Former FDA commissioner suggests regulatory pathway for CBD in opinion piece

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Former FDA commissioner Scott Gottlieb, MD recently wrote an opinion piece in the Washington Post about how the agency should handle cannabidiol (CBD) in food and dietary supplements. Gottlieb acknowledges that determining the ideal regulatory pathway for legally incorporating CBD into food and dietary supplements would take too long given that it’s a process subject to notice and comment, as well as a substantial amount of scientific data to evaluate. A more practical solution, he says, is to approve the sale of some CBD products immediately, while at the same time effecting a framework for their regulation, and a pathway for an enforceable market.

“The FDA could put the onus on manufacturers to bring forward petitions to demonstrate that CBD can be safely added to products such as food,” Gottlieb explains. “These submissions can take the form of new dietary ingredient notifications or food additive petitions, which would include toxicity studies to evaluate the safety of CBD. These are the same standards any new food ingredients are held to. Congress can help by passing language saying that the FDA doesn’t need to issue a broad regulation on CBD and can instead rely on petitions filed by individual, prospective producers.”

Under this proposed framework, FDA could exercise enforcement discretion to allow CBD to be marketed as long as the products meet certain conditions such as good manufacturing practices, traceability, and adhering to safe levels. Such products would also be prohibited from making any claims to treat disease. Gottlieb states that this framework would have to be specific to CBD to avoid the risk that it becomes a precedent for food and supplement makers seeking a back door to add other drugs to food.

“Obligating the industry to do the front end of this scientific work - and sweeping the market of those who won’t - could advance a safe path and help establish the stable market for hemp-derived CBD envisioned by lawmakers,” Gottlieb concludes.

This opinion is in line with many industry trade groups who are urging FDA to take immediate action.