LG Sciences markets Methyl 1-D as an “AAS (anabolic/androgenic steroid) hormone” on their website and on their blog.

METHYL 1-D™ may be one of the most potent androgens since the prohormone ban in January 2005. With METHYL-1D, you get an AAS (anabolic/androgenic steroid) hormone that’s a chemical cousin to Testosterone. METHYL 1-D converts easily into TEST and also has an estrogen blocker to prevent bloat and bitch tits along with a 5aR inhibitor, so you can keep your hair.

LG Sciences is minimizing the significance of the FDA raid involving U.S. Marshalls and maintains that their products are DSHEA compliant.

In response to recent action taken by the FDA, LG Sciences wishes to clarify that we contend that all of its products are completely legal and safe. The FDA’s detainment is merely a preliminary step in determining compliance with food regulations. LG Sciences wishes to specifically note that no court has made any determination as to the correctness of FDA’s allegations. Although LG Sciences feels that the temporary restraint of its product by the FDA is inappropriate, the company appreciates that the FDA wishes to protect the public and will cooperate in every possible way.

Unfortunately, the Dietary Supplement Health Education Act (DSHEA) of 1994 is ambiguous and unclear in determining what substances are considered new dietary ingredients (NDI). An NDI requires data be submitted to the FDA regarding safety for human consumption prior to its introduction into the market. Due to a lack of a definitive list of approved dietary ingredients, the FDA mistakenly asserts that the products seized contain substances that are either not dietary ingredients, as defined in the Federal Food, Drug, and Cosmetic Act or that the substances are NDI. However, the substances are not NDI because these ingredients are naturally occurring, with confirmed studies over 25 years ago, and have been on the market in competitors products for several years. Thus, the ingredients have empirically been shown to be safe to consumers.

Items deemed unapproved food additives by the FDA 1,4,6 etiocholan-dione or commonly known as ATD or 1,4,6 Androstatriene3,17-dione. Additionally items alleged to require a new dietary ingredient status 4-etioallocholen-3,6,17-trione or better known by the trade name 6-OXO-4-androstenedione. LG Sciences looks forward to assisting the FDA in clarifying this matter and the prompt return of its inventory.

Legal Gear, the predecessor to LG Sciences, previously ran afoul of the FDA by selling unapproved new drugs containing synthetic anabolic steroids. Legal Gear discontinued the product after receiving a cease and desist from the FDA.

In March 2006, the FDA warned a company called Legal Gear – the predecessor to LG Sciences – to cease distribution of another product that was marketed as a dietary supplement but was actually an unapproved new drug containing synthetic steroids, the government’s statement said.

Former NFL running back Femi Ayanbadejo has filed a lawsuit against Author L. Rea of ALR Industries. He claims an undisclosed ingredient in ALRI Max LMG caused him to fail an NFL doping test leading to his release by the Arizona Cardinals and Chicago Bears. Ayanbadejo tested positive for a “form of nandrolone.” Ayanbadejo’s attorney is blaming the positive steroid test on the manufacturer for possibly intentionally “spiking” the supplement with banned substances or contamination from the manufacturing facility.

I have not had a chance to review legal documents in the case. The owner of ALR Industries did not seem to be aware of the lawsuit and could not provide me with any insight into the case.

But on the surface, I’m not sure it has merit from a legal standpoint. Keep in mind that substances prohibited by the NFL (or WADA) are not necessarily prohibited by DSHEA as over the counter supplements (nor should they be). It does not appear that ALR Industries is guilty of producing supplements unintentionally contaminated with steroids or supplements containing undisclosed steroidal products unless there is evidence other than the failed drug test.

It appears that the ingredient that caused Ayanbadejo to test positive on the NFL’s steroid test was clearly listed on the label and/or marketing materials and identified as a legal progestin similar to other progestin-based steroids like trenbolone and nandrolone.

The active compound in Max LMG is 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one… It is legal because it is a progestin, and before anyone thinks “birth-control”, remember that trenbolone, nandrolone, methyltrienolone and Methyl-Dien all are also progestins. I doubt anyone will disagree with the effects of these compounds upon favorable body composition.

In addition, the label warned consumers about androgenic side effects.

Possible side effects include acne, hair loss, hair growth on the face (in women), aggressiveness, irritability, and increased levels of estrogen.

When an ingredient is said to be in the same class of compounds as banned steroids “trenbolone” and “nandrolone” (legality notwithstanding) and the side effect of “hair growth on the face (in women)” is listed on the bottle, I think this would be indicative of a dietary supplement that a drug-tested athlete would be wise to avoid. In other words, Ayanbadejo made a mistake and should have known better.

My opinion is based on the following assumptions:

1. Max LMG is not contaminated with undisclosed steroidal hormones, either intentionally or unintentionally.

2. The active ingredient in Max LMG is accurately disclosed as 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one.

3. A metabolite of 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one resulted in Femi Ayanbadejo’s positive steroid test for a “form of nandrolone.”

4.  The compound 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one was legally permitted under DSHEA and the Anabolic Steroid Control Act of 2004 whereas the “term `anabolic steroid’ means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone).”

Given these assumptions, there does not appear to be a violation of law nor a failure of enforcement (of DSHEA).  Comments are welcomed.

“As I have previously suggested, perhaps the Congress should examine whether the Dietary Supplement Health and Education Act–DSHEA, as it is commonly known–is being adequately enforced,” Fehr said [...]

I have got some news for Donald Fehr: They don’t sell steroids in the supplement aisle. They don’t sell the “cream” or the “clear,” either. That’s because this industry does a better job of policing itself than Major League Baseball ever could.

Clearly, Fehr was disingeniously trying to blame DSHEA for the problem baseball was having with anabolic steroids. He tried to use the supplement industry as a scapegoat for MLB’s problems and it deservedly failed.

But the supplement industry needs to pull their heads out of the stand, stop patting themselves on the back for a job well-done, and respond honestly to criticisms of their industry.

First, they have failed miserably at self-regulating the supplement industry. Steroids are currently sold in the supplement aisle. And they have been for over a decade. They were sold legally under DSHEA up until the loophole was closed by the Anabolic Steroid Control Act of 2004. They were even sold using pharmaceutical delivery methods most likely not permitted by DSHEA. And since 2004, supplement companies have continued to sell designer steroids. Supplement industry expert, William Llewellyn, clarified this for me in his comments to a previous post:

Designer steroids are still sold, as has been discussed above. SOmetimes they are not labeled as ingredients, but most often they are clearly listed. The fact remains, however, that synthetic designer steroids are considered unapproved new drugs, and are NOT covered by DSHEA as legal dietary supplements. Patrick Arnold was charged, and served time, for such a crime – no new law needs to be passed to address this.

Andro, norandro etc were covered by DSHEA because you could find them in most animals, and hence in the food supply. No animals, plants, etc naturally produce DMT, Epistane, methyl, 1-4ADD, etc etc.

I am sure there are only a few companies flaunting DSHEA and this doesn’t reflect the practices of the entire industry. But my point is that the industry is NOT doing a good job self-policing itself because the practice continues unabated.

Furthermore, significant percentages of dietary supplements have been reported to be contaminated with anabolic steroids and stimulants that are not disclosed in the ingredients. It would be nice to share my protein shake with my 6-year old daughter without worrying about the possibility of contamination due to poor quality control.

If the supplement industry is content to ignore the problem of poor self-regulation, then they share in the blame should a backlash against DSHEA occur as a result of the present-day steroid hysteria.

The next time you hear an “industry expert” say something like this (“Major League pain for supplements,” February 11)…

They don’t sell steroids in the supplement aisle.

Or this…

Anabolic steroids are not dietary supplements and dietary supplements are not anabolic steroids,” said Council of Responsible Nutrition president Steve Mister.

…please ask them to be honest for the sake of the future of DSHEA. Steroids and designer steroids are and have been sold, legally and illegally, as dietary supplements.

But I have to give credit to Rob Eder. In his closing comments, he sarcastically suggested that Fehr donate $20 million to help the FDA enforce DSHEA.

So where exactly did Fehr think the government would get the money to conduct that kind of an investigation? Rather than spend $20 million to pay for former Sen. Mitchell’s investigation, why not just donate the $20 million to the Food and Drug Administration whose job it is to police the dietary supplement industry? Contrary to popular belief, DSHEA absolutely grants FDA regulatory authority over the dietary supplement industry.

If MLB was really concerned about what products the FDA allows to come to market, they’d spend the $20 million to lobby Congress for a greater annual budget allocation for FDA.

Bravo. Illegal or undisclosed steroids in our dietary supplements is more important than the voluntary use of steroids by professional baseball players. It is time that Congress reevaluate their priorities. I like DSHEA. It just needs to be enforced. It is clear that the supplement industry can’t regulate itself as they are not even aware of any problems. Rather than waste money on steroids in baseball, federal money would be better spent enforcing a good law like DSHEA and making our dietary supplements safe.

While CNN is technically inaccurate, it is closer to the truth than Levin’s advocacy would suggest. From a consumer standpoint, I feel it is safer to assume that dietary supplements are unregulated. Most regulations are actually “post-marketing” measures i.e. very little prevents a new supplement from being sold in the marketplace.

I like the Dietary Health and Supplement Education Act (DSHEA) in principle too. But the supplement industry has abused and exploited DSHEA and utterly failed to self-regulate in the face of legislative challenges to DSHEA. It remains to be seen whether DSHEA is salvaged or systematically dismantled.

There is a reason that dozens of steroids have been and continue to be sold as dietary supplements for over a decade in the U.S.; DSHEA makes it legal. As long as supplement companies avoid certain claims and meet certain criteria well-known within the industry, the steroidal supplements can be introduced to the marketplace without “burdensome” requirements that the supplement company notify the government. This is the legacy of DSHEA.

At least one of the two most infamous designer steroids in the history of sport steroid scandals could have probably been legally sold as dietary supplements if they did not become scrutinized due to the spotlight of the BALCO steroids in baseball scandal i.e. tetrahydragestrinone aka THG aka “The Clear” and desoxymethyltestosterone aka DMT aka Madol synthesized by the convicted “father of prohormones” Patrick Arnold.

Pat Arnold’s indictment didn’t identify these so-called designer steroids as “anabolic steroids” because, legally, they were not. In response to the BALCO scandal, the FDA issued a press release on THG stating it was an “unapproved new drug” and not a “dietary supplement” to stop manufacturers who felt it met DSHEA criteria from selling it. (Actually, the latter steroid DMT was introduced into the marketplace but quickly (and voluntarily) pulled by its manufacturer shortly after the press associated it with the BALCO scandal and Patrick Arnold.)

THG and DMT did not legally become “anabolic steroids” until the passage of the Anabolic Steroid Control Act of 2004.

Several new steroid products are currently sold as dietary supplements legally and others illegally. But little is done about either due to the laissez faire regulation of the industry.

Furthermore, dietary supplements contaminated with steroids and stimulants continues to be a problem; for this reason alone I would be cautious about teenagers or children using any dietary supplement. Sadly, the supplement industry (or more accurately, several companies within the industry) are giving legislators every excuse to gut DSHEA.