I saw the FDA announcement as well ā talk about adding to the ongoing confusion. My first knee-jerk reaction was to assume FDA was overreaching its authority. After all, the farm bill aimed to legalize hemp and all of its derivatives. But, upon re-reading the legislative text, I realize it may not be an overreach at all.
The FDA notice shed light on a number of flaws in the legislation, which CBD producers will need to continue working around: 1. hemp is now legal to grow but hemp-derived CBD remains a Schedule 1 controlled substance under CSA; 2. as such CBD producers wonāt be able to transport CBD product outside of the state where itās produced; 3. FDA has jurisdiction over hemp food and supplements but, rather than treating CBD like any other legal supplement like Vitamin C, it is treating hemp CBD as an illicit drug, which it is technically ever since the DEA assigned it a numerical designation to distinguish it from āMarihuanaā in Schedule 1 two years ago.
Prior to that, CBD derived from imported hemp was legal to buy and sell everywhere in the U.S. under the 2004 9th Circuit Appellate Court Rule (HIA v DEA). Bob Hoban, who represented HIA in that case, explains it well in this interview.
In February 2017, right after the DEA gave CBD its Schedule 1 designation (Federal Registry, Dec 2016), HIA contested it with the 9th Circuit and lost. In April this year, the finally court upheld the DEAās authority to schedule CBD. The FDA put regulation states on notice, which caused a cascade of bans on CBD edibles. For example, California DPH banned CBD infused food (but not THC edibles, ironically) because, unlike THC/marijuana named in the CA law, CBD is a Schedule 1 controlled substance not legalized per the California adult use law.
These events werenāt well publicized so thereās still a lot of confusion ā and few producers seem to know or care whether CBD (hemp derived or otherwise) is legal or not, evidenced by the fact that the CBD industry continues to thrive, business as usual. The 2018 Agricultural Act intended to fix that. (Congressman James Comer, who sponsored and co-authored the hemp provisions, talks about that in this interview.)
Although the legislators were careful to include all hemp biomass, extracts and derivatives in the definition of āhempā in Section 7605 ("ā¦term āhempā means 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 concentration of not more than 0.3 percent on a dry weight basis."), they failed to explicitly exempt CBD in Section 12,609 of the bill, which removes hemp from Schedule 1 by excluding it from the definition of āMarihuanaā as described in the CSA. That provision also explicitly exempts THC (all tetrahydrocannabinols naturally occurring in hemp at <.3%) from Schedule 1 but failed to mention anything about cannabinoids like cannabidiol - CBD.
The flaws could easily be fixed with an amendment. But, for the time being it appears FDA will police hemp CBD because it is still a federally-illegal controlled substance.
As for FDA approval of CBD when makers claim curative benefits, even legal substances like Vitamin C require approval if used in a nutritional supplement that makes health claims. Word to the wise, product companies should always refrain from making any claims ā leave that up to us, the journalists⦠Itās within our 1st Amendment right to tout the medical benefits of cannabis all day long!
If anyone has any firsthand updates or more information about this, Iād love to hear about it.