Staying in bounds: Part 2, Sports nutrition enforcement trends

Editor’s note: This is the second installment of a two-part series, Staying in bounds: Policing and penalties in sports nutrition, an excerpt of which appeared in the recent digital magazine Innovation in sports nutrition.

Roundtable overview

If competitive sports can be a game of inches and of winners decided by hundredths of a second or point, why wouldn’t athletes hunt for the slightest of potential advantages, including via dietary supplements? This is indeed the core culture of sports and sports nutrition, from the consumers back through the brands, but with this thirst and game plan comes the high potential for wrongdoing. Many such entrepreneurial risk-takers have found themselves on the wrong side of the law and facing significant fines and jail time, not to mention severe damage to their reputations. It’s “any given Sunday” in the sports nutrition regulatory arena, where sometimes the companies win and sometimes the regulators score a victory.

Natural Products Insider welcomed two longtime sports nutrition industry experts to a roundtable discussion on the regulatory climate in sports nutrition, including what actions and ingredient types tend to hit FDA’s radar and what level of enforcement is appropriate and effective. Rick Collins, Esq., partner at Collins Gann McCloskey & Barry PLLC, and Doug Kalman, PhD, RD, vice president of scientific and regulatory affairs at Nutrasource and co-founder of the International Society for Sports Nutrition (ISSN), offer insights on the finer points of sports nutrition regulation, answering many burning questions about this very active segment of dietary supplements.

In part two, the discussion turns to enforcment trends, including criminal actions and various penalties. 

Enforcement trends: Penalties and consequences

Insider: Let’s switch to enforcement. Is sports/active nutrition getting sufficient enforcement attention?

Collins: FDA has a division called the Office of Criminal Investigations (OCI) to conduct and coordinate criminal investigations. They work with the DOJ and various U.S. Attorney’s Offices to prosecute violators of the food and drug laws. OCI has a relatively small number of field agents and has been somewhat sporadic and limited in its criminal enforcement activity other than in certain product categories, or if there’s a serious public safety issue. FDA typically mentions weight loss, male enhancement and bodybuilding products as categories of concern. But it targets only a few of the many violators. Organized enforcement operations are few and far between.

Insider: Of course, the “bodybuilding” category is sports nutrition, right?

Collins: Yup. And that generally breaks down into steroid/steroid-like substances (“prohormones”), SARMs, which I mentioned earlier, and DMAA and similar stimulants. Each was the subject of public FDA advisories several years ago:  

Kalman: I would add FDA has always had a special focus on products that attempt to take advantage of a person, products offering cures from cancer or HIV or other debilitating diseases, and products that contain undeclared and illegal ingredients. It also seems that from a products perspective, yes, FDA and other agencies have gone after individuals and companies who were selling these questionable compounds (i.e., prohormones, pro-drugs), and rightly so. From a dietary supplements perspective, it does appear that weight loss, sexual health and sports nutrition are the three categories that FDA focuses most on when it comes to screening products for illegal ingredients/medicines. We should not forget that FDA had, in the past, singled out brands and products of concern as related to “steroid-like substances."

References:

Insider: Can you give us some background on enforcement against anabolic steroids and steroid-like substances in the sports nutrition market?

RC: I’ve done a lot of work in the anabolic steroid arena, having written a book and many articles on it and having defended countless cases nationwide. In around 1999, I presented to Drug Enforcement Administration (DEA) officials in Pentagon City, VA, why androstenedione could not be treated as an anabolic steroid under the then-existing 1990 steroid law. I was very involved in the BALCO case around 2002. I was later invited as a member of a working group at the U.S. Sentencing Commission tasked with reconfiguring the sentencing guidelines for steroid crimes in the wake of the Anabolic Steroid Control Act of 2004. Anyway, back in the early part of the 2000s, anabolic steroids and their precursors not explicitly listed in the then-existing Anabolic Steroid Control Act permeated the sports nutrition market. That law added many steroidal “prohormones” marketed as dietary ingredients to the federal list of scheduled substances.

Kalman: Historically, we know the FTC has acted against companies perceived as having misleading advertising. I bring this up as the old “Weider Anabolic Mega-Paks” were probably one of the first high-profile products and brands to have to deal with this issue. You see, Weider marketed the Anabolic Mega-Pak as a steroid replacer to gain lean muscle mass. Problem is, the advertisement implied the product would have anabolic steroid-like effects on the muscle and, in reality, it contained no steroids nor was it believed to be a product that would help a person add any muscle. In 1985, Weider paid a $400,000 fine for this form of advertising.

Reference: https://www.latimes.com/archives/la-xpm-1985-08-20-me-2049-story.html

Insider: Did enforcement actions and prosecutions follow the 2004 change in the steroid law?

Collins: Yes. I represented the first supplement company to be criminally prosecuted for the sale of prohormones. The company had received an FDA warning letter pointing out eight illegal products containing synthetic steroids. The case was resolved with a corporate plea only; the owners of the company were never prosecuted. I defended clients on many other cases that arose from the execution of a search warrant at the Boise, Idaho offices of Bodybuilding.com in 2009 (https://www.nytimes.com/2009/09/25/sports/baseball/25doping.html). The search warrant included a list of some 60+ prohormone products manufactured by 25 different companies that were subject to seizure. I defended multiple cases arising from the warrant in Idaho, California and Colorado federal courts, successfully protecting any corporate owners from personal prosecution.

Later, even after the law was amended, some marketers continued to be accused of attempting to circumvent the statute. I defended yet other federal prohormone investigations in New Hampshire, and two in both Texas and Tennessee. I had a prohormone client in Virginia that started in state court. None of his products were controlled substances under federal law, but they estimated the value of the stock in his warehouse as if it were black market steroids and set the poor guy’s bond at one million dollars! It was nuts. I was retained and was able to redirect the case to federal court, getting a great result for the client.

Insider: How did the government charge defendants in prohormone cases?

Kalman: Selling prohormones that were not explicitly listed in the steroid control law was typically charged as the FDA felony of “introducing a misbranded or adulterated product into interstate commerce with the intent to defraud and mislead.” That generally has a three-year prison term maximum. But to ratchet up the prison exposure, prosecutors would sometimes charge mail fraud or money laundering. They still do that on various FDA cases.

Insider: Are prohormones still a big problem?

Collins: Not as much. The Designer Anabolic Steroid Control Act of 2014 stemmed the flow, yet there are still some underground companies out there. But mostly, the prohormone market was replaced by the SARMs market.

Insider: OK, then. Let’s talk about SARMs. We see a lot about Ostarine.

Collins:  Selective androgen receptor modulators (SARMs) were popularized as sport nutrition ingredients starting around 2008, and the World Anti-Doping Agency (WADA) subsequently added them to their "prohibited list" as a category in 2008. Ostarine and andarine are among the popular SARMs among active consumers, especially bodybuilders. Ostarine is the registered trademark name for enobosarm, an investigational new drug (IND) by the pharmaceutical company GTx for use in women with certain types of breast cancer. The substance is of interest to those looking to build muscle or improve athletic performance. Ostarine and other SARMs are not legal to sell as dietary ingredients.

Kalman: I would add that a few years back, I was involved in clinical development and clinical research for the development of specific SARMs to be used in cancer treatment. I do also recall some work looking at SARMS as a potential medicine to lessen or ward off sarcopenia associated with aging. I never did and still do not see any connection nor rationale for any individual to think about or engage in selling these drugs and believe somehow they would qualify as a legal dietary ingredient. It has always been quite clear to me that these chemicals are drugs and that companies selling them were playing the whack-a-mole game with regulatory and legal authorities. More importantly, these drugs never made it to FDA evaluation for approval for use in medicine. The studies revealed safety concerns, lack of efficacy concerns, and development on many SARMS has stalled. Again, these are not dietary ingredients; they are drugs.

Insider: Despite the increased coverage of SARMs as not legal dietary ingredients, I’ve seen a recent high-profile case involving SARMs.

Collins: Yes, but that’s not the only one going on right now. I’ve handled other cases involving SARMs, and I’m working on a new one right now. It’s working out well for the client. I’ve found most clients prefer to avoid prison, so I push for that.

Insider: That is good for the client, but how do jail-free sentences act as a deterrent? We are often told that until bad actors go to jail, these acts will continue.

Collins: I’ve seen the criminal justice system from every side—I was a criminal prosecutor before I went into private practice. I think prison should be a last resort in most cases and that mass incarceration policies in America have failed. But while we have generally over-incarcerated our society, not under-incarcerated, there obviously are situations where imprisonment is appropriate. If that’s deemed the best solution for its deterrent effect, okay, but just don’t do it with my clients [laughing].

Kalman: To me, as my parents taught me growing up—for that matter, so did society—people have to be accountable for their actions. I think the question surrounding jail, as well as what punishments deter criminal behavior, is a larger philosophical sociological kind of question that may have more discussion points than we can fit in this roundtable today. In other words, jail sentences are needed; how much they detract the next person from breaking the law, I am unsure.

Insider: Back to SARMs. Are they controlled substances like anabolic steroids?

Collins: No, but with encouragement from the supplement industry, Congress introduced the yet-to-be-passed SARMS Control Act of 2019 with nine compounds and related substances proposed for regulation. It would make these SARMs into Schedule III controlled substances just like anabolic steroids. The push is coming from the anti-doping establishment, as numerous athletes (including several UFC fighters) have tested positive for SARMs, causing public embarrassment, event cancellations and lost profits. Also, supplement industry trade groups see SARMs as a black eye on the industry.

Kalman: It seems to me that if contract manufacturers are willing to put in questionable ingredients or illegal compounds in products that will make it to the proverbial retail shelf, then not only is the company who sells it responsible, but so is the retailer's contract manufacturer. It has been a concern to where athletes who compete in drug-tested sports have tested positive for ingredients that are not on the label of the product and or not supposed to be in the product that they are in. My athletes, under the direction of USADA, only utilize products and brands that have been certified for Good Manufacturing Practices (GMPs) and for no banned substances in their finished product. Using products with these certifications lessens chances of a positive drug test from contamination, intentional or not. If you wish to learn more, here are the certifications acknowledged by USADA as having value:

Insider: Do you support the SARMs control bill?

Collins: No, I don’t. Selling SARMs as “dietary supplements” is already illegal, and FDA has the ability to bring criminal and civil enforcement actions. Imposing controlled substance status on SARMs and adding them to DEA’s "war on drugs" would make anyone who possesses any amount of a SARM for personal use subject to arrest and imprisonment as a federal drug criminal.  If the law passes, most states would alter their laws so that state and local police could arrest anyone for possessing SARMs. This would turn otherwise law-abiding consumers into convicted drug criminals with all the collateral consequences on employment, education, licensing and housing. I don’t think we need to go that far.

Insider: If the legislative goal is to stiffen penalties and your goal is to not make federal felons out of simple possessors, is there a compromise that accomplishes both or is the issue not so much penalties as it is the need for more aggressive enforcement?

Collins: Yes. Existing statutes regarding unapproved, misbranded and adulterated drugs are the answer, especially combined, where appropriate, with conspiracy, mail fraud and money laundering charges. FDA and the Department of Justice have all the tools they need under the existing laws. They just need to use them more often than they do.

Insider: What about dimethyamylamine (DMAA) and stimulants?

Collins: DMAA was originally marketed as a nasal decongestion drug until the early 1980s. It made a comeback in the 2000s as an ephedrine alternative in the dietary supplement market, first described as an extract of geranium oil (methylhexaneamine). FDA issued a public advisory and a bunch of warning letters on it and its chemical cousins. DMAA was the subject of extensive litigation between industry and FDA. A criminal indictment resulted in millions of dollars in fines and prison time for brand executives. 

Kalman: Stimulants are a part of American and global history. Do not forget that tea and coffee are the two most ingested beverages globally—both being of the caffeinated and decaffeinated variety (by law, decaffeinated products may still contain up to 3% caffeine). Hence, caffeine is a globally consumed stimulant. In the sports nutrition world, the original stimulant, the botanical ephedra, was marketed for energy, weight control and more.  From ephedra, we get ephedrine, which is sold as an OTC nasal decongestant drug. Once FDA successfully pulled ephedra from market, there was a void, and this void allowed other potential stimulants, legal and or not, to come to market, as many companies were trying to score an “ephedra replacer.” This included things like Citrus aurantium and Coleus forskohlii. The most recently popular stimulant DMAA is not a dietary supplement and should have never been put in the products. If the regulatory rules were followed, this category would be much less discussed.

Insider: We’ve seen many “bad actors” fly under the radar and avoid enforcement. So how, in general, do sports nutrition companies end up on FDA’s radar?

Collins: Typically, it’s for one or more of a few hot button reasons. I got involved in one case that initially arose from a consumer fraud class action lawsuit. The lawsuit claimed the company misled consumers into thinking SARMs were legal “dietary supplements” when they were unapproved drugs. The company hired a law firm to defend the case. I’m not sure whether the firm understood the illegal nature of its client’s products or they would have quickly settled for a reasonable number. Instead, FDA caught wind of it, and a criminal prosecution resulted. By the time I got involved, the situation had turned ugly. Other cases start with a cooperating informant, somebody in the industry trying to work off their own criminal case, often for the same or similar charges. Other cases start with outrageous marketing. Still others are related to a consumer injury or complaint. Years ago, I handled a case involving DNP (2,4-Dinitrophenol), which was being sold on a fitness site for weight loss despite being a fertilizer and industrial chemical unfit for human consumption. A young girl took it and died, and the family called regulators.  

Insider: What generally happens to the companies and their owners who get investigated by FDA-OCI?

Collins: What happens varies widely. Good lawyering and smart decisions can often avoid the worst potential consequences. I’ve had a few situations where a search warrant was executed by FDA-OCI, but swift remedial response resolved the situation. I’ve also been able to work out creative alternatives to individual (personal) charges or avoid prison in cases where individuals were charged. Knowing what issues to dig in and fight on and where to compromise is critical and, sadly, not always judiciously exercised by lawyers and their clients. Also, controlling the client’s public statements during the pendency of the case is important, as prosecutors and law enforcement agents don’t look kindly upon “F*ck the Government!” types of social media posts (I am representing one of the January 6^th U.S. Capitol “visitors” and watching as other defendants are being sentenced, and the difference between prison or probation can sometimes be the nature of the things that they said afterwards on social media).

Insider: How does enforcement affect other companies in the industry?

Collins: There’s a buzz for a while, then it’s too often forgotten. The companies that are targeted for enforcement are only a fraction of the market, which fails to have much chilling impact. Plus, when FDA-OCI and DOJ do go after a big player in the industry, the smaller companies then often just try to stay under FDA's radar. They’ll avoid the crazy claims. They’ll tone down their marketing profile on social media. They’ll stay in the middle of the pack—like the running antelope surrounded by others, the chances of getting picked off by the cheetah is low. To switch metaphors, there’s a lot of low-hanging fruit left on the tree. 

Insider: So, do you think FDA-OCI should get more aggressive in enforcement?

Collins: As a lawyer who often defends members of industry who go astray, I’m not going to urge FDA to start handcuffing everyone tomorrow. You can’t go from spotty, occasional enforcement to DEFCON 1. There’s also an issue of available resources. Where should FDA prioritize its attention? The agency has said it prioritizes public safety. That makes sense. If there were limitless resources, then FDA could go after every minor non-compliance. For now, though, focusing on ingredients that pose a danger makes sense.

Insider: I understand this point from a criminal prosecution perspective, but when the industry suffers from continued violations by “bad actors,” especially those getting big media coverage, is focusing only on known injuries or potential serious danger—such as in the case of widespread liver injuries due to taking a sports or weight loss supplements—the right solution for the industry’s reputation?

Collins: I represent some of the “white hat” companies in the industry. These are the people who are doing the right thing, day in and day out, and my law firm helps them to do that. They’re selling compliant ingredients and making substantiated claims. So, they want a clean market, and tough punishments for bad actors is one way to get there. But I also represent companies that may think they’re doing it right but mess up somewhere along the line and then come to me terrified. I really wouldn’t want to see these guys get mixed in with the truly bad actors who, in some cases, are told to stop selling illegal stuff and respond by ignoring that advice. Sadly for them, some of those individuals are paying the price for that right now.

Kalman: The industry suffers any time there is a bad apple and suffers more when the bad apple becomes known to Congress. I am not sure of the balance that is needed to make a totally clean market. That may never happen in any industry given human nature. However, the laws on the books need to be enforced uniformly and not capriciously to better help regulatory compliance, and for the safety of the public.

Click here to check out Part 1: Sports nutrition regulations.