CBD Product Safety and Standardization Act of 2021
Bill: H.R.6134 | Sponsor: Rep. Rice, Kathleen M. (D-NY)
Policy area: Health

Summary:
CBD Product Safety and Standardization Act of 2021
This bill requires the Food and Drug Administration (FDA) to regulate food containing cannabidiol (CBD) derived from hemp as a food additive. (The FDA has determined that food containing added CBD cannot be sold in interstate commerce.)
Under this bill, in order to be sold, a food containing CBD derived from hemp must conform with current FDA requirements pertaining to food additives or be generally recognized as safe (GRAS). (Under current law, a food additive with the GRAS designation is not subject to FDA premarket review and approval requirements.)
In addition, such a food must comply with all other relevant FDA and labeling requirements.
Such a food shall be exempt from an existing provision that prohibits the sale of a food containing an additive that is (1) an FDA-approved drug or biological product, or (2) subject to certain clinical investigations.
The FDA must issue regulations pertaining to such foods that specify (1) the maximum amount of CBD derived from hemp per serving, (2) labeling and packaging requirements, and (3) any conditions for intended use.

To authorize the regulation of interstate commerce with respect to food 
   containing cannabidiol derived from hemp, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``CBD Product Safety and 
Standardization Act of 2021''.

SEC. 2. REGULATION OF INTERSTATE COMMERCE WITH RESPECT TO FOOD 
              CONTAINING CANNABIDIOL DERIVED FROM HEMP.

    (a) Standards and Regulations.--Chapter IV of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 342 et seq.) is amended by inserting 
after section 409 the following:

``SEC. 409A. FOOD CONTAINING CANNABIDIOL DERIVED FROM HEMP.

    ``(a) Standards.--The standards specified in this section for a 
food (other than a dietary supplement) containing cannabidiol derived 
from hemp (as defined in section 297A of the Agricultural Marketing Act 
of 1946) are that the food--
            ``(1) is--
                    ``(A) in conformity with a regulation issued 
                pursuant to section 409(c)(1)(A);
                    ``(B) the subject of a notice submitted to the 
                Secretary under subpart E of part 170 of title 21, Code 
                of Federal Regulations (or any successor regulations); 
                or
                    ``(C) generally recognized, among experts qualified 
                by scientific training and experience to evaluate its 
                safety, as having been adequately shown through 
                scientific procedures to be safe under the conditions 
                of its intended use, within the meaning of section 
                201(s); and
            ``(2) complies with all other applicable requirements 
        under, or pursuant to, this Act and the Fair Packaging and 
        Labeling Act.
    ``(b) Regulations.--The Secretary shall issue, through notice and 
comment rulemaking pursuant to section 553 of title 5, United States 
Code, regulations specifying, with respect to a food containing 
cannabidiol derived from hemp--
            ``(1) a maximum amount of cannabidiol derived from hemp per 
        serving;
            ``(2) labeling and packaging requirements; and
            ``(3) conditions of intended use, including any conditions 
        specific to a food category described under subpart A of part 
        170 of title 21, Code of Federal Regulations (or any successor 
        regulations).
    ``(c) Effective Date.--The standards under this section shall apply 
beginning on the date of enactment of the CBD Product Safety and 
Standardization Act of 2021, regardless of whether regulations have 
been issued under subsection (b).''.
    (b) Prohibited Acts.--Section 301(ll) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 331(ll)) is amended, in the matter 
preceding paragraph (1), by inserting ``(other than a food containing 
cannabidiol that meets the requirements specified in section 409A)'' 
after ``made public''.
    (c) Conforming Amendments.--
            (1) Adulteration.--Section 402 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 342) is amended by adding at the 
        end the following:
    ``(j) If it is a food (other than a dietary supplement) that 
contains cannabidiol derived from hemp (as defined in section 297A of 
the Agricultural Marketing Act of 1946), unless such food meets the 
requirements specified in section 409A.''.
            (2) Misbranding.--Section 403 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 343) is amended by adding at the 
        end the following:
    ``(z) If it is a food (other than a dietary supplement) that 
contains cannabidiol derived from hemp (as defined in section 297A of 
the Agricultural Marketing Act of 1946), unless the labeling of such 
food meets the requirements specified in or pursuant to section 
409A.''.
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