The FDA recently released its current thinking on marijuana in a variety of forms in a web-based document titled “FDA and Marijuana: Questions and Answers.” The most notable question and answer related to whether cannabidiol (“CBD”), a non-narcotic extract of industrial hemp, can be marketed as a dietary supplement, a position that was unclear following a set of warning letters FDA released in February 2015. FDA’s current response, pasted below, is both unqualified and possibly open to review.
“No. 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 (an IND was filed in 2014 relative to a CBD-based epilepsy 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.”
FDA does not address the legality of CBD or the universe of “available evidence” that it considered in making this determination. FDA suggests that interested parties with evidence contrary to this determination may present such information to the agency.
The definition of “marketed as” includes physically offering the article for sale at a retail establishment, listing it for sale in a catalog or price list, or through advertising or other promotion.” CBD proponents likely will rely on historical uses of hemp in the food supply as evidence of prior marketing if evidence of CBD-specifically cannot be verified. Whether they submit such evidence to FDA proactively or wait to see how the agency proceeds may be another question. FDA sidestepped a Q&A on enforcement by indicating that it considers many factors and may consult with other authorities in determining whether or not to bring an enforcement action.