FDA yanks pending CBD enforcement proposal

27-Jan-2021 - Last updated on 27-Jan-2021 at 17:09 GMT

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The White House Office of Management and Budget pulled six FDA guidances and rules from its review, including the proposal "Cannabidiol Enforcement Policy; Draft Guidance for Industry" — handing the CBD industry yet another setback.

The move was prompted by President Joe Biden’s freeze on all regulations issued by the previous administration that have not yet gone into effect.

The withdrawal follows a Biden administration memo to all federal agencies instructing them to withdraw pending rules, which includes the CBD guidance that would have laid out FDA’s cannabidiol enforcement policy.

New Administration, new setbacks

While the postponement was anticipated, industry insiders still find the setback frustrating.

“CRN is of course disappointed that FDA has withdrawn this draft guidance from OMB. However, this development is not surprising as the new Administration is reevaluating all regulatory actions that were still in progress when the Presidency passed to President Biden. This is not an action directed specifically at CBD,” said Steve Mister, president & CEO, Council for Responsible Nutrition, who added that the move presents a setback to long-overdue agency action on CBD regulation.

"We look forward to working with the new Congress and new leadership at FDA to address their concerns and promote the interests of both consumers and our members to create a well-regulated, robust and vibrant supplement marketplace for CBD,” said Mister.

For now, hemp and CBD businesses are left in the dark, with limited guidance as they produce and sell hemp-derived products that were made legal under the 2018 Farm Bill.

Hemp allies represented in USDA

As the industry continues to wait on new guidance, it’s worth noting that USDA has now tapped two members of the National Industrial Hemp Council (NIHC) to the USDA and United States Trade Representative (USTR) advisory panel. Kevin Latner, vice president of marketing for the group, was appointed to the Agricultural Technical Advisory Committee for Trade in Processed Foods in July. Earlier this month, Patrick Atagi, chairman of the board at the National Industrial Hemp Council (NIHC), will serve as a member of USDA’s Agricultural Technical Advisory Committee for Trade in Tobacco, Cotton and Peanuts.

While no timeline was announced for re-submitting a CBD proposal, the FDA said the agency plans to work with the new administration to “advance appropriate regulations and policies that are in line with the agency’s public health mission.”

“CRN is reminded that we have new FDA staff to interact with and to make the case yet again why swift action from the agency is so critical to establish a legal pathway for CBD in dietary supplements," added Mister.