On August 13 2013 the US Food and Drug Administration (FDA) issued an updated version of its Guidance for Industry: Frequently Asked Questions About Medical Foods. This is the second edition of the guidance, and provides further information on the definition, labelling 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 that the FDA has raised in numerous warning letters over the last decade.
In the guidance, the 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 emphasises that the term 'medical foods' does not apply to 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. The FDA does not regulate medical foods as drugs and does not apply the Nutrition Labelling and Education Act requirements to medical foods. However, medical foods must comply with all other applicable FDA requirements for food products including good manufacturing practice regulations, acidified food requirements, allergen labelling regulations and food additive requirements for product ingredients.
As part of the update, the guidance notes the FDA's reliance on the compliance programme guidance manual entitled Medical Foods Programme - Import and Domestic , which has been available on the 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, the FDA does not object to the use of language communicating the need for medical supervision on the labelling. In addition, medical foods should not include national drug code numbers, as these numbers are intended for human drugs only.
The 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 and general essential nutrient and protein deficiencies are not conditions eligible for medical foods. The FDA explains that pregnancy is not a disease, and that both types of diabetes 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.
For further information on this topic please contact Diane McEnroe at Sidley Austin LLP by telephone (+1 212 839 5300) or by fax (+1 212 839 5599) or by email ([email protected]).
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