In October 2017, representatives of the Council for Responsible Nutrition (CRN), Natural Products Association (NPA) and U.S. Anti-Doping Agency (USADA) met with FDA.
The topic: selective androgen receptor modulators (SARMs), a class of drugs under clinical research by the pharmaceutical industry and producing steroid-like effects that are said to pose health risks to athletes, bodybuilders and others who take them.
Collaboration is key, industry leaders said, in removing from the market pharmaceutical ingredients in products falsely marketed as dietary supplements.
Since the meeting with FDA, the agency has taken more action against SARMs, said Daniel Fabricant, Ph.D., president and CEO of NPA.
“It speaks volumes that it’s a priority at the agency,” Fabricant said in a phone interview, “and I think they’re [FDA officials] going to continue to, when they see something, act on it.”
In addition to working with FDA, dietary supplement leaders have been working behind the scenes with members of Congress on potential legislation to target SARMs.
The idea is to give the Drug Enforcement Administration (DEA) authority to crack down on SARMs in a similar way in which it has authority to target designer anabolic steroids under the Designer Anabolic Steroid Control Act (DASCA), said Steve Mister, president and CEO of CRN. Signed into law in 2014 by former President Barack Obama, DASCA drew the support of the dietary supplement industry, sports organizations and health groups.
“Is there discussion of possible language on SARMs” in Congress, Fabricant said. “Yes, there is, and we look forward to whatever form that takes. Those ingredients that have been approved as drugs are not part of the industry and shouldn’t be.”
FDA and DEA declined to comment on potential SARMs legislation.
The co-chairs of the congressional dietary supplement caucus—including Sen. Orrin Hatch, the senior Republican from Utah—did not respond to requests for comment. Other lawmakers who chair committees that could introduce SARMs legislation as a standalone bill or part of a more comprehensive package also did not return requests for comment.
The SARMs issue reflects unanimity among industry associations and federal regulators in targeting products marketed as dietary supplements but tainted with pharmaceutical ingredients. Such products are adulterated and mislabeled and need to come off the market, said Loren Israelsen, president of the United Natural Products Alliance (UNPA).
Industry leaders said companies should notify FDA when they detect products spiked with drugs, and encourage the agency to take prompt action.
“When you see something, say something,” Fabricant said. “Who are the gatekeepers? Well, everyone’s the gatekeeper and that doesn’t mean everyone is guilty until proven innocent. I think everyone deserves due process.”
Some members of CRN have purchased competitors’ supplements and identified substances that didn’t belong in the products, Mister noted.
“In those cases, we do very strongly encourage our companies to provide that data to FDA in hopes that it gives FDA a roadmap of where they should be looking,” he said.
But he cautioned FDA must do its own independent tests and investigation.
Industry leaders have not only urged FDA to use all its powers under the law to swiftly remove adulterated products from the market, they stressed it’s important to hold people accountable.
Fabricant—FDA’s former head dietary supplement official—would like to see the agency bring more misdemeanor cases. The Federal Food, Drug & Cosmetic Act (FDCA) is known as a strict liability statute, and executives of companies can be held liable for a criminal misdemeanor without proof that they intended to violate the law.
“The swiftness of it is a critical factor,” Fabricant said. “People know, ‘Hey, as soon as I introduce this [in] the market, the agency is going to be on the scene, and they’re going to come after me with a misdemeanor.’
“We know everyone wants to bring the big Eliot Ness case and take down Al Capone, but they took down Capone on tax evasion,” Fabricant observed. “That wasn’t exactly sexy at the time. In some ways, it’s whack-a-mole, and when you start whacking enough moles, it doesn’t have to be the kill shot.”
Industry attorney Marc Ullman feels FDA isn’t whacking enough moles. He argued the agency is bringing too few enforcement cases for violations of the FDCA and failing to sufficiently publicize criminal prosecutions.
“You can’t enforce against everybody,” said Ullman, of counsel to Rivkin Radler LLP, in a phone interview. “You’re never going to catch every criminal … so we rely on a deterrent effect. And absent a deterrent effect, how do you have an effective regulatory enforcement regime?”
Israelsen, though, pointed out FDA faces resource constraints.
“It takes so much time to do the analytical work to really know what you’re dealing with with these spiked ingredients, and they’re changing all the time,” he said in a podcast interview. “It’s whack-a-mole.”
Amy Eichner, Ph.D., is USADA’s special advisor for drugs and dietary supplements. She cited a growing number of adulterated products on the market sold as supplements. The problem is contributing to athletes testing positive for banned substances like SARMs.
“And it’s whack-a-mole to the extreme,” she said.
It’s a problem that continues to vex regulators. Even when FDA or Congress take action against a class of illegal substances marketed in sports supplements, for example, new potentially dangerous compounds emerge.
“I think a legislative solution is one important step, but I don’t think it’s enough,” Eichner said. “I think we need to have more, and I’m not sure what that more is. Whatever it is, the end goal is to make it impossible or extremely uncomfortable for an unscrupulous or low-quality supplement company to exist.”
To that end, industry trade associations have urged companies to speak up when they identify adulterants in products falsely disguised as supplements.
“When you see, ‘Hey, take 20 minutes before sexual activity,’ I think some of those tell-tale signs are out there still,” Fabricant said. “And when the industry sees them, they should tell the agency … and not just FDA but FTC” and state attorneys general as well.