Sec. 7. Regulation of marijuana products by Food and Drug Administration
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In this section, the term marijuana product means any product made or derived from marijuana that is intended for human or animal consumption, including any component of marijuana (except for raw materials other than such marijuana used in manufacturing a component of such product). In this section: The term biological product has the meaning given to that term in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) ). The term marijuana has the meaning given to that term in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ).
The terms cosmetic , device , dietary supplement , drug , food , and tobacco product have the meanings given to such terms in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ). A marijuana product meeting the definition of a drug shall be treated as a drug for purposes of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ). The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall have the same authorities under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) and other applicable law to regulate a marijuana product that is food or a dietary supplement as the Food and Drug Administration has with respect to food containing alcohol.
A marijuana product meeting the definition of a cosmetic shall be treated as a cosmetic for purposes of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ). A marijuana product that is not covered by subsection (b), (c), or
(d)may be lawfully marketed pursuant to regulations issued under paragraph (2). Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate a regulation with respect to marijuana products described in paragraph (1). The regulation under paragraph
(2)shall include requirements for— contaminant testing; manufacturing practices; and marketing practices and postmarket reporting, with special attention to preventing consumption by youths. The regulation under paragraph
(2)shall not require premarket approval of marijuana products described in paragraph (1). A marijuana product marketed in combination with a drug, a biological product, a device, a tobacco product, or an alcohol product is deemed to be adulterated for purposes of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ).
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Sec. 7
Regulation of marijuana products by Food and Drug Administration
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