Anna Benevente

Director of Labeling, Ingredient and Product Review

Chocolate, As Defined By FDA

Oct 28, 2015

Did you know the U.S. is among the top ten chocolate consuming countries? Being a host of millions of chocolate lovers makes the U.S. a great market for chocolate manufacturers around the world.  Before you ship chocolate products to the U.S., it’s important to comply with FDA chocolate regulations. These include determining whether your product must meet one of the U.S. Food and Drug Administration’s (FDA) standards of identity for chocolate.  FDA standards of identity mandate required and optional ingredients a product may contain to be marketed in the U.S. under a certain name.

There are three types of chocolate commonly consumed in the United States:

Milk Chocolate

Milk chocolate is the most popular type of chocolate in the United States.  To be marketed as milk chocolate, a product must contain at least 10 percent chocolate liquor, at least 3.39 percent milkfat, and at least 12 percent milk solids.

White Chocolate

Until 2002, white chocolate was not considered “chocolate” in the United States, but rather a “confectionary.”  Previous FDA standards of identity required that “chocolate” contain chocolate liquor, which gives chocolate its brown color.  Due to petitioning by the Hershey Foods Corporation and the Chocolate Manufacturers Association, FDA published a final rule that established a standard of identify for white chocolate in 2002.  To be marketed as white chocolate, a product must contain at least 20 percent cocoa butter, at least 14 percent total milk solids, at least 3.5 percent milkfat.  It cannot consist of more than 55 percent nutritive carbohydrate sweetener.

Dark Chocolate

FDA does not have a standard of identity for dark chocolate as a type of chocolate.  However, to be marketed as dark chocolate, a product must meet FDA’s policy for nonstandardized foods bearing the term “chocolate”:

” The label of a nonstandardized food which bears no artificial chocolate flavor or natural flavor derived from a source other than cacao beans may bear the term “chocolate” (in contrast to “chocolate flavor”) provided the product meets one of the following conditions:

  1. The product bears as its only source of chocolate flavoring an ingredient that complies with one of the standards of identity for cacao products found in 21 CFR 163.111; 163.123; 163.130; 163.135; 163.140; or 163.145. In addition, products which comply with 21 CFR 163.153 or 163.155 may bear the term “chocolate” followed by the specific name of the vegetable oil used.
  2. The product is flavored with cocoa and the food is one that consumers have long recognized as containing cocoa as the characterizing chocolate flavoring ingredient and is one that consumers do not expect to contain a chocolate ingredient.”

Marketing a product as milk, white, or dark chocolate without complying with FDA chocolate regulations can lead to warning letters, detentions, and more.  Registrar Corp can review food labels for FDA compliance.  Along with ensuring that your product meets any necessary FDA standard of identity, Registrar Corp’s Label and Ingredient Review Specialists will check for proper formatting, review your Nutrition Facts Chart, and more.  Clients receive a detailed report along with a print-ready graphic file of their label that includes Registrar Corp’s changes.

Questions About Labeling Your Products? We Can Help.

Registrar Corp’s Regulatory Specialists help companies comply with FDA labeling regulations.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email:, or chat with a Regulatory Advisor 24-hours a day:

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Anna Benevente

Director of Labeling, Ingredient and Product Review

Highly regarded as a top expert on FDA labeling regulations, Anna Benevente continues to educate companies on existing regulations and updates from U.S. FDA for food and beverage, cosmetic, drug, and medical device products. She has researched thousands of products to determine whether they meet the FDA requirements for compliance. In addition, Ms. Benevente has conducted multiple seminars for trade and customs broker associations.

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