Medical Foods

Continued from Yesterday

Medical Foods: Between a Rock and a Hard Place

For GRAS status, an ingredient must have technical evidence of safety that is accepted by qualified experts. FDA states, the minds of “competent scientists” must have reasonable certainty that the substance is not harmful under its intended conditions of use. In addition, the safety data must be generally available.

Even with FDA’s seemingly distinct guidelines between supplements, drugs and medical foods, meeting the requirements for medical food can be difficult because the definition can be interpreted a number of different ways, according to Mike Bush, Ganeden’s vice president of business development. FDA’s actions in this area may even turn some manufacturers away from this market. “There are strict guidelines on medical foods,” Bush said. “Because of the tight regulations, more manufacturers are changing product status from medical foods to supplements or functional foods and beverages.”

To ensure a medical food passes legal muster, the marketer must demonstrate that the target patient population has distinctive nutritional requirements. An August 2010 paper from the law offices of Hyman, Phelps and McNamara stated: “It is essential, therefore, that a manufacturer be able to demonstrate the unique nutritional need that results from the disease, and the fact that the product is specially formulated to meet that need.” Further, the paper noted, “It is also very important, in any discussion of these requirements in labeling or elsewhere, to avoid drawing attention to any possible similarity in action or effect between the medical food and any approved drug for the disease. Emphasis should be placed on food status and on the digestion/metabolism aspect of the disease.”

Sticking to the regulations is crucial in the medical-foods arena, as FDA appears to have no qualms about correcting rule breakers. “FDA has communicated concern over the accuracy and validity of claims and product safety of medical foods, as they are intended for use by vulnerable populations,” Minich noted. “More recently, FDA has stated it will review the medical food category; perhaps this additional guidance will result in the category being modified. In the meantime, the best approach to ensuring the future of the medical-food category is to develop products that are accurately labeled and clinically demonstrated to truly serve the needs of their target population. A company entering this market must make sure it has well-staffed R&D, quality control (QC) and regulatory departments to develop, test and support their products.”

While regulation may be stringent, it has been relatively static, according to Sandy Bigelow, principal, Vanguard Global Associates. Therefore, industry can still safely follow the 1977 operating standard for medical foods outlined in the ANPR. “FDA regulation of medical foods in the United States has reached a point of ‘stasis’ as compliance issues for particular products in the marketplace have been handled through the normal enforcement processes,” she said.

Continued Tomorrow

http://www.naturalproductsinsider.com/articles/2010/10/medical-foods-between-a-rock-and-a-hard-place.aspx

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