SARMs—or selective androgen receptor modulators—are an illegal class of ingredients that also go under the descriptive term of ‘pro hormones.’ These are compounds that have effects similar to anabolic steroids but because of slight chemical differences don’t meet the definition of a steroid and thus don’t fall under the aegis of the Designer Anabolic Steroid Control Act. DASCA was signed into law in 2014 with the support of CRN and other dietary supplement industry trade organizations. DASCA was designed to give the Drug Enforcement Administration and FDA the tools to quickly get nascent steroid ingredients off the market in an effort to keep up with the inventive and highly productive chemists active in the field.
FDA issued warnings
No such statutory mechanism yet exists for SARMs, though that doesn’t mean that FDA has not taken action on these ingredients. In early November FDA issued a consumer warning on the ingredients and sent four warning letters to companies marketing products that contained them. FDA told consumers to stop using the products immediately and consult a physician if they are showing signs of health problems. According to FDA, among the dangers associated SARMs are liver toxicity and the potential to increase the risk of heart attack and stroke. But the agency said the long-term effects of these substances on the body are unknown.
FDA spokeswoman Lyndsey Meyer said at that time the problem extends well beyond the three companies that received warning letters. From a simple time and manpower perspective, FDA has to take action where it can have the biggest multiplier effect, she said.
“A warning letter is not something we can get out quickly,” Meyer told NutraIngredients-USA. “These are highly resource intensive. From a resource perspective, we could never send a warning letter to every company at once. We try to go after companies that represent a ‘best snapshot’ of the issue. The message to other companies is ‘you could be next.’”
CRN president and CEO Steve Mister said that the issue with SARMs is acute enough that the organization felt that immediate action was necessary.
“FDA has authority in this area and has issued some warning letters,” Mister said. “But the FDA process is a slow one. Our thought is that this is an illicit drug problem, and that you have to address that on the demand side.”
SARMs are on the world and US anti doping lists. To inform the bodybuilding and fitness communities, CRN created a #SARMsCanHarm toolkit for fitness organizations that includes customizable flyers, newsletter material, and social media content featuring educational information on SARMs and how athletes can protect themselves from products containing these illicit ingredients. The organization has also included a longer list of tips for consumers about how to choose compliant and safe products. CRN says it has the support of leading associations representing fitness organizations and sports clubs, who are circulating the toolkit among their members and encouraging them to disseminate the educational information to their consumer clientele.
“Every athlete knows the importance of honesty and fairness, and these unscrupulous companies are anything but sportsmanlike. Bad actors tarnishing the reputation of responsible industry must never be tolerated. CRN and its member companies fully support FDA’s efforts to crack down on companies unlawfully manufacturing products containing SARMs,” Mister said.
Taking responsibility to protect consumers
In the past, that term ‘illegal drug’ might have been the end of the matter for dietary supplement companies. Those products don’t fall under the definition of legitimate dietary supplement and are made by people who are essentially criminals and therefore are not the industry’s concern, or so the argument used to go. But Mister said the days of trying to draw that line in the sand are over and the industry has to sit up and take notice when these kind of products masquerading as dietary supplements hit the market.
“We need to educate the consumer that these products are not safe and they can’t use them without risk. We can’t just wash our hands. Some of these things will really cause harm and we are going to take action. We want to reach people like the mother of a teenage athlete who might be thinking about what they could take to boost their performance,” Mister said.
Mister said that efforts are underway to craft new legislation that relates to SARMs. Whether that would be a standalone law or an amendment to DASCA remains to be determined.
“Travis Tygart (head of USADA, the US Anti Doping Agency) has told us that he feels the DASCA model has been a success,” Mister said.