Background
Peptides are smaller versions of proteins that may provide pro-aging support, anti-inflammatory, or muscle-building properties. Although popular peptides include weight loss drugs such as semaglutide or tirzepatide, certain peptides such as BPC-157 and Sermorelin are currently being used at med spas for therapeutic purposes. Peptides that are used for therapeutic purposes are not FDA-approved, so they are considered off-label use.
First Consideration: The FDA Is Aware of the Risks of Peptides
The FDA has classified certain peptides, such as BPC-157 and Thymosin Beta-4, in Category 2 of bulk drug substances. Category 2 is for substances where the FDA has identified “significant safety risks” associated with compounding, which means pharmacies cannot compound drugs containing substances in Category 2 without going through the FDA-approval process first. For BPC-157 and Thymosin Beta-4, for example, the FDA has cited certain risks that these peptides can invoke an immune response in the body, but the agency also lacks enough information about whether the peptides would harm humans when administered to them.
The FDA has issued warning letters to pharmacies for compounding drugs containing substances in Category 2. Although enforcement has been primarily against pharmacies or manufacturers for compounding and selling drugs with certain peptides in them, we are monitoring whether the FDA will seek enforcement actions against med spas and other practices for offering peptides to patients.
Second Consideration: Med Spas Should Be Cautious Before Selling or Using Peptides That Are Marketed for “Research Use Only”
According to the FDA, drugs that are marketed “for research use only” have not been approved for human use for diagnostic purposes. Peptides in Category 2 cannot be compounded for human use without going through the FDA-approval process, so companies that have marketed drugs that are labeled “for research use only” to humans have triggered scrutiny from the FDA and other government entities for misbranding and false advertising. For example, the federal government has prosecuted a business for marketing peptides to humans that were labeled “for research use only.” Because these drugs are not FDA-approved, using peptides that are labeled “for research use only” can lead to adverse reactions for patients and may expose med spas to potential lawsuits or penalties for using unapproved drugs.
If you need assistance setting up a med spa that offers peptides, have questions about whether your practice is compliant with the various laws and regulations surrounding peptides, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.