F.D.A. clearing the way for medical food advances

by Keith Nunes
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The market for medical foods, products specifically formulated for patients who have nutrition needs that may not be met by normal diet modification, is gaining greater attention from the Food and Drug Administration. In mid-August, the F.D.A. released a draft guidance document for industry that answers frequently asked questions about medical foods. The most notable aspects of the document are F.D.A.’s determination it will not regulate medical foods as drugs and access to such a product will not require a prescription. The guidance document does clearly state such products should only be used under the supervision of a doctor.

The F.D.A. also made clear what it does not consider to be a medical food, stating that foods and beverages “simply recommended by a physician or other health care professional as part of an overall diet designed to reduce the risk of a disease or medical condition or as weight loss products to not be medical foods.”

The draft guidance document is not legally binding and reflects the F.D.A.’s interpretation of its regulations as they may relate to medical foods. A 60-day comment period will allow interested parties to express their views of the F.D.A.’s interpretation.

Nevertheless, release of the document is welcome news for food and beverage companies considering opportunities in the emerging medical foods market. Several companies, most notably Nestle S.A., have made their intentions clear how they view the category. In the case of Nestle, the company has established the Nestle Institute of Health Science to conduct research.

The market for medical foods is estimated to have $12 billion in annual sales, according to the market research firm Technology Catalysts International. Companies such as Abbott Labs, Fresneius Kabi, a global health care company based in Homburg, Germany, and Nestle have established themselves as leaders in the category. But Technology Catalysts said the category is in a growth stage as companies develop products that are designed to meet the nutritional requirements of lifestyle-related diseases such as cardiovascular disease, diabetes and Alzheimer’s.

The F.D.A.’s draft guidance addresses diabetes, but the agency considers “diet therapy” rather than medical foods to be the mainstay of the condition’s management. The agency says people with Type 1 diabetes should use a carbohydrate counting or carbohydrate exchange system to match insulin dose to carbohydrate intake, and those with Type 2 diabetes should restrict calories, eat regularly, increase fiber intake and limit the intake of refined carbohydrates.

In September 2010, Nestle announced its intention “to pioneer a new industry between food and pharma.” The outline presented by the company at the time was a significant step beyond the traditional role food plays in providing sustenance.

Since then Nestle has embarked on a series of acquisitions to bolster its foothold in the category. Products now included under the company’s medical nutrition umbrella target such conditions as gastrointestinal disorders, clinical dietary management of Alzheimer’s disease, and genetic disorders that affect how food is processed by some consumers.

Within the food industry there is some trepidation about food being taken beyond its traditional role as sustenance, and specially developed food products being used as a key component in the treatment of medical conditions. That is why the F.D.A.’s publication of the draft guidance for medical foods is welcome. It begins to lay the groundwork for a regulatory framework that will separate the role of traditional foodstuffs from those intended to be used as medicine, and the emerging market segment will give those companies willing to invest in the category additional areas of opportunity.
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