April 24, 2023
Robert M. Califf M.D.
Commissioner, U.S. Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
RE: Docket No. FDA-2023-D-0451, Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry; Request for Comments
Dear Commissioner Califf,
Pennsylvania Farm Bureau (PFB) is pleased to offer its comments on the U.S. Food and Drug Administration’s (FDA) draft milk guidance addressing labeling of plant-based milk alternatives (#FDA-2023-D-0451). PFB is the Commonwealth’s largest general farm organization, representing over 30,000 members engaged in all manner of agricultural activities, including the production and processing of crops; the production and processing of animals; the production and processing of forestry products; landscaping and horticultural services; agriculture-related support services; and food manufacturing.
PFB calls on FDA to vigorously enforce food standards regarding the labeling of dairy products and prohibit the misleading labeling of nut- and plant-based food products as “milk” or other common dairy names. Failing to do so is an abdication of FDA’s responsibility to assure science-based product labeling for consumers.
FDA’s standard of identity (SOI) defines milk in 21 CFR 131.110 as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” Under the Federal Food, Drug and Cosmetic Act, in accordance with FDA’s definition of milk, plant-based beverages should not be allowed to be labeled as milk. Even with these clear directives, FDA makes the false claim that plant-based alternatives of milk do not purport to be milk, nor are they represented as milk, therefore they are exempt from requirements. FDA appears to suggest plant-based alternatives may fall under their current classification as “non-standardized foods,” a category of foods that do not have an established definition or SOI. In these cases, food items must use common names known to the public without being misleading. Given that plant-based alternatives have only surpassed 10% market share in the past 10 years, claiming that “milk” is an organically common name for this wide range of diverse products is irrational. Plant-based milk alternatives are claiming to be milk in a consumers’ basket, but as they do not contain any milk as defined by FDA’s SOI, they cannot utilize the term. If these items are not attempting to represent the qualities that define milk, there should be no concern with dropping the term.
This draft guidance would not only hurt dairy farmers’ business but also damages consumer transparency. FDA admits on page 6 of the guidance that several studies showed that consumers do not understand the nutritional differences between milk and plant-based beverages. Non-dairy products labeled as milk that lack the foundational nutritive components of milk can be misleading and harmful. It is very deceiving to put a high processed, high sugar, and low protein plant-based beverage labeled as milk next to a carton of dairy milk with thirteen natural and essential nutrients. From 1970 to 2019, the daily per capita milk consumption decreased by 49 percent. Pediatricians and medical doctors have said dairy milk is vital for healthy growth and development because it is the only beverage that naturally provides large quantities of calcium, protein, vitamin A, vitamin D, magnesium, phosphorus, potassium, riboflavin, vitamin B-12, zinc, choline, and selenium. The Dietary Guidelines for Americans, 2020-2025, recommends individuals consume 2 to 3 cup equivalents of dairy products per day depending on age, gender, and physical fitness. Only 10 percent of the U.S. population meets that recommendation1. Part of this is due to FDA not enforcing milk’s SOI, and consumers purchasing alternatives to dairy milk.
PFB believes that plant-based alternative milk products should adhere to current labeling laws and regulations and that consumers should be presented with scientific information on a product’s label so that they can make an informed choice about the wide range of attributes associated with milk and other dairy terms, including butter, ice cream, yogurt, etc. We ask that FDA amend their draft guidance to prohibit the use of “milk” or other dairy terms on non-dairy substitutes unless products follow proper use of imitation terminology, as defined by existing law.
President, Pennsylvania Farm Bureau