Industry groups: FDA harm-reduction framework threatens DSHEA

The heads of two Washington, D.C.-based trade associations representing ingredient suppliers, manufacturers and retailers of dietary supplement products contend a “harm-reduction” framework for CBD envisioned by FDA would undermine the law applicable to the commodity and is unnecessary.

The leaders of the Council for Responsible Nutrition (CRN) and Natural Products Association (NPA) maintain FDA has sufficient tools under the Dietary Supplement Health and Education Act of 1994 (DSHEA) to regulate CBD-containing supplements and doesn’t need additional powers. DSHEA constituted an amendment to the Federal Food, Drug & Cosmetic Act (FDCA).

“When you have something that is clearly a botanical constituent and could be regulated under DSHEA, to move it out and say, ‘We don’t have the right tools,’ basically sends a message that DSHEA isn’t working,” said Steve Mister, a lawyer who’s been leading CRN since 2005. “And we know that it is.”

During a May 25 call with industry stakeholders, FDA official Patrick Cournoyer, Ph.D., said the “highly protective safety standards of the food ingredient and dietary supplement pathways” don’t provide room for risks. And he distinguished the regulatory pathway for drugs from supplements and food.

With FDA-approved drugs, “There may be risks but as long as they’re outweighed by a benefit … then a drug can be approved,” said Cournoyer, who leads FDA’s Cannabis Product Committee.

Mister contends FDA is misinterpreting the law.

“Everything has risks, including sodium, including sugar, including caffeine, and FDA’s job is to reduce risk,” he said. “It is not a risk-elimination category.”

“And in fact, when it comes to dietary supplements, the standard for safety is an unreasonable risk of injury or illness,” the lawyer added. “So, risk is built into the statute. So, when I hear FDA say, ‘Well, we need a new category that will allow for risk reduction because supplements don’t allow that,’ that’s simply not true.”

Supplements that pose "a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling" are considered "adulterated" or unlawful under DSHEA, though FDA bears the "burden of proof on each element to show that a dietary supplement is adulterated."

NPA President and CEO Dan Fabricant, Ph.D., also has expressed concerns about the impact of a new regulatory framework on DSHEA. He oversaw FDA’s Division of Dietary Supplement Programs from 2011 until 2014.

A harm-reduction framework is the mechanism for tobacco, he said.

“Forget it,” Fabricant said when asked whether he would support a harm-reduction framework for CBD. “You kill the [supplements] category … It’s a slow cut in DSHEA.”

Fabricant for years called on FDA to set a safe limit for daily CBD exposure.

But during the recent stakeholder call, FDA's Cournoyer said establishing a safe dosage level is essentially asking FDA to perform a toxicological risk assessment that could take many years to complete. And following such a review, it’s perhaps likely that the acceptable daily intake for CBD “would be so low as to not be useful to the marketplace as is stands,” he said.

Fabricant isn’t persuaded, citing actions in Canada and the United Kingdom, for example.

In September 2022, a group of experts advising Health Canada concluded CBD is “safe and tolerable for short-term use (a maximum of 30 days) at doses from 20 milligrams per day to a maximum dose of 200 mg/day,” MJBizDaily reported. And in the UK, the Food Standards Agency (FSA) recommends no more than 70 milligrams a day of CBD for healthy adults, unless a doctor agrees to more.

“This doesn’t mean that these levels are definitely safe, but that the evidence we have suggests adverse health effects could potentially be seen above this,” FSA states in a consumer advisory last updated on March 31, 2022.

Referencing the recommendations in Canada and UK, Fabricant declared, "FDA can’t fall somewhere in that zone, which is ridiculous." 

Ultimately, a new regulatory framework for CBD “is really in Congress’ hands,” Cournoyer acknowledged. But in general terms, he outlined such basic consumer protections for CBD as truth in labeling, disclosure of certain ingredients and ensuring products contain no contaminants.

Cournoyer also identified hazard-mitigation safeguards such as content limits on CBD or other cannabinoids, and measures to mitigate accidental risk of ingestion by children.

According to Mister, Fabricant and two other former FDA officials who worked in the Office of Dietary Supplement Programs (ODSP), the agency could implement the measures above through its current authorities. For example, Mister said mandatory child-resistant packaging was placed on iron products years ago through the Consumer Product Safety Commission (CPSC) to ensure kids don’t ingest high levels of iron in supplement products.

FDA, in collaboration with the CPSC, could require child-resistant packaging on all CBD products, Mister said. Robert Durkin, a partner in the nation’s capital with the law firm Arnall Golden Gregory LLP, agreed the CPSC could implement measures to mitigate CBD use by children. Before joining AGG in 2019, Durkin worked in leadership roles at ODSP, including as deputy director and acting director.

Durkin said FDA also has authority to require clear supplement labels under its cGMP (current good manufacturing practices) rule (21 C.F.R. 111) and could impose CBD content limits based on the adulteration standard in DSHEA related to products that pose “a significant or unreasonable risk of illness or injury.”

Durkin described FDA’s proposed harm-reduction framework for CBD as “largely redundant to the risk-reduction framework” in effect for dietary supplement products.

In recent years, some manufacturers of hemp extracts containing CBD—including market leader Charlotte’s Web—have submitted premarket notifications to FDA to demonstrate their supplement ingredient “will reasonably be expected to be safe," based on a requirement in DSHEA. FDA determined the notifications failed to meet the applicable safety standard in the law. FDA also concluded CBD is excluded from the definition of a dietary supplement since it was first authorized for investigation as a new drug.

Many industry professionals have interpreted FDA’s public pronouncements as evidence that FDA would find unacceptable risks with any new dietary ingredient notification (NDIN) for CBD, regardless of the comprehensiveness of the safety information presented to the agency.

In a 2023 response to a citizen petition filed by CRN, FDA rejected the argument that the NDIN process would sufficiently protect the public from potentially unsafe supplements if FDA opted to regulate CBD through a notice-and-comment rulemaking.

"Under current law, FDA has no systematic way to know when new dietary supplements are introduced to the marketplace and whether they have complied with the NDIN requirement," Douglas Stearn, deputy director for regulatory affairs for the Center for Food Safety and Applied Nutrition (CFSAN), explained in response to CRN's petition. "Further, even when an NDIN has been submitted and evaluated by FDA, the NDIN authorities do not always prevent unsafe products from being marketed. For example, if an FDA response letter raises identity or safety concerns with a particular NDI, but the notifier nonetheless proceeds to market, FDA’s only recourse (once it becomes aware of such marketing) is to attempt to remove the product from the market by undertaking a resource-intensive enforcement action in which we would bear the burden of proof to demonstrate that the product is adulterated. In the meantime, the unsafe dietary supplement could remain on the market."

FDA anticipates "NDINs that would be submitted for CBD-containing products as proposed in the (CRN) petition would describe products that would not meet the safety standard for dietary supplements and would therefore be adulterated," Stearn wrote. "However, as a practical matter, FDA does not have the resources to take enforcement action against every violative product in this exploding market. The petition’s suggested approach would potentially strain our limited enforcement and NDIN review resources because they would be skewed toward CBD products at the expense of the rest of the dietary supplement marketplace, which would be to the detriment of the public health."

Durkin argued FDA's CBD proposal for a harm-reduction framework reflects an "unrealistic position" taken by the agency.

“The only reason FDA thinks it needs a harm-reduction framework for CBD as a dietary ingredient, beyond what is already provided by DSHEA, is due to its unrealistic position that dietary ingredients cannot present any risk of harm,” said the former ODSP official. “From this perspective, the safety standard for dietary ingredients—a reasonable expectation of safety under the conditions of use—would essentially be no different than the safety standard required for food additives and GRAS (generally recognized as safe) substances: a reasonable certainty of no harm.”

But “Congress explicitly rejected” the GRAS standard for supplements “when it passed DSHEA,” Durkin said.

One of Durkin’s former FDA colleagues, Sibyl Swift, Ph.D., is chief science officer and VP of regulatory affairs with cbdMD Inc., a marketer of CBD products.

Swift worked at ODSP from October 2014 until December 2019. In her role as associate director of research and strategy, Swift was co-chair of the Botanical Safety Consortium and led ODSP’s internal and external research portfolio and its enforcement strategy and priorities, she said.

When lobbying on Capitol Hill for FDA to regulate CBD, Swift said, she makes two main points.

“We are not marijuana. We are not trying to get someone high. This is a dietary supplement,” she said.

Then, she explains the regulatory framework applicable to supplements under DSHEA.

“The laws work, the rules work," Swift proclaimed, "and at the end of the day, we as an organization … are struggling to see how hemp is really truly different than any other botanical dietary ingredient."