Is FDA exploring how to leverage third-party audit information for cGMP compliance?

The FDA published the final rule for current good manufacturing practice requirements (cGMPs) for dietary supplements in 2007, with implementation for all companies taking full effect in 2010. Fifteen years on, cGMP inspections are still revealing compliance issues for some companies.

The agency averages between 500 and 600 inspections per year (the exception being 2020 and 2021 when the pandemic severely limited inspection numbers).

“We’re probably about tapped out on how many inspections we can get done in a year,” said Dr. Cara Welch, director of the FDA’s Office of Dietary Supplement Programs (ODSP), during a presentation at the recent GRMA Summit in Chicago, hosted by the Global Retailer Manufacturers Alliance.

“I actually don’t hear a lot of criticism on the number of inspections, because I think folks really understand there’s going to be a cap to how many inspections FDA can complete in a year,” she added. “However, what I do hear is how can we improve the inspections that are getting done—some of the work that has been ongoing to [...] improve our inspectional coverage."

Most of the inspections performed by the agency are traditional surveillance inspections, with a much smaller number described as ‘for-cause inspections’ of a particular facility that can be requested in relation to a negative testing result or an adverse event, for example.

The GRMA Summit took place March 25-28, before an internal HHS memo was leaked that indicated that FDA was planning to outsource routine inspections of food facilities (which includes dietary supplement facilities) to the states.

Mature third-party programs

Dr. Welch noted that there are a number of third-party audit programs that were in place before FDA published the final rule in 2007.

“Are there opportunities to take the information that might come about as part of the third-party audit and apply it into FDA inspectional planning process? I don’t have a really clear answer,” she said, but noted that she has had discussions with GRMA and other stakeholders on the opportunity to leverage that external data.

“I don’t have explanation of how this might happen, but absolutely, I think FDA would appreciate continued discussion about some of these opportunities to leverage this data there,” she said. “And I would harken back to that Office of Surveillance strategy and risk prioritization, right? We’re going to prioritize the inspections.”

Dr. Welch said that a review of the inspection data over the years shows the same top 10 violations year after year, presenting the opportunity to engage with stakeholders to consider changes to approach, language or venues to make sure the messaging gets through.

To help plan inspections for the next year, the FDA has constructed an algorithm, and Dr. Welch noted that it could be “really powerful” if there were a way to feed data from those third-party inspections into those calculations.

“And so that’s something we are absolutely amenable to continuing to discuss,” she said. “There’s a lot that goes into inspection planning, and [it involves] many offices beyond mine, of course. I want to be sure I’m not speaking ahead of any of my colleagues, but being able to have a really knowledgeable inspection planning process, I think, is everyone’s goal, because the answer is not always more inspections.”

Reorganization

ODSP was subsumed by the Office of Food Chemical Safety, Dietary Supplements, and Innovation during the recent reorganization that created the Agency’s Human Foods Program.

“This is now a super office,” Dr. Welch explained. “Allowing ODSP to be more closely aligned with both the pre-market additive safety and the post-market assessment offices is going to provide some opportunities to really leverage expertise and resources across these programs.”

The closer alignment is important given that ingredients are increasingly moving from conventional foods into the dietary supplement space and vice versa.

This is “absolutely acceptable, assuming it’s all safe,” she said, noting that there are also more product types on the market that are really similar—dietary supplement dosage forms that look really food-like and conventional foods that are looking a lot more like a dietary supplement.

“So having these programs more closely aligned really allows for our programs to be talking more closely as the office of post-market assessment gets set up and gets their systematic approaches in place,” Dr. Welch said. “I really hope to see not just the review of chemicals in foods but also chemicals.

“And if we don’t want to use that word [chemicals], we can use substances... A lot of ingredients that we hear being discussed in foods are also in dietary supplements, so leveraging that expertise across programs is going to be really helpful and really set up both of our programs for success as we move forward.”

Gummies

One of the dosage forms for dietary supplements that is attracting a huge amount of consumer attention is gummies. Dr. Welch also revealed that the FDA undertook a fact-finding project around gummies in 2024 to better understand this dosage form.

“Gummy supplements is a huge area, but there are some distinct complexities with manufacturing gummies,” she said. “We engaged with some stakeholders to learn a bit more about what goes into gummy manufacturing. Just to be clear, we had great support from our dietary supplement stakeholders, and I would really offer up a thank you to those who did engage with us, as well as a thank you to everyone who offered to engage with us. That was a great opportunity to catch up our staff on the complexities that are involved with gummies, specifically the manufacturing, the design and formulation, but [also catch up] with our lab colleagues on the analysis [because] finished product testing of gummies can be difficult.”

FDA also toured some gummy facilities (“not inspections, just visits,” she said).

“It was so refreshing to have the opportunity to engage, with industry very forthcoming on the information they were willing to share that allows us to internally focus our energies,” Dr. Welch said. “We want to engage with the investigators to make sure that they understand how gummy manufacturing might be special as well.”

Looking ahead: Transparency

Dr. Welch concluded by noting that the FDA is looking to leverage connections and communicate its priorities.

“We really want to make sure consumers understand what direction we’re headed,” she said. “Manufacturers and all aspect of our firms understand where we are headed. We want to make sure that we have opportunities for engagement with our stakeholders.”

She added that there are many aspects where FDA may not have the expertise and that suppliers, product manufacturers or even stakeholder groups may be able to offer “really important perspectives.”

“I think that opportunity for engagement helps us move forward with more certainty and more assurance that we’re heading in the right direction,” she said.