FDA supplements chief identifies ‘regulatory gap’

An FDA official who oversees regulation of dietary supplements on Wednesday described a “regulatory gap” that he said “responsible industry” and others should move to narrow.

“The regulatory gap represents the space between” requirements in the law and what can be “realistically” achieved through enforcement, said Steven Tave, director of FDA’s Office of Dietary Supplement Programs (ODSP). “The existence of a regulatory gap explains how there can simultaneously be a responsible industry and a market that is less than perfectly regulated. And the larger the regulatory gap, the less well-regulated the market.”

Tave spoke during the virtual Dietary Supplements Regulatory Summit, a collaboration among five trade associations, including the United Natural Products Alliance (UNPA), which hosted the all-day event. Other trade associations included the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA) and the Natural Products Association (NPA).

‘Red herring’

Tave emphasized the supplement sector is subject to plenty of regulations, and he said “responsible participants generally comply with those regulations.” But he described as a “red herring” the question of whether supplements are regulated.

“The question that really matters is this: Is the dietary supplement marketplace well regulated?” Tave asked.

FDA’s supplements chief analyzed the question from the perspective of consumers. When considering using, purchasing or recommending a supplement, he explained, consumers should be able to expect three things: that the product won’t cause death, illness or injury; that it contains ingredients specified on the label in the right amounts and doesn’t include anything not labeled; and “there is a scientific basis for believing that the product will have whatever effect it claims.”

“Can consumers feel confident that all three of these expectations will be met for any dietary supplement he or she can purchase?” Tave asked. “I would suggest that this consumer perspective model should be the baseline for ongoing discussions” related to modernizing how supplements are regulated.

Tave concluded, “I think we can comfortably say at a minimum that the dietary supplement market isn’t perfectly regulated."

“The complaints and criticism that we hear from all corners makes that abundantly clear,” he said, “but we can let the facts and the data tell the story.”

Tave then analyzed core elements of the regulatory framework governing supplements, including a requirement that food facilities register with FDA. He pointed out there is no requirement that actual products are registered with FDA.

“While we might know about more than 10,000 registered facilities around the world, we do not know what they are producing,” he said. “And we don’t have a systematic way to know when new products are introduced to the market and what ingredients they contain.”

Commenting on a requirement in the Dietary Supplement Health and Education Act of 1994 (DSHEA) that firms provide identity and safety information to FDA before marketing a new dietary ingredient (NDI), Tave pointed out FDA has received less than 1,200 notifications in 26 years.

At a public meeting in May 2019, he estimated that, based on very conservative assumptions, his agency should have received at least four times as many notifications.

“One possible reason for that underreporting is a loophole in the law, which has recently begun to get more attention,” he noted. “And many stakeholders talk understandably about a relevant lack of incentives for complying with the requirements, including a perceived absence of enforcement.”

While supplement manufacturers must comply with cGMPs (current good manufacturing practices) to ensure the quality of their products, Tave pointed out that before COVID-19, FDA was only inspecting around 500 dietary supplement facilities annually—a fraction of the total number of registered food facilities; and many inspections, he added, are re-inspections.

What’s more, he cited a high level of noncompliance with cGMPs. FDA officials have complained for many years about failures in meeting basic cGMP requirements, such as establishing specifications and testing ingredients to ensure those specs are met.

Although many companies comply with cGMPs, Tave stressed later in his talk that the purpose of his analysis isn’t just to consider legal requirements and whether responsible companies are meeting such obligations.

“The point is to question whether a consumer can reasonably expect that any hypothetical product found in the market has satisfied those requirements,” he explained. “It’s not necessarily a natural or an easy shift in perspective to make, especially if you’re someone who invests the time and energy to ensure that you do comply with all of these requirements. But it’s also an undeniable truth that there is a difference between what responsible firms are doing and what is happening on the market more broadly.”

Widening his analysis beyond compliance with existing requirements in the law, Tave highlighted the presence of products labeled as supplements but tainted with active pharmaceutical drugs. And ingredients FDA has stated are unlawful in dietary supplements continue to be sold in such products, even after the agency has taken action against them, he noted.

“I applaud those of you who stand behind your own products,” Tave said. “But can you stand with the same conviction behind every product on the market that holds itself out as a dietary supplement? I believe that the explanation for this disconnect lies in the regulatory gap.”

Tave noted FDA works with parties to help them achieve voluntary compliance with the law. “In cases where an actor might not be inclined to do the right thing, the threat of enforcement can be what convinces them,” he said.

But he mentioned various situations in which FDA might not be able to take action against every violation of the law. For example, a regulator might not be able to identify the violation, prove it or have the resources to target it.

Closing the gap

Tave explored changes in the industry and world since DSHEA was passed, including a market that has grown from $4 billion a year to well over $40 billion—with at least 50,000 products today and perhaps more than 80,000. The law was passed when the internet was in its infancy, and the current supply chain of supplement ingredients is a complex one throughout the globe.

“DSHEA was a law that was designed to regulate the market as it existed at the time,” said Tave, who described as “reasonable” the framework put in place in 1994.

“But with the benefit of hindsight, we can see that its operational provisions didn’t account for all of the changes that ensued because the law wasn’t drafted with the benefit of a crystal ball,” he said. “We can’t responsibly ignore the regulatory gap or pretend it isn’t there. That’s not in anyone’s interest. Consumers, responsible industry or regulators—all of us who expect or demand a better-regulated dietary supplement market—share a duty to identify and pursue ways to narrow the regulatory gap.”

In 2019, FDA announced new efforts to strengthen its regulation of supplements by modernizing and reforming its oversight.

“In fact, when we talk about modernization, we’re really talking about closing the regulatory gap,” Tave said.

Tave said his agency “stands behind the twin pillars of DSHEA,” which include preserving consumers’ access to supplements while protecting them from unsafe and unlawful products.

“The task that we’re all faced with now is updating the regulatory framework to ensure that those twin pillars remain viable in today’s world,” he said.

A key part of FDA’s modernization efforts include its support for a requirement that dietary supplement products are listed with FDA. Many stakeholders, he noted, are in support of such a listing. The proposal also has a number of detractors.

“Responsible industry is ready for this change, and I look forward to working constructively with you all to make this a reality,” he stated.

While Tave noted FDA has an important role in the discussions, he said his agency “shouldn’t be dictating its terms.”

Addressing the virtual audience of industry execs, Tave said everyone should consider “whether the goal is for the dietary supplement market to be well regulated or for it to be regulated just enough.”

“From a public health perspective, I would argue that there is one thing even more dangerous than a poorly regulated market,” he said. “And that thing is a poorly regulated market that the public wrongly believes to be well regulated.”