In a letter dated May 19, 2015, Senators Hatch (R-UT) and Heinrich (D-NM) outlined their “deep concern” to US AG Loretta Lynch about individuals and companies engaging in “blatant criminal activity by manufacturing and marketing products that masquerade as “dietary supplements” but contain anabolic steroids, active pharmaceutical ingredients (APIs), or analogues of APIs.
“These illegal products constitute a serious public health risk,” stated the Senators. “Therefore, we strongly urge DOJ, in cooperation with the Food and Drug Administration (FDA), to prioritize the aggressive pursuit of individuals and companies that illegally manufacture and sell misbranded drug products falsely labelled as dietary supplements. Such an approach would both incapacitate current criminal endeavors and deter new criminality.”
FDA has identified about 400 products over the past six years that illegally contain anabolic steroids, including some marketed for bodybuilding, said the Senators, while undeclared APIs or their analogues have been detected in sexual enhancement and weight loss products.
“Unfortunately, DOJ’s inconsistent use of enforcement actions against the entities the FDA has identified as manufacturers of these illegal products has weakened the deterrent effect of such actions,” wrote Hatch and Heinrich.
“By selling adulterated products under the guise of legitimate dietary supplements, these bad actors hijack the credibility of reputable industry members and erode consumer trust in legitimate products.”
The Senators also noted that FDA warning letters and actions to prohibit the sale of particular products are not enough of a deterrent without subsequent punitive actions from the DOJ.
“Given our concerns about this serious matter, we ask that you detail how DOJ plans to deploy a forward-thinking regulatory and enforcement strategy to address this public health concern.”
‘Responsible industry that is playing by the rules’
The letter was welcomed by the Council for Responsible Nutrition and the Natural Products Association.
Daniel Fabricant, PhD, CEO and executive director of the NPA: “We’re very happy to see this, we’ve said for some time now what is the deterrent plan in place and are there other authorities that can be used to stop this problem that is criminal and taints our industry. Products with drugs aren’t supplements, we look forward to further dialogue with all stakeholders on the matter to solve this regulatory problem once and for all.
“NPA is very grateful for the support from both Senators on this, they know that the legal tools are there, they work it’s now just a matter of deployment in the most effective way possible.”
Mike Greene, VP of government relations for the CRN, said: “We’re appreciative of the Senators taking this step because it protects not only consumers but responsible industry that is playing by the rules. We have no tolerance for companies manufacturing illegal steroids and falsely marketing them as dietary supplements.
“We thank the Senators for stepping up to the plate and hope that the Justice Department will do the same and work with FDA to rid the market of these kinds of illegal products.”
To read the full letter, please click here: