FDA WARNING_LETTER - Realm Labs, LLC - March 31, 2013

The FDA issued a Warning Letter to Realm Labs, LLC, following a March 2013 review of their websites, www.realmlabs.net and www.neuremedy.com. The agency determined that the firm's NeuRemedy products are in violation of the Federal Food, Drug, and Cosmetic Act. The primary violations include misbranding and marketing unapproved new drugs. Specifically, NeuRemedy products are misbranded under Section 403(a)(1) of the Act because they are labeled and marketed as medical foods but do not meet the statutory definition or criteria in 21 CFR 101.9(j)(8). The FDA noted that patients with neuropathy, the condition targeted by NeuRemedy, do not have distinct nutritional requirements for thiamine or impaired capacity to metabolize ordinary foodstuffs, failing 21 CFR 101.9(j)(8)(ii). Furthermore, due to therapeutic claims on the websites, such as "Improve The Symptoms of Pain, Burning, Numbness & Tingling," the products are deemed drugs under Section 201(g)(1) of the Act. As they are not generally recognized as safe and effective, they are considered "new drugs" under Section 201(p) and are illegally marketed without prior FDA approval (Section 505(a)). The products are also misbranded under Section 502(f)(1) for lacking adequate directions for use. Realm Labs must respond within fifteen days outlining corrective actions to avoid further enforcement, including product seizure or injunction.