(Pub. L. 87-70, title VII, § 707, as added Pub. L. 89117, title IX, § 907, Aug. 10, 1965, 79 Stat. 496, and amended Pub. L. 90-19, § 18 (c), May 25, 1967, 81 Stat. 25; Pub. L. 91-609, title IV, § 401, Dec. 31, 1970, 84 Stat. 1783.)

AMENDMENTS

1970 Pub. L. 91-609 reenacted provisions without change.

1967-Subsec. (a). Pub. L. 90-19 substituted "Secretary" for "Administrator" wherever appearing.

§ 1500d. Authorization of appropriations.

There are authorized to be appropriated for purposes of making grants under this chapter not to exceed $660,000,000 prior to September 30, 1972, plus not to exceed $63,000,000 for the fiscal year beginning July 1, 1973. Any amounts appropriated under this section shall remain available until expended. (As amended Pub. L. 92-213, § 8(b), Dec. 22, 1971, 85 Stat. 776; Pub. L. 92-335, § 5, July 1, 1972, 86 Stat. 405; Pub. L. 93-117, § 7, Oct. 2, 1973, 87 Stat. 422.)

located in an urban area which has value for (A) park and recreational purposes, (B) conservation of land and other natural resources, or (C) historic, architectural, or scenic purposes.

(2) The term "urban area" means any area which is urban in character, including those surrounding areas which, in the judgment of the Secretary, form an economic and socially related region, taking into consideration such factors as present and future population trends and patterns of urban growth, location of transportation facilities and systems, and distribution of industrial, commercial, residential, governmental, institutional, and other activities.

(3) The term "State" means any of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the territories and possessions of the United States.

(4) The term "local public body" means any public body (including a political subdivision) created by or under the laws of a State or two or more States, or a combination of such bodies, and includes Indian tribes, bands, groups, and nations (including Alaska Indians, Aleuts, and Eskimos) of the United States.

(5) The term "open-space uses" means any use of open-space land for (A) park and recreational purposes, (B) conservation of land and other natural resources, or (C) historic, architectural or scenic purposes. (Pub. L. 87-70, title VII, § 709, as added Pub. L. 89-754, title VI, § 605(g), Nov. 3, 1966, 80 Stat. 1280, and amended Pub. L. 91-609, title IV, § 401, Dec 31, 1970, 84 Stat. 1783.)

AMENDMENTS

1970-Pub. L. 91-609 substituted provisions respecting definitions (formerly covered in former section 1500e of this title) for provisions relating to grants for historic preservation, now covered in section 1500a (a) of this title.

(2) For the purpose of assuring effective implementation of standards adopted pursuant to paragraph (1) the President shall, in consultation with appropriate local, State, and Federal agencies, public and private organizations, and interested individuals, conduct a study and investigation of methods to control the release of pesticides into the environ

ment which study shall include examination of the persistency of pesticides in the water environment and alternatives thereto. The President shall submit a report on such investigation to Congress together with his recommendations for any necessary legislation within two years after April 3, 1970.

(c) Exemptions.

(d) Regulations pursuant to petition; publication of notice; time for issuance; referral to advisory committees; effective date; hearings. (e) Regulations pursuant to Administrator's proposals.

(f) Data submitted as confidential.

(g) Advisory committees; appointment; composi. tion; compensation; clerical assistance.

(h) Right of consultation.

(1) Judicial review.

(1) Temporary tolerances.

(k) Regulations based on public hearings before January 1, 1953.

(1) Pesticides under Federal Insecticide, Fungicide, and Rodenticide Act; functions of Administrator of the Environmental Protection Agency; certifications; hearing; time limitation; opinion; regulations. (m) Amendment of regulations. (n) Guaranties.

(0) Payment of fees; services or functions as conditioned on; waiver or refund of fees. Same; appropriations.

346b

CHAPTER REFERRED TO IN OTHER SECTIONS

This chapter is referred to in sections 601, 607,620, 679, 1033, 1049, 1052 of this title; title 16 section 778e; title 26 section 4817.

SUBCHAPTER I.-SHORT TITLE

8 301. Short title.

This chapter may be cited as the Federal Food, (June 25, 1938, ch. 675. Drug, and Cosmetic Act. § 1, 52 Stat. 1040.)

EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Sections 342 (c), 343 (e) (1), (g)-(k), 351(a) (4), 352(b), (d)-(h), 361(e) and 362(b) of this title effective Jan. 1, 1940 and sections 343 (e) (1), (g)—(k), 352 (b), (d)-(h) and 362 (b) of this title effective July 1, 1940 as provided by regulations for certain lithographed labeling and containers bearing certain labeling, see act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, set out as a note under section 392 of this title.

Federal Hazardous Substances Act as not modifying this chapter, see Pub. L. 86-613, 17, July 12, 1960, 74 Stat. 380, set out as a note under section 1261 of Title 15, Commerce and Trade.

(c) The term "Department" means the Department of Health, Education, and Welfare.

(d) The term "Secretary" means the Secretary of Health, Education, and Welfare.

(e) The term "person" includes individual, partnership, corporation, and association.

(f) The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

*

(h) The term "device" (except when used in paragraph (n) of this section and in sections 301 (i), 403 (f), 502(c), and 602 (c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not

(k) The term "label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

(1) The term "immediate container" does not include package liners.

(m) The term "labeling" means all labels and other written. printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

(n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.

(q) The term "pesticide chemical" means any substance which, alone, in chemical combination or in formulation with one or more other substances. is an "economic poison" within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act as now in force or as hereafter amended, and which is used in the production, storage, or transportation of raw agricultural commodities.

(r) The term "raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.

(s) The term "food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately

shown through scientific procedures (or, in the case as a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include

(1) a pesticide chemical in or on a raw agricultural commodity; or

(2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; or

(3) a color additive; or

(x) The term "animal feed", as used in paragraph (w) of this section, in section 360b of this title, and in provisions of this chapter referring to such paragraph or section, means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal. (June 25, 1938, ch. 675, § 201, 52 Stat. 1041; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg. Plan No. 1, § 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; July 22, 1954, ch. 559, § 1, 68 Stat. 511; Sept. 6, 1958, Pub. L. 85-929, § 2, 72 Stat. 1784; July 12, 1960, Pub. L. 86618, title I, § 101, 74 Stat. 397; Oct. 10, 1962, Pub. L. 87-781, title I, § 102(a), title III, § 307(a), 76 Stat. 781, 796; July 15, 1965, Pub. L. 89-74, §§ 3(a), 9(b). 79 Stat. 227, 234; July 13, 1968, Pub. L. 90-399, § 102. 82 Stat. 351; Oct. 24, 1968, Pub. L. 90-639, §§ 1, 4(a), 82 Stat. 1361, 1362; Oct. 27, 1970, Pub. L. 91-513, title II, § 701(a), (g), 84 Stat. 1281, 1282; Pub. L. 94-278, title V, § 502(a) (2) (A), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-295, § 3(a) (1) (A), May 28, 1976, 90 Stat. 575.)

REFERENCES IN TEXT

The Food and Drugs Act of June 30, 1906, as amended, act June 30, 1906, ch. 3915, 34 Stat. 768, as amended, referred to in subsecs. (p) (1) and (w) (1), was repealed by section 902(a) of act June 25, 1938 (set out as a note under section 392 of this title), and is covered by this chapter.

The Federal Insecticide. Fungicide, and Rodenticide Act, referred to in subsec (q), is classified to section 135 et seq. of Title 7, Agriculture.

The Poultry Products Inspection Act, referred to in subsec. (s) (4) is classified to chapter 10 of this title. The Meat Inspection Act of Mar. 4, 1907, referred to in subsec. (s) (4) is now the Federal Meat Inspection Act. and is set out in section 601 et seq. of this title.

AMENDMENTS

1976 Subsec. (h). Pub. L. 94-295 substantially revised subsec. (h).

Subsec. (n). Pub. L. 94-278 added "or advertising" after "labeling" wherever the latter appeared.

1970-Subsec. (a) (2). Pub. L. 91-513, 701 (g), struck out reference to sections 321, 331(1), 331(p), 331(q), 332, 333, 334, 337, 360, 360a, 372, 373, 374, and 375 of this title as they apply to depressant or stimulant drugs.

4(a), added

Subsec. (v). Pub. L. 91-513, § 701 (a), struck out subsec. (v) which defined "depressant or stimulant drug". 1968-Subsec. (a)(2). Pub. L. 90-639, material extending provisions covering depressant and stimulant drugs, the containers thereof, and equipment used in manufacturing, compounding, or processing such drugs, to the Canal Zone.

Subsec. (p). Pub. L. 90-399, § 102 (a), (b), inserted "(except a new animal drug or an animal feed bearing or containing a new animal drug)" following "Any drug" in subpars. (1) and (2), respectively.

Subsec. (s). Pub. L. 90-399, § 102(c), added subpar. (5). Subsec. (u). Pub. L. 90-399, § 102(d), inserted a reference to section 360b of this title.

Subsec. (v) (3). Pub. L. 90-639, § 1, added specific reference to lysergic acid diethylamide.

Subsecs. (w), (x). Pub. L. 90-399, § 102(e), added subsecs. (w) and (x).

1965 Subsec. (g). Pub. L. 89-74, § 9(b), designated existing provisions as subpar. (1), redesignated clauses (1)-(4) thereof as (A)—(D), substituted therein "(A), (B), or (C)" for "(1), (2), or (3)" and added subpar. (2). Subsec. (v). Pub. L. 89-74, § 3(a), added subsec. (v). 1962-Subsec. (a). Pub. L. 87-781, § 307(a), designated existing provisions as clause (2), inserted "Commonwealth of Puerto Rico and the" therein, and added clause (1).

Subsec. (p)(1). Pub. L. 87-781, § 102(a)(1), inserted "and effectiveness" following "to evaluate the safety". and "and effective" following "as safe."

Subsec. (p) (2). Pub. L. 87-781, § 102 (a) (2), inserted "and effectiveness" following "safety."

1960-Subsec. (s). Pub. L. 86-618, § 101(a), excluded color additives from the definition of the term "food additive."

Subsec. (t). Pub. L. 86-618, § 101(c), added subsec. (t). Former subsec. (t) redesignated (u).

Subsec. (u). Pub. L. 86-618, § 101(b), redesignated former subsec. (t) as (u) and included therein a reference to section 376 of this title.

1958-Subsecs. (s) and (t). Pub. L. 85-929 added subsecs. (s) and (t).

1954 Subsecs. (q) and (r). Act July 22, 1954, added subsecs. (q) and (r).

§ 321a. Same; butter.

For the purposes of this chapter "butter" shall be understood to mean the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80 per centum by weight of milk fat, all tolerances having been allowed for. (Mar. 4, 1923, ch. 268, 42 Stat. 1500: June 25, 1938, ch. 675, § 902 (a), 52 Stat. 1059.)

§ 321b. Same; package.

The word "package" where it occurs in this chapter shall include and shall be construed to include wrapped meats inclosed in papers or other materials as prepared by the manufacturers thereof for sale. (July 24, 1919, ch. 26, 41 Stat. 271; June 25, 1938, ch. 675, § 902 (a), 52 Stat. 1059.)

§ 321c. Same; nonfat dry milk; milk.

For the purposes of this chapter, nonfat dry milk

is the product resulting from the removal of fat and water from milk, and contains the lactose, milk proteins, and milk minerals in the same relative proportions as in the fresh milk from which made. It contains not over 5 per centum by weight of moisture. The fat content is not over 12 per centum by weight unless otherwise indicated.

The term "milk", when used herein, means sweet milk of cows. (Mar. 2, 1944, ch. 77, 58 Stat. 108: July 2, 1956, ch. 495, 70 Stat. 486.)

SUBCHAPTER III-PROHIBITED ACTS AND PENALTIES

§ 331. Prohibited acts.

The following acts and the causing thereof are prohibited:

(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.

(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.

(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.

(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 344 or 355 of this title.

(e) The refusal to permit access to or copying of any record as required by section 373 of this title; or the failure to establish or maintain any record, or make any report, required under section 355 (1) or (j), 357 (d) or (g), 360b, (j), (l), or (m), 360e (f), or 360i of this title, or the refusal to permit access to or verification or copying of any such required record.

(f) The refusal to permit entry or inspection as authorized by section 374 of this title.

(g) The manufacture within any Territory of any food, drug, device, or cosmetic that is adulterated or misbranded.

(h) The giving of a guaranty or undertaking referred to in section 333 (c) (2) of this title which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the food, drug, device, or cosmetic; or the giving of a guaranty or undertaking referred to in section 333 (c) (3) of this title which guaranty or undertaking is false.

(1) (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by regulations promulgated under the provisions of sections 344, 356, 357, or 376 of this title.

(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing