Does FDA’s Epidiolex CBD Drug Approval Threaten Legal Status of CBD Supplements?

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FDA last month approved the first drug made from cannabidiol (CBD), a derivative of the hemp plant (Cannabis sativa). Epidiolex, the drug from GW Pharmaceuticals, is a treatment for severe forms of epilepsy, and it has also long been cited as a potential threat to whether FDA considers CBD dietary supplements legal. Nutritional Outlook sought the opinion of few industry stakeholders on whether, in their opinion, the Epidiolex drug approval further threatens the legal status of CBD supplements.

The legal status of CBD as a dietary supplement ingredient has been mired in gray area for some time. The legality of CBD as a supplement ingredient has been, according to some, uncertain in part because of two existing Investigational New Drug (IND) applications that GW Pharmaceuticals filed years ago for Epidiolex as well as its other CBD drug, Sativex. According to section 201(ff)(3)(B)(ii) of the Food, Drug, and Cosmetic Act, if FDA has already authorized an ingredient for investigation as a new drug “for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.” FDA also quoted this section of the FD&C Act in warning letters the agency sent in February 2016 to CBD companies the agency said made unproven and unlawful health and drug claims for products marketed as dietary supplements.

On the other hand, hemp advocates argue that CBD was marketed as a dietary supplement ingredient prior to when FDA granted GW Pharmaceuticals’ IND applications, which would make CBD eligible to be a dietary supplement ingredient.

Epidiolex Is Here. What Now?

FDA Commissioner Scott Gottlieb, MD, announced the Epidiolex approval on June 25 in a press release and added that FDA is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Nutritional Outlook interviewed Kristi Wolff, a partner in the advertising and food and drug law practice of Kelley Drye & Warren LLP, on whether the Epidiolex FDA drug approval in any way jeopardizes the status of CBD as a dietary supplement ingredient. Wolff notes that in Gottlieb's June 25 statement, the commissioner seems to focus attention mostly on CBD products making unauthorized health claims.

“In its press release regarding Epidiolex, FDA appears to re-state its position that CBD is not a dietary ingredient but also possibly indicates that its intent with regard to enforcement is focused on instances where CBD is marketed with disease treatment claims. Although opposition to CBD as a supplement generally could be understood from prior warning letters, FDA did not state in its announcement that it intends to expand its enforcement on CBD marketed as a dietary supplement absent any therapeutic claims.”

She adds, “Whether this is a manner of indicating that FDA is exercising enforcement discretion without saying as much remains to be seen.”

Wolff says she doesn’t believe Epidiolex’s approval will “impact the existing arguments for legality of hemp-derived CBD, which focus on the long history of hemp being used for a variety of products in the U.S.”

The CBD and hemp industry recently celebrated a major victory: the Congressional passage of the Farm Bill in June. The bill legalizes, for the first time, growing commercial hemp on U.S. soil.

The Hemp Farming Act of 2018, which was rolled up into the Farm Bill that ultimately passed, had strong bipartisan support. “Given the existing momentum in Congress to discuss issues around hemp and cannabis legalization, it seems most likely that hemp’s legal status will be clarified in the relatively near future,” Wolff says.

Hemp advocacy group the U.S. Hemp Roundtable appears to be confident in CBD’s legal standing. On its website on June 26, the group, along with its FDA legal counsel law firm Amin Talati Upadhye, stated, “Fundamentally, Epidiolex’s approval has no legal impact on the sale of hemp-derived CBD.”

Like Wolff, the U.S. Hemp Roundtable points out that FDA has directed its enforcement effort thus far against companies making unproven, unlawful health claims. “The Roundtable applauds the FDA’s efforts to target bad actors in the industry who undermine legitimate hemp-derived products by making unproven claims,” the group said.

The U.S. Hemp Roundtable maintains the CBD-supplement industry’s opinion that CBD was marketed as a dietary supplement ingredient prior to the GW Pharmaceuticals IND application.

“The arguments related to the marketing of hemp-derived CBD as a dietary supplement remain the same as before FDA’s approval of Epidiolex,” the group’s website states. “[Amin Talati Upadhye] contends that hemp-derived CBD was marketed as a food or dietary supplement prior to the institution of substantial clinical investigation of Epidiolex that was made public by GW Pharmaceuticals, and even prior to the date on which FDA authorized the article for investigation as a drug. This would mean that dietary supplement versions of hemp-derived CBD would be permissible.”