We have done a number of posts over the last year about the actions that FDA has taken regarding dietary supplements and their safety and efficacy. Many of the actions have been targeted towards dietary supplements that contain undeclared drugs (some of which the FDA has removed from the market for safety reasons). Some of the actions relate to new dietary ingredients being marketed without the proper notification to the FDA along with the manufacturer’s information demonstrating that the new dietary ingredient is safe. Remember that currently there is no need for an efficacy determination to be made by FDA.
I recently read a very interesting article about some big vitamin companies and their stock performance. The article can be found here. I think that it deserves some attention because, when people outside of the Food and Drug Community start writing about potential problems, and when those problems translate into increased FDA enforcement actions, then Congress takes note and then (all of a sudden) laws get rewritten and regulations get passed and, the next thing you know, a segment of the industry is changed forever – or at least until the next time the government changes its mind. Maybe the November 2016 elections will hasten the efforts, maybe they will dampen the effort for reform. We will have to wait and see.
