Protecting consumers from unsafe and illegal dietary supplements continues to represent an enormous challenge for FDA regulators. The time has certainly come for a different approach to this longstanding public health menace. FDA’s announcement that new enforcement strategies are on the horizon is therefore a welcomed and timely development that suggests the agency grasps the seriousness and urgency of the problem.
FDA has already amassed an impressive list of accomplishments in this space and is poised to make an even greater footprint. Over the years, FDA has issued nearly a thousand alerts on tainted weight-loss, sexual enhancement, and muscle-building products and has undoubtedly dedicated massive amounts of laboratory and other valuable agency resources to this effort. FDA should be commended for its relentless dedication to protecting consumers from these and other illegal supplements and for deciding that new enforcement strategies are needed.
According to FDA Commissioner Scott Gottlieb M.D., “there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk. As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.” Dr. Gottlieb offers a very accurate assessment of the problem. Without question, his agency has the data and expertise to back this up.
It’s also clear that Dr. Gottlieb understands the urgency of the problem. He added, “On the one hand, advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health. At the same time, the growth in the number of adulterated and misbranded products – including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks – creates new potential dangers.”
Thanks to FDA’s evolving enforcement strategy, I’m confident that corrupt dietary supplement manufacturers and distributors will eventually pose less of a threat to consumers. I just hope that FDA puts this effort on the fast track. As I’ve mentioned before, this problem is a ticking public health time bomb.
See one of my recent posts on this topic here.