FDA on Thursday announced its determination that it needs a new pathway to oversee the market for cannabidiol (CBD), and it denied three citizen petitions requesting the agency engage in rulemaking to allow the hemp-based compound to be marketed in dietary supplements.
The citizen petitions had been filed in recent years by three trade associations: the Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA) and Natural Products Association (NPA).
Following “careful review,” FDA has determined the need for a new regulatory pathway “that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” FDA Principal Deputy Commissioner Janet Woodcock, M.D., said in a news release. “The agency is prepared to work with Congress on this matter.”
FDA has safety concerns about CBD, especially its long-term use. Woodcock said the compound has demonstrated the potential for possible harm to the liver, interactions with particular medications and possible harm to the reproductive system.
“CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant,” she added.
Woodcock said consumers would benefit from a new regulatory pathway that would offer oversight and protections to abate and manage risks associated with CBD products. She referenced such potential measures as clear labels, content limits on CBD, a minimum purchase age and prevention of contaminants.
Woodcock chairs a working group that has examined studies related to the CBD-based drug Epidiolex, published scientific literature and information submitted to a public docket. The working group also has assessed studies that FDA has conducted and commissioned.
“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” she proclaimed in the news release. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.”
CBD in animals, FDA enforcement
Animals also face risks from CBD, and unbeknownst to people, they could be exposed to the compound through eggs, meat and milk from animals who consumed CBD, Woodcock said.
FDA does not plan to initiate rulemaking related to the use of CBD in animal food, as it is not evident how such products could meet the applicable safety standard, she said. But Woodcock raised the prospect that certain CBD-containing products for animals could be overseen under a new regulatory pathway.
“The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate,” Woodcock concluded in her statement. “We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”
NPA calls decision 'astonishing dereliction of duty'
The Natural Products Association, whose 2022 CBD citizen petition was denied by FDA, responded swiftly and harshly to Thursday's big announcement.
“This is an astonishing dereliction of duty, especially compared to the agility and professionalism the agency showed it was capable of during the pandemic,” NPA President and CEO Dan Fabricant, Ph.D., said in a statement. “After more than a decade of promises, hearings, data sharing, market proliferation and states filling the regulatory vacuum, the FDA’s Dietary Supplement Office claims it cannot do what Congress authorized, which is to regulate dietary supplements under the law.”
Fabricant said the message from FDA “gets scarier.”
“When you read between the lines of today’s FDA statement, the agency appears to be saying that it would prefer to defy and attack DSHEA [Dietary Supplement Health and Education Act of 1994] and develop different regulatory paths for ingredients at its own discretion,” he added. “That could include requiring premarket approval, unnecessary testing or who knows what. That is an especially dangerous precedent not only for CBD but for the entire natural products industry and ingredients like hemp that clearly fall under the agency’s jurisdiction. We couldn’t be more disappointed and will look for relief with every branch of government and will need the help of our members to right the wrong.”
FDA action would be 'unprecedented' and 'unnecessary'
The U.S. Hemp Roundtable, whose members include many CBD brands, was disappointed in FDA’s decision and challenged the agency’s conclusions.
“When it comes to the safety of CBD, the FDA gets it wrong,” Jonathan Miller, general counsel to the U.S. Hemp Roundtable, said in a statement. “Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. CBD products have been sold at retail for nearly a decade with no significant safety issues.”
He added his organization recently met with FDA and shared safety studies that demonstrated the safety of standard CBD sizes, which are distinguishable from substantially higher doses associated with risks based on pharmaceutical studies.
“We therefore see no need for FDA to go through the lengthy, burdensome exercise of establishing a new regulatory pathway for CBD, or other hemp-derived cannabinoids,” Miller said. “This action would be unprecedented and is unnecessary given the existing dietary supplement and food pathways provided under the Federal Food, Drug & Cosmetic Act, which include robust, comprehensive requirements aimed at ensuring the safety and quality of products, in addition to extensive FDA regulations covering the manufacturing, labeling and marketing of products.”
However, the U.S. Hemp Roundtable remains in favor of a legislative solution to permit the marketing of hemp-derived cannabinoids, including CBD, as dietary supplements and foods.
“We look forward to working with the large, bi-partisan coalition that has developed in Congress to re-introduce legislation in this new Congress in the coming days to direct FDA to utilize the existing regulatory pathways for CBD and other hemp-derived cannabinoids, one that ensures the safety and quality of products,” Miller added. “We also remain willing to work with the FDA to ensure that hemp-derived cannabinoids like CBD are safe and adequately regulated.”