If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such [1] (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a processed food, a color additive, or asection 346 of this title; or (B) if it bears or contains asection 346a(a) of this title; or (C) if it is or if it bears or contains (i) anysection 348 of this title; or (ii) asection 360b of this title; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title.
(b) Absence, substitution, or addition of constituentsIf any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.
(c) Color additivesIf it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e(a) of this title.
(d) Confectionery containing alcohol or nonnutritive substance If it is confectionery, and—has partially or completely imbedded therein any nonnutritive object, except that this subparagraph shall not apply in the case of any nonnutritive object if, in the judgment of the (2)
bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum by volume derived solely from the use of flavoring extracts, except that this clause shall not apply to confectionery which is introduced or delivered for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionery is permitted under the laws of the (3)
bears or contains any nonnutritive substance, except that this subparagraph shall not apply to a safe nonnutritive substance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture, packaging, or storage of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of any provision of this chapter, except that the (e) Oleomargarine containing filthy, putrid, etc., matter
If it is oleomargarine or margarine or butter and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance, or such oleomargarine or margarine or butter is otherwise unfit for (f) Dietary supplement or ingredient: safety
(1) If it is a dietary supplement or contains a dietary ingredient that— (A) presents a significant or unreasonable risk of illness or injury under— conditions of use recommended or suggested in labeling, orif no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;
is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
In any proceeding under this subparagraph, the United (2) Before the [2] (1)(A) for a civil proceeding, the (g) Dietary supplement: manufacturing practicesIf it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the (2)
If it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation ofsection 350e of this title.
[1] So in original. The period probably should be “; or”.
[2] So in original. Probably should be “subparagraph”.
1996—Par. (a). Pub. L. 104–170 added subpar. (2) and struck out former subpar. (2) which read as follows: “(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than one which is (i) asection 346 of this title, or (B) if it is asection 346a(a) of this title, or (C) if it is, or if it bears or contains, anysection 348 of this title: Provided, That where asection 346a of this title and suchsection 360b of this title;”. That part of Pub. L. 104–170 which directed the substitution of “or (3) if it consists” for “(3) if it consists” was executed by making the substitution for “(3) If it consists” to reflect the probable intent of Congress .
1993—Par. (a). Pub. L. 103–80, § 3(i)(1), substituted a period for “; or” at end of subpar. (1) and “If it” for “if it” at beginning of par. (3). That part of Pub. L. 103–80, § 3(i)(1), which directed the substitution of a period for “; or” at end of subpar. (2) could not be executed because “; or” did not appear.
Par. (d)(1). Pub. L. 103–80, § 3(i)(2), substituted “, except that this subparagraph” for “: Provided, That this clause”.
Par. (d)(3). Pub. L. 103–80, § 3(i)(3), substituted “, except that this subparagraph shall not apply” for “: Provided, That this clause shall not apply” and “, except that thePub. L. 102–571 substituted “379e(a)” for “376(a)”.
1986—Par. (d)(2). Pub. L. 99–252 inserted provision that this clause not apply to confectionery introduced or delivered for introduction into or received or held for sale in,Pub. L. 90–399 added cls. (A)(iv) and (D).
1966—Par. (d). Pub. L. 89–477 permitted the imbedding of nonnutritive objects in confectioneryPub. L. 86–618, § 102(a)(1), substituted “other than one which is (i) aPub. L. 86–618, § 102(a)(2), amended par. (c) generally, substituting provisions deeming asection 376 of this title for provisions which related tosection 346 of this title, and struck out provisos which related to the use ofPub. L. 86–618, § 105(c), substituted “authorized coloring” for “harmless coloring”.
1959—Par. (c). Pub. L. 86–2 extended from Mar. 1, 1959 , to May 1, 1959 , the period during which par. is inapplicable to oranges which have been colored with F.D. & C. Red 32, and inserted proviso requiringPub. L. 85–929, among other changes, inserted cl. (2)(C) relating tosection 348 of this title, and toJuly 9, 1956 , inserted second proviso relating to coloring of oranges.
1954—Par. (a)(2). Act July 22, 1954 , provided in the case of anysection 346a of this title.
1950—Par. (e). Act Mar. 16, 1950 , added par. (e).
Statutory Notes and Related Subsidiaries Effective Date of 2005 AmendmentAmendment by Pub. L. 109–59 effective Oct. 1, 2005 , see section 7204 of Pub. L. 109–59, set out as a note under section 331 of this title.
Effective Date of 1968 AmendmentAmendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968 , see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.
Effective Date of 1960 AmendmentAmendment by Pub. L. 86–618 effective July 12, 1960 , subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.
Effective Date of Nematocide, Plant Regulator, Defoliant, and Desiccant Amendment of 1959Effective date of par. (a)(2) as in force prior to July 22, 1954 , with respect to particular commercial use of a nematocide, plant regulator, defoliant, or desiccant in or on aJan. 1, 1958 , see section 3(b) of Pub. L. 86–139, Aug. 7, 1959 , 73 Stat. 288.
Effective Date of 1958 AmendmentExcept as provided in subsections (b) and (c) of this section, this Act [amending this section, sections 321, 331, 346, and 348 of this title, and section 210 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 321 and 451 of this title] shall take effect on the date of its enactment [ Sept. 6, 1958 ].
Except as provided in subsection (c) of this section, section 3 of this Act [amending this section and section 346 of this title] shall take effect on the one hundred and eightieth day after the date of enactment of this Act [ Sept. 6, 1958 ].
Either (A) one year after the effective date established in subsection (b) of this section, or (B) at the end of such additional period (but not later than two years from such effective date established in subsection (b)) as the “(2)
on the date on which an order with respect to such use under section 409 of the Federal Food, Drug, and Cosmetic Act [section 348 of this title] becomes effective,
Act July 22, 1954, ch. 559, § 5, 68 Stat. 517, provided that:
“This Act [amending this section and section 321 of this title and enacting sections 346a and 346b of this title] shall take effect upon the date of its enactment [ July 22, 1954 ], except that with respect toFederal Food, Drug, and Cosmetic Act [section 346a of this title], the amendment to section 402(a) of such Act [par. (a) of this section] made by section 2 of this Act shall not be effective—
for the period of one year following the date of the enactment of this Act [ July 22, 1954 ]; orfor such additional period following such period of one year, but not extending beyond two years after the date of the enactment of this Act [ July 22, 1954 ] as the Effective Date of 1950 Amendment
Amendment by act Mar. 16, 1950 , effective July 1, 1950 , see section 7 of act Mar. 16, 1950 , set out as an Effective Date note under section 347 of this title.
Effective Date; PostponementPar. (c) effective Jan. 1, 1940 , 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.
Short Title“That this Act [amending provisions set out as a note under this section and section 135 of Title 7, Agriculture] may be cited as the ‘Food Additives Transitional Provisions Amendment of 1964’.”
Updating Guidance Relating to Fish and Fisheries Products Hazards and Controls“(a) In General.— Not later than 90 days prior to the issuance of any guidance, regulation, or suggested amendment by the Food and Drug Administration to the National Shellfish Sanitation Program’s Model Ordinance, or the issuance of any guidance or regulation by the Food and Drug Administration relating to the Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration (parts 123 and 1240 of title 21, Code of Federal Regulations (or any successor regulations)[)], where such guidance, regulation or suggested amendment relates to post harvest processing for raw oysters, theSenate and the Committee on Energy and Commerce of the House of Representatives a report which shall include—
an assessment of how post harvest processing or other equivalent controls feasibly may be implemented in the fastest, safest, and most economical manner;
the projected public health benefits of any proposed post harvest processing; the projected costs of compliance with such post harvest processing measures;the impact post harvest processing is expected to have on the sales, cost, and availability of raw oysters;
criteria for ensuring post harvest processing standards will be applied equally to shellfish imported from all nations of origin;
an evaluation of alternative measures to prevent, eliminate, or reduce to an acceptable level the occurrence of foodborne illness; and
the extent to which the Food and Drug Administration has consulted with the “(b) Limitation.—Subsection (a) shall not apply to the guidance described in section 103(h) [section 103(h) of Pub. L. 111–353, set out as a note above].
“(c) Review and Evaluation.— Not later than 30 days after the “(1)review and evaluate the report described in (a) and report to Congress on the findings of the estimates and analysis in the report;
compare such proposed regulation or guidance to similar regulations or guidance with respect to other regulated “(3)
evaluate the impact of post harvest processing on the competitiveness of the domestic oyster industry in the United “(d) Waiver.—
The requirement of preparing a report under subsection (a) shall be waived if the “(e) Public Access.—
Any report prepared under this section shall be made available to the public.”Domestic Fish or Fish Product Compliance With Food Safety Standards or Procedures Deemed To Have Met Requirements for Federal Commodity Purchase Programs
“Hereafter, notwithstanding any other provision of law, any domestic fish or fish product produced in compliance with Food and Drug Administration as satisfying the requirements of the ‘Procedures for theFood and Drug Administration as a final regulation in the Federal Register of December 18, 1995 ), shall be deemed to have met any inspection requirements of the Department of Agriculture or other Federal agency for any Federal commodity purchase program, including the program authorized under section 32 of the Act of August 24, 1935 (7 U.S.C. 612c) except that the Department of Agriculture or other Federal agency may utilize lot inspection to establish a reasonable degree of certainty that fish or fish products purchased under a Federal commodity purchase program, including the program authorized under section 32 of the Act of August 24, 1935 (7 U.S.C. 612c), meet Federal product specifications.”