Peptide Advertising Regulations: FTC & FDA Rules

If you sell peptides, market a peptide clinic, or run a telehealth platform that prescribes them, the rules about what you can say are stricter than most people realize. Two federal agencies — the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) — share jurisdiction over health product advertising, and both have been actively enforcing against the peptide industry.

This guide covers the actual rules, how they apply to peptides specifically, what enforcement looks like in practice, and where the lines are between legal marketing and the kind of claims that trigger warning letters, fines, and injunctions.

Table of Contents

How FDA and FTC Split Jurisdiction
The FDA's Rules: Labeling, Intended Use, and Unapproved Drug Claims
The FTC's Standard: Competent and Reliable Scientific Evidence
What Peptide Companies Cannot Say
The "Research Use Only" Disclaimer Problem
Structure/Function Claims vs. Disease Claims
Enforcement Actions: Real Examples
State Attorney General Enforcement
Compliance Guidelines for Peptide Businesses
The Political Winds: Deregulation Pressures
FAQ
The Bottom Line
References

How FDA and FTC Split Jurisdiction

The FDA and FTC divide their authority over health product marketing through a long-standing FDA-FTC Liaison Agreement. Understanding who regulates what is the first step in understanding the rules.

The FDA controls labeling. This includes packaging, product inserts, websites that accompany or refer to specific products, and anything the agency considers part of the product's "labeling" — a term that extends well beyond the physical label.

The FTC controls advertising. This covers print ads, digital ads, social media posts, influencer marketing, email campaigns, video content, and promotional materials that are not directly part of the product's labeling.

In practice, the boundary between "labeling" and "advertising" blurs constantly. A company's website might contain both labeling (product descriptions, usage instructions) and advertising (promotional claims, testimonials). Both agencies can and do take action against the same company for the same claims.

The practical effect: peptide companies face two separate sets of rules, enforced by two separate agencies, with overlapping jurisdiction. Getting compliant with one does not guarantee compliance with the other.

The FDA's Rules: Labeling, Intended Use, and Unapproved Drug Claims

The FDA's approach to peptide regulation starts with one question: what is the product's intended use?

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a product's legal classification depends on how it is marketed, not just what it physically is. A peptide sold as a "research chemical" becomes a "drug" the moment anyone — the seller, its website, its social media, or its sales team — claims or implies it can treat, mitigate, cure, or prevent a disease or condition in humans.

Once classified as a drug, the peptide must have an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) to be legally marketed. Since most wellness peptides have neither, they become unapproved new drugs — and selling them is a federal violation.

This is not hypothetical. The FDA has issued dozens of warning letters making exactly this argument. The trigger points include:

Therapeutic claims on websites. Stating that a peptide "accelerates healing," "promotes fat loss," or "supports immune function" establishes intended use as a drug.
Dosing instructions. Providing reconstitution guides, injection protocols, or dosage recommendations implies human use.
Customer reviews. If a company's website hosts reviews where customers describe health benefits, the FDA considers those claims attributable to the company.
Product bundling. Selling peptides alongside bacteriostatic water, syringes, or alcohol swabs signals intended human use.

The FDA does not need to prove that someone actually used the product. The intended use can be established entirely through marketing materials.

The FTC's Standard: Competent and Reliable Scientific Evidence

The FTC's approach to health claims is governed by Section 5 of the FTC Act, which prohibits "unfair or deceptive acts or practices." For health products, this translates into a specific evidentiary standard that the FTC updated in December 2022 with its revised Health Products Compliance Guidance.

The standard is called "competent and reliable scientific evidence," and here is what it actually requires:

Randomized controlled trials (RCTs) in humans. The FTC considers RCTs the gold standard for health claims. Animal studies, in vitro research, epidemiological data, and anecdotal evidence are not sufficient. For most peptides, which have only preclinical data, this is an almost impossible bar to clear.
Independent replication. While no specific number of studies is required, replication by independent researchers strengthens the evidence. A single company-funded study is weak evidence under FTC standards.
Statistical and clinical significance. Results must be statistically significant and clinically meaningful. Post hoc data mining — running a study, failing to find the expected result, then reanalyzing subsets until something looks positive — is specifically rejected.
Totality of evidence. Companies cannot cherry-pick favorable studies and ignore unfavorable ones. The FTC expects advertisers to consider the full body of relevant research.

The 2022 guidance also tightened rules around qualifying language. Terms like "may help," "promising research," or "preliminary evidence suggests" are not adequate disclaimers in the FTC's view. The agency has stated that consumers interpret these words as positive product attributes rather than meaningful limitations.

This matters enormously for peptides. Most marketed peptides — BPC-157, CJC-1295, ipamorelin, GHK-Cu — have little to no published human RCT data. Their evidence base consists primarily of animal studies and mechanistic research. Under the FTC's current standard, essentially no health benefit claim about these peptides could be legally substantiated.

What Peptide Companies Cannot Say

Based on FDA and FTC enforcement patterns, here are the specific types of claims that trigger regulatory action:

Disease treatment claims:

"Treats inflammation" / "Heals injuries" / "Reverses aging"
"Effective for gut healing" / "Repairs connective tissue"
"Treats sexual dysfunction" / "Cures hair loss"

Efficacy claims without FDA approval:

"Clinically proven" / "Scientifically validated" / "Real results"
"Same active ingredient as [FDA-approved drug]"
"FDA-quality" / "Pharmaceutical grade" (when not from a licensed pharmacy)

Implied equivalence to approved drugs:

"Generic version of Ozempic" / "Same as Wegovy but cheaper"
Marketing compounded semaglutide as interchangeable with branded products

Safety claims without evidence:

"Safe and well-tolerated" / "No side effects" / "All natural"
"Minimal risk" when no human safety data exists

Before/after or results claims:

Customer testimonials describing weight loss, healing, or performance gains
Before/after photos attributed to peptide use
"Results not typical" disclaimers do not cure deceptive testimonials under FTC rules

The "Research Use Only" Disclaimer Problem

Many online peptide sellers rely on disclaimers like "For research purposes only — not for human consumption" as a legal shield. The FDA has been explicit: this does not work.

In warning letters to companies like Summit Research Peptides (December 2024) and Pinnacle Peptides (December 2025), the FDA stated that evidence from the companies' own websites established that their products were "intended to be drugs for human use," regardless of the disclaimer.

The factors that undermine a "research use only" disclaimer include:

Therapeutic claims anywhere on the site, social media, or marketing materials
Dosing guidance or reconstitution instructions
Products sold with injection supplies (syringes, bacteriostatic water)
Customer reviews describing personal health outcomes
Product names that match known therapeutic peptides (e.g., "Semaglutide 5mg vial")
Social media posts promoting health benefits

The FDA has called these disclaimers "a ruse to avoid FDA scrutiny" and treated them as evidence of bad faith rather than legal protection.

Structure/Function Claims vs. Disease Claims

One area of frequent confusion involves the distinction between "structure/function" claims and disease claims.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements can make structure/function claims — statements about how a product affects the body's structure or function — without FDA pre-approval. "Supports joint health" is a structure/function claim. "Treats arthritis" is a disease claim.

However, this distinction has limited relevance for most peptides, for two reasons:

Most peptides are not dietary supplements. The FDA considers many peptides to be "new drugs" that were investigated as drugs before they were marketed as supplements. Under the FD&C Act's "new drug" exclusion provision, a substance that was first studied as a drug cannot later be marketed as a dietary supplement. BPC-157, for example, was investigated as a drug in clinical trials before any company tried to sell it as a supplement.
The FTC does not recognize DSHEA's structure/function framework for advertising. The FTC has been clear that its advertising standards "make no bright-line distinctions between categories of health-related products." Structure/function claims in advertising are subject to the same substantiation requirements as disease claims. A peptide company that carefully crafts structure/function language for its labels may still face FTC action if those claims appear in advertising without RCT-level evidence.

Enforcement Actions: Real Examples

Understanding the rules in the abstract is useful. Seeing how agencies actually enforce them is more useful.

FTC v. NextMed (2025). In July 2025, the FTC filed a complaint against NextMed, a telehealth provider, for using deceptive advertising to sell GLP-1 weight-loss programs. The FTC alleged that NextMed exploited consumer interest in drugs like Wegovy and Ozempic by making false claims about compounded alternatives. A final order was approved in December 2025.

FDA September 2025 Warning Letter Wave. In September 2025, the FDA issued more than 50 warning letters to companies marketing compounded semaglutide and tirzepatide. Violations included calling compounded products "generic versions" of FDA-approved drugs, claiming equivalent safety and efficacy, and marketing compounded GLP-1s for weight loss with unsubstantiated efficacy claims. Companies targeted included Hims & Hers Health, DirectMeds, and dozens of smaller operations.

Novo Nordisk and Eli Lilly (September 2025). The FDA did not spare brand-name manufacturers. Both Novo Nordisk and Eli Lilly received warning letters for promoting GLP-1 drugs on the Oprah television special "Shame, Blame, and the Weight Loss Revolution" in a manner that failed to present serious risks truthfully.

Summit Research Peptides (December 2024). The FDA warned Summit Research for selling semaglutide, retatrutide, cagrilintide, tirzepatide, and mazdutide while labeling them "for research purposes." The company's Facebook page promoted "Enhanced Weight Loss" through peptide combinations. The FDA found this constituted marketing unapproved drugs for human use.

For a deeper analysis, see our FDA warning letters to peptide companies analysis.

State Attorney General Enforcement

Beyond the FDA and FTC, state attorneys general have become a third — and increasingly aggressive — enforcement vector.

In 2025, more than 40 state attorneys general sent a formal multi-state letter to the FDA describing what they called a "national ecosystem" of counterfeit, contaminated, and research-grade GLP-1 peptides entering the U.S. through unregulated channels. The letter specifically identified:

Counterfeit semaglutide imported from China, Turkey, and India
Online sellers promoting "research-only" peptides while providing injection instructions
Consumers mixing raw peptide powders at home based on social media guidance

State AGs are using consumer protection statutes, unfair trade practice laws, and public health authority to go after peptide sellers and telehealth platforms that federal agencies have not yet reached. This represents a growing regulatory gap that state-level enforcers are filling.

State-level enforcement actions can include:

Civil investigative demands (CIDs)
Cease-and-desist orders
Civil penalties under state consumer protection statutes
Injunctions prohibiting specific marketing practices
Mandatory consumer restitution

For companies operating across multiple states, this creates 50 potential enforcement actions on top of federal exposure. The legal costs alone can be devastating, even before penalties are assessed.

Compliance Guidelines for Peptide Businesses

For companies that want to operate within the rules, here is what compliance actually looks like in 2026:

For research peptide sellers:

Do not make any claims about human use, safety, or efficacy
Do not provide dosing instructions, reconstitution guides, or injection protocols
Do not sell peptides alongside injection supplies
Moderate customer reviews to remove health outcome claims
Do not use product names that imply therapeutic use
Maintain records of all marketing materials

For compounding pharmacies and 503B outsourcing facilities:

Compound only peptides that have Category 1 status or appear on the 503A/503B Bulks List
Do not market compounded products as "generic" or "equivalent to" FDA-approved drugs
Follow current Good Manufacturing Practice (cGMP) requirements
Label compounded products as "This is a compounded drug"
Submit adverse drug reaction reports to the FDA
Do not engage in mass marketing of compounded products (this can jeopardize 503A status)

For telehealth peptide clinics:

Do not make unsubstantiated efficacy claims on websites or advertising
Clearly distinguish between FDA-approved and compounded products
Obtain proper informed consent from patients
Route prescriptions through licensed pharmacies
Maintain documentation of medical necessity for each prescription
Do not use before/after images or patient testimonials as marketing

For all peptide businesses:

Have advertising materials reviewed by a healthcare regulatory attorney before publication
Maintain substantiation files for any health-related claims
Monitor social media accounts for user-generated content that could be attributed to the company
Stay current on FDA warning letter trends — they signal where enforcement is headed

The Political Winds: Deregulation Pressures

The regulatory environment for peptide advertising is not static. Political forces are actively pushing to change the rules.

Robert F. Kennedy Jr., before Trump's reelection, warned that the FDA would face a "reckoning" for what he described as its "aggressive suppression" of vitamins, peptides, nutraceuticals, and other supplement products. A petition filed with the FTC seeks to flip the burden of proof — instead of requiring companies to prove their products work, the government would have to prove they don't.

The FTC under the Trump administration has not announced new enforcement actions against supplement makers as of early 2026, though it has distributed refunds from prior settlements. Some COVID-related enforcement actions have been reversed.

Whether these political shifts will lead to lasting deregulation is unclear. The FTC's substantiation standard has survived multiple administrations because it is rooted in the FTC Act, not in agency guidance alone. But the practical effect of reduced enforcement — fewer warning letters, slower investigations, less aggressive litigation — could create a period where companies test boundaries with less immediate consequence.

This does not make aggressive marketing legal. It means enforcement may be delayed, not eliminated. Companies that build marketing practices around temporary enforcement gaps often face consequences when the pendulum swings back.

FAQ

Can a peptide company claim its product "supports" health without FDA approval?

Structure/function claims (like "supports joint health") are permitted for legitimate dietary supplements under DSHEA. But most peptides do not qualify as dietary supplements because they were first investigated as drugs. And even for genuine supplements, the FTC requires competent and reliable scientific evidence — meaning human clinical trials — for any health benefit claim in advertising.

What happens if a company gets an FDA warning letter?

The company has 15 working days to respond with a corrective action plan. If it fails to correct the violations, the FDA can pursue seizure of products, injunctions, civil penalties, and criminal prosecution. Warning letters are publicly posted on the FDA website and can damage a company's reputation immediately.

Are customer testimonials regulated?

Yes. Both the FDA and FTC hold companies responsible for testimonials that appear on their platforms. If a customer review on a company's website describes weight loss or healing from a peptide, the company can be held liable for that claim. The FTC requires that testimonials reflect typical results and that any material connections (free products, paid endorsements) be disclosed.

Can clinics advertise peptide therapy without naming specific peptides?

General claims about "peptide therapy" are still subject to FTC substantiation standards if they imply specific health benefits. Stating "Our peptide therapy programs help patients lose weight and recover faster" is an efficacy claim that requires RCT-level evidence, regardless of whether specific peptides are named.

Yes. The FTC applies the same standards to social media that it applies to traditional advertising. An Instagram post claiming a peptide "changed my life" from a paid influencer is subject to endorsement disclosure rules and substantiation requirements. Companies are responsible for claims made by influencers they compensate.

Are the rules different for FDA-approved peptides like semaglutide?

FDA-approved drugs have an approved label that defines what the drug can be marketed for. Brand-name manufacturers can only promote approved indications and must present risk information alongside benefit claims. Even Novo Nordisk and Eli Lilly received warning letters in 2025 for presenting their GLP-1 drugs in a misleading manner on television.

The Bottom Line

Peptide advertising sits at the intersection of FDA drug regulation, FTC advertising law, and state consumer protection enforcement. The rules are not ambiguous — they are just spread across multiple agencies with overlapping jurisdiction.

The core principles are straightforward: you cannot market an unapproved drug for human use; you cannot make health claims without human clinical trial evidence; "research use only" labels do not protect against enforcement when the marketing tells a different story; and both federal and state regulators are actively watching this space.

Companies that treat compliance as optional are not operating in a regulatory vacuum. They're operating in a period of enforcement backlog that will eventually clear. The warning letters, fines, and injunctions from 2024-2025 make that trajectory clear.

For the latest on FDA enforcement actions, see our analysis of FDA warning letters to peptide companies and the broader FDA peptide compounding crackdown.

References

Federal Trade Commission. "Health Products Compliance Guidance." December 2022. https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance
Federal Trade Commission. "FTC Approves Final Order against Telehealth Provider NextMed Over Charges It Used Deceptive Advertising Claims to Sell GLP-1 Weight-Loss Programs." December 2025. https://www.ftc.gov/news-events/news/press-releases/2025/12/ftc-approves-final-order-against-telehealth-provider-nextmed-over-charges-it-used-deceptive
FDA. "Summit Research Peptides Warning Letter 695607." December 10, 2024. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024
FDA. "Pinnacle Professional Research dba Pinnacle Peptides Warning Letter 719337." December 12, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025
Wilson Sonsini. "FDA Sends Warning Letters to More Than 50 GLP-1 Compounders and Manufacturers." September 2025. https://www.wsgr.com/en/insights/fda-sends-warning-letters-to-more-than-50-glp-1-compounders-and-manufacturers.html
Stevens & Lee. "GLP-1 Weight Loss Drug Enforcement in 2025: State Attorneys General Step into a Growing Regulatory Gap." https://www.stevenslee.com/health-law-observer-blog/glp-1-weight-loss-drug-enforcement-in-2025-state-attorneys-general-step-into-a-growing-regulatory-gap/
Your Peptide Brand. "FDA & FTC Compliance for Research Peptide Brands: The Complete Guide for 2025." https://yourpeptidebrand.com/fda-ftc-compliance-for-research-peptide-brands/
Holt Law. "Peptide Legal Frequently Asked Questions." https://djholtlaw.com/peptide-legal-frequently-asked-questions/
Holt Law. "The Unregulated World of Peptides: A Legal Minefield for Providers." https://djholtlaw.com/the-unregulated-world-of-peptides-a-legal-minefield-for-providers/
PolitiFact. "FTC has long said products must back up health claims. A MAHA lawsuit would upend that." August 2025. https://www.politifact.com/article/2025/aug/25/ftc-health-false-advertising-maha-fda-xylitol-rfk/
MedBio Institute. "Peptides in Limbo: The Legal and Ethical Crossroads of America's Booming Bioregulator Market." https://www.medbioinstitute.com/resources/topics/peptides-in-limbo-the-legal-and-ethical-crossroads-of-americas-booming-bioregulator-market
Frier Levitt. "Regulatory Status of Peptide Compounding in 2025." https://www.frierlevitt.com/articles/regulatory-status-of-peptide-compounding-in-2025/