Wellness and supplement brands: 59 matched rules, 32 that block approval

• Disease claims27
• Platform policy15
• Efficacy and proof5
• Replaces care5
• Regulatory status4
• Patient quotes and reviews2
• Absolute promises1

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

1. CG-DIS-002 · Blocks approval · Citation checked against stored text

   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.

   21 CFR 101.93(g) · Needs counsel review

2. CG-DIS-013 · Blocks approval · Citation checked against stored text

   A pain-relief claim for a supplement or wellness product treats a symptom of disease, which is a drug claim. For an approved over-the-counter drug or a clinical service, check that the wording matches the label or what you can support.

   Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Health Products Compliance Guidance

   Safer wording: For a drug, use the approved indication from the label. For a service, describe the care and say results vary.

   21 CFR 101.93(g) · Needs counsel review

3. CG-DIS-019 · Blocks approval · Citation checked against stored text

   Claims to slow, stop or prevent a serious disease, or to restore function after spinal cord injury, are disease claims that need drug approval and evidence.

   Source: FDCA 201(g)(1); 21 CFR 101.93(g); FDA consumer alerts on stem cell and dietary supplement disease claims; FTC Act section 5

   Safer wording: Remove disease slowing, prevention and recovery claims. Describe a supplement by its nutrients only, and a stem cell service only as an investigational study.

   21 CFR 101.93(g) · Needs counsel review

4. CG-DIS-022 · Blocks approval · Citation checked against stored text

   Copy aimed at people who have a named disease ("Suffering from Crohn's?", "women with endometriosis love this") tells the reader the product is for that disease. FDA reads the intended use from this kind of audience targeting, and it makes a supplement an unapproved drug.

   Source: 21 CFR 101.93(g); 21 CFR 201.128 - intended use; FDCA 201(g)(1); FTC Health Products Compliance Guidance

   Safer wording: Describe the product and the normal function it supports, and do not address people by their disease. A clinic may describe who it treats and that results vary.

   21 CFR 101.93(g), 21 CFR 201.128 · Needs counsel review

5. CG-DIS-026 · Blocks approval · Citation checked against stored text

   Claims that a product stops or reverses cognitive decline or memory loss are claims to treat or prevent dementia and related disease.

   Source: 21 CFR 101.93(g); FDCA 201(g)(1); FTC Act section 5; FTC Health Products Compliance Guidance

   Safer wording: Describe the ingredients. A supplement may not claim to prevent or reverse cognitive decline.

   21 CFR 101.93(g) · Needs counsel review

6. 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

7. CG-DIS-054 · Blocks approval · Citation checked against stored text

   Naming a repurposed drug, supplement or alternative therapy as a treatment for cancer is a drug claim for a use FDA has not approved. FDA and FTC have sent joint warning letters over unproven cancer treatments, and patients who delay or replace proven care are harmed. Laetrile, black salve and similar products are on FDA's list of fake cancer cures.

   Source: FDCA 201(g)(1); 21 CFR 201.128 (intended use); FTC Act section 5; FDA 187 Fake Cancer Cures Consumers Should Avoid; FTC Health Products Compliance Guidance

   Safer wording: Do not name unapproved agents as cancer treatments. If you offer supportive or integrative care next to standard treatment, say it does not treat cancer and name the symptom it addresses (for example "acupuncture for nausea during chemotherapy").

   21 CFR 201.128 · Needs counsel review

8. CG-EFF-050 · Blocks approval · Citation checked against stored text

   A promise that something heals or speeds recovery by a stated time, or faster than normal, is a performance claim that needs competent and reliable evidence. For a supplement, cosmetic or device it also describes an effect on a condition, which FDA treats as an unapproved drug claim.

   Source: FTC Act section 5; FDCA 201(g)(1); 21 CFR 101.93(g); 21 CFR 201.128 (intended use); FTC Health Products Compliance Guidance

   Safer wording: Drop the timeframe and the "faster" comparison. If you have a controlled study, say what was measured, in whom, and against what, and cite it.

   21 CFR 101.93(g), 21 CFR 201.128 · Needs counsel review

9. CG-RAF-005 · Blocks approval · Citation checked against stored text

   Saying a supplement or consumer product helps, reduces or cures autism, ADHD, anxiety, depression or insomnia is an unapproved claim to treat a disease, and parent testimonials about meltdowns target a vulnerable audience.

   Source: FDCA 21 USC 321(g) and 21 CFR 101.93(g) (disease claims on supplements); FDA warning letters on unapproved disease claims; FTC Act section 5. UK ASA rulings are the origin of the pattern but UK law is out of scope.

   Safer wording: Do not claim a product treats or reduces a medical or developmental condition. Keep to approved structure and function wording and add the standard disclaimer.

   21 CFR 101.93(g) · Needs counsel review

10. CG-RAF-008 · Blocks approval · Citation checked against stored text

    Detox and cleanse products that claim to remove toxins or heavy metals or produce weight loss make unsubstantiated claims. Medical detoxification for addiction is excluded.

    Source: FTC Act section 5 (FTC guidance on detox and cleanse claims); 21 CFR 101.93(g). UK ASA rulings are the origin of the pattern but UK law is out of scope.

    Safer wording: Remove claims that a product removes toxins or heavy metals or causes weight loss, or provide human studies of the finished product.

    21 CFR 101.93(g) · Needs counsel review

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.

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