Designer Anabolic Steroid Control Act

Whenever somebody asks me a question about prohormones, the first thing I have to do is make sure we’re on the same page. Do we even share a common definition for the word “prohormone”? The term is ambiguous even if you understand the biological role of a prohormone. This is because the scientific definition is not identical to the legal one. Adding to the murkiness is the fact that within the dietary supplement industry the definition has evolved. This also goes for the relevant laws, much of which seem to have been ad-libbed. Only somewhere near the intersection of science, the law, and historical analysis can we reach a better understanding, or at least less confusion. These definitions, as you’ll see, can have life and death consequences.

This scientific term “anabolic steroids” is the same as it’s been for a century and unlikely to change. The same consistency applies to the word prohormone, but only in a scientific sense. Again, the legal definition is constantly shifting. But when you add a stable scientific definition to a constantly shifting legal one, things can get more, not less, confusing. Some prohormones are completely legal, some are not, and nobody is sure which are which. What’s legal today may be illegal tomorrow. But scientifically, what was an anabolic steroid yesterday will remain one today and will still be an anabolic steroid tomorrow.

physically fit man doing ab workouts while wearing a face mask
Courtesy of Redcon1

Prohormones and Responsible Nutrition

My own definition of the term prohormone lies somewhere between the two options but leans heavily towards science. The reason for this slant is that science has the power to compel legislative change, but no piece of legislation carries the power to change a scientific fact. In such a fight, science always wins. In the end, we just want the word to describe a thing that we can identify. That’s the point of…well, words.

Legalities Around the Supplement Industry and Illegal Products

Neither the legal nor scientific definition is perfect. At least, not for the “prohormones” that are spoken about in the fitness world. My own practical definition of a prohormone is 1.) any substance that converts to an anabolic androgenic steroid (AAS) in the body and 2.) is not a controlled substance. The whole prohormone market exists to sell legal pills that convert in the body to AAS that can be purchased without breaking the law. This is because a prohormone is not a controlled anabolic steroid unless specifically listed under the CSA. Consumers of prohormones are AAS users. The primary goal of AAS users is muscle growth.

A more scientifically expansive definition of prohormone would include the fact that methylated and esterified anabolic steroids are modified in such a way as to make them (technically) prohormones (the more accurate term might be prodrug). Dianabol (methandrostenolone) is an oral steroid attached to a methyl group that is metabolized by the liver into (you guessed it) anabolic metabolites. A similar mechanism holds for Equipoise (boldenone undecylenate), an injectable steroid with an ester attached which the body must first detach, metabolizing it into the parent hormone (e.g. boldenone without the ester) before it exerts its effect. These two anabolic steroids have entirely different metabolites, and totally disparate effects. One is methylated and the other is esterified, but otherwise they are completely identical. Masteron (drostanolone propionate) is the injectable version of Superdrol aka methyldrostanolone, sometimes called methasterone (methyl + Masteron). The FDA refers to false labeling (misbranding) in terms that would make a typo on these labels technically into illegal drugs. From this technically-precise perspective, all steroids are basically prohormones! But this definition fails to do what we want words to do, i.e. tell us what something is (or is not).

The distinctions above fail to distinguish between regular anabolic steroids and designer steroids and steroid analogues. The politicians legislating these substances and the alphabet soup of agencies (DEA, FDA, DOJ, ETC.) regulating their use haven’t provided much help, either.

In biological terms, a prohormone is a substance that is a precursor to a hormone (pro = a prefix meaning “before” + hormone). Simple enough? Not when science meets the law. Here’s an example: the most widely used prohormone is dehydroepiandrosterone (DHEA), which is available as both an over-the-counter dietary supplement, and prescription medication. It’s a prohormone that is eventually metabolized into testosterone, making it a prohormone of testosterone. But what about testosterone itself? Well, it’s a prohormone too. Testosterone is metabolized into dihydrotestosterone (and estrogen, and a bunch of other stuff). Technically, this makes testosterone a prohormone of each of these compounds. Testosterone and DHEA are both regular hormones and prohormones.

Clarity Around New Designer Anabolic Steroids

This lack of clarity comes at a cost. I’ve recently obtained internal FDA investigatory reports (through a Freedom of Information Act request, which I’ve made available online, free to anyone who can answer the following question: “How does Google work?”). These reports are from the Food and Drug Administration, Office of Criminal Investigation (FDA OCI). In them, FDA scientists express the opinion that DHEA-derivatives are legitimate and compliant dietary supplements. Yet, at the time of this writing, the Department of Justice is prosecuting a manufacturer in the Northern District of Georgia for selling them. The disconnect between science and law creates a situation where government scientists issue opinions that are ignored by prosecutors. We can only hope juries don’t ignore them.

Testosterone and Athletic Performance

Nobody talks about testosterone as a prohormone because it’s frequently the desired target hormone of prohormones such as DHEA. In other words, athletes may consume DHEA to elevate their testosterone levels, but very few would take testosterone in hopes of elevating their DHT or estrogen levels. For the most part, all anabolic steroids fit the definition of being a prohormone of something else. The metabolites of anabolic steroids are frequently anabolic (even if minimally so) and convert to other metabolites that also may be anabolic. For example, Nandrolone is a reasonably potent anabolic, and is a prohormone of dihydronandrolone (a metabolite of nandrolone), which is still mildly anabolic.

This may sound a bit convoluted but it’s not unworkable…until you start looking at the supplement industry. Prohormones are substances that the body metabolizes into hormones. They themselves are also hormones. But at least we have a clear dividing line between prohormones and other dietary supplement categories like vitamins and minerals, right?

The Private Sector Mandates Supplements Beyond Steroids

Not so fast. Vitamin D is a hormone (go ahead, Google it). More specifically, it is a steroid hormone produced in the skin from 7-dehydrocholesterol. This is the vitamin you get from being out in the sun. Is sunlight a prohormone? Answer: probably not, as sunlight isn’t typically categorized as a “substance” but rather a form of energy. But yeah, E=mc2 so maybe sunlight is a prohormone. Here, the combination of science and the law produces definitions that are far from logically bulletproof. Luckily, when Congress began passing laws regulating the sale and use of prohormones they were unencumbered by either science or logic. But that story begins before the introduction of prohormones to the supplement market.

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The DEA’s Enhanced Authority

America’s first legal crackdown on steroids was partly to address the rising popularity of steroids in the bodybuilding community, but also because of the anti-steroid craze of the era. In large part this was a response to Ben Johnson breaking the 100m Olympic (and world) sprint record, then testing positive for stanozolol two days later. Almost immediately after Johnson was stripped of his gold medal, Congress took a hard look at scheduling anabolic steroids. They must be bad; they almost cheated America’s fastest man out of a gold medal (never mind that “our guy” Carl Lewis had recently failed three separate doping tests for banned stimulants). Congress had previously toyed with the idea of making (just) Dianabol a controlled substance. The FDA, DEA, and American Medical Association (AMA) all opposed that bill, and it died in the Senate. According to these agencies, anabolic steroids had no business being listed as controlled substances. Up until that point, a controlled substance was scheduled as a result of its (recreational) effects as (for example) a stimulant, narcotic, psychedelic, or depressant. Anabolic steroids possess none of the attributes required to schedule a drug as a controlled substance. Neither the science nor the law changed, and yet anabolic steroids still managed to fall into Schedule III of the Controlled Substances Act. The spirit of the law was being stretched, while the letter of the law was disfigured to now apply to anabolic steroids.

The resulting 1990 Anabolic Steroid Control Act took on only the most popular anabolic steroids. These were the ones widely available in most gym locker rooms. A few had already been discontinued, but there was still remaining stock for those who knew where to look. Basically, if you can name a popular anabolic steroid (like testosterone, trenbolone, or Winstrol), it was probably made a controlled substance by this law. But in 1990, prohormones were not on anyone’s radar, so they were not addressed. If you’ve been paying attention, you’re probably shouting, “all steroids are prohormones” but we’ll get around to that a bit later.

The history of prohormones as dietary supplements starts in 1996, when Dan Duchaine wrote an article that would change the dietary supplement industry forever. In the article, he introduced a new product called androstenedione. Neither the idea nor the product was his, but people cared because it was Duchaine talking about it. At the first steroid hearings, one of the witnesses testified that if horse manure were anabolic, bodybuilders would eat it. I would add that if Duchaine said horse manure was anabolic, bodybuilders would buy a ranch. It’s near impossible to calculate his influence on the market. When he told the world that androstenedione (“Andro”) was anabolic, the market crashed overnight. Companies couldn’t keep up with the demand and customers couldn’t get enough. Keep in mind that this is the same guy who introduced the bodybuilding world to whey protein, clenbuterol, DNP, insulin, and even growth hormone. His writings are now considered scripture. When he talked, people didn’t just listen; whole markets shifted. Almost immediately, variations on Andro appeared on the market (nor-andro, etc). The first generation of prohormones were barely effective (if at all), but at least they were expensive.

It didn’t hurt that androstenedione had been used with great success by the largest, most scientifically-minded, well-funded, doping program in the world. The East Germans absolutely dominated strength and power sports in the Olympics, and one of the many drugs their athletes used was – you guessed it – Andro. So in one respect, the history of prohormones really started decades before their appearance on the United States market. Recall our definition (assuming you’ve accepted my argument thus far) for a prohormone is a compound that converts to an AAS but is not a controlled substance. The second prong of that definition is inapplicable if we start at the outset of the GDR sports doping program; anabolic steroids were not controlled substances either in the GDR or the United States at that time, and their use in sports had not formally been made against the rules. Our definition requires the controlled status of anabolic steroids, yet the East German use predates the existence of anti-doping/steroid (rules and) laws.

Andro was released two years after the Dietary Supplement Health Education Act came into effect in 1994. The act, which fell under the FDA’s jurisdiction, carved out a separate category for regulating dietary supplements. Previously, they were treated as food or food additives, which wasn’t terribly accurate for most products. DSHEA also grandfathered in anything previously sold on the market, so DHEA was still allowed – which, if you think about it, is a bit weird. DHEA is an adrenal androgen (a weak anabolic steroid) and it’s also a prescription medication. Had Andro and similar products been on the market a few years earlier, they would have been grandfathered in as well.

A few years after Andro, the second generation of prohormones began trickling into the market. This included ingredients such as boldione, 1-testosterone, and 4-androstenediol. It was a few years before they fully displaced the first generation, but there was near-universal agreement on their superior results. Prohormones were (and are) unique as a category for the fact that better products were constantly displacing older, less effective ones. By the third generation of prohormones, many had stand-alone anabolic properties. In other words, third generation prohormones still underwent metabolic conversion in the body, but unlike androstenedione, this was not necessary for them to become effective.

As it stands, most of the first- and second-generation prohormones are now controlled substances, as they are listed in Schedule III of the Controlled Substances Act. Some but not all of the third generation are listed as well. Superdrol was added to the list in 2012, and according to a DEA presentation given in 2017* there are plans to add methyl-1 etiocholonolol, dimethazine, and methylstenbolone (*which I obtained through a FOIA request, and is available freely online, if you’re interested in Googling the document). Yet to date, these three steroids have not been added. Any prohormone may be added to Schedule III of the Controlled Substance Act, and we’ve seen this happen multiple times. The DEA may do this at any time, but not without notice. They also can’t schedule DHEA without an act of Congress. Dimethazine is actually a homodimer (two of the same molecule attached as a pair through an azine bond) of Superdrol, to create a different, unique, and unscheduled compound. But without an act of Congress, it’s not a scheduled compound, just like methyl-1 etiocholonolol and methylstenbolone (which is why the DEA purportedly has plans to schedule them).

Because DHEA is an anabolic steroid but not a controlled substance, it’s a bit of an outlier. There was a bill introduced to the Senate in 2007 to add DHEA to the Controlled Substances Act as an anabolic steroid but it didn’t pass. Then in 2009, the same idea was floated after the Congressional steroid hearings, with the same result. This is typically how we see anabolic steroids added to Schedule III: through an official act of Congress. Again, because anabolic steroids don’t meet the traditional requirements for controlled substances, they must be added to the CSA through a legislative act of Congress.

The other way for a substance to become controlled is for the DEA to schedule it. Congress has explicitly delegated this power to the Attorney General (who has delegated it to the head of the DEA, who I’m sure eventually delegated it to his college roommate, or his cousin or something). This type of scheduling involves following a set of criteria that includes a multi-factor scientific analysis and publication of a notice of intent in the Federal Register (which you can find online at Publishing in the Federal Register gives fair warning to citizens who are selling or using the substance and affords them the opportunity to respond and have their concerns heard. This process typically involves a notice by the regulating authority (here, the DEA), a period of replies from interested parties, and eventually responses to those replies, which potentially results in deviation from the original proposed rule by the agency. Other than by Congress passing a bill or the DEA thus adding a substance to the Schedule III list (either temporarily or permanently) there is no other way for an anabolic steroid to become a controlled substance. A prohormone is not a controlled substance (an illegal anabolic steroid) unless it appears on the Schedule III list. Whether it is legal for sale as a dietary supplement involves separate determination using a different set of criteria, which is performed by the FDA, and not the DEA. The FDA is in charge of DSHEA, the DEA is in charge of the CSA; both share overlapping responsibility under the relevant Code of Federal Regulations.

Generally speaking, in order to be permissible for sale as a dietary supplement, a new prohormone would have to be a vitamin (like vitamin D), mineral, herb, botanical, or amino acid (or combination of those categories). If it doesn’t occur in nature at the supplemental dosage, then it must go through the New Dietary Ingredients Notification (NDIN) process. That’s where a company provides the FDA with safety information, manufacturing flowcharts, and other assorted data points, and the FDA rejects the ingredient and says not to sell it. But back in 1996, when prohormones started flooding the market, the NDIN process was non-existent.

In 1998, just two years after the first prohormone crawled out of the primordial ooze, Mark McGwire was on track to break the single season record for home runs (which had been set by Roger Maris’s 61 homers in 1961). An eagle-eyed journalist, doing what journalists do, spotted a bottle of Andro in McGwire’s locker. The market exploded again, but this time instead of hardcore bodybuilders and Duchaine acolytes, it was weekend warriors who ran to their GNCs and bought every bottle they could get their hands on. Now, a student on every high school baseball team was using Andro. At this point, it wasn’t illegal and certainly wasn’t banned by the governing body of any sport in the world. This wasn’t a bodybuilding story, or even a traditional supplement industry story. This was national news, because it was the discovery of a “secret weapon” being used by the biggest name in baseball, at a time when the nation was paying attention to each at-bat: this was a time when newspapers ran front page stories about McGwire and Sammy Sosa’s neck-and-neck race to claim the record.

McGwire finished the season with 70 home runs, demolishing the previous record. Big hits sparked the revival of Major League Baseball. People were actually interested again, and attendance at games spiked, as did television viewership. By this time, four baggers were increasingly common, and players were getting noticeably…bigger. Unlike with Maris, McGwire’s record wouldn’t even stand for half a decade. By 2001 it was claimed by Barry Bonds, who hit 73 homers in a single season. The very next year, IRS Agent Jeff Novitzky opened an official investigation into the Bay Area Laboratory Co-Operative (BALCO), a sports doping ring that had been supplying athletes with designer steroids. The United States Anti-Doping agency began a simultaneous investigation. Bonds was BALCO’s crown jewel.

Just as baseball players were getting bigger and faster, hitting the ball harder, and putting butts in seats, Congress took notice. They held a series of hearings (photo opportunities), to which they invited nearly every big-name ballplayer suspected of using anabolic steroids. In 2003, Congress spent even more time addressing the “problem” of anabolic steroids in sports than any other topic. Major League Baseball didn’t have a testing policy in place until 2003, but Congress was undeterred. By that point, the horse was out of the barn (no word on whether its manure was anabolic), and an update to the Anabolic Steroid Control Act was in the works. This one took effect in 2004 and allowed the Attorney General (who, naturally, delegated this power to the DEA) to add new substances to the existing list of illegal anabolic steroids. Bizarrely, Congress specifically crafted the 2004 Act to allow a substance that wasn’t “anabolic” to be added to the list of illegal anabolic steroids. Re-read that sentence. Congress wrote the 2004 Act in such a way that anabolic steroids no longer needed to be anabolic to be considered…uhh…anabolic steroids. Remember the beginning of this article when I said we’d be using my own definition(s) for some terms? Yeah, this is why.

The 2004 Act was written in such a way as to ignore science (and logic), and Andro was added to the list of illegal anabolic steroids specifically to address the problem of prohormones. By this time, the market was flooded with prohormones that converted to everything from nandrolone to boldenone, and everything in between. But the undisputed king was Superdrol, a methylated version of the injectable steroid Masteron. Superdrol was (and is) so good (h/t- M.C.), that it’s still found on underground price lists, and being manufactured by overseas (and domestic) labs.

The United States Anti-Doping Agency was also conducting parallel investigations at the same time as government agencies. These USADA investigations are important because although the organization was created by an act of Congress and receives much of their funding from tax dollars, they are not a government agency per se. Despite not being a government agency, they will work with the DEA and FDA on matters like this and engage in ham-fisted attempts influence both agencies behind the scenes. Recently they have stepped into a trial support role for the DOJ, with USADA scientists performing duties typically reserved for DEA scientists. But unlike actual government agencies, USADA is not subject to any checks or balances. They’re not subject to any reasonable oversight, such as compliance with the Freedom of Information Act. Athletes facing a USADA investigation do not have the protection of due process.

Naturally, USADA is staunchly anti-prohormone and (less staunchly) anti-dietary supplement. The problem is that USADA wants to be like Congress and write laws. Because hey, as long as prohormones are banned in sports, why not make them illegal too? One month after BALCO headquarters was raided by government agents in late 2003, USADA announced their parallel investigation into a “doping conspiracy.” Of course, when USADA investigates doping, they’re not forced to recognize stuff like…the Constitution or the Bill of Rights. Or anything else the founding fathers recognized as a safeguard against tyranny.

In February of 2004, an indictment was filed against the principals involved with BALCO. Notably, this included the very man (inventor isn’t quite right, since it’s naturally occurring) whose idea it had been to put Andro on the supplement market. By this time, everyone knew what Andro was and who had come up with the idea. When the BALCO story broke, Andro and prohormones were naturally part of the story. One month later, the Anabolic Steroid Control Act of 2004 was introduced in Senate. Steroid legislation is a direct result of doping in professional sports and the media attention it generates. We can trace each of these acts to professional athletes with tainted urine, not a legitimate social problem.

The Anabolic Steroid Control Act of 2004 was crafted to make prohormones illegal, to explicitly schedule certain ones that Congress thought should be removed from the market, and to remedy a problem with the definition of anabolic steroids (*that they’re…you know…anabolic). Originally, among other things, the definition of anabolic steroids required proof that a given substance was anabolic. But in attempting to schedule many first generation prohormones, the DEA was unable to demonstrate this quality. My own conclusion is that the anabolic effects were either absent entirely or so minimal that they could not be observed in the anabolic/androgenic studies typically conducted on rodents. Given the fact that nobody got huge using this stuff, it seems logical that the science reflected reality (*the reality of homerun records would seem to indicate that Andro was not the only substance in play). Instead of succumbing to reality, he DEA’s chosen course of action was to ask Congress to change the requirements, rather than admit shortcomings in their methodology or that (gasp) some of what was scheduled simply isn’t anabolic. The fact that laws can not change science will not stop the DEA from asking Congress to legislate in a fashion that ignores science. And common sense. This is exactly what we saw with the prior steroid control act (1990), where steroids didn’t fit the scientific requirements to be controlled substances, so Congress legislated around (and ignored) the science.

Compliance arguments for prohormones were easily made at first. These are the arguments a supplement company must make in order to sell an ingredient (“it’s found in geraniums…”). Androstenedione occurred naturally and could be found in the food supply. The general rule was that if it could be found in nature, the FDA would leave you alone. At some point they decided that every synthetic ingredient (post 1994) required an NDIN, even if it was merely a synthesized version of an otherwise naturally occurring substance. Then an appellate ruling out of the 11th Circuit said otherwise (after 25 years of the FDA enforcing a completely made-up regulation, and issuing public warning letters to companies). Because this wasn’t challenged through judicial review when the FDA first proposed this interpretation (a whole cloth fabrication), it stood unchallenged.

A note about FDA Warning Letters: they’re legally worthless. They’re not economically worthless, because they cause untold damage to the recipient’s goodwill in the marketplace, but they’re a legal nothingburger. They confer neither rights nor obligations upon the recipient. As a result, they can’t be challenged in court (not subject to judicial review) because they’re a legal nullity. They’re a way for the FDA to publicly shame a company and cause retailers to stop carrying certain products, all while not being held accountable or forced to defend their position. Take the FDA to court over a Warning Letter, and the first thing they say to the judge is “Whoa, this isn’t a final action, it’s no big deal, it’s just an opinion.” But it’s an opinion that can nevertheless crush a business. The FDA once declared Cheerios a drug in a Warning Letter, and another time cited a company for misbranding when they included “love” as an ingredient (h/t- J.M.).

Some prohormone manufacturers became more creative with their compliance arguments-one prohormone occurred naturally in the intestines of horses, and therefore (?) in the food supply. Another could be found in the feces of certain animals. I know some of the people who made these arguments, although not well enough to vouch for the veracity of these compliance arguments… but I’m not in a hurry to find out.

The 2004 Act was hardly the first piece of legislation that caused as many problems as it “solved.” But it took another decade before Congress passed their latest act to regulate prohormones in the nutritional market. Drawing on (and misinterpreting) a popular phrase from the BALCO investigation, Congress started looking into “designer steroids.”

This was an expected development, as the chemist who came up with the idea for Andro was also synthesizing designer steroids for BALCO. The designer steroids in question were tetrahydrogestrinone (THG) and norbolethone. Although Agent Novitzky was successful in his BALCO investigation (producing arrests, prison time, and fines), none of baseball’s steroid era heroes (players) ever saw the inside of a jail cell. There was particular outrage at the government for the expenses incurred by those prosecutions. For Barry Bonds it cost taxpayers approximately $50 million dollars and for Roger Clemens it was around $3-5 million. Congress decided it might be easier and less expensive just to make “designer steroids” illegal through another control act.

This happened, despite the fact that when the 2004 act was in the process of being passed, a congressman, speaking to Congress, noted that he had originally proposed legislation to make all designer steroids illegal, but was later convinced by the judicial chair that such legislation would never have survived legal scrutiny. This is because “designer steroid,” by the original definition, is almost a non-definition. It defines the term as much by what it is, by what it is not.

The original definition (which is still in use) of designer steroids describes an anabolic steroid specifically created to avoid detection by anti-doping authorities. This is the definition I use in the books I have authored, and it is the definition used by most fellow authors in the genre. It’s also the original definition used by the scientific community:

“These steroids are manufactured to closely resemble existing known compounds, but with sufficient chemical diversity to ensure that their detection by the WADA accredited laboratories is more difficult.”[1]

“Designer anabolic steroids are deemed ones that are manufactured specifically to circumvent doping tests in human sport…”[2]

Hence, creation of a legitimate designer steroid involves the synthesis of a novel compound, one so unique that the parent molecule has a dissimilar structure to any detectable (and tested-for) anabolic steroid. The parent molecule also must fail to convert to a detectable anabolic steroid or metabolite. This is the definition Congress received from the head of USADA:

“The proliferation of designer steroids began with an effort by rogue chemists to create steroid compounds that would allow an athlete to dope without being detected through routine anti-doping screening procedures.”

The BALCO chemist (or if you prefer, the Andro Chemist), appearing as a government witness against professional cyclist Tammy Thomas, defined a designer steroid as a substance with steroid-like effects that would not be detectable on a doping test:

Q: Please explain what you mean by that term, “designer steroid.”

A: Well, what I mean by that is that it was not a compound that had ever been manufactured before, had never been synthesized.

Q: Was part of your intent with THG to have a substance that would have steroid-like effects but not be detectable by the sports testing authorities?

A: That’s the primary reason THG was developed, yes. That definition accorded with the one given by the world’s foremost anti-doping chemist when he testified for the government against Barry Bonds:

Q: Now, are you familiar with the term “designer steroids”?

A: Yes.

Q: What do you understand that to mean?

A: It’s-It’s meant to mean many different things and it’s really misused. But a designer steroid, strictly speaking, is a new steroid that has just been found and has never, ever before been found. Nobody has ever seen it before, nobody has ever described it, nobody has ever gotten a spectrum of it. (155 18-25). Somebody created it and put it out there. That would be a designer steroid. There’s very few of those. Only one.

As the witness points out, the term is widely misused. The scientific literature even misuses it (now, but not when these testimonies were given), when referencing designer steroids as being nearly identical to known anabolic steroids, but altered minimally to avoid illegality through a steroid control act. But this definition is nonsensical, a designer steroid cannot be simultaneously an unknown molecule, unlike any other, while also being nearly identical to a known compound. This may be the exact reason why Congress avoided any legislation that attempted to define the term at all. In fact, they purposely rejected it on multiple occasions.

This rejection took a while. There wouldn’t be another attempt to regulate sales of prohormones and anabolic steroids until the Designer Anabolic Steroid Control Act – almost a decade later. Surely Congress would adopt the same definition provided by the nation’s foremost experts. Nope, not even close. In fact, the phrase “designer steroid” isn’t defined at all in DASCA. Apart from the title, it doesn’t even make a cameo. Remember 2010, when USADA kicked off an investigation and prosecution into “designer steroids” that it subsequently lost? Well, the ingredient in question was exactly the opposite of what the definition above describes. The government (i.e. DOJ lawyers) seems to interpret “designer steroid” in a variety of contradictory ways, depending on the substance in question. If you’re keeping score at home, that’s not how the law works-the government’s lawyers can’t make up a new (contradictory) definition to create a crime whenever they want.

Throughout the time between the 2004 Act and DASCA, the market exploded, and it would be easy to point a finger at numerous “reputable” dietary supplement companies who had their start shilling prohormones. With little to no knowledge of either the chemistry or biology involved, a manufacturer could quite easily take a bottle that cost $6 in raw materials and turn it around for a retail price of $60. This was and is an incredibly easy revenue stream, as minimal expertise is required to rebrand raw ingredients.

In early 2009, Philadelphia Phillies relief pitcher J.C. Romero failed a doping test. The culprit was claimed to be a dietary supplement purchased at a local GNC, and the manufacturer was the same chemist responsible for Andro (and BALCO). As a result, a senator from Pennsylvania wrote a steroid provision into the Food Safety and Modernization Act. This time, designer steroids were the target instead of prohormones, and the goal was to make both designer steroids and their analogues illegal. Although the first iteration included a definition for “anabolic steroid analogue,” that definition is no longer relevant, as that term was completely removed from subsequent iterations (along with any instance of the word “analogue”). As expected, the provision didn’t make the final cut, but the whole point had been to put something on paper that could be addressed by the next session of Congress.

In 2010, USADA tipped the FDA off to a dietary supplement company (Primordial Performance) selling “designer steroids,” kicking off a five-year investigation and six-count criminal indictment. On the eve of trial, the prosecution removed one of the six charges (which had likely been added to improve their chances of forcing a plea bargain). In 2016, a jury found the company not guilty on each of the five charges, but by that point they were out of business. The owner suffered not only the reputational damage of a very public indictment but the financial damage of having his company ruined, even though he had still beat the charges. And the money the government spent on the prosecution? USADA certainly didn’t cut the taxpayers a check for the waste.

Around the time the first version of DASCA appeared, the FDA’s Office of Criminal Investigations began investigating a company selling prohormones-Primordial Performance. None of these prohormones were on the naughty list. Nonetheless, Agent Novitzky, who had become an agent of the FDA OCI, went undercover* to investigate the company further (*he phoned the company pretending to be a customer-undercover operations into dietary supplements don’t exactly require the assistance of a Donnie Brasco).

In the interest of full disclosure, I have spoken to this agent more than once. I have also known the owner of Primordial Performance since before the official launch of his company. The creator of Superdrol? One of my closest friends. The BALCO chemist? Not so much. But I’ve interacted with him on more than a few occasions. While I don’t know the politicians who crafted the various laws and regulations governing prohormones, anabolic steroids, and designer steroids, I know virtually all of the people who were central to the history of these compounds (not on paper, but in the real world). I’m not sure if this might make me more or less biased, but there it is.

As far as Primordial Performance is concerned, their products were a type of DHEA combined with some other non-hormonal bells and whistles to enhance absorption. None of the laws concerning prohormones specifically address potential variations of DHEA, but the wording of the 2004 Act strongly implies that they are not illegal. As the investigation progressed, the DOJ asked an FDA scientist for his opinion on the products in question. Please take a moment to reflect on this: the government invested time and money investigating a company without first knowing if what they sold was actually illegal. That’s a problem. But what happens next is even worse.

It took me approximately four years to obtain the relevant records from the FDA pursuant to a FOIA request (I’ve made the Investigative Reports available online, for free). Of particular interest they show that an FDA scientist, Robert Moore, examined DHEA derivatives being sold by Primordial Performance, and determined them to be eligible dietary ingredients. Nevertheless, in 2017, the United States government indicted another individual for selling these same ingredients. It seems to me that prosecutors should be following the scientific criteria for legality, but that doesn’t appear to be how it works. Of course, that scientist disappeared before the Primordial trial, and was never able to be called as a witness. The trial was originally based on (false) accusations of selling anabolic steroids. By the end, the trial centered around minimal (too low to have a physiological effect) amounts of anabolic steroids found in the products in question (adulteration resulting from the synthesis of the products, not actual ingredients added to break the law).

Leading up to that case, because J.C. Romero had tested positive, the stage had been set for the first Designer Anabolic Steroid Control Act in 2010. Many third-generation prohormones were included by name in the act. In the process, the language about analogues was removed, but much of the rest remained intact. If passed, this bill would have made it possible for the government to prosecute dietary supplement companies and their owners for selling unlisted substances-and this would have been possible, if and only if, it could be proved at civil or criminal trial that they were anabolic steroids. Imagine a company selling a prohormone: the government would now be able to arrest the owner for selling an anabolic steroid. Then, the government would be able to prosecute the seller, not because the law said a specific compound was an illegal anabolic steroid, but rather because the law said that it “could be” an anabolic steroid if it were proven to be one at trial. That’s not how science works, by the way. A scientific fact is a scientific fact, regardless (or in spite of) 12 people agreeing that it is. The bill failed to pass in 2010. The word “analogue” was subsequently removed. In 2012 it was reintroduced to the Senate, and again failed to pass. Then an interesting thing happened.

In 2014, DASCA was introduced as written to the Senate and in a different form to the House of Representatives. For the third time (if we don’t count the attempt to slip it into the Food Safety Modernization Act), the bill died in the Senate. But the House passed it. The difference between the bills was small but important. The version that passed excluded the part allowing prosecution for unlisted compounds based on trial evidence.

Why did it fail to pass every other time? I think the answer is clear that Congress did not want to see prosecution for selling “anabolic steroids” that were neither listed nor formally controlled substances. I mean…there wasn’t even an attempt to define “designer steroid” in the legislation. Certainly, Congress is justified in relying on scientists to make these determinations. Lawyers (and the general public) are likewise justified in relying on the statutes, and rules established to interpret such statutes. In legal parlance, the way statutes are interpreted is referred to as statutory construction, and this type of interpretation consists of “canons of construction” (the legal rules governing criteria by which a law must be applied). Without going too deeply into canons, legal scholars are thus far united in opinion that Congress did not, and does not, intent for unlisted anabolic steroids to be prosecuted as such. Outlining what is and what is not an anabolic steroid is clearly the domain of scientists, and not the that of a jury or the prosecution, right? Wrong.

Prosecutors have made these calls even when DEA scientists stand in opposition (don’t worry, those “scientists” have been known to change their opinion just in time for testimony, and none have ever faced perjury charges as a result). Department of Justice lawyers ignore and (purposely?) misrepresent canons of construction in their efforts to prosecute defendants under dubious interpretations of the law. For example, at the time of this writing, Natalie Barton sits in a Louisiana jail cell. She has been charged under DASCA with selling designer steroids. But as we know that term is undefined in the Act. How can she be charged with selling something the law has failed to define?

According to court documents, she is a cancer survivor with some additional mental health concerns and is at extreme risk of contracting COVID-19. The facility where she is confined is overpopulated and inmates are crammed into cells thisclose. The virus is rampant throughout the entire prison system, but it’s especially bad in the close, overpopulated quarters where she is confined. The Department of Justice has fought to keep her confined while awaiting trial, while her state appointed counsel has fought valiantly, though unsuccessfully, to free her. The government has turned this into a life and death situation, opting to put a non-violent offender at risk of contracting what could be (to her) a fatal virus. But hey, innocent until proven guilty, right?

There are currently companies in the industry selling what they believe – and have every reason to believe-are legal dietary supplements. These same people fear that their door might be kicked in at any moment when a prosecutor decides they’re in the business of writing laws instead of following them.

The Primordial Performance case was overcharged. This happens when prosecutors charge defendants with excess counts, with the purpose of bargaining some of the excess away on a plea deal. But there was no deal here, and the prosecution had to remove one of the excess charges (from six charges down to five) on the eve of trial. This would avoid the embarrassment of having to admit a lack of evidence at trial, and making the other charges look weak by association. It worked. Sort of. Instead of being embarrassed with a not guilty verdict on six counts, the Department of Justice was embarrassed with a not guilty verdict on just the remaining five. The investigation took roughly half a decade and was based entirely on trace amounts of adulterants, plus some overzealous marketing statements. The jury wasted little time deciding that the government failed to prove its case, and showed no interest in the pseudo-science wielded by the prosecution.

By now, I think the need for clarity in the terms prohormone, designer steroid, and even anabolic steroid, has become self-evident. At least in a legal sense, the terms should be defined in a consistent way, and shouldn’t be so flexible as to allow the government to violate due process and indict people under a fabricated definition, not provided by any law. I hope, now that our time is over, we not only agree on these definitions, but that stakes are not only felt in the market and in the gym, but are literally no less than life and death in some instances.


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