This article was originally published on Vicente Sederberg and appears here with permission.
Hemp was federally legalized nearly four years ago. Since then, the industry has dealt with constantly changing rules, despite being in regulatory purgatory due to snail-paced progress from the U.S. Food & Drug Administration (FDA). After all this time, the FDA has yet to develop a regulatory framework for legal hemp in consumer products. And, in 2021, we experienced more painfully slow progress from the FDA in conjunction with the increased popularity of Delta-8 THC and other minor cannabinoids, which contributed to an even more complex and impractical state patchwork of regulations than what previously existed.
Going into 2022, the patchwork includes varying state definitions of permissible THC content, serving size limits, and differing standards as to what may be considered synthetic or intoxicating. With the market moving faster than the FDA, there’s a dire need for consumer trust and safety and regulatory certainty. The untenable status quo has contributed to further congressional action, as three bills seek to allow hemp as ingredients in food and/or dietary supplements and others would address FDA hemp regulation as part of broader cannabis reform, detailed below.
Remarkably, multiple federal proposals for full cannabis legalization were put forward in 2021 that would establish a regulatory framework for the whole plant—regulating hemp separately from cannabis. Since the industry and government are considering how the whole plant should be best regulated, some lingering questions will remain at the forefront of the debate in 2022.
What is the role of the FDA in regulating cannabis; should this be different than hemp?
Should cannabis be regulated like alcohol?
Where do “intoxicating” hemp products fit?
How is “intoxicating” defined?
Can and will the FDA establish adequate safety standards?
While federal regulatory approaches are considered and the FDA remains largely absent, state hemp regulations will become more complex—simply out of necessity. And the successes and failures of the various state hemp programs—and relevant data arising out of them—will inform the most effective federal regulatory approaches. With years of data, state hemp testing laboratories will become very important. Additionally, the state models, from New York’s approach to regulating “cannabinoid hemp” as its own category and Oregon’s “mini FDA” approach, to major markets like Texas and California prohibiting smokeable products, will tell what type of regulation is most effective for consumer safety.
The historic 2021 federal proposals for regulation of consumable hemp and cannabis, regardless of the likelihood of success, are critical opportunities to consider the best approaches as we near full federal cannabis legalization. Without a doubt, 2022 will be an important year for the industry and any congressional action could be a game-changer.
Federal Hemp CBD Legislation
Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021(H.R 841): Dietary Supplements Only
Introduced in February 2020 by Rep. Kurt Shrader (D-OR), this bill would legalize any hemp-derived ingredient, including CBD, for use as a dietary ingredient in a dietary supplement where compliant with applicable the Federal Food, Drug, and Cosmetic Act (FDCA) by exempting hemp, CBD, and other derivatives from the “drug preclusion language” in the definition of dietary supplement contained in the FDCA (21 U.S.C. § 321(ff)) (the “Drug Preclusion Rule”). Products containing hemp, CBD, or other derivatives would ultimately be required to comply with standard FDCA requirements for dietary supplements which contain a new dietary ingredient.
Hemp Access and Consumer Safety Act (S. 1698): Food and Dietary Supplements
Introduced in May 2021 by Senators Wyden (D-OR) and Rand Paul (R-KT), S. 1698 would permit any hemp-derived ingredient, including CBD used in a food or dietary supplement by exempting hemp, CBD, and other derivatives from the Drug Preclusion Rule for both dietary supplement and food. See FFDCA (21 U.S.C. § 321(ff), 331(ll)). This bill would also give the FDA express discretion to establish packaging and labeling requirements and to take additional enforcement actions with respect to products labeled as dietary supplements that do not meet the definition of dietary supplement.
CBD Product Safety Standardization Act of 2021 (H.B.6134): Food Only
Introduced in December 2021 by a bi-partisan group of U.S. representatives led by Rep. Kathleen Rice (D-NY), this bill would permit hemp-derived CBD to be included in food but would not affect the regulation of other hemp derivatives. The bill would similarly exempt CBD from the Drug Preclusion Rule. If passed, CBD would be expressly permitted in food where compliant with applicable food regulations in the Fair Packaging and Labeling Act and the FDCA, specifically that the food ingredient is (a) the subject of a food additive regulation; (b) subject of a Generally Recognized As Safe Notice; or (c) is otherwise generally recognized as safe. The bill would also amend sections that govern adulterated and misbranded food by providing that a food containing CBD derived from hemp will not be adulterated or misbranded if it meets the requirements of the FDCA’s food additive provisions. Notably, H.B. 6134 would also expressly direct the FDA to issue rules, through notice and comment, establishing a maximum serving limit, conditions of intended use, and packaging and labeling requirements for food containing CBD.
Hemp Economic Mobilization Plan (HEMP) Act of 2021 (S.1005): THC Content in Hemp
Introduced by Sen. Rand Paul (R-KT) in March of 2021, S.1005 would amend the 2018 Farm Bill’s definition of hemp to increase the THC content in hemp from .3% THC to 1% THC. While unlikely to pass and not directly relevant to the FDA regulation of consumer products, this is likely the first of many efforts to increase the allowable THC content in hemp, which is important in informing future consumable product regulation.
Federal Cannabis Legislation that Includes Hemp
Cannabis Administration and Opportunity Act: Dietary Supplements Only
The democratic “CAO Act,” led by Senators Schumer (D-NY), Booker (D-NJ), and Wyden (D-OR), has not yet been introduced but was distributed for comment in July. The CAO Act would legalize cannabis and establish a federal regulatory framework that includes a legal pathway for hemp-derived CBD in dietary supplements by removing the FDA’s Drug Preclusion Rule, and would give the FDA significant regulatory authority over cannabis and hemp. However, it would not remove the Drug Preclusion Rule for CBD in food. The CAO Act expressly requires vendors and producers of CBD dietary supplements to submit a New Dietary Ingredient Notification and comply with applicable dietary supplement regulations in FDCA. Notably, the CAO Act would authorize the FDA to determine a serving limit for CBD and does not waive the Drug Preclusion for cannabinoids other than CBD.
States Reform Act (H.R. 5977): Food and Dietary Supplements
The republican sponsored States Reform Act, introduced in November 2021 by Rep. Nancy Mace (R-SC) would also legalize cannabis and establish a regulatory framework, with cannabis being regulated substantially like alcohol through oversight of the Bureau of Alcohol, Tobacco, Firearms and Explosives, the FDA for medical usage, and U.S. Department of Agriculture for production. Regulation of hemp, however, would remain under the oversight of the FDA. The Act would exempt both cannabis and hemp from the Drug Preclusion Rule as applied to both food and dietary supplements, thus permitting the addition of hemp-derived CBD to both food and dietary supplement products. The Bill would also require the FDA to establish standard serving sizes for cannabinoids and to further clarify intended conditions of use of whole-plant cannabis extracts and individual cannabinoid extracts used as food additives and in dietary supplements.