Washington, D.C. – The U.S. Food and Drug Administration (FDA) has made changes to its “frequently asked questions” (FAQ) about CBD ahead of a scheduled May 31 public hearing that presumably will help the agency set cannabinoid policy going forward.
FDA FAQs serve as de facto guidance for manufacturers, sellers, and the public.
The Farm Bill passed by Congress in December defined as hemp any cannabis and associated derivatives containing no more than 0.3 percent THC by weight. The legislation also removed hemp from the Controlled Substances Act. Cannabis containing more than 0.3 percent THC remains a Schedule I banned substance, in the company of LSD and heroin.
Although the farm bill may have removed hemp from the list of controlled substances, it did little to remove confusion over what producers and sellers can do with CBD products. Hemp-derived CBD products containing less than 0.3 percent THC were thought by many to be fair game. Unfortunately for several producers who received warning letters from the FDA in March, this is not quite the case.
The FDA seems primarily concerned about two issues: products that make unverifiable medical claims and ingestible products containing CBD. The FDA has not approved any cannabis products, including hemp-derived CBD, as a cure for any medical ailment, so marketing that insinuates CBD will treat or prevent diseases runs afoul of regulations. The agency also has not approved cannabis, CBD, or hemp as a food additive and currently takes the position interstate sales of edible CBD products are prohibited.
That hasn’t stopped anyone from making, selling, and using the products.
Updates to the FAQ may be well-intended but have not provided the clarity producers and seller seek. Here we highlight several critical questions answered (in a manner of speaking) by the FAQ.
How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
The FDA answers this question by citing the 0.3-percent definition cited in the law. This may be one of the clearest answers from the agency, although the information is not exactly new. “[T]his new law changes certain federal authorities relating to the production and marketing of hemp, defined as ‘the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis,”‘ the FDA wrote. “The 2018 Farm Bill, however, explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds.”
Is it legal for me to sell CBD products?
This is the key question everyone wants answered. Unfortunately, the FDA’s response starts anything but decisive. “It depends,” the response begins. The rest of the answer notes CBD products must comply with the Federal Food, Drug, and Cosmetic Act (FD&C) but does not provide any details about how that may be accomplished.
What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?
Another important question for producers. Basically, do CBD producers operating in accordance with state regulations have to worry about federal prosecution? “The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so,” the FDA states in response, which does little to assuage the concerns of those operating in the space. “We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives so that we can provide information on federal and scientific standards,” the agency goes on to say. This is great news for states but doesn’t address whether law-abiding producers are in the clear.
The lack of detail in the FDA FAQ highlights the urgent need for the public hearing scheduled to take place May 31. The hearing will be webcast, and a link to a transcript will be provided thereafter. Registration information was not available at the time of this writing. The FDA encouraged those interested in attending to “check back soon.” Those who wish to submit comments may do so through docket number FDA-2019-N-1482. Below are additional meeting details:
May 31, 2019
8:00 a.m. – 6:00 p.m. ET
FDA’s White Oak Campus
Building 31, Room 1503 – Great Room
10903 New Hampshire Avenue
Silver Spring, Maryland 20993