“The Tan Sheet” Reports on Increased FDA Warning Letters Sent to Supplement Firms

More GMP Inspectors Reviewing Adverse Event Reporting Data and Finding Violations of AER Reporting Requirements

The cover story of the July 21st edition of “The Tan Sheet” reports on the rise in warning letters being sent to supplement firms as a result of violations of adverse event reporting (“AER”) requirements found during good manufacturing practices (“GMP”) inspections. According to the article, GMP inspectors reviewing AER data are “checking that all firms meet the basic AER requirements, and looking at how firms benchmark the data using sql software and others to evaluate other GMP requirements.”

The article, entitled “Supplement GMP Inspections Reveal Adverse Event Reports, Prompting Warning Letters” discusses the increase in warning letters citing AER issues being sent to supplement firms from 2011 to 2014 – noting that in 2013 there was a 200% increase in letters being sent to supplement firms referencing AER violations. Warning letters are issued when a supplement company fails to “report serious adverse events to the agency, or not provide on product labels a domestic address or phone number consumers can use to report AERs to the manufacturer or marketer.” According to analysis by ”The Tan Sheet”, three-quarters of the AER violations cited in warning letters from 2011 on have to do with labeling deficiencies, for companies failing to include on product labels an address or phone number for making reports.

This article brings to light the importance of all supplement companies today having good Standard Operating Procedures in place when it comes to the reporting of adverse events, as well as the importance of ensuring that labels include a domestic address or domestic phone number for their firm for consumers to report serious adverse events. With inspectors expected to continue to closely review AER data during GMP inspections, it is critical that supplement companies are following proper protocol regarding adverse event reports in order to avoid the potential of a warning letter being issued after a GMP inspection.

The attorneys at Collins, McDonald & Gann are experienced in helping supplement firms ensure that they are in full compliance with all FDA regulations, including AERs and proper labeling. If you have any questions or would like to speak with us regarding AERs or any other aspect of dietary supplement law, call us at 516-294-0300.

Read “Supplement GMP Inspections Reveal Adverse Event Reports, Prompting Warning Letters” in “The Tan Sheet”, click here.