Four dietary supplement trade groups on Tuesday urged Congress to pass legislation clarifying hemp-derived CBD is a lawful dietary ingredient if the supplement meets established product safety and quality criteria.
Lawmakers also were asked to devote sufficient resources to shield consumers from unsafe CBD products.
While FDA has been examining the potential for a rulemaking that would authorize CBD to be added to food and marketed as a dietary supplement, agency officials have stressed such a process could take several years to complete.
Industry representatives have expressed fears that a lack of federal oversight could endanger the health of the public and continue to foster an environment of uncertainty, stymieing investments and innovation.
The U.S. market is already inundated with CBD products and a patchwork of state testing and labeling laws governing them.
Since at least 2015, FDA has asserted CBD can’t be marketed in a dietary supplement under federal law because, in short, the compound was first studied as a pharmaceutical drug. Last year, the agency approved the first CBD medicine, Epidiolex, to treat seizures associated with two severe forms of epilepsy.
Despite the drug-related exclusion above, the Federal Food, Drug & Cosmetic Act (FD&C Act) grants the head of the U.S. Department of Health and Human Services (HHS) discretion to authorize CBD to be marketed in supplements.
In the Oct. 8 letter to Congress, the trade associations noted any CBD products subject to such a “limited waiver” would need to meet the definition of hemp in the 2018 Farm Bill and comply with applicable requirements of the FD&C Act and FDA’s regulations related to dietary supplements, including requirements for new dietary ingredients.
An appropriations bill in the U.S. Senate provides an additional $2 million for FDA’s CBD work, the trade groups noted. However, they requested Congress devote additional resources so FDA could effectively oversee the market, “including funding for efficient and timely review of new dietary ingredient notifications and enforcement of existing laws governing the safety, manufacturing and labeling of dietary supplements containing CBD.”
The letter was signed by the leaders of the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA) and United Natural Products Alliance (UNPA).
“While we can appreciate the FDA’s deliberative interest in making sure that consumers have access to safe CBD products, we are concerned that continuing to leave the marketplace without clarity and adequate oversight for an extended period of years will both endanger consumers and the bright future of the hemp derived products they seek,” the trade associations wrote to members of the House of Representatives and Senate. “Since it appears FDA is unlikely to provide a timely and effective resolution to this challenge, Congress must act.”
FDA in recent months has faced increasing pressure to act on CBD. For instance, Reps. Chellie Pingree (D-Maine) and James Comer (R-Kentucky) in September sent a letter to FDA, requesting the agency announce a policy of enforcement discretion through a guidance. Twenty six members of Congress signed the bipartisan letter.
"FDA’s current regulatory posture on CBD has created significant regulatory and legal uncertainty for participants in this quickly evolving industry," lawmakers wrote to FDA Acting Commissioner Ned Sharpless. "We are discouraged by FDA’s estimation that a rulemaking process could span three to five years. We believe there are more expeditious measures that FDA could take that would establish regulatory clarity while pursuing enforcement actions against bad actors.”
In a separate letter to Sharpless, Sen. Richard Blumethal (D-Connecticut) and five other senators recently urged FDA to implement and finalize a thorough regulatory framework for hemp-derived CBD. "Consumers and manufacturers of this fledging industry are counting on regulatory oversight and certainty that only the FDA can provide," the senators wrote to Sharpless. "Your efforts to date have been woefully inadequate."