Saying federal safety standards are insufficient to manage the CBD industry, the U.S. Food and Drug Administration (FDA) has called on Congress to set rules for the products through legislation.
The agency said Thursday that not enough is known about CBD products to regulate them as foods or supplements under the FDA’s current structure.
“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” FDA Deputy Commissioner Janet Woodcock said in a statement.
Same old song
FDA has repeatedly cited studies that say CBD could harm the liver and male reproductive system, and said little is known about how it interacts with drugs, and its effects on children and pregnant women.
Hulled hemp seeds, hempseed oil, and seed-based protein powder are allowed as ingredients in human food by the FDA. But CBD, which is derived from hemp flowers, is not.
In calling for Congress to act, the agency said its existing foods and dietary supplement authorities are not able to manage many of the risks associated with CBD under rules for dietary supplements and food additives. “Given the available evidence, it is not apparent how CBD products could meet safety standards” for such products, FDA said in the statement.
Petitions rejected
The FDA underscored its position on CBD by simultaneously announcing it had denied three petitions from stakeholder groups that had asked the agency for rules that would have allowed the marketing of CBD products as dietary supplements.
Lawmakers and CBD stakeholders have repeatedly called out the FDA for its inaction on CBD. The Oversight Committee of the U.S. House of Representatives had said recently that it was preparing to investigate the agency over its regulatory jurisdiction.
Instead of supporting CBD research and making rules, the FDA has mostly cracked down on vendors with repeated waves of warning letters over the last few years.
FDA said recently that it is only months away from finalizing some recommendations for how cannabis should best be regulated, and called for a framework “that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.” The agency said Thursday it will work with Congress to develop a cross-agency strategy for regulation.
The lack of rules for CBD, long-awaited by stakeholders, is a factor in stalled investment in the sector, which at any rate is massively downsized as a result of a crash that has lingered for more than two years. Interest in the sector could be revived if federal rules allow hemp-derived cannabinoids to be treated as food or supplements instead of drugs.
Swift criticism
Critics were swift to respond to the FDA’s announcement.
“Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years,” said Jonathan Miller, general counsel at the U.S. Hemp Roundtable. “CBD products have been sold at retail for nearly a decade with no significant safety issues.”
Miller argued that existing dietary supplement and food pathways and regulations covering the manufacturing, labeling, and marketing of products are sufficient for CBD.
“We are going on five years with no regulation being blamed on concerns for health implications and we need those investments to support research that showcases the benefits and effectiveness of CBD use – and helps develop dosage guidelines based on those concerns,” Chase Terwilliger, CEO of Balanced Health Botanicals, told FOX Business.
Steve Mister of the Council for Responsible Nutrition, one of three petitioners which had asked FDA to allow the marketing of CBD products as dietary supplements,” told the Washington Post that the agency is “kicking the can down the road while ignoring the realities of the marketplace” by turning to Congress for a resolution.
“FDA has repeatedly disregarded evidence demonstrating safety that is relevant to CBD at the levels commonly used in supplements,” Mister said, claiming the agency’s concerns about CBD are based, wrongly, on indicators related only to high dosage CBD products, such as Epidiolex, a prescription drug that is the only cannabis-based product the FDA has approved.
Lawmaking
Congress has already been looking at CBD, having drafted legislation in 2021 that would have ensured that hemp-derived CBD and other non-intoxicating hemp ingredients could be marketed as dietary supplements. “The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021,” which also would have required CBD products and hemp extract manufacturers to comply with existing safety rules for dietary supplements, appears to have died in a House committee early this month.
CBD could be dealt with in the 2023 Farm Bill which will be negotiated this year. Stakeholders have urged lawmakers to incorporate language into the Farm Bill that would designate CBD and other non-intoxicating cannabinoids as dietary supplements.