Compliance

I recently read a very interesting article about some big vitamin companies and their stock performance. 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.

Recently, FDA took administrative action by detaining at the border a product containing kratom, a plant material that may have the potential for abuse and potential serious health consequences. Then the Department of Justice filed a complaint in US District Court on behalf of the FDA “alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act.”

The Department of Justice (DOJ) and its federal partners are being very vocal about turning up the heat on compounders and dietary supplement manufacturers and marketers in 2016 and beyond. 2016 is guaranteed to be a record year for enforcement actions against manufacturers of these products that are not in compliance with the regulatory framework governing their manufacture and distribution.