2010—Par. (q)(5)(A)(i). Pub. L. 111–148, § 4205(a)(1), inserted “except as provided in clause (H)(ii)(III),” before “which is served”.
Par. (q)(5)(A)(ii). Pub. L. 111–148, § 4205(a)(2), inserted “except as provided in clause (H)(ii)(III),” before “which is processed”.
Par. (q)(5)(H). Pub. L. 111–148, § 4205(b), added cl. (H).
2006—Par. (y). Pub. L. 109–462 added par. (y).
2004—Pars. (w), (x). Pub. L. 108–282 added pars. (w) and (x).
2002—Par. (h). Pub. L. 107–171, § 10808(b), added subpar. (3) and concluding provisions.
Par. (t). Pub. L. 107–171, § 10806(a)(2), added par. (t).
Par. (u). Pub. L. 107–171, § 10806(b)(2), added par. (u).
Par. (v). Pub. L. 107–188 added par. (v).
2000—Par. (o). Pub. L. 106–554, which directed repeal of section 403(o) of the Food, Drug, and Cosmetic Act, was executed by repealing par. (o) of this section, which is section 403 of the Federal Food, Drug, and Cosmetic Act, to reflect the probable intent of Congress. Prior to repeal, par. (o) provided that a food containing saccharin was to be deemed misbranded unless a specified warning statement was placed in a conspicuous place on its label.
1997—Par. (r)(2)(B). Pub. L. 105–115, § 305, amended cl. (B) generally. Prior to amendment, cl. (B) read as follows: “If a claim described in subparagraph (1)(A) 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—
“(i) the blank shall identify the panel on which the information 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.”
Par. (r)(2)(G), (H). Pub. L. 105–115, § 304, added cls. (G) and (H).
Par. (r)(3)(C), (D). Pub. L. 105–115, § 303, added cls. (C) and (D).
Par. (r)(4)(A)(i). Pub. L. 105–115, § 302, inserted after second sentence “If the Secretary does not act within such 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner.”, inserted “or the petition is deemed to be denied” after “If the Secretary denies the petition”, and inserted at end “If the Secretary does not act within such 90 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner. If the Secretary issues a proposed regulation, the rulemaking shall be completed within 540 days of the date the petition is received by the Secretary. If the Secretary does not issue a regulation within such 540 days, the Secretary shall provide the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate the reasons action on the regulation did not occur within such 540 days.”
Par. (r)(7). Pub. L. 105–115, § 301, added subpar. (7).
1996—Par. (p). Pub. L. 104–124 struck out par. (p), which deemed products containing saccharin and offered for sale, but not for immediate consumption, by retail establishment, to be misbranded, unless notice of information required by subsec. (o) was provided by manufacturer and prominently displayed near product.
1994—Par. (q)(5)(F). Pub. L. 103–417, § 7(b), amended cl. (F) generally. Prior to amendment, cl. (F) read as follows: “If a food to which section 350 of this title applies (as defined in section 350(c) of this title) contains one or more of the nutrients required by subparagraph (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 subparagraphs (1) and (2) in a manner which is appropriate for such food and which is specified in regulations of the Secretary.”
Par. (r)(2)(F). Pub. L. 103–417, § 7(c), added cl. (F).
Par. (r)(6). Pub. L. 103–417, § 6, added subpar. (6).
Par. (s). Pub. L. 103–417, § 10(c), inserted at end: “A dietary supplement shall not be deemed misbranded solely because its label or labeling contains directions or conditions of use or warnings.”
Pub. L. 103–417, § 7(a), added par. (s).
1993—Par. (e). Pub. L. 103–80, § 3(j)(1), substituted “count, except that” for “count: Provided, That”.
Par. (i). Pub. L. 103–80, § 3(j)(2), substituted “unless sold as spices, flavorings, or such colors” for “, other than those sold as such” and “naming each. To the extent” for “naming each: Provided, That, to the extent”.
Par. (k). Pub. L. 103–80, § 3(j)(3), substituted “, except that” for “: Provided, That”.
Par. (l). Pub. L. 103–80, § 3(j)(4), substituted “chemical, except that” for “chemical: Provided, however, That”.
Par. (q)(5)(E) to (G). Pub. L. 103–80, § 2(b), added cl. (E) and redesignated former cls. (E) and (F) as (F) and (G), respectively.
Par. (r)(1)(B). Pub. L. 103–80, § 3(j)(5), substituted “(5)(D)” for “5(D)”.
Par. (r)(4)(B). Pub. L. 103–80, § 3(j)(6), substituted “paragraph” for “subsection”.
1992—Par. (i). Pub. L. 102–571, § 107(5), substituted “379e(c)” for “376(c)”.
Par. (m). Pub. L. 102–571, § 107(6), substituted “379e” for “376”.
1991—Par. (i). Pub. L. 102–108, § 2(c), amended directory language of Pub. L. 101–535, § 7(1), (3). See 1990 Amendment note below.
Par. (q)(4)(A). Pub. L. 102–108, § 2(a), substituted “(D)” for “(C)”.
1990—Par. (i). Pub. L. 101–535, § 7, as amended by Pub. L. 102–108, § 2(c), substituted “Unless” for “If it is not subject to the provisions of paragraph (g) unless”, inserted “and if the food purports to be a beverage containing vegetable or fruit juice, a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food”, and substituted “colors not required to be certified under section 376(c) of this title” for “colorings” the first time appearing.
Par. (q). Pub. L. 101–535, § 2(a), added par. (q).
Par. (r). Pub. L. 101–535, § 3(a), added par. (r).
1977—Par. (o). Pub. L. 95–203, § 4(a)(1), added par. (o).
Par. (p). Pub. L. 95–203, § 4(b)(1), added par. (p).
1976—Par. (a). Pub. L. 94–278 inserted “(1)” after “If” and inserted “, or (2) in the case of a food to which section 350 of this title applies, its advertising is false or misleading in a material respect or its labeling is in violation of section 350(b)(2) of this title” after “any particular”.
1970—Par. (n). Pub. L. 91–601 added par. (n).
1960—Par. (k). Pub. L. 86–537, § 1(1), exempted pesticide chemicals when used in or on a raw agricultural commodity which is the produce of the soil.
Par. (l). Pub. L. 86–537, § 1(2), added par. (l).
Par. (m). Pub. L. 86–618 added par. (m).
Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress,
Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress,
Pub. L. 109–462, § 3(d)(1), (2), “(1) Except as provided in paragraph (2), the amendments made by this section [enacting section 379aa–1 of this title and amending this section and section 331 of this title] shall take effect 1 year after the date of enactment of this Act [“(2) Section 403(y) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(y)] (as added by this section) shall apply to any dietary supplement labeled on or after the date that is 1 year after the date of enactment of this Act [
Amendment by Pub. L. 108–282 applicable to any food that is labeled on or after
Amendment by Pub. L. 105–115 effective 90 days after
Pub. L. 103–417, § 7(e), “(1) may be labeled after the date of the enactment of this Act [“(2) shall be labeled after
Pub. L. 101–535, § 10(a), “(1) Except as provided in paragraph (2)—“(A) the amendments made by section 2 [amending this section] shall take effect 6 months after—“(i) the date of the promulgation of all final regulations required to implement section 403(q) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)], 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 [amending this section] 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 [“(C) the amendments made by section 4 [amending section 337 of this title] shall take effect 24 months after the date of the enactment of this Act [“(D) the amendments made by section 5 [amending sections 321 and 345 of this title] 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.“(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 proposed 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 hardship, the Secretary may delay the application of such sections for no more than one year.”
Pub. L. 101–535, § 10(c), “(1) Except as provided in paragraphs (2) and (3), the amendments made by section 7 [amending this section] shall take effect one year after the date of the enactment of this Act [“(2)(A) If a food subject to section 403(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(g)] or a food with one or more colors required to be certified under section 721(c) [of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 379e(c)] bears a label which was printed before “(B) If a food described in subparagraph (A)—“(i) bears a label which was printed after “(ii) meets the requirements of the proposed regulation of the Secretary of Health and Human Services published in 56 Fed. Reg. 28592–28636 (such food shall not be subject to the amendments made by section 7(1) and section 7(3) [amending this section].“(3) A food purported to be a beverage containing a vegetable or fruit juice which bears a label attached to the food before
Pub. L. 95–203, § 4(a)(2),
Pub. L. 95–203, § 4(b)(2),
Amendment by Pub. L. 94–278 effective 180 days after
Amendment by Pub. L. 91–601 effective
Amendment by Pub. L. 86–618 effective
Subsecs. (e)(1) and (g) to (k) effective
Pub. L. 111–148, title IV, § 4205(d), “(1) to preempt any provision of State or local law, unless such provision establishes or continues into effect nutrient content disclosures of the type required under section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)] (as added by subsection (b)) and is expressly preempted under subsection (a)(4) of such section;“(2) to apply to any State or local requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food; or“(3) except as provided in section 403(q)(5)(H)(ix) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)(ix)] (as added by subsection (b)), to apply to any restaurant or similar retail food establishment other than a restaurant or similar retail food establishment described in section 403(q)(5)(H)(i) of such Act [21 U.S.C. 343(q)(5)(H)(i)].”
Pub. L. 108–282, title II, § 203(b),
Nothing in amendment by Pub. L. 107–188 to be construed to limit authority of Secretary of Health and Human Services or Secretary of the Treasury to require marking of articles of food imported or offered for import into the United States which are refused admission, see section 308(c) of Pub. L. 107–188, set out as a note under section 381 of this title.
Pub. L. 101–535, § 9,
Pub. L. 101–535, § 2(b), “(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 [21 U.S.C. 343(q)] within 12 months after the date of the enactment of this Act [“(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 understand 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 nutrition information which is in addition to the information 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 nutritional value.“(2) If the Secretary of Health and Human Services does not promulgate final regulations under paragraph (1) upon the expiration of 24 months after the date of the enactment of this Act, the proposed regulations issued in accordance with paragraph (1) 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 “(3) If the Secretary of Health and Human Services does not promulgate final regulations under section 403(q)(4) of the Federal 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)(4)(C) 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.”
[Pub. L. 102–571, title II, § 202(a)(2)(C),
Pub. L. 101–535, § 3(b), “(1)(A) Within 12 months of the date of the enactment of this Act [“(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 “(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
[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.]
Pub. L. 115–334, title XII, § 12516,
Pub. L. 108–282, title II, § 202, “(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.”
Pub. L. 118–42, div. B, title VII, § 745, “(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 “(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,
Pub. L. 107–171, title X, § 10809,
Pub. L. 103–417, § 12, “(a) 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) “(1) The Commission shall be composed of 7 members who shall be appointed by the President.“(2) 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) 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) “(1) 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) 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) There are authorized to be appropriated such sums as may be necessary to carry out this section.“(e) “(1) Not later than 24 months after the date of enactment of this Act [“(2) The report described in paragraph (1) shall contain such recommendations, including recommendations for legislation, as the Commission deems appropriate.“(3) 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
Pub. L. 103–261,
Pub. L. 103–80, § 2(a), “(1) Before “(2) After
Pub. L. 102–571, title II, § 202(a)(1),
Pub. L. 102–571, title II, § 202(b),
Pub. L. 102–571, title II, § 203,
Pub. L. 101–535, § 2(c), “(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.”
Pub. L. 95–203, § 2,
Pub. L. 95–203, § 4(a)(3),
Pub. L. 86–537, § 2,
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.