The U.S. FDA signaled strengthening of regulation of dietary supplements in remarks by FDA Commissioner Scott Gottlieb, M.D. He notes “…In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.”
FDA “sent out 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases.”
To some of us, the promotion of nutritional supplements by some firms goes beyond that allowed by law. Further, some firms prey upon patients’ unfounded belief that “If it’s natural, it must be safe”.