SARMS Decoded: Why The FDA Urges Caution

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SARMS Decoded: Why The FDA Urges Caution

By John Cornell | Frequently Asked Questions | 0 Comments | 11 December, 2017

In October 2017, the FDA issued a warning about a group of body-building supplements that contain potentially hazardous ingredients and are currently under the agency's investigation. These ingredients are known as "selective androgen receptor modulators (SARMS)." The warnings issued about these ingredients are based on reports that some consumers who took supplements containing SARMS experienced life-threatening reactions and other complications, as well as the alleged illegal activities of the brands. To avoid involvement with situations like this one, it is important for all supplement brands to research the ingredients they include in their products and avoid any unsafe or controversial ingredients. 

What Are SARMS?

SARMS are an ingredient that is chemically similar to an anabolic steroid. A number of these ingredients are available, including Cardarine, Andarine, Ligandrol and Ostarine

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SARMS work by impacting androgens, which are hormones responsible for producing the signs of masculinity, such as a deeper voice and larger muscles.

When an individual isn't taking steroids or similar medications, his or her body regulates the production of androgens carefully.      

However, when a consumer takes an SARM or a steroid, the body is flooded with more androgens than it would normally produce on its own, which causes all of the affected cells to respond more dramatically. For body-builders, this can mean larger, stronger muscles. 

FDA's Concerns

The FDA is concerned about the safety of SARMS in supplements. These ingredients have not been approved for medical use, and they have been associated with serious side effects and complications. The FDA states that some individuals who have taken supplements that contained SARMS have suffered from:

  • Liver toxicity
  • Increased risk of heart attack
  • Increased risk of stroke

The FDA also cautions that these ingredients could cause other side effects or complications that have not yet been discovered. The agency recommends that all consumers using these body-building products discontinue their use immediately. They also recommend that consumers should consult a healthcare professional if any adverse events occurred. 

The FDA sent its warning letters to three different companies: Panther Sports Nutrition, IronMagLabs and Infantry Labs, LLC. In the letters, the FDA accused these companies of unscrupulously marketing these unapproved ingredients as "dietary supplements." Under the accepted definition of dietary supplements, ingredients that have been "authorized for investigation as a new drug" are excluded. The companies responded by either removing the products from their offerings entirely or replacing it with other ingredients. 

Why Supplement Brands Should Pay Attention

This situation was serious for the supplement brands involved. Because they were marketing unapproved supplements inappropriately, they were subjected to warnings and threats from the FDA. In addition, the controversy made the news, which damaged the reputation of these companies as well. Furthermore, any consumers who took these supplements and suffered severe complications could eventually decide to file lawsuits against the brands. 

Other supplement brands can learn a great deal from the experiences of these three companies. Although all three companies are still operating at this time, this situation may have impacted their profitability and overall success significantly. In addition, it could have been avoided entirely if the companies had done more research and investigated relevant laws more thoroughly before creating these products. 

To avoid becoming involved in a situation like this one, supplement brands should be vigilant when it comes to creating and marketing new products. Before offering any new product, supplement brands should investigate each ingredient carefully. Supplement brands should never include any ingredients that are currently under investigation, associated with controversies or considered unsafe. Supplement brands should also be careful about the way they present supplements in marketing materials, avoiding any false claims or illegal labeling. 

Perhaps the most important thing a supplement brand can do to protect their company from controversy is to work with a reputable manufacturer. A reputable manufacturer like ABH Pharma can help supplement brands make sure that their products are thoroughly tested, effective and safe for human consumption. 

Sources: 

  1. https://www.naturalproductsinsider.com/blogs/insider-law/2017/10/fda-issues-warning-letters-on-sarms-in-dietary-su.aspx
  2. https://legionathletics.com/sarms/

Frequently Asked Questions

John Cornell

Written by John Cornell

John is the vice president of business development here at ABH Pharma. John has years of experience working with both Supplement Brands & Manufacturers, giving him great insider knowledge of operations & sales methodology that works within this industry. John is constantly reviewing new product trends and listening to feedback from industry leaders to better his clients. He is also particularly intuitive when it comes to the formulation of supplements.

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