Source: https://www.law.cornell.edu/uscode/text/21/343
Timestamp: 2016-05-27 16:43:59
Document Index: 801409837

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21 U.S. Code § 343 - Misbranded food | US Law | LII / Legal Information Institute
Misbranded foodA food shall be deemed to be misbranded—
(h) Representation as to standards of quality and fill of containerIf it purports to be or is represented as—
(i) such food has been subjected to a safe process or treatment that—
Unless its label bears (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient 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; except that spices, flavorings, and colors not required to be certified under section 379e(c) of this title [1] unless sold as spices, flavorings, or such colors, may be designated as spices, flavorings, and colorings without naming each. To the extent that compliance with the requirements of clause (2) of this paragraph is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary.
(o) Repealed. Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73
(p) Repealed. Pub. L. 104–124, § 1, Apr. 1, 1996, 110 Stat. 882
(i) Upon the expiration of 12 months after November 8, 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 subparagraphs (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—
(A) Subparagraphs (1), (2), (3), and (4) shall not apply to food—
which is a medical food as defined in section 360ee(b) of this title, or
which is described in section 345(2) of this title.
(i) During the 12-month period for which 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)General requirements for restaurants and similar retail food establishments.—
Except for food described in subclause (vii), in the case of food that is a standard menu item that is offered for sale in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items, the restaurant or similar retail food establishment shall disclose the information described in subclauses (ii) and (iii).
(ii)Information required to be disclosed by restaurants and retail food establishments.—Except as provided in subclause (vii), the restaurant or similar retail food establishment shall disclose in a clear and conspicuous manner—
(iii)Self-service food and food on display.—
Except as provided in subclause (vii), in the case of food sold at a salad bar, buffet line, cafeteria line, or similar self-service facility, and for self-service beverages or food that is on display and that is visible to customers, a restaurant or similar retail food establishment shall place adjacent to each food offered a sign that lists calories per displayed food item or per serving.
(iv)Reasonable basis.—
For the purposes of this clause, a restaurant or similar retail food establishment shall have a reasonable basis for its nutrient content disclosures, including nutrient databases, cookbooks, laboratory analyses, and other reasonable means, as described in section 101.10 of title 21, Code of Federal Regulations (or any successor regulation) or in a related guidance of the Food and Drug Administration.
(v)Menu variability and combination meals.—
(vi)Additional information.—
If the Secretary determines that a nutrient, other than a nutrient required under subclause (ii)(III), should be disclosed for the purpose of providing information to assist consumers in maintaining healthy dietary practices, the Secretary may require, by regulation, disclosure of such nutrient in the written form required under subclause (ii)(III).
(I)In general.—Subclauses (i) through (vi) do not apply to—
(II)Written forms.—
Subparagraph (5)(C) shall apply to any regulations promulgated under subclauses (ii)(III) and (vi).
(I)In general.—In the case of an article of food sold from a vending machine that—
An authorized official of any restaurant or similar retail food establishment or vending machine operator not subject to the requirements of this clause may elect to be subject to the requirements of such clause, by registering biannually the name and address of such restaurant or similar retail food establishment or vending machine operator with the Secretary, as specified by the Secretary by regulation.
(II)Registration.—
Within 120 days of March 23, 2010, the Secretary shall publish a notice in the Federal Register specifying the terms and conditions for implementation of item (I), pending promulgation of regulations.
(III)Rule of construction.—
Nothing in this subclause shall be construed to authorize the Secretary to require an application, review, or licensing process for any entity to register with the Secretary, as described in such item.
(I)Proposed regulation.—
Not later than 1 year after March 23, 2010, the Secretary shall promulgate proposed regulations to carry out this clause.
(II)Contents.—In promulgating regulations, the Secretary shall—
(III)Reporting.—
The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a quarterly report that describes the Secretary’s progress toward promulgating final regulations under this subparagraph.
(xi)Definition.—
In this clause, the term “menu” or “menu board” means the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection.
(A) Except as provided in subparagraphs (4)(A)(ii) and (4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a claim described in subparagraph (1)(A)—
If a claim described in subparagraph (1)(A) is made with respect to a nutrient in a food and the Secretary makes a determination that the food contains a nutrient at a level that increases to persons in the general population the risk of a disease or health-related condition that is diet related, the label or labeling of such food shall contain, prominently and in immediate proximity to such claim, the following statement: “See nutrition information for ___ content.” The blank shall identify the nutrient associated with the increased disease or health-related condition risk. In making the determination described in this clause, the Secretary shall take into account the significance of the food in the total daily diet.
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 paragraph (a).
a person has submitted to the Secretary, at least 120 days (during which the Secretary may notify any person who is making a claim as authorized by clause (C) that such person has not submitted all the information required by such clause) before the first introduction into interstate commerce of the food with a label containing the claim, (I) a notice of the claim, which shall include the exact words used in the claim and shall include a concise description of the basis upon which such person relied for determining that the requirements of subclause (i) have been satisfied, (II) a copy of the statement referred to in subclause (i) upon which such person relied in making the claim, and (III) a balanced representation of the scientific literature relating to the nutrient level to which the claim refers;
the claim and the food for which the claim is made are in compliance with clauses (A) and (B), and are otherwise in compliance with paragraph (a) and section 321(n) of this title; and
(A) Except as provided in subparagraph (5), a claim described in subparagraph (1)(B) may only be made—
a person has submitted to the Secretary, at least 120 days (during which the Secretary may notify any person who is making a claim as authorized by clause (C) that such person has not submitted all the information required by such clause) before the first introduction into interstate commerce of the food with a label containing the claim, (I) a notice of the claim, which shall include the exact words used in the claim and shall include a concise description of the basis upon which such person relied for determining that the requirements of subclause (i) have been satisfied, (II) a copy of the statement referred to in subclause (i) upon which such person relied in making the claim, and (III) a balanced representation of the scientific literature relating to the relationship between a nutrient and a disease or health-related condition to which the claim refers;
the claim and the food for which the claim is made are in compliance with clause (A)(ii) and are otherwise in compliance with paragraph (a) and section 321(n) of this title; and
This paragraph does not apply to infant formulas subject to section 350a(h) of this title and medical foods as defined in section 360ee(b) of this title.
(s) Dietary supplementsIf—
(A) the label or labeling of the supplement fails to list—
the name of each ingredient of the supplement that is described in section 321(ff) of this title; and
the supplement contains an ingredient described in section 321(ff)(1)(C) of this title, and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived;
(v) Failure to label; health threat If—
it fails to bear a label required by the Secretary under section 381(n)(1) of this title (relating to food refused admission into the United States);
the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen under section 321(qq)(2)(A) or (B) of this title.
As used in this subsection, the term “name of the food source from which the major food allergen is derived” means the name described in section 321(qq)(1) of this title; provided that in the case of a tree nut, fish, or Crustacean shellfish, the term “name of the food source from which the major food allergen is derived” means the name of the specific type of nut or species of fish or Crustacean shellfish.
Any person may petition the Secretary to exempt a food ingredient described in section 321(qq)(2) of this title from the allergen labeling requirements of this subsection.
(A) A person need not file a petition under paragraph (6) to exempt a food ingredient described in section 321(qq)(2) of this title from the allergen labeling requirements of this subsection, if the person files with the Secretary a notification containing—
(June 25, 1938, ch. 675, § 403, 52 Stat. 1047; Pub. L. 86–537, § 1, June 29, 1960, 74 Stat. 251; Pub. L. 86–618, title I, § 102(a)(3), July 12, 1960, 74 Stat. 398; Pub. L. 91–601, § 6(c), formerly § 7(c), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, § 1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 94–278, title V, § 502(a)(1), Apr. 22, 1976, 90 Stat. 411; Pub. L. 95–203, § 4(a)(1), (b)(1), Nov. 23, 1977, 91 Stat. 1452, 1453; Pub. L. 101–535, §§ 2(a), 3(a), 7, Nov. 8, 1990, 104 Stat. 2353, 2357, 2364; Pub. L. 102–108, § 2(a), (c), Aug. 17, 1991, 105 Stat. 549; Pub. L. 102–571, title I, § 107(5), (6), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §§ 2(b), 3(j), Aug. 13, 1993, 107 Stat. 773, 776; Pub. L. 103–417, §§ 6, 7(a)–(c), 10(c), Oct. 25, 1994, 108 Stat. 4329, 4330, 4332; Pub. L. 104–124, § 1, Apr. 1, 1996, 110 Stat. 882; Pub. L. 105–115, title III, §§ 301–305, Nov. 21, 1997, 111 Stat. 2350–2353; Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73; Pub. L. 107–171, title X, §§ 10806(a)(2), (b)(2), 10808(b), May 13, 2002, 116 Stat. 526, 527, 530; Pub. L. 107–188, title III, § 308(b), June 12, 2002, 116 Stat. 672; Pub. L. 108–282, title II, § 203(a), Aug. 2, 2004, 118 Stat. 906; Pub. L. 109–462, § 3(c), Dec. 22, 2006, 120 Stat. 3475; Pub. L. 111–148, title IV, § 4205(a), (b), Mar. 23, 2010, 124 Stat. 573.)
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).
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).
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—
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).
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”.
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).
Pub. L. 109–462, § 3(d)(1), (2), Dec. 22, 2006, 120 Stat. 3475, provided that:
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 [Dec. 22, 2006].
“(2)Misbranding.—
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 [Dec. 22, 2006].”
Pub. L. 103–417, § 7(e), Oct. 25, 1994, 108 Stat. 4331, provided that: “Dietary supplements—
may be labeled after the date of the enactment of this Act [Oct. 25, 1994] in accordance with the amendments made by this section [amending this section and section 350 of this title], and
shall be labeled after December 31, 1996, in accordance with such amendments.”
Pub. L. 101–535, § 10(a), Nov. 8, 1990, 104 Stat. 2365, as amended by Pub. L. 102–571, title II, § 202(a)(3), Oct. 29, 1992, 106 Stat. 4501, provided that:
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
if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations [Nov. 8, 1992, see 57 F.R. 56347],
the date of the promulgation of final regulations to implement section 403(r) of the Federal Food, Drug, and Cosmetic Act, or
if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations [Nov. 8, 1992, see 57 F.R. 56347], 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 additional 6 months to comply with section 3,
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 [Nov. 8, 1990], except that such amendments shall take effect with respect to such dietary supplements [probably means dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances, see section 202(a)(1) of Pub. L. 102–571, set out below] on December 31, 1993, and
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.
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.
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.
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), Nov. 8, 1990, 104 Stat. 2367, as amended by Pub. L. 102–108, § 1, Aug. 17, 1991, 105 Stat. 549; Pub. L. 102–571, title I, § 107(17), Oct. 29, 1992, 106 Stat. 4500, provided that:
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 [Nov. 8, 1990].
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 July 1, 1991, and which is attached to the food before May 8, 1993, such food shall not be subject to the amendments made by section 7(1) and section 7(3) [amending this section].
bears a label which was printed after July 1, 1991, but before the date the proposed regulation described in clause (ii) takes effect as a final regulation and which was attached to the food before May 8, 1993, and
meets the requirements of the proposed regulation of the Secretary of Health and Human Services published in 56 Fed. Reg. 28592–28636 (June 21, 1991) as it pertains to the amendments made by this Act [see Short Title of 1990 Amendment note set out under section 301 of this title],
A food purported to be a beverage containing a vegetable or fruit juice which bears a label attached to the food before May 8, 1993, shall not be subject to the amendments made by section 7(2) [amending this section].”
Pub. L. 95–203, § 4(a)(2), Nov. 23, 1977, 91 Stat. 1453, provided that: “The amendment made by paragraph (1) [amending this section] shall apply only with respect to food introduced or delivered for introduction in interstate commerce on and after the 90th day after the date of the enactment of this Act [Nov. 23, 1977].”
Pub. L. 95–203, § 4(b)(2), Nov. 23, 1977, 91 Stat. 1453, provided that: “The amendment made by paragraph (1) [amending this section] shall apply with respect to food which is sold in retail establishments on or after the 90th day after the effective date of the regulations of the Secretary of Health, Education, and Welfare [now Secretary of Health and Human Services] under paragraph (p)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(p)(4)].”
Pub. L. 111–148, title IV, § 4205(d), Mar. 23, 2010, 124 Stat. 576, provided that: “Nothing in the amendments made by this section [amending this section and section 343–1 of this title] shall be construed—
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;
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
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), Aug. 2, 2004, 118 Stat. 908, provided that: “The amendments made by this section [amending this section and sections 321 and 343–1 of this title] that require a label or labeling for major food allergens do not alter the authority of the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to require a label or labeling for other food allergens.”
Pub. L. 101–535, § 9, Nov. 8, 1990, 104 Stat. 2365, provided that: “The amendments made by this Act [enacting section 343–1 of this title and amending this section and sections 321, 337, 345, and 371 of this title] 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 [21 U.S.C. 301 et seq.], the Federal Meat Inspection Act [21 U.S.C. 601 et seq.], the Poultry Products Inspection Act [21 U.S.C. 451 et seq.], and the Egg Products Inspection Act [21 U.S.C. 1031 et seq.].”
Pub. L. 108–282, title II, § 202, Aug. 2, 2004, 118 Stat. 905, provided that: “Congress finds that—
approximately 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies; and
each year, roughly 30,000 individuals require emergency room treatment and 150 individuals die because of allergic reactions to food;
eight major foods or food groups—milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans—account for 90 percent of food allergies;
at present, there is no cure for food allergies; and
a food allergic consumer must avoid the food to which the consumer is allergic;
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
nationally, the number of recalls because of unlabeled allergens rose to 121 in 2000 from about 35 a decade earlier;
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;
ingredients in foods must be listed by their ‘common or usual name’;
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
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
celiac disease is an immune-mediated disease that causes damage to the gastrointestinal tract, central nervous system, and other organs;
the current recommended treatment is avoidance of glutens in foods that are associated with celiac disease; and
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. 101–535, § 2(b), Nov. 8, 1990, 104 Stat. 2356, as amended by Pub. L. 102–571, title II, § 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500, 4501, provided that:
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,
include regulations which establish standards, in accordance with paragraph (1)(A), to define serving size or other unit of measure for food,
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
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.
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 December 31, 1993. There shall be promptly published in the Federal Register notice of new status of the proposed regulations [see 57 F.R. 56347].
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), Oct. 29, 1992, 106 Stat. 4501, provided that: “The amendments made by subparagraph (B) [amending sections 2(b) and 3(b) of Pub. L. 101–535, set out above and below] shall not be construed to modify the effective date of final regulations under sections 2(b) and 3(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535] (21 U.S.C. 343 note) with respect to foods that are not such dietary supplements.”
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:
(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—
shall identify claims described in section 403(r)(1)(A) of such Act which comply with section 403(r)(2) of such Act,
shall identify claims described in section 403(r)(1)(B) of such Act which comply with section 403(r)(3) of such Act,
light or lite,
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,
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,
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,
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,
may permit a claim described in section 403(r)(1)(A) of such Act to be made for butter,
may, in defining terms under section 403(r)(2)(A)(i), include similar terms which are commonly understood to have the same meaning, and
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.
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]
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].”
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.”
Pub. L. 103–417, § 12, Oct. 25, 1994, 108 Stat. 4332, provided that:
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’).
“(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.
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.
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.—
“(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.
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.”
Pub. L. 103–80, § 2(a), Aug. 13, 1993, 107 Stat. 773, provided that:
“(1)Before .—
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 .—
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.”
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.”
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).”
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).”
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—
the availability of nutrition information in the label or labeling of food, and
the importance of that information in maintaining healthy dietary practices.”
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.
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.
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.”
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