On August 13, 2013, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued an updated version of its 2007 Guidance for Industry: Frequently Asked Questions About Medical Foods. This is the second edition of the guidance, and it provides further information on the definition, labeling, and availability of medical foods, as well as answers to new questions that have arisen since its first publication in May 2007. In many respects, it reflects concerns FDA has raised in numerous warning letters throughout the last decade.
In the guidance, FDA explains that the agency narrowly construes the statutory definition of medical foods to include only foods intended to meet distinctive nutritional requirements of a disease or condition under medical supervision. The guidance emphasizes that the term “medical foods” does not apply to any and all foods recommended by physicians to manage or reduce the risk of a disease or a condition. Instead, medical foods must be products that are specially formulated and processed for seriously ill patients or those requiring the product as a major component of the specific dietary management of a disease or condition. FDA does not regulate medical foods as drugs and does not apply the Nutrition Labeling and Education Act labeling requirements to medical foods. However, medical foods must comply with all other applicable FDA requirements for foods, when relevant, including good manufacturing practice regulations, acidified food requirements, allergen labeling regulations, and food additive/GRAS requirements for product ingredients.
As part of the update, the guidance notes FDA’s reliance on the compliance program guidance manual entitled “Medical Foods Program- Import and Domestic”, which has been available on FDA’s website since 2008. It also explains that consumers do not need a prescription to obtain a medical food, and that medical foods must not bear the “Rx only” symbol. However, because the product is to be used entirely under the supervision of a physician, FDA does not object to the use of language communicating the need for medical supervision on the labeling. Additionally, medical foods should not include National Drug Code numbers, as these numbers are only intended for human drugs.
FDA also discusses whether specific diseases or conditions are appropriately treated with medical foods. Inborn errors of metabolism, for example, are considered diseases or conditions that could be managed by a medical food, as these disorders occasionally cannot be addressed with modification of the diet alone. However, pregnancy, Diabetes Mellitus, and general essential nutrient and protein deficiencies are not conditions eligible for medical foods. FDA explains that pregnancy is not a disease and that both types of Diabetes Mellitus and any kind of nutrient deficiency can be treated with diet modification alone.
Comments on the guidance are due by October 15, 2013. The guidance can be accessed here.
If you have any questions regarding this update, please contact Diane McEnroe ( ; 1.212.839.5621) or the Sidley lawyer with whom you usually work.
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