For the first time, the FDA is making public data from adverse events consumers have experienced with dietary supplements.
The move by the FDA is a huge step toward improved transparency when it comes to the side effects associated with supplements, which do not go through the rigorous clinical testing and demonstration of efficacy that prescription drugs must go through. Supplements are subject to alarmingly little regulation by the FDA, or any government agency.
The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is not only making adverse event data about supplements available through a database, but side effects about foods and cosmetics as well. All the information has been culled by the agency based on reports submitted by consumers, doctors and nurses, and industry between 2004 and September of this year. The FDA will update the data quarterly.
You can examine this data to check up on any supplements, foods or cosmetics you may have concerns about by visiting the CFSAN Adverse Event Reporting System (CAERS) website.
“The goal of CAERS is to provide indications, or ‘signals’ of potential hazards,” two FDA officials said in a blog post. “FDA uses these adverse event reports to monitor the safety of foods, including conventional foods and dietary supplements, and cosmetics.
“This information can, and has, led to investigations of specific products, targeted inspections and product testing, import alerts, warning letters, and enforcement actions.”
