Industry rules

Drug and device marketing: 121 matched rules, 37 that block approval

The checker matches 121 rules to drug and device marketing by what the rules are about: prescription drugs, devices, approval and clearance claims and side effects. 2 rules that block elsewhere only warn on drug and device copy, so 37 block here. Most sit under state law (49), regulatory status (22) and disease claims (17). State rules reach 31 states, and Connecticut has the most (3). Ad platform policy adds 10 rules that name 15 platforms.

The numbers for this industry

121

Matched rules

63 federal, 48 state, 10 platform

Block approval

2 more only warn for this copy

305

Shared rules

Run on all health copy, not listed here

State and platform pages

Only where the gate is met

Where the matched rules sit

State law49
Regulatory status22
Disease claims17
Platform policy12
Replaces care6
Absolute promises5
Efficacy and proof4
Offers and pricing3
Outcome statistics1
Patient quotes and reviews1
Superiority1

Rules that weigh most for drug and device marketing

Federal and general rules first, blocking before warning, citations checked against stored text before the rest. Rules with their own page link there.

CG-ABS-003 · Blocks approval · Citation checked against stored text
Claims of no risk or no side effects are unsubstantiated safety claims.
Source: FTC Act section 5; FTC Health Products Compliance Guidance; 21 CFR 202.1 (prescription drug advertising, fair balance)
Safer wording: State known risks and side effects fairly, or say who should talk to a clinician first.
21 CFR 202.1 · Needs counsel review
CG-ABS-012 · Blocks approval · Citation checked against stored text
Zero-risk, zero-pain and no-downside claims are absolute safety claims. Every treatment has risks, and they must be disclosed fairly.
Source: FTC Act section 5; FTC Health Products Compliance Guidance; 21 CFR 202.1
Safer wording: Describe the known risks and side effects, or say where they are explained, in place of claiming there are none.
21 CFR 202.1 · Needs counsel review
CG-DIS-028 · Blocks approval · Citation checked against stored text
Comparing a supplement to a GLP-1 prescription drug ("natural Mounjaro", "mimics Ozempic") claims drug-like effects on weight and blood sugar and implies the product does what an approved drug does.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Act section 5; FTC Health Products Compliance Guidance
Safer wording: Do not name or compare to a prescription drug. Describe the ingredients.
21 CFR 101.93(g) · Needs counsel review
CG-RAF-002 · Blocks approval · Citation checked against stored text
Discounting and price-led promotion of prescription weight-loss treatment, such as sales events and rock-bottom prices, markets a prescription drug as a commodity and invites purchase without a clinical assessment.
Source: 21 CFR 202.1 (prescription drug advertising); FDA warning letters to telehealth firms on compounded GLP-1 marketing; FTC Act section 5. UK ASA rulings are the origin of the pattern but UK law is out of scope.
Safer wording: Do not use sales or lowest-price framing for prescription weight-loss treatment. State that treatment depends on a clinician assessment and describe fees plainly.
21 CFR 202.1 · Needs counsel review
CG-RAF-009 · Blocks approval · Citation checked against stored text
A testimonial about stopping prescription medication after taking a supplement, or a product pitched as a safer alternative to prescription drugs, encourages consumers to stop treatment and implies the product treats the condition.
Source: FTC Endorsement Guides, 16 CFR 255.2; 21 CFR 101.93(g) and 21 USC 321(g); FTC Act section 5. UK ASA rulings are the origin of the pattern but UK law is out of scope.
Safer wording: Do not feature stories about stopping medication. State that people should not stop prescribed medicines without a clinician.
16 CFR 255.2, 21 CFR 101.93(g) · Needs counsel review
CG-REG-006 · Blocks approval · Citation checked against stored text
Compounded drugs are not FDA approved and are not the same as, or generics of, the brand product. Telehealth sellers have received FDA warning letters for these claims.
Source: FDCA 503A and 503B; FDA warning letters to telehealth firms on compounded GLP-1 marketing; FTC Act section 5
Safer wording: Say the medication is compounded, that it is not FDA approved, and that a licensed clinician decides whether it is appropriate.
FDCA 503A · Needs counsel review
CG-REG-007 · Blocks approval · Citation checked against stored text
FDA has sent warning letters to telehealth and online sellers over marketing of compounded GLP-1 drugs and unapproved peptides. Compounded drugs are not FDA approved, and these products raise misbranding and unapproved-drug issues.
Source: FDCA 503A and 503B; FDA warning letters to telehealth firms on compounded GLP-1 marketing
Safer wording: If you offer a compounded drug, say it is compounded and not FDA approved, that a licensed clinician decides if it is appropriate, and have counsel review the claims and the pharmacy relationship.
FDCA 503A · Needs counsel review
CG-REG-008 · Blocks approval · Citation checked against stored text
Claiming that a government agency approved, endorsed or inspected a product or plan creates a false impression of official backing.
Source: FTC Endorsement Guides, 16 CFR Part 255; Lanham Act 43(a), 15 U.S.C. 1125(a); 42 CFR 422.2263
Safer wording: Remove any suggestion of agency endorsement. State only a specific, verifiable status, such as an FDA clearance number, with the source.
42 CFR 422.2263, 16 CFR Part 255, 15 U.S.C. 1125 · Needs counsel review
CG-REG-052 · Blocks approval · Citation checked against stored text
A product labeled "for research use only" but sold with dosing guides, stacks or shipping to consumers is a drug marketed for human use. FDA reads intended use from the circumstances of sale, not from the label disclaimer. Most of these peptides are not approved for any use, and several are on FDA's list of bulk substances that raise safety concerns for compounding.
Source: FDCA 201(g)(1); 21 CFR 201.128 (intended use is shown by the circumstances of sale); FDA bulk drug substances guidance for compounding (503A); FTC Act section 5
Safer wording: Do not sell or describe unapproved peptides for human use. If a peptide is a prescription drug that a licensed pharmacy compounds for a patient with a prescription, say that, and make no performance claims.
21 CFR 201.128 · Needs counsel review
CG-RFA-003 · Blocks approval · Citation checked against stored text
Anti-cancer, anti-inflammatory, immune-restoring, detox or regenerative claims describe the treatment or mitigation of disease and are unapproved drug claims when made for a supplement, cosmetic or biologic.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Health Products Compliance Guidance
Safer wording: Remove anticancer, anti-inflammatory and regenerative claims. Do not describe the product as acting on disease processes.
21 CFR 101.93(g) · Needs counsel review

What the checker flags

Sample wording we wrote to test these rules, run through the real engine at build time. The rule ids, reasons, sources and safer wording are the rule-set's own.

Drug post · actual checker output2 claims flagged

Tired of chemo side effects? Ask your doctor about Zelvora, the best treatment for lung cancer.

Blocks approvalCG-TRA-011
Branded prescription drug ads that name the drug and a benefit without the required risk information and fair balance, or that say side effects are rare, are misbranding.
Source. FDCA 502(n); 21 CFR 202.1 (prescription drug advertising, fair balance); FTC Act section 5
Safer wording. Include the major risks and indications as required for prescription drug advertising, and do not downplay side effects.
Blocks approvalCG-DIS-002Also matches CG-SUP-004
A treatment claim for a named disease is a drug claim for a product, and needs support for a clinical service.
Source. FDCA 201(g)(1); 21 CFR 101.93(g); FTC Act section 5
Safer wording. For a clinical service, state who delivers care and what is offered ("our licensed clinicians evaluate and manage ..."). For a supplement, remove the disease reference.

Device claim · actual checker output1 claim flagged

Our device is FDA approved and cures chronic pain.

Blocks approvalCG-DIS-001Also matches CG-DIS-016, CG-REG-001
Saying a product or service cures a condition makes it an unapproved drug claim.
Source. FDCA 201(g)(1), 21 U.S.C. 321(g)(1) (drug definition); 21 CFR 101.93(g) (disease claims); FTC Health Products Compliance Guidance
Safer wording. Describe what the service does (for example "supports", "helps manage") and name only outcomes you can substantiate.

Safety absolute · actual checker output2 claims flagged

No side effects. Works for everyone.

Blocks approvalCG-ABS-003Also matches CG-EFF-013, CG-TRC-011, CG-TRH-002
Claims of no risk or no side effects are unsubstantiated safety claims.
Source. FTC Act section 5; FTC Health Products Compliance Guidance; 21 CFR 202.1 (prescription drug advertising, fair balance)
Safer wording. State known risks and side effects fairly, or say who should talk to a clinician first.
WarningCG-ABS-004
Claims that something works for everyone or always works cannot be substantiated.
Source. FTC Act section 5; FTC Health Products Compliance Guidance
Safer wording. Say who it was studied in and what share improved, with the source, or drop the claim.

Where it changes by state and platform

10 pages below meet the gate: at least 6 applicable rules and at least 3 that belong to that state or platform alone.

Next step

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