Bioenergy Receives Warning Over Medical Foods

MINNEAPOLISFDA issued a warning letter to Bioenergy Inc. regarding the marketing of its Corvalen® products as medical foods, informing the company it does not believe the products meet the statutory definition of a medical food per federal regulations. Instead, the agency considers the Corvalen and Corvalen M® to be misbranded foods and/or new drugs.

With regard to the medical food marketing, the Corvalen products are positioned to address fibromyalgia, chronic fatigue syndrome and cardiovascular disease (CVD). However, FDA stated the statutory definition of a medical food" per federal regulations to narrowly constrain the types of products that fit within this category." Specifically, it noted the medical foods must address conditions for which there are distinctive nutritional requirements that cannot be managed by modification of the normal diet.

As the products are currently marketed with therapeutic claims addressing how Corvalen ribose may help address fatigue associated with CVD, chronic fatigue syndrome and fibromyalgia, FDA therefore considers them to be drugs. However, the Corvalen products have not been approved by FDA as new drugs, making them out of regulatory compliance.