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.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6134 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 6134
To authorize the regulation of interstate commerce with respect to food
containing cannabidiol derived from hemp, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 2, 2021
Miss Rice of New York (for herself, Mr. Griffith, Ms. Craig, and Mr.
Crenshaw) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line