An FDA warning letter and a raid of a California company’s offices highlight issues concerning the supplements some feel are a healthy substitute for steroids.

Move over steroids.

The popularity of gray-market research chemicals known as selective androgen receptor modulators (SARMs) among bodybuilding and fitness buffs is growing.

Healthcare professionals and national regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the U.S. Anti-Doping Agency (USADA), are watching closely.

SARMs are a novel class of drugs similar to androgenic steroids, including testosterone. They aren’t currently approved for use in humans in the United States or any other country.

Nonetheless, they remain available through various outlets on the internet as well as some supplement companies in the United States.

The drugs are touted as an aid for muscle building without many of the side effects of traditional steroids.

Researchers and bodybuilders both appear to be interested in them for this reason.

“SARMs have been shown in early clinical studies to build lean mass and muscle strength,” James Dalton, PhD, dean of pharmaceutical sciences at the University of Michigan, told Healthline.

“They differ from commonly used androgenic steroids by their ability to stimulate muscle and bone growth with lesser prostatic effects in males and virilizing effects in females,” he added.

Steroids vs. SARMS
Androgenic steroids are known to increase muscle development but are accompanied by a host of undesirable effects.

For men, this often means things like acne, breast development (gynecomastia), enlarged prostate, and shrinking of the testicles.

Women may experience increased body hair growth, acne, and increased clitoral size.

More serious health concerns include liver damage and numerous cardiovascular complications, including increased risk of heart attack and blood clots.

SARMs potentially represent a step toward a safer class of androgenic drugs. They have “revived an almost dormant search for improved androgens,” wrote researchers in the Journal of Medicinal Chemistry.

Dalton notes that so far the drugs are “generally well-tolerated” in clinical trials, but none of them have ever reached final approval by a regulatory body.

One SARM in particular, known by a variety of names including enobosarm, ostarine, and S-22, has made it through phase III clinical trials.

Concerns over growing popularity
However, clinical research on SARMs, including their potential use for preventing muscle wasting on cancer patients, has recently been overshadowed by their off-label popularity among bodybuilders.

Last fall, the FDA issued warning lettersTrusted Source to three supplement companies in the United States that were offering the drugs for sale.

“We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients,” they said in a press statement.

“Life threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke, and the long-term effects on the body are unknown,” FDA officials said.

In December, the FDA reportedly conducted a raid on several facilities operated by Sacramento-based supplement company Enhanced Athlete for allegedly selling the drug ostarine. The FDA declined to comment or confirm this to Healthline, citing a policy against commenting on potentially ongoing criminal investigations.

Representatives for Enhanced Athlete didn’t return numerous inquiries by Healthline.

In a public statement, the company announced that the FDA had confiscated caches of Ostamuscle (their own brand of ostarine) and “many other research chemicals.”

The company has framed their sale of the drugs as an issue of personal freedom for consumers.

“We feel that freedom of information and choice, as long as provided within the context of the law, is imperative. This means that we intend to carry on doing what we have always done until told to do otherwise by the proper authorities,” the company writes.

Nonetheless, they also expect a growing federal crackdown on the sale of SARMs, at which point they admit “we will have no choice but to concede.”

Crackdown on SARMs
Many chemicals and substances are able to get around FDA oversight when being classified as a “dietary supplement.”

Due to legislation from 1994 known as the Dietary Supplement Health and Education Act (DSHEA), products classified as dietary supplements are exempted from pre-market studies prior selling to the public.

In a prior interview with Healthline, Dr. Carl Baum, a member of the American Academy of Pediatrics (AAP) said, “All bets are off,” when it comes to knowing what’s really in a dietary supplement.

The FDA does take action against dangerous or misbranded supplements using their own criminal investigation unitTrusted

Many athletes and gym-goers are turning to a popular but potentially dangerous new pill to help them build muscle and gain strength: a steroid alternative known as SARMs.

The pills are widely marketed online as “legal steroids” that provide the muscle-building benefits of anabolic steroids without the troubling side effects. And while the products are legal — at least so far — their spread has alarmed health authorities, who say they are not necessarily safe.

Drug companies developed SARMs, which stands for selective androgen receptor modulators, as an alternative to anabolic steroids for people who suffer from age and disease-related muscle loss. But they are the subject of ongoing clinical trials and have not been approved for use by the Food and Drug Administration.

In October, the agency issued a public advisory cautioning that SARMs were unapproved drugs linked to “serious safety concerns,” including the potential for an increased risk of liver toxicity, heart attacks and strokes

A month later, a study published in JAMA revealed that products marketed as SARMs were frequently misbranded and tainted with unlisted ingredients. Out of 44 products that were purchased online and analyzed, only about half contained an actual SARM, while 10 percent contained none at all. Roughly 40 percent had other hormones and unapproved drugs. Several contained a drug that was abandoned by GlaxoSmithKline a decade ago after it was found to cause cancer in animals.

The long-term consequences of using SARMs are largely unknown, and people who purchase products marketed as them cannot be entirely sure what they are putting in their bodies, said Dr. Shalender Bhasin, the director of research programs in men’s health, aging and metabolism at Brigham and Women’s Hospital and an author of the JAMA report.

“We don’t know whether these compounds are safe,” he said, “but we do know that some of them have side effects.”

That has not stopped many people from experimenting with them.

Thaddeus Owen, 42, a self-described biohackerwho lives in Saint Paul, Minn., began using SARMs in 2016 in combination with a diet and exercise program. He said that the pills helped him pack on five pounds of muscle in four weeks, which he documented on his website, “PrimalHacker.” He argued that informed adults should be allowed “to experiment on ourselves and improve our biology,” but added, “this is definitely a use-at-your-own-risk type of supplement.”

Anti-doping officials have known about SARMs for some time and have seen an increasing number of elite athletes using them. Since 2015, the United States Anti-Doping Agency has imposed sanctions on more than two dozen track and field stars, weight lifters, cyclists, mixed martial artists and others for testing positive for a variety of SARMs, most frequently one called ostarine.

SARMs, or selective androgen receptor modulators, have been around for a lot longer than most people realize. The first wave of SARMs was introduced in the 1940’s by Ligand Pharmaceuticals, and was marketed as a way to help treat cancer, osteoporosis, and other diseases. These were known as “steroidal SARMs.”

aIt wasn’t long before researchers discovered that these “steroidal SARMs” had a lot of side effects. Patients would often see huge gains in muscle, of up to 30 pounds within a matter of months. Needless to say, doctors very quickly realized that there were a number of negative side effects as well.

Steroids, and steroidal SARMs, often cause side effects such as gynecomastia, low libido, damaged to the liver, and heart disease. It was clear that doctors couldn’t continue prescribing these steroidal SARMs in their current form, so they were put on the shelf. Not much would be spoken of steroidal SARMs for decades.

Fast forward to the 1990’s however, and companies like GTx, Incorporated began to create “non-steroidal SARMs,” which are what we now simply call “SARMs.” Due to the protein-based chemical structure of these wonder drugs, they’re able to give us many of the benefits of steroids, with almost no side effects.