An FDA proposal to help the agency enforce against “supplements” tainted with undeclared drugs and other products that don’t meet the definition of a dietary supplement could become law under a bill introduced last week in the U.S. Senate.

In its justification to Congress for its requested FY23 budget, FDA proposed an amendment that would clarify its “authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products.”

The FDA Safety and Landmark Advancements (FDASLA) Act would make it a “new prohibited act” to introduce into interstate commerce “any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under section 201(ff)” of the Federal Food, Drug & Cosmetic Act (FDCA).

This provision could lead to unintended and harmful consequences for responsible companies, industry sources have argued. For instance, they warned FDA could use this new authority to limit access to “dietary supplements” in instances where the agency and industry disagree over the legal status of an ingredient—such as what has occurred with hemp-based CBD and NAC (N-acetyl-L-cysteine).

Raising the stakes, individuals and companies who commit a “new prohibited act” could face criminal prosecution leading to imprisonment.

Sidley Austin LLP Partner Scott Bass said the “new prohibited act” language reflects FDA’s position that its current authority isn’t explicit enough to enforce against products marketed as dietary supplements but spiked with undeclared pharmaceutical ingredients.

The language “could encompass differences of opinion with FDA that shouldn’t rise to a criminal offense,” according to Bass, who is a founder of his law firm’s Global Life Sciences and Food and Drug Law practices in China, Europe and the U.S. “The intent of this section, which is to catch tainted products, [is] overbroad and using a shotgun for something that needs a rifle.”

After a draft of the bill was released but prior to its formal introduction in the Senate, Bass cautioned in an interview the provision “can apply to any technical argument about whether something’s a supplement or not.”

Facilitating enforcement

Cara Welch, director of FDA’s Office of Dietary Supplement Programs (ODSP), declined to comment on any specific bills pending on Capitol Hill.

However, Welch articulated why her agency is seeking clarity of its authority over products marketed as dietary supplements that do not meet the definition of a dietary supplement. Natural Products Insider interviewed her a day before the FDASLA Act was formally introduced in the Senate.

FDA feels clarification “would help us facilitate enforcement against unlawfully marketed products and to better protect consumers,” she said, adding stakeholders have expressed support for providing clarity.

“These products look like a dietary supplement, but for one reason or another, are not dietary supplements,” Welch explained.

FDA must determine what the products actually are and what authorities it has over them.

“At times, that analysis can be fact-intensive,” Welch said. “It can require a case-by-case analysis. And clarification of FDA’s authority over these products would facilitate the enforcement, and I think ultimately better protect consumers.”

Welch was asked why FDA’s current authorities are not adequate to enforce against products marketed as supplements that contain active pharmaceutical ingredients (APIs). Some industry stakeholders have maintained FDA has ample authority today to crack down on these products.

Welch reiterated FDA wants to be efficient in its use of resources devoted to enforcement.

In assessing a specific product, FDA must examine how it is labeled, what FDA-regulated commodity it fits under and what authorities are appropriate, she said.

She suggested the analysis may be time-consuming, depending on the specific product.

If the product is labeled as a supplement but is excluded from the definition of a supplement because it contains a drug, “dietary supplement authorities are not appropriate,” requiring FDA “to look elsewhere,” Welch explained. “It’s more of an inefficiency of our resources, and I think we want to ensure that we are as efficient for these products as we can be.”

Commenting on products tainted with APIs, she pointed out FDA notifies the public when the agency tests and identifies products containing unlabeled drug ingredients. Notifications about tainted products marketed as dietary supplements are disclosed on an FDA Medication Health Fraud webpage.

A search of public notifications in an FDA Health Fraud Product Database yielded 31 tainted dietary supplement products in 2021 and 18 such products in 2022, an FDA spokesperson said. For example, FDA in early February published an announcement by a company (ABC SALES 1 INC) that it was recalling products marketed as dietary supplements after Amazon found they contained sildenafil and tadalafil, ingredients in FDA-approved products to treat male erectile dysfunction.

Products containing APIs “obviously present a safety concern,” and “FDA’s top priority is to get these products off the market to ensure that consumers don’t take” them, Welch said.

Proposed amendment

Steve Mister is among the stakeholders concerned about the “new prohibited act” language in the FDASLA Act.

“We understand FDA’s concern that if a product is held out as a dietary supplement, that FDA says, ‘Technically, if it does not contain a dietary ingredient, it’s really not a dietary supplement,’ and therefore [FDA] cannot hold it to the requirements of a supplement,” said Mister, president and CEO of the Council for Responsible Nutrition (CRN).

That means FDA must refer the matter to the Center for Drug Evaluation and Research (CDER) for prosecution, he said.

“We’re sympathetic to that,” Mister elaborated in an interview, “but we don’t agree with this idea of creating a new prohibited act. There are other ways to address the problem.”

Based on the current language in the Senate bill, FDA could leverage the threat of a criminal prosecution against companies in cases where industry and the agency disagree over whether a substance is a dietary ingredient or whether a disease claim is being made, he warned.

Mister said Congress “can amend the definition of a dietary supplement with some language … that basically says if a firm holds out a product as a dietary supplement and they market it with intent that it is to be a dietary supplement,” the product is subject to all the requirements applicable to dietary supplements in the FDCA.

For example, if a company sold a steroid and included a Supplement Facts panel on the back of the label, it’s “conceded that for purposes of regulation, FDA may treat it like a supplement,” Mister explained.

That would give FDA’s Center for Food Safety and Applied Nutrition (CFSAN) authority to take action against a product—such as requiring a recall—and not have to wait for CDER to act, he said.

“People forget that like food, supplements are subject to mandatory recall,” Mister said. “So by giving FDA that authority to say, ‘If it quacks like a duck, you can treat it like a duck,’ … the product is also subject to mandatory recall, even if it has a drug ingredient in it.”

Impending deadline

The FDASLA Act is considered a piece of must-pass legislation since it reauthorizes FDA’s prescription drug, generic drug, biosimilar and medical device user fee agreements. The “new prohibited act” language is just one of many provisions in the bill that would impact the dietary supplement industry. For instance, the bill also would require manufacturers list their dietary supplement products with FDA under a proposal that continues to divide industry stakeholders.

The Natural Products Association (NPA) is among the critics of mandatory product listing and passionately opposed to the idea while other stakeholders, including Bass, have perceived benefits to FDA's proposal.

A version of the bill introduced in the House of Representatives does not include language on dietary supplements, and it remains to be seen whether any final bill negotiated between the House and Senate—and ultimately passed by Congress—will impact the industry.

Congress doesn’t have much time to reach an accord. User fee agreements expire Sept. 30, “but it is imperative that legislation reach” the desk of President Joe Biden by Aug. 1, according to Steven Grossman, executive director of the Alliance for a Stronger FDA, in an analysis and commentary. “Otherwise, lay-off notices could be sent to thousands of FDA employees whose work is supported by expiring user fee programs.”