As FDA ramps up enforcement in food and dietary supplements, companies need to know what claims can be made for their products based on their level of substantiation.
FDA's final rule on cGMPs could be the best thing to happen to dietary supplements since the passing of DSHEA if companies approach these new regulations in a practical, balanced manner.
Even with the regulatory guidance of DSHEA, the supplement industry remains full of ambiguity. The NREA aims to close loopholes and boost consumer confidence.
There has been ongoing debate as to whether or not the dietary supplement industry needs a mandatory adverse event reporting system; the reality is that this is a system the industry cannot live without.