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

 

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

 

(Austin, TX) December 15, 2010. At1pm EST today the US Food and Drug Administration held a press conferenceannouncing that it was sending a letter to all dietary supplement tradeassociations, as well as posting a message to consumers, about the growing problemrelated to the sale of various misbranded drug products masquerading as“dietary supplements.” This practice of adulterating or “spiking” what appearsto be a fairly innocuous dietary supplement with active pharmaceuticalingredients (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 asresponsible members of the dietary supplement industry, health professionals,and others have become increasingly concerned about this practice.

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

Dr. Sharfstein noted that a letterwas issued today from FDA Commissioner Margaret Hamburg to all industry tradegroups announcing new initiatives in this area. This includes, among otheroptions, a new rapid public notification system (RSS feed) to report taintedproducts: www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml.

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

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

The press conference includedstatements from representatives of 5 major industry trade associations andseveral other FDA officials.

Steve Mister, President of theCouncil for Responsible Nutrition, commended the FDA for taking a strongerpublic stand on this issue. Criminals are endangering American consumers withthese illegal products, he said. “Our companies are not part of this problembut we will be part of the solution.”

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

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

John Gay, President of the NaturalProducts Association noted that the spiking of dietary supplements with APIs isa crime. “It endangers the public and it undermines retailers and other sellersof legitimate supplements. We will continue to work with FDA and others to helpeducate industry and the public.”