Silver Spring, MD—There needs to be new regulatory pathway for cannabidiol (CBD) that balances consumers’ desire for access to CBD products with regulatory oversight that can manage risks. That's the conclusion the U.S. Food and Drug Administration (FDA) has reached after convening an internal working group to explore potential regulatory pathways for CBD products.

FDA said it is prepared to work with Congress to develop a cross-agency strategy for the regulation of CBD products.

FDA also reported that it has denied three citizen petitions that called on the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements. Petitions had been filed by theConsumer Healthcare Products Association(CHPA), theCouncil for Responsible Nutrition(CRN), and theNatural Products Association(NPA)

"The use of CBD raises various safety concerns, especially with long-term use," said FDA's Janet Woodcock, M.D., Principal Deputy Commissioner - Office of the Commissioner, in astatement. "Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant."

Dr. Woodcock added that a new regulatory pathway would provide consumers with safeguards and oversight to "manage and minimize risks related to CBD products." Risk management tools could include:
  • clear labels
  • prevention of contaminants
  • CBD content limits
  • measures, such as minimum purchase age, to mitigate the risk of ingestion by children.
The new pathway also could provide access and oversight for certain CBD-containing products for animals, Dr. Woodcock noted.

The problem with FDA’s existing foods and supplement authorities:

"The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products," Dr. Woodcock said. "Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive."

Outlining concerns identified by the working group, Dr. Woodcock said available evidence (which includes studies related to the drugEpidiolex, published scientific literatureinformation submitted to a public docket, and studies conducted and commissioned by FDA) does not establish:
  • How CBD products could meet safety standards for dietary supplements or food additives, with inadequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.
  • How CBD products could meet the safety standard for substances in animal food.

Industry responds to FDA's CBD decision

FDA's claim that the agency does not have appropriate authority to regulate the CBD was met with strong reaction from natural products industry leaders.

FDA’s "dereliction of duty on CBD regulation"

“This is an astonishing dereliction of duty, especially compared to the agility and professionalism the agency showed it was capable of during the pandemic," said Daniel Fabricant, Ph.D., NPA President and CEO, 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 Division claims it cannot do what Congress authorized, which is to regulate dietary supplements under the law. But it 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 attackDSHEAand develop different regulatory paths for ingredients at its own discretion. 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's "punt" to Congress a disservice to consumers

“Today, FDA continues its long exercise of kicking the can down the road while ignoring the realities of the current marketplace and offering little to show for its purported four-year review of a dietary supplement CBD regulatory pathway," said CRN President and CEO Steve Mister, in comments that share CRN’s continued frustration with the agency. "FDA has had ample time to consider scientific evidence and develop a regulatory pathway for CBD within the existing legal framework. Since Congress enacted the 2018 Farm Bill, FDA’s inaction and indecision have frustrated consumer interest in having safe and beneficial CBD products available to them and allowed a ‘gray’ CBD marketplace to emerge without meaningful oversight. The agency’s ‘punt’ to Congress, asking it to intervene after four years, is a further disservice to consumers and responsible industry.

“It seems that no level of safety evidence will be good enough for FDA. During the last four years, FDA has repeatedly disregarded evidence demonstrating safety that is relevant to CBD at the levels commonly used in supplements and continues to rely heavily on safety concerns related to high-dosage Epidiolex to support the agency’s inaction. In its statement today, FDA noted that a new regulatory pathway would benefit consumers by providing clear labels, prevention of contaminants, CBD content limits, and limits on use in certain populations—all this can and should be addressed through the existing dietary supplement NDIN process once FDA creates a legal pathway for CBD in dietary supplements. CRN offered the agency a blueprint for that pathway, and it has been ignored.

Regarding CRN's citizen petition, Mister stated, “FDA’s response to CRN’s CBD citizen petition does not address why safety is a factor in drug preclusion and FDA’s exercise of its rulemaking authority to create a legal pathway for CBD in dietary supplements. In essence, FDA is saying ‘it is because we say it is’—without support for that view in the statute. As we have continued to point out, nothing is stopping FDA from using its rulemaking authority for CBD, other than FDA itself. Instead, FDA suggests Congress must fix this issue when FDA has had the authority to address it all along.

“Today’s announcement and response to our petition does nothing to make consumers any safer. It is yet another example of the agency shrinking from its critical public health role in hopes that Congress will make those decisions instead. CRN looks forward to continuing its work with congressional lawmakers to develop a legislative solution given the absence of FDA leadership.”

Congress needs to act swiftly to protect access to CBD

"The Alliance for Natural Health USA strongly disagrees with the FDA's decision against a rulemaking process to legally permit CBD oil in dietary supplements," said Gretchen DuBeau, Executive and Legal Director of ANH-USA, in a statement. "We urge Congress to act swiftly to protect access to CBD for the millions of American consumers who rely on this supplement to support their health."

Concerns about the precedent this sets for future NDIs

“FDA indecision has been the decision on CBD for far too long, and a confused marketplace of unregulated CBD products has emerged that does not serve the public health," said CHPA President and CEO Scott Melville, in a statement by the organization. "In this respect, CHPA welcomes today’s action on the Citizen’s Petition we filed in 2019. However, FDA cannot—via a citizen petition response —undermine the Federal Food, Drug, and Cosmetic Act’s direction and authority to initiate rulemaking to address the exclusory provisions and to let the New Dietary Ingredients (NDI) notification pathway serve its essential function, which is to require sponsors to demonstrate the safety of new ingredients before going to market. Therefore, we have concerns about FDA’s sweeping action today and the precedent it sets for future NDI submissions.

“There is a legal process to evaluate the safety of new dietary ingredients, and this is not it. We look forward to working with Congress to explore modernization of the Dietary Supplement Health and Education Act (DSHEA) and to ensure that the NDI process works as was originally intended.”

Additional industry statements will be added when available.

Related: FDA Warns Companies for Illegally Selling Food & Bev Products Containing CBD β-NMN Is Not a Dietary Supplement? CRN Responds Navigating the Hemp/Phytocannabinoids Space