The top U.S. regulatory official who oversees dietary supplements said in an interview he is devoted to protecting consumers from unsafe products in the marketplace.
"The No 1 priority is consumer safety," said Steven Tave, director of FDA’s Office of Dietary Supplement Programs (ODSP).
Tave doesn’t have an easy job.
Dietary supplements aren’t subject to premarket approval, tens of thousands of products are on the U.S. market, and the burden is on FDA to establish a supplement is unsafe. Complicating matters for FDA, many products sold online and labeled as “supplements" are laced with undeclared, active pharmaceutical ingredients.
As an agency with limited resources, Tave said ODSP seeks to achieve voluntary compliance with its regulations when feasible. He said his office is open to meeting with the industry and other stakeholders.
Tave first joined FDA in 2007 as a litigator in the Office of Chief Counsel and was named last year to oversee ODSP. Previously, from 2014 through 2016, several FDA officials including Tave rotated as acting directors in the top supplement job.
In a telephone interview last week with INSIDER, Tave laid out his office’s objectives: protecting consumers from unsafe products; ensuring “product integrity;" and finally, conveying meaningful information to consumers and other third parties regarding supplements.
“We want to make sure that products that can harm consumers are not available to consumers," the lawyer said, “and if we find out about a dangerous product on the market, we want to move as quickly as we can to get it off the market and inform consumers, so that they're safe."
Ensuring Supplements Contain Labeled Ingredients
Tave described product integrity as a second, or “No. 2 priority," for ODSP.
"Products should contain the ingredients that they're labeled to contain, and nothing else," he said. "If a product claims to include a certain ingredient, that ingredient should be in there at the right amount, and anything that's not on the label should not be in the product."
Tave’s remarks likely resonate with a supplement industry that endured condemnation two years ago following a widely publicized investigation by New York Attorney General Eric Schneiderman. Schneiderman alleged supplements sold at national retail chains failed to contain the labeled herbs and were contaminated with undeclared substances.
Industry experts questioned whether Schneiderman’s use of DNA barcoding was the proper test method, and one of the retailers subject to the probe—supplement giant GNC Holdings Inc.—said there was no evidence its herbal supplements were made in a way that deviated from FDA regulations.
However, the allegations of fraud were widely reported, renewing debate about FDA’s role in policing supplements and the adequacy of the federal law governing such products. Editorials in major U.S. newspapers, and other critics, advocated for changes in the 1994 Dietary Supplement Health and Education Act (DSHEA) to ensure greater oversight of products that are reportedly taken by more than 170 million Americans.
Ensuring product integrity includes a second component, Tave explained. Specifically, supplements “need to be manufactured in a consistent, quality manner," in compliance with FDA’s current Good Manufacturing Practices (cGMPs), he said.
FDA’s strategy for responding to cGMP noncompliance is a multi-pronged one that includes moving for judicial action in cases of repeated and flagrant violations of the regulations, Tave explained. The U.S. Justice Department and FDA have announced a few injunctions in recent months against supplement manufacturers that were charged with violating cGMPs.
According to a Justice Department complaint against one dietary supplement manufacturer that is the recent subject of a proposed consent decree of permanent injunction, several FDA inspections between 2012 and 2016 revealed the defendants neglected to ensure the composition, identity, purity and strength of their finished products.
FDA and the Justice Department have been accused of moving too sluggishly to shut down noncompliant manufacturing operations. cGMP violations reported on FDA inspection reports—known as Form 483s—and FDA warning letters are often inadequate to deter unlawful behavior and protect consumers from unsafe supplements, FDA critics have argued.
Tave addressed such criticisms.
Enforcement actions consume “a lot of resources," he explained, “and we don’t have a lot of resources … We do try to achieve voluntary compliance when we can. And so when we do an inspection, that’s why there’s a 483, and we want to work with companies to help them get their cGMPs up to par."
FDA and the industry also play a role in educating companies on cGMPs, Tave said.
“In the dietary supplement industry, there are a lot of smaller firms that don’t necessarily have the resources to hire expensive lawyers … [and] expensive consultants," he explained. “We want to figure out ways to get the information out to them so that they’re able to comply, and they’re able to learn how to comply, in the way that we expect."
Conveying ‘Reliable and Useful Information’
Tave laid out his office’s final priority: “[D]oing what we can to make sure that consumers and health care providers have access to reliable and useful information that will help them make the decision of whether to take or to prescribe or recommend a dietary supplement, and to determine which one they want to take and how to do so."
He cited as an example FDA’s efforts to make publicly available, and easily accessible, the agency’s responses to new dietary ingredient (NDI) notifications. Manufacturers and distributors of supplements containing NDIs are required under DSHEA and FDA regulations to notify the agency, providing evidence that the new ingredient is reasonably expected to be safe.
The notifications, and FDA’s responses to them, can provide important information to the public, including whether FDA believes it has a reasonable assurance that an ingredient is safe.
"To the extent that there is public information, that there is meaningful information, we want to make it available," Tave said.
But as INSIDER reported, FDA has been about two years behind in publishing the notifications and its responses to them.
Tave acknowledged the NDI filings are public and should be readily available. While FDA works to make the NDI filings more readily available, he noted the information can be obtained through Freedom of Information Act (FOIA) requests.
"We're working on it in the context of having to deal with other offices and whatever the other technical constraints are," said Tave, who added FDA must verify confidential information like trade secrets aren’t publicized.
As part of FDA’s efforts to convey useful information to the public, the agency also relies on consumer advisories, such as a 2015 alert regarding pure powdered caffeine.
Finally, Tave observed assumptions are made at FDA and outside the agency about what consumers and others think about dietary supplements.
"One of our longer-term goals is to really get a better understanding of what people actually think, and then craft our messaging around that," he said. "What do they understand, what don't they understand, [and] where do we need to provide some education?"