FDA Steps Up Efforts Against “Tainted” Products Masquerading as Dietary Supplements

By Riëtte van Laack –

On December 15, 2010, FDA took several steps to increase its enforcement against products that are marketed as dietary supplements but contain analogs of, or the same active ingredients as, FDA-approved drugs, or other substances that do not qualify as dietary ingredients, e.g., synthetic steroids. 

In a letter to the Dietary Supplement Industry, followed by a call for the media, FDA stressed that the manufacture and marketing of these products is illegal and constitutes a criminal activity.  According to FDA, the “spiked” products pose a serious public health threat and have been associated with serious adverse events, including strokes, acute liver injury, kidney failure, and death.  Spiking appears to be more prevalent in products promoted for weight loss, sexual enhancements, and bodybuilding.  Since 2007, FDA has issued warning letters and initiated seizures and criminal prosecutions concerning approximately 300 products.  In addition, FDA has issued consumer alerts and a fact sheet on retailer and distributor responsibilities.  Although these enforcement efforts have been effective, the Agency has concluded that more needs to be done to protect the public health and is stepping up its efforts.

In its December 15, 2010 letter, FDA asks the industry for support in its efforts.  The allegedly illegal active ingredients do not ordinarily appear in a product by accident.  Somewhere in the production chain, a party intentionally incorporates an illegal ingredient.  However, under the law, any party in the chain of manufacturing and marketing a dietary supplement is responsible for ensuring that the product complies with the law and regulations.  Thus, accountability and liability are not limited to the party that adds the ingredient.  FDA recommends that those involved in the manufacturing and marketing of dietary supplements give special attention to products in the weight loss, sexual enhancement and body building categories.

FDA is reaching out to people who know the industry well and know about products that may be spiked.  FDA asks the industry to report any suspected "tainted" supplements or supplement ingredients and the manufacturers or distributors who market these products.  For this purpose, FDA has created an e-mail address taintedproducts@fda.hhs.gov.  Alternatively, for those who prefer to submit reports anonymously, there is the option of using the form “Report Suspected Criminal Activity” located at www.fda.gov/oci.

During the call for media, various trade associations, including the Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association, expressed their support of FDA’s actions.  The groups subsequently issued a press release.

Dr. Joshua Sharfstein, principal deputy commissioner of the FDA, will lead an online chat Monday at 1 p.m. about "tainted" products marketed as dietary supplements. Directions to join the chat are here.