FDA Says CBDs Can’t Be Marketed as Dietary Supplements
May 26th, 2015
Policy, Top News
The U.S. Food and Drug Administration (“FDA”) ruled that cannabidiol (“CBD”) products don’t fit the legal definition of dietary supplements and therefore can’t be marketed as such under the federal Food, Drug, and Cosmetic Act.
The FDA’s Q&A covering CBDs specifically addresses the issue:
“Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if a substance (such as cannabidiol) has been authorized 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. 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. For more information on this provision, including an explanation of the phrase “marketed as,” see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
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 FDA’s ruling could have broad implications for an entire cottage industry built atop the potential health benefits of CBDs. In fact, the move could force companies that are already producing CBDs to revise their marketing strategies or even change their product labeling to account for the new rules. The federal agency didn’t specify any enforcement actions, but recent actions within the pet industry suggest that it has taken an aggressive stance.
In the ruling, the FDA did acknowledge that it would continue to work with companies that are interested in bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of marijuana.
The FDA sent warning letters to several CBD product manufacturers back in February, including five human and two pet companies, warning their products are not “generally recognized as safe and effective” and the companies are engaging in illegal interstate commerce. While the warning letters came as a surprise, many cannabis advocates applauded the efforts by the federal agency to weed out bad actors in the space.
Companies may be able to avoid these warning letters and related FDA actions by avoiding interstate commerce (e.g. only selling products within states that have legalized medical marijuana) and avoiding claims as to proven efficacy without FDA approval. In reality, these are the same rules that apply to traditional nutritional supplements, including vitamins, in order to protect the public from false advertising and other harmful claims.
This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.
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