FDA sent a warning letter to Elite Supplement Center LLC and Elite Training Center LLC and the companies’ principal, Matthew Chaffee. The warning letter cited the sale of several products containing SARMs, or Selective Androgen Receptor Modulators, which are chemicals that can mimic the effects of anabolic steroids.
SARMs started to appear on the market in large quantities after the Designer Anabolic Steroids Control Act took effect in 2014. That law made it easier for federal regulators to get new analogues of steroids off the market, substances that were not called out by name in earlier legislation.
FDA: SARMs pose uacceptable risks
FDA warns that, “SARMs have been linked to life-threatening reactions including liver toxicity, and have the potential to increase the risk of heart attack and stroke.”
The warning letter cited five specific products that are for sale on the company’s website. They are: Ostarine (MK-2866), Ligandrol (LGD-4033), Testolone (RAD-140), Ibutamoren MK-677 and Cardarine GW501516. FDA said all of these are SARMs and as such are unapproved new drugs.
On the company’s website the product pages for the above SKUs show only an image of a black, featureless bottle with the following disclaimer: “Due to the nature of this product we are unable to provide listed brand names. Please call one of our locations to discuss product further.”
The warning letter was dated July 6 and gives Chaffee the customary 15 days to respond. As of publication time, though some of the products were still visible through a search function on the company’s website, an employee told NutraIngredients-USA that they are no longer for sale.
Criminal case hinged on apparently identical products
Interestingly, three of the products, using the same names—Ostarine (MK-2866), Ligandrol (LGD-4033), and Testolone (RAD-140)—figured into a case in 2019 in which a supplement marketer named Brian Michael Parks was sentenced to a year and a day in prison and ordered to pay a $350,000 fine.
FDA was contacted as to why the sales of these products resulted in a criminal prosecution in once case and only a warning letter in another. A response will be provided here if the Agency choses to respond.