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Closer FDA CBD product regulation – and recalls – appear inevitable

We’ve seen sweeping regulatory changes before, but the FDA’s anticipated regulation of cannabis and CBD-infused products – a market expected to reach more than $20B globally by 2024 – promises to pose significant and unprecedented challenges to food and cosmetics manufacturers already using cannabidiol as an ingredient.

Acting FDA Commissioner Norman Sharpless issued strong warning signals recently during the agency’s first hearing on CBD products. “There are important reasons to generally prohibit putting drugs in the food supply,” Sharpless told a packed hearing room at the FDA’s Rockville, MD headquarters. “Cannabis extracts like CBD are no exception.”

FDA regulators have many questions about CBD, which is already sold in pills, skin lotions, soda pop, and pet foods. Among other things, they want to know how CBD interacts with other drugs, how it may affect children or pregnant women, and what its long-term effects on teens and adults might be.

Regulations could dictate what products go on the market, how they can be marketed, who can purchase them, and how they can be used. There is only one thing we can count on in this scenario. FDA will undoubtedly regulate these products after they have been on the market and in fairly widespread use.

That raises several issues companies need to be aware of even before the FDA imposes regulation.

  • Legality of the product. Dozens of products have entered the market. Other items are waiting in the wings, like Ben and Jerry’s CBD-infused ice cream and other highly-anticipated munchies. But for now, the FDA put its foot down on the use of CBD in food products. According to FDA’s statutory provisions, the fact that agency previously approved cannabidiol as a treatment for pediatric seizures means it cannot be used as an ingredient in food products or dietary supplements. Yet retailers from CVS to Kroger are already eagerly stocking whatever they can sell. While consumer product companies are eager capitalize on consumer demand, companies need to be ready to act if FDA pulls the plug on the entire CBD-infused product category.
  • Potential for false marketing allegations. We’ve seen it already. The FDA and FTC are pursuing actions against companies making “unsubstantiated” health claims about CBD products. Even when you haven’t yet drawn regulatory attention, remember that for every consumer that sings your praise, there’s another that may say the product didn’t live up to its expectations. That’s an even bigger problem when the expected benefits are health-related.
  • Product recalls. Just because the FDA hasn’t figured out how to regulate the category doesn’t mean you have recall immunity. In fact, recalls have already been ordered by the California Bureau of Cannabis Control this year as a result of falsified lab results. If these types of events happen with any frequency, they will suggest to cautious regulators that the industry as a whole cannot be trusted.

FDA will accept written and electronic comments and submissions to the public docket (FDA-2019-N-1482) through July 2, 2019. Those comments will be considered when the agency starts to share its findings from a designated internal working group as early as August.

In the meantime, we encourage anyone involved in the cannabis and CBD product category – from producer to retailer – to examine your quality standards and safety protocols, review your marketing communications, and think through how your business would pivot should the FDA take aggressive action. Worst case, are you ready to manage a recall of products already on the market?

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