On September 27, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued his third public statement since June addressing the use of dairy statements of identity for plant-based foods. Examples of products of concern to the agency include “soy milk,” “almond milk” and “vegan mozzarella cheese.” The statement raises the prospect of potentially increased regulatory enforcement and litigation risk for food companies who market plant-based products using dairy-based names and descriptions.

Standards of Identity, Dairy Products and Plant-Based Alternatives

For decades, standards of identity have been part of the FDA regulations defining dairy products. For example, milk is defined as the “lacteal secretion . . . obtained from the complete milking of one or more healthy cows.” As the Commissioner has previously acknowledged, FDA has not actively enforced these standards of identity. At the same time, health trends and shifting consumer preferences for plant-based diets have encouraged rapid growth in plant-based products as alternatives to traditional dairy products. FDA now has expressed concerns that, because these plant-based foods are being sold in packaging similar to dairy products and in the dairy section of many grocery stores, consumers may be misled into purchasing products that do not have the same applications or nutritional profile of dairy products — or that consumers may not realize are plant-based products.

The FDA’s Request for Information

Specifically, FDA has requested information on the following:

• Consumer uses of plant-based products.
• How consumers understand terms such as “milk” or “yogurt” when it appears on a plant-based product.
• Consumer understanding of the difference between the nature, characteristics and ingredients of plant-based products.

The Federal Register notice indicates that this information will be used in the agency’s efforts to develop standards of identity for plant-based products. In his June 26, 2018 statement, Commissioner Gottlieb also noted that such information gathering activities would inform FDA decision making with regard to increasing its enforcement of the dairy standards of identity.

Impact and Next Steps for Food Manufacturers and Food Brands

In addition to potential increased regulatory enforcement, FDA’s statements and potential actions in connection with the dairy standards of identity may increase litigation risk exposure for companies using dairy-based product names or descriptions on plant-based products.

We encourage brands and manufacturers with an interest in this area to consider submitting comments or data on consumer perceptions, as such data may ultimately provide the foundation for potential rulemaking and enforcement decisions by the agency. Responses to the Request for Information are due on November 27, 2018.