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INSIDER Law

With FDA guidance withdrawn, CBD industry mired in regulatory abyss

White House 2020
Withdrawal of a CBD guidance document, while expected, highlights the CBD industry's frustrations with FDA inaction to regulate the market.

An FDA document related to CBD that had been pending for several months before the White House has been withdrawn, consistent with a freeze on regulations and guidance documents issued by the administration of President Joe Biden.

While stakeholders had not seen the actual document—“Cannabidiol Enforcement Policy; Draft Guidance for Industry”—pending before the White House’s Office of Management and Budget (OMB) since July, many were hopeful that publication of the guidance would help provide some measure of certainty to an industry operating for years in a state of regulatory limbo at the national level.

Withdrawal of the policy highlights “two years have passed since the 2018 Farm Bill made CBD legal, and FDA has made no meaningful progress on a clear regulatory path for CBD consumer products,” said Duffy MacKay, senior vice president of scientific and regulatory affairs with San Diego-based CV Sciences Inc., a marketer of hemp-based CBD products, in an email. “In my opinion, the ongoing debate amongst stakeholders whether legislation is needed or if FDA has the regulatory tools necessary to regulate hemp-derived CBD products is over—we need Congress to act now.”

Although the development was not surprising due to the Biden administration’s reevaluation of regulatory actions, withdrawal of the CBD guidance “presents a setback to long-overdue agency action on CBD regulation,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), a trade association representing the dietary supplement and functional food industry, in an email. “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.”

Brandon Beatty, founder and CEO of Bluebird Botanicals, a CBD brand in Louisville, Colorado, also was disappointed in the recent withdrawal of the CBD guidance.

"While the contents of the FDA's Cannabidiol Enforcement Policy were not made public prior to this withdrawal, we're disappointed that the CBD industry has to face another delay in receiving guidance,” he said in an email. “After the passage of the 2018 Farm Bill, we were optimistic that federal guidance would be forthcoming. Yet, the industry has continued to face numerous obstacles and setbacks over the past several years, which has allowed unscrupulous CBD companies to damage the industry. We understand that this freeze is part of the due process for the incoming administration, and we are hopeful that the FDA will work with the new OMB team to expedite this guidance as much as possible in the interest of public health."

Stuart Titus, Ph.D., CEO of Medical Marijuana Inc., which also sells hemp-derived CBD products, expressed hope that Congress will intervene. 

"It looks like the process to create these regulations will have to start from scratch, but hopefully, congressional action will supersede any potential FDA enforcement activities," he said in an email. "The CBD industry remains hopeful that congressional action will allow CBD to be freely sold as a dietary supplement and food ingredient.”

Rend Al-Mondhiry, a lawyer in Washington, D.C., who counsels CBD brands, said the industry will face “status quo for the near future, which has been regulatory limbo.”

“Perhaps it could motivate Congress to take a closer look at H.R. 8179 and potentially other measures to legalize hemp-derived ingredients like CBD now that this [document] has been withdrawn,” Al-Mondhiry, a partner with Amin Talati Wasserman LLP, said in an interview.

H.R. 8179 was introduced last year to legalize CBD in dietary supplements. Jonathan Miller, general counsel of the U.S. Hemp Roundtable, a nonprofit advocacy organization, told Natural Products Insider he is cautiously optimistic that a bill directing FDA to regulate CBD will be passed in the 117th Congress.

It remains to be seen whether industry will see a more immediate measure: FDA guidance. FDA’s leadership hasn’t been settled.

Although Dr. Janet Woodcock is serving as acting commissioner of FDA, the president has not named a permanent successor to Dr. Stephen Hahn, who departed FDA Jan. 20.

Stories in the media have reported several names as being under consideration to serve as the next permanent FDA commissioner, including Woodcock; Dr. Amy Abernethy, who has worked on CBD issues at the agency; and Dr. Joshua Sharfstein, a former principal deputy commissioner of FDA.

If Abernethy is tapped by Biden to head FDA and had a big role in drafting the CBD guidance, perhaps it doesn’t change much, Al-Mondhiry said.

“But it’s also possible that it’s back to the drawing board for that draft policy guidance document,” the lawyer said.

Shirley Simson, an FDA spokeswoman, said several FDA items that were pending review with OMB’s Office of Information and Regulatory Affairs have been withdrawn, consistent with a Jan. 21 memo from OMB. The document provided guidance on implementing a memo from Biden’s chief of staff, Ronald Klain, which requested the heads of executive departments and agencies impose a freeze on pending rules and guidances.

Asked about FDA’s plans in 2021 with regard to regulating CBD or issuing any guidance to industry, Simson issued a general statement. “The FDA will work closely with the new administration to advance appropriate regulations and policies that are in line with the agency’s public health mission.”

Withdrawal of the CBD guidance came on the heels of a statement published Jan. 8 by FDA officials that they needed better data to understand the use and safety profile of CBD. Their remarks were perceived by some as a signal that FDA is not ready to move forward with regulations for CBD in conventional food and dietary supplements.

Reflecting on the Jan. 8 statement, Al-Mondhiry said, “It sounds like FDA isn’t anywhere close to coming up with a potential rulemaking, for example, on CBD. It looks like they’re still working through the safety gaps that they’ve identified and haven’t come to any resolution on whether those can be addressed yet.”

FDA is working with a third party to sample 1,000 to 3,000 CBD products as part of a second phase of a marketplace sampling and testing study.

“If [FDA officials] find widespread product adulteration or contamination issues, I think that could impact how states are regulating these products,” Al-Mondhiry said.

FDA’s findings, the lawyer added, also could give FDA another reason to rigorously oversee CBD products or further delay a rulemaking to legalize hemp-derived CBD in food and supplements if the agency doesn’t feel the industry is following cGMPs (current good manufacturing practices).

Kelly Shea is senior vice president of government affairs and communications with Charlotte's Web, a company synonymous with CBD. 

“While we appreciate guidance on enforcement, as there are products in the marketplace that should not be, these are not the main type of regulations we are waiting for,” Shea said in an email. “We want regulations that provide a clear pathway for hemp CBD wellness products to be regulated as dietary supplements. Charlotte’s Web will continue to advocate for sensible federal regulations for hemp products.” 

Plenty of other stakeholders also are likely to continue to press FDA and Congress on the benefits of creating a legal pathway for ingestible CBD products.

“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,” Mister of CRN said.

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