peptides in fLorida Med spas: reguLatory Considerations
Health Care law Section Co-Chairs: RebeccaSiviglia – MoffittCancerCenter & DaniellaLee – EpsteinBeckerandGreen, P. C.
In recent years, the use of peptides in medical spas— often marketed for“ wellness,”“ anti-aging,” or“ performance enhancement”— has surged in Florida and nationally. While these offerings may appear innocuous to consumers, they operate within a regulatory gray area that requires careful navigation under both federal law and Florida’ s healthcare and pharmacy statutes.
At the federal level, the United States Food and Drug Administration( FDA) regulates peptides based on intended use, which is inferred from a variety of sources, including: marketing claims, website content, training materials, how clinicians explain
the product to patients, and route of administration( e. g., injections). When a peptide is intended to diagnose, treat, mitigate, or prevent disease— or to affect the structure or function of the body— it is generally considered a drug. Peptides such as BPC-157( tissue repair), sermorelin( growth hormone stimulation), NAD +( cellular metabolism), and GHK-Cu( collagen synthesis) are almost always promoted for structure- or function-altering effects.
Florida law largely tracks federal classifications. Chapter 499, Florida Statutes, prohibits the manufacture, distribution, or administration of
while these offerings may appear innocuous to consumers, they operate within a regulatory gray area that requires careful navigation under both federal law and florida’ s healthcare and pharmacy statutes.
adulterated or misbranded drugs, incorporating federal standards by reference. As a result, if a peptide is considered an unapproved drug under federal law, its use in a Florida med spa— particularly when paired with therapeutic claims— may expose the spa and its medical director to enforcement risk, even if no Florida statute expressly names the peptide.
One source of confusion is that some peptides are FDA-approved drugs, for example, GLP-1 agonists( like semaglutide and tirzepatide) and certain growth
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