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FDA Issues Swiss Company a Temporary Permit to Market “Ruby Chocolate” in the United States

On November 22, 2019, the Food and Drug Administration (FDA) announced that it had issued a temporary permit (TMP) to Barry Callebaut, a Swiss company in accordance with 21 CFR 130.17.  The TMP will allow the company to market test a product known as “ruby chocolate.”  Although the company has been selling ruby chocolate in other parts of the world, it requires a TMP from the FDA before it could call its product “chocolate” in the United States, as FDA’s standards of identity for chocolate products limit what can be labeled “chocolate.”   The FDA’s standards of identity establish the common or usual name for a food, its basic nature, and the types of ingredients that it must contain and may contain.

Ruby chocolate contains the principal ingredients used in most of the current standards for cacao products under 21 CFR part 163, but it deviates from existing standards of identity for chocolate in terms of its final composition, taste, and color.  FDA will not penalize a food that fails to conform to the applicable definition and standard of identity if the company who introduces the food into interstate commerce holds an effective TMP.

TMP is a step towards establishing a standard of identity for ruby chocolate under FDA regulations.  The TMP allows for the temporary marketing of ruby chocolate, which will allow the Swiss company to evaluate commercial viability of the product and collect data on consumer acceptance in support of a future petition for a new standard of identity.  We will continue to monitor any developments.

© 2020 Keller and Heckman LLP

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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