Methinks They Doth Protest Too Much…

Posted By elissa on Oct 4, 2009 | 1 comment

It’s time for another round of congressional and agency posturing over dietary supplements… particularly those that – in the words of this New York Times article – “illegally contain steroids.”

Now Congress is investigating whether laws, health agency resources and manufacturing guidelines are adequate to protect the public from products that illegally contain steroids but masquerade as dietary supplements.

…Testifying on Tuesday at a Senate hearing on bodybuilding products, Travis T. Tygart, chief executive of the United States Anti-Doping Agency, estimated that hundreds of illegal products containing steroids were now available in the United States. As evidence of the problem, Mr. Tygart introduced Jareem Gunter, a former college baseball player who said he suffered acute liver failure after taking a bodybuilding product called Superdrol.

“Jareem had no way of knowing that a regulatory scheme designed over 15 years ago for a few companies selling a limited number of simple vitamins and mineral supplements has been hijacked by unscrupulous profiteers,” Mr. Tygart told members of the Senate Judiciary Committee Subcommittee on Crime and Drugs at the hearing on bodybuilding products.

…Mr. Tygart, of the Anti-Doping Agency, recommended legislative changes that would give the agency greater power over dietary supplements both before and after they go on sale.

There’s really only one word to describe this song and dance: it’s horses**t.

Let’s be completely clear: I’m not “for” giving supp companies carte blanche to market steroid-based products over-the-counter for a variety of reasons.  But the FDA has ALWAYS had the power to regulate the sale of these “supplements” – the sale of which has been completely out in the open.  Here’s what guru Will Brink wrote about Superdrol on the “Bodybuilding Revealed” forum, back in September 2005:

“You ask good questions that have no answers, and that is precisely what I see as the major problem with the new crop of “andro” supplements. They are modified versions of existing compounds/hormonal analogs, and we don’t know their pharmacology in terms of efficacy, side effects, etc. A certain amount can be figured out from the chemistry (e.g., its potential to convert to estradiol, etc.) but make no mistake, small changes in hormones and hormone analogs can have profound changes on their pharmacology that are not discovered from a simple look at their molecular structure. Make no doubt about this, these new compounds are NOT pro hormones but true designer steroids of unknown pharmacology. For that reason alone, I recommend people avoid them. You are not using any sort of normal pro hormone, but a true designer steroid here with all the known-and more important-unknown effects good and bad. How can this possibly be legal you ask? Due to loop holes and poor language in the current law, it’s not legal per se, but it’s not exactly illegal either, and as expected, banning the true prohormones only led to more effective and potentially more dangerous gray market “supplements”. Use at your own risk, but if it were me, I would use tried and true steroids that have well known safety records and pharmacology (i.e., Deca, Anavar, etc.), assuming you have decided to use steroids in the first place. I will add additional info about these new compounds as we know more, but I would never take them myself, and that should tell you something…..”

Emphasis mine.  That was FOUR YEARS AGO.  The industry was selling steroids (modified to be orally available), and everybody knew it.

Including the FDA…

March 9, 2006

FDA Warns Manufacturers About Illegal Steroid Products Sold as Dietary Supplements

The U.S. Food and Drug Administration today warned several manufacturers and distributors of unapproved drugs containing steroids that continued distribution and sale of these products without FDA approval could result in regulatory action including seizure and injunction. FDA is concerned that the use of these products, which are marketed as dietary supplements and promoted for building muscle and increasing strength, may cause serious long-term adverse health consequences in men, women, and children. These products claim to be anabolic and problems associated with anabolic steroids include: liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.

“FDA takes its responsibility to protect Americans from dangerous unapproved drugs seriously. Today’s action is indicative of our resolve,” said Margaret O’K. Glavin, FDA’s Associate Commissioner for Regulatory Affairs.

Consumers who have any of the products listed below should stop taking them and return them to their place of purchase. FDA issued warning letters for the following so-called dietary supplement products:

• Anabolic Xtreme Superdrol, manufactured for Anabolic Resources LLC, Gilbert, Arizona, and distributed by Supplements To Go, Cincinnati, Ohio
• Methyl-1-P, manufactured for Legal Gear, Brighton, MI and distributed by Affordable Supplements, Wichita, Kansas

These warning letters are part of FDA’s continued efforts to protect consumers from dangerous steroid products. In March 2004, FDA sent warning letters to 23 manufacturers and distributors of products containing androstenedione.

Superdrol and several other supps made by the more prominent companies were discontinued or reformulated after the warning letters went out, but then, nada… until the recent raids on American Cellular Laboratories and Bodybuilding.com.

So riddle me this: if the FDA could act against Superdrol et al in 2006… what was keeping the agency from pursuing any similar enforcement actions?  It worked, after all, without having to resort to raids or whinging to Congress.   I can see needing more money, perhaps, to enforce the existing regs more efficiently.  But does the FDA really need “greater power over dietary supplements both before and after they go on sale”?  I’m pretty skeptical of this.  The agency’s actions against ACL and BB.com demonstrate they have plenty of power already, and I see no real justification for more.