FDA Holds Press Conference, Issues Letters and Consumer Advisory on Drugs Masquerading as Dietary Supplements

(Austin, TX) December 15, 2010. At 1pm EST today the US Food and Drug Administration held a press conference announcing that it was sending a letter to all dietary supplement trade associations, as well as posting a message to consumers, about the growing problem related to the sale of various misbranded drug products masquerading as “dietary supplements.” This practice of adulterating or “spiking” what appears to be a fairly innocuous dietary supplement with active pharmaceutical ingredients (APIs) — i.e., actual or modified forms of pharmaceutical drugs — appears to have become more and more common in recent years. The FDA as well as responsible members of the dietary supplement industry, health professionals, and others have become increasingly concerned about this practice.

In today’s press conference, Joshua Sharfstein, MD, principal deputy commissioner at FDA, noted that there were about 300 different tainted products spiked with APIs for which the FDA has issued warning letters and/or recalls. These include 70 products recalled for sale in the area of sexual enhancement, 40 products recalled for weight loss, and 80 products recalled for body building.

Dr. Sharfstein noted that a letter was issued today from FDA Commissioner Margaret Hamburg to all industry trade groups announcing new initiatives in this area. This includes, among other options, a new rapid public notification system (RSS feed) to report tainted products: www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml.

FDA has also set up a new method for the public to report tainted products anonymously to the FDA website. They can do so via email to TaintedProducts@fda.hhs.gov or via an anonymous reporting form at http://www.fda.gov/oci.

The issues and means for contacting FDA are explained in the FDA Consumer Advisory, available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm236774.htm.

The press conference included statements from representatives of 5 major industry trade associations and several other FDA officials.

Steve Mister, President of the Council for Responsible Nutrition, commended the FDA for taking a stronger public stand on this issue. Criminals are endangering American consumers with these illegal products, he said. “Our companies are not part of this problem but we will be part of the solution.”

Anthony Young, general counsel for the American Herbal Products Association, noted that Commissioner Hamburg’s letter is strong and firm. “It is the strongest I’ve seen in over 35 years of practice,” he noted.

Loren Israelsen, President of the United Natural Products Alliance, stated that he and his organization’s member are joining with the FDA and other trade groups “to drive these pirates out of this industry! We are astonished,” he added, “by the growth of these products from out of the shadows.”

John Gay, President of the Natural Products Association noted that the spiking of dietary supplements with APIs is a crime. “It endangers the public and it undermines retailers and other sellers of legitimate supplements. We will continue to work with FDA and others to help educate industry and the public.”