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FDA ‘appreciates’ CRN’s product registry efforts

By Stephen Daniells+

15-Apr-2016
Last updated on 15-Apr-2016 at 18:21 GMT2016-04-15T18:21:07Z

Image: iStockPhoto
Image: iStockPhoto

The US Food and Drug Administration tells NutraIngredients-USA that it looks forward to learning more about the Council for Responsible Nutrition’s proposed industry-wide dietary supplement product registry.

CRN announced this week that its Board had unanimously authorized the creation of a dietary supplement product registry to be launched by the end of the year.

“This is one step we’re making to take back our industry from the lawbreakers, from the renegades, from the companies that spurn regulation,” said Steve Mister, CRN President & CEO. “Our member companies have turned a corner and are fully engaged in efforts to separate the legitimate manufacturers marketing healthful products from the hit-and-run, fly-by-nighters selling quick fixes and illegal drugs wrapped with a supplement label. We need all companies who care about our consumers and the sustained growth of this industry to join with us in this initiative.”

According to CRN, the initiative comes at a time when the supplement industry is primed to work more closely together and with regulators to help solve the problems that have attracted increasing public scrutiny. “The days of the regulators sitting on their hands are long gone and we appreciate that we’re seeing stronger enforcement action of the law,” said Mister.

In an email statement to NutraIngredients-USA, Steve Tave, Acting Director of the Office of Dietary Supplement Programs at the FDA, said: “The FDA appreciates CRN’s efforts to promote industry compliance through self-regulation and we look forward to learning more about how CRN’s program will be implemented.

“However, all dietary supplement manufacturers and distributors are required to comply with federal regulations, and the agency continues to be focused on ensuring that there is full compliance throughout the industry.”   

Moving away from a “ping-pong” dialogue

The topic of a registry was discussed by former FDA official Dr Joshua Sharfstein, MD, at this week’s 16th Annual International Conference on the Science of Botanicals in Oxford Mississippi. Dr Sharfstein addressed attendees two days before the CRN announcement.

Dr Sharfstein presentation explored proposals outlined in a paper he co-authored in Drug Testing and Analysis last year, which floated the idea of new regulatory framework based on “access with safety” and not “benefit versus risk”. The first phase includes an assessment of what products are already on the market, and the need to register products with the FDA. Our earlier coverage of that paper and the industry reaction can be found HERE .

Dr Joshus Sharfstein. Image: Johns Hopkins Bloomberg School of Public Health

“I cannot think of one thing where there is so much agreement and yet so much disagreement,” said Dr Sharfstein about the industry. “There is agreement that there are elements of concern like illicit pharmaceuticals in some products, novel chemicals in some products that can be dangerous, disease claims without evidence, and so on.

“The disagreement comes from the ‘why’,” he said. “On one side you have people saying that the market is essentially unregulated, while on the other you have people saying that the FDA is ineffectual: It is largely illegal products that are causing the problem and we should advocate for greater FDA resources and enforcement.

“The result is a ping-pong dialogue,” he said.

“FDA are in their underwear and are blindfolded”

Dr Sharfstein proposed moving away from a risk-benefit assessment model of the products, which requires a discussion of efficacy. The major concern at this point should be safety, he said.

“FDA is policing the market, but they’re in their underwear and are blindfolded,” he said. “To expect a regulator to enforce in that kind of market is unreasonable.

“In a regulated market where safety is fundamental, no company should be able to change a formulation and not notify the agency.” For that reason, he sees a product registry as the first phase of a new way to regulate the products.

“I do think that there is a path, and I don’t think we need to continue to play ping-pong with mounting levels of distrust,” he said. “Congressional support will be essential and the FDA has to be central to any proposed changes, but I think there is more common ground than is appreciated.”