H.R. 7212

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7212 Introduced in House (IH)]

<DOC>

119th CONGRESS
2d Session
H. R. 7212

To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
regulation of cannabinoid hemp products, and for other purposes.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

January 22, 2026

Mr. Griffith (for himself and Mr. Veasey) introduced the following 
bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
regulation of cannabinoid hemp 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.

This Act may be cited as the ``Hemp Enforcement, Modernization, and 
Protection Act''.

SEC. 2. TABLE OF CONTENTS.

The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Definitions.
Sec. 4. Cannabinoid hemp product regulation.
``Chapter X--Cannabinoid Hemp Products

``Sec. 1001. Definitions.
``Sec. 1002. Adulterated cannabinoid hemp products.
``Sec. 1003. Misbranded cannabinoid hemp products.
``Sec. 1004. Standards for oral cannabinoid hemp products.
``Sec. 1005. Standards for inhalable cannabinoid hemp products.
``Sec. 1006. Standards for topical cannabinoid hemp products.
``Sec. 1007. Minimum age of sale.
``Sec. 1008. Manufacturing and testing.
``Sec. 1009. Facility registration and product listing.
``Sec. 1010. Inspection of foreign cannabinoid hemp facilities.
``Sec. 1011. Mandatory recall authority.
``Sec. 1012. Applicable thresholds for cannabinoid content.
``Sec. 1013. Cannabinoid hemp products advisory committee.
Sec. 5. Enforcement.
Sec. 6. Rules of construction.

SEC. 3. DEFINITIONS.

Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321) is amended--
(1) in paragraph (ff)(1), by striking ``(other than 
tobacco)'' and inserting ``(other than a cannabinoid hemp 
product or tobacco)'';
(2) in paragraph (rr)(2), by striking ``or a combination 
product described in section 503(g)'' and inserting ``a 
combination product described in section 503(g), or a 
cannabinoid hemp product under paragraph (uu)''; and
(3) by adding at the end the following:
``(tt)(1) The term `cannabinoid' means a chemical, regardless of 
its source, that meets one or more of the following criteria:
``(A) A chemical belonging to any of the following chemical 
subclasses, including any acid, acetate, salt, ester, ether, 
derivative, or isomer thereof:
``(i) Cannabigerol.
``(ii) Cannabichromene.
``(iii) Cannabidiol.
``(iv) Delta-9 tetrahydrocannabinol.
``(v) Delta-8 tetrahydrocannabinol.
``(vi) Cannabicyclol.
``(vii) Cannabielsoin.
``(viii) Cannabinol.
``(ix) Cannabinodiol.
``(x) Cannabitriol.
``(xi) Any cannabinoid that is naturally found in, 
or produced by, the plant Cannabis sativa L. but is of 
a different chemical subclass than the subclasses 
listed in subclauses (i) through (x).
``(xii) Any cannabinoid that is not naturally found 
in or produced by the plant Cannabis sativa L. and can 
only be created through synthetic means, such as 
hexahydrocannabinol or tetrahydrocannabinol acetate.
``(B) Any chemical, regardless of origin or method of 
production, that--
``(i) is equivalent in chemical structure to a 
chemical referred to in clause (A); or
``(ii) has both a similar terpenophenolic chemical 
structure and pharmacological effect to a chemical 
referred to in clause (A).
``(C) Any chemical derived from a plant of the genus 
Cannabis that is a CB-1 or CB-2 receptor agonist or partial 
agonist.
``(D) Any chemical that the Secretary by regulation deems 
to meet the criteria specified in clause (A), (B), or (C).
``(2) The Secretary shall--
``(A) maintain, and periodically update through publication 
on the website of the Department of Health and Human Services, 
a list of cannabinoid compounds that the Secretary has 
determined meet the definition of cannabinoid as set forth in 
subparagraph (1); and
``(B) not later than 1 year after the date of the enactment 
of this paragraph, publish the initial list under clause (A).
``(uu)(1) The term `cannabinoid hemp product' means, except as 
provided in subparagraph (2), any article, including its components or 
parts, that contains or purports to contain one or more cannabinoids on 
the list maintained by the Secretary under paragraph (tt)(2) that is 
intended for use in or on the body of humans or animals.
``(2) The term `cannabinoid hemp product' does not include the 
following:
``(A) A drug that is the subject of an application approved 
under subsection (c) or (j) of section 505 or sections 512 or 
571, or is an indexed drug under 572.
``(B) A drug that is the subject of an application that has 
been authorized for investigation pursuant to section 505(i) 
only to the extent it is being used for such investigation, or 
a drug intended solely for investigational use that conforms to 
the terms of an exemption in effect under section 512(j) only 
to the extent it is being used for such investigation.
``(C) A drug that may lawfully be marketed pursuant to 
section 505G.
``(D) A biological product that is subject to an approved 
biologics license application under section 351 of the Public 
Health Service Act or licensed under the virus, serum, toxin, 
and analogous products provisions of the Act of Congress 
approved March 4, 1913 (21 U.S.C. 151).
``(E) A device that may lawfully be marketed pursuant to 
section 510(k), 513, or 515.
``(F) A food additive for which there is in effect a 
regulation issued under section 409 prescribing the conditions 
under which such additive may be safely used, if the additive's 
use or intended use is in conformity with such regulation.
``(G) Any cannabis plant actively under cultivation that is 
being cultivated in accordance with the requirements of 
subtitle G of the Agricultural Marketing Act of 1946 (7 U.S.C. 
1639o et seq.).
``(vv)(1) The term `inhalable cannabinoid hemp product' means a 
cannabinoid hemp product intended to be delivered to the respiratory 
tract by oral inhalation, such as by smoking, combusting, or 
aerosolizing, and regardless of whether done through the use of a 
device, including devices such as vaporizers.
``(2) Such term includes any component, part, or accessory thereof.
``(ww)(1) The term `oral cannabinoid hemp product' means a 
cannabinoid hemp product intended for oral consumption through 
ingestion, sublingual absorption, or buccal absorption.
``(2) Such term includes an edible product, a beverage, a tincture, 
an oil, a tablet, a capsule, an oral pouch, a softgel, and a gelcap.
``(3) Such term does not include a topical product or product for 
inhalation.
``(xx)(1) The term `prohibited cannabinoid product' means, except 
as provided in subparagraph (2), any product for human or animal use 
that meets one or more of the following criteria:
``(A) In the case of an oral cannabinoid hemp product, the 
product contains or purports to contain an amount per serving 
of total intoxicating cannabinoid content that exceeds the 
applicable threshold specified under section 1012.
``(B) In the case of an oral cannabinoid hemp product, the 
product contains or purports to contain an amount per package 
or container of total intoxicating cannabinoid content that 
exceeds the applicable threshold specified under section 1012.
``(C) In the case of a cannabinoid hemp product for 
inhalation, the material to be inhaled in the product contains 
or purports to contain more than 0.3 percent on a weight basis 
of total intoxicating cannabinoid content in the product form 
for its intended use.
``(D) In the case of a cannabinoid hemp product for 
inhalation that is required under section 1005(e) to utilize a 
prefilled, nonrefillable cartridge, the cartridge contains or 
purports to contain an amount of total cannabinoid content that 
exceeds the applicable threshold specified under section 1012.
``(E) In the case of a topical cannabinoid hemp product, 
the product is, or is intended to be, systemically absorbed 
through the skin.
``(F) In the case of a topical cannabinoid hemp product, 
the product contains or purports to contain more than 0.3 
percent on a weight basis.
``(G) The product contains, or purports to contain, a 
cannabinoid of the type referred to in paragraph 
(tt)(1)(A)(xii), or another cannabinoid that is not naturally 
occurring in the plant Cannabis sativa L. or is produced by the 
plant Cannabis sativa L. only through genetic engineering or 
other manipulation of the plant.
``(H) The product is a cannabinoid hemp product that does 
not meet the definition of an oral cannabinoid hemp product, 
inhalable cannabinoid hemp product, or topical cannabinoid hemp 
product.
``(I) The product is a cannabinoid hemp product intended 
for, used in or on, food-producing animals.
``(2) The term `prohibited cannabinoid product' does not include--
``(A) any product specified in clauses (A) through (G) of 
paragraph (uu)(2); and
``(B) marijuana as defined in section 102(16) of the 
Controlled Substances Act.
``(yy) The term `topical cannabinoid hemp product' means a 
cannabinoid hemp product intended to be applied externally to the body 
or any part thereof.
``(zz) The term `total intoxicating cannabinoid content' means the 
total amount of all chemicals present in a cannabinoid hemp product 
that satisfy any of the following:
``(1) The chemicals meet the criteria of subclause (iv) or 
(v) of paragraph (tt)(1)(A).
``(2) The chemicals are deemed by the Secretary under 
paragraph (tt)(1)(D) as meeting the criteria specified in 
paragraph (tt)(1)(B) by reference to--
``(A) chemicals meeting the criteria of subclause 
(iv) or (v) of paragraph (tt)(1)(A); or
``(B) hexahydrocannabinols or tetrahydrocannabinols 
meeting the criteria specified in paragraph 
(tt)(1)(A)(xii).
``(3) Any other chemical that--
``(A) the Secretary has deemed to be a cannabinoid 
under paragraph (tt)(1)(D); and
``(B) has, or is marketed to have, a 
pharmacological effect that is similar to--
``(i) chemicals meeting the criteria of 
subclause (iv) or (v) of paragraph (tt)(1)(A); 
or
``(ii) hexahydrocannabinols or 
tetrahydrocannabinols meeting the criteria 
specified in paragraph (tt)(1)(A)(xii).''.

SEC. 4. CANNABINOID HEMP PRODUCT REGULATION.

(a) In General.--The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended--
(1) by redesignating chapter X as chapter XI;
(2) by redesignating sections 1001 through 1014 as sections 
1101 through 1114;
(3) in section 505(n)(2), by striking ``section 1004'' and 
inserting ``section 1104'';
(4) in section 516(a), in the matter following paragraph 
(2), by striking ``section 1006'' and inserting ``section 
1106'';
(5) in section 704(g)(13), by striking ``section 1003(g)'' 
and inserting ``section 1103(g)'';
(6) in subsection (a)(5)(A) of section 1109 (as 
redesignated by paragraph (2)), by striking ``section 1008'' 
and inserting ``section 1108''; and
(7) by inserting after chapter IX the following:

``CHAPTER X--CANNABINOID HEMP PRODUCTS

``SEC. 1001. DEFINITIONS.

``For the purposes of this chapter:
``(1) Adverse event.--The term `adverse event' means any 
health-related event associated with a cannabinoid hemp product 
that is adverse.
``(2) Derivative.--The term `derivative' includes chemical 
modifications of substances, including chemical modifications 
of substances obtained from cannabis.
``(3) Facility.--The term `facility' includes any 
establishment (including an establishment of an importer) that 
manufactures, processes, labels, or imports cannabinoid hemp 
products.
``(4) Responsible person.--The term `responsible person' 
means the manufacturer, packer, or distributor of a cannabinoid 
hemp product whose name appears on the label of such product.
``(5) Serious adverse event.--The term `serious adverse 
event' means an adverse event that results in--
``(A) death;
``(B) a life-threatening adverse event;
``(C) inpatient hospitalization or prolongation of 
existing hospitalization;
``(D) a persistent or significant disability or 
incapacity;
``(E) a congenital anomaly or birth defect; or
``(F) a serious medical event that requires, based 
on reasonable medical judgment, a medical or surgical 
intervention to prevent an outcome described in 
subparagraphs (A) through (E).

``SEC. 1002. ADULTERATED CANNABINOID HEMP PRODUCTS.

``A cannabinoid hemp 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 prepared, packed, or held under 
insanitary conditions whereby it may have been contaminated 
with filth, or whereby it may have been rendered injurious to 
health;
``(3) its package is composed, in whole or in part, of any 
poisonous or deleterious substance which may render the 
contents injurious to health;
``(4) its content of total cannabinoids exceeds any limit 
set forth in section 201(xx);
``(5) it is a cannabinoid hemp product intended for, or to 
be used in or on, food-producing animals;
``(6) it contains any added substance, such as alcohol, 
caffeine, tobacco, nicotine, or melatonin, or another substance 
with effects that could interact with cannabinoids or enhance 
or alter their effects as determined by the Secretary by order;
``(7) it is an oral cannabinoid hemp product and it bears 
or contains any food additive that is unsafe within the meaning 
of section 409;
``(8) it is intended for use in animals and--
``(A) is also intended for use by humans;
``(B) is an inhalable cannabinoid hemp product; or
``(C) is sold in a place or in a manner such that a 
member of the general public under customary conditions 
of purchase would believe it will be used by humans;
``(9) it has been manufactured, 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;
``(10) in the case of an oral cannabinoid hemp product, it 
fails to comply with the requirements of subsection (a) or (c) 
of section 1004;
``(11) in the case of an inhalable cannabinoid hemp 
product, it fails to comply with the requirements of subsection 
(a), (b), (c), (d), (e), (g), or (h) of section 1005; or
``(12) in the case of a topical cannabinoid hemp product, 
it fails to comply with the requirements of section 1006.

``SEC. 1003. MISBRANDED CANNABINOID HEMP PRODUCTS.

``A cannabinoid hemp product shall be deemed misbranded if--
``(1) its labeling is false or misleading in any 
particular;
``(2) its advertising or promotion is false or misleading 
in any particular;
``(3) it is in package form unless it bears a label 
containing--
``(A) the name, place of business, and contact 
information of the manufacturer, packer, or 
distributor;
``(B) an accurate statement of the quantity of the 
contents in terms of weight, measure, and numerical 
count;
``(C) a statement on the front of the product 
packaging indicating that the product is a cannabinoid 
hemp product;
``(D) in the case of an oral cannabinoid hemp 
product--
``(i) the serving size; and
``(ii) the number of servings per 
container;
``(E) the ingredients;
``(F) the content per serving and per package of--
``(i) cannabidiol, even if absent; and
``(ii) total naturally occurring 
intoxicating cannabinoid content, even if 
absent;
``(G) the content of all cannabinoids other than 
those specified in clause (F), if present above a 
specified level, per serving and per package;
``(H) for products intended for human use, a 
disclaimer of the presence in the product of any major 
food allergen, processing aid, or compound, which the 
Secretary may, by order, require to be disclosed;
``(I) a disclaimer of known risks to special 
populations, including children, those who are pregnant 
or breastfeeding, and those taking drugs known to 
interact with the product;
``(J) a quick response (QR) code, any other 
scannable mechanism, or internet address that leads to 
a web page with testing results for the cannabinoid 
hemp product in the form of a certificate of analysis;
``(K) clear instructions of use, if applicable; and
``(L) information about how to report adverse 
events;
``(4) it is in package form unless it bears a label 
formatted in such manner as the Secretary may prescribe by 
order;
``(5) it exceeds dose limits or otherwise does not meet the 
standards specified in section 1004;
``(6) the Secretary has issued orders requiring that its 
labeling bear adequate directions for use, or adequate warnings 
against use by children, that are necessary for the protection 
of users, unless its labeling conforms in all respects to such 
orders;
``(7) 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 general 
public under customary conditions of purchase and use;
``(8) its labeling does not include a disclaimer of risks 
posed by the specific cannabinoid contained or purported to be 
contained in the product, including the risk of drug test 
failure;
``(9) its labeling does not include a disclaimer that the 
Food and Drug Administration has not determined the product to 
be safe or effective for treating any condition;
``(10) its labeling does not include a statement that the 
product is not required to meet standards for foods or dietary 
supplements;
``(11) its labeling makes a claim regarding the product's 
effect (or lack thereof) on the structure or any function of 
the body of humans or other animals;
``(12) it is in package form and the product packaging does 
not meet the requirements of section 1700.15 of title 16, Code 
of Federal Regulations (or any successor regulations);
``(13) it is in package form containing multiple servings 
that are not in prepacked servings unless such packaging 
includes one or more indicators or barriers to entry which, if 
breached or missing, can reasonably be expected to provide 
visible evidence to consumers that tampering has occurred;
``(14) it is in package form intended for use by humans, 
and it contains product packaging features imitating images 
popularly used to advertise to children or otherwise market to 
anyone under 21 years of age, including--
``(A) labeling depicting or in the shape of 
characters (real or imaginary), animals, vehicles, 
cartoons, candy, or fruit; and
``(B) brightly colored products and packaging;
``(15) it is in package form intended for use in animals, 
and its label and labeling do not contain prominently placed, 
conspicuous--
``(A) warnings that the product should not be used 
by humans; and
``(B) statements that the product is intended for 
use in animals, including any such statements 
specifying the intended species;
``(16)(A) it was manufactured, processed, packed, labeled, 
imported, or held by or in an establishment not duly registered 
under section 1009(a);
``(B) it was not included in a list required by section 
1009(b); or
``(C) it was manufactured, processed, packed, labeled, 
imported, or held by or in an establishment for which the 
registration was suspended under section 1009(d) and the 
registration has not been reinstated;
``(17) there was a failure or refusal to furnish any 
material or information required by section 1008;
``(18) it is labeled as a dietary supplement, or otherwise 
purports to be a dietary supplement;
``(19) in the case of an oral cannabinoid hemp product, it 
fails to comply with the requirements of section 1004(b);
``(20) in the case of an inhalable cannabinoid hemp 
product, it fails to comply with the requirements of section 
1005(f);
``(21) in the case of a topical cannabinoid hemp product, 
it fails to comply with the requirements of section 1006; or
``(22) any word, statement, or other information required 
by or under this Act to appear on the label or labeling is not 
in compliance with any formatting requirements as the Secretary 
may specify by order.

``SEC. 1004. STANDARDS FOR ORAL CANNABINOID HEMP PRODUCTS.

``(a) Additional Requirements.--An oral cannabinoid hemp product 
shall be subject to the requirements of this section, in addition to 
any other requirements of this Act applicable to cannabinoid hemp 
products.
``(b) Serving Size and Content Limits.--
``(1) Oral cannabinoid hemp products.--An oral cannabinoid 
hemp product shall contain no more than the amount of total 
cannabinoids or of specified individual cannabinoids per 
serving and per package as the Secretary may specify by 
regulation under section 1012.
``(2) Package containing multiple servings of oral 
cannabinoid hemp products.--If a package contains multiple 
servings of oral cannabinoid hemp products, the contents shall 
be divided and separated from each other into portions 
equivalent to one serving.
``(3) Liquid containers.--Liquid containers of oral 
cannabinoid hemp products shall--
``(A) contain only one serving; or
``(B) include with such container a convenient 
device for measuring servings, such as a dropper or 
measuring cup.
``(c) Labeling Standards for Oral Cannabinoid Hemp Products.--
``(1) Front-of-package labeling.--An oral cannabinoid hemp 
product shall include prominent labeling on the front of the 
product packaging clearly indicating that it is a cannabinoid 
hemp product.
``(2) Standardized information panel.--The Secretary may 
prescribe by order a standardized format, label panel, or 
identifying symbols under which label information required 
under this subsection and section 1003 shall be displayed.
``(d) Tamper-Evident and Child Safety Packaging.--The Secretary may 
issue orders to establish requirements for tamper-evident and child 
safety packaging for oral cannabinoid hemp products.

``SEC. 1005. STANDARDS FOR INHALABLE CANNABINOID HEMP PRODUCTS.

``(a) Additional Requirements.--An inhalable cannabinoid hemp 
product shall be subject to the requirements of this section, in 
addition to any other requirements of this Act applicable to 
cannabinoid hemp products.
``(b) Sourcing.--An inhalable cannabinoid hemp product shall not 
contain, nor shall any ingredient or substance used in an inhalable 
cannabinoid hemp product contain, a pesticide chemical residue that is 
at a level greater than is specified by any tolerance under this Act or 
under the Federal Insecticide, Fungicide, and Rodenticide Act.
``(c) Ingredients and Additives.--An inhalable cannabinoid hemp 
product shall not include any of the following:
``(1) Any added terpene or flavoring agent unless such 
terpene or flavoring agent is designated by the Secretary by 
order as being both--
``(A) naturally occurring in the plant Cannabis 
sativa L.; and
``(B) not posing an unreasonable risk to the public 
health.
``(2) Any amount of total or specific naturally occurring 
terpene or flavoring agent that exceeds the concentration 
limits as set forth by the Secretary by order.
``(3) Any ingredient that is not a cannabinoid, or is not 
derived from the plant Cannabis sativa L., unless--
``(A) the Secretary has, by order, established a 
level at which such ingredient may permissibly be added 
to inhalable cannabinoid hemp products without posing 
an unreasonable risk to the public health; and
``(B) the ingredient is added in accordance with 
such order.
``(d) Solvents and Extraction Methods Used in Manufacturing.--An 
inhalable cannabinoid hemp product shall not be manufactured using any 
solvent, extraction method, or other means of production unless the 
Secretary has designated by order that such solvent, extraction method, 
or other means of production is permissible because it poses no 
unreasonable risk to the public health. With respect to any solvent so 
permitted to be used in the manufacturing process, the Secretary may, 
by order, limit the amount of residual solvent.
``(e) Components, Parts, and Accessories.--A component, part, or 
accessory of an inhalable cannabinoid hemp product shall--
``(1) not present an unreasonable risk to the public 
health;
``(2) meet each of the standards established by the 
Secretary by order, including standards regarding--
``(A) the types of materials determined to be 
permissible for use as a component, part, or accessory 
of such a product;
``(B) the permissible level of one or more 
leachable substances from such a component, part, or 
accessory;
``(C) specifications related to the heating, 
burning, or combusting of any such materials; or
``(D) specifications for temperature controls; or
``(3) meet any standard (or a portion of such standard) 
established by a third-party, standard-setting entity for which 
the Secretary publishes an order adopting such standard (or 
portion).
``(f) Prefilled and Nonrefillable Cartridges or Devices.--
``(1) In general.--Except for an inhalable cannabinoid hemp 
product described in paragraph (2), any inhalable cannabinoid 
hemp product, including an oil, concentrate, or extract (such 
as a resinous extract or secretion of the plant Cannabis sativa 
L.), that is marketed or intended for use via aerosolization 
shall be sold in a cartridge or device that is prefilled and 
nonrefillable.
``(2) Exception.--Paragraph (1) shall not apply with 
respect to an inhalable cannabinoid hemp product that consists 
of whole cannabis inflorescence processed only through 
trimming, drying, curing, or grinding, or a combination of such 
methods.
``(g) Labeling Standards for Inhalable Cannabinoid Hemp Products.--
``(1) In general.--The label of an inhalable cannabinoid 
hemp product shall prominently display in boldface type a 
warning statement determined appropriate by the Secretary.
``(2) Prefilled, nonrefillable cartridges or devices.--Any 
cartridge or device described in subsection (f)(1) shall, in 
addition to the statement described in paragraph (1), bear a 
standardized mark or symbol (in such manner as may be specified 
by the Secretary by order) on the label identifying the 
cartridge or device as containing cannabinoids.
``(h) Additional Content Limits.--In addition to any other 
applicable content limits, a cartridge or device described in 
subsection (f)(1) shall contain not more total cannabinoid content than 
the applicable threshold specified under section 1012.
``(i) Pre-Market Notification.--
``(1) New products.--Except as specified in paragraph (2), 
not later than 90 days before introducing or delivering for 
introduction into interstate commerce an inhalable cannabinoid 
hemp product, a person seeking to so introduce or deliver such 
product and who is required to register under section 1009 
shall report to the Secretary (in such form and manner as the 
Secretary shall prescribe) the product's formulation and 
labeling.
``(2) Existing products.--In the case of a person described 
in paragraph (1) who is the responsible person with respect to 
an inhalable cannabinoid hemp product that, as of the date of 
the enactment of the Hemp Enforcement, Modernization, and 
Protection Act, has been introduced or delivered for 
introduction into interstate commerce, such person shall report 
to the Secretary (in such form and manner as the Secretary 
shall prescribe), the product's formulation and labeling not 
later than 60 days after such date of enactment.
``(j) Labeling Standards for Inhalable Cannabinoid Hemp Products.--
``(1) Front-of-package labeling.--An inhalable cannabinoid 
hemp product shall include prominent labeling on the front of 
the product packaging clearly indicating that it is a 
cannabinoid hemp product.
``(2) Standardized information panel.--The Secretary may 
prescribe by order a standardized format, label panel, or 
identifying symbols under which label information required 
under this subsection and section 1003 shall be displayed.
``(k) Tamper-Evident and Child Safety Packaging.--The Secretary may 
issue orders to establish requirements for tamper-evident and child 
safety packaging for inhalable cannabinoid hemp products.

``SEC. 1006. STANDARDS FOR TOPICAL CANNABINOID HEMP PRODUCTS.

``(a) Additional Requirements.--A topical cannabinoid hemp product 
shall be subject to the requirements of this section, in addition to 
any other requirements of this Act applicable to cannabinoid hemp 
products.
``(b) Content Limits for Topical Cannabinoid Hemp Products.--A 
topical cannabinoid hemp product shall contain not more than the amount 
of total cannabinoids per package, or such other amount of total 
cannabinoids, or of specified individual cannabinoids per package, as 
the Secretary may specify under section 1012.
``(c) Labeling Standards for Topical Cannabinoid Hemp Products.--
``(1) Front-of-package labeling.--A topical cannabinoid 
hemp product shall include prominent labeling on the front of 
the product packaging clearly indicating that it is a 
cannabinoid hemp product.
``(2) Standardized information panel.--The Secretary may 
prescribe by order a standardized format, label panel, or 
identifying symbols under which label information required 
under this subsection and section 1003 shall be displayed.
``(d) Tamper-Evident and Child Safety Packaging.--The Secretary may 
issue orders to establish requirements for tamper-evident and child 
safety packaging for topical cannabinoid hemp products.

``SEC. 1007. MINIMUM AGE OF SALE.

``It shall be unlawful for any retailer to sell a cannabinoid hemp 
product to any person younger than 21 years of age.

``SEC. 1008. MANUFACTURING AND TESTING.

``(a) Uniform Requirements.--Cannabinoid hemp products shall be 
subject to uniform manufacturing and testing requirements established 
by order by the Secretary that shall include--
``(1) specifications for key components, potential 
contaminants, and cannabinoid content; and
``(2) any other manufacturing and testing standards the 
Secretary determines necessary.
``(b) Standards Developed by Appropriate Standard-Setting Bodies.--
In establishing requirements under subsection (a), the Secretary may 
recognize and rely upon standards developed by appropriate standard-
setting bodies that have relevant expertise and are subject to third-
party auditing.
``(c) Inspection of Records.--The Secretary may inspect records as 
necessary to demonstrate compliance with manufacturing and testing 
requirements under this section.

``SEC. 1009. FACILITY REGISTRATION AND PRODUCT LISTING.

``(a) Registration.--
``(1) In general.--Any facility engaged in manufacturing, 
processing, packing, importing, labeling, or holding 
cannabinoid hemp products for consumption in the United States 
shall be registered with the Secretary. To be registered--
``(A) in the case of a domestic facility, the 
owner, operator, or agent in charge of the facility 
shall submit a registration to the Secretary; and
``(B) in the case of a foreign facility, the owner, 
operator, or agent in charge of the facility shall--
``(i) submit a registration to the 
Secretary; and
``(ii) include with the registration the 
name of the United States agent for the 
facility.
``(2) Registration.--
``(A) Contents.--An entity (referred to in this 
section as the `registrant') shall submit a 
registration under paragraph (1) to the Secretary 
containing--
``(i) information necessary to notify the 
Secretary of the name, address, and telephone 
number of each facility at which, and all trade 
names under which, the registrant conducts 
business;
``(ii) the email address and telephone 
number for the contact person of the facility 
or, in the case of a foreign facility, the 
United States agent for the facility;
``(iii) the general activities conducted, 
including with respect to each cannabinoid hemp 
product category manufactured, processed, 
packed, or held at such facility;
``(iv) the facility registration number, if 
any, previously assigned by the Secretary;
``(v) all brand names under which products 
manufactured, processed, or packaged in the 
facility are sold; and
``(vi) such other information as the 
Secretary may require.
``(B) Inspection.--A registration under paragraph 
(1) shall contain an assurance that the Secretary will 
be permitted to inspect the facility at the times and 
in the manner permitted by this Act.
``(C) Time and manner of submission.--A 
registration under paragraph (1) shall be submitted at 
such time and in such manner as the Secretary may 
prescribe.
``(3) Initial registration.--
``(A) Existing facilities.--Every person that, on 
the date of the enactment of the Hemp Enforcement, 
Modernization, and Protection Act, owns or operates a 
facility that engages in the manufacturing, processing, 
packing, importing, labeling, or holding of a 
cannabinoid hemp product for distribution in the United 
States shall register such facility with the Secretary 
not later than 1 year after such date of enactment.
``(B) New facilities.--Every person that owns or 
operates a facility that engages in the manufacturing, 
processing, packing, or holding of a cannabinoid hemp 
product for distribution in the United States shall 
register with the Secretary such facility within 60 
days of first engaging in such activity or 60 days 
after the deadline for registration under subparagraph 
(A), whichever is later.
``(4) Biennial registration renewal.--A person required to 
register a facility under paragraph (1) shall renew such 
registrations with the Secretary biennially.
``(5) Procedure.--At the time of the initial registration 
of any facility under paragraph (3), the Secretary shall assign 
a facility registration number to the facility. Upon receipt of 
a completed registration described in paragraph (1), the 
Secretary shall notify the registrant of the receipt of such 
registration.
``(6) Up-to-date list.--The Secretary shall compile and 
maintain an up-to-date list of facilities that are registered 
under this section. Such list and any registration documents 
submitted pursuant to this subsection shall not be subject to 
disclosure under section 552 of title 5, United States Code. 
Information derived from such list or registration documents 
shall not be subject to disclosure under section 552 of title 
5, United States Code, to the extent that such information 
discloses the identity or location of a specific registered 
person.
``(b) Cannabinoid Hemp Product Listing.--
``(1) In general.--For each cannabinoid hemp product, the 
responsible person shall submit to the Secretary a cannabinoid 
hemp product listing, or ensure that such submission is made, 
at such time and in such manner as the Secretary may prescribe.
``(2) Listing.--
``(A) In general.--Not later than 120 days after 
the first day on which a cannabinoid hemp product 
(other than an inhalable cannabinoid hemp product) is 
marketed, the responsible person for such product shall 
submit to the Secretary a cannabinoid hemp product 
listing for such product, except as provided in 
subparagraph (B).
``(B) Currently marketed products.--In the case of 
a cannabinoid hemp product (other than an inhalable 
cannabinoid hemp product), that was marketed before the 
date of the enactment of the Hemp Enforcement, 
Modernization, and Protection Act, or that is first 
marketed within 245 days after such date of enactment, 
the responsible person shall submit to the Secretary a 
cannabinoid hemp product listing not later than 1 year 
after such date of enactment.
``(C) Inhalable cannabinoid hemp products.--
``(i) In general.--Not later than 90 days 
after the first day on which an inhalable 
cannabinoid hemp product is marketed, the 
responsible person for such product shall 
submit to the Secretary a cannabinoid hemp 
product listing for such product, except as 
provided in clause (ii).
``(ii) Currently marketed inhalable 
cannabinoid hemp products.--In the case of an 
inhalable cannabinoid hemp product that was 
marketed before the date of the enactment of 
the Hemp Enforcement, Modernization, and 
Protection Act, or that is first marketed 
within 455 days after such date of enactment, 
the responsible person shall submit to the 
Secretary a cannabinoid hemp product listing 
not later than 1 year after such date of 
enactment.
``(D) Updates.--A responsible person for a 
cannabinoid hemp product shall, beginning one year 
after the date on which such cannabinoid hemp product 
is first listed under subparagraph (A), (B), or (C), 
submit to the Secretary an update of such listing on an 
annual basis.
``(3) Contents of listing.--
``(A) In general.--Each listing under paragraph (1) 
shall include--
``(i) the facility registration number of 
each facility where the cannabinoid hemp 
product is manufactured or processed;
``(ii) the name and contact number of the 
responsible person;
``(iii) the name of the cannabinoid hemp 
product, as such name appears on the label;
``(iv) the name and contact number of the 
person submitting the listing;
``(v) an electronic copy of the label, and 
an electronic copy of the package insert, if 
any;
``(vi) a list of ingredients, and the 
amount of cannabinoids, in the cannabinoid hemp 
product;
``(vii) the product listing number, if any, 
previously assigned by the Secretary;
``(viii) whether the product is an oral 
cannabinoid hemp product, inhalable cannabinoid 
hemp product, or topical cannabinoid hemp 
product; and
``(ix) any other information as the 
Secretary may by order require.
``(B) Flexible listings.--A single listing 
submission under paragraph (1) for a cannabinoid hemp 
product may include multiple cannabinoid hemp products 
with identical formulations, or formulations that 
differ only with respect to flavors or quantity of 
contents.
``(C) Updates.--A responsible person that is 
required to submit a cannabinoid hemp product listing 
under paragraph (1) shall submit any updates to such 
listing annually.
``(D) Optional inclusion in facility 
registration.--A responsible person may submit a 
listing required by paragraph (1) as part of a facility 
registration or separately.
``(c) Facility Registration and Product Listing Numbers.--At the 
time of the initial registration of any facility or initial listing of 
any cannabinoid hemp product, the Secretary shall assign--
``(1) a facility registration number to the facility; and
``(2) product listing numbers for the listed products.
``(d) Suspensions.--
``(1) Suspension of registration of a facility.--The 
Secretary may suspend the registration of a facility under this 
section if the Secretary--
``(A) determines that a cannabinoid hemp product 
manufactured, processed, packed, or held by such 
facility and distributed in the United States has a 
reasonable probability of causing serious adverse 
health consequences or death to humans or other 
animals; and
``(B) has a reasonable belief that other products 
manufactured, processed, packed, or held by such 
facility may be similarly affected because of a failure 
that--
``(i) cannot be isolated to a product or 
products; or
``(ii) is sufficiently pervasive to raise 
concerns about other products manufactured, 
processed, packed, or held in the facility.
``(2) Notice of suspension.--Before suspending a facility 
registration under this section, the Secretary shall provide--
``(A) notice to the registrant or other responsible 
person, as appropriate, of the intent to suspend the 
facility registration, which notice shall specify the 
basis of the determination by the Secretary that the 
facility registration should be suspended; and
``(B) an opportunity, within 5 business days of 
providing the notice under subparagraph (A), for the 
responsible person to provide a plan for addressing the 
reasons for possible suspension of the facility 
registration.
``(3) Hearing of suspension.--The Secretary shall--
``(A) provide the registrant subject to a notice of 
suspension under paragraph (2) with an opportunity for 
an informal hearing, to be held as soon as possible but 
not later than 5 business days after the issuance of 
the notice, or such other time period agreed upon by 
the Secretary and the registrant, on the actions 
required for reinstatement of registration and why the 
registration that is subject to the suspension should 
be reinstated; and
``(B) reinstate the registration if the Secretary 
determines, based on evidence presented, that adequate 
grounds do not exist to continue the suspension of the 
registration.
``(4) Post-hearing corrective action plan.--If, after 
providing opportunity for an informal hearing, the Secretary 
determines that the suspension of registration remains 
necessary, the Secretary shall--
``(A) require the registrant to submit a corrective 
action plan to demonstrate how the registrant plans to 
correct the conditions found by the Secretary; and
``(B) review such plan not later than 14 business 
days after the submission of the plan or such other 
time period as determined by the Secretary, in 
consultation with the registrant.
``(5) Vacating of order; reinstatement.--Upon a 
determination by the Secretary that adequate grounds do not 
exist to continue the suspension of a facility's registration 
under this subsection, the Secretary shall promptly vacate the 
suspension and reinstate the registration of the facility.
``(6) Effect of suspension.--If the registration of the 
facility is suspended under this section, no person shall--
``(A) export or import cannabinoid hemp products 
into the United States from such facility;
``(B) offer to export or import cannabinoid hemp 
products into the United States from such facility; or
``(C) otherwise introduce or deliver for 
introduction into interstate commerce cannabinoid hemp 
products from such facility.

``SEC. 1010. INSPECTION OF FOREIGN CANNABINOID HEMP FACILITIES.

``(a) Inspection.--The Secretary--
``(1) may enter into arrangements and agreements with 
foreign governments to facilitate the inspection of foreign 
facilities registered under section 1009; and
``(2) shall direct resources to inspections of foreign 
facilities, suppliers, and cannabinoid hemp products, 
especially such facilities, suppliers, and cannabinoid hemp 
products that present a high risk (as identified by the 
Secretary), to help ensure the safety and security of the 
supply of such products in the United States.
``(b) Effect of Inability To Inspect.--Notwithstanding any other 
provision of law, a cannabinoid hemp product shall be refused admission 
into the United States if it is from a foreign factory, warehouse, or 
other establishment of which the owner, operator, or agent in charge, 
or the government of the foreign country, refuses to permit entry of 
United States inspectors or other individuals duly designated by the 
Secretary, upon request, to inspect such factory, warehouse, or other 
establishment. For purposes of this subsection, such an owner, 
operator, or agent in charge shall be considered to have refused an 
inspection if such owner, operator, or agent in charge does not permit 
an inspection of a factory, warehouse, or other establishment during 
the 24-hour period after such request is submitted, or after such other 
time period, as agreed upon by the Secretary and the foreign factory, 
warehouse, or other establishment.

``SEC. 1011. MANDATORY RECALL AUTHORITY.

``(a) In General.--If the Secretary determines that there is a 
reasonable probability that a cannabinoid hemp product is adulterated 
under section 1002 or misbranded under section 1003 and the use of or 
exposure to such cannabinoid hemp product will cause serious adverse 
health consequences or death, the Secretary shall provide the 
responsible person with an opportunity to voluntarily cease 
distribution and recall such article. If the responsible person refuses 
to or does not voluntarily cease distribution or recall such 
cannabinoid hemp product within the time and manner prescribed by the 
Secretary (if so prescribed), the Secretary may, by order, require, as 
the Secretary determines necessary, such person to immediately cease 
distribution of such article.
``(b) Hearing.--The Secretary shall provide the responsible person 
who is subject to an order under subsection (a) with an opportunity for 
an informal hearing, to be held not later than 10 days after the date 
of issuance of the order, on whether adequate evidence exists to 
justify the order.
``(c) Order Resolution.--After an order is issued according to the 
process under subsections (a) and (b), the Secretary shall, except as 
provided in subsection (d)--
``(1) vacate the order, if the Secretary determines that 
inadequate grounds exist to support the actions required by the 
order;
``(2) continue the order ceasing distribution of the 
cannabinoid hemp product until a date specified in such order; 
or
``(3) amend the order to require a recall of the 
cannabinoid hemp product, including any requirements to notify 
appropriate persons, a timetable for the recall to occur, and a 
schedule for updates to be provided to the Secretary regarding 
such recall.
``(d) Action Following Order.--Any person who is subject to an 
order pursuant to paragraph (2) or (3) of subsection (c) shall 
immediately cease distribution of or recall, as applicable, the 
cannabinoid hemp product and provide notification as required by such 
order.
``(e) Notice to Persons Affected.--If the Secretary determines 
necessary, the Secretary may require the person subject to an order 
pursuant to subsection (a) or an amended order pursuant to paragraph 
(2) or (3) of subsection (c) to provide either a notice of a recall 
order for, or an order to cease distribution of, such cannabinoid hemp 
product, as applicable, under this section to appropriate persons, 
including persons who manufacture, distribute, import, or offer for 
sale such product that is the subject of an order and to the public.
``(f) Public Notification.--In conducting a recall under this 
section, the Secretary shall--
``(1) ensure that a press release is published regarding 
the recall, and that alerts and public notices are issued, as 
appropriate, in order to provide notification--
``(A) of the recall to consumers and retailers to 
whom such cannabinoid hemp product was, or may have 
been, distributed; and
``(B) that includes, at a minimum--
``(i) the name of the cannabinoid hemp 
product subject to the recall;
``(ii) a description of the risk associated 
with such article; and
``(iii) to the extent practicable, 
information for consumers about similar 
cannabinoid hemp products that are not affected 
by the recall; and
``(2) ensure publication, as appropriate, on the website of 
the Food and Drug Administration of an image of the cannabinoid 
hemp product that is the subject of the press release described 
in paragraph (1), if available.
``(g) Delegation.--The authority conferred by this section to order 
a recall or vacate a recall order shall not be delegated to any officer 
or employee other than the Commissioner, or an individual at or above 
the level of individuals empowered to approve a drug (such as division 
directors within the Center for Drug Evaluation and Research).
``(h) Effect.--Nothing in this section shall affect the authority 
of the Secretary to request or participate in a voluntary recall, or to 
issue an order to cease distribution or to recall under any other 
provision of this chapter.

``SEC. 1012. APPLICABLE THRESHOLDS FOR CANNABINOID CONTENT.

``(a) In General.--The Secretary shall issue a rule specifying--
``(1) the applicable thresholds for the content limits of 
total cannabinoid content in inhalable cannabinoid hemp 
products, oral cannabinoid hemp products, and topical 
cannabinoid hemp products for such products; and
``(2) the applicable thresholds for the content limits of 
total intoxicating cannabinoid content in oral cannabinoid hemp 
products.
``(b) Timing.--The Secretary shall--
``(1) not later than 60 days after the date of the 
enactment of the Hemp Enforcement, Modernization, and 
Protection Act, publish in the Federal Register a notice of 
proposed rulemaking with respect to the content limits referred 
to in subsection (a); and
``(2) not later than 3 years after such date of enactment, 
finalize the rule specified in such subsection.
``(c) Failure To Timely Finalize Final Rule.--If the Secretary 
fails to finalize the rule specified in subsection (a) within the 3-
year period specified in subsection (b)(2), the applicable threshold 
specified in this section shall be the following:
``(1) With respect to section 1004(b), 10 milligrams per 
serving, and 50 milligrams per package.
``(2) With respect to section 1005(h), 100 milligrams per 
serving, and 500 milligrams per package.
``(3) With respect to section 1006(b), 100 milligrams per 
serving, and 500 milligrams per package.
``(4) With respect to subparagraph (A) of section 
201(xx)(1), 5 milligrams per serving, and with respect to 
subparagraph (B) of such section, 30 milligrams per package or 
container.

``SEC. 1013. CANNABINOID HEMP PRODUCTS ADVISORY COMMITTEE.

``(a) Establishment.--The Secretary shall establish an advisory 
committee, to be known as the Cannabinoid Hemp Products Advisory 
Committee (in this section referred to as the `Advisory Committee').
``(b) Membership.--
``(1) In general.--
``(A) Members.--The Secretary shall appoint as 
members of the Advisory Committee individuals who--
``(i) are technically qualified by training 
and experience in medicine, medical ethics, 
science, or technology involving the 
manufacture, evaluation, or use of cannabinoid 
hemp products; and
``(ii) are of appropriately diversified 
professional backgrounds.
``(B) Composition.--The membership of the Advisory 
Committee shall be composed of 16 individuals, 
represented as follows:
``(i) 3 individuals representing the Food 
and Drug Administration.
``(ii) 7 individuals who are physicians, 
scientists, or health care professionals 
practicing in the area of oncology, 
pulmonology, cardiology, toxicology, 
pharmacology, addiction, or any other relevant 
specialty.
``(iii) 1 individual who is an officer or 
employee of a State or local government or of 
the Federal Government.
``(iv) 1 individual as a representative of 
the general public.
``(v) 1 individual with experience as a 
State regulator for Cannabis sativa L.
``(vi) 1 individual as a representative of 
the interests of the Cannabis sativa L. 
manufacturing industry.
``(vii) 1 individual as a representative of 
the interests of the small business cannabinoid 
hemp product manufacturing industry, which 
position may be filled on a rotating, 
sequential basis by representatives of 
different small business cannabinoid hemp 
product manufacturers based on areas of 
expertise relevant to the topics being 
considered by the Advisory Committee.
``(viii) 1 individual as a representative 
of the interests of the Cannabis sativa L. 
growers.
``(C) Nonvoting members.--The members of the 
Advisory Committee described in clauses (vi), (vii), 
and (viii) of subparagraph (B) shall serve as 
consultants to those described in clauses (i) through 
(iv) of subparagraph (B) and shall be nonvoting 
representatives.
``(D) Conflicts of interest.--No members of the 
Advisory Committee, other than members described in 
clauses (vi), (vii), and (viii) of subparagraph (B) 
shall, during the member's tenure on the committee or 
for the 18-month period prior to becoming such a 
member, receive any salary, grants, or other payments 
or support from any business that manufactures, 
distributes, markets, or sells cigarettes or other 
tobacco products.
``(2) Chairperson.--The Secretary shall designate 1 of the 
members described in clauses (ii), (iii), (iv), and (v) of 
paragraph (1)(B) to serve as chairperson.
``(c) Duties.--The Cannabinoid Products Advisory Committee shall 
provide advice, information, and recommendations to the Secretary--
``(1) as provided in this chapter;
``(2) on the limits (in milligrams) of total cannabinoid 
content allowed in cannabinoid hemp products, and categories 
thereof; and
``(3) on the limits (in milligrams) of total intoxicating 
cannabinoid content allowed in cannabinoid hemp products, and 
categories thereof, to be established pursuant to section 1012.
``(d) Compensation; Support; Chapter 10 of Title 5.--
``(1) Compensation and travel.--Members of the Advisory 
Committee who are not officers or employees of the United 
States, while attending conferences or meetings of the 
committee or otherwise engaged in its business, shall be 
entitled to receive compensation at rates to be fixed by the 
Secretary, which may not exceed the daily equivalent of the 
rate in effect under the Senior Executive Schedule under 
section 5382 of title 5, for each day (including travel time) 
they are so engaged; and while so serving away from their homes 
or regular places of business each member may be allowed travel 
expenses, including per diem in lieu of subsistence, as 
authorized by section 5703 of title 5 for persons in the 
Government service employed intermittently.
``(2) Administrative support.--The Secretary shall furnish 
the Advisory Committee clerical and other assistance.
``(3) Nonapplication of chapter 10 of title 5.--Section 
1013 of title 5 does not apply to the Advisory Committee.
``(e) Proceedings of Advisory Committees.--The Advisory Committee 
shall make and maintain a transcript of any proceeding of the Advisory 
Committee. Each such committee shall delete from any transcript made 
under this subsection information which is exempt from disclosure under 
section 552(b) of title 5.
``(f) Report to Congress.--The Advisory Committee shall report to 
Congress annually on--
``(1) any changes to the limits under section 1012 the 
Advisory Committee recommends; and
``(2) any other information the Advisory Committee 
determines necessary to carry out this chapter.''.
(b) Effective Date.--This section and the amendments made by this 
section shall apply with respect to cannabinoid hemp products 
introduced or delivered for introduction into interstate commerce on or 
after the date of the enactment of this Act.

SEC. 5. ENFORCEMENT.

(a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended--
(1) in paragraphs (a), (b), (c), (g), (h), and (k) by 
inserting ``cannabinoid hemp product,'' before ``or cosmetic'' 
each place such term appears;
(2) in paragraph (e), by striking ``or 920'' and inserting 
``920, or 1011'';
(3) in paragraph (ll)--
(A) in the matter preceding subparagraph (1), by 
striking ``or a drug or a biological product for which 
substantial clinical investigations have been 
instituted and for which the existence of such 
investigations has been made public'' and inserting ``a 
drug or a biological product for which substantial 
clinical investigations have been instituted and for 
which the existence of such investigations has been 
made public, or a cannabinoid hemp product'';
(B) in subparagraph (3)(E), by striking ``or'' at 
the end;
(C) in subparagraph (4), by striking the period at 
the end and inserting ``; or''; and
(D) by adding at the end the following:
``(5) the finished product is a cannabinoid hemp product 
that conforms with the requirements of this Act.''; and
(4) by adding at the end the following:
``(jjj)(1) The introduction or delivery for introduction into 
interstate commerce of a prohibited cannabinoid product;
``(2) the receipt in interstate commerce of a prohibited 
cannabinoid product, and the delivery or proffered delivery thereof for 
pay or otherwise;
``(3) the doing of any act with respect to an article, if such act 
is done while such article is held for sale (whether or not the first 
sale) after shipment in interstate commerce and results in such article 
being a prohibited cannabinoid product;
``(4) the holding for sale or distribution in interstate commerce 
of a prohibited cannabinoid product;
``(5) the sale by a retailer of a cannabinoid hemp product to any 
person younger than 21 years of age in violation of section 1007; or
``(6) the failure to adhere to uniform manufacturing and testing 
requirements in accordance with section 1008.
``(kkk) The refusal or failure to follow an order under section 
1011.''.
(b) Enhanced Criminal Penalties.--Section 303(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333(b)) is amended by adding at 
the end the following:
``(9) Enhanced Criminal Penalties.--Notwithstanding subsection (a), 
any person who knowingly violates section 301(jjj) shall be imprisoned 
for not more than 10 years or fined in accordance with title 18, United 
States Code, or both.''.
(c) Seizure.--Section 304 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 334) is amended--
(1) in subsection (a)(2)--
(A) by striking ``and (H)'' and inserting ``(H)''; 
and
(B) by inserting before the period at the end the 
following: ``, (I) Any adulterated or misbranded 
cannabinoid hemp product, and (J) Any prohibited 
cannabinoid product'';
(2) in subsection (d)(1)--
(A) by inserting ``cannabinoid hemp product,'' 
before ``or cosmetic''; and
(B) in the last sentence, by inserting ``an article 
in violation of section 301(jjj) or'' after ``by reason 
of its being''; and
(3) in subsection (g)--
(A) in paragraph (1)--
(i) by striking the first sentence and 
inserting the following: ``If during an 
inspection conducted under section 704 of a 
facility or a vehicle, a device, cannabinoid 
hemp product, or tobacco product, which the 
officer or employee making the inspection has 
reason to believe is adulterated or misbranded 
is found in such facility or vehicle, or the 
officer or employee making the inspection has 
reason to believe the product is a prohibited 
cannabinoid product, such officer or employee 
may order the device, cannabinoid hemp product, 
prohibited cannabinoid hemp product, or tobacco 
product detained (in accordance with 
regulations prescribed by the Secretary) for a 
reasonable period which may not exceed twenty 
days unless the Secretary determines that a 
period of detention greater than twenty days is 
required to institute an action under 
subsection (a) or section 302, in which case he 
may authorize a detention period of not to 
exceed thirty days.''; and
(ii) in each of the second, third, and 
fourth sentences, by striking ``device or 
tobacco product'' each place it appears and 
inserting ``device, cannabinoid hemp product, 
prohibited cannabinoid product, or tobacco 
product''; and
(B) in paragraph (2)(A), in the matter preceding 
clause (i), by striking ``device or tobacco product'' 
and inserting ``device, cannabinoid hemp product, 
prohibited cannabinoid product, or tobacco product''.
(d) Food Additives.--Section 409(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 348(a)) is amended by adding at the end of the 
matter following paragraph (3) the following: ``A food bearing or 
containing a cannabinoid hemp product that meets the requirements of 
chapter X shall not, by reason of bearing or containing such a 
cannabinoid hemp product, be considered adulterated under section 
402(a)(1).''.

SEC. 6. RULES OF CONSTRUCTION.

Except as expressly provided in this Act (or the amendments made by 
this Act), nothing in this Act (or such amendments) shall be construed 
as modifying or limiting--
(1) any applicable provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health 
Service Act (42 U.S.C. 201 et seq.); or
(2) the authority of the Secretary of Health and Human 
Services or the Commissioner of Food and Drugs under such Acts.
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