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Sovereign Nations. Different Laws. One Complicated Payments System. On Indigenous Peoples' Day, it's time to examine why tribal gaming, ...
The FDA issued more than 50 warning letters to peptide companies in September 2025 alone. It followed those with additional enforcement actions in early 2026, targeting companies selling retatrutide, tirzepatide, and other compounds in research or with supplement-like positioning that the agency determined crossed the line into unapproved drug territory. For any business selling peptide products today, label language is not a marketing decision — it is a compliance decision.
The FDA determines a product's intended use based on the totality of its presentation under 21 CFR 201.128. That includes the label itself, the website, social media content, email marketing, customer service scripts, and even product bundle configurations. A company that sells a peptide vial alongside bacteriostatic water and a syringe kit has, in the FDA's view, demonstrated human injection intent regardless of what the label says.
This is why "research use only" disclaimers have failed to protect companies in recent enforcement actions. The FDA has explicitly stated that RUO labeling is a ruse when the surrounding marketing context indicates consumer or therapeutic use. The disclaimer is not a shield — it is one data point among many.
For peptides marketed as dietary supplements under the Dietary Supplement Health and Education Act (DSHEA), structure-function claims are permissible if substantiated, truthful, and not misleading. These claims describe how a nutrient affects the body's structure or function — not the treatment or prevention of disease.
Approvable examples for collagen peptides include claims like "supports joint flexibility" or "helps maintain skin elasticity." What makes these claims defensible is that they describe a physiological process without asserting medical benefit, are supported by substantiation the manufacturer can produce on request, and carry the required DSHEA disclaimer linking the claim to the statement that it has not been evaluated by the FDA.
On the disclaimer itself, the FDA issued updated guidance in December 2025 clarifying that the full disclaimer no longer needs to appear on every label panel — only once, clearly linked via asterisk to each structure-function claim. That removes a common source of class-action litigation risk, but it does not change the underlying requirement to include the disclaimer.
For topical peptide products classified as cosmetics, the acceptable claim territory is appearance-based. "Helps reduce the appearance of fine lines" survives. "Rebuilds damaged skin tissue" or "stimulates fibroblast activity" does not — the FDA issued warning letters in 2025 to companies making exactly those claims for GHK-Cu serums, classifying the products as unapproved drugs.
The clearest enforcement targets in 2025 and 2026 share common patterns:
Disease treatment language immediately converts a product to drug status. Claims describing weight loss through appetite suppression, insulin sensitivity modulation, or glucose handling — language the FDA cited directly in March 2026 warning letters to multiple peptide vendors — constitute drug claims requiring an approved New Drug Application that none of these companies hold.
Mechanism language is equally dangerous. Describing how a peptide works at the cellular or molecular level, referencing clinical trial outcomes, or citing study data on weight reduction percentages all signal therapeutic intent. The FDA found this language on product pages for retatrutide and tirzepatide sold under generic-sounding trade names, and the warning letters followed.
Comparative claims to FDA-approved drugs — positioning a compounded or research peptide as equivalent to or a generic version of semaglutide or tirzepatide — are explicitly prohibited. The FDA emphasized this in the September 2025 GLP-1 enforcement wave.
Label compliance requires more than careful word choice. Companies need documented substantiation for every structure-function claim, batch-level Certificates of Analysis confirming ingredient identity and potency, and a systematic review process for all consumer-facing content, including third-party retail listings and influencer partnerships.
The FDA's enforcement posture in this category is not easing. HHS Secretary Robert F. Kennedy Jr. indicated in February 2026 a preference for moving certain Category 2 peptides back toward compoundable status, but no formal rulemaking has occurred as of April 2026. Current rules remain in effect, and the enforcement record over the past eight months makes it clear that the agency is active.
Contact Qredible today to learn how our quality management solutions help peptide businesses implement defensible structure-function claim documentation, maintain batch-level Certificate of Analysis infrastructure, and build the marketing compliance monitoring systems necessary to withstand FDA review in an increasingly enforcement-focused regulatory environment.
