Speaking with NutraIngredients-USA via video on June 30, Steve Mister, President and CEO of the Council for Responsible Nutrition (CRN), said: “There’s an unanimity among all the associations in the industry. We are looking to include everything that has a supplements fact box on the label. In the initial version of the bill, all of those things would be included in HSAs and FSAs.”
Including dietary supplements in HSAs and FSAs was the number one ask during CRN’s recent Day on the Hill for meetings with members of Congress and their staff.
“This was our first chance to get back with our Congressional fly-in day since the height of the pandemic,” said Mister. “We also talked a little bit about what’s going on with CBD, and FDA’s position on that. And more broadly, the drug preclusion issue and the fact that Congress may have to step in one way or the other on that issue as well.”
Drug preclusion principle
Ingredients like CBD, NAC, and NMN have put the drug preclusion principle at the center of a clash between the industry and the US Food and Drug Administration (FDA).
“On the Hill, a lot of that [conversation about the drug preclusion principle] at this point is simply education,” said Mister. “Members of Congress have not been following our issues with N-acetyl cysteine, NMN, so a lot of it is starting at zero and helping them understand that this was just a provision that was written into DSHEA to provide some balance between pharmaceutical interests and supplement interests. It was rightfully put in to make sure people just didn’t take an ingredient and steal it away from the pharma industry.
“But what has happened with recent FDA activity is that that balance is now out of whack, and it is definitely favoring pharmaceutical interests and ignoring the incentives we need to have for innovation in supplements.”
The ongoing saga with CBD was also up for discussion on the Hill. “There are members of Congress from Red States and Blue States that have hemp farmers in their districts that have hemp that they now can’t sell. They have consumers in their districts who want to be able to use CBD, but they want to know that it’s a reputable industry and that the products they’re buying have some level of support and regulation around them. There really was bipartisan interest around it,” said Mister.
“Our message was a very strong call for Congress to make FDA use the regulatory structures that it has. There’s no reason that CBD cannot be appropriately regulated under DSHEA. It gives FDA all the tools they say they need under this new paradigm. They’ve got them, they just need to use them.”
Mister also discussed the announcement last week about the FDA reorganization of its food program, and proposals to relocate the Office of Dietary Supplement Programs within a new Office of Food Chemical Safety, Dietary Supplements, and Innovation.
Watch the video for all the insights.