What is the regulatory current state of play with CBD?
Since the 2018 Farm Bill legalized hemp, CBD and other cannabinoids have become increasingly popular in the health and wellness sector. But can CBD be legally marketed today in a dietary supplement or conventional food or beverage?
U.S. Drug Enforcement Administration (DEA)
The Farm Bill removed hemp from the Controlled Substances Act. However, tetrahydrocannabinol (THC, the cannabinoid largely responsible for the "high" associated with marijuana use) content must be no higher than 0.3%. Higher-THC-content marijuana remains a Schedule I controlled substance.
U.S. Food and Drug Administration (FDA) and hemp
Many hemp-based food products have received Generally Recognized As Safe (GRAS) status, including hulled hemp seed, hemp seed protein powder and hemp seed oil. Hemp oil, which contains CBD as well as many other compounds, cannot be marketed specifically for the presence of CBD or other specific cannabinoids, according to FDA. For several years, the agency has asserted products containing CBD (or THC, even where legal) cannot be sold as dietary supplements.
Why Is GW Pharma important to CBD legal status?
Why can't products containing CBD be legally marketed as dietary supplements, according to FDA? Because of the existence of substantial clinical investigations conducted by GW Pharmaceuticals regarding Sativex and Epidiolex—two drugs containing CBD. FDA has cited an exception in the law if CBD was first marketed in a dietary supplement or food, but the agency is not aware of any evidence that would alter its conclusions.
FDA CBD enforcement
FDA has enforced its stance on CBD through warning letters. The letters are focused on claims being made by products containing CBD, along with some mention of the GW Pharma issue. Marketers targeted by FDA have made claims that their CBD products treat diseases like epilepsy and cancer.
Is there a path forward for CBD?
Members of Congress and industry representatives want FDA to identify a lawful pathway for CBD in food and dietary supplements. The Secretary of the U.S. Department of Health and Human Services has authority to permit CBD to be lawfully sold as a dietary supplement by issuing a regulation following a notice and comment period; however, FDA's former commissioner, Scott Gottlieb, M.D., stated, "We’ve never done this before, it would be a highly novel rulemaking process. The most efficient way to get to a pathway would be through legislation.” Such a process could take years.
Although the 2018 Farm Bill removed hemp from the Controlled Substances Act, it did not preempt states from regulating the crop. Issues within various states remain.
– South Dakota's governor vetoed a bill legalizing the growth, production and processing of industrial hemp in the state.
– Idaho's Office of Drug Policy opposes legalization of marijuana in any form, other than specific marijuana-based medications that have received FDA approval.
– Nebraska's Attorney General has stated CBD has been and continues to be included in Nebraska Controlled Substance Act Marijuana definition.
– Iowa requires a medical CBD registration card for purchase of any CBD-containing products.
Despite the legal gray area in which CBD currently resides, all kinds of products can be found containing the compound. Candy, beer, coffee, snacks, condiments and beauty products containing CBD are all on the market. Even CBD treats for an anxious pup can be found. No matter its current regulatory status, the CBD market is booming.