FDA Commissioner Margaret Hamburg identified “enforcement of the law” as the overriding objective of the FDA under her leadership at a presentation for the Food and Drug Law Institute in Washington, D.C. on August 6, 2009.
Hamburg cited the FDA raid of American Cellular Labs and the FDA public health advisory regarding steroids in supplements as examples of the increased enforcement activity by the agency; Hamburg promised additional efforts targeting the “illegal sale of anabolic steroids” sold “under the guise of dietary supplements”.
Hamburg did not specifically identify the Dietary Supplement and Health Education Act (DSHEA) by name in her speech. Nonetheless, her comments may provide some guidance to sports nutrition companies recently affected by increased FDA enforcement and provide clues to the future of DSHEA.
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
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
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.
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
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)
A recent study revealed approximately 25% of popular dietary supplements in the U.S. were contaminated with low levels of steroids; 11% of supplements were contaminated with stimulants, most commonly ephedrine. These steroidal and stimulant ingredients were not declared on the product label.
The study was done by Informed Choice, a nonprofit coalition of dietary supplements, and the analysis was conducted by the British company, HFL, to investigate levels of steroid and stimulant contamination in popular supplements available on the US market. The names of the supplements that were tested were not identified. This is most likely out of fear of legal action against them by any company should it be named in the study results.
Of course, the results shocked Travis Tygart, the CEO of the US Anti-Doping Agency (USADA). In recent years, the USADA has asserted, even in the absence of any hard data, that contamination of dietary supplements is not a problem for drug-tested athletes. He further claimed that no American athletes has tested positive for steroids due to contaminated supplements since 2004. He has called for Informed Choice to publish the names of the implicated supplement company so the “illegal activity” can be stopped.
Of course, such assertions have been made in the self-interest of the USADA rather than out of concern for athletes. The presence of undeclared banned substances in dietary supplements could lead the way for significant doubt about the guilt of athletes who fail drug tests, thereby making the job of the US Anti-Doping Agency significantly more difficult.
The present study is only further evidence of the quality control problems in the dietary supplement industry and the risks for competitive athletes subject to doping tests. In recent years, at least one athletes has successfully sued a supplement manufacturer. The IOC conducted a similar study between 2000 and 2002 that revealed 15% of dietary supplements purchased in various countries contained undeclared steroid and/or prohormone ingredients.
There are several explanations for the high incidence of steroids and stimulants found in sports supplements:
- Intentional contamination. There have been allegations that some supplement companies may have added some undeclared ingredients, usually by the addition of a stimulant, so that the consumer actually “feels” that the product is working. The overall success of the sports nutrition supplement industry is due to the “placebo effect” – if the consumer “feels” something from the supplement, they think it is working. If they think it is working, it may actually have benefit (placebo) and they will continue to buy the product.
- Cross-contamination. Many factories manufacturer various different categories of supplements in the same facility. For example, ephedrine products may be processed on the same equipment as vitamin and mineral products; hormonal products may be processed on same line as protein powders. If the equipment is not cleaned properly, contamination could result.
- Contaminated raw material. Supplement manufacturers often import raw materials from Asia, India and Eastern Europe. This could be contaminated with impurities.
http://www.usatoday.com/sports/hfl-supplement-research-report.pdf
