Gottlieb Opens the Toolbox for Dietary Supplements – Beware the Hammer!

In our blog, over the years, we have addressed the issue of dietary supplements and some actions of bad actors relative to the chase for the almighty dollar.  Today, Commissioner Gottlieb announced the “agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight” (here) .

The Dietary Supplement Health and Education Act (DSHEA) was passed some 25 years ago and, as the Agency rightly noted, the industry has grown from a $4 billion to over $40 billion.  We all know that dietary supplements do play an important part of the health of Americans; however, it is when these products are promoted to cure, treat, or prevent disease (with few exceptions requiring FDA approval), it can lead to patients delaying appropriate medical treatment.  Some “bad actors” (as the Commissioner states) take advantage of the FDA’s limited resources but now the Agency’s attention will be focusing more on the offenders and enforcement activities focused on them.

The Agency identified three priorities:

  • Ensuring the safety of dietary supplements
  • Maintaining product integrity: we want to ensure that dietary supplements contain the ingredients that they’re labeled to contain, and nothing else, and that those products are consistently manufactured according to quality standards
  • Informed decision-making by consumers which means assuring that the consumer has the right information about the dietary supplement and any problems that the Agency might identify.

We have been predicting an increase in scrutiny of the dietary supplement market and the potential for additional enforcement activities (see here, here  /, here, here),  among other posts [please search our blog under dietary supplements]) for the last 4-5 years and now it looks like FDA has the industry in its sights.  Keep a close eye on further actions but, for now, in the Commissioner’s statement, it was noted that FDA issued 12 new Warning Letters and 5 online advisory letters with the announcement of this initiative.