This article was updated on April 13, 2023. 

In the years following passage of the 2018 Farm Bill, which opened a legal pathway for hemp products, dietary supplement stakeholders have been critical of FDA’s inaction on cannabidiol (CBD). So FDA’s decision not to use its current regulatory authority to grant an exception that would permit CBD dietary supplements wasn’t all that surprising; but it was disappointing to many.

“FDA continues its long exercise of kicking the can down the road while ignoring the realities of the current marketplace and offering little to show for its purported four-year review of a dietary supplement CBD regulatory pathway,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), which filed one of three citizen petitions that FDA denied in January.

The Consumer Healthcare Products Association (CHPA) also had its petition denied. CHPA President and CEO Scott Melville said in a statement: “FDA indecision has been the decision on CBD for far too long, and a confused marketplace of unregulated CBD products has emerged that does not serve the public health.”

He went on to say that “FDA cannot—via a citizen petition response—undermine the Federal Food, Drug, and Cosmetic Act’s direction and authority to initiate rulemaking to address the exclusory provisions and to let the New Dietary Ingredients (NDI) notification pathway serve its essential function, which is to require sponsors to demonstrate the safety of new ingredients before going to market.”

The Natural Products Association (NPA) filed a petition with FDA on behalf of cbdMD, which asked the agency to review its safety data on scientific merits—“not on a broad policy statement on drug exclusion”—and issue an NDIN response letter. Following FDA’s denial, NPA President and CEO Daniel Fabricant, PhD, said the agency’s inaction amounted to “an astonishing dereliction of duty.”

Still Hope for CBD Supplements?

Is it still possible for CBD to eventually be permitted in dietary supplements? Yes, according to experts. But don’t expect that to happen soon.

In its announcement this January that current regulatory frameworks for foods and dietary supplements are not appropriate for CBD, the FDA said it will continue to monitor the market for safety issues. Over the past four years, the agency has mostly issued warning letters to brands making disease claims.

“We are, of course, very disappointed by FDA’s continued refusal to take action on CBD,” United Natural Products Alliance (UNPA) President Loren Israelsen said in a statement. “That said, it is noteworthy the FDA has acknowledged its support for a pathway to market CBD-containing dietary supplements. That is clearly progress and an important step in resolving the persistent delays that have been bad for consumers and responsible industry.”

Israelsen said UNPA will continue its “aggressive work to seek a legislative solution that provides a clear and reasonable regulatory pathway for hemp-derived dietary supplements,” adding that “an active and constructive engagement by the agency with Congress will be essential if a solution is to be found.”

Rend Al-Mondhiry, partner at the law firm Amin Talati Wasserman, LLP, also noted a “silver lining” that “FDA has not completely shut the door on a non-drug pathway for CBD.”

“In fact, we even have glimpses of what that pathway might look like, given FDA’s reference to risk management tools that ‘could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age,’ along with a possible pathway for CBD products for animals.”

FDA has ample tools to regulate CBD as a dietary supplement, according to Mister, “like mandatory recall authority, seizures, import restrictions, etc. that it could use. Even just a few strong enforcement efforts would send a powerful deterrent message if there are products on the market that FDA truly believes are unsafe.”

“The agency’s concern with an exploding market and their ability to now regulate this market is one of FDA’s own making,” he added. “The agency could have gotten ahead of the market when the Farm Bill was passed in several ways, including through meaningful enforcement tools and the agency’s drug preclusion rulemaking authority. Instead, it made a few public pronouncements and then shrank from any meaningful enforcement or other oversight of the market.”

What Do CBD Brands Do Now?

FDA’s position on CBD hasn’t changed following its announcement, “so we anticipate it will be status quo for the foreseeable future,” Al-Mondhiry said. “We don’t anticipate a major shift in the enforcement landscape, but this is a good time for companies to review their marketing claims and the basis for concluding their specific CBD products can be safely marketed, and ensuring cGMPs are being followed.”

Brands should also be watching how states react to see if FDA’s announcement changes how they approach regulating CBD.

Duffy MacKay, ND, senior vice president of dietary supplements at CHPA, said FDA’s announcement “is a reminder to companies selling CBD in dietary supplements or foods that FDA maintains its position that these products are adulterated, which is likely to increase market and consumer confusion in states with laws that allow the sale of CBD products.”

In states that have enacted laws allowing for the sale of hemp-derived products, “companies may lawfully market these products based on that state’s manufacturing, labeling, and marketing rules,” MacKay said. “However, FDA has made it clear that these products should not be labeled as dietary supplements or conventional food and sold across state lines, or they are considered adulterated.”

Congressional Action on the Horizon?

As for federal legislation, there was bipartisan support in the 117th Congress for HR 841, which would have allowed CBD and other hemp-derived ingredients in dietary supplements.

“Lack of Congressional action on bipartisan legislation during the last session was unfortunate,” said Mister, “but the new House leadership has an opportunity to get the ball rolling.”

To that end, on Mar. 17, Congressman Morgan Griffith (R-VA) and Congresswoman Angie Craig (D-MN) reintroduced two pieces of legislation that had previously stalled in Congress.

The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 would make hemp, CBD derived from hemp, and other hemp-derived products lawful for use in dietary supplements under the Federal Food, Drug, and Cosmetic Act.

Meanwhile, the CBD Product Safety and Standardization Act would direct the FDA to regulate CBD as the agency would for other food ingredients, setting requirements for quality and labeling, among other areas.

Jonathan Miller, general counsel for the U.S. Hemp Roundtable, said in a statement that “a legislative solution is necessary to allow the marketing of hemp-derived cannabinoids including CBD as dietary supplements and foods … We also remain willing to work with the FDA to ensure that hemp-derived cannabinoids like CBD are safe and adequately regulated.”

Safety Standards

As for its four-year review of CBD safety, FDA said it “examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency.”

However, according to Miller, “Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. CBD products have been sold at retail for nearly a decade with no significant safety issues. The Roundtable recently met with the FDA and shared a broad range of safety studies showing that standard CBD serving sizes are safe, while the FDA continues to rely on pharmaceutical studies that show risk at significantly larger doses that are not commonly found in CBD products sold at retail.”

According to Al-Mondhiry FDA appears to be applying “a very high safety standard for CBD—higher than we’ve seen for other dietary supplements ingredients, including botanicals.”

“It’s not evident that FDA is relying on safety studies using dosages of CBD that reflect the types of products being sold at retail,” she added. “For example, the agency continues to point to the high dosage studies on Epidiolex. There are several published toxicity studies demonstrating CBD’s safety at lower amounts, but it’s unclear how and whether those are factoring into FDA’s review of CBD. There’s also now several years of adverse event data and observational data collected by groups like Validcare speaking to the safety of CBD; and again it’s not clear whether FDA is considering this data.”

According to Mister, it seems that no level of safety evidence will be “good enough” for FDA. “For new dietary ingredients, such as CBD, a manufacturer must demonstrate that the ingredient is ‘reasonably expected to be safe when used under the conditions recommended or suggested in the labeling.’ Safety is tied to the specific ingredient amount, form, label information, etc. for each new dietary supplement.”

“FDA continues to largely rely on safety data submitted in connection with Epidiolex (which provides high doses of CBD in amounts that are well above common supplement levels) as the basis to object to CBD in supplements,” he added. “It has been dismissive of data demonstrating safety at much lower ranges, such as the extensive safety data provided in the Charlotte’s Web NDIN in 2021 and the robust clinical study conducted by Validcare. Further, the concerns being raised by FDA for CBD use in certain populations (e.g., pregnant women, children, those on prescription medications) can be addressed with labeling, as is already done for numerous other dietary supplement products on the market.”

FDA Problems and Restructuring

FDA itself is undergoing a shakeup following the infant formula crisis and other food safety failures.

An independent investigation conducted by the Reagan-Udall Foundation recommended a restructuring of FDA’s human foods program. An internal investigation of FDA’s response to the infant formula crisis also offered recommendations for more resources, including a stronger foods workforce.

On Jan. 31, FDA Commissioner Robert Califf issued a statement proposing a redesign of the agency’s human foods program and the Office of Regulatory Affairs (ORA) to enhance coordinated prevention and response activities.

“Under this plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), as well as certain functions of ORA will be unified into a newly envisioned organization called the Human Foods Program. The FDA will conduct a competitive national search for a Deputy Commissioner for Human Foods, who will oversee the Program.”

The agency announced on Feb. 28 that it has begun a national search for a new Deputy Commissioner for Human Foods. According to FDA’s proposal, “An empowered Deputy Commissioner for Human Foods will be established to provide executive leadership and strategic direction over the entire portfolio, including resource allocation strategy, risk prioritization, integrated food safety partnership programs, communications, policy initiatives, and cultural transformation.”

At the same time, “A larger executive team for the Human Foods Program will be put in place with clearly defined lines of authority to ensure decisive leadership over the program’s vast responsibilities. This includes a Principal Associate Commissioner for Human Foods position, reporting to the Deputy Commissioner, to provide strong, effective operational management of the program’s day-to-day operations. In addition, a team of executives for the program’s major areas of responsibility will be created to provide the necessary management infrastructure.”

‘An Attack on DSHEA’

Sibyl Swift, PhD, chief science officer at cbdMD, has held multiple senior positions at FDA, including more than five years at the Office of Dietary Supplement Programs (ODSP) where she managed its research portfolio. She also co-chaired the Steering Team for the Botanical Safety Consortium, a collaboration between scientists from government agencies, academia, and industry.

As a former federal official, Swift said she’s concerned with FDA’s review process for botanical dietary ingredients, saying the agency’s teams don’t have enough industry experience or understanding of what they’re reviewing.

She voiced frustration that FDA would ask for new regulatory authorities, “as if it lost its current ones” under the Dietary Supplement Health and Education Act (DSHEA). The agency also seems to be forgetting its mission and mandate, she added. “FDA is here to protect people,” but instead it appears intent on denying consumers access to safe ingredients.

cbdMD has invested in toxicology studies to address any data gaps and areas FDA has questioned, Swift said. In April of 2022 the company received validation of its Novel Food Application from the EU’s Food Safety Authority (FSA).

Asked about reports the House Oversight Committee might investigate FDA’s handling of hemp and CBD, Swift said: “I’d hope for an OIG (Office of Inspector General) inquiry … That’s the only time I’ve seen FDA respond—by calling them in and making them explain why this is difficult. Show your math. Explain to us why this is so difficult.”

FDA’s January announcement on CBD should signal to Congress that it needs to intervene and direct FDA to address CBD through the current regulatory framework, said Fabricant. “FDA is defiant and digging their heels in. Congress should be very direct on what they want FDA to carry out.”

Fabricant also expects more of the same from FDA, saying the agency’s announcement spells a certain level of “disingenuousness” and “hostility toward the industry in general.”

“It’s telling that FDA says it’s willing to work with Congress now when it’s had years to come to a decision. If there’s a real public safety concern on an ingredient, the agency has the authority to act. They’ve done nothing about it. So how concerned are they?”

FDA has protected the drug exclusion clause “at all costs,” he added. “They’re not interested in coming to the table to have any honest discussion.”

FDA’s announcement goes beyond CBD, Fabricant suggested. “This is an attack on DSHEA,” he said, and the fact that FDA is saying the current regulatory structure for supplements isn’t adequate “should cause alarm for everyone.”

FDA sued FDA over its handling of NAC, and the agency eventually relented. FDA said it would exercise enforcement discretion and consider rulemaking. The same drug exclusion issue has come up most recently with NMN.

When asked if NPA might sue FDA again, Fabricant said the association will consider all its options in consultation with its board of directors.

“We will use every tool at our disposal, in all branches of government. We’re not the ones hiding behind mixed messaging. The industry has been pretty transparent.”