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).Â
- “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
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
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
The INTERPOL operation codenamed Pangea targeted internet pharmacies in ten countries that were selling counterfeit pharmaceuticals. Operation Pangea involved regulatory agencies associated with INTERPOL from the United States, United Kingdom, Australia, Canada, Germany, Ireland, Israel, New Zealand, Singapore and Switzerland.
The internet pharmacies that were raided as result of the operation were primarily sellers of prescription drugs for conditions such as diabetes, obesity and hair loss but also involved internet pharmacies selling ancillary bodybuilding drugs (”Interpol Media Release: Illegal online medicine suppliers targeted in first international Internet day of action,” November 13).
The first international Internet day of action co-ordinated by the Permanent Forum on International Pharmaceutical Crime, INTERPOL and the World Health Organisation’s (WHO) International Medical Products Anti-Counterfeiting Taskforce (IMPACT), targeting the illegal online sale of medicines to the public has resulted in a series of arrests and the seizure of potentially harmful medicines in operations carried out around the world.
Â
Codenamed Pangea, the operation focused on those individuals behind Internet sites which illegally sell and supply unlicensed or prescription-only medicines claiming to treat a range of ailments.
While steroids and steroid pharmacies were not specifically targeted, Operation Pangea has significant ramifications for international steroid distribution. The most significant consequence results from a new definition of counterfeit drugs proposed by a World Health Organization’s (WHO) funded body allegedly supported by pharmaceutical multi-national corporations (MNCs).
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)
Today, the U.S. Food and Drug Administration (FDA) approved a new recombinant growth hormone manufactured by the Canadian drug company, Cangene, and designed for subcutaneous injection. The brand name for Cangene’s injectable growth hormone is Accretropin. Accretropin has an identical amino acid sequence to natural human growth hormone produced in the pituitary. It was approved for treatment of children with short stature and Turner’s Syndrome (a chromosomal disorder in girls resulting in short stature and infertility). Cangene submitted the new drug application (NDA) to the FDA in July 2006.
 Accretropin joins several other 191-amino acid sequence growth hormone brands currently approved by the FDA including Nutropin AQ, Saizen, Genotropin, Humatrope, Serostim, Zorbtive, Norditropin and Zomacton
