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How to Send Chocolate to the U.S. for Valentine’s Day – without a Regulatory Heartbreak!

U.S. Food and Drug Administration (FDA) regulates the use of the word “Chocolate” in food labels. The FDA issued a guidance document specifically stating when the use of the term “chocolate,” rather than “chocolate flavoring,” on a label is permitted. The FDA guidance document states that the label of a non-standardized 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 criteria:

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;
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.

FDA has a standard of identity written for many different types of chocolate. In 21 CFR Sec. 163, the FDA divides the standards of identity for chocolate and chocolate ingredients into the following categories: Chocolate liquor, sweet chocolate, milk chocolate, buttermilk chocolate, skim milk chocolate, mixed dairy product chocolate, and bittersweet chocolate. In each of these sections, the FDA states requirements regarding the formulation of each type of chocolate, such as the milk and sugar contents that the chocolate must have to be classified into each category as well as restrictions as to what ingredients may be added to the product.

Though FDA includes standards of identity for many different types of chocolate, FDA does not include a standard of identity for “dark chocolate.” This often presents a dilemma for manufacturers of dark chocolate, as it is important for dark chocolate manufacturers to fit into one of the standards of identity listed in the CFR in order to label a product as “chocolate.” Registrar Corp’s experts can review your label to minimize the prospects of detention by FDA.

While some products do not meet the FDA’s standard of identity for chocolate as described above, the FDA allows products that consumers expect to be chocolate flavored and have long been recognized as chocolate products to still be labeled as “chocolate” as opposed to “chocolate flavored.” These include: chocolate cake, chocolate cookies, chocolate pudding, chocolate milk, etc. The FDA exempts these types of products from having to meet the strict labeling requirements set forth in the CFR because of their prior labeling history.

Another important FDA regulation that chocolate manufacturers need to know is the filing of Prior Notice. The Bioterrorism Act requires that the FDA receive prior notice before food or beverage is imported or offered for import into the United States. Advance notice of import shipments allows FDA, with the support of the Bureau of Customs and Border Protection (CBP), to target import inspections more effectively and help protect the United States’ food supply against terrorist acts and other public health emergencies. Importers of food and beverage, i.e. chocolate, must comply with the Bioterrorism Act.

Valentine’s Day is a big day for chocolate manufacturers. Be careful that your products properly comply with FDA requirements. For questions related to the labeling of your particular product or any U.S. FDA regulation, please contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177.