• On October 1, 2020, the U.S. Food and Drug Administration (FDA) published the results of its sampling project on domestically manufactured dark chocolate bars and dark chocolate chips labeled with claims such as “dairy free.” FDA conducted the sampling assignment to better understand the extent to which these products contain potentially hazardous levels of milk and therefore may cause serious health consequences to consumers with an allergy to milk.
  • FDA’s sampling assignment focused on products that did not include milk as a disclosed ingredient; were manufactured in the U.S.; bore claims such as: “dairy free,” “milk free,” “100% milk free,” and “contains no milk,” on packaging or website (this sampling assignment did not target “lactose-free” or standalone “vegan” claims in the absence of “dairy free”-type claims); and consisted solely of dark chocolate, without other component ingredients such as fillings, candy shells, fruits, nuts, seeds, etc. From July 2018 to October 2019, FDA collected 119 samples (88 dark chocolate bars and 31 packages of dark chocolate chips), representing 52 products, at retail (including online).  FDA found that four of the products sampled (4 of 52 products; 12 of 119 samples) had milk levels ranging from 600-3,100 parts per million (ppm), and the potential to cause severe reactions in consumers with milk allergy.
  • Dark chocolate can be made with or without milk as an intentionally-added ingredient. Some dark chocolate is made without the addition of milk as an ingredient, but milk may nevertheless be found present in these products due to inadvertent cross-contact, or the fact that dark chocolate is often produced on equipment used to produce milk chocolate, and it can be very challenging to thoroughly clean the equipment between product runs.
  • Milk is one of the eight major allergens identified by FDA (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans), and manufacturers are required to label products that contain these ingredients and/or proteins accordingly. Undisclosed allergens are a leading cause of FDA requests for food recalls.  FDA believes milk is the most common undeclared food allergen, and that milk has been observed to be the leading cause of consumer adverse reactions to foods recalled due to undeclared allergens.  Based on consumer surveys, millions of people in the U.S. (estimated at approx. 2% of the population) are believed to experience symptoms of milk allergy, ranging from mild to severe (including hives, facial swelling, upset stomach, vomiting, wheezing, and anaphylaxis).
  • In response to the findings of the sampling project, all four products were recalled by the three manufacturers involved. The Agency will continue to monitor the issue, and will conduct additional sampling of domestic and imported dark chocolate.
  • On June 26, 2020, Sheehan & Associates, P.C., on behalf of a proposed class of Plaintiffs, filed a class action lawsuit against Hain Celestial Group, Inc. asserting that the company had deceptively labeled its “Organic Plus Vanilla Soymilk” because it (1) contained non-vanilla flavor and (2) disguised sugar as “Evaporated Cane Juice.”
  • On the first claim, Plaintiffs alleged that the ingredient list’s disclosure of “Vanilla Flavor With Other Natural Flavors” indicated that the product contained non-vanilla flavor. Furthermore, they alleged that this non-vanilla flavor contained vanillin. Additionally, they alleged that because vanilla is governed by standards of identity (see 21 CFR 169.175 (“Vanilla extract); 21 CFR 169.177 (“Vanilla flavoring”)), the general flavoring rules of 21 CFR 101.22, including the designation of “with other natural flavors,” do not apply and any non-vanilla flavor must be disclosed as an artificial flavor.
  • As to the sugar claim, Plaintiffs alleged that consumers expect an ingredient with the term “juice” to be derived from a consumable fruit or vegetable, that “evaporated cane juice” “had little in common” with this definition of juice because it was “another name for . . . ‘sugar,”’ and that the choice of labeling resulted in the misleading impression that the product was a better nutritional choice than comparable products.
  • Plaintiffs’ vanilla claim echo a plethora of similar class-action lawsuits, many dozen of which have been filed by the same firm. However, unlike some of these cases, including one that was recently dismissed, Plaintiffs did not solely rely on the declaration of “natural flavors” in the ingredient list to conclude that a non-vanilla flavor was present, but rather specifically allege that the challenged product contains vanillin. Keller & Heckman will continue to monitor and provide updates regarding class-action litigation in the food industry.
  • On April 11, Virginia Governor Ralph Northam vetoed a bill that would have limited the use of the term “milk.” HB 119 was introduced to the Virginia House on December 16, 2019 and defined “milk” as “the lacteal secretion of a healthy hooved mammal and provides that a food product is unlawfully misbranded if its label states that it is milk and it fails to meet such definition, except for human breast milk.” The bill directed the Board of Agriculture and Consumer Services to implement a plan to ban all products misbranded as milk.
  • Governor Northam explained his decision to veto by stating that “[e]liminating the ability to label certain food products with the term “milk” could hinder some businesses’ ability to thrive in Virginia. This bill likely conflicts with both the United States Constitution and the Constitution of Virginia and each’s protection of commercial speech. Accordingly, I veto this bill.”
  • As our readers are aware, since 2018, dozens of states have introduced similar labeling bills, many of which have been challenged in court. On the federal level, U.S. Senator Tammy Baldwin introduced the Dairy Pride Act in March 2019 to prohibit non-dairy products made from nuts, seeds, plants, and algae from being labeled with dairy terms like milk, yogurt, and cheese. Although it has yet to be referred out of committee. Additionally, the FDA requested comments on the use of dairy terms, such as milk, yogurt, and cheese, in the labeling of plant-based products. FDA received 14,000 comments but has yet to act further.

 Danone Dodges Deceptive Ad Suit Over Coconut Milk (Subscription to Law360 required)

  • The U.S. District Court for the Southern District of California on August 14, 2019 dismissed a proposed class action alleging the term “healthy” is deceptive when used to market coconut milk containing high levels of saturated fat.  At issue in Andrade-Heymsfield v. Danone US, Inc. were marketing claims that So Delicious coconut milk contains “good fats” and can help promote bone strength through calcium and vitamin D.  U.S. District Judge Cathy Ann Bencivengo found the advertised benefits are permitted under the Food and Drug Administration (FDA) guidelines, that the labeling made accurate admissions about the saturated fat content, and “plaintiffs cannot claim deception on label statements modelled on FDA guidance.”  The judge also rejected the plaintiffs breach of an express or implied warranty claim about treating osteoporosis, finding statements about the coconut milk’s nutrients and their effects are structure and function claims permitted by FDA.
  • Under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(r)(1)(A)), a food is misbranded if it bears claims that characterize the level of a nutrient which is of a type required to be declared in nutrition labeling unless the claim is made in accordance with a regulatory definition established by FDA.  FDA’s regulation at 21 CFR 101.65(d) provides such regulatory definition for use of the term “healthy” as an implied nutrient content claim on the label or in labeling of a food that meets certain nutrient conditions, including specific criteria for nutrients to limit in the diet, such as saturated fat.
  • As previously reported on this blog, FDA is considering updating its nutrient content claim regulations to be consistent with current federal dietary guidance.  In the interim, food manufacturers may continue to use the term “healthy” on foods that meet the current regulatory definition (21 CFR 101.65(d)).  FDA has also issued a guidance document, stating that FDA does not intend to enforce the regulatory requirements for foods that use the implied nutrient content claim “healthy” on their labels which: (1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.  It is the second provision of FDA’s enforcement policy that the U.S. District Court found applicable to the “healthy” claim on Danone’s coconut milk.
  • On June 11, Louisiana joined a growing number of states, including Missouri and Arkansas, that have enacted legislation aimed at protecting traditional agricultural products from the growing popularity of plant-based and cell-based meat products or riced vegetables.
  • Louisiana Governor John Bel Edwards signed two bills into law aimed at prohibiting the use of common labeling terms on food products derived from non-traditional sources.  Louisiana Act No. 273, or the “Truth in Labeling” law, broadly bans the use of the terms “meat,” “rice” or “sugar” on food products derived from non-traditional sources, such as plant-based or cell-derived “meats” and cauliflower “rice.”  Louisiana Act No. 184 specifically targets milk product labeling, which prohibits a beverage from being labeled as “milk” unless the product comes from a cow, goat, or other hooved mammals.  Both bills were sponsored by Louisiana Democratic Senator Francis Thompson, who claims that the legislation is designed to protect the Louisiana agriculture and dairy industries, as well as protect consumers from misleading labels.
  • The “Truth in Labeling” law makes it unlawful to represent any food product as an agricultural product unless it meets a definition prescribed by statute, or defined historically in reference to a specific agricultural product.  The law defines “meat” to mean a portion of beef, pork, poultry, alligator, farm-raised deer, turtle, domestic rabbit, crawfish, or shrimp, and does not include products derived from a plant or cell culture grown in a lab.  The law also prevents use of the term “rice” unless the product contains rice, and “sugar” unless the product is derived from plant-based simple sugar or sucrose.
  • The “Milk Labeling” law cross-references the U.S. Food and Drug Administration’s (FDA’s) standard of identity for milk 21 C.F.R. § 131.110, defining it as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”  The law further specifies that the word “milk” is to be interpreted to include the milk of hooved mammals, such as cows, goat, sheep and water buffalo.
  • The Milk Labeling Law becomes effective on August 1, 2019.  The Truth in Labeling law becomes effective on October 1, 2020, with violators subject to a civil penalty of up to $500 per day per violation.
  • As previously reported on this blog, FDA’s comment period on the use of the terms, such as milk, yogurt, and cheese, in the labeling of plant-based products ended on January 28, 2019. FDA’s standard of identity for milk defines milk in part as the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.
  • On February 21, 2019, after the end of FDA’s comment period, the National Milk Producers Federation filed a citizen petition to FDA requesting that the agency: (1) enforce existing “imitation” labeling requirements against non-dairy substitutes for dairy foods; and (2) codify FDA policies to permit the name of a standardized dairy food to be used in the statement of identity of a non-dairy substitute for standardized food when products are deemed nutritionally equivalent to the dairy products they reference.
  • Pursuant to 21 CFR 10.30(e)(2), the FDA must respond to citizen petitions within 180 days of receipt although the response may not be substantive and could simply be that they need more time to review the citizen petition.  FDA action or response to its request for comments on labeling of plant-based products is also forthcoming.  We will continue to monitor this situation and report on any developments.
  • As previously reported in September on this blog, FDA requested comments on the use of dairy terms—such as milk, yogurt, and cheese—in the labeling of plant-based products. FDA’s Standards of Identity define milk in part as the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” The original deadline for comments was November 27. However, on October 21, 2018, FDA announced that the comment period would be extended by 60-days to January 28, 2019. (See 83 Fed. Reg. 58775.)
  • FDA received 13,077 comments on the use of dairy terms in the labeling of plant-based products by yesterday’s deadline. While most of the comments are from individual consumers, industry and nongovernment organizations also weighed in with diverse opinions. The dairy industry urged FDA to enforce the Standard of Identity for milk. Some are the comments expressing this view are summarized below.
    • The Ohio Dairy Producers Association’s comments, submitted on November 14, state that it “opposes allowing imitation dairy products, such as those made from soy, almond or other non-dairy ingredients, to bear the names of traditional or standardized dairy foods.”
    • The National Milk Producers Federation (NMPF) posted comments that it submitted on January 28 on its website. In a news release about the comments, NMPF stated, “The U.S. Food and Drug Administration must enforce its existing rules against mislabeling plant-based products with dairy terms to address widespread consumer confusion over the nutritional content of dairy-product imitators.” The NMPF commissioned a poll that found 49% of those questioned believe that non-dairy brands should not be allowed to use the term “milk” on their product labels because they are often less nutritious than dairy milk. Also, 61% of those polled said that they believe the FDA should restrict non-dairy beverage companies from using the term “milk,” while 23% believe that FDA should not restrict non-dairy beverage companies. The poll was conducted by Ipsos on January 4-7, 2019, and involved online interviews of 1,005.
    • James O’Reilly, professor of public health systems and director of the Concentration in Health Services Management at the College of Medicine of the University of Cincinnati, also submitted comments. Noting that he has taught food and drug law for 30 years and has no financial interest in a milk products company or alternative “milk” marketer, he stated, “Until and unless Congress changes the statute, FDA should enforce it. FDA should recognize that standards of identity have a long standing special position within the food safety and food marketing regulatory environment.”
  • Opposing opinions were expressed by organizations representing plant-based dairy producers and many of the individual commenters. Some of these comments are summarized below.
    • The Good Food Institute (GFI) stated in comments submitted on January 28, “FDA should not restrict plant-based dairy producers from using conventional dairy terms on their labels. However, if the agency were to depart from longstanding practice and create new rules that substantially affect how plant-based dairy producers conduct their business, it must promulgate a new regulation through notice-and comment rulemaking.” To support this view, GFI cited the fact that FDA has for several decades allowed products to be labeled using qualified standardized terms, such as “gluten-free bread” even through it doesn’t meet the standard of identity for bread. GFI also pointed out that 37% of all U.S. households purchase plant-based milk and that the plant-based milk category now stands at $1.8 billion annually. It concluded by stating, “Without a showing that consumers are actually confused by the labels of plant-based dairy products, and that there is no less restrictive means possible of ensuring clarity other than prohibiting plant-based dairy producers from using conventional dairy terms on their labels, FDA has no authority to act.”
    • The Vegetarian Resource Group (VRG), stated in its comments, “We believe that prohibiting plant-food labels from including words like milk, cheese, and yogurt in the name of these products would lead to consumer confusion. We urge you to permit the labeling of plant-based products with names that include milk, cheese, and yogurt.”
  • The Ninth Circuit upheld the dismissal of a proposed class action that alleged Almond Breeze almond milk is mislabeled and instead should be labeled as “imitation milk.”  Plaintiff Cynthia Painter focused on the nutritional differences between almond milk and 2% dairy milk and argued that the plant-based milk lacked the essential nutrients that are inherent in dairy milk, but are marketed as equally, if not more nutritious.  Indeed, Painter argued that Almond Breeze manufacturer, Blue Diamond, has “deceptively informed and led its customers to believe that they were purchasing, for a premium price, a dairy milk alternative that is nutritionally equivalent, and even superior, to dairy milk.”  Painter further alleged that by calling these almond beverages “milk,” Blue Diamond capitalized on the reasonable consumer’s understanding of the well-known health benefits associated with diary milk without actually providing those same health benefits.
  • In May 2017, Judge Stephen V. Wilson dismissed the case on the grounds of federal preemption and added that “even an unsophisticated consumer, would not assume that two distinct products have the same nutritional content.”  Painter appealed Wilson’s dismissal order, which the Ninth Circuit then upheld on December 20, 2018 via a memo judgement.  The appeals panel said the lower court correctly found that Painter’s state law claims were preempted by the Food, Drug, and Cosmetic Act (FDCA), which bars a state from establishing labeling requirements that differ from federal ones.  Further, the Ninth Circuit said the lower court correctly dismissed Painter’s deceptive marketing claims because she did not plausibly claim that a reasonable consumer would, based on the labeling, believe almond milk and dairy milk to be nutritionally equivalent.  While the Ninth Circuit’s memo judgment offers insight into the court’s thinking on the matter, it does not set legal precedent and cannot be cited by other courts.
  • Notably, the Painter suit focused on the nutritional differences between the beverages, instead of alleged violations of the standard of identity (SOI) for milk.  As previously reported on this blog, industry and certain lawmakers have taken issue with the use of the term “milk” by manufacturers of plant-based products, such as soy milk and almond milk, taking the position that it is a violation of the standard of identity.  Milk is defined as the “lacteal secretion . . . obtained by the complete milking of one or more healthy cows”, though FDA regulations also contemplate milk from other animals.  FDA has begun the process of modernizing SOIs, with a focus on the use of the term “milk” in the labeling of plant-based products. In September 2018, FDA invited interested parties to provide input related to the labeling of plant-based products and in November, FDA extended the comment period, which is now set to close on January 28, 2019.  However, due to the government shutdown, FDA’s SOI modernization efforts will likely be impacted.
  • As previously reported in The Daily Intake, FDA has requested comments pertaining to consumer awareness and understanding of the use of milk and other dairy terms on plant-based alternatives.  Depending upon the feedback received, FDA could then potentially revisit its policy of not enforcing the standard of identity for milk as it pertains to labeling plant-based products like almond milk, soy yogurt, and vegan cheese.
  • FDA’s Standards of Identity define milk in part as the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”  The International Food Information Council Foundation (IFIC Foundation) has released the responses from an on-line poll of 1,000 U.S. adults as to which of various products do or do not contain cow’s milk.
    • Percentages responding “contains cow’s milk” were:  Whole milk (90%), Chocolate milk (85%), Nonfat milk (78%), Skim milk (74%), Lactose-Free milk (48%), Coconut milk (9%), Soymilk (9%), Almond milk (9%), Cashew milk (8%), and Rice milk (7%).
    • Percentages responding “does NOT contain cow’s milk” were:  Whole milk (4%), Chocolate milk (7%), Nonfat milk (9%), Skim milk (14%), Lactose-Free milk (31%), Coconut milk (74%), Soymilk (75%), Almond milk (75%), Cashew milk (72%), and Rice milk (73%).
    • Percentages responding “Don’t know” were:  Whole milk (5%), Chocolate milk (9%), Nonfat milk (12%), Skim milk (13%), Lactose-Free milk (22%), Coconut milk (18%), Soymilk (16%), Almond milk (16%), Cashew milk (20%), and Rice milk (20%).
  • The IFIC Foundation characterizes the survey results above as demonstrating a “low level” of consumer confusion on the nomenclature and basic differences between milk and dairy based products as compared to plant-based alternatives.  According to Food Navigator, however, the National Milk Producers Federation (NMPF) believes the results show an unacceptable level of uncertainty or confusion.  The NMPF also notes that the survey did not gauge consumer understanding of the nutritional qualities of dairy milk versus plant-based beverages, which that group sees as a major concern.
  • The NMPF submitted a request for extension of the November 27, 2018 deadline for submitting comments to FDA regarding the use of the names of dairy foods in the labeling of plant-based products.  Thus far, no arguments from the dairy or plant-based industries are among the 561 comments posted to the docket.

 

Statement from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products (FDA Statement)

  • As reported on this blog, FDA held a public meeting on July 26, 2018 to discuss the FDA’s Nutrition Innovation Strategy (NIS), which promotes public health through efforts to empower consumers to make better and more informed decisions about their diets and health, foster the development of healthier food options, and expand the opportunities to use nutrition to reduce morbidity and mortality due to chronic disease. FDA’s plans to possibly limit use of the term ‘milk’ in labeling plant-based products were a prominent feature of the NIS meeting.
  • A Press Release from FDA Commissioner Dr. Scott Gottlieb immediately following the NIS meeting characterizes it as the first step in the process of modernizing FDA’s standards of identity by gathering stakeholder feedback. While focusing on milk, Dr. Gottlieb’s statement also mentions the need for potentially updating nearly 300 other standards of identity as well.
  • FDA’s next step – possibly coming by late summer or early fall – will be to release a specific set of questions pertaining to consumer awareness and understanding of the use of milk and other dairy terms on plant-based alternatives. Depending upon the feedback received, FDA could then potentially revisit its policy of not enforcing the standard of identity for milk as it pertains to plant-based beverages.