The passage of the 2018 Farm Bill on Thursday ushered-in the long-awaited return of commercial hemp production in the United States and opened up a wealth of new opportunities for the cultivation, production, and sale of one of the world’s most versatile plants.
But while the plant has many uses, hemp-derived cannabidiol (CBD) may currently be one of its more sought after features. And it’s a feature that the Food and Drug Administration (FDA) is taking seriously.
The Farm Bill removed hemp from the Controlled Substances Act, but it also preserved the FDA’s authority to regulate products that contain cannabis or are derived from it.
“We continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds,” wrote the FDA in a press release Thursday. “Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective.”
Under the Food, Drug, and Cosmetic Act, it is illegal to introduce food products containing tetrahydrocannabinol (THC) or CBD into interstate commerce or market them as dietary supplements, though the FDA says that they do provide options for exceptions if the proper requirements have been met.
“We treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products,” stated the agency. “Meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance.”
Earlier this year, the FDA granted final approval to GW Pharmaceuticals to release their CBD formulation Epidolex in the United States for use by epileptic patients.
The FDA has deemed hulled hemp seeds, hemp seed protein, and hemp seed oil to be generally recognized as safe and says that they can be added to food products without special approval.
According to the FDA, they will be holding a public meeting in the near future so that stakeholders may come and share their experiences and offer their insights on the returning industry and the safety of the products it produces.
