The new agriculture bill signed into law Thursday legalizes hemp — something activists have been supporting for years. But that doesn’t mean that hemp products containing certain cannabis-related compounds can be sold freely, the Food and Drug Administration said.
The new law removes hemp from the Controlled Substances Act because it has such low levels of THC, the compound that gives other varieties of cannabis its mood-changing properties.
But that doesn’t mean people can just start selling hemp-derived cannabis products as medicine or as supplements, FDA commissioner Dr. Scott Gottlieb said.
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“Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act,” Gottlieb said in a statement.
“We’re aware of the growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD),” he added.
“In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act.”
The FDA has already issued warnings to people selling cannabis and CBD oil for medical uses.
“In particular, 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,” Gottlieb said.
Such products are regulated just as any other drug would be, the FDA said.
But websites, stores and some medical practices are selling CBD products with a variety of claims. “This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases,” Gottlieb said.
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“Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements.”
It’s possible to get FDA approval for such products, but makers have to prove their products are safe and work as intended. “For example, in June 2018, the FDA approved a drug, Epidiolex, that contains cannabis-derived CBD for the treatment of seizures associated with two rare and severe forms of epilepsy. That approval was based on adequate and well-controlled clinical studies,” Gottlieb said.
And hemp-derived food products can be marketed as "generally recognized as safe" or GRAS.
The FDA gave a nod to three such products Thursday. "GRAS notices were submitted by Fresh Hemp Foods, Ltd. The agency has no questions about Fresh Hemp Food’s conclusion that the following ingredients are GRAS under their intended conditions of use: hulled hemp seed, hemp seed protein powder, and hemp seed oil," the FDA said.
"Although hemp is from the same species as cannabis (marijuana), the seeds themselves do not naturally contain tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant."
