Tuesday, February 25, 2020

Tuesday, February 25, 2020

Cannabis regulation not in FDA jurisdiction, industry expert says

The Food and Drug Administration has been gathering comments on how to regulate cannabis products, but a cannabis industry expert says the FDA should lay off and let states do their jobs.

“The FDA regulates the pharmaceutical industry,” Arthur Livermore, the national director for the American Alliance for Medical Cannabis, told the FDA Reporter. “Cannabis is not a pharmaceutical. It's a plant.”

Livermore did say the FDA could regulate pills made from cannabis products.

“Cannabis is used for hemp fabrics, rope, canvas sails, herbal remedies, bio-fuel, food and drinks,” Livermore said. “The appropriate regulatory agencies should do their part. The FDA might regulate pills made from Cannabis.”

Last week, the FDA held a public hearing about cannabis products, including non-psychoactive cannabidiol (CBD).

The issue came to the forefront because the FDA recently approved a seizure treatment drug called Epidolexis and the compound in the drug uses CBD as an active ingredient. According to its press release, the FDA believes that allowing CBD in food products would hinder the drug approval process.

A number of health organizations weighed in on the issue.

The American Medical Association said in a statement that it believes clinical trials are necessary for all new drugs, including potential cannabis products. The statement also clarified that the AMA "opposes the legalization of cannabis for medicinal use through the state legislative, ballot initiative, or referendum process."

"[The AMA] will develop model legislation requiring the following warning on all cannabis products not approved by the U.S. Food and Drug Administration: ‘Marijuana has a high potential for abuse. This product has not been approved by the Food and Drug Administration for preventing or treating any disease process,’” according to the statement.

Amyris said in a statement that it was in favor of allowing the public access to CBD products.

“The U.S. market needs safe CBD product solutions," the Amyris statement said. "The US market needs affordably priced CBD product solutions. The biotech industry urges FDA to provide clarity of all potential regulatory pathways to market. [The] biotech industry looks to partner with and serve as a resource for FDA for rapid establishment of safety processes and quality endpoints. We think that appropriate controls are critical to ensure that ingredients and products are safe.”

Livermore, though, probably summed it up best.

“Cannabis prohibition began as a racist law in the early 1900s," Livermore said. "We're smarter than that now.”

Organizations in this Story

US Food and Drug Administration

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FDA Reporter