Last week, we explored whether the addition of hemp-derived cannabidiol (CBD) to food and beverages is actually unlawful, notwithstanding FDA policy. In that article we explained that we hadn’t seen much in the way of FDA enforcement, and that we “believe that FDA will likely continue to act where people make health claims that violate the Food Drug & Cosmetic Act” and not much more. A few days later, outgoing FDA commissioner Scott Gottlieb clarified the FDA’s enforcement position in testimony to a Senate subcommittee. That clarification was essentially in line with what we had presumed. So today we can talk about that.
In his testimony, Gottlieb stated that the FDA has been using enforcement discretion. Specifically, Gottlieb advised that “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider over-the-line claims”; for example, that CBD can “cure cancer or prevent Alzheimer’s disease.” Gottlieb continued:
But there are products on the market right now that, given our enforcement priorities and our limited resources, we haven’t taken action against. That’s not an invitation for people to continue marketing these products—we’re concerned about it—but we heard Congress loud and clear here.”
The products Gottlieb is talking about are seemingly everywhere these days, from farmer’s markets to big box retail stores. Every week, we receive scores of inquiries from current and potential manufacturers, distributors and retailers of these products. They are everywhere. In his testimony on enforcement priorities, Gottlieb acknowledged that Congress intended to legalize industrial hemp and its derivatives via the 2018 Farm Bill. It’s also fair to say, though, that Congress didn’t give much consideration to the effects (or non-effects) the Farm Bill would have on the FDA’s CBD position.
In any case, FDA is focused on the “problem actors” given its limited resources. Problem actors are the people who advertise medical solutions that entice consumers to forego approved treatment, and who generally mislead the public. As we wrote last week, FDA’s concern there is nothing new: it has always been vigilant about unapproved medical claims. (The agency fired off another round of warning letters last Thursday.)
What else can we glean from Gottlieb’s testimony? A couple of things. The first is that the situation with CBD in foods and beverages (and cosmetics, and everything else) is about as legally cumbersome as could be. It has put FDA in a bind. The second is that everyone wants answers, including Congress, which probably should have addressed this in the Farm Bill or in companion legislation. And the third is that FDA’s position could change fast. Gottlieb’s testimony was an exit interview for all intents and purposes. Not only is Gottlieb departing, but the agency has since announced public hearings on CBD products next month, along with a work group “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed.”
We wrote last week that FDA appears to be moving toward solutions for hemp-CBD in the marketplace, rather than in the opposite direction. People in the market today with products that 1) are responsibly sourced and 2) do not make health claims, have a big head start. Time will tell if those propositions pay off, but they look pretty good right now — at least from an FDA enforcement perspective.
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Author: Vince Sliwoski