Fraudulent products marketed as dietary supplements are a continuing public health menace. These products, predominantly sold for sexual enhancement, bodybuilding and weight loss are likely to be the cause of our next public health catastrophe, possibly exceeding the New England Compounding Center and counterfeit Avastin incidents of 2012 in magnitude.
An FDA web page devoted to this issue warns that “FDA has received numerous reports of harm associated with the use of these products, including stroke, liver injury, kidney failure, heart palpitations, and death.” Nevertheless, the number of FDA warnings about these products has risen steadily. FDA issued 36 warnings for fraudulent weight loss products in 2014, while only 32 such warnings were issued in 2012 and 2011 combined. FDA warnings for sexual enhancement products have also increased dramatically, from 15 in 2012 to 24 in 2014.
Apparently, consumers are not getting the message. The same goes for those who openly sell these products on the Internet and at retail establishments, like gas stations and convenience stores. Albert Einstein once said the definition of insanity was doing the same thing over and over again and expecting different results. Committed as FDA may be to this issue, the current strategy must be re-tooled if it is not producing the desired effect.
While these bogus products may be labeled as dietary supplements, they often contain varying levels of undeclared and unsafe drug ingredients or other compounds, like designer steroids, that turn unsuspecting and vulnerable consumers into guinea pigs.
In November 2013, FDA announced that USPlabs LLC in Dallas, Texas was recalling three of its OxyElite Pro dietary supplements “after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated.” FDA referenced a previous warning letter informing the company that OxyElite Pro and another dietary supplement, VERSA-1, contained aegeline, a new dietary ingredient that lacked a history of use or evidence of safety.
A recently-issued Natural Products Insider article on USPlabs provided additional details. OxyElite Pro, it was reported, had been linked to an outbreak of hepatitis that may have sickened over 100 people in more than a dozen states. Further, the article pointed to court documents indicating that USPlabs imported aegeline at least 20 times since June 2012 from Siwadaka Chemical Company in Beijing, China.
Tainted dietary supplements are a ticking time bomb. These products and those who manufacturer and market them in the U.S. are susceptible to the same deadly form of economically motivated adulteration that unfolded in Panama back in 2006. In November 2008, the New York Times reported “at least 174 people were poisoned, 115 of them fatally, by counterfeit cold medicine linked to an unlicensed Chinese chemical plant.” The article added, “a supposedly safe drug ingredient in the cold medicine actually contained diethylene glycol, an industrial solvent used in some antifreeze. It was made by a Chinese chemical company that did not have a license to sell drug ingredients.”
It is unknown how many unlicensed or unregulated chemical companies in China and elsewhere sell drug ingredients and other substances to U.S. firms that manufacturer and market tainted dietary supplements. Consumers who purchase suspect products for sexual enhancement, weight loss and bodybuilding may become victims to the same type of economically motivated adulteration scenario that killed many vulnerable Panamanians almost ten years ago. FDA should strongly consider the wisdom of Mark Twain. Novel enforcement approaches are urgently needed to protect consumers from these types of potentially dangerous and deadly products.