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Capitol Hill 2019

Sen. Wyden urges FDA to issue ‘discretion policy,’ interim rule on CBD in dietary supplements

A U.S. senator characterized as “fully unacceptable” a suggestion by FDA that publishing a final rule authorizing the use of hemp-derived CBD in dietary supplements could take three to five years.

U.S. Sen. Ron Wyden on Tuesday urged top federal health officials to announce a “formal enforcement discretion policy” by Aug. 1 regarding CBD as a food additive or dietary ingredient in supplements.

Without such a policy, “hemp producers and their customers will continue to be left in a regulatory gray zone,” Wyden, a Democrat from Oregon, wrote to the leaders of FDA and the U.S. Department of Health and Human Services (HHS).

In a letter to HHS Secretary Alex Azar and FDA Acting Commissioner Ned Sharpless, M.D., Wyden also urged FDA to publish an interim final rule to ensure CBD can be lawfully sold in food and dietary supplements, pending the agency’s publication of a final rule.

Congress in 2018 removed hemp from the federal Controlled Substances Act (CSA), but lawmakers preserved FDA’s authority to regulate cannabis-derived products.

FDA has maintained CBD cannot be lawfully added to conventional food or marketed as a dietary supplement because essentially the compound was first studied as a drug. The agency, however, has authority to create an exception, and it hosted an all-day public hearing May 31 to examine issues around its regulation of cannabis-derived products.

Wyden characterized as “fully unacceptable” a suggestion by FDA that publishing a final rule authorizing the use of hemp-derived CBD in dietary supplements could take three to five years.

“The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time,” the senator wrote.

Wyden also urged FDA to streamline the process for reviewing safety-related notifications for hemp-derived CBD ingredients and dedicate staff to the process.

“I feel strongly the FDA must undertake a process to make lawful a safe level for conventional foods and dietary supplements containing hemp-derived CBD,” Wyden said.

In response to a request for comment, Michael Felberbaum, an FDA spokesman, said the agency would respond directly to the senator.

Michael McGuffin, president of the American Herbal Products Association (AHPA), commended the senator for his efforts.

“AHPA is extremely pleased to see Sen. Wyden showing leadership in advocating for the secretary of the Health & Human Services and the commissioner of the Food & Drug Administration to move promptly to resolve the current regulatory uncertainty surrounding CBD," McGuffin said in a statement. "At the same time, the approach outlined by the senator ensures that these agencies’ commitment to public health is fully maintained.”

House amendment—setting safe level of CBD

At FDA’s recent public hearing, the leader of the Natural Products Association (NPA), Daniel Fabricant, Ph.D., urged FDA to establish a safe level at which CBD can be sold in food and dietary supplements, pending the agency’s release of any formal regulation.

The U.S. House of Representatives in June passed an amendment that would appropriate funds to undertake a process to make lawful a safe level for CBD-containing conventional foods and dietary supplements. Rep. Jerry McNerney, a Democrat from California who worked on the CBD amendment, said the amendment was included in the House's passage of H.R. 3055, the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2020.

“Consumer safety and confidence is of the utmost importance, and it was the driving factor behind my introduction of the CBD amendment," the congressman said in a statement. "By directing the Food & Drug Administration to set safe CBD consumption levels, we will be giving consumers peace of mind and outlining standards for producers to ensure a safe and reliable market for these products."

NPA reported what it is asking FDA to do—establish a safe level at which CBD can be marketed in dietary supplements—is not unprecedented. According to the trade association, FDA has used such enforcement discretion in the past with regard to an approved drug ingredient in red yeast rice products marketed as dietary supplements.

“We are proud to work with Congressman McNerney to pass this critical amendment that will provide consumers with the clarity and assurance that CBD products are safe,” Fabricant, who previously led FDA's Division of Dietary Supplement Programs, said in a statement. "We look forward to working with members of both the House and the Senate to ensure to pass this important legislation for American consumers.”  

‘Unanswered questions’

During the May 31 public hearing, Sharpless underscored FDA has many “unanswered questions” when it comes to the safety of CBD, such as how much is safe to consume in a day and how the compound would interact with other drugs taken by a person. Allowing CBD to be marketed in conventional food or dietary supplements, two FDA officials wrote in a recent article, “raises important and challenging questions of regulatory policy and public health.”

“We remain steadfast in our effort to obtain research, data, and other safety and public health input to inform our approach and to address consumer access in a way that protects public health, maintains incentives for cannabis drug development, and creates a robust administrative record needed to support the initiation of any rulemaking,” concluded Amy Abernethy, M.D., Ph.D., principal deputy commissioner, and Lowell Schiller, principal associate commissioner for policy. “As we learn more, we will continue to update the public about our path forward and provide information that is based on sound science and data.”

The FDA officials, however, did not signal in the article whether they would issue interim rules or guidance anytime soon.

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