This update includes FDA and USDA updates, FDA warning letters, lawsuits, and other articles of interest, including exemptions from food traceability requirements, regulating genetically edited meat, an update on avian flu in the raw milk industry, and more.
FDA Updates
Sufficient Lab Capacity Reached for Import-Related Food Testing under LAAF Program
June 3: As described in our May 2024 update, the FDA determined that there is sufficient laboratory capacity in the Laboratory Accreditation for Analyses of Foods (LAAF) program for the import-related food testing for mycotoxins. Importers must use accredited labs for mycotoxin food testing starting December 1, 2024. As the program expands capacity for other analytes, they will be listed on the LAAF Dashboard with the compliance date set at six months from the date a specific analyte is posted on the Dashboard. More information can be found here.
FDA Collecting Information on Record Retention Requirements for Soy Protein and Reduced Risk of Coronary Heart Disease Health Claim
June 6: FDA announced a proposed collection of information pertaining to record retention requirements for the soy protein and reduced risk of coronary heart disease (CHD) claim. This information collection enables FDA to review food labeling ingredient information to determine the basis of soy protein/CHD health claims. Respondents are required to retain records for inspection regarding calculation of the ratio of soy protein to total protein in a food when that food bears a soy protein/CHD health claim. Written comments are due July 8, 2024. More information can be found here.
FDA Collecting Information on Irradiation in Production, Processing and Handling of Food
June 7: FDA announced a proposed collection of information pertaining to irradiation in the production, processing, and handling of food. Respondents to the information collection are businesses engaged in the irradiation of food. Written comments must be submitted by July 8, 2024. More information can be found here.
FDA Co-Sponsors Report on the Role of Seafood Consumption in Child Development
June 11: The FDA commissioned a study to help provide the agency with the most recent information on seafood and child development. The National Academies of Sciences, Engineering, and Medicine (NASEM) published a final report, The Role of Seafood in Child Growth and Development, that was co-sponsored by the FDA. The report concluded that there is not enough evidence to suggest a need to revise the amounts of seafood recommended in the Dietary Guidelines for Americans. Furthermore, there is not enough evidence to assess the impact of exposure to contaminants from seafood other than mercury. The report recommends that the FDA monitor the evidence as well as methodologies for integrating and assessing both risks and benefits from seafood on child developmental outcomes. More information can be found here.
FDA Proposes to Exempt Grade “A” Cottage Cheese from Food Traceability Requirements
June 14: The FDA issued a proposed exemption for certain cottage cheese products from the Food Traceability Rule requirements that are regulated under the Grade “A” Pasteurized Milk Ordinance. The proposed exemption would apply to all Grade “A” cottage cheese products that appear on the Interstate Milk Shippers List. The deadline for submitting written comments on the proposed exemption is September 16, 2024. More information can be found here and the proposed rule can be found here.
FDA Official Expresses Frustration Over Persistent Kratom Market Despite Federal Stance
June 28: The director of the FDA’s Office of Dietary Supplement Programs expressed frustration at the continued presence of kratom products in the U.S. market despite the FDA’s clear stance against them. The FDA reaffirmed its position that kratom is not lawfully marketed in the U.S. as a drug product, dietary supplement, or food additive in conventional food. Despite FDA efforts, kratom, a substance sourced from a Southeast Asian tree and used by millions in the U.S., remains available. The FDA considers kratom a new dietary ingredient (NDI) for which there is inadequate information to ensure it does not pose a significant or unreasonable risk of illness or injury. The American Kratom Association disputes the FDA’s assertions, claiming safe use of kratom by over 15 million Americans and accusing the FDA of bias against dietary supplements. Eleven states have passed Kratom Consumer Protection Acts, contrary to the FDA’s position. More information can be found here.
FDA Warning Letters
Bimbo Bakery Mislabeled Bakery Products: The FDA issued a warning to Bimbo Bakeries USA for mislabeling bakery products with allergens not included in the formulation. The warning letter was prompted by findings during two inspections at Phoenix and Topeka facilities in late 2023 where certain bakery products from Bimbo Bakeries included ingredients that are or contain major food allergens on their labels, but those ingredients were not actually present in the product formulations. Several ready-to-eat (RTE) bread products incorrectly labeled allergens such as sesame, walnuts, almonds, and hazelnuts. More information can be found here.
Adulterated Food: The FDA issued a warning letter to Dollar Tree Inc. for the receipt and sale of adulterated WanaBana Apple Cinnamon Fruit Puree pouches. Since October 2023, the FDA has investigated high lead levels in WanaBana Apple Cinnamon Fruit Puree pouches that were linked to several cases of elevated blood lead levels in children. Lab tests confirmed extremely high concentrations of lead, leading to a voluntary recall by Wanabana USA. The FDA alleged that Dollar Tree stores continued to sell the recalled products which is a violation of the Federal Food, Drug, and Cosmetic Act. Although Dollar Tree took steps to address the issue, the FDA found these measures inadequate and continued finding the product on shelves through December, expressing concerns over Dollar Tree’s long-term corrective actions.
A database of warning letters can be found here.
USDA Updates
USDA Proposes Measures to Improve Poultry Markets and Protect Growers
June 3: The U.S. Department of Agriculture (USDA) has proposed new steps to create fairer markets for poultry growers and farmers. These actions seek to address competition issues, enhance transparency, and protect producers. The proposed rule Poultry Grower Payment Systems and Capital Improvement Systems targets abuses related to payment systems and capital investment requirements for broiler chicken contract growers. USDA is also introducing publicly available cattle market transparency tools. These efforts align with President Biden’s commitment to promote competition in the American economy. More information can be found here.
Other Articles of Interest
FDA Takes Lead in Regulating Genetically Edited Meat
June 4: The FDA announced that it will lead the regulatory process for bringing gene-edited meat to market. Gene editing, often referred to as CRISPR, allows researchers to modify specific genes in an animal’s genome, seeking to improve health, productivity, and nutritional benefits. Unlike genetic modification, which involves inserting foreign DNA, gene editing works within a species’ own DNA. Last year, the FDA authorized pork from gene-edited pigs for human consumption, emphasizing that the edits did not involve foreign DNA but were changes that could naturally occur. This move reflects the agency’s commitment to keeping regulatory approaches aligned with scientific advancements. More information can be found here.
FDA Issues Safety Alert for Potentially Contaminated Shellfish from Oregon and Washington
June 5: The FDA issued a safety alert advising restaurants and retailers not to serve or sell, and consumers not to eat, certain shellfish from Oregon and Washington harvested between 5/26/2024 and 5/30/2024 because they may be contaminated with the toxins that cause paralytic shellfish poisoning. The safety alert can be found here.
FDA Releases Findings from Southwest Agricultural Region Environmental Microbiology Study
June 5: The FDA released preliminary findings from an environmental study in the Southwest agricultural region, conducted with several partners, to understand how human pathogens such as E. coli survive, move, and potentially contaminate produce prior to harvest. The 5-year study, initiated after the 2018 outbreak of E. coli linked to leafy greens, collected environmental samples across a 54-mile area to observe pathogen variability. The study confirmed that pathogens, including the E. coli pathogen, can survive in air and be distributed via dust to the environment. More information can be found here.
FDA Urges Increased Testing and Restrictions Amid Bird Flu Outbreak in Raw Milk
June 11: The FDA urged states to increase testing and restrictions on potentially infectious raw milk sold to consumers within their borders. However, officials in Wyoming and Iowa, where laws limit state oversight of raw milk, have stated that their hands are tied. While raw milk is already prohibited from being sold across state lines, some states allow its sale within their borders. The FDA recommends implementing surveillance programs to test for the H5N1 virus on dairy farms selling raw milk. The FDA continues to emphasize that pasteurized milk remains safe to consume. More information can be found here.
Biden-Harris Administration Announce National Strategy to Reduce Food Loss and Waste
June 12: The Biden-Harris Administration released the National Strategy for Reducing Food Loss and Waste and Recycling Organics which lays out a path for the United States to meet its national goal of reducing food loss and waste by 50% by 2030. The FDA, USDA and EPA will collaborate to prevent food loss and waste, increase the recycling rate for all organic waste, and support policies that incentivize and encourage the prevention of food loss and waste and organics recycling. More information can be found here.
Sunscreen Ingredient Found in Frozen Pizza and Other Foods Raise Concerns
June 14: Titanium dioxide, an ingredient in sunscreen, is also used in foods such as pizza, salsa, and frosting to brighten colors in food and make it look more appealing. Titanium dioxide is most prevalent in candy, coffee creamers and frosted or powdered baked goods. It is also found in chewing gums and mints. There is growing concern about the potential health risks of eating titanium dioxide. Some research, done mainly on animals, suggests that eating titanium dioxide might be linked to immune system problems, inflammation and DNA damage that could lead to cancer. New research in people has found a link between titanium dioxide consumption and inflammation in the gut. However, the science is not conclusive as some studies have not shown negative health effects. The European Union has banned titanium dioxide in food since 2022. Some public-health advocacy groups have petitioned the U.S. Food and Drug Administration to not allow titanium dioxide to be used in foods. And some food companies are removing titanium dioxide from products. More information can be found here.
FDA Grant Available to Establish Animal and Veterinary Innovation Centers
June 25: The FDA announced a grant opportunity for cooperative agreements with academic research institutions to establish Animal and Veterinary Innovation Centers that would encourage development of innovative products to better support animal health and veterinary interventions, including those that prevent, control, or eliminate Highly Pathogenic Avian Influenza virus (bird flu) in animals, or interventions that reduce the circulation of the virus in the ecosystem. More information can be found here.
USDA Proposes Rule for Fair Livestock and Poultry Markets
June 28: The USDA proposed a new rule called Fair and Competitive Livestock and Poultry Markets to establish fairer, more competitive, and more resilient meat and poultry supply chains. This initiative is a part of the Biden-Harris Administration’s efforts to lower food costs and support farmers by addressing issues of unfairness and competitive injury in the livestock, meat, and poultry sectors. The proposed rule clarifies enforcement of prohibitions on unfair practices under the Packers and Stockyards Act, intending to protect farmers, ranchers, and market participants. It defines clearer frameworks for identifying harmful market practices to ensure that livestock producers and poultry growers receive full value for their products. Comments on the proposed rule are due August 27, 2024. A copy of the proposed rule and fact sheet can be found here. More information can be found here.
FDA Updates Priority Guidance Topics for Foods Program
June 28: The FDA released an updated list of priority draft and final guidance topics for the FDA Foods Program for completion in 2024. New topics include dietary supplement master files, procedures and timeframes for New Dietary Ingredient Notification, foods derived from genome-edited plants, and more. An updated list of guidance documents under development are listed at the Foods Program Guidance Under Development webpage. Public comments on the list of human food and cosmetic guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to https://www.regulations.gov/, using Docket FDA-2022-D-2088. More information can be found here.
FDA and Wisconsin Warn Consumers to Avoid Diamond Shruumz Products
June 28: The FDA, as well as the Wisconsin Department of Health Services, issued an advisory warning consumers and retailers to not eat, sell, or serve any flavor of Diamond Shruumz- Brand Chocolate Bars, Cones, and Gummies. The FDA, along with the CDC, America’s Poison Centers and state and local partners, are investigating a series of illnesses associated with eating Diamond Shruumz-brand Chocolate Bars, Cones, and Gummies. People who became ill from Diamond Shruumz-brand edibles reported a variety of severe symptoms including seizures, loss of consciousness, confusion, sleepiness, abnormal heart rates, high or low blood pressure, nausea, and vomiting. As of June 25, there have been a total of 39 illnesses reported in 20 states, with half leading to hospitalization. No illnesses have been reported in Wisconsin and no deaths have been reported. The FDA is working to determine the cause of these illnesses and the investigation is ongoing. More information can be found here.
Lawsuits
Judge Recommends Throwing Out Target Pomegranate Water Enhancer False-Advertising Suit
June 7: A magistrate judge for the US District Court for the Middle District of Florida recommended that a proposed class action lawsuit, Broodie v. Target Corp., be dismissed. The suit alleged that Target falsely advertised its Market Pantry-brand berry pomegranate flavored water enhancer as containing only natural flavors when it actually contains DL-malic acid, a synthetic flavoring. The plaintiff argued that this misrepresentation could deceive consumers who seek products without chemical additives. However, the court found that the plaintiff lacked standing to sue due to overly conclusory overpayment allegations. Additionally, the complaint was considered a “shotgun pleading” because the allegations were not properly incorporated into the plaintiff’s claims. As a result, the magistrate judge recommended dismissing the suit without prejudice and without leave to amend.
Coca-Cola Temporarily Prevails in False Ad Lawsuit Over PFAS in Simply Orange Juice
June 10: Coca-Cola temporarily defeated a proposed false advertising class action lawsuit alleging its Simply Tropical fruit juice contains PFAS. The Simply Orange lawsuit centers around allegations that The Coca-Cola Company and its subsidiary, The Simply Orange Juice Company, falsely marketed their Simply Tropical fruit juice as containing only natural ingredients. The lawsuit claims that the juice contained per- and polyfluoroalkyl substances (PFAS). The PFAS chemicals were not disclosed on the juice’s label, which promised a natural and organic product. A judge for the U.S. District Court for the Southern District of New York dismissed the class action, citing the lack of a strong connection between the testing results and the plaintiff’s actual juice purchase. While the case is not over, this ruling provides a temporary victory for Coca-Cola. Despite this dismissal, the Judge granted the Plaintiff leave to amend the complaint to address the deficiencies in standing. More information can be found here.
Judge Rules in Favor of Kroger Co. Over Cold-Pressed Avocado Oil Mislabeling Lawsuit
June 24: A federal judge for the US District Court for the Central District of California ruled that a lawsuit alleging that Kroger Co. mislabeled its Cold-Pressed Avocado Oil lacked factual evidence showing the product was adulterated or that the product was advertised as “pure”. Although the plaintiff in the case, McConnon v. Kroger Co., presented third-party lab tests indicating the oil’s composition differed from “pure” avocado oil, the product’s label did not actually use the word “pure.” The judge pointed out that the label only mentioned “avocado oil” without specifying purity. The plaintiff also failed to clarify what “pure” meant—whether it implied exclusivity of avocados as the ingredient, absence of impurities, or lack of other oils. Due to the ambiguity in defining “pure” and insufficient details in the allegations, the claims under California consumer protection laws, breach of warranty, and misrepresentation were dismissed.
Plant Based Foods Association Lacks Standing to Challenge Oklahoma Meat Labeling Law
June 25: A federal judge for the US District Court for the Western District Oklahoma ruled that the Plant Based Foods Association (PBFA), along with Tofurky Co., lacks standing to contest an Oklahoma statute that prevents the mislabeling of products as meat unless they come from livestock. The court found that the members of the PBFA did not face any real risk of legal action under the Oklahoma Meat Consumer Protection Act since the law targets meat sellers. The PBFA contended that the law, established in 2020, was influenced by the cattle industry’s preferences in response to the growing market for plant-based products, and asserted that consumers are not confused by plant-based meat labels. Both the PBFA and Tofurky Co. sought to have the court reinterpret the law according to their interpretations. However, the judge said that judicial amendment of the statute would be inappropriate. The court’s view was that the statute’s goal is to ensure consumers are well informed and to protect traditional meat producers from decisions by uninformed buyers. The suit, Plant Based Foods Ass’n v. Stitt, was dismissed.
Ice Cream Manufacturer Sued Over Recalled Listeria-Contaminated Products
June 27: Totally Cool Inc. is facing a proposed class action lawsuit after voluntarily recalling over 60 ice cream products due to the risk of Listeria monocytogenes contamination. The lawsuit, filed in the Southern District of New York, accuses the company of deceptive marketing for not disclosing the potential presence of the harmful bacteria on their product packaging. The recall includes items from brands like Friendly’s, Hershey’s, Jeni’s, and Dolcezza Gelato. The complaint asserts that consumers depend on the manufacturer to be transparent about their products’ contents, and criticizes the recall process as being insufficient, arguing that it’s unlikely to reach or compensate many affected consumers. Customers are required to return the recalled items to the original point of purchase for a refund, which the plaintiff contends is impractical as many would have disposed of the products upon learning of the recall. More information can be found here.
This Regulatory Update covers information from June 2024.
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