FDA Passes the Buck (Back) to Congress for Legislative Solution on … – JD Supra

While the state of the U.S. Food and Drug Administrations (FDAs) regulation of Cannabidiol (CBD) remains gray, the agency now sees a path forward through federal legislation. Heres what companies in the cannabis industry need to know:

The FDA is looking to provide a new regulatory pathway for CBD, while still committing to its enforcement of unlawful CBD marketing and sales. On January 26, 2023, the FDAissueda statement acknowledging that a new regulatory pathway for CBD is neededone that balances access to CBD products with regulatory oversight. The statement included the FDAs denial of three citizen petitions that asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements. The FDAs existing authorities provide limited tools for managing many of the risks associated with CBD products, andaccording to the FDAit is not apparent how CBD products could meet safety standards for dietary supplements or food additives under the Food, Drug, and Cosmetic Act (FD&C Act). In the statement, the FDA says it is looking to Congress to develop a cross-agency strategy for the regulation of these products to protect the publics health and safety.

The FDAs recent move to shift the responsibility of CBD regulation to Congress is just the latest instance in a longstanding game of regulatory hot potato. On April 17, 2023, the Chair of the House Oversight and Accountability Committee sent aletterto the FDA Commissioner, announcing an investigation into the FDAs decision to not engage rulemaking for CBD and criticized the insufficient rationale for inaction on CBD regulations.

Current Regulation of CBDTwo Steps Forward, Three Steps Back

2018 Farm Bill

All hemp is cannabis, but not all cannabis is hemp. CBD is the second most prevalent active ingredient in cannabis (behind THC), and while it is an essential component of marijuana, it can also be derived from the hemp plant. Three hemp derivatives (hemp seed oil, hemp seed protein powder, and hulled hemp seedalso known as hemp hearts) were firstgenerally recognized as safe (GRAS)food ingredients in 2018 by the FDA. Up until April 2018, all CBD was considered a Schedule 1 substance under the Controlled Substances Act (CSA) because it is a chemical component of the cannabis plant. However, the2018 U.S. Farm Billremoved hemp-derived CBD with very low levels of THC (0.3 percent or less) from the definition of marijuana in the CSA. Over the past five years, industry stakeholders have advocated for regulation of the gray area of CBD outside that limited definition of the Farm Billspecifically, regulation of cannabis-derived CBD and of hemp-derived CBD with levels of THC over 0.3 percent.

The 2018 Farm Bill explicitly preserved the FDAs authorities over hemp products, including hemp-derived CBD, meaning that hemp products must meet any applicable FDA requirements and standards, just like any other FDA-regulated product. For example, the FDAs existing authorities over foods, dietary supplements, human and animal drugs, and cosmetics apply to hemp products to the extent such hemp products fall within those categories. These products include food or beverage products labeled as containing CBD that you may see at your local grocery store. However, aside from the three GRAS hemp ingredients, the FDA has not approved any CBD ingredients for food and beverage products.

By the FDAs own admission, the FDAs existing authorities provide limited tools for managing many of the risks associated with CBD products, and it is not apparent how CBD products could meet safety standards for dietary supplements or food additives under the FD&C Act, as discussed more below. The FDA has stated that, because CBD is outside of the statutory definition of a dietary supplement, it is unlawful under the FD&C Act to introduce into interstate commerce a food (including any animal food or feed) to which CBD (an unregulated substance) has been added. This rule limits makers of food and beverage products containing cannabis-derived CBD or hemp-derived CBD with any levels of THC from shipping their products online, even if they are selling their products in states where CBD is legal.

Pathways to Regulation of CBD

The FDA has interpreted two similar provisions in the FD&C Act prohibiting marketing of hemp-derived CBD known as the exclusionary clauses: one for foods (FD&C Act 301(ll)) and one for dietary supplements (FD&C Act 321(ff)(3)(B)). The exclusionary clause for dietary supplements states that the dietary supplements do not include an article that was either approved as a new drug, antibiotic, or biologic, or authorized for investigation as a drug, antibiotic, or biological for which substantial clinical investigations have been instituted and made public.

However, a dietary supplement that would otherwise be excluded can be exempted if the Secretary of Health and Human Services (HHS) issues a regulation (following the notice and comment process) finding the article would be lawful for use as a food or dietary supplement. But the FDA has held firm that this is not a possible route for CBD regulation because it has previously been investigated as a new drug. The FDA points to the June 2018 approval of CBD-based drugEpidiolex, which treats seizures associated with two very rare and severe pediatric epileptic syndromes.

Since 2019, three industry trade organizations have filed citizen petitions with the FDA, each addressing longstanding industry desires to the use of CBD in dietary supplements, conventional foods, and animal food. The petitions, submitted byConsumer Healthcare Products Association,Council for Responsible Nutrition(CRN), andNatural Products Association, propose that the FDA require manufacturers of dietary supplements containing CBD to submit a new dietary ingredient notification for CBD and use appropriate labeling and claimsas opposed to using drug claims. Alternatively, the organizations propose, the FDA can clarify the definition of article for purposes of the exclusionary clause. For example, CRN asserted that hemp extracts that contain CBD should not be classified as the same article when Epidiolex involved a 99 percent pure CBD, while many commercially available hemp extract contain numerous cannabinoids other than CBD, flavonoids, terpenes, and other phytochemicals. Lastly, the organizations ask that the Secretary of HHS engage in the notice and comment process, issuing a final rule legalizing CBD.

The FDAs Desire to Find a Path ForwardJust Not Through Them

On January 26, 2023, the FDAissueda statement acknowledging that, while a new regulatory pathway for CBD is needed that balances access to CBD products with regulatory oversight, it would not be doing so through rulemaking. The statement also announced the FDAs denial of the three citizen petitions asking the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.

The FDA continued in its statement that CBD raises various safety concerns with long-term use, and a new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products.

The statement notes that a high-level internal working group, chaired by Principal Deputy CommissionerJanet Woodcock, has closely examined studies related to the CBD-based drugEpidiolex. Commissioner Woodcock stated: Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.

The FDAs concern is not without basisin a recent studypublished on April 25, 2023, in JAMA, researchers found that one of the 25 products labeled as melatonin gummies tested contained no melatonin at allit was just CBD.

Instead of pursuing rulemaking allowing the use of CBD in dietary supplements, conventional foods, or animal food, the FDA said it is looking to collaborate with Congress. The FDA said it looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the publics health and safety.

Havent We Been Here Before?

Yesa few times. In 2021, bipartisan groups in both the House and Senate introduced bills that would address the regulatory gap for hemp-derived CBD. In May 2021, a bipartisan group of senators introduced the Hemp Access and Consumer Safety Act, and in December 2021, a bipartisan group of representatives introduced the CBD Product Safety and Standardization Act. Both bills, which would require the FDA to develop regulations for food and beverages containing hemp-derived CBD and allow for their interstate commerce, only made it as far as referrals to their respective health committees in 2021.

On March 17, 2023, theCBD Product Safety and Standardization Act(HR 1628) was reintroduced in the House along with a new siblingtheHemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023(HR 1629). The former proposes to authorize the regulation of interstate commerce with respect to food containing cannabidiol derived from hemp, and for other purposes; the latter proposes to make hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp lawful for use under the [FD&C] Act as a dietary ingredient in a dietary supplement, and for other purposes. The new bills would direct the FDA to issue regulations establishing a maximum allowable amount of CBD per serving, labeling and packaging requirements, and conditions of intended use.

On April 17, 2023, the Chair of the House Oversight and Accountability Committee, Representative James Comer (R-KY) sent aletterto the FDA Commissionerin direct response to the FDAs January statementannouncing an investigation into the FDAs decision to not engage rulemaking for CBD. Representative Comer wrote that the agencys argument that theres not a regulatory pathway to enact CBD regulations is an insufficient rationale for inaction that is directly affecting the welfare of the American public. Representative Comer listed documents and information for the FDA to provide to the committee by May 1, 2023:

The FDA has not yet responded to the request.

Next Steps for Manufacturers

Manufacturers of hemp-derived CBD products will need to closely monitor the FDAs and Congresss pathway for CBD and be careful to not violate the FD&C Act in the interim. The FDA said in the January 26th statement that it will continue its enforcement actions against CBD and other cannabis-derived products to protect the public.

James Ravitz and Marissa Hill Daleycontributed to the preparation of this Wilson Sonsini Alert.

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FDA Passes the Buck (Back) to Congress for Legislative Solution on ... - JD Supra