Steve Mister on proposed FDA reorg, MPL, CBD, and CRN at 50
Earlier this week, the FDA unveiled a “transformative vision” for a unified Human Foods Program that will bring together under one empowered deputy commissioner nearly all of its major food components that currently are scattered across multiple divisions to better protect and promote and safe US food supply.
The dramatic overhaul responds to a scathing report by the Reagan-Udall Foundation published last month that found the agency’s current culture, structure and governance inhibits its ability to protect public health, and a separate internal review of the agency’s infant formula supply chain response.
Noteworthy throughout all of the communication from FDA about the proposed new human foods program is a lack of discussion around dietary supplements, which are regulated as a subset of food.
During a media call with reporters on January 31, FDA Commissioner Dr Robert Califf and FDA Principal Deputy Commissioner Dr Janet Woodcock were asked how the changes would affect dietary supplements. Dr Califf responded: “We’re working on that now, and we don’t have anything new to say today.
“We got new authorities on cosmetics, which we have sought for a long time, to help that industry produce the highest quality product. And so now we have to figure out where in the system it will fit… Dietary supplements is a whole different kettle of fish that we can discuss at a later time, but I assure you we’ll be working on that.”
Commenting on the news, CRN’s Mister told us: “I think dietary supplements both are and are not part of that conversation. We have not been expressly called out in any of the research that the Reagan-Udall group did when they have conversations with the staff at FDA. We’re not in the report and that’s troubling that we were omitted.
“But on the other hand we are very squarely in CFSAN… and when you look at some of the specific recommendations they have, they are things that we very much feel in the industry: The lack of coordination and interaction between the office of regulatory affairs, which is where the inspections come out of, that lack of communication with ODSP and CFSAN and the people who are making policy, we see that all the time.”
“I would hope that ODSP will take this as an opportunity to integrate themselves more with the investigators, so we’ll see better inspections, we’ll see investigators show up who really know 111, who understand how our requirements differ from traditional foods or cosmetics.”
Mister also discussed the recent FDA announcement that a "new regulatory pathway for CBD is needed that balances an individual's desire for access to CBD products with the regulatory oversight needed to manage risks." The announcement was widely met with disappointment among industry stakeholders, so were does it go from here?
“I think it’s clear it goes to Capitol Hill,” said Mister. “We’ve been concerned for several years that FDA was just going to kick the can down the road, shy away from making tough decisions, and that’s exactly what they’ve done. They had every opportunity to start a rulemaking under the drug preclusion language. They could have created a pathway forward for CBD. There was every reason to do that.
“We’ve already started conversations on The Hill with the new Congress… it’s very clear FDA is not going to solve the problem.”
Mandatory Product Listing (MPL)
“I think there will still be conversations [on the MPL],” he said. “But we have to be practical about the politics we’re living in right now – the new House of Representatives is very much interested in oversight and investigation, less likely to give an agency a new tool to exercise a new authority.
“It is a huge missed opportunity for the industry… We need to show ways that we can address online products that are not compliant and mandatory listing had the opportunity to get the major online players to the table.”
CRN at 50
Having been founded in 1973, this year marks the 50th birthday of CRN. The association has lots of plans to mark the occasion, culminating in a celebration at its annual conference in October, said Mister.