Disease claims: what rule CG-RAF-005 checks

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