Most people are now aware of the medical benefits of constituents in the marijuana plant. But not too many people in the US understand the diference between “THC” (tetrahydrocannabinol), the mood altering and occasionally hallucinogenic part of marijuana that is the source of being “stoned”, and canabidiol, aka, “CBD.” Many a songwriter and lead guitarist might owe some of that creative artistry to the former substance. But both are involved with the so-called “endocannabinoid” system — a complex network of long chain fatty acids, receptors, and enzymes that influences many processes such as appetite, carcinogenesis, cardiovascular diseases, fertility, immune functions, memory, neuroprotection, and pain sensitivity. A graphic might look like this (credit to Frontiers in Behavioral Neuroscience):
There are many non mood altering chemistries in cannabis one of which is a substance called “cannabidiol”. This fatty acid like substance has considerable effects on inflammation especially in the brain and peripheral nerves and has been found to be very helpful in individuals with seizures and Lyme disease among other things. It has very little toxicity and can also be found in hemp oil. Hemp oil can be purchased on Amazon if you wish and is considered to be a bit of a health food all by itself. Now for individuals who benefit from the use of cannabidiol by taking hemp oil this can be a truly beneficial “over-the-counter” remedy with far fewer risks than Tylenol or Pepto Bismol. It was great while it lasted, eh? Enter the FDA. Although this is simply a warning to companies making promises about products that are technically unproven, there is always the fear that a drug company might pay someone enough to own the plant product that contains a substance that they would like to “research”.
What does all of this mean?
None of this is surprising. And it should not be taken lightly. In fact, the best conservative practices would dictate a pause in sales and production until the issue is resolved. But the cannabis industry has always proceeded in the face of risk and adversity. That said, what does this mean for the CBD industry?
Let’s start with the FDA. Its analysis as set forth in the Q&A and the February 9th letters is incomplete and does not render this issue a “final decision” by the FDA. Instead, the law dictates, pursuant to the FD&C Act, that the conclusion it has reached can be conclusively determined only if substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. No such substantial clinical investigations have been instituted, nor made public to date. Instead, the FDA has summarily announced that these are “substantial clinical investigations.”
But more importantly, the FDA duly notes that, “[t]here is an exception if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the new drug investigations were authorized,” and further invites, “[i]nterested parties [to] present the agency with any evidence that they think has bearing on this issue.” Seehttp://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm.
This begs the question of whether CBD was marketed as a dietary supplement prior to the subject IND application. And it is important to note that following the above-referenced Q&A, the CBD industry provided substantial evidence and information indicating that CBD was, in fact, marketed and sold as a dietary supplement for many years prior to the IND application at issue. Sarah Syed, director of marketing at CV Sciences, one of the larger CBD companies in the industry stated that, “[i]t is our opinion, which is broadly shared by the marketplace, that CBD has been marketed as a dietary supplement prior to commencement and public notice of any substantial clinical investigations instituted on CBD…thereby rendering the IND preclusion inapplicable.” Seehttps://www.newcannabisventures.com/cv-sciences-responds-to-fda-warnings-issued-to-8-marketers-of-cbd/. Importantly, a number of other dietary supplement ingredients have similarly been subject to the same scrutiny and yet continue to be sold as dietary supplements –red yeast rice, trans-resveratrol, P5P, NAC and DHEA. Id.
Thus, as a practical matter, this announcement by the FDA is premature; is part of a larger discussion; has failed to identify the date of the particular IND (and its applicants); and, there is no information to suggest that the IND clinical investigations applicable here preempt the ability to market, sale, and produce CBD as a dietary supplement at all. In short, while an important guidance document, the Q&A posting and corresponding position noted in the February 9th letters, does not have the effect of a final determination on this issue.
More importantly, the FDA has made no determination or assertion that CBD products are illegal or in any way run afoul of the Controlled Substances Act (CSA). As was established by the Ninth Circuit in 2004, the sale, production and distribution of CBD oils/products derived from imported raw material industrial hemp, such as those produced and sold are not in violation of the CSA. See Hemp Indus. Ass’n. v. DEA, 357 F.3d 1012 (9th Cir. 2004). In fact, this case stands for the proposition that naturally occurring cannabinoids are not unlawful under the CSA.
Last, under the FDA guidelines, there are a variety of categories in which a product can be placed/registered. This current FDA position addresses the category of “dietary supplements” only. It does not appear that the FDA has taken a position as to the sale or marketing of CBD products as a constituent of hemp, a food product, cosmetic product, other FDA classification, or the like.
So, for now, those of you using hemp oil for CBD are likely not going to see your supply dry up, but never underestimate the power of the FDA to control who makes the $$ over natural substances that are actually helpful and relatively harmless.