The Food and Drug Administration’s letter to industry sent Dec. 15 is one of the most important and commendable actions against the proliferation of anabolic steroids in the United States since the Anabolic Steroid Control Act of 2004, as it comes with the promise of significant enforcement action. Unfortunately, the Anabolic Steroid Control Act did not stem the widespread availability of steroids it merely ushered in a new era of designer steroids. By providing a list of those that were “illegal,” it pushed the prohormone manufacturers to find new compounds or name old ones using obscure nomenclature to confuse the authorities. This recent forceful FDA action has the potential to change the landscape and it is already seeing evidence of its effect, but there is a great deal of work to do.
The letter began as follows: “This letter addresses the significant public health problems posed by products that are marketed as dietary supplements but that contain the same active ingredients as FDA-approved drugs, analogs of the active ingredients in FDA-approved drugs, or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.”
It goes on to commit to serious enforcement. “Manufacturers, ingredient suppliers and distributors should not expect that a warning letter will be issued if FDA discovers potentially harmful violative ingredients in products marketed as dietary supplements. FDA recognizes that active ingredients at meaningful levels do not appear by accident in a product marketed as a dietary supplement – somewhere in the supply chain, the active ingredient is incorporated into the ingredient or the finished product. Actions that pose a risk to public health should expect a swift and strong agency response.”
The threat of significant and immediate action without any warning is what is needed to finally control the flow of these dangerous products. This action is just in time as the situation was truly getting out of control. An example using one retailer of such products demonstrates the problem and the effect of the FDA action.
When we first mentioned nutritionarsenal.com on Sept. 15 in our blog post, Despite numerous efforts to the contrary, prohormones remain widely available today, we found 84 products listed as prohormones. As we noted on Dec. 12 in our blog post, New designer steroids appearing at an alarming rate, 15 new products in two months!, the explosion of such products was astounding as the number of prohormones listed had ballooned to 99! We visited nutritionarsenal.com again today and were quite pleased to see the evidence of the FDA activity. Today the number of prohormones offered is at 75 and dropping three weeks after the FDA letter, a clear sign that it is being taken seriously.
As we say, however, much work remains. One of the most blatant examples comes in Competitive Edge Labs M-Drol product. Although it was included in the FDA’s action against Bodybuilding.com in late 2009, it has remained for sale at a number of retailers since that time. At nutritionarsenal.com, a new label has been added on the sales page for M-drol: “This item has been discontinued. All sales are FINAL,” another sign that the FDA letter, and perhaps our posts, have been effective.