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.”