Under the Federal Food, Drug and Cosmetic Act (FD&C), FDA has jurisdiction over the labeling for food products, including how the product may be named. Called the "statement of identity," it is generally the "common or usual" name for that food product and is required to be declared prominently on the packaging.

In certain cases, FDA will dictate conditions on the type of food that can be called by a certain name. These "standards of identity" set requirements that must be fulfilled for a food product to be marketed under that name. If the food does not meet those conditions, then it must be marketed under a different, non-standardized name. FDA has established over 280 standards of identity across multiple food categories, ranging from milk and cheese to canned tuna and jam.

Standard of identity for milk

FDA’s standard of identity for milk is the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” The standard goes on to mandate that the product shall be pasteurized or ultra-pasteurized and must contain not less than 8.25% milk solids not fat and not less than 3.25% milkfat. Any product that falls under this standard may be labeled with “milk” as its statement of identity.

Standards of identity for other dairy products

FDA has standards of identity for other traditionally dairy-based products such as ice cream, cream, yogurt, sherbet, butter and different types of cheeses. These standards function in a manner like that of the milk standard, explicitly laying out what can be included as an ingredient. Most will require a dairy ingredient such as milk or cream, and none offer a nondairy plant-based milk alternative as an option. Manufacturers of dairy-free products find themselves unable to use the standardized names due to the regulatory definition of "milk."

Are changes on the horizon?

The rapid growth of dairy-free products in the marketplace comes at a time when FDA is reassessing its approach to standards of identity. The agency issued a proposed rule in 2005 that sought to modernize the system to allow for technological advances while still ensuring that standards promoted honesty and fair dealing in the interest of consumers. The rule lay dormant until resurrected in 2018 with its comment period reopened to allow for additional public input. FDA stated its intent to publish a new proposed rule or a final rule based on the updated record.

To read this article in its entirety, check out the Formulating for Success in the Dairy Alternative Aisle – digital magazine.

Anna Benevente is a senior regulatory specialist at Registrar Corp, an FDA consulting firm that helps companies comply with FDA regulation. She has been assisting companies with FDA regulations since 2009 and has researched over 370 products to determine whether they meet FDA requirements for compliance.