Editor’s note: This is part of a series of articles on FDA cGMP inspections of dietary supplement facilities in FY22.
The FDA in its last fiscal year conducted nearly 500 inspections of dietary supplement companies to comply with manufacturing regulations, reflecting a sharp increase in annual audits from the previous year, Natural Products has learned. Insider.
In FY22 ending Sept. 30, the agency conducted 471 domestic dietary supplement inspections and 15 foreign inspections, an FDA spokesperson said. These numbers are up from 277 domestic inspections and four foreign inspections in the previous fiscal year.
The FDA inspects facilities to confirm compliance with cGMP (current good manufacturing practices), which are regulations designed to ensure that dietary supplement products are consistently produced to quality standards.
“The FDA is working to achieve all of our goals and has made significant progress since the start of the Covid-19 pandemic,” an FDA spokesperson said, in response to a question about whether the number of dietary supplement inspections in fiscal year 22 met or exceeded its Goals.
In a typical year, the FDA conducts about 500 to 600 dietary supplement inspections, according to Cara Welch, who directs the FDA’s Office of Dietary Supplement Programs (ODSP). But she said the number of annual inspections is only about 5% of facilities, given that there are up to 10,000 FDA-registered facilities. The FDA does not disclose the actual number of food facilities that manufacture dietary supplements.
The FDA has “received some pushback” on the number of annual cGMP inspections, “and that’s fair,” Welch said at a recent conference hosted by the Consumer Healthcare Products Association (CHPA). “Five percent of facilities inspected each year really don’t give the FDA a good picture of the industry’s overall manufacturing compliance.”
Although the FDA faces limits on the number of inspections it can perform, the agency is evaluating “how we can do more,” she told the conference.
“Not only how can we do more inspections, but how can we ensure that we are doing the right inspections and that those inspections can have the greatest impact on public safety and product quality? Welch said.
For example, she cited the FDA’s use of remote regulatory assessments (RRAs) during the pandemic, which for dietary supplements is a voluntary program in which the agency requests and reviews cGMP documents. The FDA is also considering how it could leverage third-party cGMP certification programs to improve its oversight of the dietary supplement industry.
Duffy MacKay, senior vice president of dietary supplements at CHPA, said he was pleased to learn that the number of domestic and foreign cGMP inspections had increased year on year.
Yet the CHPA is among the groups that believe that the number of annual cGMP inspections is insufficient to sufficiently monitor the market. And the trade group supports the idea of the FDA officially recognizing third-party cGMP audits.
“Welch’s sentiment is shared by responsible industry that there is still a glaring discrepancy in the number of facilities that are inspected at an acceptable frequency,” MacKay said in an interview. “We have to fix it. There’s just no two ways to do that.
Former FDA investigator Larisa Pavlick, senior director of product quality and technical affairs at CHPA, said the agency “is making tremendous progress” in the number of cGMP inspections since the emergence of Covid-19. However, she also acknowledged that the FDA only audits “a small fraction of the industry” each year.
Natural Products Association (NPA) President and CEO Dan Fabricator stressed that it was important for the FDA to provide as much context as possible about cGMP inspections, given the resources invested in various parts of the industry. agency to perform inspections, review audit reports and track potential enforcement. Shares.
Not analyzing and sharing such detailed results, he suggested, contributes to an “information gap” in the dietary supplement market recently highlighted by Welch. She referred to such a shortcoming as the basis for supporting the mandatory listing of dietary supplement products with the FDA.
Assuming that only 5% of dietary supplement facilities are inspected each year, “what if those 5% of facilities manufacture 90% of the product?” asked Manufacturer, who from 2011 to 2014 oversaw the FDA’s Dietary Supplement Programs Division.
CHPA leaders also supported the FDA to share more data on cGMP inspections and other aspects of its dietary supplement business. Pavlick, for example, mentioned the difficulties in obtaining “useful information” about supplements in the FDA Data Dashboard.
“If the FDA prioritizes identity testing and [supplements manufacturers are] getting a lot of beatings on ID testing, the industry is getting better at ID testing,” MacKay remarked. “It is really important that the industry gets [FDA] information as granular as possible as it becomes a learning tool for self-improvement.
