FDA reconsiders safety of CBD for use in dietary supplements, industry not satisfied

0

With thousands of CBD products on the market and clear consumer demand, industry advocates say the lockdown has only led to the proliferation of unregulated and potentially harmful products.

“Another Delaying Tactic”

“I view Tuesday’s FDA Science Board hearing as another delaying tactic,” Sibyl Swift, vice president of scientific and regulatory affairs for the CBD cbdMD brand, told Nutra Ingredients-USA.

Swift also served as senior vice president of scientific and regulatory affairs at the Natural Products Association and associate director of research and strategy at the FDA.

During the day-long session, FDA experts highlighted the scientific and regulatory challenges of marketing CBD and other cannabinoids as dietary supplements due to their pharmacological effects. In the afternoon, the agency focused on its own ongoing reviews and concerns about CBD safety. Commentators gave their opinion in a public hearing before the session.

“I appreciate that we had the opportunity to speak, but after watching all day of FDA presentations, especially those in the afternoon session, I feel like the FDA is not don’t really understand the supplement industry,”Swift added.

Jonathan Miller, general counsel for the U.S. Hemp Roundtable, also expressed disappointment, noting that FDA staff have once again blamed the lack of progress on safety concerns emanating from studies of the prescription drug CBD. in high doses Epidiolex.

However, they continue to ignore recent studies which demonstrate that CBD poses no significant safety concerns at the levels typically found in many dietary supplements and foods, and which also address specific safety concerns raised by the FDA,” he added.

“A lot of security data”

During the public hearing, industry players such as NSF International, an independent product testing, inspection and certification organization headquartered in Ann Arbor, Michigan, agreed that it there was “a lot of safety data on CBD”​, both in publicly available literature and in companies around the world.

Swift referenced extensive safety data submitted to the UK Food Standards Agency and the European Food Safety Authority, which recently validated cbdMD’s Novel Food Application for its broad-spectrum CBD formulation.

“The cbdMD safety study performed on our broad-spectrum extract covered multiple systems and was more than sufficient for the rigorous review in the UK and EU”,she says. “Yet the FDA refuses to review this same data.”

CbdMD filed a citizen petition with the support of the Natural Products Association asking that its safety study be given the opportunity to be reviewed in the United States. It also provides a basis for the argument that CBD should not be excluded by the drug exclusion rule, but should be considered a novel food ingredient.

The drug exclusion rule

© Olena Starostenko/Getty Images

In 2018, the FDA approved the use of CBD in the drug Epidiolex for the treatment of seizures associated with rare and severe forms of epilepsy. The drug exclusion rule of the Food, Drugs and Cosmetics Act, however, provides that once a substance is the active ingredient of an approved new drug, products containing that substance cannot be legally classified as dietary supplements or shipped in interstate commerce.

Swift notes that cannabinoids are not the first ingredient to have pharmacological activity, referring to caffeine, EGCG, EPA/DHA, carnitine, N-acetyl cysteine ​​and quercetin. She also points out that there is both a structure/function notification process and a well-established system for assessing the safety of dietary supplements and food ingredients, i.e. the notification processes for new dietary ingredients. and generally recognized as safe.

“It is not acceptable for the Agency to continue to suggest that it does not know how to move forward,” she stated.

“There is a way forward and it has been there for decades. The only real challenge for the FDA is how to use the tools it already has in place.

The path to follow

The lack of regulatory and legislative progress at the federal level toward opening a pathway to edibles or supplements for CBD has forced states to fill the void.

“We now have a confusing and overwhelming patchwork of state laws due to federal inaction,” said Rend Al-Mondhiry, partner at Amin Talati Wasserman, LLP and advisor on regulatory and compliance issues affecting hemp and CBD products.

“A federal solution won’t fix this right away, but it’s certainly needed sooner rather than later.”

Based on the recent Scientific Council meeting, however, she says that “it does not appear that the FDA will provide a pathway in the near future, or that a change from the status quo is on the horizon” and therefore any short-term change would have to come from Congress.

During a congressional hearing in May 2022, FDA Commissioner Robert Califf testified about the agency’s lack of action on CBD and suggested a creative approach might be needed, asking Congress to broader regulatory powers.

“I am very committed to taking a path on this,” Califf said at the time. “And just to put a marker, I don’t think the current authorities that we have on the food side or on the drug side necessarily give us what we need to move on the right paths. We will have to invent something new. »

Several bills are sitting in Congress, but Al-Mondhiry says they are unlikely to be tabled before a congressional hearing.

“We have heard that a hearing could take place this year, but the timing is uncertain,”she added. “Fortunately, groups like the American Hemp Roundtable continue to keep the pressure on Congress for a hearing.”

Miller says the Hemp Roundtable hopes that the hemp industry-backed legislation, HR 841, HR 6134 and S. 1698, which together would establish a regulatory pathway for CBD as a dietary supplement and food additive and drinks, “will provide the kind of powers Califf is looking for and allow the FDA to finally regulate CBD and other hemp derivatives.”

Share.

Comments are closed.