As I read this week’s Forbes article titled, “Cannabis Could Be The Most Profitable Ingredient In Skincare, If The U.S. Government Allows It,” it felt like déjà vu. Legislators, law enforcement, lawyers, and cannabis business owners have been going in circles for years now trying to figure out how, exactly, CBD products fit within the current state and federal regulatory structure. But despite the potential legal ramifications of violating the Controlled Substances Act (CSA), CBD companies, particularly those manufacturing beauty and skincare products, are cropping up everywhere and expanding rapidly.
We wrote a few months ago about Target, which pulled a line of CBD products from its website after a BuzzFeed article calling out the sales. And even Forbes, which stated that “A Sephora executive who asked to remain anonymous confirmed the beauty giant has plans to launch at least one CBD-based skincare brand this year,” was unable to reach anyone at Sephora for comment. These large companies have legal counsel who are undoubtedly cautioning them against venturing into the realm of cannabis and CBD; such high-profile sales of CBD products would be an easy target for federal enforcement.
Because we’ve been getting so many inquiries on this topic in California and elsewhere from companies that are unsure whether or not they need a manufacturing license to make these products and a retail license to sell them, and because this is obviously still a hot topic in the media, we thought it would be a good time to revisit the Drug Enforcement Agency’s (“DEA”) stance on the subject, as well as the scenarios under which CBD products are arguably legal under federal law.
Currently, the DEA’s stance is that CBD as well as other cannabinoids derived from cannabis are Schedule I substances under the CSA, regardless of their source. In 2016, the DEA clarified that “marihuana extract,” which is an extract “containing one or more cannabinoids derived from any plant of the genus Cannabis,” is marijuana, and therefore a Schedule I controlled substance. The DEA’s use of the word “any” means that this interpretation applies to any derivative of the cannabis plant, including CBD and any of the other cannabinoids found in cannabis. This definition is extremely broad, and according to the DEA, makes derivatives of the cannabis plant that were formerly thought to be legal, illegal.
As we’ve discussed before, there are three scenarios in which cannabis extracts are arguably legal under federal law. The first scenario is when extracts are derived from the “mature stalk” of the cannabis plant, because the CSA’s definition of marijuana “does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.” 21 USC §802(16). The DEA has clarified that the rule does not apply to portions of the plant specifically exempt from the CSA’s definition of marijuana, but there is debate as to whether products that contain any meaningful amount of CBD can be derived from the mature stalks.
Another scenario is when extracts are derived from an industrial hemp plant lawfully grown in compliance with Section 7606 of the 2014 US Farm Bill (“The Farm Bill”). The Farm Bill allows states to enact pilot programs for hemp research purposes. Hemp that is cultivated in compliance with a state’s pilot program is legal pursuant to the Farm Bill, although the sale of any products derived from this research is not explicitly allowed.
The third scenario is when products are derived from imported hemp. In the early 2000’s, two cases out of the Ninth Circuit, Hemp Indus. Ass’n v. DEA, 357 F.3d 1012 (9th Cir. Cal. 2004) and Hemp Indus. Ass’n v. DEA, 333 F.3d 1082 (9th Cir. 2003) clarified that the DEA could not regulate hemp products merely because they contained trace amounts of THC. This was because some portions of the cannabis plant are explicitly outside the scope of the CSA, and the DEA was not permitted to expand the scope of the CSA to encompass all parts the cannabis plant. At the time of the ruling, it was illegal to grow hemp so it only applied to hemp imported from outside the USA. Some now argue that the holding could apply to hemp grown pursuant to the Farm Bill although, as stated above, commercial sales of these products is not explicitly allowed.
The Hemp Industries Association has sued the DEA over the “marijuana extract” rule, and that case is still pending. Until it’s decided, we’re left with a legal quagmire of rules interpretations that leave businesses selling CBD products in a precarious legal position. And of course, if you’re hoping to sell to cannabis dispensaries in any regulated state, including California, you’ll have to be licensed by that state, and you’ll only be able to sell to other licensees. Given the recent shift in federal enforcement priorities, we wouldn’t be surprised to see an uptick in enforcement action against companies selling CBD skincare and beauty products, particularly in interstate commerce and outside the ambit of state regulatory systems. But that’s a legal and business risk that many are clearly still willing to take.
This article originally posted …: Canna Law Blog