FDA officials in recent years have cited unique challenges dealing with products labeled in the U.S. as “dietary supplements” but tainted with active pharmaceutical ingredients (APIs).
“We have these jurisdiction and definitional challenges, where you’ve got products that are presented as dietary supplements,” explained Steven Tave, director of FDA’s Office of Dietary Supplement Programs (ODSP), in a recent interview. “They look to all the world like dietary supplements but for one reason or another, they fall outside of our legal jurisdiction because of the way the law was written.”
FDA officials have cited as a prime example products tainted with APIs, such as sildenafil, which is found in Viagra to treat erectile dysfunction, or sibutramine, an appetite suppressant previously sold under the brand name Meridia and sometimes found in “supplements” marketed for weight loss.
“The way the law is written, those (products) are definitionally not dietary supplements,” Tave said.
FDA faces the same challenges with products labeled as supplements that contain only ingredients excluded from the definition of a dietary supplement because they were first studied or approved as a drug.
And it doesn’t matter if such a product contains a Supplement Facts panel or the required disclaimer under the Dietary Supplement Health and Education Act of 1994 (DSHEA), Tave noted.
“Even if a product is openly and clearly and unequivocally intended for use as a dietary supplement, if it contains an ingredient that’s excluded under [201(ff)(3)(B) of the Federal Food, Drug & Cosmetic Act], it is not a supplement by definition,” Tave said during a recent conference (“NOW, NEW, NEXT”) hosted by the Council for Responsible Nutrition (CRN). “Period. There is no ambiguity in the law there.”
FDA doesn’t have jurisdiction to use its “food and supplement authorities” to target such products, which “creates challenges” for the agency, Tave observed in a follow-up interview.
“Some of those products might have drug claims, but administratively, that’s difficult, and it creates complications,” said Tave, an attorney who practiced law for nearly 15 years as a litigator in FDA's Office of Chief Counsel and in the private sector.
“I also think it’s not a case where the dietary supplement industry … meant to have this loophole where tainted products and some of these rogue ingredients can find a way onto the market,” he told Natural Products Insider. “I think everybody agrees things like phenibut shouldn’t be in dietary supplements.”
During a speech about a year ago, an FDA official at the time, Lowell Schiller, cited situations in which a product containing undisclosed sildenafil is marketed as a dietary supplement and explicitly claims to treat impotence. (Schiller, whose last position with FDA was principal associate commissioner for policy, left the agency in September).
“In such cases, the claims about impotence establish that the product is intended for use as a drug, and classifying the product as an unapproved new drug will be a fairly straightforward determination for us to make,” Schiller said. “But other cases may be more complicated. For example, if a drug substance is mislabeled as a dietary supplement, but there are no express claims, then depending on the facts, it could be resource-intensive or otherwise challenging to determine the best path forward.”
Tave identified a change in the law as a solution.
“This is not something that we can change through regulatory steps because it is in the law, and we do not have the ability to change the law that Congress has written and the president has signed,” he said Oct. 14 during the CRN conference. “But this is something that could be changed through legislation.”
He suggested a legislative fix as part of FDA’s proposal that manufacturers be required to list their dietary supplement products with the agency.
“As we have worked on listing legislation, I think a very important piece of that would be a fix that holds that any product that represents itself as a dietary supplement is subject to the same laws as every legitimate dietary supplement,” Tave said during the CRN conference. “And the reason why that’s so important is because if one of the purposes of listing is to help identify these rogue products—these illegitimate spiked products that are out there and that shouldn’t be—they shouldn’t be able to get away from enforcement of the listing provision by saying, ‘Well, technically, I’m not a dietary supplement, so those rules don’t apply to me.’”
In the follow-up interview, Tave expanded on the legislative idea. “What we’re thinking is something that would clarify that these products are subject to agency jurisdiction as supplements or as foods without really changing the parameters of what DSHEA intended to allow as supplements,” he explained.
Schiller last year also described a change in the law as a solution to the challenges facing FDA.
“One way to help address this issue would be to move the drug substance exclusion out of the definition of ‘dietary supplement,’ and make it clear that the presence of such substances in a dietary supplement renders the product an adulterated dietary supplement—which would be in addition to any other potential violations,” he said during a Nov. 7, 2019 conference hosted by CRN. “The universe of what could be a lawful supplement wouldn’t change, but FDA would have a clear and direct way to use our authorities over adulterated dietary supplements to move against these unlawful and potentially dangerous products containing drug ingredients.”
Miriam Guggenheim is an attorney in Washington, D.C., who advises food and dietary supplement companies. Speaking on a lawyer panel during last month's CRN conference, she said she remains “perplexed at this view that FDA has negotiated against itself” that it lacks “authority to take action against purported dietary supplements that contain drug ingredients.”
“But if they think a statutory fix is needed for that, I would give them that because they should absolutely have that authority,” she said.
Whether FDA could garner sufficient support in the next Congress for a mandatory product listing—including language addressing the jurisdictional concerns above—remains to be seen.
FDA has yet to publish a specific legislative proposal, and Tave made it clear the process is not within his control. “For FDA to issue a proposal, it’s not a matter of me telling you what I want to see,” he told Natural Products Insider.
Such a proposal is subject to clearances through FDA, the U.S. Department of Health and Human Services (HHS) and the White House’s Office of Management and Budget (OMB), Tave observed.
“And obviously, this is an extremely busy time, and the agency, the Department, [and] the government are busy with a lot of things, so we don’t have control over that,” he said.
He added it’s not FDA’s intent to dictate the terms of a mandatory product listing.
“We appreciate that people are deferring to us, but we’ve also said we shouldn’t be dictating the terms of what listing should look like,” Tave said. “And we want to have stakeholder and industry input in it. There’s no reason that somebody else can’t put a proposal on the table too.”