FDA oversight and milligram limitations

(a) Definitions Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended— (1) in paragraph (g)(1), by adding at the end the following: Such term does not include a hemp-derived cannabinoid product.; (2) in paragraph (s), in the matter preceding subparagraph (1), by striking food (including any substance and inserting food (including industrial hemp intended for human or animal use and hemp seed, hemp seed oil, or hempseed protein not containing cannabinoids, any substance; and (3) by adding at the end the following: (tt) (1) The term hemp-derived cannabinoid product — (A) means any finished product for human or animal use that— (i) that meets the criteria specified in paragraph (1) to be considered hemp; and (ii) contains one or more cannabinoids; (B) includes a hemp-derived cannabinoid dietary supplement; (C) includes, in cases that the Secretary determines appropriate, an intermediate hemp-derived cannabinoid product; and (D) may include ingestibles, beverages, oral tinctures and sublinguals, capsules and tablets, inhalables, and topicals and transdermals. (2) A hemp-derived cannabinoid product shall be deemed to be a food within the meaning of this Act. (uu) The term hemp-derived cannabinoid dietary supplement — (1) means a dietary supplement that— (A) is derived from hemp; (B) contains one or more cannabinoids; and (C) is for ingestion in tablet, capsule, softgel, gelcap, powder, gummy, chew, lozenge, tincture, oil, spray, strip, or liquid form; (2) may include ingestibles, oral tinctures and sublinguals, and capsules and tablets; and (3) does not include— (A) any product for inhalation, application to the skin, or transdermal absorption; (B) raw, floral hemp material, an unfinished hemp-cannabinoid ingredient, or work-in-process materials; (C) industrial hemp; (D) hemp seed, hemp seed oil, or hempseed protein not containing cannabinoids; and (E) a product containing any cannabinoid not found in, or capable of being produced in, the hemp plant, as identified on the lists published and updated under section 425(d). (vv) The terms hemp, industrial hemp, and unfinished hemp-cannabinoid ingredient have the meanings given those terms in section 297A of the Agricultural Marketing Act of 1946. (ww) The term GRAS substance means a substance that is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use, as described in section 201(s).. (b) Prohibited acts Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following: (jjj) The introduction or delivery for introduction into interstate commerce of a hemp-derived cannabinoid product that is not derived exclusively from hemp cultivated in the United States, processed within the United States, and finished, packaged, and labeled within the United States. (kkk) (1) The sale of a hemp-derived cannabinoid product to any person younger than 21 years of age. (2) The possession or consumption of a hemp-derived cannabinoid product by any person younger than 21 years of age.. (c) Adulteration Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the following: (j) If it is a hemp-derived cannabinoid product, and— (1) its cannabinoid content exceeds a maximum allowable amount established under section 425(b); (2) it contains a cannabinoid not included on the lists published and updated under section 425(d); (3) it is a cannabinoid hemp product for, or to be used in or on, food-producing animals; (4) it contains any added substance, such as alcohol, caffeine, tobacco, nicotine, or melatonin, which, when combined with cannbinoids, could interact with such cannabinoids or enhance or alter the effects of such cannabinoids in a manner that is harmful to the consumer, as determined by the Secretary; (5) it contains a food additive or a GRAS substance, which when combined with the cannabinoids in such product, could cause harm to the consumer (as determined by the Secretary); or (6) 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 of, or refuses to permit entry to, or inspection of, such factory, warehouse, or establishment.. (d) Misbranding Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following: (z) If it is a hemp-derived cannabinoid product, and— (1) its labeling does not adhere to the requirements under section 425(a); (2) its advertising or promotion is false or misleading in any particular; (3) it is in package form, unless it bears a label formatted in such manner as the Secretary may prescribe by order; (4) its labeling does not bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users, or conform to such other requirements in all respects as may be prescribed by the Secretary; (5) 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; (6) 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; (7) 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; (8) it is in package form 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; (9) it is in package form 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 for use in animals, including any such statements specifying the intended species; (10) it was manufactured, processed, packed, labeled, or held by or in an establishment that has not been issued a permit under section 5902A of the Internal Revenue Code of 1986; (11) it does not adhere to the uniform manufacturing and testing requirements established under section 425(c) or there was a failure or refusal to provide access to any records as required under chapter 56 of the Internal Revenue Code of 1986; or (12) it is not in compliance with such formatting requirements as the Secretary may specify (such as a requirement for the use of standard and uniform labeling and an identifying symbol) with respect to any word, statement, or other information the Secretary requires to appear on the label or labeling of the product.. (e) Hemp-Derived cannabinoid products Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at the end the following: 425. Hemp-derived cannabinoid products (a) Labeling requirements A hemp-derived cannabinoid product shall be considered misbranded within the meaning of section 403(z) unless such labeling meets the following requirements: (1) Its principal display panel displays, in a font size not smaller than 8 points, the statement Contains __ mg THC per serving and __ mg THC per package. For users 21+ only., where the blanks shall be filled in with the applicable quantity of THC in milligrams per serving and per package, respectively. (2) (A) Its principal display panel bears a warning statement concerning the effects of consuming hemp-derived cannabinoid products, including with respect to pregnancy and impaired driving. (B) The statement under subparagraph (A) shall— (i) appear in a conspicuous and prominent location on the principal display panel; (ii) be printed in a font size not smaller than 6 points, or not smaller than the smallest type size used elsewhere on the label, whichever is larger; (iii) appear in a color that contrasts with the background on which it appears; (iv) include the words GOVERNMENT WARNING in capital letters and bold type; and (v) be worded in such manner as the Secretary, in consultation with the Surgeon General of the Public Health Service, determines appropriate. (3) If it is in package form, bears a label containing— (A) a statement on the front of the product packaging indicating that the product is a cannabinoid hemp product; (B) (i) the serving size; and (ii) the number of servings per package; (C) the ingredients; (D) the content per serving and per package of any and all cannabinoids, if present above a nominal level, as determined by the Secretary; (E) for products for human use, a disclaimer of the presence in the product of any major food allergen, processing aid, or compound, which the Secretary may require to be disclosed; (F) a statement clearly specifying if the product is intended for animal use, human use, or for use by humans and animals; (G) 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; (H) 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; (I) clear instructions of use, if applicable; and (J) information about how to report adverse events resulting from use of the product. (b) Maximum cannabinoid content (1) Establishment Not later than 12 months after the date of enactment of this section, the Secretary shall establish, with respect to any hemp-derived cannabinoid product— (A) a maximum allowable amount of total cannabinoid content for such product and each serving of such product; and (B) for each cannabinoid present in such a product, a maximum allowable amount of such cannabinoid for such product and each serving of such product. (2) Frequency of review The Secretary shall review and, as appropriate, revise the maximum allowable amounts under paragraph (1) not less frequently than— (A) once every 3 years; or (B) as soon as scientific evidence warrants reconsideration. (3) Rulemaking The Secretary shall establish and revise the maximum allowable amounts under paragraph (1) through a notice-and-comment rulemaking process that is informed by— (A) peer-reviewed scientific research on the safety and physiological effects of individual cannabinoids; (B) consumer usage data and adverse event reports; (C) input from qualified medical and scientific experts; (D) consultation with State regulatory authorities with experience overseeing hemp or cannabis markets; and (E) consideration of product form, intended use, and target consumer population. (4) Failure to timely establish maximum allowable amounts In the case that the Secretary fails to establish the maximum allowable amounts under paragraph (1) within the 12-month period described in such paragraph, until such time that the Secretary establishes alternative amounts, the following maximum allowable amounts for total tetrahydrocannabinol content shall apply: (A) With respect to a hemp-derived cannabinoid product for oral consumption, 5 milligrams per serving. (B) With respect to an inhalable hemp-derived cannabinoid product, 50 milligrams per serving. (C) With respect to a topical hemp-derived cannabinoid product, 50 milligrams per serving. (c) Manufacture and testing (1) Establishment The Secretary shall establish such uniform manufacturing and testing requirements for hemp-derived cannabinoid products (including intermediate hemp-derived cannabinoid products) as the Secretary determines to be necessary. Such requirements shall include the following: (A) Manufacturing and testing requirements for key components, potential contaminants, and cannabinoid content. (B) A requirement that each such product be tested by a laboratory accredited to ISO/IEC 17025— (i) following post-harvest processing, extraction, or any other manipulation, as determined by the Secretary; and (ii) when the product is in the form in which it is to be sold to a consumer. (2) Reliance on standard-setting bodies In establishing the uniform manufacturing and testing requirements under paragraph (1), the Secretary may recognize and rely on standards developed by appropriate standard-setting bodies that have relevant expertise and are subject to third-party auditing. (3) Inspection of records The Secretary may inspect such records as may be necessary to determine compliance with the uniform manufacturing and testing requirements under paragraph (1). (d) Publication of list (1) In general Not later than 90 days after the date of the enactment of the Lawful Hemp Production Act, the Secretary, in consultation with other relevant Federal agencies, shall publish— (A) a list of all cannabinoids known to the Secretary to be capable of being naturally produced by a Cannabis sativa L. plant, as reflected in peer reviewed literature; and (B) a list of all tetrahydrocannabinol class cannabinoids known to the Secretary to be naturally occurring in the plant. (2) Updates The Secretary shall periodically review and update the lists under subparagraphs (A) and (B) of paragraph (1).. (f) Applicability The amendments made by this section shall only apply with respect to hemp and any products derived from or containing hemp, including industrial hemp, hemp-derived cannabinoid products, and unfinished hemp-cannabinoid ingredients introduced or delivered for introduction into interstate commerce on or after the date that is 180 days after the date of enactment of this Act.