FDA more than doubles annual foreign inspections of dietary supplements

The number of FDA inspections of dietary supplement facilities outside the U.S. more than doubled in the most recent fiscal year, as the public health agency audited 40 firms in 17 countries from China to New Zealand and the United Kingdom, Natural Products Insider has learned.

Dietary supplements comprised 3% of total FDA foreign inspections in FY23, compared to 5% in FY22, according to Michael Dutcher, FDA Acting Assistant Commissioner for Human and Animal Food Operations.

“Since FY2023, FDA has resumed a normal cadence of inspections in all program areas,” Dutcher said in an email through an FDA spokesman.

Foreign FDA inspections of firms for compliance with cGMP (current good manufacturing practices) regulations applicable to dietary supplement products increased to 40 in FY23 from 17 in the prior year, according to data obtained by Natural Products Insider from FDA staff and through Freedom of Information Act (FOIA) requests.

FDA in FY23 performed 501 inspections under the cGMPs that are incorporated in 21 CFR Part 111, with 8% comprising international audits.

In the fiscal year that ended on Sept. 30, 2023, FDA conducted the largest number of inspections in Canada (7), followed by New Zealand (5), China and Korea (4 each), India and United Kingdom (3 each), Australia and Fiji (2 each).

Related:FDA inspections of dietary supplement facilities back to typical levels for second year

Several countries were the subject of only one foreign FDA inspection including Austria, Denmark, France, Italy, Slovenia, South Africa, Taiwan and Turkey, FDA data shows.

As Natural Products Insider previously reported, in the year that ended on Sept. 30, 2022, FDA conducted 471 domestic dietary supplement inspections and 15 foreign inspections.

FDA data may be updated over time. Subsequent inquires for this story revealed FDA conducted 17 foreign inspections in FY22, including nine audits in Canada, two in India and one in China, where many ingredients marketed in dietary supplements are sourced.

FY23 represented the second year in a row that dietary supplement inspections returned to typical levels. The Covid-19 pandemic significantly limited FDA’s inspectional oversight of supplements and other commodities it regulates. In FY20, for example, the number of dietary supplement inspections was down 52% from 598 in the prior fiscal year.

“During the pandemic, FDA prioritized mission critical inspections,” Dutcher explained. “After the resumption of international travel, FY22 foreign inspections were still limited due to travel restrictions. Our analysis did not identify a significant difference in FDA’s foreign inspection coverage related to dietary supplements as a share of the overall number of foreign inspections conducted in FY2022 and FY2023.”

Of the 40 foreign FDA inspections in FY23, 60% of firms were issued a Form 483 for observations or alleged violations of the cGMP regulations, which are intended to ensure dietary supplement products are made consistently to quality standards. By comparison, 47% of domestic firms (216) received a Form 483, FDA data shows.

FDA observations data—reported for this article and obtained via a FOIA request—was retrieved from an FDA inspection database, which may exclude Form 483s that are manually prepared.

FDA conducted five foreign inspections “for cause” and all five facilities subsequently received a Form 483, FDA data shows. The identities of these firms and their country of origin were not disclosed in the FOIA records.

Following the foreign inspections in FY23, FDA classified four as OAI, or official action indicated, the most serious classification by FDA recommending regulatory action based on finding objectionable conditions. Fifteen inspections were designed VAI (voluntary action indicated) and 14 were classified NAI (no action indicated). At the time FDA retrieved the data in response to the FOIA request, seven foreign inspections had not received a regulatory classification.

Industry reaction to FDA data

Tara Lin Couch, a longtime cGMP consultant to manufacturers and distributors of dietary supplement products, indicated she was encouraged to see the FY23 data on FDA foreign inspections.

“This has been an area generally overlooked by the agency in recent years. Overall, FDA dietary supplement cGMP inspections are certainly not at the level necessary to consistently and fairly enforce the regulations,” Couch of TLC Regulatory and Laboratory Consulting said in an email. “However, it is good to see that more effort is being made to ensure that dietary supplements marketed to the U.S. consumer by foreign facilities are being inspected to ensure cGMP, as well as other statutory requirement compliance. Hopefully, this upward trend in foreign inspections from FY22 to FY23 will continue and will also be applied to domestic dietary supplement facility inspections.”

United Natural Products Alliance (UNPA) President Loren Israelsen said 40 FDA foreign inspections “just barely gives you any sense of what’s really going on.”

“I say that understanding the budget limitations, the complexity of going to a lot of places,” he said in an interview.

The FDA data left unanswered for Israelsen many questions, including how the agency prioritizes its foreign inspections and why places like China and India had relatively few inspections, considering the volume of dietary materials imported into the U.S. from those countries.

“New Zealand’s a nice place to go and visit. I would like to believe that government tourism is not at work here, but I can’t explain why you would have five inspections in New Zealand and four in China with the relative [percentage] of goods coming from those two countries,” Israelsen added.

He also offered a perspective on the FDA data from two competing points of view.

“Honestly, this kind of data should just cause everyone to pause and just say, ‘Wow. We need to do better than that,’” Israelsen commented. “The counterpoint would be, ‘Well, we don’t see it reflected in public health records, the people getting sick eating food.’ I think … do we really know that? A whole lot of people get what they think is the stomach flu or something, and more than likely it’s a food poisoning event of some kind.”