FDA WARNING_LETTER - Standard Homeopathic Company, Inc.

This Warning Letter, dated September 25, 2013, addresses Standard Homeopathic Company, following a May and September 2013 review of their websites (hylands.com and hylandsearache.com). This review revealed numerous misbranded homeopathic drug products, a recurring issue from a previous April 29, 2011, Warning Letter that primarily focused on cGMPs and a small sample of misbranded drugs.

The FDA found that products like "Arnicaid," "Arthritis Pain Formula," "Earache Tablets," "Teething Tablets," and various "Single Remedies" and "Cell Salts" were misbranded. These products are considered drugs under sections 201(g)(1)(B) and (C) of the FD&C Act due to their intended use in disease treatment or affecting body structure/function.

The core violations include: 1. **Misbranding under Section 503(b)(4) and 301(a):** Many products are prescription drugs because they treat conditions requiring physician diagnosis/treatment, but their labels lack the "Rx only" symbol. 2. **Misbranding under Section 502(f)(1):** Labeling fails to bear adequate directions for use, as the indications are not appropriate for OTC use. 3. **Misbranding under Section 502(a):** Labeling is false or misleading,