CRN’s Mister on FDA reorg, FTC petition, and state of the market

The knowledge gap, which Mister called “disturbing” shows that the industry has a lot of work to do to “educate both Dr Califf and Mr Jones, to the extent that they are willing to be educated”.

Mister was speaking with NutraIngredients-USA at the recent SupplySide West in Las Vegas, where we asked him about recent statements made by Dr Robert Califf, FDA’s Commissioner, and Jim Jones, the new deputy director of FDA’s Human Foods Program. Having heard from both men, we asked Mister how he is feeling about the direction of the agency and their approach to the regulation of dietary supplements.

“I wish I could say I’m more optimistic, but I’m not,” he told us. “The fireside chat I had with Dr Califf [at CRN’s Annual Conference]​ was, I think, really illuminating. Not necessarily the answers we wanted to hear, but very important for the industry to get an inside view of his perspective of the industry.

“The recent media briefing by Jim Jones […] also revealed there is a fundamental lack of understanding of how dietary supplements are regulated in DSHEA. I think that’s probably because of that counter-narrative that has always been out there that DSHEA weakened the Agency, it took authority from the Agency. That is still there, and it appears that the current leadership at the Agency has bought into that. So, we have a lot of work as an industry ahead of us to educate both Dr Califf and Mr Jones, to the extent that they are willing to be educated, on what exactly the authority of the Agency is.”

Mister said he was very concerned about recent comments by both Jones and Califf about structure claims and the substantiation of such claims. “They seem to believe that there’s no requirement for substantiation,” he said. “We know it’s written into the law that any of the claims that you make have to be substantiated with credible evidence.

“So very disturbing to us that there is this apparent knowledge gap within the upper echelons of the Agency.”

FTC​

Mister also addressed questions about CRN’s Citizen Petition to the Federal Trade Commission (FTC)​ seeking clarification of the commission’s Health Products Compliance Guidance. The petition asserts the FTC has departed from long-standing guidance, which said that nonprescription drugs and supplements do not require drug-level clinical trials.

“Unlike a Citizen Petition at FDA, where there is a clock running, […] at FTC there is no official clock. We filed this under the category of being a petition to the FTC, but they are not required to respond and there’s certainly no time limit on that,” said Mister. “But we are hoping that our petition gives us an opening now with the FTC to go in and have some serious conversations with them about the discrepancies between what the established case law says for supplement substantiation and what’s in the guidance, because there is a difference.”

Watch the video for the full interview.