Company pulls product after InvestigateTV asks questions
By: Jamie Grey & Lee Zurik
Published: Feb. 2, 2020
Nashville, Tennessee (InvestigateTV) – Taylor Lewan was worried about the impact playing professional football would have on his life after the game. Specifically, he said he was worried about his brain and being able to spend meaningful time with his young daughter as she grows up.
So, he took supplements with the goal of keeping his brain healthy while continuing to play a violent game. Those supplements got him into trouble.
The 6-foot-7, more than 300-pound offensive tackle has given and taken his share of hits in his six seasons with the Tennessee Titans.
He started the 2018 season with a collision during week one that put him in the NFL’s concussion protocol.
Lewan then started the 2019 season missing four games after the NFL suspended him. The league hit him with the penalty after he tested positive for banned substances during a May drug screening.
He tested positive for Ostarine, which is a drug that has been banned by the World Anti-Doping Agency (WADA) for more than a decade. The drug is sometimes illegally marketed and sold as a supplement for body-building.
But Lewan said during a team-hosted news conference that he didn’t intentionally take Ostarine. He blamed contamination. He said the supplements he took with advice from a nutritionist and his doctors were tainted.
“I just wanted to make it clear to [fans] that I didn’t take anything knowingly,” Lewan said. “I’ve never done anything knowingly that would cheat the game.”
Lewan is far from the only high-caliber athlete who has tested positive for banned substances and claimed they had no intention of doping. Notably, Clemson went into the 2019 national championship football game missing three players – all found with Ostarine in their systems.
“I love this team and my family too much to even think about putting a substance like that in my body,” said Dexter Lawrence, who played for Clemson at the time and now plays for the New York Giants. “I don’t know where it came from. I don’t know how it got there.”
And, it’s a plausible scenario, according to scientists who study supplements. There is repeated evidence that unintentional contamination happens, particularly because of haphazard manufacturing processes.
Some athletes have proven their contamination cases in court or to their sports organizations. Scientists unaffiliated with teams or specific sports have found supplements laced with heavy metals, mold – and steroids and steroid-similar compounds.
Those contaminated supplements, according to athletes, sports attorneys and scientists are easily found online. But they are also found in grocery stores, sports nutrition stores, and gyms.
“The dietary supplement industry has some of the finest manufacturing facilities and brands in the world, but it also has a low threshold for entry and has some pretty scary things out there,” said David Trosin, who manages the dietary supplement certification program for NSF International, the laboratory that helped develop the national standards for the industry.
When Trosin began working for NSF about 12 years ago, WADA had banned 108 substances. There are now 272 banned, with WADA continuously researching and adding more.
Some of those drugs, such as Ostarine, are not only banned in professional, collegiate and Olympic sports – because they are not FDA-approved, they are also illegal to sell for human consumption.
But InvestigateTV has found them to be readily available to purchase, which experts said is why the substances are popping up in other supplements. A manufacturer making a banned substance may taint a batch of another supplement because of poor quality control.
For most people, a professional athletic career is not at stake. But NSF said anyone buying supplements should be concerned about contamination.
“There are cases where there have been consumer deaths. It doesn’t get any more serious than that,” Trosin said. “This is not just about the professional athlete. This is about people who are looking at a product that’s making a promise. And you don’t know.”
The Council for Responsible Nutrition (CRN), which is the trade association for the dietary supplement industry, said the vast majority of contamination happens in the performance-enhancement categories of the industry: Bodybuilding, weight loss and sexual enhancement. Those categories also represent a small fraction of the industry – but make a big difference for anyone from “weekend warriors” to professional athletes.
“If you are someone who is using one of those products, you should certainly be concerned about it,” said Steve Mister, the president and CEO of the supplement association CRN. “But we’re really not talking about contamination problems when you’re talking about multivitamins and probiotics and fish oils and things like that.”
InvestigateTV analyzed the FDA’s database of nearly 1,000 tainted products illegally marketed as dietary supplements since 2007. The results showed 98% of the tainted products were in the performance-enhancement categories. Sexual enhancement products were the most frequently reported, followed by weight loss and muscle building products.
Former Saints player: ‘I never wanted to be a guy that said I didn’t work hard enough’
For nearly a decade, Deuce McAllister suited up for the New Orleans Saints, the team he’d grown up watching as a kid growing up in Mississippi. He was a first-round draft pick in 2001 and a powerhouse running back in the NFL, frequently leading his division in yards.
But toward the end of his career, he made headlines with two fellow Saints players for something else: Violating the league’s drug policy.
It all happened, he said, because he was trying to drop weight.
“We were in the weight room, as far as lifting. You would go in the sauna, the steam room, and try to sweat the weight out, sweat away the extra pounds,” McAllister said.
For McAllister, that meant staying at 218 pounds when he began his career and 237 by the time he retired. The penalty if he didn’t hit weight: He owed the team money.
“You had to weigh in. And if you were over weight, your prescribed weight by the coach as well as the strength and conditioning coach, you got fined for it,” McAllister said.
In trying to keep his weight down, McAllister turned to using diuretics. He said for four years he’d used the same product, as had many other athletes he knew. But in 2008, he said that same diuretic tripped his drug test.
He tested positive for a specific diuretic that is banned because it can be used to mask steroid use. McAllister said his usual diuretic was contaminated, and he was devastated because he said he played clean.
“I never wanted to cheat the game,” he said. “If I knew that it was something that was going to put a negative stain on my name and what I had worked for, I’d never have [taken the diuretic].”
McAllister said he even had the product checked by trainers.
“They sent it over, the product was tested, and … not that particular batch was tainted, but another batch was tainted,” he said.
He also said the particular product was easily accessible for all consumers like many products marketed as supplements.
“A lot of times you may be stopping at a gas station, and you see some of the products up front. Or you see some different products, and you say, ‘Hey look, I’ve seen that product on television,’” McAllister said.
The non-profit organization NSF International runs certification programs for supplement companies that submit their products. NSF also shops the market for questionable products. It’s that second category where it frequently finds banned substances.
“We’re surfing the web to see what doesn’t look right. We’re into forums to see what athletes are talking about and seeing what products they’re referencing. We’re going to the retailers and looking at the shelves,” Trosin said.
In some cases, Trosin said the contamination is intentional, but more often, bad manufacturing processes are to blame.
“They don’t clean their machinery, and next thing you know, trace amounts of banned substance are finding their way into a product,” Trosin said.
In one case, scientists found trace amounts of a narcotic in a pre-workout supplement.
“A company submitted for certification. They thought, ‘Hey, we know our stuff. We’re trying to be the best of the best. We’re trying to demonstrate that we make a quality product.’ But yet when we did testing, we found a trace amount of morphine,” said John Travis, an NSF scientist who has worked for the laboratory since 1995.
In that case, NSF worked with the company to correct the issue and found the source of contamination. But for many other products, those fixes don’t happen.
“It’s like any industry. You have your top, cream of the crop manufacturers and suppliers and brands. And then you also have folks that operate in the gray areas of the law,” Travis said.
The industry, which NSF said is estimated to be worth more than $40 billion this year, is tough to keep a hold on – with many of these supplements being sold online or in even less-regulated ways.
“There have been instances where people will manufacture them in their basement, and they’ll go to their local gym or whatever and sell out of their car trunk,” Travis said.
Found online: Drugs sold “not for human consumption”
InvestigateTV looked online for products, particularly those that contain Ostarine, the drug that got the Clemson players and Lewan suspended.
Ostarine is a drug that is being studied in clinical trials to help with muscle-wasting. However, it is not yet FDA-approved, and it is not currently a drug even doctors can prescribe, according to USADA.
“There are in fact products that contain Ostarine, but only illegal ones,” the agency states on its website. “Given that Ostarine is not approved for human use or consumption in the U.S., or in any other country, there are no legal medications that contain Ostarine.”
The drug compounds are sometimes marketed as “legal steroids” and is part of a category of drugs the FDA warns against: selective androgen receptor modulators (SARMs). Specifically, the agency states that the drugs can cause liver toxicity, heart attack and stroke.
But the government said they are instead illegally marketed and sold as supplements.
And in the bodybuilding world, they still are in demand – and frequently discussed on chat forums.
For example, on one weightlifting forum, one user asked about products that would be similar to steroids, including SARMs. One person responded saying their local nutrition store encouraged using SARMs – and liked the results. Another said they had vision issues using the drugs.
“The SARMs problem is something we are very concerned about,” said Mister, from the supplement trade association. “Even though it’s a very small portion of the industry, it really does have the potential to hurt consumers in many ways – Not only the physical effects that some of these SARMs can have but also what they can do to an athlete’s career if they test positive.”
An attorney who has represented multiple athletes facing doping allegations told InvestigateTV Ostarine is the biggest problem drug for supplement contamination currently.
The main issue, he said, is that a facility that manufactures Ostarine will then turn around and manufacture another supplement – causing adulteration.
Finding products advertised online as SARMs or Ostarine is simple. A Google search will lead straight to retailers. But what consumers will notice are two common phrases: “Intended for laboratory research use only” and “not for human consumption.”
One such company, Panther Sports Nutrition, sold Ostarine online with those specifications. But earlier, in 2017, the FDA warned the company in a letter. The agency stated the company was selling Ostarine as a dietary supplement, but that the products are in fact unapproved new drugs.
That classification of drug, according to the FDA, is illegal to distribute under the Federal Food, Drug, and Cosmetic Act.
In mid-January, InvestigateTV found an Ostarine product with the same ingredient list named in the FDA’s warning letter still for sale by the New Jersey company.
Using internet archives, InvestigateTV compared the old marketing language on the website and photos of the packaging. Changes included the addition of the words “not for human consumption” and changing the front label from “dietary supplement” to “performance supplements.”
While the product stated it is not for human consumption, there was language in the company’s packaging and marketing that suggested the idea of taking the product.
For example, the package pictured online in mid-January included the phrases “physique enhancing agent” and “mass builder” and listed dosing information.
The company also posted the product on its social media accounts with hashtag labels such as #gym, #fitness, #gains, #shredded and #sixpack. Commenters stated they were using or taking the SARM product.
Panther Sports Nutrition did not respond to requests for comment. After InvestigateTV sent emails and a letter to the company and contacted the FDA about the status of the warning letter, the company pulled the product from its website in late January.
Athletes winning appeals and lawsuits – but organizations vary on action
Sports regulators are constantly changing their lists of banned substances and changing associated penalties. In recent years, Ostarine and other SARMs have been a big topic amongst those groups – particularly because contamination is becoming a more prevalent issue.
Different leagues have different appeals policies that could reverse strict sanctions. Some are changing to their policies to account for contamination.
The mixed martial arts Ultimate Fighting Championship (UFC) organization works directly with the United States Anti-Doping Agency for drug testing. It recently made major changes to its policies after numerous athletes tested positive for Ostarine.
The UFC eliminated a zero-tolerance policy for SARMs because of evidence of contamination. In November 2019, the organization and USADA announced that for certain substances such as SARMs, a low-level positive test would result in more investigation, not automatic suspension. There would have to be more proof that a fighter intentionally or recklessly took banned substances.
Earlier in 2019, the United States Anti-Doping Agency announced it had completed a lengthy investigation into Ostarine cases involving four UFC fighters. All four were found to have no evidence of intentionally taking the drug.
The NFL has adopted a strict policy for its players with clearly outlined punishments. For a first-time positive test for a stimulant or anabolic agent, the league levels a four game suspension.
Players are allowed to appeal; however, athletes said it’s difficult to win or have punishment reduced because they are responsible for what they take – no matter what. The players union also makes it very clear all responsibility is on the player.
“At the end of the day, it’s up to the individual to know exactly what’s going in their body,” former Saints player McAllister said.
Lewan, the Titans player suspended in 2019, appealed his suspension, but the NFL upheld its decision. According to sports attorneys, it would be extremely rare under the league’s zero tolerance rules for the suspension to have been reduced or rescinded.
“The appeal process in this situation is much more difficult than an appeal process for a game fine or something like that,” Lewan said. “The way that it’s written in the [Collective Bargaining Agreement]… you’re guilty once that’s in your system.”
NSF works with leagues including the NFL, MLB and NHL with its Certified for Sport program, which is a testing and certification program for supplement manufacturers to help ensure safer products. The leagues tell athletes to look for the certification; some even require it.
“I’m not saying that every time an athlete tests positive it’s inadvertent. There’s some intentional doping that takes place. But there are a number of cases we’ve found where people have just taken the wrong product and tested positive because of it,” Trosin, with the NSF certification program, said.
Trosin said the government estimates there are as many as 75,000 supplement products on the market. Only around 1% are tested and even fewer certified.
What about government regulation?
The FDA does hold authority over the dietary supplement industry, but its relationship with the industry is more similar to food product oversight than drug oversight because there is no pre-market approval.
By legal definition, supplements are different from drugs in that they are not meant to treat, diagnose, prevent or cure any diseases.
Dietary supplements fall under the Dietary Supplement Health and Education Act of 1994. That law makes it illegal for supplement companies to market misbranded or adulterated products; however, the initial responsibility of following that law falls on the makers.
“Manufacturers and distributors of products labeled as dietary supplements are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all of the requirements,” wrote an FDA spokesperson via email.
In practice, what that means is while the FDA has oversight of a pharmaceutical drug before it hits the shelves, it does not in the world of supplements. Unless a company is using an ingredient that wasn’t sold in the United States before October 1994, it does not have to give the FDA any evidence of a product’s safety before it starts selling.
However, once a product is being sold, the FDA has oversight powers and is responsible for taking action against companies that sell contaminated products. The Federal Trade Commission also looks at supplement companies and has authority to regulate false advertising claims.
Mister, the Council for Responsible Nutrition’s president and CEO, said he believes the laws give the FDA adequate oversight and regulation tools such as mandatory recalls and the right to seize products.
“The agency actually has a broad spectrum of ways to enforce the law. I guess where we get concerned is that the agency doesn’t use often those tools that it has, and sometimes it’s even constrained by a lack of resources that it has to enforce the law,” Mister said.
The association recently successfully pushed for an increase in FDA funding specifically for supplement programs. Mister said one goal was increasing facility inspections.
“It would take them 20 years to get to every facility at the rate they’re working through them now, and we think facilities ought to be inspected a lot more often,” he said.
Additionally, Mister is calling for more product testing to catch problematic products – and particularly named illegal dietary compounds such as Ostarine.
Supplement experts said those illegal dietary compounds can be hard for authorities to track and punish efficiently.
For example, Travis said DMAA, an amphetamine derivative, has been another recent particular concern. The FDA said the stimulant was once approved for nasal decongestion, but it is now considered a health risk. In fact, it is illegal to put in a dietary supplement. Even so, products with DMAA are still marketed online.
Travis said there are numerous other similar compounds that manufacturers will put into supplements, and because they are illegal, they are not independently studied for safety.
“There’s no safety data on these compounds. They’re being put in supplements without the manufacturers or the ingredient suppliers having performed any safety analysis,” Travis said.
The FDA has sent letters to numerous companies demanding they stop marketing their products as dietary supplements. The companies have 15 days to prove they have corrected or have a plan to correct the violations. If not, the FDA has the authority to seize products.
The agency also continues to follow up with companies to ensure they have addressed concerns. In the case of Panther Sports Nutrition, FDA records show the agency has not closed the two-year old case.
While some companies warned may continue to sell, the Department of Justice has ultimately pursued some cases where the government said owners tried to evade the FDA.
The indictment charges the company Blackstone Labs, one of its manufacturers and several current and former employees. The filing includes multiple examples of emails from company executives referencing selling SARMs and knowledge it would be illegal.
For example, the court documents show a company executive stated in an email, “Osterine [sic] for instance is in level 2 testing meaning it’s considered not safe for human consumption. To sell them as a dietary supplement would be illegal and comparable to putting something like heroin in bottles and selling it.”
That company, according to federal attorneys, also falsely claimed to have manufactured products in an FDA-approved, registered and inspected facility that followed FDA guidelines. It also claimed to have third-party lab tests done on its compounds.
Blackstone’s attorney sent InvestigateTV a statement calling the charges false and inaccurate. It states, in part: “It is Blackstone’s belief that the government is overreaching in this case because of its ongoing, wrong-headed attack on strength and bodybuilding athletes and the nutritional supplement industry.”
Read the full statement below.
Lawmakers have been working on legislation that would allow the Drug Enforcement Administration to crack down even more on SARMs. In late 2019, Sens. Chuck Grassley (R-Iowa) and Sheldon Whitehouse (D-Rhode Island) introduced the SARMs Control Act of 2019. The bill would classify SARMs like Ostarine as controlled substances in the same category as anabolic steroids.
USADA supports the bill, saying it would give the DEA the ability to find and remove SARMs from the market. CRN, which also backed the anabolic steroids legislation, also strongly supports the new SARMs bill and has a campaign called SARMs Can Harm.
How do you know what to take?
A major concern with supplements is that what’s printed on the label may not really be what’s inside the capsules.
“That’s the scary part. You’re thinking that it’s one thing, and there may be a small amount or a trace amount of another product that’s listed in that product or that’s not listed in that product,” McAllister, the former Saints running back, said. “There are everyday people that take the products and not knowing what they’re putting into their body.”
Scientists at NSF said that’s one of the biggest concerns with products on the market.
“The bad players aren’t going to put the illegal products on the label. So how do you know? You stick to products that are certified, and that’s the best way to do it,” Trosin said.
One of the pieces of NSF’s Certified for Sport processes includes making sure all ingredients are accurately listed on the product’s label. After certification, the organization also does regular onsite audits and annual contaminant testing to make sure facilities maintain compliance.
“Anybody who’s taking a product wants to know that they’re actually getting what they’re paying for, that it’s not an adulterated product,” Trosin said. “Because adulteration doesn’t just have to be a steroid or something incredibly dangerous. It can be putting amino acids into protein powder rather than protein, so you’re getting just a portion of the protein you think you’re getting.”
The NSF Certified for Sport program also prohibits manufacturing facilities from having any banned substances in the facility.
The MLB and NHL will only recommend or provide supplements that have been through the NSF Certified for Sport testing and certification process. Scientists there said that’s a good idea for anyone looking to use supplements.
To find out if a product has been certified, you can download the NSF app on your phone and scan products in the store. The organization’s website also provides search tools to look up certified products.
Each supplement listed has the lot number that has been certified, so athletes can look for those specific numbers on bottles as well. Only lots that have been tested get certification; once a new lot is started, a company goes through the certification process again.
CRN also advised checking for third-party certifications such as those from NSF, Informed Choice, USP, and Underwriters Lab. The association said one without a certification isn’t necessarily bad, but the extra assurance is good to look for.
Additionally, CRN said everyone should talk to a health care provider before taking supplements and to avoid products that seem to make outrageous, too-good-to-be-true promises.
The FDA also has resources for consumers, including explanations about the laws for labeling and good manufacturing practice regulations.
Some athletes who have tested positive for drugs and faced the public scrutiny and league sanctions said they plan to do even more work to find non-contaminated supplements.
Thank you to everyone who sees this video and supports me. My family and I are so grateful to the Tennessee Titans organization and fans for your support. I will post the polygraph information next. #NoBadDays pic.twitter.com/lE9iEMmLxw
— Taylor Lewan (@TaylorLewan77) July 24, 2019
McAllister and Lewan both said the team medical and training staff helped them check their supplements, but they believe they had random bad batches.
The NFL does not require Certified for Sport supplements, but the players union offers that as one resource for players to use.
“There’s really no way to be 100%. I’m working with my group of people, and we’re going to figure out a healthy and safe way to do this so this doesn’t come up again,” Lewan said.
Lewan said one idea is to buy in bulk from one lot number and have each new batch he buys tested.
“There are little kids out there who see 77 on the field and look up to him and want to be him, whether they know my name or not. And I want those kids to know and those people to know that I’m not a cheater,” Lewan said.
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