New JAMA Research Underscores FDA Performance Failures

New JAMA Research Underscores FDA Performance Failures

Washington- The Natural Products Association, (NPA) responded to a report, “Recalls, Availability, and Content of Dietary Supplements Following FDA Warning Letters,” published today in the Journal of the American Medical Association.

“This study reaffirms FDA’s performance failures gaps going back to a report published by the Office of the Inspector General in 2017,” said Daniel Fabricant, Ph.D. president and CEO of the Natural Products Association.

“Companies who receive a warning letter are required to notify FDA within 15 days of receipt of their warning letter and the specific steps they have taken to address any violations. Failure to do so is supposed to result in legal action including seizure and injunction. This should be considered low-hanging fruit for the agency but it’s obvious there’s an element of willpower that’s absent.”

In 2017, the Office of the Inspector General published a report highlighting the annual number of facility inspections dropped despite increased spending for domestic facility inspections. Additionally, the report found the Agency “often took no action in response to significant inspection violations nor did the FDA proactively follow up with companies identified as having significant violations to ensure that all violations were correct.

“These gaps in actions indicate that new authorities to the FDA clearly aren’t warranted, when current authorities, where problems have been located aren’t followed up with. This study makes it clear the agency has adequate authority to pursue products masquerading as dietary supplements, the repeated absence of follow through requires oversight and accountability”