Next FDA commissioner must address regulations
2018 was the year for cannabidiol: the U.S. Food and Drug Administration (FDA) granted its first-ever approval of a CBD-containing drug, GW Pharmaceutical’s Epidiolex, which is used to treat certain epileptic seizures; shortly thereafter, the DEA took FDA-approved, CBD-containing drugs off Schedule I of the Controlled Substances Act; then Congress passed the 2018 Farm Bill at the end of the year, creating potential legal avenues for the production of hemp-derived CBD.
But these landmark measures failed to relieve the stringent FDA policies prohibiting companies from adding CBD to food, drinks and dietary supplements. The Farm Bill tasked the FDA with the job of creating a regulatory pathway for CBD derived from hemp.
After President Trump signed the Farm Bill, FDA Commissioner Scott Gottlieb released a statement pertaining to the bill’s implications. He described how the FDA is taking steps toward evaluating whether it should exercise its authority to issue a regulation allowing CBD as an ingredient in foods or dietary supplements. Gottlieb cautioned that the FDA would only consider issuing new CBD regulations if all the requirements of the Food, Drug and Cosmetics Act could be met.
“For CBD to be legally marketed as an ingredient in a food or dietary supplement, the law requires that the FDA first would need to issue a regulation to permit such marketing,” Gottlieb advised. He testified before the House Appropriations Committee on Feb. 27 and announced the FDA was planning an April meeting to initiate the rulemaking procedure to establish a regulatory framework for CBD products.
Gottlieb explained how the complexity of regulating CBD under the current Farm Bill could make the rulemaking procedure last for years, and that the end result could just be kicking the issue back to Congress to make new legislation on CBD. Not even a week after he opined on these developments and announced the FDA’s intent to make progress in April, Gottlieb unexpectedly resigned from his position as commissioner.
So, what now for CBD?
No date was set to kick off the rulemaking procedures for CBD regulation; whether that plan is still in place remains unknown. Without this hearing, it remains illegal to add CBD to food or drinks. Gottlieb was the driving force behind CBD regulation. He had a knack for getting the FDA involved in significant contemporary health issues. He outwardly recognized Congress’ intent for the FDA to make avenues for the availability of CBD when it passed the Farm Bill. Sources at CBD-Intel, a UK-based regulatory and market intelligence company for the CBD sector, commented, “As he prepares to depart, Gottlieb has hinted that his own preferred policy toward CBD would be a broadly tolerant one, encouraging study of higher concentrations for pharmaceutical applications and perhaps permitting lower ones for food and dietary supplements.”
The progress of regulated CBD will largely be determined Gottlieb’s replacement. CBD-Intel stated, “The best-case scenario for the industry is a positive loosening of FDA regulations. The worst case is the status quo — and even that isn’t so bad.”
Big business has already taken an interest in CBD products. Time will tell whether the FDA is a protagonist or antagonist to the growing consumer demands for this new ingredient.
Charles Feldmann is a founding partner of Feldmann Nagel Cantafio Margulis Gonnell, PLLC and head of the law firm’s international cannabis team. He uses his past experience as a Marine Corps federal prosecutor, DEA Drug Task Force commander and Colorado state narcotics prosecutor to assist his clients in establishing strict regulatory compliance protocols at the state, federal and international levels. Read his full bio at MJBusinessAttorneys.com.