Posted May 24, 2013

Maker of Neuropathic Pain Product Warned For Drug Claims, Misbranding

On April 11, 2013, the FDA issued a warning letter to Realm Labs, LLC, following a review of the company’s websites which found statements made about its NeuRemedy products to be drug claims.

NeuRemedy contains thiamine (vitamin B1) and was promoted for neuropathic pain, with statements such as “nourishes dysfunctional nerves allowing them to conduct impulses more normally,” and “used … to successfully help tens of thousands of patients suffering from peripheral neuropathy in Asian and Europe.”

NeuRemedy was also found to be misbranded because it was labeled and marketed as a medicinal food, but does not meet criteria for medicinal food. These criteria require, among other things, that a medicinal food provide nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition and that it be intended for use under medical supervision.

(See’s Review of B Vitamin Supplements for tests of related products.)

To read the FDA’s warning letter, use the link below.