FDA makes its position clear on dietary supplements

There are “significant public health problems posed by products that are marketed as dietary supplements but that contain the same active ingredients as FDA-approved drugs… that do not qualify as dietary ingredients.”

Here are the highlights from the December 15th letter  to manufacturers of dietary supplements.

  • Hidden or deceptively labeled ingredients
  • There are an alarming variety of undeclared active ingredients in products marketed as dietary supplements.
    • Blood thinners (eg, warfarin, Coumadin)
    • Antiseizure meds (eg, phenytoin, Dilantin)
    • HMG-CoA reductase inhibitors (statins) (eg, lovastatin, Mevacor),
    • Phosphodiesterase type 5 inhibitors (eg, sildenafil, Viagra)
    • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, indomethacin, Indocin)
    • Beta blockers (eg, propranolol, Inderal)
    • Active pharmaceutical ingredients removed from the market for safety reasons (eg, fenfluramine, Pondimin)
    • New chemical ingredients of unknown safety

Responsibility of manufacturers, distributors, importers, and others

  • Those in the supply chain are responsible to ensure that their products comply with the FDA statutes and regulations.

The bottom line?

As we have seen over and over, FDA will hold these groups responsible for the content and safety of their products.

FDA will also establish a RSS feed on its website to alert consumers more rapidly when FDA finds that a product marketed as a dietary supplement is tainted. Following the public alert, FDA’s investigation will include contacting the responsible firm to immediately address product that remains on the market or in the hands of consumers.

12/19/10 16:49 JR

Hi, I’m JR

John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at www.Vicus.com, a complementary and alternative medicine website.