§ 343. Misbranded food

Pub. L. 101–535, § 3(b), Nov. 8, 1990, 104 Stat. 2360, as amended by Pub. L. 102–571, title II, § 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500, 4501, provided that: “(1)(A) Within 12 months of the date of the enactment of this Act [Nov. 8, 1990], the Secretary of Health and Human Services shall issue proposed regulations to implement section 403(r) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(r)], except that the Secretary shall issue, not later than June 15, 1993, proposed regulations that are applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances to implement such section. Such regulations—“(i) shall identify claims described in section 403(r)(1)(A) of such Act which comply with section 403(r)(2) of such Act, “(ii) shall identify claims described in section 403(r)(1)(B) of such Act which comply with section 403(r)(3) of such Act, “(iii) shall, in defining terms used to characterize the level of any nutrient in food under section 403(r)(2)(A)(i) 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(r)(2)(A)(i) of such Act, “(v) shall provide that if multiple claims subject to section 403(r)(1)(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)(2)(B) of such Act, “(vi) shall determine whether claims respecting the following 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(r)(1)(B) 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(r)(1)(A) of such Act to be made for butter, “(ix) may, in defining terms under section 403(r)(2)(A)(i), include similar terms which are commonly understood to have the same meaning, and “(x) shall establish, as required by section 403(r)(5)(D), 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)(5)(D) of such Act: folic acid and neural tube defects, antioxident [sic] 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 of this Act, the Secretary shall issue final regulations to implement section 403(r) of the Federal Food, Drug, and Cosmetic Act, except that the Secretary shall issue, not later than December 31, 1993, such a final regulation applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances..[sic] “(2) If the Secretary does not promulgate final regulations under paragraph (1)(B) upon the expiration of 24 months after the date of the enactment of this Act, the proposed regulations issued in accordance with paragraph (1)(A) shall be considered as the final regulations upon the expiration of such 24 months, except that the proposed regulations applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances shall not be considered to be final regulations until December 31, 1993. There shall be promptly published in the Federal Register notice of the new status of the proposed regulations [see 57 F.R. 56347].”

[For construction of amendment made by section 202(a)(2)(B) of Pub. L. 102–571 to section 3(b) of Pub. L. 101–535 set out above, see section 202(a)(2)(C) of Pub. L. 102–571 set out above following section 2(b) of Pub. L. 101–535.]

Compliance With Requirements in Effect Before Effective Date of Final Rule

Pub. L. 119–37, div. B, title VII, § 783, Nov. 12, 2025, 139 Stat. 561, provided that: “(a) During the period beginning on the effective date of the final rule entitled ‘Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” ’ published in the Federal Register by the Food and Drug Administration on December 27, 2024 (89 Fed. Reg. 106064 et seq.) and ending on the compliance date specified in such final rule (referred to in this section as the ‘compliance period’), a manufacturer may also continue to comply with the requirements in effect on the day before such effective date relating to an implied nutrient content claim of ‘healthy’ made with respect to a food. “(b) In the case of a food that bears labeling making an implied nutrition content claim that the food is ‘healthy’ during the compliance period, the manufacturer of the food shall not be directly or indirectly subject to any State law requirement relating to labeling making an implied nutrient content claim that a food is ‘healthy’ during such period that is not identical to either—“(1) the Federal requirements for labeling to make an implied nutrition content claim that a food is ‘healthy’ that were in effect on the day before the effective date of such final rule; or “(2) the updated Federal requirements specified in the final rule for such a claim.”

Labeling Exemption for Single Ingredient Foods and Products

Pub. L. 115–334, title XII, § 12516, Dec. 20, 2018, 132 Stat. 5000, provided that: “The food labeling requirements under section 403(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar, honey, agave, or syrup, including maple syrup, that is packaged and offered for sale as a single-ingredient food bear the declaration ‘Includes X g Added Sugars.’.”

Findings

Pub. L. 108–282, title II, § 202, Aug. 2, 2004, 118 Stat. 905, provided that: “Congress finds that— “(1) it is estimated that—“(A) approximately 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies; and “(B) each year, roughly 30,000 individuals require emergency room treatment and 150 individuals die because of allergic reactions to food; “(2)(A) eight major foods or food groups—milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans—account for 90 percent of food allergies; “(B) at present, there is no cure for food allergies; and “(C) a food allergic consumer must avoid the food to which the consumer is allergic; “(3)(A) in a review of the foods of randomly selected manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin in 1999, the Food and Drug Administration found that 25 percent of sampled foods failed to list peanuts or eggs as ingredients on the food labels; and “(B) nationally, the number of recalls because of unlabeled allergens rose to 121 in 2000 from about 35 a decade earlier; “(4) a recent study shows that many parents of children with a food allergy were unable to correctly identify in each of several food labels the ingredients derived from major food allergens; “(5)(A) ingredients in foods must be listed by their ‘common or usual name’; “(B) in some cases, the common or usual name of an ingredient may be unfamiliar to consumers, and many consumers may not realize the ingredient is derived from, or contains, a major food allergen; and “(C) in other cases, the ingredients may be declared as a class, including spices, flavorings, and certain colorings, or are exempt from the ingredient labeling requirements, such as incidental additives; and “(6)(A) celiac disease is an immune-mediated disease that causes damage to the gastrointestinal tract, central nervous system, and other organs; “(B) the current recommended treatment is avoidance of glutens in foods that are associated with celiac disease; and “(C) a multicenter, multiyear study estimated that the prevalence of celiac disease in the United States is 0.5 to 1 percent of the general population.”

Rulemakings on Labeling

Pub. L. 118–42, div. B, title VII, § 745, Mar. 9, 2024, 138 Stat. 112, provided that: “(a) After the effective date of any final rule the Food and Drug Administration (FDA) publishes in connection with its proposed rule to update these requirements (87 Federal Register 59168, issued on September 29, 2022), manufacturers may also continue to comply with the previous requirements promulgated by the FDA for the implied nutrient content claim ‘healthy’ through the ‘compliance date’ FDA provides in the final rule. “(b) Any food product manufactured and labeled as ‘healthy’ during the compliance period FDA provides in that final rule shall not be directly or indirectly subject to any state-law requirements that are not identical to either (i) the Federal requirements for the implied nutrition content claim ‘healthy’ that were in effect as of the date FDA issues the final rule, or (ii) the updated Federal requirements that FDA promulgates in the final rule, assuming the updated requirements go into effect during the regulatory compliance period.”

Pub. L. 108–282, title II, § 206, Aug. 2, 2004, 118 Stat. 910, provided that: “Not later than 2 years after the date of enactment of this Act [Aug. 2, 2004], the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, shall issue a proposed rule to define, and permit use of, the term ‘gluten-free’ on the labeling of foods. Not later than 4 years after the date of enactment of this Act, the Secretary shall issue a final rule to define, and permit use of, the term ‘gluten-free’ on the labeling of foods.”

Pub. L. 107–171, title X, § 10809, May 13, 2002, 116 Stat. 531, provided that: “The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall publish a proposed rule and, with due consideration to public comment, a final rule to revise, as appropriate, the current regulation governing the labeling of foods that have been treated to reduce pest infestation or pathogens by treatment by irradiation using radioactive isotope, electronic beam, or x-ray. Pending promulgation of the final rule required by this subsection [probably should be “this section”], any person may petition the Secretary for approval of labeling, which is not false or misleading in any material respect, of a food which has been treated by irradiation using radioactive isotope, electronic beam, or x-ray. The Secretary shall approve or deny such a petition within 180 days of receipt of the petition, or the petition shall be deemed denied, except to the extent additional agency review is mutually agreed upon by the Secretary and the petitioner. Any denial of a petition under this subsection shall constitute final agency action subject to judicial review by the United States Court of Appeals for the District of Columbia Circuit. Any labeling approved through the foregoing petition process shall be subject to the provisions of the final rule referred to in the first sentence of the subparagraph on the effective date of such final rule.”

Commission on Dietary Supplement Labels

Pub. L. 103–417, § 12, Oct. 25, 1994, 108 Stat. 4332, provided that: “(a) Establishment.—There shall be established as an independent agency within the executive branch a commission to be known as the Commission on Dietary Supplement Labels (hereafter in this section referred to as the ‘Commission’). “(b) Membership.—“(1) Composition.—The Commission shall be composed of 7 members who shall be appointed by the President. “(2) Expertise requirement.—The members of the Commission shall consist of individuals with expertise and experience in dietary supplements and in the manufacture, regulation, distribution, and use of such supplements. At least three of the members of the Commission shall be qualified by scientific training and experience to evaluate the benefits to health of the use of dietary supplements and one of such three members shall have experience in pharmacognosy, medical botany, traditional herbal medicine, or other related sciences. Members and staff of the Commission shall be without bias on the issue of dietary supplements. “(c) Functions of the Commission.—The Commission shall conduct a study on, and provide recommendations for, the regulation of label claims and statements for dietary supplements, including the use of literature in connection with the sale of dietary supplements and procedures for the evaluation of such claims. In making such recommendations, the Commission shall evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families. “(d) Administrative Powers of the Commission.—“(1) Hearings.—The Commission may hold hearings, sit and act at such times and places, take such testimony, and receive such evidence as the Commission considers advisable to carry out the purposes of this section. “(2) Information from federal agencies.—The Commission may secure directly from any Federal department or agency such information as the Commission considers necessary to carry out the provisions of this section. “(3) Authorization of appropriations.—There are authorized to be appropriated such sums as may be necessary to carry out this section. “(e) Reports and Recommendations.—“(1) Final report required.—Not later than 24 months after the date of enactment of this Act [Oct. 25, 1994], the Commission shall prepare and submit to the President and to the Congress a final report on the study required by this section. “(2) Recommendations.—The report described in paragraph (1) shall contain such recommendations, including recommendations for legislation, as the Commission deems appropriate. “(3) Action on recommendations.—Within 90 days of the issuance of the report under paragraph (1), the Secretary of Health and Human Services shall publish in the Federal Register a notice of any recommendation of Commission for changes in regulations of the Secretary for the regulation of dietary supplements and shall include in such notice a notice of proposed rulemaking on such changes together with an opportunity to present views on such changes. Such rulemaking shall be completed not later than 2 years after the date of the issuance of such report. If such rulemaking is not completed on or before the expiration of such 2 years, regulations of the Secretary published in 59 FR 395–426 on January 4, 1994, shall not be in effect.”

Extension of Compliance Deadline for Certain Food Products Packaged Prior to August 8, 1994

Pub. L. 103–261, May 26, 1994, 108 Stat. 705, provided: “That before August 8, 1994, sections 403(q) and 403(r)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q), (r)(2)] and the provision of section 403(i) of such Act added by section 7(2) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535], shall not apply with respect to a food product which is contained in a package for which the label was printed before May 8, 1994 (or before August 8, 1994, in the case of a juice or milk food product if the person responsible for the labeling of such food product exercised due diligence in obtaining before such date labels which are in compliance with such sections 403(q) and 403(r)(2) and such provision of section 403(i)), if, before June 15, 1994, the person who introduces or delivers for introduction such food product into interstate commerce submits to the Secretary of Health and Human Services a certification that such person will comply with this section and will comply with such sections 403(q) and 403(r)(2) and such provision of section 403(i) after August 8, 1994.”

Limitations on Application of Small Business Exemption

Pub. L. 103–80, § 2(a), Aug. 13, 1993, 107 Stat. 773, provided that: “(1) Before may 8, 1995.—Before May 8, 1995, the exemption provided by section 403(q)(5)(D) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(D)] shall be available in accordance with the regulations of the Secretary of Health and Human Services published at 21 C.F.R. 101.9(j)(1)(i)(1993). “(2) After may 8, 1995.—After May 8, 1995, the exemption provided by section 403(q)(5)(D) of the Federal Food, Drug, and Cosmetic Act shall only be available with respect to food when it is sold to consumers.”

Prohibition on Implementation of Pub. L. 101–535 With Respect to Dietary Supplements

Pub. L. 102–571, title II, § 202(a)(1), Oct. 29, 1992, 106 Stat. 4500, provided that: “Notwithstanding any other provision of law and except as provided in subsection (b) [set out as a note below] and in the amendment made by paragraph (2)(A) [amending provisions set out as notes above], the Secretary of Health and Human Services may not implement the Nutrition Labeling and Education Act of 1990 (Public Law 101–535; 104 Stat. 2353) [see Short Title of 1990 Amendments note set out under section 301 of this title], or any amendment made by such Act, earlier than December 15, 1993, with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances.”

Health Claims Made With Respect to Dietary Supplements

Pub. L. 102–571, title II, § 202(b), Oct. 29, 1992, 106 Stat. 4501, provided that: “Notwithstanding section 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(5)(D)) and subsection (a) [enacting provisions set out as notes above and amending provisions set out as notes above and under section 343–1 of this title], the Secretary of Health and Human Services may, earlier than December 15, 1993, approve claims made with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances that are claims described in clauses (vi) and (x) of section 3(b)(1)(A) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535] (21 U.S.C. 343 note).”

United States Recommended Daily Allowances of Vitamins or Minerals

Pub. L. 102–571, title II, § 203, Oct. 29, 1992, 106 Stat. 4502, provided that: “Notwithstanding any other provision of Federal law, no regulations that require the use of, or are based upon, recommended daily allowances of vitamins or minerals may be promulgated before November 8, 1993 (other than regulations establishing the United States recommended daily allowances specified at section 101.9(c)(7)(iv) of title 21, Code of Federal Regulations, as in effect on October 6, 1992, or regulations under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(1)(A)) that are based on such recommended daily allowances).”

Consumer Education

Pub. L. 101–535, § 2(c), Nov. 8, 1990, 104 Stat. 2357, provided that: “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.”

Studies Concerning Carcinogenic and Other Toxic Substances in Food and Impurities in and Toxicity of Saccharin

Pub. L. 95–203, § 2, Nov. 23, 1977, 91 Stat. 1451, directed Secretary of Health, Education, and Welfare to conduct a study concerning carcinogenic and other toxic substances in food and impurities in and toxicity of saccharin and make a report respecting the carcinogenic and other substances to Committee on Human Resources of the Senate within 12 months of Nov. 23, 1977, and a report respecting saccharin to such committee within 15 months of Nov. 23, 1977.

Report to Congressional Committees Respecting Action Taken Pursuant to Former Par. (o)(2)

Pub. L. 95–203, § 4(a)(3), Nov. 23, 1977, 91 Stat. 1453, provided that the Secretary was to report to specified congressional committees any action taken under former par. (o)(2) of this section.

State or Territorial Requirements

Pub. L. 86–537, § 2, June 29, 1960, 74 Stat. 251, provided that: “Nothing in the amendments made by the first section of this Act [amending this section] shall affect any requirement of the laws of any State or Territory.”

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.