The CBD category has come under intense scrutiny over the past couple of weeks as the FDA issued a raft of warning letters and said it “is not aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food”, and then a number of companies were hit by putative class actions.
Such actions have made the “need for prompt action by Congress was made even more clear and urgent”, wrote the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA) in a letter to Senators and Representatives dated December 12, 2019.
Targeted statutory change
The AHPA-CHPA-CRN-UNPA letter goes on to state: “We strongly urge that there should be safeguards to make certain consumers can access CBD products which are safe, accurately labeled, and produced under the highest quality conditions.
“To further that goal, we have advocated for a targeted statutory change to the Food, Drug, and Cosmetic Act (FDCA) that would establish a legal and regulatory framework for dietary supplements containing hemp-derived CBD accompanied by increased appropriations for FDA oversight necessary to serve the interests of consumers, responsible industry and our nation’s hemp farmers.
“Under this framework, CBD used in dietary supplements would have to be derived from hemp as defined by the 2018 Farm Bill, and any dietary supplement containing hemp-derived CBD must fully comply with applicable requirements for new dietary ingredients under the FDCA. These requirements demand that companies provide the FDA with evidence of safety of the ingredient under the labeled conditions of use prior to going to market. This is an important safety guard rail.
“These products would also be required to fully comply with all other provisions of the FDCA and FDA’s implementing regulations applicable to dietary supplements, including those requiring accurate product labeling and good manufacturing practices as well as the prohibition against making any drug claims.”
Recent action
Referencing the recent warning letters, the trade associations noted that those primarily targeted firms making alleged illegal drug claims. While they commend such actions, they urged “Congress to take would promptly (without a 3-5 year rulemaking process) clarify the agency’s authority to exercise these important tools to protect the public health.
“By expressly allowing hemp-derived CBD to be sold as a dietary supplement, this legislation would confer FDA with authority to address the myriad violations of general dietary supplement regulations presented by these CBD products.”
The trade associations also called on Congress to make substantial resources available – above and beyond the potential $2 million included in the House and Senate FY 2020 Agriculture and Related Agencies Appropriations bills - to enable “effective FDA oversight of this fast-growing category, 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 AHPA-CHPA-CRN-UNPA letter also discussed statements made by Lowell Schiller, principal associate commissioner for policy in FDA’s Office of Policy, who told attendees at the Council for Responsible Nutrition annual conference that FDA is hampered in its efforts to regulate some CBD products labeled as dietary supplements because they “may not actually be a dietary supplement at all.”
“This FDA interpretation of its authority seems to preclude the agency from enforcing the full range of safety and quality controls set forth in the law for dietary supplements,” stated the letter.
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