“We are very concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients. Body-building products that include selective androgen receptor modulators, or SARMs, have never been approved by the FDA and are related to serious safety issues, such as possible to raise the possibility of heart attack or stroke and life-threatening reactions like liver impairment,” explained Donald D. Ashley, J.D., director of the Office of Compliance from the FDA’s Center for Drug Evaluation and Research. “We’ll continue to take action against companies marketing these products to safeguard public health.”
The U.S. Food and Drug Administration recently issued warning letters into Infantry Labs, LLC, IronMagLabs and Panther Sports Nutrition for distributing products that include SARMs. Even though the products identified in the warning letters are advertised and labeled as dietary supplements, they’re not dietary supplements. The goods are unapproved drugs that have never been reviewed by the FDA for safety and efficacy.
Life-threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the capability to boost the risk of heart attack and stroke, and the long-term effects on the body are still unknown. Consumers should stop using these body-building goods immediately and consult a healthcare professional if they are experiencing some adverse reactions which may be related to their usage.
Health care professionals and consumers should also report any adverse events associated with the usage of these body-building products into the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be filed online or via fax to 1-800-FDA-0178.
The firms that received a warning letter should react to the FDA identifying how the problems mentioned by the FDA are going to be adjusted within 15 working days. Businesses that don’t correct the issues risk additional enforcement action such as seizure, injunction or prosecutions.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, efficacy, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical apparatus. The agency is also accountable for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that give off digital radiation, and for regulating tobacco products.