The question of why is sermorelin banned? is often based on a critical misunderstanding of its legal and regulatory history. Unlike controlled substances or drugs removed for safety reasons, sermorelin was voluntarily discontinued by its manufacturer, and a version is still legally accessible via compounding pharmacies. This article will explore the full story, distinguishing between the commercial market withdrawal and its prohibited status in professional athletics.
The Commercial Discontinuation of FDA-Approved Sermorelin
In 2008, EMD Serono, the manufacturer of the brand-name sermorelin product Geref®, made the business decision to stop its production. The U.S. Food and Drug Administration (FDA) subsequently withdrew its approval in 2009, not due to safety concerns, but because the manufacturer removed the product from the market. The FDA confirmed in 2013 that the product was not withdrawn for reasons of safety or effectiveness.
Key Reasons for Commercial Discontinuation
- Competition from More Effective Alternatives: At the time of discontinuation, other growth hormone replacement therapies were proving more effective or convenient. Recombinant human growth hormone (rhGH), which replaces the hormone directly, offered more potent and consistent results, making sermorelin a less competitive option in the market.
- Manufacturing Difficulties: In addition to commercial considerations, the manufacturer cited specific manufacturing difficulties as a factor in the decision to discontinue Geref®.
- Limited Approved Use: Sermorelin's FDA approval was originally limited to diagnosing and treating growth hormone deficiency in children. Its off-label use for anti-aging and wellness, while widespread, was not part of its official approved indication, which likely influenced the commercial viability of maintaining the drug.
Sermorelin's Status in the Compounding Market
Because sermorelin was not pulled for safety reasons, it can still be prepared and sold by licensed compounding pharmacies with a doctor's prescription. Compounding allows pharmacists to create customized medications that are no longer commercially available, a practice that is legal but does have regulatory differences.
Compounded vs. FDA-Approved Sermorelin
| Feature | Commercially Available (Geref®) | Compounded Sermorelin |
|---|---|---|
| Manufacturer | EMD Serono (Discontinued) | Licensed Compounding Pharmacy |
| FDA Oversight | Standardized, FDA-verified for safety and efficacy | Not directly FDA-reviewed; oversight falls under state pharmacy boards |
| Availability | No longer available | Available with a doctor's prescription |
| Usage | Approved for pediatric growth hormone deficiency | Used legally for off-label purposes, such as age-related hormone decline |
| Regulation | Federal oversight of manufacturing and labeling | State-level pharmacy regulations; quality can vary |
The Ban in Professional Athletics
While the FDA did not ban sermorelin, major athletic organizations like the World Anti-Doping Agency (WADA) and the U.S. Anti-Doping Agency (USADA) have strictly prohibited its use.
Why is sermorelin banned in sports?
- Growth Hormone Promotion: Sermorelin stimulates the pituitary gland to increase the body's natural production of human growth hormone (hGH).
- Performance Enhancement: This increase in hGH can lead to muscle growth, enhanced recovery, and improved endurance, giving athletes an unfair advantage.
- Anti-Doping Regulations: The use of any substance that can artificially boost a hormone like hGH is against anti-doping rules, regardless of its FDA status. A Therapeutic Use Exemption (TUE) for sermorelin is highly unlikely for athletes, as safer, non-prohibited alternatives are available for legitimate medical needs.
Legal Implications and Safety Considerations
For the average person, obtaining sermorelin from a licensed compounding pharmacy with a prescription is legal and represents the safest route. However, purchasing unregulated peptides online or from the black market carries significant risks, including receiving counterfeit or contaminated products.
Legal and Safety Cautions with Compounded Sermorelin
- Prescription is Required: It is illegal to buy or sell sermorelin without a valid prescription from a licensed healthcare provider.
- FDA Scrutiny: The FDA has issued warning letters to companies illegally marketing unapproved peptides, including sermorelin, for human use.
- Compounding Quality: The quality and purity of compounded medications are not guaranteed by the FDA, making it essential to use a reputable pharmacy.
Conclusion: A Tale of Two Bans
The perception that "sermorelin is banned" is misleading and requires careful distinction. The commercial, FDA-approved version was discontinued by its manufacturer for business-related reasons and was not removed for safety issues. This allowed for its continued, legal availability through licensed compounding pharmacies for legitimate, off-label prescriptions. Simultaneously, the substance is banned by sports anti-doping agencies because its performance-enhancing effects violate fair-play rules. The different contexts—commercial market dynamics versus athletic regulations—highlight why the term "banned" is not a simple descriptor for sermorelin's complex status.
For more information on the FDA's decision-making process, the FDA's Determination that GEREF (Sermorelin Acetate) Injection was not withdrawn for safety or effectiveness provides official insight.
