Industry association hits back against “disinformation” over mandatory product listing

09 Aug 2022 --- In an open letter to industry, the Council for Responsible Nutrition (CRN) president and CEO Steve Mister has hit back against “disinformation” spread over the association’s involvement in creating a dietary supplement registry for the US Food and Drug Administration (FDA).

Discussions to create mandatory product listing has divided industry representatives, with the CRN supporting the FDA suggestion, while the Natural Products Association and American Herbal Products Association have described it as misguided and dangerous.

“I am distressed to see so much disinformation being promoted that reflects a lack of understanding of the complicated Congressional process, intentional misdirection and false information about what is in the bill, and intentional efforts to deceive the industry about the consequences of this legislation. So I would like to set the record straight,” says Mister.

Deflecting from the real issue?
Also caught up in the crossfire is the contentious FDASLA Act, aiming to grant the FDA more control over cosmetic and dietary supplements. According to Mister, press reports are quoting sources which say the provisions related to dietary supplements should not be included in the FDASLA Act.

“They have insisted that legislation should be limited to only pharmaceutical and device issues. That opinion is both naïve and ill-informed. Drug user fees have been reauthorized five times since the Prescription Drug User Fee Act (PDUFA) was first enacted in 1992. Since then, this must-pass piece of legislation every five years has been both tacked on to other larger bills.”

In 2002, it was part of a much larger bioterrorism bill and has been a vehicle for a variety of other FDA-related proposals including devices and food, Mister adds. In 2017, it included prohibited acts related to food. “The notion that FDASLA must remain ‘pure’ to drugs and devices only is an effort to deflect attention from the real issues.”

The FDA’s ability to manage the supplement industry has been a contentious issue. Supplements: the bill’s downfall?
According to Mister, some stakeholders are promoting the notion that the dietary supplement provisions of the FDASLA Act could potentially “doom the user fee reauthorization to defeat.” 

“That is a wildly over-inflated estimation of the role dietary supplement issues will have in this legislation. While important to our industry, other drug-related issues are likely taking precedence in the FDASLA negotiations.”

“Dietary supplement issues will not be responsible for shutting down FDA or any of the other parade of horribles that are being trotted out. If the legislation does not pass, it will be over an impasse on drug issues. We would get jettisoned very quickly.”

A few weeks ago, US Senator Richard Burr tabled a new FDA User Fee Program citing the “devastating” impact of the FDASLA Act. “The legislation I’ve introduced preserves the user fee agreements as they’ve already been negotiated – without harmful additions,” he said at the time. 

“It keeps FDA’s critical operations running, protects existing scientific experts and ongoing hiring activities at the agency and ensures the agency can continue to review new medical products while encouraging private sector investment in the next generation of developments.”

Calls for pragmatism
Supporting the mandatory product listing, Senator Dick Durbin accused the industry of selling “ gas station heroin,” highlighting the importance of greater FDA control. Nonetheless, the agency has come under fire after accusations it fails to enforce laws, carry out inspections and hold companies accountable. 

“Some stakeholders continue to say that mandatory listing should wait and be included in a much broader package of reforms to DSHEA (Dietary Supplement Health and Education Act). While the CRN certainly has a wish list of other items we would like to change in the current law, that has to be balanced with pragmatism and a dose of what realistically can be accomplished in this Congress - or even in the next one.”

A study also flagged that the FDA appears to be ineffective in removing dangerous supplements from the market, with warning letters by the agency often going unheeded. 

By Andria Kades