As reported by NutraIngredients-USA, Senators Hatch (R-UT) and Heinrich (D-NM) wrote a letter dated May 19, 2015 to US Attorney General Loretta Lynch, outlining their “deep concern” 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.”
‘A massive, and wide-ranging, consumer-protection problem’
The DoJ has now responded, with a September 9, 2015 letter from signed by Peter J. Kadzik, Assistant Attorney General, stating that the department, “share[s] your concern about illegal activity in the dietary supplements industry. Such activity has become a massive, and wide-ranging, consumer-protection problem”, wrote Kadzik.
“As you note, some products contain active pharmaceutical ingredients, often unbeknownst to the customers who purchase them. Other products contain undeclared ingredients, many of which are known allergens. Many products are made in facilities that do not comply with good manufacturing practices. And some products are sole with disease claims that are unsubstantiated,” he notes.
“The consumer harm that results from all of this illegal activity is considerable. Reports of illnesses, even deaths, are all too common. Put simply, we can all do more to make certain that consumers who purchase dietary supplements know that the products are safe and that the products will deliver on their advertised promises.
“The Department of Justice has put fighting illegal activity in the dietary supplement industry high on the priority list within its consumer protection agenda.
“We are committed to taking steps to root out and, as appropriate, address unlawful activity in the dietary supplement industry.”
An ongoing dialogue
Daniel Fabricant, CEO of the Natural Products Association, told us that he was encouraged that the Department was open to some industry collaboration. “I wouldn’t be surprised if there was follow-up to this from Senators Hatch and Heinrich. This is ongoing dialogue and the Senators and the DoJ have the same goal, and the industry has the same goal as well, but a score’s got to be kept, so what are the numbers? What is the Department doing? Can they give us some idea on the number of cases, the priorities, the recommendations?”
Judy Blatman, Sr VP of communications for the Council for Responsible Nutrition, said: “We appreciate Sens. Hatch and Heinrich reaching out to the Attorney General’s office, and we’re grateful to see that the response indicated that the Department of Justice considers fighting illegal activity in the supplement industry to be a high priority.
“The overwhelming majority of companies in our industry are following the laws, and these responsible companies are committed to ensuring that consumers have access to safe products," added Blatman. "There is no place for companies illegally manufacturing unapproved pharmaceutical products and marketing them as dietary supplements. As CRN indicated in a separate letter to the Department of Justice following the Senators’ letter, we ‘…urge the DOJ to work more closely with FDA to implement a proactive regulatory and enforcement strategy to address this public health concern.”