[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5243 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
2d Session
S. 5243
To amend the Federal Food, Drug, and Cosmetic Act to provide for the
regulation of cannabis and cannabinoid products, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 25, 2024
Mr. Wyden introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide for the
regulation of cannabis and cannabinoid products, 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; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Cannabinoid Safety
and Regulation Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--FOOD AND DRUG ADMINISTRATION REGULATION OF CANNABINOID
PRODUCTS
Sec. 101. FDA regulation of cannabinoid products.
Sec. 102. Amendments to the Federal Food, Drug, and Cosmetic Act.
Sec. 103. Regulation of cannabinoid beverages containing
tetrahydrocannabinol.
TITLE II--PUBLIC HEALTH
Sec. 201. Public health surveillance and data collection.
Sec. 202. Awards to prevent underage cannabis use.
TITLE III--CANNABIS-IMPAIRED DRIVING PREVENTION
Sec. 301. Definitions.
Sec. 302. Cannabis-impaired driving research.
Sec. 303. DOT cannabis-impaired driving prevention programs.
Sec. 304. State cannabis-impaired driving prevention grant program.
Sec. 305. National cannabis impairment standard.
Sec. 306. Funding.
TITLE I--FOOD AND DRUG ADMINISTRATION REGULATION OF CANNABINOID
PRODUCTS
SEC. 101. FDA REGULATION OF CANNABINOID PRODUCTS.
(a) In General.--The Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) is amended by adding at the end the following:
``CHAPTER XI--CANNABINOID PRODUCTS
``SEC. 1101. CENTER FOR CANNABINOID PRODUCTS.
``Not later than 120 days after the date of enactment of the
Cannabinoid Safety and Regulation Act, the Secretary shall establish
within the Food and Drug Administration the Center for Cannabinoid
Products, which shall report to the Commissioner in the same manner as
the other agency centers within the Food and Drug Administration. The
Center shall be responsible for the implementation of this chapter and
related matters assigned by the Commissioner.
``SEC. 1102. ADULTERATED CANNABINOID PRODUCTS.
``A cannabinoid product shall be deemed to be adulterated if--
``(1) it consists in whole or in part of any filthy,
putrid, or decomposed substance, or is otherwise contaminated
by any added poisonous or added deleterious substance that may
render the product injurious to health;
``(2) it has been manufactured, prepared, processed,
packed, or held in insanitary conditions whereby it may have
been contaminated with filth, or whereby it may have been
rendered injurious to health;
``(3) it bears or contains any poisonous or deleterious
substance that may render it injurious to health;
``(4) its container is composed, in whole or in part, of
any poisonous or deleterious substance that may render the
contents injurious to health;
``(5) it bears or contains an unsafe color additive that is
unsafe within the meaning of section 721(a);
``(6) the methods used in, or the facilities or controls
used for, its manufacture, preparing, processing, packing, or
storage are not in conformity with applicable requirements
under section 1105(c);
``(7) it has been manufactured, prepared, processed,
packed, or held in any factory, warehouse, or establishment and
the owner, operator, or agent of such factory, warehouse, or
establishment delays, denies, or limits an inspection, or
refuses to permit entry or inspection; or
``(8) it bears or contains, or has been manufactured,
prepared, or processed from, artificially or synthetically
derived cannabinoids of any kind.
``SEC. 1103. MISBRANDED CANNABINOID PRODUCTS.
``A cannabinoid product shall be deemed to be misbranded--
``(1) if its labeling, advertising, or promotion is false
or misleading in any particular, except that no cannabinoid
product shall be deemed to be misbranded solely because its
labeling, advertising, or promotion uses the term `cannabis';
``(2) if it is a finished product, unless it bears a label
containing--
``(A) a prominent statement on the front of the
product packaging, and on any internal product insert
or packaging, that the product contains cannabinoids;
``(B) the name, place of business, and contact
information (including, as applicable, phone number,
email address, and physical address) of its
manufacturer, packer, or distributor;
``(C) an accurate statement of the quantity of its
contents in terms of weight, measure, or numerical
count;
``(D) a statement of its form as specified in
regulations promulgated pursuant to section 1105(a);
``(E) if it is intended for animal consumption or
human consumption and is packaged and labeled in such a
way as to suggest more than one serving, dose, or the
equivalent, information on how such product may be
divisible into, or measured into, a portion equivalent
to one serving, dose, or the equivalent;
``(F) if it is intended for animal consumption or
human consumption and is packaged and labeled in such a
way as to suggest more than one serving, dose, or the
equivalent, a statement of the amount of total
tetrahydrocannabinol, in milligrams, in one serving,
dose, or the equivalent;
``(G)(i) a statement of the content and amount, in
milligrams, of any other cannabinoids in the product,
other than naturally occurring cannabinoids present at
trace amounts; and
``(ii) if it is packaged and labeled in such a way
as to suggest more than one serving, dose, or the
equivalent, a statement of the amount of such other
cannabinoids in one serving, dose, or the equivalent;
``(H) adequate directions for use and how to report
adverse events, if deemed necessary for the protection
of the public health in regulations promulgated
pursuant to section 1105(a);
``(I) if it is intended for human consumption, a
statement disclosing the presence or the possibility of
the presence of any major food allergen or other food
allergen which the Secretary may, by order, require to
be disclosed;
``(J) if it is intended for human use, a statement
disclosing any known risks to special populations,
including children, individuals who are pregnant or
breastfeeding, and individuals taking drugs known to
interact with the product, including the following
statement: `Keep out of reach of children and pets.
This product should not be consumed by women who are
pregnant or nursing. Consult your health care provider
if you have any other medical conditions or are taking
any medication(s). This product may be purchased only
by persons 21 and older.';
``(K) a statement disclosing risks posed by
consuming or using the specific cannabinoid contained
or purported to be contained in the product, including
the risk of drug test failure;
``(L) unless it is a dietary supplement that bears
the statement required by section 403(r)(6)(C), a
statement disclosing that the Food and Drug
Administration has not determined the product to be
safe or effective for treating any condition, including
the following statement: `This product has not been
evaluated for safety or efficacy by the Food and Drug
Administration.';
``(M) if it is intended for use in animals, a
prominently placed, conspicuous--
``(i) warning that the product should not
be used by humans; and
``(ii) statement that the product is
intended for use in animals, including a
specification of the intended species;
``(N) the applicable universal symbol described in
section 1105(d);
``(O) beginning not later than 90 days after
issuance of an order or finalization of a rule under
section 1105(f)(1), as applicable, information on the
safety test results for such product, or information on
where to obtain such safety test results; and
``(P) such other information as the Secretary
determines, in regulations promulgated pursuant to
section 1105(a), to be necessary for the protection of
the public health;
``(3) if it is a dietary supplement or a food and its label
or labeling bears a statement describing the role of a cannabis
constituent or cannabinoid intended to affect the structure or
any function of the body of humans or other animals, unless
there is substantiation that such statement is truthful and not
misleading;
``(4) if any word, statement, or other information required
by or under authority of this Act to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to
render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use;
``(5) if it purports to be, or is represented as, a
cannabinoid product that is subject to a cannabinoid product
standard established under section 1106 unless such cannabinoid
product is in all respects in conformity with such standard;
``(6) if its sale, distribution, or label or labeling is
not in conformity with applicable requirements under
subsections (a) and (b) of section 1105;
``(7) if it was manufactured, prepared, propagated,
compounded, processed, packaged, packed, imported, labeled, or
held in an establishment not duly registered under section
1104, if it was not included in a list required by section
1104, or if it was manufactured, prepared, propagated,
compounded, processed, packaged, packed, imported, labeled, or
held by or in an establishment for which the registration was
suspended under section 1104 and such registration has not been
reinstated;
``(8) if it takes such a form as to imitate or replicate a
product that is marketed to or is commonly associated with
children or minors, imitates a commercially available candy,
snack, or beverage packaging or labeling, or is in the shape of
real or imagined animals, people, vehicles, or characters,
including anthropomorphic non-human animals, vehicles, foods,
plants, or other characters, and including cartoon characters;
``(9) it is a gummy product, unless it is in the shape of a
cube, rectangle, sphere, or other geometric shape; or
``(10) if it purports to be, or is represented as, an eye
drop, nasal spray, or injectable.
``SEC. 1104. REGISTRATION.
``(a) Registration by Covered Entities.--
``(1) Initial registration.--
``(A) Existing facilities.--Each covered entity
that, on the date of enactment of the Cannabinoid
Safety and Regulation Act, owns or operates a facility
that carries out a covered activity shall register each
such facility with the Secretary not later than 90 days
after such date of enactment, in accordance with
subsection (b).
``(B) New facilities.--Each covered entity that
owns or operates a facility that first carries out,
after the date of enactment of the Cannabinoid Safety
and Regulation Act, a covered activity shall register
with the Secretary not later than 30 days after the
date on which a covered entity first engages in such
covered activity or 30 days after the deadline for
registration under subparagraph (A), whichever is
later, in accordance with subsection (b).
``(2) Renewal of registration.--Each covered entity
required to register a facility under this section shall renew
such registration with the Secretary on or before December 31
of each even-numbered year.
``(b) Content of Registration.--
``(1) In general.--For each facility at which a covered
entity carries out a covered activity, such covered entity
shall submit to the Secretary, through the website established
under paragraph (2)(A), a registration that includes--
``(A) information necessary to notify the Secretary
of the name (including trade name), address, and
telephone number of such facility;
``(B)(i) in the case of a domestic facility, the
email address and telephone number for the contact
person of such facility; or
``(ii) in the case of a foreign facility, the email
address and telephone number for the United States
agent for such facility;
``(C) the general activities conducted at such
facility, including the 1 or more categories of
cannabinoid products manufactured, prepared,
propagated, compounded, processed, packaged, packed,
imported, labeled, or held at such facility;
``(D) the facility registration number for such
facility, if any, previously assigned by the Secretary;
``(E) all brand names under which cannabinoid
products manufactured, prepared, propagated,
compounded, processed, packaged, packed, imported,
labeled, or held in such facility are sold, on the
condition that the Secretary shall keep such
information confidential;
``(F) an assurance that the Secretary will be
permitted to inspect such facility at the times and in
the manner permitted by this Act, including section
704; and
``(G) any other information the Secretary may
require.
``(2) Procedure.--
``(A) Website.--
``(i) In general.--Not later than the
applicable date described in clause (ii), the
Secretary shall establish a website for
submission of registration under this
subsection.
``(ii) Applicable date described.--The
applicable date described in this clause is--
``(I) 180 days after the date of
enactment of the Cannabinoid Safety and
Regulation Act; or
``(II) if December 31 is less than
180 days after such date of enactment,
240 days after such date of enactment.
``(B) Notification of receipt; registration
numbers.--Not later than 30 days after the date on
which the Secretary receives a completed registration
submitted under this subsection, the Secretary shall--
``(i) notify the applicable covered entity
of the receipt of such registration; and
``(ii) assign such covered entity a
registration number.
``(C) Owners, operators, and agents in charge.--A
registration under this subsection shall--
``(i) in the case of a domestic facility,
be submitted by the owner or operator of such
facility; and
``(ii) in the case of a foreign facility,
be submitted by the owner or operator of such
facility.
``(c) Uniform Product Identification System.--The Secretary may--
``(1) by regulation prescribe a uniform system for the
identification of cannabinoid products; and
``(2) require persons who are required to list such
cannabinoid products under subsection (f)--
``(A) to list such cannabinoid products in
accordance with such system; and
``(B) to include the identification number for such
cannabinoid products on the labels for such cannabinoid
products.
``(d) Registration Information.--The Secretary shall compile and
maintain an up-to-date list of facilities that are registered under
this section.
``(e) Fee for Registration.--
``(1) In general.--The Secretary may charge a fee for
registration under this section, which shall be due upon
submission of such registration.
``(2) Electronic payment.--Payment of the fee under
paragraph (1) may be made electronically pursuant to an online
method of payment provided by the Secretary.
``(3) Amount of fee; inflation adjustments.--
``(A) In general.--If the Secretary charges a fee
under paragraph (1), the Secretary shall establish the