The rule library
15 rules, version 2026.10.18. Each one encodes wording from an FDA or FTC page that we opened and read on the date shown. A rule flags copy for review; it never decides that copy is lawful or unlawful.
FDA approval, sameness and sourcing
The claim types FDA cited in its 2025 and 2026 warning letters to telehealth companies selling compounded GLP-1 drugs.
- Critical
approval_claim
Compounded product described as FDA-approved or FDA-reviewed
Compounded drugs do not go through FDA approval. FDA warning letters cite copy that represents compounded products as FDA-approved or otherwise evaluated for safety and effectiveness.
Safer direction. State that the medication is compounded by a state-licensed pharmacy and that compounded drugs are not FDA-approved or reviewed by FDA for safety, effectiveness or quality.
FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs, checked 2026-10-18: “Compounded drugs are not FDA-approved.” Open the source
- Critical
pharmacy_approval
Pharmacy or facility called FDA-approved or FDA-licensed
FDA states it grants no "FDA-approved" or "FDA-licensed" designation to pharmacies or outsourcing facilities, so the phrase implies an authorization that does not exist.
Safer direction. Name the pharmacy as state-licensed (for example "filled by a state-licensed 503A pharmacy"). FDA does not approve or license pharmacies or outsourcing facilities.
FDA warning letter to Altru Telehealth, MARCS-CMS 728274 (June 8, 2026), checked 2026-10-18: “The FD&C Act does not establish an "FDA-approved" or "FDA-licensed" designation for pharmacies or outsourcing facilities.” Open the source
- Critical
sameness
Compounded product equated with an approved brand
FDA cites claims "implying sameness with FDA-approved products" as a primary violation in its 2026 telehealth warning letters.
Safer direction. Do not compare the compounded product to a brand-name drug. Say it is a compounded preparation that is not FDA-approved and not the same as any brand-name product.
FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs (Feb 6, 2026), checked 2026-10-18: “Companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA.” Open the source
- Critical
same_ingredient
Same active ingredient as an approved brand
FDA states that companies cannot say compounded drugs use the same active ingredient as FDA-approved drugs, because that implies equivalence the product has not shown.
Safer direction. Remove comparisons to brand-name drugs. Describe the product as a compounded medication prescribed after a clinical evaluation.
FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs (Feb 6, 2026), checked 2026-10-18: “They also cannot state compounded drugs use the same active ingredient as the FDA-approved drugs.” Open the source
- Critical
generic_claim
Compounded product called generic
FDA states compounded drugs are not the same as generic drugs, which are FDA-approved, and that companies cannot call compounded products generic versions.
Safer direction. Call it a compounded preparation. Generic drugs are FDA-approved; compounded drugs are not.
FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs (Feb 6, 2026), checked 2026-10-18: “Companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA.” Open the source
- High
brand_as_product
Brand name used for a compounded product
FDA cited a website that displayed "MOUNJARO" for compounded tirzepatide, finding that the claim implied the product was the same as an FDA-approved product.
Safer direction. Use the compounded ingredient name (for example "compounded semaglutide") and never a brand name such as Ozempic or Mounjaro for a compounded product.
FDA warning letter to GLP-1 Solution, MARCS-CMS 715883 (Sept 9, 2025), checked 2026-10-18: “Your claims imply that your products are the same as an FDA-approved product when they are not.” Open the source
- Worth a look
registration_claim
FDA registration presented as a trust signal
FDA regulations state that registration does not denote approval, and that any representation creating an impression of approval because of registration is misleading.
Safer direction. If you mention registration, say plainly that FDA registration does not mean FDA approval of the facility or its products.
21 CFR 207.77: What legal status is conferred by registration and listing?, checked 2026-10-18: “Any representation that creates an impression of official approval because of registration or listing is misleading and constitutes misbranding.” Open the source
- Critical
salt_form
Semaglutide salt form offered
FDA says salt forms such as semaglutide sodium and semaglutide acetate should not be used to compound semaglutide.
Safer direction. Remove semaglutide sodium and semaglutide acetate offerings. FDA states these salt forms are different active ingredients with no lawful basis for compounding.
FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, checked 2026-10-18: “Salt forms should not be used to compound semaglutide.” Open the source
- Critical
unapproved_substance
Unapproved substance or research-use product marketed for people
FDA states retatrutide and cagrilintide may not be used in compounding and has warned sellers whose "research use" products were sold for human use with dosing instructions.
Safer direction. Remove retatrutide, cagrilintide and other unapproved substances, and never pair "research use only" labels with dosing or patient instructions.
FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, checked 2026-10-18: “Unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide that are falsely labeled "for research purposes" or "not for human consumption".” Open the source
Efficacy and safety
Health claims the FTC expects to be backed by competent and reliable scientific evidence.
- High
clinical_proof
Clinically proven or clinically studied claim
FDA states companies cannot claim compounded drugs are clinically proven to produce results; the FTC requires competent and reliable scientific evidence for health claims.
Safer direction. Remove "clinically proven" for compounded products. If you cite research, name the study and say it was done on an FDA-approved product, not this compounded preparation.
FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs (Feb 6, 2026), checked 2026-10-18: “Or that compounded drugs are clinically proven to produce results for the patient.” Open the source
- High
disease_cure
Claim to cure, reverse or treat a disease
The FTC requires competent and reliable scientific evidence for health claims, including disease claims, and testimonials do not substantiate them.
Safer direction. Remove cure, reversal and treatment claims unless they match an FDA-approved indication. Describe what the service involves and that results vary.
FTC Health Products Compliance Guidance, checked 2026-10-18: “Health-related efficacy and safety claims require competent and reliable scientific evidence.” Open the source
- High
guarantee
Guaranteed health or weight-loss outcome
An outcome guarantee is an efficacy claim that needs competent and reliable scientific evidence; individual medical results cannot be guaranteed.
Safer direction. Remove the guarantee. Say results vary and describe typical outcomes you can support with evidence.
FTC Health Products Compliance Guidance, checked 2026-10-18: “Health-related efficacy and safety claims require competent and reliable scientific evidence.” Open the source
- High
absolute_safety
Claim of no side effects or no risk
Safety claims are health claims that require competent and reliable scientific evidence; no medication or procedure is free of risk.
Safer direction. Remove absolute safety language. Say that all treatments carry possible side effects and that a clinician reviews them with each patient.
FTC Health Products Compliance Guidance, checked 2026-10-18: “Health-related efficacy and safety claims require competent and reliable scientific evidence.” Open the source
- Worth a look
weight_promise
Specific weight-loss promise
Specific weight-loss amounts are efficacy claims that need competent and reliable scientific evidence for the product as marketed.
Safer direction. Avoid specific weight-loss promises. If you cite an average, name the study and the product it used, and say results vary.
FTC Health Products Compliance Guidance, checked 2026-10-18: “Health-related efficacy and safety claims require competent and reliable scientific evidence.” Open the source
Reviews and testimonials
Incentives the FTC Consumer Reviews and Testimonials Rule prohibits.
- High
review_incentive
Incentive tied to a positive review
The FTC rule prohibits incentives conditioned, expressly or by implication, on a review expressing a particular sentiment.
Safer direction. Offer any review incentive for an honest review of any rating, and disclose it. Never tie a reward to a positive or five-star review.
FTC Consumer Reviews and Testimonials Rule: Questions and Answers (16 CFR Part 465), checked 2026-10-18: “You cannot suggest that reviews must be positive in order to obtain a promised incentive, even if you do not say so explicitly.” Open the source
What Claim Guard does not check
- Text in images, video and audio. Claim Guard reads the words on the page or the copy you paste.
- Pages that build their text with JavaScript after loading, or that block automated readers. Paste their copy instead.
- Whether a product is lawful to sell, whether a pharmacy is properly licensed, or what is printed on a vial label.
- State medical board, state pharmacy and state advertising rules. The library covers federal FDA and FTC sources today.
- Meaning that depends on several sentences together. FDA judges the overall impression of a page; a person still has to.
- Substantiation. A flagged weight-loss figure may be accurate and supported; Claim Guard marks it so someone checks.