FDA’s 2026 warning letters quote peptide sellers’ own websites as evidence. Truli reviews your claims, labels, COAs, and suppliers against that enforcement record, shows what to fix, and keeps watching.
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March 3, 2026
30 telehealth companies warned
FDA cited claims implying compounded GLP-1s were the same as approved drugs, plus branding that obscured who compounded them.
June 2026
25 more telehealth letters
Another batch followed for the same type of claims, keeping compounded GLP-1 marketing in FDA’s sights.
August 24, 2026
Online peptide vendors cited
Five letters treated website claims, dosing guidance, reconstitution calculators, and bacteriostatic water as evidence of drug intent, despite “research use only” language.
October 28, 2026
HHS drafts a conditional path
In a draft policy, HHS said it does not intend to act on qualifying 503A compounding of six peptides. The conditions cover sourcing, COAs, labeling, and adverse event reporting. It is not FDA approval.
Research-use disclaimer
High priority
“For research use only. Reconstitute with bacteriostatic water, 250 mcg daily.”
A disclaimer does not settle intended use. When dosing and benefit language sit beside it, FDA treats the product as a drug for people.
21 CFR 201.128 · FD&C Act §505(a)
Brand-drug sameness
High priority
“Same active ingredient as Ozempic, at a fraction of the cost.”
Implying a compounded product matches an approved drug is the pattern at the center of FDA’s telehealth letters.
FD&C Act §502(a), §502(bb)
Obscured sourcing
High priority
“Acme Semaglutide, made for you.”
Branding a compounded drug under your own name, without qualification, can imply that you are the compounder.
FD&C Act §502(a), §502(bb)
Investigational peptides
High priority
“Retatrutide now in stock.”
Retatrutide is unapproved worldwide and cannot be compounded under Section 503A. Truli flags it at any dose, wherever it appears.
FD&C Act §505(a)
Disease and healing claims
High priority
“Speeds tissue repair and reverses joint damage.”
Claims about treating disease or changing the body can make a product a drug, whatever category you sell it under.
FD&C Act §201(g)(1)
Results and testimonials
High priority
“Our patients lost 23% of their body weight.”
Weight-loss results and testimonials need competent, reliable support. The FTC has pursued a GLP-1 telehealth seller over them.
FTC Act §5 · 16 CFR 255
Example language is illustrative and does not describe any company.
Closed tabs and accordions
Product details, dosing tabs, and FAQs count even when they’re collapsed when the page loads.
Meta descriptions and alt text
Search snippets and image text can carry the same claims as the page, so Truli reads those too.
Pages behind gates
Age gates and member logins still lead to content your customers can read. With your permission, Truli signs in and reviews what’s behind them.
A risk score you can track
See where each page stands, which findings matter most, and how the score moves as your team makes fixes.
Rescan and compare
Run the scan again after a change to confirm what was resolved and catch anything new.
Findings by page and product
Every finding ties back to the page and product it affects, so the right person can act on it.
01
Listed peptide only
The drug uses BPC-157, Epitalon, KPV, MOTS-c, Semax, or TB-500.
Truli: Reads your label and catalog
02
Matching identity and route
The substance matches the sequence, structure, molecular weight, formula, and route HHS lists.
Truli: Reads your COA and label
03
Registered source, valid COA
It comes from an FDA-registered facility, with a COA covering identity, purity, potency, and contaminants.
Truli: Reads your COA and supplier records
04
Original manufacturer disclosed
The original manufacturer is registered and follows cGMP, and the COA lists its location. Resellers must document their validation.
Truli: Reads your COA and supplier records
05
Adverse event and quality reporting
Serious events and quality issues go to MedWatch and the relevant states, with the procedure on patient labeling.
Truli: Reads your label; you confirm reporting
06
Required label statement
The label states, “This is a compounded drug product. Not for resale.”
Truli: Reads your label
07
Single active ingredient
The product contains one listed active ingredient, so blends fall outside the policy.
Truli: Reads your label and catalog
08
Oral bioavailability records
Oral forms need documentation that the formulation achieves adequate bioavailability in humans.
Truli: Asks for your records
09
Delivery device
The only included or co-packaged device is an FDA 510(k)-cleared syringe.
Truli: Reads your product listing; you confirm
10
All other FD&C Act requirements
That includes sanitary compounding and a valid patient-specific prescription.
Truli: You confirm with your pharmacy and counsel
This is a draft, with comments due November 13, 2026. It applies to state-licensed pharmacies, federal facilities, and licensed physicians, not 503B outsourcing facilities. It doesn’t approve these peptides or bind state boards. Conditions are summarized from Arnold & Porter’s advisory.
HHS draft conditions
BPC-157, TB-500, KPV, MOTS-c, Epitalon, Semax
Still unapproved drugs. HHS’s draft reaches only qualifying 503A compounding, not research-use or supplement sales.
Approved brand drugs
Semaglutide and tirzepatide
Compounded versions can’t be marketed as the same as the approved drug, the pattern behind FDA’s telehealth letters.
Investigational
Retatrutide
Unapproved worldwide and not eligible for 503A compounding. Truli flags it at any dose, wherever it appears.
High enforcement risk
Research-use-only vials
A disclaimer doesn’t settle intended use. FDA’s August letters looked at the site as a whole, including dosing guidance.
Sold as supplements
Collagen peptides
A lawful supplement category, until disease or drug-like claims move the product over the line.
Cosmetic claims
Copper peptides (GHK-Cu)
Appearance claims can stay cosmetic. Claims about repairing tissue or changing the body can make a product a drug.
Payment processor readiness
Truli checks your site against common processor, card network, and LegitScript concerns, then shows what a reviewer is likely to question.
Ad platform policies
Review landing pages and ad copy against Meta, Google, TikTok, and Amazon health policies before you submit them.
Buyer checks and checkout language
Truli can review how your age gates, buyer attestations, and checkout wording read alongside the rest of your site. It doesn’t verify buyers or run checkout.
No approval is guaranteed
Truli isn’t a payment processor, certifier, or ad platform. Processors, card networks, LegitScript, and platforms make their own decisions and can change their rules. A buyer attestation also doesn’t make a research-use product lawful.
Distributors and online stores
Review catalogs, product pages, blogs, calculators, and bundles for evidence of human use, then re-check after every site change.
GLP-1 and telehealth
Catch brand comparisons, sameness claims, and unclear sourcing on compounded GLP-1 pages before they reach patients or ad platforms.
Clinics and med spas
Review service pages, patient-facing marketing, and testimonials for drug claims and results language that needs support.
Supplement, skincare, and sports nutrition brands
Keep collagen, copper peptide, and sports nutrition claims on the right side of the drug line, on the label and in your marketing.
Bring in what you sell. Fix what’s flagged. Keep watching what changes.
01
Bring product pages, labels, claims, COAs, and supplier records into one shared workspace.
One source of truth
02
Truli checks language and substances against FDA and FTC enforcement patterns, with citations and next steps.
Cited findings
03
Monitors scan live content, route issues through review, and alert your team when pages, posts, or regulations change.
Always audit-ready
Straight answers on enforcement, the HHS policy, and how Truli fits into a peptide compliance program.
Truli is not a law firm and does not provide legal advice. Warning letters are FDA’s allegations, not final findings. Regulatory information is current as of November 4, 2026 and may change, so confirm your obligations with qualified counsel.
Review peptide websites, labels, claims, COAs, and supplier records in one connected workflow.
One source of truth
Fast, thorough reviews
Proactive and cost-effective
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