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FDA Announces It Will Not Issue Rules To Allow CBD As Dietary Supplements Or Food Items, Punting To Congress For Regulations



The Food and Drug Administration (FDA) says that it will not be creating rules to allow the marketing of CBD as dietary supplements or food items, leaving the massive industry without regulations despite repeated calls for administrative action from lawmakers, advocates and stakeholders.

Following a “careful review” of the non-intoxicating cannabinoid, FDA said it reached the conclusion that the existing regulatory pathways that are in place for other dietary supplements and food additives will not work for CBD. Instead, the agency said that wants to “work with Congress on a new way forward.”

In the meantime, FDA is also denying three citizen petitions that had requested rulemaking for the marketing of CBD.

The announcement comes days after the agency released finalized guidance that focuses on developing cannabis-based drugs and outlined the process and unique considerations for scientists when it comes to hemp and marijuana.

FDA isn’t saying that CBD shouldn’t be regulated; rather, it said that certain safety concerns and data gaps make it an administrative impossibility under the current standards.

“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” FDA Principal Deputy Commissioner Janet Woodcock said. “Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”

The agency’s emphasis on working with Congress to address the issue legislatively comes as the newly seated chair of the House Oversight and Accountability Committee, Rep. James Comer (R-KY), says he is preparing to confront FDA over their failure to enact regulations for hemp-derived products like CBD.

“The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products,” Woodcock said. “Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.”

“The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”

Relatedly, FDA denied citizen petitions for CBD rulemaking from the Council for Responsible Nutrition, Natural Products Association and Consumer Healthcare Products Association.

This is frustrating news for advocates and stakeholders who’ve been strongly pushing FDA to take some regulatory action on hemp-based products like CBD as the market continues to rapidly expand with few guardrails in place.

FDA has faced increased pressure from bipartisan lawmakers and industry groups to do something about the issue since hemp and its derivatives were federally legalized under the 2018 Farm Bill.

It did say in a notice that industry stakeholders cold “provide input regarding this announcement” either by submitting public comment or participating in engagement meetings that it will be hosting over the “next several months.”

Top officials in the agency have previously signaled that they felt it may take work from Congress to adequately regulate CBD.

“It’s likely we will see FDA continue to maintain its non-enforcement approach and deference to the states, except where products have material public safety concerns,” Shawn Hauser, partner at Vicente Sederberg LLP who co-chairs the firm’s Hemp and Cannabinoids Department, told Marijuana Moment.

“Woodcock is clear FDA will maintain its current enforcement approach to protect public safety in coordination with state agencies, where appropriate,” she said. “I expect we will continue to see more robust state regulatory programs governing finished hemp products, including limitations on THC content and synthetics.”

Michael Bronstein, president of the American Trade Association for Cannabis & Hemp (ATACH), said in a press release that “FDA’s findings highlight the increased need for Congressional action as it relates to the regulatory framework of CBD products for use in food, beverage, and as dietary supplements.”

“We will diligently work with Congress to develop and advance a pathway that protects consumers, creates certainty in the marketplace for CBD goods, and provides for sound regulation,” he said.

An FDA cannabis task force FDA assessed concerns about whether CBD can be used safely in the long-term, and what impacts consumption might have during pregnancy. The rise in popularity of delta-8 THC products, which the Drug Enforcement Administration (DEA) says are not controlled substances, has further complicated rulemaking.

Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to FDA Commissioner Robert Califf in September, demanding answers over the continued lack of regulations for CBD for those purposes.

Griffith and other bipartisan lawmakers sent a separate, related letter to the FDA commissioner in August. They expressed frustration over the “completely insufficient response” the agency provided in response to their bill calling for hemp-derived CBD to be permitted and regulated as a food additive.

After the CBD Product Safety and Standardization Act was filed in December 2021, the sponsors sought technical assistance from FDA to advise on key provisions. But four months after they sent the inquiry, FDA returned a “one-page” response that was “simply a reformatting of a document provided to Congress over two years ago,” the lawmakers said

At a House Appropriations subcommittee hearing in May, FDA’s Califf recognized that the agency had moved slowly with rulemaking for CBD in the food supply, stating that the situation “looks pretty much the same in terms of where we are now” as compared to when he first worked on the issue in 2016.

He said the FDA has taken steps to research the safety profile of cannabinoids to inform future rules, but he also punted the criticism about inaction to Congress, saying he doesn’t feel that “the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.”

“We’re going to have to come up with something new,” Califf said. “I’m very committed to doing that.”

FDA also recently touted its role helping a state agency crack down on a company selling delta-8 THC gummies that they said are linked to “serious adverse events.”

In November, the agency sent warning letters to five companies that sell foods and beverages containing CBD.

The agency didn’t specify why it targeted those particular five companies out of the many more that market similar cannabidiol-infused consumables, but it said that they sell products “that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.”

All of this comes in the background of a major task for FDA: Conducting a scientific review into marijuana, at the direction of President Joe Biden, to aid in an assessment of its federal scheduling. FDA’s recommendation won’t be binding, but officials say they expect DEA to product a scheduling recommendation that’s consistent with their findings about its risks and benefits.

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Photo courtesy of Kimzy Nanney.

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