The New Designer Steroid Bill and YOU:
Questions and Answers with Rick Collins
Q: What is the “Designer Anabolic Steroid Control Act of 2012”?
A: It’s a Senate Bill (SB 3431) introduced by Senators Orrin Hatch (R-Utah) and Sheldon Whitehouse (D-R.I.) and referred to the Judiciary Committee. If passed by Congress, it will amend the Controlled Substances Act to more aggressively regulate steroidal substances being sold as dietary supplement ingredients. The clear intent is to remove remaining “prohormone” products from the market and prevent new ones from being introduced. The bill would take such past or present supplement products as ATD, 6-oxo, 6-bromo, Furazadrol, Halodrol, Havoc, and Tren and legally classify them as anabolic steroids and Controlled Substances. Here’s what Sen. Whitehouse said in introducing the bill on July 25[SUP]th[/SUP], 2012:
“… I am pleased to join Senator Hatch in introducing the bipartisan Designer Anabolic Steroid Control Act of 2012. This measure will help keep American children and families safe from dangerous designer drugs that masquerade as healthy dietary supplements. This legislation is based on Senator Specter’s work in the previous Congress, and I thank him for his leadership on this issue.
Doctors and scientists have long recognized the health hazards of non-medical use of anabolic steroids. For that reason, Congress has previously acted to ensure that these drugs are listed as controlled substances. Nonetheless, according to investigative reporting and Congressional testimony, a loophole in current law allows for designer anabolic steroids to easily be found on the Internet, in gyms, and even in retail stores.
Designer steroids are produced by reverse engineering existing illegal steroids and then slightly modifying the chemical composition, so that the resulting product is not on the Drug Enforcement Administration’s, DEA, list of controlled substances. When taken by consumers, designer steroids can cause serious medical consequences, including liver injury and increased risk of heart attack and stroke. They may also lead to psychological effects such as aggression, hostility, and addiction.
These designer products can be even more dangerous than traditional steroids because they are often untested, produced from overseas raw materials, and manufactured without quality controls. As one witness testified at a Crime Subcommittee hearing in the last Congress, ‘all it takes to cash in on the storefront steroid craze is a credit card to import raw products from China or India where most of the raw ingredients come from, the ability to pour powders into a bottle or pill and a printer to create shiny, glossy labels.’
The unscrupulous actors responsible for manufacturing and selling these products often market them with misleading and inaccurate labels. That can cause consumers who are looking for a healthy supplement--not just elite athletes, but also high school students, law enforcement personnel, and mainstream Americans--to be deceived into taking these dangerous products.
Loopholes in existing law allow these dangerous designer steroids to evade regulation. Under current law, in order to classify new substances as steroids, the DEA must complete a burdensome and time-consuming series of chemical and pharmacological testing. As a DEA official testified before Congress: ‘in the time that it takes DEA to administratively schedule an anabolic steroid used in a dietary supplement product, several new products can enter the market to take the place of those products.’'
The Designer Anabolic Steroid Control Act of 2012 would quickly protect consumers from these dangerous products. First, it would immediately place 27 known designer anabolic steroids on the list of controlled substances. Second, it would grant the DEA authority to temporarily schedule new designer steroids on the controlled substances list, so that if bad actors develop new variations, these products can be removed from the market. Third, it would create new penalties for importing, manufacturing, or distributing anabolic steroid’s [sic] under false labels.
Senator Hatch and I have worked closely with a range of consumer and industry organizations to ensure that this legislation would not interfere with consumers’ access to legitimate dietary supplements. I am pleased that the measure has been endorsed by the United States Anti-Doping Agency, the Alliance for Natural Health, the Council for Responsible Nutrition, the American Herbal Products Association, the Natural Products Association, the Consumer Health Products Association, and the United Natural Products Alliance.
I thank these organizations for their support, and look forward to working with them, with Senator Hatch, and with colleagues from both sides of the aisle to enact this common sense measure into law.”
Q: Is the bill specific in naming the substances to be added to the list of anabolic steroids?
A: The “Discussion Draft” of the bill that I reviewed would specifically add 27 chemical compounds to the list of substances defined as anabolic steroids in Title 21 of the U.S. Code [21 USC 802(41)]. The bill presents the chemical nomenclature for these substances. Some of the chemical names listed, according to steroidal supplement guru Patrick Arnold, contain errors or refer to compounds that may actually not exist. But any minor mistakes aside, it seems that the drafters of the bill extensively canvassed the supplement market and perhaps even the Internet message boards in an effort to identify and specifically name as many compounds as possible. This isn’t the first time that Congress has expanded the list of anabolic steroids. The original list, compiled in 1990, was amended in 2004 to include androstenedione and a variety of other steroidal products. The DEA later issued a Final Rule (http://www.gpo.gov/fdsys/pkg/FR-2009-12-04/pdf/E9-28572.pdf), effective January 2010, classifying three more compounds as anabolic steroids (boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione, along with their salts, esters and ethers). Then the DEA last year published a notice of proposed rulemaking to add yet two more steroidal compounds, prostanozol and methasterone (marketed as Superdrol), along with their salts, esters and ethers, to the list. The Final Rule on these two was issued on July 30[SUP]th[/SUP], 2012 (http://www.gpo.gov/fdsys/pkg/FR-2012-07-30/pdf/2012-18495.pdf), effective August 29[SUP]th[/SUP], 2012. This new bill just follows up by adding a whole bunch more (although now a moot point, it includes the recently scheduled prostanozol and Superdrol) … and by design, misses very few.
Q: What about steroidal substances that are not on the list?
A: The bill changes the way unlisted steroidal compounds are dealt with. It says that “a drug or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed … and is derived from, or has a chemical structure substantially similar to, 1 or more
[listed] anabolic steroids [is considered an anabolic steroid] if … [it] has been created or manufactured with the intent of [promoting muscle growth or having pharmacological effects like testosterone or] has been, or is intended to be, marketed or otherwise promoted [to suggest it will promote muscle growth or have pharmacological effects like testosterone]. Notice that there’s no proof requirement that the substance actually promote muscle growth or act like testosterone pharmacologically – only that it’s created, manufactured, marketed or promoted with the intent of doing so. So, for supplement industry purposes, a company that markets any product that is derived from or has substantial chemical similarity to a listed anabolic steroid and is also created or marketed to build muscle or have a pharmacological effect like testosterone is marketing an anabolic steroid. An interesting question arises in the following theoretical scenario: Company A markets an ingredient derived from a listed anabolic steroid for health and wellness purposes, and the ingredient has neither anabolic nor androgenic effects. Company B markets the same ingredient but makes the claim, falsely, that the ingredient builds muscle. If Company B is prosecuted and convicted for marketing the ingredient as an anabolic steroid, where does this leave Company A? While it would seem reasonable that the ingredient is an anabolic steroid only with respect to Company B, the issue is not addressed in the language of the bill.
Questions and Answers with Rick Collins
Q: What is the “Designer Anabolic Steroid Control Act of 2012”?
A: It’s a Senate Bill (SB 3431) introduced by Senators Orrin Hatch (R-Utah) and Sheldon Whitehouse (D-R.I.) and referred to the Judiciary Committee. If passed by Congress, it will amend the Controlled Substances Act to more aggressively regulate steroidal substances being sold as dietary supplement ingredients. The clear intent is to remove remaining “prohormone” products from the market and prevent new ones from being introduced. The bill would take such past or present supplement products as ATD, 6-oxo, 6-bromo, Furazadrol, Halodrol, Havoc, and Tren and legally classify them as anabolic steroids and Controlled Substances. Here’s what Sen. Whitehouse said in introducing the bill on July 25[SUP]th[/SUP], 2012:
“… I am pleased to join Senator Hatch in introducing the bipartisan Designer Anabolic Steroid Control Act of 2012. This measure will help keep American children and families safe from dangerous designer drugs that masquerade as healthy dietary supplements. This legislation is based on Senator Specter’s work in the previous Congress, and I thank him for his leadership on this issue.
Doctors and scientists have long recognized the health hazards of non-medical use of anabolic steroids. For that reason, Congress has previously acted to ensure that these drugs are listed as controlled substances. Nonetheless, according to investigative reporting and Congressional testimony, a loophole in current law allows for designer anabolic steroids to easily be found on the Internet, in gyms, and even in retail stores.
Designer steroids are produced by reverse engineering existing illegal steroids and then slightly modifying the chemical composition, so that the resulting product is not on the Drug Enforcement Administration’s, DEA, list of controlled substances. When taken by consumers, designer steroids can cause serious medical consequences, including liver injury and increased risk of heart attack and stroke. They may also lead to psychological effects such as aggression, hostility, and addiction.
These designer products can be even more dangerous than traditional steroids because they are often untested, produced from overseas raw materials, and manufactured without quality controls. As one witness testified at a Crime Subcommittee hearing in the last Congress, ‘all it takes to cash in on the storefront steroid craze is a credit card to import raw products from China or India where most of the raw ingredients come from, the ability to pour powders into a bottle or pill and a printer to create shiny, glossy labels.’
The unscrupulous actors responsible for manufacturing and selling these products often market them with misleading and inaccurate labels. That can cause consumers who are looking for a healthy supplement--not just elite athletes, but also high school students, law enforcement personnel, and mainstream Americans--to be deceived into taking these dangerous products.
Loopholes in existing law allow these dangerous designer steroids to evade regulation. Under current law, in order to classify new substances as steroids, the DEA must complete a burdensome and time-consuming series of chemical and pharmacological testing. As a DEA official testified before Congress: ‘in the time that it takes DEA to administratively schedule an anabolic steroid used in a dietary supplement product, several new products can enter the market to take the place of those products.’'
The Designer Anabolic Steroid Control Act of 2012 would quickly protect consumers from these dangerous products. First, it would immediately place 27 known designer anabolic steroids on the list of controlled substances. Second, it would grant the DEA authority to temporarily schedule new designer steroids on the controlled substances list, so that if bad actors develop new variations, these products can be removed from the market. Third, it would create new penalties for importing, manufacturing, or distributing anabolic steroid’s [sic] under false labels.
Senator Hatch and I have worked closely with a range of consumer and industry organizations to ensure that this legislation would not interfere with consumers’ access to legitimate dietary supplements. I am pleased that the measure has been endorsed by the United States Anti-Doping Agency, the Alliance for Natural Health, the Council for Responsible Nutrition, the American Herbal Products Association, the Natural Products Association, the Consumer Health Products Association, and the United Natural Products Alliance.
I thank these organizations for their support, and look forward to working with them, with Senator Hatch, and with colleagues from both sides of the aisle to enact this common sense measure into law.”
Q: Is the bill specific in naming the substances to be added to the list of anabolic steroids?
A: The “Discussion Draft” of the bill that I reviewed would specifically add 27 chemical compounds to the list of substances defined as anabolic steroids in Title 21 of the U.S. Code [21 USC 802(41)]. The bill presents the chemical nomenclature for these substances. Some of the chemical names listed, according to steroidal supplement guru Patrick Arnold, contain errors or refer to compounds that may actually not exist. But any minor mistakes aside, it seems that the drafters of the bill extensively canvassed the supplement market and perhaps even the Internet message boards in an effort to identify and specifically name as many compounds as possible. This isn’t the first time that Congress has expanded the list of anabolic steroids. The original list, compiled in 1990, was amended in 2004 to include androstenedione and a variety of other steroidal products. The DEA later issued a Final Rule (http://www.gpo.gov/fdsys/pkg/FR-2009-12-04/pdf/E9-28572.pdf), effective January 2010, classifying three more compounds as anabolic steroids (boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione, along with their salts, esters and ethers). Then the DEA last year published a notice of proposed rulemaking to add yet two more steroidal compounds, prostanozol and methasterone (marketed as Superdrol), along with their salts, esters and ethers, to the list. The Final Rule on these two was issued on July 30[SUP]th[/SUP], 2012 (http://www.gpo.gov/fdsys/pkg/FR-2012-07-30/pdf/2012-18495.pdf), effective August 29[SUP]th[/SUP], 2012. This new bill just follows up by adding a whole bunch more (although now a moot point, it includes the recently scheduled prostanozol and Superdrol) … and by design, misses very few.
Q: What about steroidal substances that are not on the list?
A: The bill changes the way unlisted steroidal compounds are dealt with. It says that “a drug or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed … and is derived from, or has a chemical structure substantially similar to, 1 or more
[listed] anabolic steroids [is considered an anabolic steroid] if … [it] has been created or manufactured with the intent of [promoting muscle growth or having pharmacological effects like testosterone or] has been, or is intended to be, marketed or otherwise promoted [to suggest it will promote muscle growth or have pharmacological effects like testosterone]. Notice that there’s no proof requirement that the substance actually promote muscle growth or act like testosterone pharmacologically – only that it’s created, manufactured, marketed or promoted with the intent of doing so. So, for supplement industry purposes, a company that markets any product that is derived from or has substantial chemical similarity to a listed anabolic steroid and is also created or marketed to build muscle or have a pharmacological effect like testosterone is marketing an anabolic steroid. An interesting question arises in the following theoretical scenario: Company A markets an ingredient derived from a listed anabolic steroid for health and wellness purposes, and the ingredient has neither anabolic nor androgenic effects. Company B markets the same ingredient but makes the claim, falsely, that the ingredient builds muscle. If Company B is prosecuted and convicted for marketing the ingredient as an anabolic steroid, where does this leave Company A? While it would seem reasonable that the ingredient is an anabolic steroid only with respect to Company B, the issue is not addressed in the language of the bill.