Walk through any supplement store or browse online peptide vendors, and you'll see dramatic health claims: "boosts muscle growth," "reverses aging," "heals injuries," or "burns fat." But are these claims legal? The short answer is: almost never. Understanding FDA and FTC regulations on peptide health claims protects you from both ineffective products and potentially illegal substances.
FDA Rules on Peptide Health Claims: The Legal Framework
The FDA regulates health claims for peptides based on how the product is classified and marketed:
When Peptides Are Regulated as Drugs
If a company markets a peptide with claims to treat, cure, prevent, or mitigate disease, the FDA classifies it as a drug—regardless of whether the company calls it a "supplement" or "research chemical."
Drug classification triggers strict requirements:
- FDA approval through new drug application (NDA) process
- Clinical trials demonstrating safety and efficacy
- FDA-approved labeling and advertising
- Good Manufacturing Practice (GMP) compliance
- Prescription requirement for most therapeutic peptides
Selling peptides with drug claims without FDA approval is illegal and subjects companies to enforcement action, including warning letters, injunctions, product seizures, and criminal prosecution.
When Peptides Are Regulated as Dietary Supplements
Some peptides may qualify as dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) if they:
- Were marketed as supplements before 1994, OR
- Meet the "new dietary ingredient" (NDI) notification requirements, OR
- Are derived from food sources without chemical modification
Even as dietary supplements, companies face significant claim restrictions:
Permitted claims (with substantiation):
- Structure/function claims (e.g., "supports muscle health")
- Must include disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."
Prohibited claims:
- Disease claims (e.g., "treats arthritis," "cures diabetes")
- Drug-like claims (e.g., "reduces blood pressure," "increases growth hormone levels")
Reality check: Most peptides sold online don't qualify as legal dietary supplements. Synthetic peptides like BPC-157, TB-500, and ipamorelin are not derived from food and haven't met NDI requirements, making supplement claims illegal.
FTC Rules on Peptide Advertising: Truth in Advertising
Even if a peptide product somehow navigates FDA regulations, it must still comply with Federal Trade Commission advertising rules:
The FTC's Three Core Requirements
- Claims must be truthful and not misleading
- Companies must have competent and reliable scientific evidence supporting all claims
- Customer testimonials must reflect typical results, not outliers
- Claims must be substantiated before dissemination
- Randomized controlled human trials for health-related claims
- Studies must be relevant to the actual product being sold
- Claims cannot be unfair or deceptive
- Material information cannot be omitted (e.g., side effects, risks)
- Disclaimers must be clear and conspicuous
Common Illegal Peptide Marketing Tactics
The FTC has identified these frequently used deceptive practices in peptide marketing:
| Deceptive Tactic | Why It's Illegal | Example |
|---|---|---|
| Unsubstantiated efficacy claims | No clinical evidence supporting claimed benefits | "BPC-157 heals all gut conditions" |
| Disease treatment claims | Classifies product as unapproved drug | "Cures autoimmune disease" |
| "Research chemical" disclaimers | Transparent attempt to evade drug regulations | "Not for human consumption" with dosing instructions |
| Before/after photos without substantiation | Implies typical results without evidence | Dramatic body transformation photos |
| Celebrity/influencer endorsements without disclosure | Material connection not disclosed | Paid Instagram posts without #ad disclosure |
| False FDA approval claims | Misrepresents regulatory status | "FDA-registered facility" implying product approval |
The "Research Chemical" Loophole That Isn't
Many peptide vendors attempt to avoid FDA regulation by labeling products "for research purposes only" or "not for human consumption." This strategy fails legally and practically:
Why the disclaimer doesn't protect sellers:
- FDA evaluates intended use based on marketing, labeling, and seller knowledge of customer use
- Providing dosing information, cycle recommendations, or human-relevant studies demonstrates intended human use
- Selling to individuals (not research institutions) with no verification of research credentials indicates human consumption intent
- Courts routinely reject the "research chemical" defense in enforcement actions
What happens to companies using this loophole: The FDA has issued hundreds of warning letters to companies selling "research peptides," many of which escalated to seizures, injunctions, and criminal charges when companies didn't cease operations.
What Peptide Companies CAN Legally Claim
Very few peptide products can make legal health claims. Here's what IS permitted:
FDA-Approved Prescription Peptides
Companies selling FDA-approved peptides (semaglutide, tirzepatide, tesamorelin, etc.) can make claims that align with FDA-approved labeling for approved indications.
Compounding Pharmacies
Licensed compounding pharmacies can state they compound specific peptides but cannot make therapeutic claims beyond what's established in medical literature. They must clearly indicate "compounded medication, not FDA-approved."
Cosmetic Peptides
Peptides marketed solely for cosmetic purposes (appearance, not disease) may make structure/function claims if substantiated, such as "reduces the appearance of fine lines." They cannot claim to affect disease or physiological function.
Red Flags: How to Spot Illegal Peptide Marketing
Protect yourself by recognizing these warning signs of illegal peptide marketing:
- Claims to treat or cure specific diseases
- Promises of dramatic results (e.g., "lose 30 pounds in 30 days")
- "Research purposes only" label while marketing to consumers
- No licensed pharmacy or prescriber involvement
- Comparison to FDA-approved drugs ("works like Ozempic for half the price")
- Lack of proper FDA disclaimers on supplement claims
- Sale to consumers without prescription for therapeutic peptides
- Claims of "pharmaceutical grade" without proper licensing
What This Means For You
As a consumer evaluating peptide products:
- Assume most marketing claims are illegal: If it sounds too good to be true, the company is likely violating FDA and FTC regulations
- Illegal marketing indicates illegal products: Companies willing to violate advertising laws often sell illegal, mislabeled, or contaminated products
- Verify prescription requirements: Therapeutic peptides require legitimate prescriptions; direct-to-consumer sales are red flags
- Report deceptive marketing: Submit complaints to FDA's Health Fraud Program and FTC's Consumer Protection Bureau
- Work with licensed providers: Obtain peptides only through licensed healthcare providers and pharmacies
Frequently Asked Questions About Peptide Health Claims
Can peptide supplement companies make any health claims?
Only limited structure/function claims if the peptide qualifies as a legal dietary supplement and claims are substantiated. Most synthetic peptides don't qualify as supplements, making virtually all health claims illegal.
What happens to companies making illegal peptide health claims?
The FDA typically issues warning letters first, demanding immediate correction. If companies don't comply, enforcement escalates to product seizures, injunctions, civil penalties, and potentially criminal prosecution for individuals responsible.
Are before and after photos for peptides legal?
Before/after photos constitute advertising claims that must be substantiated with competent and reliable scientific evidence showing they represent typical results. Most peptide companies cannot meet this standard, making such photos deceptive advertising.
Can influencers legally promote peptide products?
Influencers must disclose material connections (payment, free products) and cannot make claims the company itself cannot legally make. Many influencer peptide promotions violate both FTC endorsement guidelines and FDA drug marketing regulations.
Do research chemical disclaimers protect peptide sellers legally?
No. The FDA evaluates intended use based on totality of marketing, distribution, and seller knowledge—not on disclaimers alone. Research chemical labels don't protect sellers from enforcement when evidence shows intended human use.
Legal Disclaimer: This article provides general information about FDA and FTC regulations affecting peptide marketing and does not constitute legal advice. Regulations are enforced based on specific facts and circumstances. Companies should consult with regulatory attorneys before making any health claims. Consumers should consult licensed healthcare providers before using any peptide products. PeptideLaws.com is an informational resource and does not provide legal representation or medical advice.