FDA increases annual domestic, foreign dietary supplement inspectionsFDA increases annual domestic, foreign dietary supplement inspections

The U.S. Food and Drug Administration performed 600 inspections of dietary supplement facilities in the U.S. and abroad in the last fiscal year, SupplySide Supplement Journal has learned.

The audits above covered FY24, or the 12-month period ending on Sept. 30, for compliance with current good manufacturing practices (cGMPs).

The number of FDA dietary supplement inspections grew from about 500 in the previous fiscal year, when the agency conducted 461 domestic and 40 foreign cGMP audits. Foreign inspections in FY24 (90) more than doubled over the prior year, while domestic inspections (510) modestly rose over FY23.

"Continued growth in the number of inspections is a good sign, but let's not forget it's measured against a much higher bar," said Robert Marriott, director of regulatory affairs with the American Herbal Products Association (AHPA). "The Food Safety Modernization Act calls for the inspection of domestic, non-high-risk food facilities no less than once every five years. The incoming administration and Congress should consider what staff, resources and new approaches are needed to get the agency to meet its goals."

SupplySide Supplement Journal obtained the FY24 FDA data through a Freedom of Information Act request.

The regulations incorporated in 21 CFR Part 111 are designed to ensure dietary supplement products are produced consistently to quality standards.

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

FDA inspects around 500 to 600 facilities annually, which is about 5% of known facilities, according to Cara Welch, Ph.D., who oversees the FDA Office of Dietary Supplement Programs (ODSP). She shared that information during a conference in 2023 hosted by AHPA.

“Facility inspections play an integral role in the FDA’s oversight of dietary supplements,” an FDA spokesperson told SupplySide Supplement Journal. “The FDA prioritizes the strategic use of our limited resources to make the biggest impact and we will continue to work collaboratively with our stakeholders to help ensure the dietary supplement marketplace is safe, well-manufactured and accurately labeled.”