FDA has hired Norman Birenbaum, an experienced cannabis policy expert, as a senior public health advisor at the Center for Drug Evaluation and Research (CDER). The move signals the agency may soon develop a regulatory framework for cannabis-derived products, including cannabidiol (CBD) products — something that CBD stakeholders have been anxiously awaiting.
Prior to joining FDA, Birenbaum oversaw cannabis regulatory schemes in Rhode Island and New York, including overseeing the creation and implementation of a new regulatory structure for the sale of CBD and other hemp-derived products in food, beverages, and dietary supplements in New York. He also served as the founding president of the Cannabis Regulators Association, an organization of state regulators focused on supporting its 40+ member jurisdictions with policy tracking efforts, best practices, and education about current and emerging regulatory challenges. In short, Birenbaum seems well-positioned to aid FDA in its ongoing effort to evaluate possible regulatory frameworks for cannabis-derived products.
In 2018, Congress legalized hemp production with the Agricultural Improvement Act of 2018, or 2018 Farm Bill. In so doing, Congress removed “hemp” and “tetrahydrocannabinols in hemp” from the Schedule I listings of “marihuana” and “tetrahydrocannabinols” in the Controlled Substances Act (CSA), 21 U.S.C. §§ 802, 812. To be considered “hemp,” Congress made clear the material had to possess limited concentrations of delta-9 tetrahydrocannabinol (THC) — the main psychoactive ingredient in the plant. Specifically, the statute defined “hemp” as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” 7 U.S.C. § 1639o.
By removing “hemp” from the Schedule I listing of “marihuana” in the CSA, Congress cleared a major obstacle for the production of hemp-derived products. Although the act gave USDA authority to promulgate regulations and guidelines related to hemp production, Congress expressly preserved FDA’s authority over hemp products as well, 7 U.S.C. § 1639r, perhaps anticipating the explosive growth of hemp-derived products to come.
And grow it has. Sales of CBD products in the United States hit $4.6 billion in 2020 and could reach as high as $15 billion to $20 billion by 2025. The global market for CBD could hit $47 billion by 2028.
What we have not yet seen over the past four years is a proposal for a regulatory framework at FDA for hemp-derived cannabis products, such as CBD. Instead, the agency so far has relied on its existing framework, considering whether such products have been or can be used in human and veterinary drugs, foods, dietary supplements, and cosmetics.
A quick survey of the regulatory landscape shows that the framework, however, has not kept up with consumer demand.
With respect to human and veterinary drugs, FDA has approved one cannabis-derived prescription drug — Epidiolex — which contains CBD and is used to treat rare, severe forms of epilepsy in children. The agency has also approved three cannabis-related prescription drugs, Marinol, Syndros, and Cesamet, which either contain synthetic delta-9 THC or active ingredients that are similar to the chemical structure of delta-9 THC. The first two of these are used to treat anorexia in AIDS patients, while the latter is used to treat nausea associated with chemotherapy. FDA has not approved cannabis for any use in animals.
With respect to foods (and beverages), FDA has found three hemp seed products, which do not contain THC or CBD, to be “generally recognized as safe” for use as food ingredients. Otherwise, the agency asserts that cannabis or cannabis-derived ingredients have not been approved by FDA for use (and may not be used) in food.
FDA has also concluded that THC and CBD products cannot be marketed as dietary supplements, because the definition of “dietary supplement” excludes active ingredients that have been approved as drugs or have been authorized for investigation as a new drug. 21 U.S.C. § 321(ff)(3)(B). Other parts of the hemp plant that do not contain THC or CBD might be available for use as dietary supplements, so long as manufacturers abide by related requirements, including notifying FDA.
With respect to cosmetics, the regulatory pathway for hemp and hemp-derived ingredients is much simpler. FDA has observed that manufacturers may be able to use hemp and hemp-derived ingredients in cosmetics without seeking premarket approval from FDA, but the cosmetics must not be adulterated or misbranded in any way. For instance, if it is unsafe for consumers, this would render the cosmetic adulterated. In addition, if the product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat, or prevent disease, it would meet the definition of a “drug,” subject to a separate set of requirements.
Setting aside cosmetics then, regulatory approval of hemp-derived ingredients in drugs, foods, and dietary supplements has been limited. This has not stopped all manufacturers though. A quick internet search for CBD-infused snacks and beverages reveals there is no shortage of options.
Enter Norman Birenbaum. We anticipate that FDA will lean on policy experts like Birenbaum to help finalize the agency’s thinking on safety, manufacturing, quality, marketing, and labeling standards for hemp-derived products and hopefully bring regulatory certainty to this space. In the past, the agency has underscored that it takes an evidence-based approach to authorize new uses of ingredients in consumer goods, and we expect that to continue with his involvement.
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