FDA WARNING_LETTER - HomeopathyStore.com

On July 6, 2015, the FDA issued a Warning Letter to Ratis, LLC, operating as HomeopathyStore.com, regarding its products Influenzinum 9C (2014-2015) and Influenzinum & Thymuline Combo. The FDA determined these products are promoted for conditions that classify them as drugs under section 201(g) of the FD&C Act and biologics under section 351(i) of the PHS Act.

The products are considered drugs due to therapeutic claims on the website, such as "prevent the flu," "avoid vaccinations," and "excellent flu shot alternative." Although Influenzinum is recognized in the Homeopathic Pharmacopeia of the United States (HPUS), compliance with HPUS does not establish safety, effectiveness, or non-misbranding.

The FDA identified several violations: 1. **False or Misleading Information:** The website makes effectiveness claims without adequate descriptions of risks, warnings, and contraindications, and the labeling lacks adequate directions for use. This misbrands the product under sections 502(a), 502(f)(1), and 201(n) of the FD&C Act, violating sections 301(a) and 301(b). 2. **Failure to Require Prescription:** The products are not dispensed under a prescription from a licensed practitioner, mis