CBD, or cannabidiol, is a non narcotic fraction of the Cannabis sativa. Most producers of the molecule, seeking to draw a sharp line in the sand between their products and medical marijuana, state that they extract their ingredients from industrial hemp, which is a cannabis cultivar with very low THC content (tetrahydrocannabinol, the intoxicant fraction of the plant).
CBD has a number of health indications for which it is purportedly beneficial. The most powerful and best researched of these are its anti-seizure properties. It also has been studied for its analgesic properties.
Illegal drug claims
The warning letters to the eight companies all cite what FDA says are illegal drug claims for the products. These include claims of anticancer activity, a “powerful remedy against inflammatory diseases,” and “treatment for a wide range of conditions, including arthritis, diabetes, alcoholism, MS, chronic pain, schizophrenia.” Regardless of how the products were to be marketed, these would be illegal in FDA’s view, as they pertain to conditions that are not amenable to self diagnosis.
But the claims language figures most prominently into the marketing of the products as dietary supplements. In six of the letters, FDA says “Based on the product label it appears you may intend to market your [brand name] product as a dietary supplement. You should be aware that, based on available evidence, FDA has concluded that CBD products are excluded from the dietary supplement definition.” The other two products, though supplement-like in appearance in tincture-type bottles, appear to be positioned as foods.
The reason for the exclusion is the existence of Investigational New Drug (IND) applications on CBD by English company GW Pharmaceuticals, which is developing two drugs called Sativex and Epidiolex featuring the molecule as an active ingredient. Sativex is aimed at quelling the spasticity associated with multiple sclerosis, whereas Epidiolex is meant to address certain intractable forms of childhood epilepsy.
Many APIs (Active Pharmaceutical Ingredients) have been developed from botanicals. The way this process is regulated, an ingredient from a botanical or other source (such as from terrestrial or marine animals, for example) can be marketed as a dietary supplement ingredient, provided it fulfills the definition of a legal dietary ingredient, and then could subsequently be picked up by a drug developer who could file an IND on the substance. Ingredients are prohibited from moving in the other direction, however; they can’t start life so to speak as an IND and then subsequently show up in a supplement.
FDA says no to CBD in supplements
In its most recent communication on the subject issued last year, 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.
The evidence which could form the crux of the issue would be proof that dietary supplements containing CBDs were legally on the market prior the filing of the INDs. FDA reissued that appeal in the eight warning letters that were filed on Feb. 4. The fact that the appeal has been reissued more less verbatim would seem to indicate that no developers of nutritional products containing CBD have yet stepped up the plate yet to prove that their products were on the market prior to the IND filing. FDA’s opinion that CBDs should not be on the market as ingredients hasn’t stopped developers, most of who seem to be hanging their hats on hemp’s status as a food. Whether FDA will turn a blind eye to these sorts of products that avoid attention-grabbing drug claims remains to be seen.