• In recent proposed legislation, Michigan (HB 5603) and West Virginia (HB 4911) have proposed allowing the sale of unpasteurized, raw milk within their respective states.  The Michigan bill is currently stalled in committee, while the West Virginia bill has been approved without the governor’s signature.
  • Currently, federal law prohibits dairies from distributing raw milk across state lines in final package form, and many states have full or partial bans on its sale within their borders.
  • Michigan’s HB 5603 was first introduced on the House floor March 24, 2024.  Under the proposed legislation, unpasteurized, raw milk may be sold to a final consumer or retail establishment in Michigan if the raw milk and raw dairy products comply with specific criteria.  This includes a warning that must be placed on the labels of covered products: “WARNING: unpasteurized milk and dairy products may contain disease-causing microorganisms. Individuals at the highest risk of disease from these microorganisms include newborns and infants; the elderly; pregnant women; individuals taking corticosteroids, antibiotics, or antacids; and individuals with a chronic illness or another condition that weakens immunity.”
  • West Virginia’s HB 4911 legalizes the sale of raw milk as long as the containers are clearly labeled as “unpasteurized raw milk” along with the seller’s name, address, the date of production, and a warning that “Consuming unpasteurized raw milk may increase your risk of foodborne illness, especially for children, elderly, immunocompromised individuals, and persons with certain medical conditions.”  The final version of the law does not include an originally proposed provision that would have made sellers of raw milk immune to lawsuit and liability for claims related to personal injury for actual or alleged act, error or omission that occurred as long as the act was not intentional.  The bill will become law 90 days after the legislature approved it on March 9, 2024.
  • Last month, the American Beverage Association (ABA), a trade organization whose members consist of manufacturers of both dairy milk and plant-based milks, submitted comments on FDA’s draft guidance titled Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements. The draft guidance, which was published in February of this year, proposes a voluntary framework for the labeling of plant-based milk alternatives (PBMAs) that allows the term “milk” in PBMAs provided that the plant-source of the beverage is disclosed and nutritional differences from milk are disclosed on the principal display panel (PDP).
  • ABA supports the FDA’s decision to allow for the use of term “milk” in PBMAs but requests that the agency reconsider the recommendation to disclose nutrient differences on the PDP. ABA argues that disclosing nutrient differences on the PDP is without precedent and could create greater consumer confusion. Instead, ABA believes that a statement on the PDP referring consumers to the nutritional facts panel would better serve consumer interests.
  • ABA also urges the FDA to revise the guidance to allow for the generic descriptor “plant-based” in the name of PMBAs. ABA argues that there are products “with multiple synergistic ingredients” and without a uniquely characterizing plant source that would be better served by a general descriptor.
  • ABA notes that the guidance is particularly important because it is likely to have implications in other plant-based product categories (e.g., plant-based meats) and because Plaintiffs’ lawyers are likely to allege that products which do not follow the recommendations of the guidance are misleading, making the recommendations “tantamount to requirements.” Comments to the draft guidance are due by July 31, 2023.
  • As we previously blogged, in February FDA published a long-awaited draft guidance document which laid out a voluntary framework on the labeling of plant-based milk alternatives. The guidance, which has been criticized by both the plant-based milk and the dairy industry, proposed to allow the use of the term “milk” in non-dairy products provided that the plant source and nutritional differences from milk are disclosed.
  • The original 60-day comment period ended yesterday (April 24th). However, in response to requests from both the plant and the dairy industry, FDA announced that it would be extending the comment period to a date that will be determined when the extension notification is published. We note that the requests asked for either 60- or 90-day extensions.
  • Apart from citing the need for additional time to consider the guidance and develop meaningful comments, many of the comments also noted that FDA relied on consumer studies, some of which are not publicly available and must be obtained through a Freedom of Information Act (FOIA) request. The comments indicated that the studies have not yet been obtained through FOIA due to a backlog in the system. We will continue to monitor any developments.
  • Yesterday a district court dismissed (Law360 subscription required) a class-action lawsuit which alleged that Ferrara Candy Company misled consumers into believing that their Brach Milk Maid caramels were made with milk fat by labeling their caramels with the phrases “Made With Real Milk” and “Rich and Creamy” and depicting a pitcher of milk. As indicated by the ingredient list, the products were made with skim milk, butter oil, and whey, but the primary source of fat was hydrogenated palm kernel oil.
  • The Court held that because the products were made with skim milk, butter oil, and whey, and there were no representations as to the type of milk the products were made with, the claim “made with real milk” was true, and the alleged equivalence between “made with real milk” and “made with real milk fat” was Plaintiff’s own unsupported interpretation. Indeed, although not pivotal to the decision, the Court noted that the milk and milk derived ingredients in the product (e.g., butter oil) would have contributed some milkfat to the product. The Court also cited to cases which held that a labeling claim regarding one ingredient (e.g., milk) does not preclude the presence of other ingredients (e.g., vegetable oil). Additionally, the Court held that the “Rich and Creamy” claim was a subjective description of quality which was not measurable and therefore constituted non-actionable puffery.
  • The case adds to a line of cases construing claims regarding the presence of ingredients narrowly. We will continue to monitor and report on class action lawsuits affecting the food industry.   
  • On February 22, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance to ensure appropriate labeling of plant-based products that are marketed and sold as milk alternatives (plant-based alternatives (PBMA)).
  • The FDA recommends that PBMA products labeled with the term “milk” in their names, such as “soy milk” or “almond milk,” and that have a nutrient composition different than milk, include a voluntary nutrient statement that conveys how the product compares to milk, based on the USDA’s Food and Nutrition Service (FNS) fluid milk substitutes nutrient criteria.  If a PBMA is not labeled with “milk” as part of its name, but instead is labeled with another term like “beverage” and does not make a claim comparing the product to milk, then the voluntary nutrient statement recommendations do not apply.  The draft guidance also clarifies that the common names of some PBMA have been established by common usage, and these names include “almond milk” and “soy milk.”
  • The draft guidance comes after FDA requested comments in 2018 to gain insight into how consumers use PBMA products and how they understand the term “milk” when included in the names of plant-based products.  The agency received more than 13,000 comments.  FDA determined that consumers generally understand that PBMA do not contain milk and choose PBMA because they are not milk, but that consumers may not be aware of the nutritional differences.
  • On a related note, we suspect that the United States will be referencing this guidance during the Codex Committee on Nutrition and Foods for Special Dietary Uses 43rd Session (CCNFSDU43) discussions, in a push for more international policies and guidelines that regulate plant-based alternatives differently than general foods. 
  • Comments on this draft guidance should be submitted within 60 days after publication in the Federal Register.  Keller and Heckman will continue to monitor and report on any developments.
  • On October 22, a California federal judge found that a proposed consumer class failed to show that calling a product “milk-based” is deceptive when milk is one, but not the main, ingredient in the product (subscription to Law360 required).
  • U.S. District Judge John Holcomb in his order said that the proposed class representative, Cecilia Martinez, had a limited interpretation of the product’s labeling and that Mead Johnson provided sufficient context, specifically in its ingredient list, to clarify the “milk-based” description. “Martinez [alleges] no factual support for why a reasonable consumer would narrowly interpret a something-based label to mean that that something must contribute the most to the product’s weight, relative to any other ingredient,” reasoned Judge Holcomb on Saturday.
  • The disposition comes after Martinez filed the class action suit in February after she purchased Enfamil powdered formula in September 2021, believing the main ingredient to be milk on the “milk-based” description, only to later discover that the primary ingredient was corn syrup solids. Mead Johnson argued that an object could be described by one of its ingredients, even if it is not the main ingredient. To illustrate this point, the company pointed out that while a can of chicken-based broth and a can of vegetable-based broth both have water as the main ingredient, the products would likely be described by their more distinctive characteristics of chicken and vegetables.
  • Judge Holcomb ultimately sided with the nutrition company and pointed out that FDA says only that product labels should “describe the basic nature of the food or its characterizing properties or ingredients,” and does not mention anything about conflating the characterizing ingredient of a product with its primary ingredient.
  • According to Judge Holcomb, customers could “easily” turn the Enfamil formula bottle around and look at the ingredient label to see that while milk is listed, corn syrup solids are listed higher. Therefore, the judge said, Martinez’s arguments appear to be “plausible misunderstandings.”
  • The proposed consumer class may file an amended complaint no later than November 10, 2022. The case is Cecilia Martinez v. Mead Johnson and Co. LLC, case number 5:22-cv-00213, located in the U.S. District Court for the Central District of California.
  • On February 17, 2022, the U.S. District Court of the Southern District of New York dismissed a lawsuit against Mars Wrigley Confectionery US, LLC (Mars) which alleged that Mars’ chocolate-coated vanilla ice cream bars (called Dove bars) deceived consumers by including vegetable oils in the bars while also making representations regarding the milk chocolate content of the bars.
  • Specifically, the labels of Dove bars stated that they were “made with milk chocolate” and that the vanilla ice cream had been dipped in milk chocolate. Plaintiff alleged that, based on these representations, consumers would not expect the product to contain “lower quality chocolate substitutes” such as coconut oil and palm oil.
  • The court dismissed these allegations as conflating the content of the milk chocolate ingredient with the content of the milk chocolate coating. As disclosed on the ingredient list, the predominant ingredient in the Dove bars was milk chocolate made with cocoa butter, and it was the chocolate coating, not the milk chocolate itself, which contained the vegetable oils. Nothing in the product labeling, including the “made with milk chocolate representation” indicated to a consumer that the product was made exclusively with milk chocolate and there was also no indication that the vegetable oils had been used to replace cocoa butter in the milk chocolate.
  • On December 1, 2020, the United States District Court Northern District of California granted Westbrae Natural, Inc.’s (“Defendant”) motion to dismiss the plaintiff’s lawsuit.  In the complaint, the plaintiff alleged that the use of the word “vanilla” on the label of Defendant’s organic unsweetened vanilla soymilk misrepresents to consumers that the soymilk’s vanilla flavor is derived exclusively from the vanilla bean plant.  The plaintiff also claimed that the soymilk is made with no or negligible amounts of natural vanilla and should be labeled “artificially flavored.”
  • In the motion to dismiss, Defendant argued that the plaintiff failed to allege that a reasonable consumer would be deceived by the “vanilla” label into believing that the soymilk’s vanilla flavor is derived exclusively from the vanilla bean.  The court agreed with the Defendant and stated that the “label does not contain any other words or pictures that suggest the vanilla flavor is derived exclusively from the vanilla bean.”
  • As support for his allegations, the plaintiff presented a 2020 survey in the complaint, which allegedly showed that 69.5% of 400 consumers believed that the “vanilla” representation on the label meant that the soymilk’s flavor comes exclusively from the vanilla bean.  The court stated that the results of the 2020 survey do not make plaintiff’s claims plausible and that a survey, alone, does not satisfy the reasonable consumer test.  The court gave plaintiff 20 days to refile his complaint to address its shortcomings.
  • This lawsuit follows several lawsuits filed in 2020 where plaintiffs accused businesses of misrepresenting the vanilla flavoring in multiple food and beverage products.  We will continue to monitor any developments.

 

  • Our readers may recall that a lawsuit filed June 26, 2020 against The Hain Celestial Group, involving Organic Plus Vanilla Soy Milk, avoided some of the pleading issues that doomed some of the numerous class action lawsuits, filed mostly by a single firm, involving other products that are claimed to contain deceptive and misleading information on their labels regarding vanilla.  Plaintiffs alleged that the disclosure of “Vanilla Flavor With Other Natural Flavors” in the soy milk’s ingredient list indicated that the product contained non-vanilla flavor and that this non-vanilla flavor contained vanillin.  The plaintiffs also 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.
  • A November 23, 2020 memorandum filed in support of The Hain Celestial Group’s motion to dismiss, (subscription to Law360 required), characterizes the plaintiffs’ case as one of “over 91 other lawsuits their counsel have filed against producers of vanilla-containing products” and asserts they are attempting to “hold-up” food companies for expensive settlements based on what “they believe is a technical violation of FDA flavoring regulations.”  In addition to arguing that the plaintiffs’ false advertising claims are preempted to the extent they assert that the product labeling does not comply with the Federal Food, Drug, and Cosmetic Act’s (FDCA) food labeling requirements and is, therefore, automatically deceptive, the defendant’s memorandum directly attacks the plaintiffs’ conclusion that “vanilla” in the product name violates FDA’s food labeling regulations, arguing that under FDA’s regulations, the statement of identity in the product’s name is “Soymilk” and “Vanilla” is a flavor designation, not subject to the standards of identity cited by the plaintiffs.
  • It is yet to be seen whether the New York federal court hearing this case will reach the issue of whether the soy milk labeling complies with the FDCA and FDA’s characterizing flavor regulations.  FDA has not issued any warning letters that would clarify the matter of product labeling involving vanilla.  Keller & Heckman will continue to monitor and provide updates regarding vanilla products and other class-action litigation in the food industry.
  • 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.