(iii) Regulations issued under subclause (i) shall permit the re-
quired information to be provided in each area of an establishment 
in which raw agricultural commodities and raw fish are offered for 
sale. The regulations shall permit food retailers to display the 
required information by supplying copies of the information pro-
vided by the Secretary, by making the information available in 
brochure, notebook or leaflet form, or by posting a sign disclosing 
the information. Such regulations shall also permit presentation of 
the required information to be supplemented by a video, live dem-
onstration, or other media which the Secretary approves. 
"(E) For purposes of this subparagraph, the term 'fish' includes 
freshwater or marine fin fish, crustaceans, and mollusks, including 
shellfish, amphibians, and other forms of aquatic animal life. 
"(F) No person who offers raw agricultural commodities or raw 
fish to consumers may be prosecuted for minor violations of this 
subparagraph if there has been substantial compliance with the 
requirements of this paragraph. 
"(5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to food— 
"(i) which is served in restaurants or other establishments in 
which food is served for immediate human consumption or 
which is sold for sale or use in such establishments, 
"(ii) which is processed and prepared primarily in a retail 
establishment, which is ready for human consumption, which is 
of the type described in subclause (i), and which is offered for 
sale to consumers but not for immediate human consumption in 
such establishment and which is not offered for sale outside 
such establishment, 
"(iii) which is an infant formula subject to section 412, 
Regulations. 
Effective date. 
Public 
information. 
104 STAT. 2356 
PUBLIC LAW 101-535—NOV. 8, 1990 
21 u s e 343 note. 
Public 
information. 
"(iv) which is a medical food as defined in section 5(b) of the 
Orphan Drug Act (21 U.S.C. 360ee(b)), or 
"(v) which is described in section 405(2). 
"(B) Subparagraphs (1) and (2) shall not apply to the label of a food 
if the Secretary determines by regulations that compliance with 
such subparagraphs is impracticable because the package of such 
food is too small to comply with the requirements of such subpara-
graphs and if the label of such food does not contain any nutrition 
information. 
"(C) If a food contains insignificant amounts, as determined by the 
Secretary, of all the nutrients required by subparagraphs (1) and (2) 
to be listed in the label or labeling of food, the requirements of such 
subparagraphs shall not apply to such food if the label, labeling, or 
advertising of such food does not make any claim with respect to the 
nutritional value of such food. If a food contains insignificant 
amounts, as determined by the Secretary, of more than one-half the 
nutrients required by subparagraphs (1) and (2) to be in the label or 
labeling of the food, the Secretary shall require the amounts of such 
nutrients to be stated in a simplified form prescribed by the 
Secretary. 
"(D) If a person offers food for sale and has annual gross sales 
made or business done in sales to consumers which is not more than 
$500,000 or has annual gross sales made or business done in sales of 
food to consumers which is not more than $50,000, the requirements 
of subparagraphs (1), (2), (3), and (4) shall not apply with respect to 
food sold by such person to consumers unless the label or labeling of 
food offered by such person provides nutrition information or makes 
a nutrition claim. 
"(E) If a food to which section 411 applies (as defined in section 
411(c)) contains one or more of the nutrients required by subpara-
graph (1) or (2) to be in the label or labeling of the food, the label or 
labeling of such food shall comply with the requirements of subpara-
graphs (1) and (2) in a manner which is appropriate for such food 
and which is specified in regulations of the Secretary. 
"(F) Subparagraphs (1), (2), (3), and (4) shall not apply to food 
which is sold by a food distributor if the food distributor principally 
sells food to restaurants or other establishments in which food is 
served for immediate human consumption and does not manufac-
ture, process, or repackage the food it sells.". 
O
t
>
) REGULATIONS.— 
(1) The Secretary of Health and Human Services shall issue 
proposed regulations to implement section 403(q) of the Federal 
Food, Drug, and Cosmetic Act within 12 months after the date 
of the enactment of this Act. Not later than 24 months after the 
date of the enactment of this Act, the Secretary shall issue final 
regulations to implement the requirements of such section. 
Such regulations shall— 
(A) require the required information to be conveyed to 
the public in a manner which enables the public to readily 
observe and comprehend such information and to under-
stand its relative significance in the context of a total daily 
diet, 
(B) include regulations which establish standards, in 
accordance with paragraph (1)(A), to define serving size or 
other unit of measure for food, 
(C) permit the label or labeling of food to include nutri-
tion information which is in addition to the information 
PUBLIC LAW 101-535~-NOV. 8, 1990 
104 STAT. 2357 
required by such section 403(q) and which is of the type 
described in subparagraph (1) or (2) of such section, and 
(D) permit the nutrition information on the label or 
labeling of a food to remain the same or permit the 
information to be stated as a range even though (i) there 
are minor variations in the nutritional value of the food 
which occur in the normal course of the production or 
processing of the food, or (ii) the food is comprised of an 
assortment of similar foods which have variations in nutri-
tional value. 
(2) If the Secretary of Health and Human Services does not 
promulgate final regulations under parsigraph (1) upon the 
expiration of 24 months after the date of the enactment of this 
Act, the proposed regulations issued in accordance with para-
graph (1) shall be considered as the final regulations upon the 
expiration of such 24 months. There shall be promptly pub-
lished in the Federal Register notice of new status of the 
proposed regulations. 
(3) If the Secretary of Health and Human Services does not 
promulgate final regulations under section 403(q)(4) of the Fed-
eral Food, Drug, and Cosmetic Act upon the expiration of 6 
months after the date on which the Secretary makes a finding 
that there has been no substantial compliance with section 
403(q)(4XC) of such Act, the proposed regulations issued in 
accordance with such section shall be considered as the final 
regulations upon the expiration of such 6 months. There shall 
be promptly published in the Federal Register notice of new 
status of the proposed regulations. 
(c) CONSUMER EDUCATION.—The Secretary of Health and Human 
Services shall carry out activities which educate consumers about— 
(1) the availability of nutrition information in the label or 
labeling of food, and 
(2) the importance of that information in maintaining healthy 
dietary practices. 
SEC. 3. CLAIMS. 
(a) LABEUNG REQUIRED.—Section 403 (21 U.S.C. 343) is amended 
by adding after the paragraph added by section 2 the following: 
"(r)(l) Except as provided in clauses (A) through (C) of subpara-
graph (5), if it is a food intended for human consumption which is 
offered for sale and for which a claim is made in the label or 
labeling of the food which expressly or by implication— 
"(A) characterizes the level of any nutrient which is of the 
type required by paragraph (q)(l) or (q)(2) to be in the label or 
labeling of the food unless the claim is made in accordance with 
subparagraph (2), or 
"(B) characterizes the relationship of any nutrient which is of 
the type required by paragraph (q)(l) or (qX2) to be in the label 
or labeling of the food to a disease or a health-related condition 
unless the claim is made in accordance with subparagraph (3) or 
5(D). 
A statement of the type required by paragraph (q) that appears as 
part of the nutrition information required or permitted by such 
paragraph is not a claim which is subject to this paragraph and a 
claim subject to clause (A) is not subject to clause (B). 
Federal 
Register, 
publication. 
Federal 
Register, 
publication. 
21 u s e 343 note. 
104 STAT. 2358 
PUBLIC LAW 101-535—NOV. 8, 1990 
"(2XA) Except as provided in subparagraphs (4XAXii) and (4XAXiii) 
and clauses (A) through (C) of subparagraph (5), a claim described in 
subparagraph (IXA)— 
"(i) may be made only if the characterization of the level 
made in the claim uses terms which are defined in regulations 
of the Secretary, 
"(ii) may not state the absence of a nutrient unless— 
"(I) the nutrient is usually present in the food or in a food 
which substitutes for the food as defined by the Secretary 
by regulation, or 
"(11) the Secretary by regulation permits such a state-
ment on the basis of a finding that such a statement would 
assist consumers in maintaining healthy dietary practices 
and the statement discloses that the nutrient is not usually 
present in the food. 
Cholesterol. 
"(iii) may not be made with respect to the level of cholesterol 
in the food if the food contains, as determined by the Secretary 
by regulation, fat or saturated fat in an amount which increases 
to persons in the general population the risk of disease or a 
health related condition which is diet related unless— 
"(I) the Secretary finds by regulation that the level of 
cholesterol is substantially less than the level usually 
present in the food or in a food which substitutes for the 
food and which has a significant market share, or the 
Secretary by regulation permits a statement regarding the 
absence of cholesterol on the basis of a finding that choles-
terol is not usually present in the food and that such a 
statement would assist consumers in medntaining healthy 
dietary practices and the regulation requires that the state-
ment disclose that cholesterol is not usually present in the 
food, and 
"(II) the label or labeling of the food discloses the level of 
such fat or saturated fat in immediate proximity to such 
claim and with appropriate prominence which shall be no 
less than one-half the size of the claim with respect to the 
level of cholesterol, 
"(iv) may not be made with respect to the level of saturated 
fat in the food if the food contains cholesterol unless the label or 
labeling of the food discloses the level of cholesterol in the food 
in immediate proximity to such claim and with appropriate 
prominence which shall be no less than one-half the size of the 
claim with respect to the level of saturated fat, 
"(v) may not state that a food is high in dietary fiber unless 
the food is low in total fat as defined by the Secretary or the 
label or labeling discloses the level of total fat in the food in 
immediate proximity to such statement and with appropriate 
prominence which shall be no less than one-half the size of the 
claim with respect to the level of dietary fiber, and 
"(vi) may not be made if the Secretary by regulation prohibits 
the claim because the claim is misleading in light of the level of 
another nutrient in the food. 
"(B) If a claim described in subparagraph (IXA) is made with 
respect to a nutrient in a food, the label or labeling of such food 
shall contain, prominently and in immediate proximity to such 
claim, the following statement: 'See 
for nutrition 
information.'. In the statement— 
PUBLIC LAW 101-535—NOV. 8, 1990 
104 STAT. 2359 
"(i) the blank shall identify the panel on which the informa-
tion described in the statement may be found, and 
"(ii) if the Secretary determines that the food contains a 
nutrient at a level which increases to persons in the general 
population the risk of a disease or health-related condition 
which is diet related, taking into account the significance of the 
food in the total daily diet, the statement shall also identify 
such nutrient. 
"(C) Subparagraph (2)(A) does not apply to a claim described in 
subparagraph (1)(A) and contained in the label or labeling of a food 
if such claim is contained in the brand name of such food and such 
brand name was in use on such food before October 25, 1989, unless 
the brand name contains a term defined by the Secretary under 
subparagraph (2)(AXi). Such a claim is subject to paragraph (a). 
"(D) Subparagraph (2) does not apply to a claim described in 
subparagraph (1)(A) which uses the term 'diet' and is contained in 
the label or labeling of a soft drink if (i) such claim is contained in 
the brand name of such soft drink, (ii) such brand name was in use 
on such soft drink before October 25, 1989, and (iii) the use of the 
term 'diet' was in conformity with section 105.66 of title 21 of the 
Code of Federal Regulations. Such a claim is subject to para-
graph (a). 
"(E) Subclauses (i) through (v) of subparagraph (2XA) do not apply 
to a statement in the label or labeling of food which describes the 
percentage of vitamins and minerals in the food in relation to the 
amount of such vitamins and minerals recommended for daily 
consumption by the Secretary. 
"(3)(A) Except as provided in subparagraph (5), a claim described 
in subparagraph (1)(B) may only be made— 
"(i) if the claim meets the requirements of the regulations of 
the Secretary promulgated under clause (B), and 
"(ii) if the food for which the claim is made does not contain, 
as determined by the Secretary by regulation, any nutrient in 
an amount which increases to persons in the general population 
the risk of a disease or health-related condition which is diet 
related, taking into account the significance of the food in the 
total daily diet, except that the Secretary may by regulation 
permit such a claim based on a finding that such a claim would 
assist consumers in maintaining healthy dietary practices and 
based on a requirement that the label contain a disclosure of 
the type required by subparagraph (2XB). 
"(B)(i) The Secretary shall promulgate regulations authorizing 
Regulations, 
claims of the tjrpe described in subparagraph (IXB) only if the 
Secretary determines, based on the totality of publicly available 
scientific evidence (including evidence from well-designed studies 
conducted in a manner which is consistent with generally recog-
nized scientific procedures and principles), that there is significant 
scientific agreement, among experts qualified by scientific training 
and experience to evaluate such claims, that the claim is supported 
by such evidence. 
"(ii) A regulation described in subclause (i) shall describe— 
"(I) the relationship between a nutrient of the type required 
in the label or labeling of food by paragraph (qXD or (qX2) and a 
disease or health-related condition, and 
"(II) the significance of each such nutrient in affecting such 
disease or health-related condition. 
104 STAT. 2360 
PUBLIC LAW 101-535—NOV. 8, 1990 
Classified 
information. 
Regulations. 
Federal 
Register, 
publication. 
21 u s e 343 note. 
"(iii) A regulation described in subclause (i) shall require such 
claim to be stated in a manner so that the claim is an accurate 
representation of the matters set out in subclause (ii) and so that the 
claim enables the public to comprehend the information provided in 
the claim and to understand the relative significance of such 
information in the context of a total daily diet. 
"(4XAXi) Any person may petition the Secretary to issue a regula-
tion under subparagraph (2XAXi) or (3XB) relating to a claim de-
scribed in subparagraph (IXA) or (IXB). Not later than 100 days 
after the petition is received by the Secretary, the Secretary shall 
issue a final decision den3dng the petition or file the petition for 
further action by the Secretary. If the Secretary denies the petition, 
the petition shall not be made available to the public. If the Sec-
retary files the petition, the Secretary shall deny the petition or 
issue a proposed regulation to take the action requested in the 
petition not later than 90 days after the date of such decision. 
"(ii) Any person may petition the Secretary for permission to use 
in a claim described in subparagraph (IXA) terms that are consistent 
with the terms defined by the Secretary under subparagraph 
(2XAXi). Within 90 days of the submission of such a petition, the 
Secretary shall issue a final decision den3dng the petition or grant-
ing such permission. 
(iii) Any person may petition the Secretary for permission to use 
an implied claim described in subparagraph (IXA) in a brand name. 
After publishing notice of an opportunity to comment on the peti-
tion in the Federal Register and making the petition available to the 
public, the Secretary shall grant the petition if the Secretary finds 
that such claim is not misleading and is consistent with terms 
defined by the Secretary under subparagraph (2XAXi). The Secretary 
shall grant or deny the petition within 100 days of the date it is 
submitted to the Secretary and the petition shall be considered 
granted if the Secretary does not act on it within such 100 days. 
"(B) A petition under clause (AXi) respecting a claim described in 
subparagraph (IXA) or (IXB) shall include an explanation of the 
reasons why the claim meets the requirements of this subsection 
and a summary of the scientific data which supports such reasons. 
"(C) If a petition for a regulation under subparagraph (3XB) relies 
on a report from an authoritative scientific body of the United 
States, the Secretary shall consider such report and shall justify any 
decision rejecting the conclusions of such report. 
"(5XA) This paragraph does not apply to infant formulas subject to 
section 412(h) and medical foods as defined in section 5(b) of the 
Orphan Drug Act. 
(B) Subclauses (iii) through (v) of subpars^aph (2XA) and 
subparagraph (2XB) do not apply to food which is served in res-
taurants or other establishments in which food is served for imme-
diate human consumption or which is sold for sale or use in such 
establishments. 
"(C) A subparagraph (IXA) claim made with respect to a food 
which claim is required by a standard of identity issued under 
section 401 shall not be subject to subparagraph (2XAXi) or (2XB). 
"(D) A subparagraph (IXB) claim made with respect to a dietary 
supplement of vitamins, minerals, herbs, or other similar nutri-
tional substances shall not be subject to subparagraph (3) but shall 
be subject to a procedure and standard, respecting the validity of 
such claim, established by regulation of the Secretary.". 
(b) REGULATIONS.— 
PUBLIC LAW 101-535—NOV. 8, 1990 
104 STAT. 2361 
(IXA) Within 12 months of the date of the enactment of this Regulations. 
Act, the Secretary of Health and Human Services shall issue 
proposed regulations to implement section 403(r) of the Federal 
Food, Drug, and Cosmetic Act. Such regulations— 
(i) shall identify claims described in section 403(rXlXA) of 
such Act which comply with section 403(rX2) of such Act, 
(ii) shall identify claims described in section 403(rXlXB) of 
such Act which comply with section 403(rX3) of such Act, 
(iii) shall, in defining terms used to characterize the level 
of any nutrient in food under section 403(rX2XAXi) of such 
Act, define— 
(I) free, 
(II)low, 
(III) light or lite, 
(IV) reduced, 
(V) less, and 
(VI) high, 
unless the Secretary finds that the use of any such term 
would be misleading, 
(iv) shall permit statements describing the amount and 
percentage of nutrients in food which are not misleading 
and are consistent with the terms defined in section 
403(rX2XAXi) of such Act, 
(v) shall provide that if multiple claims subject to section 
403(rXl)(A) of such Act are made on a single panel of the 
food label or page of a labeling brochure, a single statement 
may be made to satisfy section 403(r)(2XB) of such Act, 
(vi) shall determine whether claims respecting the follow-
ing nutrients and diseases meet the requirements of section 
403(r)(3) of such Act: Calcium and osteoporosis, dietary fiber 
and cancer, lipids and cardiovascular disease, lipids and 
cancer, sodium and hypertension, and dietary fiber and 
cardiovascular disease, 
(vii) shall not require a person who proposes to make a 
claim described in section 403(rXlXB) of such Act which is 
in compliance with such regulations to secure the approval 
of the Secretary before making such claim, 
(viii) may permit a claim described in section 403(rXlXA) 
of such Act to be made for butter, 
(ix) may, in defining terms under section 403(rX2XAXi), 
include similar terms which are commonly understood to 
have the same meaning, and 
(x) shall establish, as required by section 403(rX5XD), the 
procedure and standard respecting the validity of claims 
made with respect to a dietary supplement of vitamins, 
minerals, herbs, or other similar nutritional substances and 
shall determine whether claims respecting the following 
nutrients and diseases meet the requirements of section 
403(r)(5XD) of such Act: folic acid and neural tube defects, 
antioxident vitamins and cancer, zinc and immune function 
in the elderly, and omega-3 fatty acids and heart disease. 
(B) Not later than 24 months after the date of the enactment 
Regulations, 
of this Act, the Secretary shall issue final regulations to imple-
ment section 403(r) of the Federal Food, Drug, and Cosmetic 
Act. 
(2) If the Secretary does not promulgate final regulations 
under paragraph dXB) upon the expiration of 24 months after 
104 STAT. 2362 
PUBLIC LAW 101-535—NOV. 8, 1990 
the date of the enactment of this Act, the proposed regulations 
issued in accordance with paragraph (1)(A) shall be considered 
£is the final regulations upon the expiration of such 24 months. 
Federal 
There shall be promptly published in the Federal Register 
^^bl^^T 
notice of the new status of the proposed regulations. 
SEC. 4. STATE ENFORCEMENT. 
Section 307 (21 U.S.C. 337) is amended by striking out "All such 
proceedings" and inserting in lieu thereof "(a) Except as provided in 
subsection 0?), all such proceedings" and by adding at the end the 
following: 
"O^XD A State may bring in its own name and within its jurisdic-
tion proceedings for the civil enforcement, or to restrain violations, 
of sections 401,403(b), 403(c), 403(d), 403(e), 403(f), 403(g), 403(h), 403(i), 
403(k), 403(q), or 403(r) if the food that is the subject of the proceed-
ings is located in the State. 
"(2) No proceeding may be commenced by a State under para-
graph (D— 
"(A) before 30 days after the State has given notice to the 
Secretary that the State intends to bring such proceeding, 
"(B) before 90 days after the State has given notice to the 
Secretary of such intent if the Secretary has, within such 30 
days, commenced an informal or formal enforcement action 
pertaining to the food which would be the subject of such 
proceeding, or 
"(C) if the Secretary is diligently prosecuting a proceeding in 
court pertaining to such food, has settled such proceeding, or 
has settled the informal or formal enforcement action pertain-
ing to such food. 
In any court proceeding described in subparagraph (C), a State may 
intervene as a matter of right.", and 
(2) in the last sentence, by striking out "any such proceeding" 
and inserting in lieu thereof "any proceeding under this sec-
tion". 
SEC. 5. CONFORMING AMENDMENTS. 
(a) SECTION 405.—Section 405 (21 U.S.C. 345) is amended by adding 
at the end the following: "This section does not apply to the labeling 
requirements of sections 403(q) and 403(r).", 
(b) DRUGS.—Section 201(g)(1) (21 U.S.C. 321(g)(1)) is amended by 
adding at the end the following: "A food for which a claim, subject to 
sections 403(r)(l)(B) and 403(r)(3) or sections 403(r)(l)(B) and 
403(r)(5)(D), is made in accordance with the requirements of section 
403(r) is not a drug under clause (B) solely because the label or 
labeling contains such a claim.". 
SEC. 6. NATIONAL UNIFORM NUTRITION LABELING. 
(a) PREEMPTION.—Chapter IV is amended by adding after section 
403 the following new section: 
21 use 343-1. 
"SEC. 403A. (a) Except as provided in subsection (b), no State or 
political subdivision of a State may directly or indirectly establish 
under any authority or continue in effect as to any food in interstate 
commerce— 
"(1) any requirement for a food which is the subject of a 
standard of identity established under section 401 that is not 
identical to such standard of identity or that is not identical to 
the requirement of section 403(g), 
PUBLIC LAW 101-535—NOV. 8, 1990 
104 STAT. 2363 
"(2) any requirement for the labeling of food of the type 
required by section 408(c), 403(e), or 403(i)(2) that is not identical 
to the requirement of such section, 
"(3) any requirement for the labeling of food of the type 
required by section 403(b), 403(d), 403(f), 403(h), 403(i)(l), or 
403(k) that is not identical to the requirement of such section, 
"(4) any requirement for nutrition labeling of food that is not 
identical to the requirement of section 403(q), except a require-
ment for nutrition labeling of food which is exempt under 
subclause (i) or (ii) of section 403(q)(5)(A), or 
"(5) any requirement respecting any claim of the type de-
scribed in section 403(r)(l) made in the label or labeling of food 
that is not identical to the requirement of section 403(r), except 
a requirement respecting a claim made in the label or labeling 
of food which is exempt under clause (B) of such section. 
Paragraph (3) shall take effect in accordance with section 6(b) of the 
Nutrition Labeling and Education Act of 1990. 
"(b) Upon petition of a State or a political subdivision of a State, 
the Secretary may exempt from subsection (a), under such condi-
tions £is may be prescribed by regulation, any State or local require-
ment that— 
"(1) would not cause any food to be in violation of any 
applicable requirement under Federal law, 
"(2) would not unduly burden interstate commerce, and 
"(3) is designed to address a particular need for information 
which need is not met by the requirements of the sections 
referred to in subsection (a).". 
(b) STUDY AND REGULATIONS.— 
21 use 343-1 
(1) For the purpose of implementing section 403A(a)(3), the 
Ocwemment 
Secretary of Health and Human Services shall enter into a 
contracts, 
contract with a public or nonprofit private entity to conduct a 
study o
f
— 
(A) State and local laws which require the labeling of food 
that is of the type required by sections 403(b), 403(d), 403(f), 
403(h), 403(i)(l), and 403(k) of the Federal Food, Drug, and 
Cosmetic Act, and 
(B) the sections of the Federal Food, Drug, and Cosmetic 
Act referred to in subparagraph (A) and the regulations 
issued by the Secretary to enforce such sections to deter-
mine whether such sections and regulations adequately 
implement the purposes of such sections. 
(2) The contract under paragraph (1) shall provide that the 
study required by such paragraph shall be completed within 6 
months of the date of the enactment of this Act. 
(3)(A) Within 9 months of the date of the enactment of this 
Act, the Secretary shall publish a proposed list of sections which 
are adequately being implemented by regulations as determined 
under paragraph (1)(B) and sections which are not adequately 
being implemented by regulations as so determined. After 
publication of the lists, the Secretary shall provide 60 days for 
comments on such lists. 
(B) Within 24 months of the date of the enactment of this Act, 
the Secretary shall publish a final list of sections which are 
adequately being implemented by regulations and a list of 
sections which are not adequately being implemented by regula-
tions. With respect to a section which is found by the Secretary 
to be adequately implemented, no State or political subdivision 
104 STAT. 2364 
PUBLIC LAW 101-535—NOV. 8, 1990 
of a State may establish or continue in effect as to any food in 
interstate commerce any requirement which is not identical to 
the requirement of such section. 
(C) Within 24 months of the date of the enactment of this Act, 
the Secretary shall publish proposed revisions to the regulations 
found to be inadequate under subparagraph (B) and within 30 
months of such date shall issue final revisions. Upon the effec-
tive date of such final revisions, no State or political subdivision 
may establish or continue in effect any requirement which is 
not identical to the requirement of the section which had its 
regulations revised in accordance with this subparagraph. 
(D)(i) If the Secretary does not issue a final list in accordance 
with subparagraph (B), the proposed list issued under subpara-
graph (A) shall be considered the final list and States and 
political subdivisions shall be preempted with respect to sec-
tions found to be adequate in such proposed list in accordance 
with subparagraph (B). 
(ii) If the Secretary does not issue final revisions of regula-
tions in accordance with subparagraph (C), the proposed revi-
sions issued under such subparagraph shall be considered the 
final revisions and States and political subdivisions shall be 
preempted with respect to sections the regulations of which are 
revised by the proposed revisions. 
(E) Subsection (b) of section 403A of the Federal Food, Drug, 
and Cosmetic Act shall apply with respect to the prohibition 
prescribed by subparagraphs (B) and (C). 
21 use 343-1 
(c) CONSTRUCTION.— 
(1) The Nutrition Labeling and Education Act of 1990 shall 
not be construed to preempt any provision of State law, unless 
such provision is expressly preempted under section 403A of the 
Federal Food, Drug, and Cosmetic Act. 
(2) The amendment made by subsection (a) and the provisions 
of subsection 0?) shall not be construed to apply to any require-
ment respecting a statement in the labeling of food that 
provides for a warning concerning the safety of the food or 
component of the food. 
(3) The amendment made by subsection (a), the provisions of 
subsection 0)) and paragraphs (1) and (2) of this subsection shall 
not be construed to affect preemption, express or implied, of any 
such requirement of a State or political subdivision, which may 
arise under the Constitution, any provision of the Federal Food, 
Drug, and Cosmetic Act not amended by subsection (a), any 
other Federal law, or any Federal regulation, order, or other 
final agency action reviewable under chapter 7 of title 5, United 
States Code. 
SEC. 7. INGREDIENTS. 
Section 403(i) (21 U.S.C. 343(i)) is amended— 
(1) by striking out "If it is not subject to par^raph (g) of this 
section unless" and inserting in lieu thereof "Unless", 
(2) by inserting before "; except" the following: "and if the 
food purports to be a beverage containing vegetable or fruit 
juice, a statement with appropriate prominence on the informa-
tion panel of the total percentage of such fruit or vegetable juice 
contained in the food", and 
(3) by striking out "colorings" and inserting in lieu thereof 
"colors not required to be certified under section 706(c)". 
note. 
PUBLIC LAW 101-535—NOV. 8, 1990 
104 STAT. 2365 
SEC. 8. STANDARD OF IDENTITY REGULATION. 
Section 701(e) (21 U.S.C. 371(e)) is amended by striking out "Any 
action for the issuance, amendment, or repeal of any regulation 
under section 401, 403(j), 404(a), 406, 501(b), or 502 (d) or (h) of this 
Act" and inserting in lieu thereof the following: "Any action for the 
issuance, amendment, or repeal of any regulation under section 
403(j), 404(a), 406, 5010)), or 502 (d) or (h) of this Act, and any action 
for the amendment or repeal of any definition and standard of 
identity under section 401 of this Act for any dairy product (includ-
ing products regulated under parts 131, 133 and 135 of title 21, Code 
of Federal Regulations) or maple sirup (regulated under section 
168.140 of title 21, Code of Federal Regulations). 
SEC. 9. CONSTRUCTION. 
21 USC 343 note. 
The amendments made by this Act shall not be construed to alter 
the authority of the Secretary of Health and Human Services and 
the Secretary of Agriculture under the Federal Food, Drug, and 
Cosmetic Act, the Federal Meat Inspection Act, the Poultry Prod-
ucts Inspection Act, and the Egg Products Inspection Act. 
SEC. 10. EFFECTIVE DATE. 
21 USC 343 note. 
(a) IN GENERAL.— 
(1) Except as provided in paragraph (2)— 
(A) the amendments made by section 2 shall take effect 6 
months after— 
(i) the date of the promulgation of all final regula-
tions required to implement section 403(q) of the Fed-
eral Food, Drug, and Cosmetic Act, or 
(ii) if such regulations are not promulgated, the date 
proposed regulations are to be considered as such final 
regulations, 
except that section 403(q)(4) of such Act shall take effect as 
prescribed by such section, 
(B) the amendments made by section 3 shall take effect 6 
months after— 
(i) the date of the promulgation of final regulations to 
implement section 403(r) of the Federal Food, Drug, 
and Cosmetic Act, or 
(ii) if such regulations are not promulgated, the date 
proposed regulations are to be considered as such final 
regulations, except that any person marketing a food 
the brand name of which contains a term defined by 
the Secretary under section 403(r)(2)(A)(i) of the Federal 
Food, Drug, and Cosmetic Act shall be given an addi-
tional 6 months to comply with section 3, 
(C) the amendments made by section 4 shall take effect 24 
months after the date of the enactment of this Act, and 
(D) the amendments made by section 5 shall take effect 
on the date the amendments made by section 3 take effect. 
(2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act 
(as added by section 2) shall not apply with respect to food 
which was labeled before the effective date of the amendments 
made by section 2 and section 403(r) of the Federal Food, Drug, 
and Cosmetic Act (as added by section 3) shall not apply 
with respect to food which was labeled before the effective date 
of the amendments made by section 3. 
note. 
104 STAT. 2366 
PUBLIC LAW 101-535—NOV. 8, 1990 
(3)(A) If the Secretary finds that a person who is subject to 
section 403(q)(4) of such Act is unable to comply with the 
requirements of such section upon the effective date of final 
regulations to implement section 403(q) of such Act or of pro-
posed regulations to be considered as such final regulations 
because the Secretary has not made available to such person the 
information required by such section, the Secretary shall delay 
the application of such section to such person for such time as 
the Secretary may require to provide such information. 
(B) If the Secretary finds that compliance with section 403(q) 
or 403(r)(2) of such Act would cause an undue economic hard-
ship, the Secretary may delay the application of such sections 
for no more than one year. 
21 use 343-1 
(b) SECTION 6.— 
(1) IN GENERAL.—Except as provided in paragraph (2), the 
amendments made by section 6 shall take effect— 
(A) with respect to a requirement of a State or political 
subdivision described in paragraph (1) of section 403A(a) of 
the Federal Food, Drug, and Cosmetic Act, on the date of 
the enactment of this Act, 
(B) with respect to a requirement of a State or political 
subdivision described in paragraph (2) of section 403A(a) of 
the Federal Food, Drug, and Cosmetic Act, one year after 
the date of the enactment of this Act, 
(C) with respect to a requirement of a State or political 
subdivision described in paragraph (3) of section 403A(a) of 
the Federal Food, Drug, and Cosmetic Act, as prescribed by 
section 6(b) of the Nutrition Labeling and Education Act of 
1990, 
(D) with respect to a requirement of a State or political 
subdivision described in paragraph (4) of section 403A(a) of 
the Federal Food, Drug, and Cosmetic Act, on the date 
regulations to implement section 403(q) of such Act take 
effect, and 
(E) with respect to a requirement of a State or political 
subdivision described in paragraph (5) of section 403A(a) of 
the Federal Food, Drug, and Cosmetic Act, on the date 
regulations to implement section 403(r) of such Act take 
effect. 
(2) EXCEPTION.—If a State or political subdivision submits a peti-
tion under section 403A(b) of the Federal Food, Drug, and Cosmetic 
Act for a requirement described in section 403A(a) of such Act 
within 18 months of the date of the enactment of this Act, para-
graphs (3) through (5) of such section 403A(a) shall not apply with 
respect to such State or political subdivision requirement until— 
PUBLIC LAW 101-535—NOV. 8, 1990 
104 STAT. 2367 
(1) 24 months after the date of the enactment of this Act, or 
(2) action on the petition, 
whichever occurs later. 
(c) SECTION 7.—The amendments made by section 7 shall take 
21 use 343 note, 
effect one year after the date of the enactment of this Act. 
Approved November 8, 1990. 
LEGISLATIVE HISTORY—H.R. 3562: 
HOUSE REPORTS: No. 101-538 (Comm. on Energy and Commerce). 
CONGRESSIONAL RECORD, Vol. 136 (1990): 
July 30, considered and passed House. 
Oct. 24, considered and passed Senate, amended. 
Oct. 26, House concurred in Senate amendments. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 26 (1990): 
Nov. 8, Presidential statement.