FDA sets first hearing on CBD in May

CNBC [April 2, 2019]

FDA looks at legalizing the cannabis compound to add to food and drinks

The Food and Drug Administration will host a public hearing on CBD on May 31.
Congress legalized hemp-derived CBD in December.
The FDA’s rules still prohibit CBD from being added to food.

The Food and Drug Administration has set its first public hearing looking to legalize CBD in food and drinks for May 31 at its headquarters outside of Washington, D.C.

The agency wants data on CBD’s safety in food products and feedback on how it might regulate manufacturing, marketing and labeling, according to a notice posted Tuesday in the Federal Register. Outgoing FDA Commissioner Scott Gottlieb named Principal Deputy Commissioner Amy Abernethy and Principal Associate Commissioner for Policy Lowell Schiller to co-chair a high-level working group tasked with evaluating the issue.

“It’s critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA’s regulatory oversight of these products – especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods,” Gottlieb said in a statement Tuesday.

CBD, short for cannabidiol, is a non-psychoactive compound found in the cannabis plant that promises to relax the body without altering the mind like THC. While the federal government legalized CBD that’s derived from hemp, a close cousin of marijuana, the FDA’s rules still currently prohibit companies and restaurants from adding it to food or drinks.

Lawmakers grilled outgoing FDA Commissioner Scott Gottlieb on Capitol Hill last month, demanding the FDA figure out a way to change this. Gottlieb told them he heard Congress “loud and clear” and was working on a solution. The FDA has grappled with the issue privately and will now take its efforts public, first with the meeting.

Gottlieb said the working group plans to share its findings as soon as this summer.

“This is a complicated topic and we expect that it could take some time to resolve fully,” he said. “Nevertheless, we’re deeply focused on this issue and committed to continuing to engage relevant stakeholders as we consider potential paths forward.”

Plenty of start-ups have introduced CBD-infused seltzers, cookies and lattes anyway, in hopes that the FDA will change its regulations. But the regulatory uncertainty has kept larger consumer brands and retailers largely on the sidelines for now, even though demand is booming.

The FDA and the Federal Trade Commission on Tuesday issued warning letters to three companies – Advanced Spine and Pain’s Relievus, Nutra Pure and PotNetwork Holdings – for allegedly making unproven claims about their CBD products, such as helping to treat cancer and Alzheimer’s disease. None of the companies immediately responded to CNBC’s request for comment.

“The FDA continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain CBD that haven’t been approved by the FDA, such as the products and companies receiving warning letters today,” Gottlieb said.

It’s unlawful to use an ingredient in food or drinks that’s under clinical research or is the active ingredient in a prescription drug, which CBD is. The FDA would need to figure out a way for CBD to exist both as a drug product and a food product.

Gottlieb has suggested high concentrations might be regulated as a drug that has more stringent oversight while lower concentrations could be categorized as food products that come with an easier review process. However, Gottlieb has repeatedly warned the average rule takes two to three years for the FDA to draft and finalize and the FDA may ultimately recommend Congress fix it legislatively.

Gottlieb had previously said the meeting would be in April. His last day is Friday.

Angelica Laveto

Article Link: FDA sets first hearing on CBD in May

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