The law › Title 21, Food and Drugs › Chapter 9
21 U.S.C. 343: Misbranded food
Created in 1960 by Public Law 86-537. Changed by 17 later laws. 1 bill in this Congress would change it.
13 other sections of the Code cite this one, including 21 U.S.C. 321, 21 U.S.C. 333, 21 U.S.C. 334, 21 U.S.C. 343–1, 21 U.S.C. 343–3.
48 parts of federal rules cite it as their authority, written by Food and Drug Administration, Department of Health and Human Services (48).
- past change
- enacted this Congress
- proposed
This Congress
- H.R. 8385 Food Labeling Modernization Act of 2026 · introduced · would change (i), (r), (w), (z)
How it got here
2010
- Pub. L. 111–148, §4205(a)(1), inserted "except as provided in clause (H)(ii)(III)," before "which is served". (Patient Protection and Affordable Care Act) Law text · (q)
- Pub. L. 111–148, §4205(a)(2), inserted "except as provided in clause (H)(ii)(III)," before "which is processed". (Patient Protection and Affordable Care Act) Law text · (q)
- Pub. L. 111–148, §4205(b), added cl. (H). (Patient Protection and Affordable Care Act) Law text · (q)
2006
- Pub. L. 109–462 added par. (y). (Dietary Supplement and Nonprescription Drug Consumer Protection Act) Law text · (y)
2004
- Pub. L. 108–282 added pars. (w) and (x). Law text · (w), (x)
2002
- Pub. L. 107–171, §10808(b), added subpar. (3) and concluding provisions. (Farm Security and Rural Investment Act of 2002) Law text · (h)
- Pub. L. 107–171, §10806(a)(2), added par. (t). (Farm Security and Rural Investment Act of 2002) Law text · (t)
- Pub. L. 107–171, §10806(b)(2), added par. (u). (Farm Security and Rural Investment Act of 2002) Law text · (u)
- Pub. L. 107–188 added par. (v). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (v)
2000
- 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) provide… (Consolidated Appropriations Act, 2001) Law text · (o)
1997
- 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 … (Food and Drug Administration Modernization Act of 1997) Law text · (r)
- Pub. L. 105–115, §304, added cls. (G) and (H). (Food and Drug Administration Modernization Act of 1997) Law text · (r), (H)
- Pub. L. 105–115, §303, added cls. (C) and (D). (Food and Drug Administration Modernization Act of 1997) Law text · (r), (D)
- 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… (Food and Drug Administration Modernization Act of 1997) Law text · (r)
- Pub. L. 105–115, §301, added subpar. (7). (Food and Drug Administration Modernization Act of 1997) Law text · (r)
1996
- 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 n… Law text · (p)
1994
- 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 l… · (q)
- Pub. L. 103–417, §7(c), added cl. (F). · (r)
- Pub. L. 103–417, §6, added subpar. (6). · (r)
- 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." · (s)
- Pub. L. 103–417, §7(a), added par. (s). · (s)
1993
- Pub. L. 103–80, §3(j)(1), substituted "count, except that" for "count: Provided, That". · (e)
- 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". · (i)
- Pub. L. 103–80, §3(j)(3), substituted ", except that" for ": Provided, That". · (k)
- Pub. L. 103–80, §3(j)(4), substituted "chemical, except that" for "chemical: Provided, however, That". · (l)
- Pub. L. 103–80, §2(b), added cl. (E) and redesignated former cls. (E) and (F) as (F) and (G), respectively. · (q)
- Pub. L. 103–80, §3(j)(5), substituted "(5)(D)" for "5(D)". · (r)
- Pub. L. 103–80, §3(j)(6), substituted "paragraph" for "subsection". · (r)
1992
- Pub. L. 102–571, §107(5), substituted "379e(c)" for "376(c)". · (i)
- Pub. L. 102–571, §107(6), substituted "379e" for "376". · (m)
1991
- Pub. L. 102–108, §2(c), amended directory language of Pub. L. 101–535, §7(1), (3). See 1990 Amendment note below. · (i)
- Pub. L. 102–108, §2(a), substituted "(D)" for "(C)". · (q)
1990
- 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 inf… · (i)
- Pub. L. 101–535, §2(a), added par. (q). · (q)
- Pub. L. 101–535, §3(a), added par. (r). · (r)
1977
- Pub. L. 95–203, §4(a)(1), added par. (o). · (o)
- Pub. L. 95–203, §4(b)(1), added par. (p). · (p)
1976
- 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". · (a)
1970
- Pub. L. 91–601 added par. (n). · (n)
1960
- 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. · (k)
- Pub. L. 86–537, §1(2), added par. (l). · (l)
- Pub. L. 86–618 added par. (m). · (m)
Text, outline and history from the official U.S. Code (2024 edition) on GovInfo, published by the Office of the Law Revision Counsel. Changes made after that edition appear under This Congress.