{"id":4743,"date":"2014-05-14T17:55:31","date_gmt":"2015-06-06T17:28:39","guid":{"rendered":""},"modified":"2015-06-19T07:56:13","modified_gmt":"2015-06-19T14:56:13","slug":"designer-anabolic-steroid-control-act-2012","status":"publish","type":"post","link":"https:\/\/www.elitefitness.com\/articles\/designer-anabolic-steroid-control-act-2012\/","title":{"rendered":"Designer Anabolic Steroid Control Act of 2012 will Eradicate Steroids from the Retail Supplement Market"},"content":{"rendered":"

My friend and EF Platinum Member Rick Collins<\/a>, JD, is the lawyer that members of the bodybuilding community and nutritional supplement industry turn to when they need legal help or representation. He and his firm represent dietary supplement companies nationwide, and he has personally defended steroid criminal charges from coast to coast. This week, he shares with us his recent article \u201cThe New Designer Steroid Bill and YOU.\u201d This is a sad day for bodybuilding and the dietary supplement industry. Read on...<\/p>\n

Q: What is the \u201cDesigner Anabolic Steroid Control Act of 2012\u201d?<\/strong><\/p>\n

\"Designer
\nA:<\/strong>
\nIt\u2019s a Senate Bill (SB 3431) introduced by Senators Orrin Hatch (R-Utah) and Sheldon Whitehouse (D-R.I.) and referred to the Judiciary Committee.\u00a0 If passed by Congress, it will amend the Controlled Substances Act to more aggressively regulate steroidal substances being sold as dietary supplement ingredients.\u00a0 The clear intent is to remove remaining \u201cprohormone\u201d products from the market and prevent new ones from being introduced. \u00a0The 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.\u00a0 Here\u2019s what Sen. Whitehouse said in introducing the bill on July 25th, 2012:<\/p>\n

\u201c\u2026 I am pleased to join Senator Hatch<\/em> 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\u2019s work in the previous Congress, and I thank him for his leadership on this issue.<\/p>\n

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.<\/p>\n

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\u2019s, 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.<\/p>\n

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, \u2018all 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.\u2019<\/p>\n

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.<\/p>\n

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: \u2018in 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.\u2019'<\/p>\n

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\u2019s [sic] under false labels.<\/p>\n

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\u2019 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.<\/p>\n

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.\u201d<\/p>\n

Q: Is the bill specific in naming the substances to be added to the list of anabolic steroids?<\/strong><\/p>\n

A:<\/strong> The \u201cDiscussion Draft\u201d 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)].\u00a0 The bill presents the chemical nomenclature for these substances.\u00a0 Some of the chemical names listed, according to steroidal supplement guru Patrick Arnold, contain errors or refer to compounds that may actually not exist.\u00a0 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.\u00a0 This isn\u2019t the first time that Congress has expanded the list of anabolic steroids.\u00a0 The original list, compiled in 1990, was amended in 2004 to include androstenedione and a variety of other steroidal products.\u00a0 The DEA later issued a Final Rule (\/\/www.gpo.gov\/fdsys\/pkg\/FR-2009-12-04\/pdf\/E9-28572.pdf<\/a>), 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). \u00a0Then 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.\u00a0 The Final Rule on these two was issued on July 30th, 2012 (\/\/www.gpo.gov\/fdsys\/pkg\/FR-2012-07-30\/pdf\/2012-18495.pdf<\/a>), effective August 29th, 2012.\u00a0 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) \u2026 and by design, misses very few.<\/p>\n

Q: What about steroidal substances that are not on the list?<\/strong><\/p>\n

A:<\/strong> The bill changes the way unlisted steroidal compounds are dealt with.\u00a0 It says that \u201ca drug or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed \u2026 and is derived from, or has a chemical structure substantially similar to, 1 or more [listed] anabolic steroids [is considered an anabolic steroid] if \u2026 [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].\u00a0 Notice that there\u2019s no proof requirement that the substance actually<\/em> promote muscle growth or act like testosterone pharmacologically \u2013 only that it\u2019s created, manufactured, marketed or promoted with the intent<\/em> of doing so.\u00a0 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<\/em> is also created or<\/em> marketed to build muscle or have a pharmacological effect like testosterone is marketing an anabolic steroid.\u00a0 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.\u00a0 Company B markets the same ingredient but makes the claim, falsely, that the ingredient builds muscle.\u00a0 If Company B is prosecuted and convicted for marketing the ingredient as an anabolic steroid, where does this leave Company A?\u00a0 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.<\/p>\n

Q: Are there any exemptions provided in the bill?<\/strong><\/p>\n

A:<\/strong> Yes.\u00a0 Unlisted steroidal compounds that are herbs or botanicals are exempted.\u00a0 So are concentrates, metabolites, and extracts of an herb or botanical, or a constituent isolated directly from an herb or botanical.\u00a0 This provision was drafted as an acknowledgement to the current position of the Food and Drug Administration (FDA) articulated with respect to New Dietary Ingredients (NDI\u2019s): that a compound is a \u201cconstituent\u201d of a botanical only if it is isolated directly from it, and not<\/em> if it is instead synthetically created in a lab.\u00a0 The bill further connects the Controlled Substances Act with the Dietary Supplement Health and Education Act (\u201cDSHEA,\u201d a part of the Food, Drug, and Cosmetic Act) by requiring that any exempted substance must be a \u201cdietary ingredient\u201d under DSHEA.\u00a0 And the bill puts the burden of DSHEA compliance on the marketer, by providing that anyone \u201cclaiming the benefit of an exemption [has] the burden of going forward with the evidence.\u201d\u00a0 In other words, somebody arrested for selling an anabolic steroid whose defense is that it is an exempted constituent would have the burden of showing evidence of DSHEA compliance.<\/p>\n

Q: Does the bill make it easier to add new unlisted substances to the list?<\/strong><\/p>\n

A:<\/strong> It does, by amending a different section of Title 21 [21 USC 811] to provide a fast-track for scheduling.\u00a0 The Attorney General may issue a temporary order, to take effect 30 days after publication, adding a substance to the list if it meets certain criteria.\u00a0 The temporary order \u201cis not subject to judicial review\u201d and a permanent order could be simultaneously sought.\u00a0 But the bill also provides that an unlisted steroidal substance can be considered an anabolic steroid if it\u2019s determined to meet the criteria of an anabolic steroid \u201cin any criminal, civil, or administrative proceeding arising under this Act.\u201d\u00a0 So, while the Attorney General has the power to declare substances to be anabolic steroids through the rulemaking process, unlisted substances can nevertheless be considered to be anabolic steroids without prior rulemaking notice<\/em> if it\u2019s proven in a court of law, such as during a criminal prosecution of a supplement company or its principals.\u00a0 But the bill also makes it easier for the Attorney General to add new compounds because it changes the criteria and tosses out the rigorous scientific inquiry currently required.<\/p>\n

Q: How would the criteria for administrative action change under the proposed new law?<\/strong><\/p>\n

A:<\/strong> Under current requirements, the DEA has to extensively examine peer-reviewed published literature and sometimes even undertake its own pharmacological assay studies to determine if a compound has androgenic and anabolic activity similar to testosterone.\u00a0 This can be a huge, lengthy, complicated endeavor, and the DEA has been far from wild about it.\u00a0 For example, back in September 2009, Joseph Rannazzisi, Deputy Assistant Administrator at DEA\u2019s Office of Diversion Control, testified before the Crime Subcommittee at the hearing (\u201cBody Building Products and Hidden Steroids: Enforcement Barriers\u201d) referenced this month by Sen. Whitehouse in introducing the bill.\u00a0 Mr. Rannazzisi expressed the hurdles imposed by the current law, citing as an example the difficult process of scheduling boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione which was, at that time, in its final stages.\u00a0 He also testified that a review of three (3) additional compounds \u2013 methyldrostanolone (methasterone), prostanozol, and adrenosterone (misspelled adrenostreone in his written statement) \u2013 had begun.\u00a0 But although three compounds were reviewed, only two were scheduled.\u00a0 Neither the notice of proposed rulemaking in November 2011 nor the Final Rule issued in July 2012 referenced adrenosterone, a compound sold under the name \u201c11-oxo.\u201d\u00a0 Were there problems proving some aspect of the requirements?\u00a0 We don\u2019t know, and the implications from this are open to debate (note also that the substance is also not listed among the specific compounds in the new bill).\u00a0 In any event, under the new definition of an anabolic steroid, the process for scheduling is much easier.\u00a0 If the compound is derived from, or has a chemical structure substantially similar to a listed anabolic steroids, and it\u2019s not an estrogen, progestin, corticosteroid or DHEA, then it\u2019s considered an anabolic steroid merely if it\u2019s been created or manufactured with the intent of being anabolic or androgenic or if it\u2019s marketed or promoted to suggest that it\u2019s anabolic or androgenic.\u00a0 The new definition offers an enormous reduction in the DEA\u2019s burden to schedule a new steroid.<\/p>\n

Q: Weren\u2019t many of these supplement products already illegal under the Food, Drug, and Cosmetic Act?<\/strong><\/p>\n

A:<\/strong> Yes.\u00a0 Many of these substances were synthetically created compounds and did not meet the criteria to be sold as dietary supplements under DSHEA.\u00a0 Since they were not DSHEA compliant, they were unapproved and mislabeled \u201cdrugs\u201d and the FDA had the authority to investigate and bring charges for federal prosecution.\u00a0 Until recently, however, many in the supplement industry didn\u2019t understand the criminal penalties for non-DSHEA compliance, or didn\u2019t take the threat seriously.\u00a0 But that has changed since a number of sports nutrition companies were prosecuted for selling prohormone products in the wake of the execution of a search warrant on a distributor\u2019s Boise, Idaho facility back in 2009.\u00a0 Some of the same substances now being added to the list of anabolic steroids under the Controlled Substances Act were already declared illegal drugs under the Food, Drug, and Cosmetic Act (FD&CA) ... and the companies selling them were prosecuted federally and convicted. \u00a0The new bill, however, gives the DEA \u2013 often viewed as more aggressive at enforcement than the FDA \u2013 the authority to take action.\u00a0 Also, by classifying these substances under the Controlled Substances Act, the new bill escalates the severity of potential punishments.<\/p>\n

Q: What does the bill say about sentences for steroid crimes?<\/strong><\/p>\n

A: The bill directs the United States Sentencing Commission to \u201creview and amend the Federal sentencing guidelines.\u201d\u00a0 The last time Congress directed this, the Commission brought the hammer down and greatly escalated the punishments for steroid trafficking crimes by re-calculating the way steroids were quantified.\u00a0 As of 2006, injectable and oral steroids became quantified for punishment in a 1:1 ratio to other Schedule III drugs, resulting in a twenty-fold<\/em> measurement increase for injectable steroid units and a whopping fifty-fold<\/em> increase for oral steroid units.\u00a0 One \u201cunit\u201d of an\u00a0oral steroid became one pill, tablet or capsule rather than fifty; one unit of a liquid steroid was reduced to .5ml rather than 10ml, and steroids in other forms (\u201ce.g., patch, topical cream, aerosol\u201d) were to be reasonably estimated based on a consideration of 25mg as one unit.\u00a0 We don\u2019t know exactly what the Commission will do if this new bill passes, but the bill specifically directs that for steroid products where dosage cannot be readily ascertained, such as powders or topical creams, that \u201cthe sentence shall be determined based on the entire weight of the mixture or substance.\u201d\u00a0 So, a person trafficking a kilogram of pure testosterone powder would be at the same federal sentencing level as the person who was selling a product that contained a small or even trace amount of testosterone.<\/p>\n

Q: What does the bill say about the way products are labeled?<\/strong><\/p>\n

A:<\/strong> The bill introduces a whole new theory by which to prosecute these cases by making it a crime to import, export, manufacture, distribute, dispense, sell, offer to sell, or possess with intent to manufacture or sell any anabolic steroid, or any product containing an anabolic steroid, unless it bears a label clearly identifying the anabolic steroid by accepted (IUPAC) nomenclature.\u00a0 This provision would apply to manufacturers who use deceptive or \u201ccreative\u201d ingredient labeling to conceal that the product is an anabolic steroid.\u00a0 It would also apply to distributors and retailers who know, intend, or have reasonable cause to believe<\/em> that the product contains an anabolic steroid.\u00a0 Criminal penalties can be up to 10 years imprisonment and massive fines (up to $2.5 million on corporations).\u00a0 Civil penalties can be up to $500,000 per product violation for importers, exporters, manufacturers and distributors.\u00a0 Even retailers can be hit with a $25,000 penalty per product violation (and each package size, form, or differently labeled item is a separate product).<\/p>\n

Q: What impact would this bill have on consumers?<\/strong><\/p>\n

A:<\/strong> The bill would have a huge impact on consumers.\u00a0 While marketing prohormones that are currently illegal under DSHEA and the FD&CA subject the marketers to criminal sanctions, consumers don\u2019t face charges.\u00a0 Simple possession itself is not illegal.\u00a0 All that changes when a compound becomes classified as a controlled substance.\u00a0 By reclassifying these compounds into controlled substances, this bill criminalizes the consumers<\/em> as well as the marketers (the DEA\u2019s Final Rule on prostanozol and Superdrol, once effective, will do this on those two compounds).\u00a0 Being in simple possession of a compound that is a controlled substance is a federal crime \u2013 a federal misdemeanor that carries with it up to a year of incarceration.\u00a0 But it likely won\u2019t stop there.\u00a0 If the bill passes, it\u2019s quite probable that individual states<\/em> will view what Congress did as an important step in protecting the public, especially children, and will seek to amend their own laws to be consistent with the new federal law.\u00a0 In some states, though, simple possession of an anabolic steroid is a felony, not a misdemeanor, and in those states the simple possession of any of these compounds would be a felony<\/em>.\u00a0 If states follow suit, a person caught during a car stop with a single capsule of 6-bromo, for example, would be charged with either a misdemeanor or a felony (depending on his or her state\u2019s law).\u00a0 An old bottle of Superdrol sitting in a gym bag would be like illegally having a bottle of Vicodin.<\/p>\n

Q: Do you think this bill will achieve the intended purposes of Congress?<\/strong><\/p>\n

A:<\/strong> \u00a0Unlike the poorly conceived and drafted 2004 amendment to the Anabolic Steroid Control Act, this bill shows an investment of considerable effort and thought.\u00a0 It\u2019s clear that the intent behind it is to eradicate steroidal ingredients from the retail supplement market.\u00a0 This bill has the potential to accomplish that.\u00a0 It even requires the Administrator of the DEA to keep Congress in the loop by reporting to them every 2 years on what new steroids have been scheduled.\u00a0 Of course, the bigger picture is unclear.\u00a0 Will consumer demand for steroidal substances that may build muscle disappear?\u00a0 Or will the reclassification of these items and their removal from the dietary supplement market lead to the creation of a black market for them \u2026 or to an increased demand for the traditional pharmaceutical anabolic steroids already on the black market?\u00a0 The realities of demand and supply and our experience with alcohol Prohibition would suggest that legislative efforts like this one don\u2019t entirely eliminate problems but instead may push them underground.\u00a0 Time will tell.<\/p>\n

Q: What do you predict for this bill?<\/strong><\/p>\n

A: <\/strong>Senator Hatch is viewed as a stalwart advocate for dietary supplements.\u00a0 So, when he sponsors legislation to restrict the industry, many in Congress will see it as something that sorely needs to be done.\u00a0 The bill has received the overwhelming support of the large industry trade groups and there is no organized opposition.\u00a0 Unless there\u2019s some unexpected curveball tossed out, or Earth is hit by an asteroid, there\u2019s a high likelihood the bill will pass.\u00a0 For future updates and analysis, visit www.supplementcounsel.com<\/a> and www.steroidlaw.com<\/a> or follow me on Twitter (@RickCollinsEsq<\/a>) and at Facebook.com\/RickCollinsOnline<\/a>.<\/p>\n

 <\/p>\n

Rick Collins, JD, CSCS [www.rickcollins.com<\/a>] is the lawyer that members of the bodybuilding community and nutritional supplement industry turn to when they need legal help or representation.\u00a0 He and his firm represent dietary supplement companies nationwide, and he has personally defended steroid criminal charges from coast to coast.\u00a0 He can be reached at 516-294-0300.\u00a0 [\u00a9 Rick Collins, 2012.\u00a0 All rights reserved.\u00a0 For informational purposes only, not to be construed as legal or medical advice.]<\/strong><\/p>\n

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My friend and EF Platinum Member Rick Collins, JD, is the lawyer that members of the bodybuilding community and nutritional supplement industry turn to when they need legal help or representation. He and his firm represent dietary supplement companies nationwide, and he has personally defended steroid criminal charges from coast to coast. 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