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January 28, 2019

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

RE: Docket No. FDA-2018-N-3522 (Use of the Names of Dairy Foods in the Labeling of Plant-Based Products)


Ladies and Gentlemen:


Pennsylvania Farm Bureau (PFB) appreciates the opportunity to provide comments concerning the U.S. Food and Drug Administration’s (FDA) request for information in the labeling of plant-based products with names that include the names of dairy foods such as “milk,” “yogurt” and “cheese.” PFB is a general farm organization, made up of more than 62,000 members. Since 1950, PFB has provided support, advocacy and informational and professional services for Pennsylvania agriculture and farm families producing a diverse array of food and fiber for American consumers.


General Comments


On behalf of our members, we wish to state at the outset that it is imperative that FDA ensure consumers have accurate information about the food products they consume. 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 terms. Milk is a food product with an established standard of identity defined in 21 CFR 131.110 as: “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”


Notwithstanding the above, nut- and plant-based beverages are not held to the same standards of identity, but still share in the benefits of using the term “milk” on their packaging. The status quo of “enforcement discretion” by FDA is not acceptable and must be addressed immediately. Through their packaging, labeling and co-location in the refrigerated dairy section, these imitation products directly compete with and are marketed as substitutes for beverage milk products.


PFB requests that the FDA to take immediate action on the mislabeling of imitation dairy products. The increasing market share of these imitation products means they are no longer a small “niche” market to be overlooked by regulators, and it is also important to note that some consumers mistakenly believe that they are nutritionally equivalent to dairy products. FDA already has a process outlined in the Federal Register for dealing with these products.


Consumers rely on product indicators, such as the name on a product’s labeling, rather than technical information on the back of a label. This can create confusion when consumers decide whether to purchase milk or a non-dairy substitute. Nut- and plant-based beverages are marketed as milk, and sold in the milk case, right alongside traditional milk. These imitation products are not segregated or separated into another area of a grocery store; instead, they are sold in the refrigerated dairy section, often on the very same shelf and in the very same case as actual milk. This creates several concerns from a consumer choice perspective.


Consumer Choice and Nutritional Concerns


PFB wholeheartedly supports a consumer’s right to access dairy-free products from an allergy, intolerance, or personal dietary preference perspective. Our organization believes that these products should adhere to current regulations in their marketing process and that consumers are presented with accurate information on a product’s label so that they can make an informed choice for themselves.


PFB does not argue that most consumers purchase a nut- or plant-based beverage honestly believing that the product contains traditional milk from a cow (although a recent study conducted by the International Food Information Council Foundation shows that approximately one quarter of consumers are confused by this). The reality is that consumers associate the word “milk” with certain positive nutritional characteristics, characteristics that do not necessarily carry over to these substitute products. We elaborate on this concern in our comments below. These products are marketed as natural substitutes, but are in truth heavily processed products that include a variety of ingredients such as emulsifiers, thickeners, sweeteners, and artificially added nutrients. Yet consumers may well believe, based on marketing, that these artificial products are as natural as traditional milk.


These products can have severe consequences for parents who purchase them while believing that they possess the same nutritional profile as traditional milk for their children. FDA Commissioner Scott Gottlieb has recognized this as an issue. Because these alternative products are “often popularly referred to as milk, we intend to look at whether parents may erroneously assume that plant-based beverages’ nutritional contents are similar to those of cow’s milk, even though some of these products contain only a fraction of the protein or other nutrients found in cow’s milk.” Gottlieb has mentioned that case reports have shown that feeding young children rice-based beverages resulted in a form of severe protein malnutrition. A separate case reported a toddler being diagnosed with a disease resulting from vitamin D deficiency due to parents feeding the toddler soy milk. 


Sales Growth of Imitation Milk Products


According to an American Farm Bureau Federation (AFBF) analysis of household scanner data from Information Resources, Inc., in 2017, over $1.6 billion dollars of plant- and nut-based beverages were sold in the milk case, right next to traditional milk. These sales were up $141 million or 9 percent from 2015 levels. With sales approaching $2 billion per year, these imitation milk products are no longer a small “niche” category that can continue to be overlooked by regulators. The market share of nut- and plant-based beverages has increased from under 10 percent in 2015 to over 13 percent in 2018. During this same time, the market share of traditional milk beverages has dropped from 90 percent in 2015 to 87 percent in 2018.


The compound annual growth rates for traditional milk products and imitation milk products are on very different trajectories. The sales volumes for refrigerated almond and coconut beverages have increased annually by 8 percent and 9 percent, respectively. Other imitation milk products have increased their sales volume each year by an average of 25 percent. At the same time, analysis from the United States Department of Agriculture’s (USDA) Economic Research Service confirmed similar trends in the growth in the market share of nut- and plant-based beverage products.  During the three-year period from 2013 to 2015, the market share for imitation milk products grew from 5.3 percent to nearly 8 percent. Meanwhile, the market share for traditional milk products fell by 2 percent.



As evidenced, imitation beverage milk products have grown their market share considerably in recent years at the expense of traditional milk products. These imitation products have been able to grow their market share by exploiting FDA’s “enforcement discretion” and intentionally mislabeling their nut- and plant-based beverage products as “milk”. Further inaction by FDA is no longer acceptable, and PFB respectfully requests mislabeling of imitation dairy products be addressed immediately.


Suggested Solutions

To that end, PFB recommends that FDA model its regulations similarly to the way imitation milk beverage products are labeled in other countries such as Canada, the European Union and the United Kingdom. These governments actively police and enforce mislabeling of misbranded nut- and plant-based beverages. Dairy terms such as “milk” are not allowed to be accompanied by clarifying or descriptive terms indicating the plant origin of the product. In fact, to comply with the rules set forth in other countries, U.S.-based companies must change their labels when their products are sold in these markets. Importantly, these other countries’ enforcement of these labeling standards has not prevented these nut- and plant-based beverages from coexisting alongside real milk in the marketplace; rather they provide the consumer with accurate information about the product ingredients and dietary content.


This mislabeling of nut and plant-based beverages as “milk” confuses consumers from a nutritional equivalency standpoint. Dairy products are an important part of a healthy diet, and the 2015 Dietary Guidelines for Americans found that most Americans are not meeting recommended intake for dairy foods. Consumers know the healthiness of dairy labels such as “milk”, and likely infer that any product bearing this term possesses the same, or at least an equivalent, nutritional profile. This is not the case. For example, one serving of traditional milk contains 8 grams of protein while other imitation beverages including almond, coconut and rice have a lower protein content than milk. In many cases, the sweetened versions of the imitation beverages contain more sugars and carbohydrates than traditional non-flavored milk. Clearly, the mislabeling of nut and plant-based beverages as “milk” conveys a nutritional equivalency that is not accurate.


Empirical research confirms that imitation milk products are labeled in such a way as to directly mislead consumers on the nutritional content. Academic researchers in the Journal of Food Science and Technology recently concluded that “consumers associate these alternatives to be a direct substitute of cow’s milk which might not be true in all cases”.  Much of the research has suggested these alternatives to dairy are nutritionally inferior and shows how these products differ from cow’s milk in nutritional content. Additionally, inappropriate comparisons to traditional milk beverages by imitation products increases the risk of nutritional deficiency for under- and misinformed consumers. Consumers deserve accuracy and truth in their product labels and mounting evidence and data show that consumers are more frequently demanding this. Indeed, several recent polls have found that consumers support accurate labeling and strongly favor the FDA’s enforcement of existing regulations and prohibiting non-dairy beverage companies from mislabeling these products as “milk”. 


The failure to enforce existing regulation when it comes to nut- and plant-based beverages using the term “milk” in product labeling has contributed to an erosion in traditional milk’s market share and intentionally misrepresents the nutritional equivalency of these imitation products. The dairy case is now the center of products with false and misleading labels.


Fortunately, as mentioned in our general comments, FDA already has rules for labeling these types of products in place. FDA clearly explained these guidelines in a January 1993 Federal Register notice, which stated that if a modified food is nutritionally inferior, as is most often the case in plant and nut-based beverages, it must bear the word “imitation”. Even if the food is not nutritionally inferior, it must bear the either the words “substitute,” “alternative” or another appropriate term. If these rules are expected to be followed by the dairy industry, as is the case in the mozzarella example above, then all marketers of similar products should be expected to comply as well.


Conclusion

In closing, PFB thanks Commissioner Gottlieb for his comments expressing an understanding of the difference between true milk-based and imitation beverages, and respectfully and urgently call upon FDA to vigorously enforce existing standards of identity when it comes to dairy to ensure a fair marketplace where consumers experience truth and accuracy in product labeling.


We desire to be a part of a constructive dialogue moving forward to ensure that consumers receive accurate product information on the label. While we work to achieve these goals, it is critical that these efforts not result in changing the standards of identity for milk to include products beyond its established standard of identity to include the “nut juice” and other plant-based beverages that are currently in violation of these standards of identity.


Thank you again for the opportunity to share these comments.


Best regards,
 
Grant R. Gulibon
Director, Regulatory Affairs