Outgoing FDA chief says Congress can act faster.
Retiring Food and Drug Administration commissioner Scott Gottlieb, M.D., said on Tuesday that a rule-making process by the FDA to deal with the booming—and controversial—CBD market would take more than three years to complete, and the most efficient way to deal with marijuana’s non-intoxicating cousin would be through legislation that would focus on CBD only.
The FDA has posted comments declaring that CBD is illegal in dietary supplements because it violates the federal Food Drug & Cosmetic Act, which gives exclusive market access to ingredients the agency approves as a drug over supplements.
The FDA approved a CBD isolate, Epidiolex, in 2018, and the pharmaceutical company responsible for the ingredient, GW Pharmaceuticals, had been conducting research into the CBD isolate since before CBD as a supplement made it to market, according to the FDA.
The market has summarily ignored that advice, and today there may be 1,000 different brands marketing CBD, including Martha Stewart and Coca-Cola.
Farm Bill still leaves CBD in limbo
The December 2018 passage of the Farm Bill made clear that Congress wants CBD to be available to the public—a piece of legislation that is at odds with both the federal FD&C Act as well as the modus operandi of drug-warrioring agencies like the Drug Enforcement Administration (DEA).
“With the incredible explosion and growth of this young industry, it is important that regulations are put in place to help tame the unregulated Wild West,” said Matt Kennicott, Chief Communications Officer at Glo CBD, which markets chewable CBD tablets. “Legislation that would help fast track the process by making it less complex and putting regulations on the books in a timelier fashion for the industry should be welcomed by producers, retailers, and consumers so that everyone can rest assured that products sold and consumed are safe and reliable.”
Gottlieb stated that the FDA can finalize an “average” rule in two to three years. He suggested it would be much longer for CBD because it would be a “highly novel rulemaking to do a complex rule like this.”
“We have understood from the outset that FDA has never before applied the authority of the Secretary HHS to create exceptions to the “prior-IND” and “prior-new drug approval” provisions of the Federal Food, Drug and Cosmetic Act, which are the provisions that serve as the basis for FDA’s position that CBD cannot be added to food or marketed as a dietary supplement,” said Michael McGuffin, president of the American Herbal Products Association. “This appears to be why Commissioner Gottlieb refers to this process as ‘novel.’”
Yet a years-long rulemaking process would appear to be throwing in the towel—as if that isn’t already the opinion of the FDA from all players. Already, most observers believe too much toothpaste has come out of the CBD tube for the agency to put it back in—especially because of the ingredient’s clean safety profile and broad base of consumer support including “epilepsy moms.” Several more years is too long to leave CBD products in a state of regulatory uncertainty.