FDA says no to CBD in supplements

17-May-2015 - Last updated on 18-May-2015 at 15:06 GMT

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In a recently updated communication on marijuana, the Food and Drug Administration has flatly stated that products based on cannabidiol (CBD), a non-narcotic fraction of Cannabis sativa, cannot be marketed as dietary supplements. The reason? A pre-existing Investigational New Drug filing on the compound.

An IND was filed by GW Pharmaceuticals in 2014 on a drug based on a pure, synthetic form of CBD for the purpose of studying the compound for use in childhood epilepsy. Smaller scale studies have looked at CBD’s anti-seizure properties in the past, as well as researching its effects as a pain reliever, among other indications.

“Under the relevant provision of DHSEA, an ingredient that is the subject of an IND cannot be marketed in supplements,” Ivan Wasserman, a managing partner in the Manatt law firm, told NutraIngredients-USA. “But there is the big old exception, if prior to the filing of the IND the ingredient was marketed as a supplement or a food.”

Gray areas abound

Ever since voters around the country have started approving state measures on the medical and recreational use of marijuana, the agency has hemmed and hawed about its position on the botanical. Cannabis—the whole plant, not just fractions thereof—is still listed as a Schedule 1 substance by the Drug Enforcement Administration, so trade in the plant under federal law is still technically illegal in almost all circumstances.

FDA has not taken a position on the legality of the plant. Its recent communications on the subject sidestep that issue, and deal with its application to the supplement world via products based on CBD as if it were any other botanical.

For example, a recent spate of warning letters sent to companies marketing CBD supplements focused exclusively on the claims made on the products, not on the underlying regulatory or legal status of the ingredient. Is it an illegal drug? If it is potentially a legal dietary ingredient, should it have a New Dietary Ingredient Notification on file? The agency has been mum on these questions.

In its most recent communication, titled FDA and Marijuana: Questions and Answers, the agency admits to the prior-marketing exception, but says CBD doesn’t qualify: “There is an exception if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol.”

But the agency left itself some wiggle room on the subject, and called for interested parties to come forward with additional evidence.

“FDA is not aware of any evidence that would call into question its current conclusion that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue,” the agency wrote.

Wasserman said the resolution of the question might hinge on the precise description of GW’s drug and how that relates to the CBD products that are starting to find their way into the marketplace. One precedent that could be cited is the the omega-3 fish oil sector, where ultra-highly refined versions of the ingredient marketed as pharmaceuticals and less concentrated dietary supplement versions peacefully coexist.

“Some of the issue may revolve around hemp oil versus purified CBD and the IND seems to be for a purified CBD product,” Wasserman said.

Press on regardless

Jim Kras is president and chief marketing officer of Inergetics, a New York-based dietary supplement firm that has brought an encapsulated CBD dietary supplement to market that is being distributed in medical marijuana dispensaries in several states. Kras said he wasn’t prepared to comment yet on FDA’s position or on its call for additional information, but he said the company has no plans to suspend distribution.

“We still think there is a gray area. We are very respectful of FDA and DSHEA and those are the rules we live by. We are moving forward and we have already started to put into effect plans to push into wider markets,” Kras said.

As to whether the agency plans to use the CBD determination as a basis of enforcement actions, the agency was also somewhat circumspect, perhaps taking into account that there are now many state laws that bear on the issue in different ways.

“When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action,” the agency wrote.