CBD is “thriving” in the current regulatory environment, but is it doing so illegally?

As former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb opined last  week, “the CBD craze is getting out of hand. The FDA needs to act.”  Since the passage of the Farm Bill in December of 2018, there has been a marked uptick in interest in the cannabidiol (CBD) space from businesses and users alike.  Congress explicitly preserved the FDA’s authority to regulate CBD-containing products to ensure that they are safe and that their claims are valid.  Current federal law expressly allows for the distribution of hemp-derived CBD products that contain 0.3% tetrahydrocannabidiol (THC) or less to be sold, with certain caveats.  The FDA has provided clarity that hulled hemp seed, hemp protein powder, and hemp seed oil can be legally used in foods.  Other CBD products, however, are still subject to various state law regulations as well as the U.S. Food, Drug, and Cosmetic Act (FD&C Act), which requires FDA pre-market approval for drug products.  Currently, the FDA treats CBD products aimed at human or animal consumption as drugs and therefore they cannot be distributed without prior approval or a rulemaking exception (more on this below).  The following is a brief update on recent developments within the federal regulatory regime of CBD products. 
Continue Reading

Cannabidiol (CBD) competed with Vitamin C as a top ingredient in new cosmetic products this past year, with promises of having anti-inflammatory effects and other healing properties. Amid the hype, at the end of 2018, the Agriculture Improvement Act of 2018, P.L. 115-334 (the “2018 Farm Bill”) was signed into law, changing the marketing of hemp and derivatives of cannabis and further removing hemp from the Controlled Substances Act thereby making it no longer an illegal substance under federal law. See Section 297A. The 2018 Farm Bill amended the definition of “hemp” to specifically include “all derivatives, extracts, cannabinoids,” which has been construed as an attempt to include hemp-based CBD under the definition of industrial hemp. The 2018 Farm Bill allows, subject to certain restrictions, hemp cultivation, along with the sale, transport (including via interstate commerce), and possession of hemp-derived products.
Continue Reading

This is Washington, and we do like to speak in initials.  A plain English translation of the title of this piece would read “FDA ‘places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in Schedule V.’”  DEA Final Order, Docket No. DEA-486 Schedule V drugs include cough medicine with codeine and many pain relievers that still require a prescription.  So, really what this order does is allow doctors in the US legally to prescribe the recently approved epilepsy drug, Epidiolex, and allows pharmacies, rather than marijuana dispensaries, legally to sell the drug.
Continue Reading