The FDA has recently stepped up enforcement regarding Adverse Event compliance for all responsible parties and issued 483 citations, warning letters and applied other sanctions. For those retailers with private labeled products nearing their name, proactively reviewing roles and responsibilities between all parties will help ensure full regulatory compliance.

There are many companies who do a great job of documenting and reporting their serious adverse events; however, with the FDA recently citing statistics from their enforcement division that up to 70% of dietary supplement companies have Good Manufacturing Practice (GMP) deficiencies, along with concerns about underreporting of adverse events, it’s time for supplement manufacturer management to review their internal process and why it’s important to the product life cycle.