FDA Calls Labeling of Medical Food 'False and Misleading'

WASHINGTONLast month, FDA advised Realm Labs, LLC that its NeuRemedy products were "misbranded" in violation of federal law because its labeling was "false and misleading".

The problem? FDA said Realm Labs couldn't label and market its products as "medical food" because they failed to meet the agency's definition.

Justin Prochnow, a dietary supplement lawyer in Denver, noted the warning letter was the first one in two years that FDA has sent regarding medical foods.

Pursuant to the applicable regulation, "a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone," Emma Singleton, FDA's Director of the Florida District, wrote in the April 11 warning letter to Realm Labs President Richard Mann.

"While your labeling states that the patients for whom your NeuRemedy products are intended have low levels of the micronutrient thiamine, FDA is not aware of any evidence that patients with neuropathy have a limited or impaired capacity to ingest, digest, absorb, or metabolize thiamine, or other nutrients, or have a distinct requirement for thiamine or any other nutrient," Singleton said.

"We intend to respond to the FDA by providing them a substantial body of science that supports the nutritional benefits of the remedy," Mann, the president of Realm Labs, told Natural Products INSIDER during a brief phone call.

He did not respond Wednesday to an emailed request for further comments, including whether or not he agreed with FDA's interpretation that labeling of the company's products is false and misleading.

Recommended by doctors, NeuRemedy is a dietary supplement that supports "healthy nerve function to the feet and legs," according to http://www.realmlabs.net/. The product is targeted for diabetics, the elderly and other people who have low levels of the micro-nutrient thiamine.