KANSAS CITY — The Food and Drug Administration’s approach to regulating food and beverages formulated with cannabidiol (C.B.D.) is creating confusion in the marketplace. The agency’s official stance is it is not permissible to formulate C.B.D. into food or dietary supplements in states where cannabis is not approved for recreational use. Yet finished products featuring the ingredient are reaching the market almost unchecked. This approach to enforcement has the potential to cause long-term harm to an ingredient category with promise and erode consumer trust in the industry and the agency.
The F.D.A.’s regulatory authority is derived under the Federal Food, Drug and Cosmetic Act, which prohibits the introduction into interstate commerce of foods to which an approved drug has been added. Epidiolex is a C.B.D.-derived drug currently on the market.
Yet the F.D.A. only has taken disciplinary actions related to foods formulated with C.B.D. in the form of warning letters sent to manufacturers that have made unapproved and unsubstantiated health claims for their products, claims the F.D.A. said may discourage consumers from seeking medical assistance or treatment.
Beyond issuing warning letters, the F.D.A. has taken only rudimentary steps to caution consumers about the potential risks posed by C.B.D. Earlier this month, agency officials published an advisory telling pregnant and breastfeeding women not to use C.B.D. The Grocery Manufacturers Association (G.M.A.) applauded the move but urged the F.D.A. move with alacrity to provide clear regulatory oversight and consumer protection around C.B.D.-containing consumer products.
“American consumers are confused by the thousands of C.B.D. products that have flooded the market,” said Geoff Freeman, president and chief executive officer of the G.M.A. “There is likely a reasonable role for C.B.D. in the marketplace, but it demands stringent federal regulation that promotes safety and empowers consumers to make informed decisions. It’s past time for F.D.A. to move at the speed of the market.”
The F.D.A. said it is studying the effects of C.B.D. use from several angles, including its consumption over the course of a person’s entire life, and the effects of using various C.B.D.-containing products in combination. Clinical studies have shown C.B.D. use may cause liver toxicity, extreme sleepiness or harmful health consequences when used with other drugs.
“There are many unanswered questions about the science, safety and quality of products containing C.B.D.,” the F.D.A. said.
Yet the juxtaposition of the F.D.A.’s position regarding C.B.D. and its prevalence at the SupplySide West/Food Ingredients North America trade show, held Oct. 15-19 in Las Vegas, was startling. More than 50 exhibitors showcased C.B.D. ingredients derived through a variety of extraction processes to be used in food, beverage and personal care applications.
This past July, F.D.A. officials said they were working to answer questions about the science, safety and quality of products containing cannabis and cannabis-derived compounds, particularly C.B.D. At the same time the market is advancing at a breakneck pace.
This situation is untenable. There are multiple blind spots regarding the safety and efficacy of C.B.D. A single negative health or safety event has the potential to set the market for C.B.D. back for years. It is incumbent on the F.D.A. to take the lead regulating C.B.D. in food to ensure its safety and clear up any confusion about its potential benefits.