MESO-Rx

September 30, 2009

Dave Nelson and iForce Nutrition served FDA search warrant

The FDA served iForce Nutrition and owner Dave Nelson with a search warrant during the course of the 2009 IFBB Olympia Expo. The search warrant was executed in the days following the FDA raid of Bodybuilding.com. Four iForce Nutrition products were listed as “undercover purchases” made at Bodybuilding.com. Both the iForce Nutrition search warrant and the Bodybuilding.com search warrant alleged that these products contain anabolic steroids, unapproved new drugs, and/or misbranded drugs: 1,4 AD Bold 200 (androstenedione), 17a PheraFLEX (Madol), Dymethazine (Superdrol) and Methadrol (Superdrol).

The FDA media strategy forced several dietary supplement companies and their owners into the spotlight and made them readily accessible to both federal agents and media representatives at the 2009 Olympia Expo.

Read more

September 25, 2009

Bodybuilding.com at 2009 Olympia Expo

The federal government continued their steroid witch-hunt targeting the dietary supplement industry with a raid of Bodybuilding.com on Thursday, September 24, 2009. The criminal investigation accuses Bodybuilding.com and its corporate officers of illegal marketing and distributing several anabolic steroids, unapproved new and misbranded drugs labeled fraudulently as dietary supplements, specifically “Madol”, “Tren”, “Superdrol”, “Androstenedione”, and “Turinabol”.

Only androstenedione and Turinabol are legally classified as anabolic steroids; these ingredients were not disclosed on the product labels. The FDA has asserted that Madol, Tren and Superdrol are also anabolic steroids. However, only the DEA has the authority to administratively add these substances to the Controlled Substances list. The DEA has NOT yet made this determination. These ingredients have been widely and openly sold as listed ingredients in dietary supplements for years.

The FDA media strategy most likely intentionally staged the raid to coincide with the first day of the 2009 Olympia Weekend. The Olympia Expo, the centerpiece of the Olympia Weekend, includes a large number of sports nutrition companies as exhibitors. The Bodybuilding.com has had a prominent presence at the Expo for several years and is the main sponsor of the 2009 IFBB Mr. Olympia, the top competition in professional bodybuilding. Read more

July 29, 2009

FDA Commissioner Margaret Hamburg

The U.S. Food and Drug Administration (FDA) issued a Public Health Advisory (PHA) warning consumers to avoid using bodybuilding supplements claiming to contain “steroids”, “steroid-like substances”, “steroid alternatives” and “hormone products”. The FDA warning failed to give guidance on the specific product ingredients that were problematic. The extremely broad language cast suspicion upon all “body building supplements” marketed for performance enhancement because they might contain synthetic steroids (”FDA recommends that consumers should not use body building products marketed as containing steroids or steroid-like substances,” July 28). 

  • “marketed as containing steroids or steroid-like substances”
  • “marketed for body building and increasing muscle mass”
  • “marketed as alternatives to anabolic steroids for increasing muscle mass and strength”
  • “promoted to athletes to improve sports performance and to aid in recovery from training and sporting events”

The target was ostensibly illegal synthetic steroids that are not compliant with the Dietary Supplement Health and Education Act (DSHEA). However, the FDA news releases and statements appears to demonize ALL steroid products including those that are legally sold and marketed as dietary supplements under DSHEA. Read more

July 26, 2009

DecaVol by Advanced Muscle Science

Russ Walker, a security police officer at a high-security government nuclear weapons facility, was fired after testing positive for anabolic steroids. Walker attributes the positive steroid test to his use of the over-the-counter supplement identified as “DecaVol” manufactured by Advanced Muscle Science (AMS).

Russ Walker was a model employee at Wackenhut Services Inc. Oak Ridge (WSI-OR). WSI Oak Ridge is the private security contractor for the Y-12 nuclear weapons plant in Tennessee where nuclear warheads are manufactured for the U.S. military. Walker was asked to undergo steroid testing based on unspecified probable cause that he was in violation of company and Department of Energy policy.

Walker’s employment was terminated after he tested positive for anabolic steroids. Walker is one of several WSI-OR security police officers who have blamed positive steroid test results on the use of over-the-counter supplements  Read more

July 25, 2009

American Cellular Labs Tren Xtreme and Mass Xtreme

FDA Special Agent Jeff Novitzky, the agent who has become the face of the federal government witch-hunt against steroid users in professional sports during the BALCO scandal, has move his attention to investigating dietary supplement companies suspected of selling designer anabolic steroids.

Novitzky’s latest steroid investigation targeted two popular products sold and marketed as dietary supplements, “Tren Xtreme” and “Mass Xtreme”.  These products were manufactured by American Cellular Labs Inc. (ACL) and sold exclusively through Max Muscle Sports Nutrition (MMSN) stores and via the ACL website (”Two Dietary Supplements Said to Contain Steroids,” July 23).

The exact nature of the business relationship between ACL and MMSN is unclear. Maurice Sandoval, the owner of the Max Muscle San Francisco franchise and the Regional Marketing Director for Max Muscle, was identified as the chief executive of ACL in a government affidavit. Sandoval told the New York Times that he sold ACL in 2008. ACL, Max Muscle San Francisco, and Sandoval’s residence were targets of search warrants executed on July 23, 2009.

The FDA investigation did not involve any steroid contaminants or undisclosed anabolic steroids. Federal investigators specifically targeted the openly listed ingredients in Tren Xtreme and Mass Xtreme commonly referred to as “Tren” and “Madol”, respectively. Read more

June 19, 2009

United States Anti-Doping Agency CEO Travis Tygart

Travis Tygart, CEO of the United States Anti-Doping Agency (USADA), urged the country’s attorneys general to start suing supplement companies using consumer protection laws. Tygart made his comments at the 2009 National Association of Attorneys General (NAAG) summer conference on June 17, 2009 in Colorado Springs. Tygart wants the attorneys general to take action at the state level to further the USADA’s agenda of preventing competitive athletes from using dietary supplements that are prohibited by their respective sports and/or the World Anti-Doping Agency (WADA) (”USADA chief urges states to act on supplements,” June 19).

“If consumers could run the land, I think federal regulations would change,” Tygart said. “The political reality is that, unfortunately, we have to assume they’re not going to change. But that doesn’t deter you (states) from taking action.” [...]

For the states, however, this is a relatively new issue. If they make a move, they’ll probably have to turn to consumer-protection statutes. They could also look at recovering expenses for government-paid health care costs for treatment of people who get sick from supplement use, much the way they did in lawsuits against tobacco companies.

Rick Collins and Alan Feldstein, representing the law firm Collins, McDonald and Gann, identified state attorneys general use of consumer protection laws as a potentially serious “minefield” facing supplement companies at the International Society of Sports Nutrition Conference (ISSN) on June 15, 2009. Sports nutrition companies who focus on products aimed at improving performance are particularly vulnerable to such state attorneys general actions. Read more

May 23, 2009

ALR Industries Max LMG and NFL running back Femi Ayanbadejo

Former NFL running back Femi Ayanbadejo settled his lawsuit against ALR Industries in a confidential agreement. ALR Industries (ALRI) has NOT admitted wrongdoing. ALRI is proceeding with its defamation lawsuit seeking punitive damages against Ayanbadejo for his irresponsible and false statements alleging that ALRI spiked its supplements. Ayanbadejo tested positive for an ingredient clearly listed on the label of ALRI Max LMG during a doping test conducted by the National Football League (NFL) (”Ex-Aztec, company settle dispute over supplement’s label,” May 20).

“Sometimes athletes have a valid claim against these companies, and sometimes they don’t,” said Charles Weller, attorney for ALR Industries. “This was a perfect example of a situation where we don’t have a valid claim. Ayanbadejo tested positive for exactly what was on the label of Max LMG. In trying to save his career, he chose to point fingers at the supplement company. He took a dietary supplement without doing his due diligence.”

Ayanbadejo publicly told reporters that ALR Industries knowingly added a banned substance and intentionally failed to disclose it on the label of Max LMG. Jim Miller, Ayanbadejo’s attorney, blamed Ayanbadejo’s failed steroid test on either a cross-contaminated or intentionally spiked supplement. However, Ayanbadejo and his lawyer never submitted any evidence to support allegations that Max LMG was cross-contaminated or spiked.

An evaluation of the Max LMG label easily proves the LISTED ingredient(s) account for the failed test. Read more

April 28, 2009

Patrick Arnold and Ergopharm 6-OXO Extreme

MLB baseball player J.C. Romero has filed a civil lawsuit against the manufacturers and distributors of the 6-OXO Extreme. 6-OXO Extreme is sold as a dietary supplement and marketed as an aromatase inhibitor. Romero blames androstenedione contamination in the supplement for his positive anabolic steroid test results administered on August 26, 2008 under the Major League Baseball (MLB) drug policy. Romero of the Philadelphia Philles was suspended for 50 games as a result (”Suspended Phillie Romero files suit,” April 28).

The lawsuit names Ergopharm, Proviant Technologies, GNC and Vitamin Shoppe as the four defendants accused of negligence, intentional misrepresentation and consumer fraud. Chemist Patrick Arnold formulated and manufactured the supplement 6-OXO Extreme for his companies Erogpharm and Proviant. J.C. Romero’s lawyers have defended numerous athletes accused of doping after failing drug tests like Floyd Landis, Marion Jones, Tim Montgomery, Jessica Hardy and Deuce McAllister (”Suspended Phillies reliever J.C. Romero suing supplement makers over positive steroid test,” April 28).

The lawsuit against Ergopharm, Proviant, GNC and Vitamin Shoppe is surprisingly frivolous [misdirected] given the expertise of Romero’s lawyers which include Howard Jacobs and David Cornwell. The main issue in the case is the claim that the failure to disclose androstenedione contamination in 6-OXO Extreme by the defendents was THE REASON that J.C. Romero tested positive for anabolic steroids; this subsequently resulted in his suspension and the forfeiture of $1,245,902 in salary.

The fact is that J.C. Romero would have tested positive for anabolic steroids and received a suspension IN THE ABSENCE of ANY androstenedione contamination. The supplement 6-OXO itself would have triggered a false positive for androstenedione since it is metabolized into 6a-OH-androstenedione; this is the same urinary metabolite produced by androstenedione. The issue of androstenedione contamination is nothing more than a red herring. Read more

January 10, 2009

 

The Major League Baseball Players Association (MLBPA) appears to be using deceptive and misleading spin tactics to manipulate public opinion in their defense of J.C. Romero and Sergio Mitre. The MLB baseball players have been suspended after testing positive for androstenedione which is classified as an anabolic steroid under the MLB drug policy. The MLBPA unfairly and erroneously attempts to blame the positive steroid test on a “minute trace” of androstenedione contamination in the dietary supplement 6-OXO by Ergopharm; these assertions have been made in the absence of lab analysis showing contamination Read more

October 20, 2008

The owners of the SVN Canada in North Vancouver, British Columbia were arrested for allegedly selling the anabolic steroid methyl-1-testosterone (M1T) to teenagers. The arrest comes less than a week after an employee of ‘Your Vitamin Store’ (YVS Victoria) in nearby Victoria, British Columbia was also arrested for selling M1T. Charges in both cases involved trafficking and possession of a controlled substance (anabolic steroids) (”North Van RCMP arrest nutrition shop owners for alleged steroid sales to teens,” October 20).

Const. Marlene Morton said “a substantial amount” of a bodybuilding drug called Methyl-1-Testosterone was seized from Lower Lonsdale area shop SVN Canada, following a year-long investigation.

The store’s owners, Joao Melo, 28, and Sylvie Tran, 26, of North Vancouver, have been charged with trafficking in a controlled substance and further charges are pending, Morton said.

Health Canada issued a warning in April 2006 advising all consumers that M1T was an illegal anabolic steroid. The recent steroid arrests may be the beginning of a crackdown on illicit performance enhancing drugs in advance of the Vancouver 2010 Winter Olympic Games

M1T was legally sold and marketed as a “prohormone” in the United States as an over-the-counter “dietary supplement” until the Anabolic Steroid Control Act of 2004 made it illegal on January 20, 2005.

 

October 15, 2008

Will Canada crackdown on anabolic steroids in preparation for the Vancouver 2010 Winter Olympic Games? The steroid crackdown at the 2008 Beijing Olympic Games was understandable given the long history of China’s manufacture and distribution of raw and finished anabolic steroid and performance enhancing products.  But does anyone think steroids are a problem in Canada? After all, steroids are responsible for saving lives in Vancouver! Nonetheless, we may be seeing the beginning of a steroid crackdown in the region.

Victoria Police have arrested an employee of ‘Your Vitamin Store’ (YVS) in the Mayfair Shopping Centre in Victoria, British Columbia (Canada). The steroid bust involved a 33-year old employee now facing criminal charges for selling Methyl 1-Testosterone (M1T) in bottles of 90 capsules for $109.95. Most consumers consider M1T a “prohormone.” The employee was charged with six counts of trafficking in a controlled substance (anabolic steroids) and one count of possession for the purpose of trafficking (anabolic steroids). Read more

September 27, 2008

The popular documentary about anabolic steroids can be purchased at the 2008 Olympia Expo in Las Vegas this weekend. “Bigger Stronger Faster*” is a critical exploration of anabolic steroids and performance enhancing drugs in sports and society which tackles many more serious ethical and political issues along the way. The producers of this steroid documentary have a booth (#146) at the 2008 Olympia Expo (September 26-27) where visitors can purchase a copy of the DVD prior to its official nationwide release on September 30, 2008. The Bigger Stronger Faster DVD can also be pre-ordered from Amazon.

I have had the privilege of corresponding with the producers throughout the production and release of this terrific film. I have previously interviewed the director, Christopher Bell, and also had the chance to spend a couple of hours with him in the Magnolia Pictures press conference at the Orleans Hotel & Casino watching the bonus features that are included in the DVD version in addition to the feature presentation.

I also visited again with Tamsin Rawady and Alex Buono, the talented filmmakers who collaborated with Chris Bell to create “Bigger Stronger Faster*”. Tamsin and Alex bring a unique perspective to the documentary as outsiders to the world of anabolic steroids.

Read more

April 5, 2008

LG Sciences Methyl 1-DLG Sciences Formadrol

U.S. Marshalls acting upon authority of the Food and Drug Administration (FDA) seized the following supplements from the LG Sciences warehouse in Brighton, Michigan: Methyl 1-D, Methyl 1-D XL and Formadrol Extreme XL The FDA alleges that the products are adulterated under the Federal Food, Drug, and Cosmetic Act with “one or more unapproved food additives and/or dietary ingredients.” (”FDA seizes $1.3 million in supplements marketed for bodybuilders from Brighton warehouse,” March 4)

According to LG Sciences, the specific ingredients in question by the FDA are 1,4,6 etiocholan-dione (ATD) and 4-etioallocholen-3,6,17-trione (6-OXO-4-androstenedione).

The U.S. Attorney’s office released the following statement:

FDA has not received scientific information on the safety of the seized products and cannot determine, at this time, whether they represent a hazard to consumers. Therefore, consumers who still have the products should strongly consider discussing the use of these products with their health care professionals. FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products’ use. Consumers and health care professionals can report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at www.FDA.gov/medwatch/report.htm.

LG Sciences (formerly Legal Gear) is trying to minimize the FDA seizure.

Ronald Berry, an attorney for LG Sciences, said Friday evening that all the company’s products are legal, and the ingredients are safe for consumers. He called the FDA seizure “merely a preliminary step in determining compliance with food regulations.”

“Although LG Sciences feels the temporary restraint of its product by the FDA is inappropriate, the company appreciates that the FDA wishes to protect the public,” Berry said in a statement.

LG Sciences released the following public statement:

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.

(Hat tip to Inside Bodybuilding for the story)

March 28, 2008

Patrick Arnold and Ergopharm

Patrick Arnold’s ex-girlfriend, Kelcey Dalton, testified as a witness in cyclist Tammy Thomas steroid case. She told the court that Patrick Arnold (of Ergopharm) made very little profit from the sell of performance enhancing drugs (which were classified as “unapproved new drugs” prior to the Anabolic Steroid Control Act of 2004) ["Witness: Little Profit for Steroid Maker," March 27].

The sums of money Arnold was making were “very low,” she said. “I think we should have charged more.”

Pat confirmed via email that he only made $15-20 thousand over the course of the THREE YEARS he provided tetrahydrogestrinone (THG) and norbolethone to elite athletes while working with Victor Conte. The government calls a $5,000 a year operation a major steroid bust?!

Read more

March 12, 2008

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 (”Ex-Aztec sues supplement maker, shop over failed NFL steroid test,” March 11).

“We’re still not sure whether we have a pure cross-contamination matter (from the mixing facility), or we have a company that actually spiked the supplement (intentionally),” said Ayanbadejo’s attorney, Jim Miller.

However, he ignores a third possibility that doesn’t work in his client’s favor - that the ingredient that caused the positive drug test was plainly listed on the label and his client was unaware that the metabolites would result in a positive steroid test. Then this is no longer a case of “undisclosed ingredients” or “contaminated supplements.”

The marketing materials for ALRI Max LMG clearly list the ingredients and similarity 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.

Are supplement companies responsible for ensuring that their supplements are “IOC-friendly”? Or are supplement companies only responsible for complying with legal requirements of DSHEA (which permit certain progestin-based steroidal compounds)?