Regulatory & Compliance
Disease Claim
A claim that a product treats, cures, or prevents a disease — prohibited for supplements.
A disease claim is any statement that explicitly or implicitly asserts that a product can diagnose, treat, cure, mitigate, or prevent a disease. Under DSHEA, dietary supplements are prohibited from making disease claims unless they have undergone the FDA drug approval process. The FDA and FTC actively enforce this distinction. Examples of prohibited disease claims: 'Cures insomnia,' 'Treats alopecia,' 'Prevents heart disease.' Making unauthorized disease claims can result in FDA warning letters, product seizure, injunctions, and FTC fines up to $53,000 per violation.