In my blogs so far, I have focused on issues with the FDA and medical devices. In those blogs I discussed the ways FDA promotes distribution of safe and effective devices, while highlighting limitations of the FDA’s approaches. The FDA’s regulatory jurisdiction extends to food, drugs, medical devices, radiation-emitting products, vaccines, blood, and biologics, veterinary products, cosmetics, and tobacco products. The Food section of the FDA uses its regulatory authority to promote food safety and nutrition, also raising interesting issues. Here, I will use a particularly newsworthy example to show how the agency uses regulatory power to prevent consumer confusion. 

Under 21 U.S.C. 341, the agency regulates the labeling of prepared foods and raw produce. The labeling requirements often help inform consumers about ingredients and potential allergens. For example, the FDA issued a final rule in 2013 defining “gluten free” for food labeling primarily to help customers living with celiac disease feel confident the products they bought would not make them sick.[1] Overall, regulations and nonbinding guidance “support the FDA’s goal to improve healthy dietary patterns by providing consumers with additional and more accessible information to enhance their ability to make informed choices about the foods they buy and eat.”[2]

Since 1973, the FDA has maintained a standard of identity for products labeled as milk.[3] The FDA defined milk as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more cows.” This definition has sparked debate and litigation as nondairy milk-based alternatives have entered the market and grown in popularity. 

In two separate class action suits brought in the Northern District of California; plaintiffs argued that producers and sellers of alternatives such as Soy Milk and Almond Milk are misbranded as Milk.[4]  In both cases, the court ruled for the Defendants, stating that the FDA regulations allow for common uses to establish common naming for products and that the terms used to describe plant-based milk products are not false or misleading.[5] 

The FDA addressed both judicial interpretations in their February 22, 2023, draft guidance on labeling of plant-based products sold as milk alternative. Specifically, the guidance acknowledges that the FDA has not established alternative standards of identity for plant- based milk alternatives and thus, the products should be labeled with their common or usual name, such as soy milk or almond milk.[6] By citing FDA conducted focus groups and studies previously submitted to the FDA during a comment period, the guidance concludes that consumers “understand that plant-based milk alternatives do not contain milk when shopping for various types of products labeled with the term milk.”[7]

While the FDA draft guidance provides nonbinding recommendations to clear up several issues raised by plant-based milk products, there are still open questions. Such open questions have been and may continue to be the target of litigation in this area. 

For example, the recommended guidance on nutritional labeling does not apply to other traditional milk-based products such as yogurt, cheese, or butter. In a later voluntarily dismissed suit, a class brought action against Miyoko’s Kitchen claiming their vegan butter branding and marketing mislead consumers about the contents and nutritional value of the product.[8]

Any controversy over cheese labeling is further complicated because the FDA maintains additional guidelines standardizing cheese.[9] The guidance provides individual sections for different types of cheeses. The standardized definitions each incorporate dairy products and milk. Thus, further guidance may be needed to clarify if non-dairy cheese products also satisfy the common usage definition. 

Challenges to non-dairy milk products may continue with theories extending beyond the use of the word “milk” for plant based dairy products. For example, in two separate suits, challengers argued that labeling non-dairy milk products as vanilla flavored when they do not contain vanilla bean is deceptive.[10] 

The FDA will be accepting comments on the plant-based milk alternative draft guidance until April 23, 2023. Comments can be submitted through https://www.regulations.gov or by mail to the Dockets Management Staff (HFA-305) at Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  After the FDA closes the comment period and reviews responses, we should then expect a final guidance to industry. 

[1] https://www.fda.gov/food/food-labeling-nutrition/gluten-free-labeling-foods

[2] https://www.fda.gov/media/165420/download

[3] 21 CFR 131.110.

[4] Ang v. WhiteWave Foods Co., No. 13-cv-1953, 2013 WL 6492353, at *3 (N.D. Cal. Dec. 10, 2013), Gitson v. Trader Joe’s Co., No. 13-cv-01333-VC, 2015 WL 9121232 (N.D. Cal., Dec. 1, 2015).

[5] See Gambert, I. 2019. Got mylk? The disruptive possibilities of plant milk. Brooklyn Law Rev. 84:801-871.

[6] https://www.fda.gov/media/165420/download

[7] https://www.fda.gov/media/165420/download (internal quotes omitted)

[8] https://www.classaction.org/media/brown-v-miyokos-kitchen-inc.pdf.

[9] 21CFR133

[10] Twohig v. Shop-Rite Supermarkets, Inc., 519 F. Supp. 3d 154 (S.D.N.Y. 2021); Fahey v. Whole Foods Mkt., No. 20-cv-06737-JST, 2021 U.S. Dist. LEXIS 127685 (N.D. Cal. June 30, 2021)