FDA’s warning, issued yesterday, comes on the heels of warning letters sent to three companies that market products containing the ingredients. FDA had this to say about the offending products distributed by Infantry Labs LLC, IronMag Labs and Panther Sports Nutrition: “Although the products identified in the warning letters are marketed and labeled as dietary supplements, they are not dietary supplements. The products are unapproved drugs that have not been reviewed by the FDA for safety and effectiveness.” FDA had also sent a warning letter in 2014 about the use of a SARM in a product masquerading as a dietary supplement.
Serious health concerns
“We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients. Body-building products that contain selective androgen receptor modulators, or SARMs, have not been approved by the FDA and are associated with serious safety concerns,” said Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We will continue to take action against companies marketing these products to protect the public health.”
FDA spokeswoman Lyndsey Meyer said 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.’”
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.
Arcane regulatory issue
In the warning letters, FDA raised another, more arcane regulatory issue associated with SARMs. The two SARMs that appeared in the products from these three manufacturers — MK-2866, known as ostarine, and LGD-4033 — have previously been investigated as new drugs, which makes them ineligible for use as dietary supplements, regardless of their safety concerns.
But Meyer said the consumer warning issued yesterday makes it clear that this is not an issue merely of splitting regulatory hairs about the legal status of these substances.
“We do believe these ingredients are associated with life threatening issues,” Meyer said.
Self regulation opportunity
Duffey MacKay, ND, senior vice president of scientific and regulatory affairs at the Council for Responsible Nutrition, said CRN applauds FDA’s action against SARMs, and noted its cautious approach in the wording of the warning letters.
“The conservative answer is that these companies did not go through the proper regulatory route for these ingredients by filing an NDI notification or getting GRAS status. My answer beyond that is I do not believe SARMs are dietary ingredients. I think we are looking at the next in the growing list of questionable ingredients like DMAA, BMPEA and Acacia rigidula,” he said.
MacKay said the episode could be an opportunity for the industry to show its self regulatory chops in cooperation with FDA. Just looking the other way when these kinds of products surface is no longer a viable option.
“This is not our first rodeo with sketchy ingredients and all the questions that revolve around them. I’m expecting we might see more cohesive efforts to address this problem. I think the industry has collectively realized this is not ‘our’ industry. What about going up the supply chain? Where does ostarine come from? It’s not coming from our responsible suppliers,” he said.
Appearance on WADA list
SARMs have been on the World Anti Doping Agency (WADA) banned substances list since 2008, according to the US Anti Doping Agency (USADA). USADA’s website contains a list of ‘high risk supplements.’ Products from three companies that received the warning letters are on the list. And there are 80 matches on the lengthy list, which runs to hundreds of products, for the search term ‘SARMs.’
“We met with FDA on this issue in the company of USADA. These substances should not be for sale in products masquerading as dietary supplements,” said Dan Fabricant, PhD, executive director of the Natural Products Association.