Source: https://casetext.com/statute/united-states-code/title-21-food-and-drugs/chapter-9-federal-food-drug-and-cosmetic-act/subchapter-iv-food/section-343-misbranded-food?ref=AsVVwS!0CJWhh
Timestamp: 2019-12-08 04:03:06
Document Index: 500853381

Matched Legal Cases: ['§ 343', '§ 343', '§1', '§517', '§1', '§403', '§1', '§102', '§6', '§7', '§1205', '§502', '§4', '§2', '§2', '§107', '§2', '§6', '§1', '§301', '§1', '§517', '§10806', '§308', '§203', '§3', '§4205', '§4205', '§4205', '§4205', '§10808', '§10806', '§10806', '§305', '§304', '§303', '§302', '§301', '§7', '§7', '§6', '§10', '§7', '§3', '§3', '§3', '§3', '§2', '§3', '§3', '§107', '§107', '§2', '§7', '§2', '§7', '§2', '§2', '§3', '§4', '§4', '§1', '§1', '§3', '§7', '§10', '§202', '§10', '§1', '§107', '§4', '§4', '§4205', '§203', '§9', '§2', '§202', '§202', '§3', '§202', '§12516', '§202', '§206', '§10809', '§12', '§2', '§202', '§202', '§203', '§2', '§2', '§4', '§2']

Section 343 - Misbranded food, 21 U.S.C. § 343 | Casetext
21 U.S.C. § 343
Section 343 - Misbranded food
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(i) such food has been subjected to a safe process or treatment that-
(o) Repealed.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(p) Repealed.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-
(i) Upon the expiration of 30 months after November 8, 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 (A). Such report shall include a determination of whether there is substantial compliance with the guidelines.
(A) Subparagraphs (1), (2), (3), and (4) shall not apply to food-
(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-
(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu listing the item for sale, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and
(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu board, including a drive-through menu board, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and
(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)-
(A) Except as provided in subparagraph (5), a claim described in subparagraph (1)(B) may only be made-
(i) Any person may petition the Secretary to issue a regulation under subparagraph (2)(A)(i) or (3)(B) relating to a claim described in subparagraph (1)(A) or (1)(B). Not later than 100 days after the petition is received by the Secretary, the Secretary shall issue a final decision denying the petition or file the petition for further action by the Secretary. 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. If the Secretary denies the petition or the petition is deemed to be denied, the petition shall not be made available to the public. If the Secretary 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. 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.
(A) the label or labeling of the supplement fails to list-
(A) 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-
If it is a dietary supplement that is marketed in the United States, unless the label of such dietary supplement includes a domestic address or domestic phone number through which the responsible person (as described in section 379aa-1 of this title) may receive a report of a serious adverse event with such dietary supplement.
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.
AMENDMENTS 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).
CHANGE OF NAMECommittee 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, Jan. 3, 2001.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, Jan. 19, 1999.
EFFECTIVE DATE OF 2006 AMENDMENTPub. L. 109-462, §3(d)(1), (2), Dec. 22, 2006, 120 Stat. 3475, provided that:"(1) IN GENERAL.-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]."
EFFECTIVE DATE OF 2004 AMENDMENT Amendment by Pub. L. 108-282 applicable to any food that is labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108-282, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1994 AMENDMENTPub. L. 103-417, §7(e), Oct. 25, 1994, 108 Stat. 4331, provided that: "Dietary supplements-"(1) 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"(2) shall be labeled after December 31, 1996, in accordance with such amendments."
EFFECTIVE DATE OF 1990 AMENDMENTPub. 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:"(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 [Nov. 8, 1992, see 57 F.R. 56347],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 [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,"(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 [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"(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), 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:"(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 [Nov. 8, 1990]. "(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 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]."(B) If a food described in subparagraph (A)-"(i) 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"(ii) 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],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 May 8, 1993, shall not be subject to the amendments made by section 7(2) [amending this section]."
EFFECTIVE DATE OF 1977 AMENDMENTPub. 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) ]."
EFFECTIVE DATE; POSTPONEMENTSubsecs. (e)(1) and (g) to (k) effective Jan. 1, 1940, and such subsections effective July 1, 1940, as provided by regulations for certain lithographed labeling and containers bearing certain labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.
CONSTRUCTION OF AMENDMENT BY PUB. L. 111-148 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- "(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) ]."
CONSTRUCTION OF AMENDMENT BY PUB. L. 108-282 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."
CONSTRUCTION OF AMENDMENT BY PUB. L. 107-188 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.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535 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.]."
REGULATIONSPub. 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:"(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 [Nov. 8, 1990], 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. 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, 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] 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 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 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]."(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), 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:"(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.]
LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTSPub. 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.'."
FINDINGSPub. 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."
RULEMAKING ON LABELINGPub. 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, 1994Pub. 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 EXEMPTIONPub. 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 SUPPLEMENTSPub. 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 SUPPLEMENTSPub. 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 MINERALSPub. 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 EDUCATIONPub. 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 REQUIREMENTSPub. 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."
Section 342 - Adulterated food
Section 343-1 - National uniform nutrition labeling
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Colella v. Atkins Nutritionals, Inc.
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