Move provides defence against 'unregulated industry' criticisms
United States The US Food and Drug Administration has, perhaps unwittingly, provided a means for the US supplements industry to defend against a common mode of attack by codifying Serious Adverse Event (SAE) reporting. The supplements industry supported the move.
The new laws meet pharmaceutical industry Adverse Event Reporting standards, and mean US supplements manufacturers must refer serious adverse-event reports to the FDA and keep a record of less-serious reports.
"It is very significant to the critics of the industry who say that (the industry) is unregulated or loosely regulated," Daniel Fabricant, PhD, vice president, scientific and regulatory affairs at the Washington, DC-based Natural Products Association, told Functional Ingredients. "This is the same requirement prescription pharmaceuticals have to meet, so hopefully that criticism can now rest in peace."
His compatriot, Andrew Shao, PhD, vice president, scientific and regulatory affairs at the Washington, DC-based Council for Responsible Nutrition, agreed. "It will 'level the playing field' for AE reporting to the FDA, and it will provide all of us with an objective picture of post-market surveillance. This will help address questions about safety and, hopefully, will lead to improved consumer confidence, the ultimate goal."
Shao said the law would demonstrate "there are very few SAEs associated with supplements."
The Maryland-based American Herbal Products Association has asked the FDA to clarify aspects of the ruling. Among other things it requested the FDA use the terms 'patient' or 'subject' instead of the term 'injured person' in SAE reports.