At a seminar hosted by the U.S. Food and Drug Administration (FDA)’s Office of Dietary Supplement Programs (ODSP), Cara Welch, PhD, ODSP director discussed the agency’s regulatory priorities in the midst of an agency-wide proposed reorganization plan.

The restructuring, should it go through as planned, would merge the Human Foods Program and Office of Regulatory Affairs, and dietary supplements would be under the purview of a newly-created Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI), which ODSP would report to.

According to FDA Commissioner Robert Califf, MD, dietary supplements would remain a “critical priority,” and no resources would be diverted from ODSP, which would remain a distinct office.

“There are many similarities between the innovative new ingredients created for use in foods and dietary supplements, so this component of the restructuring reflects that,” Welch said. What sort of sub-structure would exist underneath the OFCSDSI remains to be seen after multiple layers of review by the Department of Health and Human Services and elsewhere.

Measures to Modernize

Welch noted that the agency’s enforcement capabilities are mostly for products that have already been introduced to the market, such as current Good Manufacturing Practices (cGMPs), labeling standards, structure/function claims, and adverse events reporting. Meanwhile, aside from facility registrations and New Dietary Ingredient Notifications (NDINs), the agency has little oversight into products before they’re launched and available to consumers.

Agency resources aren’t enough to sufficiently keep a finger on the pulse of the supplements marketplace, Welch said, which has expanded from $4 billion to $50 billion in sales and from 4,000 to over 95,000 product labels since passage the Dietary Supplement Health and Education Act (DSHEA). Beyond this, today’s supply chain is fully globalized, and a sizeable portion of products are sold online, Welch noted.

While she didn’t endorse pre-market approval for products, she called for changes that would give the agency more insight into supplements ahead of market introduction.

“There’s no barrier to putting a product on the market, and really no need to inform FDA that you’re putting a product on the market or reformulating it,” Welch said. “We have no systematic way to know when new dietary supplements are introduced, or what they contain.”

The agency continues to support mandatory product listing for dietary supplements, which it explicitly stated would not be used as a form of pre-market approval, but as one of a few tools to facilitate removal of unlawful products from the market. 

Improving Efficiencies

Presently, FDA inspects a few hundred facilities that manufacture dietary supplements on a yearly basis, which is just a sliver of the 10,000 facilities known to exist. Little can be done to increase those numbers based on personnel, so “getting the best coverage is important to keep in mind,” Welch said. “This means improving the quality of our inspections, rather than focusing on volume.”

“Imports are an area where we definitely want to do more, which is something that we hear from the industry too,” she added, “and we’d like to have more information on products that are entering the U.S., and determine if we have the recourse to stop products from coming in if they’re unlawful.”

The agency is considering outreach to several leading third-party testing facilities on a voluntary basis in order to glean information on matters of adulteration, Welch noted. 

New Dietary Ingredient Notifications

Many ingredient manufacturers have introduced products to market through self-affirming that an ingredient is Generally Recognized As Safe (GRAS), a designation which eschews notifying the FDA of an ingredient’s introduction, despite the fact that such products are statutorily New Dietary Ingredients, Welch said.

Welch noted that the goal of the agency in proposing an NDI amnesty period is not to dole out widespread punishment for firms that failed to submit appropriate NDINs over the years. Rather, it’s an opportunity for industry to correct course without fear of repercussions. “We’re not worried about how overdue notifications are, but whether we understand the safety profiles and identity of these ingredients,” Welch said.

The NDI process has been an issue for years, with the agency recently issuing unexpected declarations that it doesn’t consider ingredients like NAC, NMN, and others to meet the regulatory definition of a dietary ingredient. 

Communications

While FDA has historically kept things “close to the chest,” Welch said that she intends to direct the agency to establish more open lines of communication, especially when it comes to what it considers to be the biggest risks or issues at any given moment, or where resources are being devoted.

Further, the agency is considering whether warning letters and other measures of explaining why it does or doesn’t consider something to be a dietary ingredient is the best use of resources. Welch said that the agency will be looking at other avenues of communication to strengthen industry-wide compliance, for the mutual goal of consumer protection. Part of this could be through expanding collaboration with other government entities such as the Federal Trade Commission, or amplifying certain problems as highlighted by industry stakeholders.

Beyond transparency about internal functions, taking a more active role in combatting misinformation is another goal of the agency, Welch said.