H.R. 7212 — Hemp Enforcement, Modernization, and Protection Act

This section amends the definitions in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) by—(1) excluding cannabinoid hemp products from the definition of tobacco product; (2) including cannabinoid hemp products in paragraph (rr)(2), alongside combination products; and (3) adding definitions of "(tt) cannabinoid," which encompasses specified chemical subclasses (e.g., cannabidiol, delta-9 tetrahydrocannabinol), structurally or pharmacologically similar chemicals, CB-1 or CB-2 receptor agonists derived from Cannabis, and others designated by the Secretary of Health and Human Services (HHS), who must publish and update a list within one year of enactment; "(uu) cannabinoid hemp product," meaning any article containing listed cannabinoids for human or animal use but excluding FDA-approved or investigational drugs, biologics (including those licensed under the Virus-Serum-Toxin Act, 21 U.S.C. 151, for domestic animals), lawfully marketed devices or food additives, and hemp plants under cultivation; "(vv) inhalable cannabinoid hemp product" (e.g., for smoking or vaporizing); "(ww) oral cannabinoid hemp product" (e.g., edibles, tinctures, excluding topicals or inhalables); and "(xx) prohibited cannabinoid product," including oral products exceeding intoxicating cannabinoid serving or package thresholds under section 1012, and inhalable products exceeding 0.3% total intoxicating cannabinoid content or cartridge limits under section 1005(e).

This section amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by redesignating chapter X as chapter XI and sections 1001 through 1014 as sections 1101 through 1114; updating cross-references in sections 505(n)(2), 516(a), 704(g)(13), and 1109(a)(5)(A) (as redesignated); and inserting a new chapter X after chapter IX to regulate cannabinoid hemp products. The new chapter X includes (1) definitions of key terms, including adverse event, derivative (i.e., chemical modifications of cannabis substances), facility (i.e., establishments that manufacture, process, label, or import such products), responsible person (i.e., manufacturer, packer, or distributor named on the label), and serious adverse event (i.e., resulting in death, hospitalization, disability, birth defect, or requiring medical intervention); (2) standards deeming cannabinoid hemp products adulterated under 12 conditions, including if contaminated, exceeding total cannabinoid limits in section 201(xx), intended for food-producing animals, containing added substances such as alcohol or caffeine, bearing unsafe food additives (for oral products), intended for animal use in ways suggesting human use, or failing to comply with manufacturing or labeling requirements in sections 1004 through 1006; and (3) standards deeming such products misbranded if labeling or advertising is false or misleading, lacking specified label elements (e.g., manufacturer information, quantity, cannabinoid content per serving/package including cannabidiol and intoxicating cannabinoids, ingredients, allergen disclaimers, use instructions, and QR code or link to certificate of analysis), or failing prescribed label formatting. (Thus, the provisions subject cannabinoid hemp products—derived from hemp legalized under the 2018 farm bill—to FDA enforcement for safety, labeling, and manufacturing, including mandatory disclosures of cannabinoid levels and risks to vulnerable populations.)

This section amends prohibited acts under section 301 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 331) to (1) include "cannabinoid hemp product" alongside food, drug, device, tobacco product, or cosmetic in paragraphs (a), (b), (c), (g), (h), and (k); (2) expand paragraph (e) to cover refusals or failures related to section 1011; (3) revise paragraph (ll) to exempt compliant cannabinoid hemp products (i.e., those conforming to chapter X requirements) from new drug provisions, in addition to drugs or biological products with public substantial clinical investigations; and (4) add new paragraphs (jjj), prohibiting the introduction into, receipt in, or other acts resulting in interstate commerce of prohibited cannabinoid products (i.e., non-compliant cannabinoid products), sales of cannabinoid hemp products to persons younger than 21 years of age in violation of section 1007, or failures to meet uniform manufacturing and testing requirements under section 1008, and (kkk), prohibiting refusals or failures to follow orders under section 1011. The section further (1) establishes enhanced criminal penalties under FDCA section 303(b) of up to 10 years imprisonment for knowing violations of section 301(jjj); (2) expands seizure authority under FDCA section 304 to include adulterated or misbranded cannabinoid hemp products and any prohibited cannabinoid products, with detention periods of up to 20 days (extendable to 30 days if needed to institute an action); and (3) amends FDCA section 409(a) to deem foods containing compliant cannabinoid hemp products not adulterated under section 402(a)(1).

This section clarifies that, except as expressly provided, nothing in the Act or its amendments modifies or limits provisions of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, or the authority of the Secretary of Health and Human Services or the Commissioner of Food and Drugs under those Acts.