Trade Associations Respond to FDA’s Denial of CBD Citizen Petitions

The Natural Products Association (NPA), the Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA) have responded to the U.S. Food and Drug Administration’s (FDA’s) denial of the associations’ CBD Citizen Petitions on Jan. 26.

“This is an astonishing dereliction of duty, especially compared to the agility and professionalism the agency showed it was capable of during the pandemic. 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,” said Daniel Fabricant, PhD, president, and CEO of the Natural Products Association.

“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 attack DSHEA and 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,” Fabricant concluded.

“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,” commented Steve Mister, president and CEO of CRN. “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.”

Mister continued, “Further, 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,” Mister continued. “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.”

Scott Melville, president and CEO of CHPA, said “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. 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.”

For more information, visit www.npanational.org, www.crnusa.org and www.chpa.org.

“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,” commented Steve Mister, president and CEO of CRN. “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.”

Mister continued, “Further, 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,” Mister continued. “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.”