A Florida distributor of tainted dietary supplements, its owner, and an officer of the company are the subjects of a permanent injunction, FDA announced yesterday. But the activity which led to this action dates back almost five years, according to the February 2015 Warning Letter from FDA referenced in the announcement. First, in July 2013, Customs and Border Protection detained a tainted product that was destined for the Florida distributor, MyNicNaxs, LLC. Later that year, multiple tainted products were uncovered by FDA during a November 2013 inspection of the company’s facility. Most notably, the Warning Letter also cited the company’s failure to comply with a February 2014 voluntary recall.
In its March 28th announcement, the agency stated, “Marketing products with undeclared active pharmaceutical ingredients poses serious safety risks to consumers. These types of products are particularly concerning because consumers do not know what the products actually contain, and the undeclared ingredients may cause serious, even life threatening, adverse reactions.” FDA added, “Despite previous warnings, MyNicNaxs continued violating the law. The FDA will continue to take action to protect the American public when companies knowingly violate the law and put consumers at risk (emphasis added).”
As long as FDA targets companies, like MyNicNaxs, LLC, with regulatory and civil enforcement actions that take years to unfold, consumers will continue to be at risk and distributors of tainted dietary supplements that knowingly violate the law will remain undaunted. After years of pursuing the same regulatory-focused enforcement strategy, the time has finally come for FDA to change course. As I posted back in January 2015, “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.”
Senior Department of Justice officials should hear from the FDA Commissioner directly about the pressing need for DOJ’s Consumer Protection Branch and FDA’s Office of Criminal Investigations to collaborate on strategic law enforcement operations in response to this nationwide problem. FDA has repeatedly acknowledged the danger to consumers from tainted dietary supplements and now it must act with a sense of urgency to more aggressively target manufacturers, distributors, and retailers of these products. The agency has historically focused its efforts on raising consumer awareness, conducting regulatory inspections, issuing Warning Letters, and seeking the occasional injunction. But this well-intentioned approach is clearly not getting the job done. The same day that FDA announced the MyNicNaxs, LLC injunction, it alerted the public about three more tainted sexual enhancement products. How long will this cycle continue?
In October 2015, I posted that “a public health disaster is an inevitability as long as chemicals of questionable origin and safety are illicitly manufactured and marketed under the guise of dietary supplements to multitudes of uninformed or misguided consumers in a quest to achieve sexual enhancement, weight loss, and muscle building.” This alarming threat will only increase until criminal investigations play a more prominent role in FDA’s tainted dietary supplement enforcement strategy.