Search results for: milk

  • On October 11, 2024, Costco issued a recall for nearly 80,000 pounds of its Kirkland Signature butter due to a labeling oversight.  Milk, classified as one of the nine major allergens that the U.S. Food and Drug Administration (FDA) requires to be declared on product packaging, was not included on the ingredient list.  The recall included 46,800 pounds of Kirkland Signature Unsalted Sweet Cream Butter and 32,400 pounds of  Kirkland Signature Salted Sweet Cream Butter.
  • The Food Allergen Labeling and Consumer Protection Act of 20024 (FALCPA) identified eight foods as major allergens: milk, eggs, fish, crustacean, shellfish, tree nuts, peanuts, wheat, and soybeans.  The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 added sesame as the ninth major food allergen.  These laws require all food labels to identify the source names of all major food allergens.
  • The recall has gained attention across social media platforms with consumers commenting that it should be obvious that butter contains milk.  However, the purpose of allergen labeling is to help consumers with allergies avoid consuming products with hidden allergens. For those with Milk allergies, consuming products with undeclared milk ingredients can lead to serious health risks, including allergic reactions that may require medical attention. 
  • Consequently, on November 7, 2024, FDA classified the recall as a Class II recall, indicating that the product may cause temporary or medically reversible adverse health consequences.
  • Social media commentary aside, adhering to allergen labeling requirements is critical in ensuring consumer and product safety.
  • Keller and Heckman will continue to monitor and report any significant recalls.
  • On September 17, 2024, the U.S. Food and Drug Administration (FDA) released results from retail sampling of dark chocolate and chocolate-containing products labeled as “dairy free” that were collected and tested for unintended milk in 2022 and 2023.  FDA worked in cooperation with the Pennsylvania Department of Agriculture (PDA) and the Michigan State Department of Agriculture and Rural Development (MDARD).  The sampling and testing was conducted to determine whether these products may contain unintended milk at levels that may be hazardous to people with milk allergy.
  • Unlike FDA’s earlier assessment (FY 2018-2019), which focused on chocolate bars and chocolate chips, this recent effort included tested for milk in additional chocolate-containing products, such as chocolate chip cookies, chocolate syrups, and chocolate baking powders that were labeled as “dairy free.”
  • Thirteen of the 210 samples collected by PDA and MDARD tested positive for milk.  Twelve of these 13 samples contained less than 80 parts per million (ppm) of milk, with one sample testing at 1,083 ppm.  Additionally, the 13 products found to contain milk had labeling with milk allergen advisory statements (e.g., “…made in a facility that also processes milk.”
  • The 13 samples at issue were made by three different manufacturing firms.  In response to the findings, two manufacturers removed the “dairy-free” claim from their chocolate products.  The third manufacturer agreed to remove the “dairy-free” claim from its products if the cause of the presence of milk could not be determined and eliminated pending completion of a root cause analysis.
  • Last month, the U.S. Food and Drug Administration released the findings of a groundbreaking study confirming that pasteurization is effective in killing the bird flu virus in milk and other dairy products.  The study was conducted as part of ongoing efforts to ensure the safety of milk amid growing concerns about the expanding outbreak of H5N1 Highly Pathogenic Avian Influenza (HPAI).
  • The study simulated, for the first time, the exact time and temperature used in commercial milk pasteurization and demonstrated that conditions for pasteurization widely used by producers effectively inactivated the HPAI virus, even in raw milk samples that contained higher than usual concentrations of the virus.  In all 297 samples of milk and dairy products collected for the study, HPAI was inactivated after pasteurization.
  • Currently, federal law states that all milk and milk products in final package form intended for direct human consumption must be pasteurized, though there has been recent state action that would allow unpasteurized milk in the marketplace.  As we previously reported, Michigan (HB 5603) and West Virginia (HB 4911) have proposed allowing the sale of unpasteurized, raw milk within their respective states.  Delaware has also passed legislation (SB 273), since our last reporting, that would legalize the sale of unpasteurized, unprocessed milk directly from dairy producers to consumers.
  • Keller and Heckman will continue to monitor and relay any industry developments.
  • 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.