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Update Regarding April 4th Program: Regulation of Medical Food and Nutritionals in the European Union, China, and the United States

22 August 2013
Presenters: Max Gu

On April 4, 2013 K&L Gates hosted an informative webinar covering the regulation of medical food and nutritionals in the European Union, China, and the United States.

During the session, K&L Gates FDA lawyers Sebastián Romero Melchor, Max Gu, and Suzan Onel discussed the following topics:

  • With the current overhaul of the PARNUTS legislation in the EU, medical foods is now one of the few regulated categories of foods for special nutritional purposes. In Europe, this means that manufacturers continue to stretch the medical foods category as a route to market products previously conceived under other categories, in order to label those products with stronger, quasi-medicinal claims.
  • In China, the medical food category remains both underdeveloped and underutilized. The Ministry of Health drafted food safety standards on medical foods in September 2012, but these are yet to be finalized and the timing for comprehensive regulations and enforcement is less than clear.
  • In the US, the medical food category continues to entice companies because it offers the ability to distinguish their products from dietary supplements and drug products. While a marketing advantage both in terms of claims and market entry, due consideration is necessary as to the legal definition and the regulatory vulnerabilities of this product category.

To listen to a recording of this webinar, click here.

To view presentation materials, click here.

As a follow on to our webinar dated April 4, 2013, we note that in August 2013, the United States Food and Drug Administration ("FDA") issued a revised draft guidance on medical foods.

While the new draft guidance largely reiterates information provided in the first edition of “Frequently Asked Questions ("FAQ") About Medical Foods” (issued in May 2007), for the first time FDA provides specific examples of diseases or conditions that may or may not be appropriate for management by medical food.

According to the revised draft guidance, FDA generally considers inborn errors of metabolism to be diseases or conditions that a medical food could be used to manage. In contrast, FDA indicates that pregnancy, type 1 and 2 diabetes, and diseases resulting from essential nutrient deficiencies are diseases or conditions that generally do not meet the regulatory criteria for a medical food. FDA states that because the regular diet can be modified to meet the needs of an individual affected by these diseases or conditions, the agency generally would not consider a product labeled and marketed for these diseases or conditions to be medical food.

The revised draft guidance also indicates that FDA considers the use of National Drug Code (NDC) numbers and the "Rx only" symbol or statement on medical food to misbrand the product. In support of this position, the FDA states that these terms uniquely apply to drug products. As a result, if used on a medical food, such statements would be false or misleading as applied to the product.

Finally, the revised draft guidance reiterates that medical food, as food products, must comply with the cGMPs for foods, allergen labeling requirements, certain registration requirements, and FDA's compliance program guidance manual. Additionally, any ingredient used in a medical food must be either an approved food additive or a generally recognized as safe ("GRAS") ingredient.

Please click here to link to FDA's revised draft guidance (Aug. 7, 2013). FDA is accepting comments to the draft guidance through October 15, 2013.

For more information, please contact Suzan Onel, or visit our FDA practice page.