The original investigation, published on Nov. 28 in JAMA, takes a look at the availability of these products and what’s in them. The main thread was to follow the trail of crumbs left by SARMs in the marketplace. SARMs—or selective androgen receptor modulators—have appeared in many products in the marketplace in recent years, and that rate seems to have increased after the Designer Anabolic Steroid Control Act (DASCA) was signed into law in 2014.
FDA issued a consumer warning about SARMs earlier this month in conjunction with sending four warning letters to companies marketing products containing the ingredients. 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.
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 in dietary supplements, regardless of their safety concerns. But FDA spokeswoman Lindsey Meyer said the recent consumer warning makes it clear that this is not an issue of merely splitting regulatory hairs about the legal status of these substances.
“We do believe these ingredients are associated with life threatening issues,” she said.
In the JAMA study researchers, who are associated with the US Anti Doping Agency, the US military and other organizations, did a web search in early 2016 to find suspect products in the marketplace. They found 51 supplier sites offering 210 products, but about three quarters of those were listed as ‘out of stock’ or otherwise unavailable. The researchers succeeded in purchasing 44 products, which where then analyzed between April and August of 2016 with the same protocols used in anti-doping operations.
About half of the products were masquerading as dietary supplements, with supplement facts panels on the labels. Others were sold with ‘Not for human consumption, research only’ statements on the labels.
Wide variability in ingredients, dosages
The researchers found that only a little more than half of the products that claimed to have SARMs, such as Ostarine, LGD-4033, or Andarine, actually contained them. The rest contained a host of other banned substances, such as “growth hormone secretagogues, PPAR-δ agonists, and Rev-ErbA agonists, all of which are recognized by WADA as banned substances. Neither the efficacy nor the safety of these investigational drugs has been demonstrated.”
As one might suspect when dealing with manufacturers that apparently are following no particular GMP roadmap, the quality of the products were all over the map, the researchers found. Four of the products had no active ingredients at all, others did not match label claims, and many contained undeclared ingredients. And the dosages varied considerably, from one-tenth as much of active ingredient stated on the label to more than twice as much, and for many of the products tested these variances were observed in different capsules from the same lot.
“For many products, the ingredients and their amounts found in these analyses did not match the label information,” the researchers wrote. They called for tighter regulation of the sale of these products online, though they did propose an outline for what that would look like.
Industry needs to be part of solution
Duffy MacKay, ND, senior vice president of scientific and regulatory affairs for the Council of Responsible Nutrition said that the issue of the presence of these types of products in the marketplace is becoming an ever graver one for the dietary supplement industry. At one time stakeholders might have pointed to the fact that these products are not legal dietary supplements and therefore fall outside of the industry’s purview. MacKay said there’s now more of a recognition that the industry needs to step up to be part of the solution.
“We share with multiple stakeholders the concerns about this illegal activity that is taking place. We are working with others toward taking action to really look at this issue with SARMs,” MacKay told NutraIngredients-USA.
Educating the consumer
MacKay said consumers, even those purposefully looking for ‘edgy’ products, need to be made aware that companies that are trying to wedge their offerings through crevices in the regulatory wall can’t be expected to have their end users’ best interests in mind. Are products like these tested for microbial contamination, metal shavings from the production line or other accidental inclusions? Have the finished products been tested to make sure an order-of-magnitude type mistake wasn’t made during blending? Maybe. Maybe not. Almost anything could be in these bottles, and there’s really no way to know.
“We want to educate consumers to be smart about their purchases to avoid these products. What this study shows is that people who are willing to work with illegal ingredients are not very good with GMPs,” he said.
“Almost half of the sites they looked at didn’t appear to exist any more. That’s a red flag for a fly-by-night industry. We want to tell consumers to do their homework and buy from brands they know and trust. We advise them to talk to their health care providers. This shadow industry appears to be pretty tenacious and we need to see what we can do as a responsible industry to address the problem,” MacKay said.
Chemical Composition and Labeling of Substances Marketed as Selective Androgen Receptor Modulators and Sold via the Internet
Published online, Nov. 28, 2017 doi:10.1001/jama.2017.17069
Authors: Van Wagoner RM, Eicher A, Bhasin S, et al.