FDA WARNING_LETTER - Four Elements Organic Herbals, LLC - May 21, 2014

The FDA conducted an inspection of Four Elements Organic Herbals, LLC from April 25 to May 21, 2014, and reviewed their websites in May and August 2014. The FDA determined that products such as HERBAL TEA Power, Energy & Stamina, ORGANIC HERBAL TEA Tulsi TelepaTea, and others, are unapproved new drugs and misbranded.

Violations include claims on product labels and websites establishing the products as drugs intended for disease treatment, mitigation, cure, or prevention, or to affect body structure/function, violating sections 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of drug claims include treating diabetes, high blood pressure, asthma, reducing cholesterol, and healing wounds.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their intended uses. Introducing new drugs into interstate commerce without FDA approval violates sections 301(d) and 505(a). Additionally, several products are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson, as they are intended for conditions not amenable to self-diagnosis or treatment.

The company must take prompt action to correct these violations and notify the