119 HR 7212 IH: Hemp Enforcement, Modernization, and Protection Act U.S. House of Representatives 2026-01-22 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I119th CONGRESS2d SessionH. R. 7212IN THE HOUSE OF REPRESENTATIVESJanuary 22, 2026Mr. Griffith (for himself and Mr. Veasey) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of cannabinoid hemp products, and for other purposes.

1.

Short title

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

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 ProductsSec. 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.

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)..

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:X

Cannabinoid Hemp Products

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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)..

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.