An FDA warning letter along with a replica of a California company’s offices emphasizes issues regarding the supplements some believe is a healthy substitute for steroids.
Move over steroids.
The popularity of gray-market research compounds known as selective androgen receptor modulators (SARMs) one of bodybuilding and fitness buffs are increasing.
Healthcare professionals and federal 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 are not presently approved for use in humans in the USA or some other country.
Nonetheless, they remain available through different outlets on the world wide web as well as some nutritional 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.
Doctors and scientists both appear to be thinking about them for this reason.
“SARMs have been shown in early clinical studies to build lean mass and muscle strength,” James Dalton, Ph.D., dean of pharmaceutical sciences at the University of Michigan, informed Healthline.
“They differ from commonly used androgenic steroids by their capacity to stimulate muscle and bone growth with lesser prostatic effects in men and virilizing effects in guys,” he added.
Steroids vs. SARMS
Androgenic steroids are proven to boost muscle growth 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 enhanced clitoral size.
More serious health issues include liver damage and numerous cardiovascular complications, including increased risk of heart attack and blood clots.
SARMs possibly represent a step toward a safer class of antipsychotic drugs. They have”revived an almost dormant search for enhanced androgens,” wrote researchers in the Journal of Medicinal Chemistry.
Dalton notes that so much the medication has been”generally well-tolerated” in clinical trials, but none of them have ever reached final approval by a regulatory body.
1 SARM in particular, known by a variety of names such as Enobosarm, Ostarine, and S-22, has made it through phase III clinical trials.
Concerns over the growing popularity
However, clinical study on SARMs, such as their possible use for preventing muscle wasting on cancer patients, has recently been overshadowed by their own off-label popularity among bodybuilders.
Last fall, the FDA issued warning letters Trusted Source to 3 nutritional supplement companies in the USA which were offering the medication available.
“We are extremely concerned about unscrupulous firms marketing body-building products with potentially harmful ingredients,” they said in a media statement.
“Life-threatening reactions, such as liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to boost the possibility of heart attack and stroke, and the long-term effects on the body are unknown,” FDA officials said.
Back in December, the FDA allegedly ran a raid on many centers operated by Sacramento-based supplement firm Enhanced Athlete for supposedly selling the medication Ostarine. The FDA declined to comment or support this to Healthline, citing a policy against commenting on potentially ongoing criminal investigations.
Agents for improved Athlete did not return numerous queries by Healthline.
At a public announcement, the business announced that the FDA had confiscated caches of Ostamuscle (their own brand of Ostarine) and”several other research compounds.”
The business has framed its selling of the drugs as a matter of personal liberty for customers.
“We believe that freedom of information and choice, provided that supplied within the context of this law, is critical. This means that we intend to carry on doing what we have always performed until advised to do otherwise by the appropriate authorities,” the company writes.
Nonetheless, they also anticipate a developing federal crackdown on the sale of SARMs, at which stage they admit”we will not have any option but to concede.”
Crackdown on SARMs
Many chemicals and substances can get around FDA supervision when being classified as a “dietary supplement”
Due to laws from 1994 known as the Dietary Supplement Health and Education Act (DSHEA), products classified as dietary supplements are exempted from pre-market studies before selling to the public.
In a prior interview, Dr. Carl Baum, a part of the American Academy of Pediatrics (AAP) said, “All bets are off,” when it comes to knowing what is really in a dietary supplement.
The FDA does take action against dangerous or misbranded supplements with their very own criminal identification unit Trusted Source.
While not commenting on details about Enhanced Athlete, an FDA spokesperson told Healthline, “The usage of SARMs in products marketed as dietary supplements and other products which haven’t obtained FDA approval is illegal.”
In other words, SARMs marketed in the USA have been”dietary supplements” in name only and not regarded as such by the government.
This presents additional problems. A recent study in the Journal of the American Medical Association Trusted Source evaluated the chemical composition of goods being marketed as SARMs.
They found that only half of them really contained SARMs. About 60 percent comprised ingredients distinct from what was featured on the tag.
Almost 10% of the products tested did not contain an active ingredient of any kind.
In a strange twist, Improved Athlete actually used these findings to advertise their own products, composing, “the popularity of SARMs is climbing along with the Fake News is using scare tactics and misinformation in order to provoke the government into action. … We are dedicated to continued to fight for your right to experiment and also to retain your right to choose.”
However, the FDA spokesperson contacted by Healthline did not mince words:
“Consumers should stop using these body-building products immediately and consult with a healthcare professional if they’re experiencing some adverse reactions that may be associated with their usage.”