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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. 

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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.

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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.

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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.

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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.
Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for
additional information on regulatory issues that
may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.

This update includes FDA and USDA updates, FDA warning letters, lawsuits, and other articles of interest, including funding to combat avian flu in the dairy industry, a ruling on “all natural” labeling, and the FDA’s determination on the GRAS status of tara flour.

FDA Updates

FDA Issues Final Rule to Modify Agricultural Water Provisions of the Produce Safety Regulation
May 6:  FDA issued a final rule updating pre-harvest agricultural water provisions for covered produce, excluding sprouts, under Subpart E of the FDA Food Safety Modernization Act Produce Safety Rule. The new rule replaces the previous pre-harvest water microbial quality criteria and testing requirements for covered produce (other than sprouts) with requirements for systems-based, pre-harvest agricultural water assessments for hazard identification and risk management decision-making purposes.  The updated regulation will better address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.  The rule becomes effective July 5, 2024. More information can be found here.

FDA Says Tara Flour is an Unapproved Food Additive
May 15:  FDA determined that tara flour in human food does not meet the Generally Recognized As Safe (or GRAS) standard and is an unapproved food additive. The FDA’s evaluation revealed that there is not enough data on the use of tara flour in food, or a history of its safe use, to consider it GRAS. In addition, there is no food additive regulation authorizing the use of tara flour in food. The FDA issued a memo detailing its assessment of the ingredient. More information can be found here.

FDA Extends Comment Period for Color Additive Certification Services Fees
May 28:  The FDA is extending the comment period for the reopening notice entitled “Color Additive Certification; Increase in Fees for Certification Services.”  The deadline for submitting comments is June 27, 2024.  More information can be found here.

Renewed U.S. Interagency Collaboration Aims to Cut Food Waste
May 30:  The FDA has renewed its commitment to the Federal Interagency Collaboration to Reduce Food Loss and Waste (FIFLAW) along with the USDA and EPA. The U.S. Agency for International Development (USAID) also joined the collaboration. The agencies want to reduce food loss and waste in half by 2030 and encourage consumers and retailers to utilize resources provided by the FDA to help reach this goal. Collaborative efforts include education, outreach, research, community investments, voluntary programs, technical assistance, policy discourse, and public-private partnerships. The participation of USAID is expected to improve international stakeholder engagement and optimize the use of government resources.  More information can be found here.

FDA’s Reorganization Approved for Unified Human Foods Program
May 30:  The FDA is undergoing a reorganization which includes the establishment of the Human Foods Program, a new model for field operations, and other modernizations, with implementation targeted for October 1, 2024. The restructuring seeks to make the FDA more efficient and responsive to changes in industry, technology, and global factors like climate change. According to FDA, the new Human Foods Program will strengthen the FDA’s preventative measures, enhance nutrition importance, improve partnerships, and better manage innovative food products and agricultural technology.  The FDA states that it will be better positioned to uphold the safety of the nation’s food supply, and respond to food-related emergencies, such as the 2022 infant formula shortages.  The reorganization includes realigning functions from existing food safety and regulatory offices under one program and renaming the Office of Regulatory Affairs to the Office of Inspections and Investigations to reflect its role in inspections, investigations, and product safety assurance.  More information can be found here.

FDA Extends Comment Period for Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food
May 31:  The FDA is extending the comment period for a revised draft Introduction, and a revised draft Appendix 1, within a guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food” by an additional 60 days.  Comments must be submitted by August 2, 2024.  More information can be found here.

FDA Achieves Lab Capacity for Mycotoxin Testing under LAAF Program
May 31:  The FDA announced that sufficient laboratory capacity has been reached for mycotoxins testing in foods related to imports under the Laboratory Accreditation for Analyses of Foods (LAAF) program.  The FDA’s LAAF program was created to enhance food testing standards and procedures. 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 onto the Dashboard.  More information can be found here.

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FDA Warning Letters

Misbranded Food: FDA issued a warning letter to California Bread Company alleging that its Egg Bread product is adulterated because it contains a color additive which is unsafe.  FDA also alleged significant violations of the labeling regulations for foods and significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

Misbranded Cookie Dough: FDA issued a warning letter to Cookies and Milk LLC alleging that its ready-to-eat Peanut Butter Cup Edible Cookie is misbranded in that the product labels did not declare a peanut allergen and it failed to declare all the common or usual names of each ingredient used.

Low Acid Canned Food: FDA issued a warning letter to two foreign companies alleging violations of the Emergency Permit Control regulation and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation.  The violations also render the LACF products adulterated.

Adulterated Dietary Supplements: The FDA issued a warning letter to Carbon Fire, LLC involving its 213° Metabolism Boosting Complex, which is labeled as a dietary supplement.  The FDA alleged the product is an adulterated dietary supplement because it contains a new dietary ingredient under the federal Food, Drug, and Cosmetic Act.

A database of warning letters can be found here.

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USDA Updates

FSIS Classifies NRTE Breaded Stuffed Chicken Products with Salmonella Over 1 CFU/g as Adulterated
May 1: The Food Safety and Inspection Service (FSIS) announced a final determination that not ready-to-eat (NRTE) breaded stuffed chicken products, which have Salmonella levels of 1 Colony Forming Unit per gram (1 CFU/g) or above, are considered adulterated under the Poultry Products Inspection Act (PPIA). Additionally, FSIS plans to implement verification procedures that include sampling and testing the raw chicken ingredients used in these NRTE breaded stuffed chicken products before they are stuffed and breaded.  The final determination will be effective May 1, 2025.  More information can be found here.

FSIS Announces Adjusted Dollar Limitations for Retail Exemptions
May 17:  The FSIS announced the dollar limitations on the amount of meat and poultry that a retail store can sell to hotels, restaurants, and similar institutions without disqualifying itself for exemption from federal inspection requirements. In accordance with FSIS regulations, for calendar year 2024, the value for the retail dollar limitation for meat and meat products (including Siluriformes) is $100,900, and the value for the retail dollar limitation for poultry and poultry products is $74,200. These dollar limitations will be effective on June 17, 2024.  More information can be found here.

FSIS Updates Guidance on Donations of Meat, Poultry and Egg Products to Non-Profits
May 23:  The FSIS has updated its Guideline to Assist with the Donation of Eligible Meat and Poultry Products to Non-Profit Organization.  The guideline addresses food donation questions from meat and poultry establishments and non-profit organizations and explains inspection, labeling, shipping requirements, and exemptions.  More information can be found here.

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Other Articles of Interest

Joint USDA, FDA and HHS Funding Announced to Fight Avian Flu in Dairy Industry
May 13:  The USDA, FDA and HHS are coordinating efforts to combat the spread of Avian Flu (H5N1) and provide financial support for lost milk production.  The USDA is providing financial support and assistance to improve biosecurity and mitigate spread among humans and animals. They are offering up to $2,000 per month for personal protective equipment (PPE) and worker studies, $1,500 for biosecurity plans, $2,000 for waste milk heat treatment, reimbursement for veterinary costs up to $10,000, and covering shipping costs for testing. There is also funding available for producers with milk production loss and state partnership for movement restrictions.  The HHS is investing $101 million through the CDC and FDA for testing, surveillance, and treatment. A $3 million wastewater pilot is also being launched. FDA announced an additional $8 million to help with pasteurization criteria validation, surveillance, lab capacity, biosecurity training, partner activities, and research collaborations.  More information can be found here.

U.S. Justice Department Proposes Regulation to Reschedule Marijuana
May 16:  The Justice Department announced a proposal to consider reclassifying marijuana as a Schedule III drug under the Controlled Substances Act, initiating a review process requested by President Biden. Marijuana has been listed as a Schedule I substance since 1970 but following scientific review by Health and Human Services and legal advice from the Office of Legal Counsel (OLC), the Attorney General is using his authority to potentially change its classification. The formal rulemaking process involves public notice, commentary, and a hearing. Until a final ruling, marijuana continues to be treated as a Schedule I drug.  More information can be found here, along with a copy of the notice of proposed rulemaking and the OLC memorandum.

Update on USDA H5N1 Beef Safety Studies
May 24:  The FSIS conducted tests on beef tissue from 96 cull dairy cows condemned at select FSIS-inspected facilities. Meat from condemned cows is prohibited from entering the food supply. On May 22, 2024, viral particles were detected in tissue samples, including muscle, from one cow.  To date, samples from 95 cows have tested negative for viral particles.  No meat from these dairy cattle entered the food supply and USDA is confident that the meat supply is safe.  More information can be found here.

FDA Proposes to Ban Brominated Vegetable Oil
May 24:  In November 2023, the FDA proposed a new rule to ban the use of brominated vegetable oil (BVO) in food. BVO is commonly used as an emulsifier and stabilizing agent in citrus sodas and other beverages. However, studies have shown adverse health effects in animals, leading the FDA to reconsider its safety.  BVO is a vegetable oil modified with bromine, and its use has been linked to thyroid and heart problems. BVO will be banned in California in 2027.  Japan, India, and parts of Europe have previously banned BVO in drinks and food products.  More information can be found here.

USDA Allocates $824 Million to Protect Livestock Health Amid H5N1 Concerns
May 30:  The USDA announced $824 million in new funding to protect livestock health to bolster efforts in response to the detection of the H5N1 virus in dairy cattle. Additionally, USDA is launching a Voluntary H5N1 Dairy Herd Status Pilot Program, which provides dairy producers with more options to monitor herd health and move cows efficiently while expanding understanding of the disease. The emergency funding will support rapid response activities, diagnostics, field response, and food safety studies, among other critical efforts. More information can be found here.

Federal Government on Course to Update Dietary Guidelines for Americans
May 31:  The 2025 Dietary Guidelines Advisory Committee is on schedule with the federal government’s five-year mandated timetable for another version of the Dietary Guidelines for Americans. The Committee is a collaborative effort between the U.S. Departments of Health and Human Services (HHS) and USDA and is made up of 20 members, drawn mostly from academic backgrounds.  Having completed the fifth of five scheduled work sessions, it is still unclear what recommendations the 2025 Dietary Guidelines for Americans will contain. Wine could be at risk of being eliminated as the World Health Organization pushes for prohibition. Potatoes appear safe, while lactose illnesses in certain minority populations have dairy under scrutiny. The USDA and HHS are jointly responsible for updating the guidelines.  More information can be found here.

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Lawsuits

U.S. Court of Appeals Rules in Favor of Kind Over ‘All Natural’ Labeling
May 1:   The U.S. Court of Appeals Second Circuit affirmed a summary judgment for Kind LLC against a group of buyers who claimed the company misled consumers by labeling products as “all natural”.  The Court said that the plaintiffs failed to establish through evidence how a reasonable buyer would understand the term.  The Court’s opinion closes out litigation that was launched in 2015 after the FDA issued a warning letter that Kind’s “healthy and tasty” packages constituted an implied nutrient content subject to federal regulations and that the products did not meet FDA’s saturated fat content requirements to describe food as healthy. A copy of the Court’s opinion can be found here.

Sports Drink Company Accused of Mislabeling Caffeine
May 9:   A proposed class action was filed against Prime Hydration LLC, a sports drink company founded by YouTubers Logan Paul and KSI, alleging that the company practices false and deceptive advertising by understating the caffeine in its energy drinks.  According to the complaint filed in the US District Court for the Southern District of New York, beverages in the Prime Energy line are advertised to contain 200 mg of caffeine but contain substantially more than that.  Prime’s audience includes a large share of adolescents. A copy of the complaint can be found here.

Publix ‘Naturally Flavored’ Cereal Bars Lawsuit Dismissed
May 23:   A federal judge for the U.S. District Court for the Middle District of Florida dismissed a proposed class action against Publix Super Markets Inc.  that alleged its apple and strawberry flavored cereal bars were deceptively advertised as “naturally flavored” when they contained DL-malic acid.  The judge said that none of the packaging labels state that the bars lack artificial flavor or that the bars include only flavor from a ‘natural’ strawberry or apple.  More information can be found here.

Bai WonderWater Maker Faces False Advertising Lawsuit over Artificial Sweetener
May 24:    A new proposed class action was filed in the US District Court for the Southern District of New York alleging that Bai Brands LLC deceptively advertised its flavored waters as free from artificial sweeteners despite containing artificial sugar replacements such as stevia leaf extract, erythritol, or monk fruit extract.  The consumers brought claims for deceptive trade practices and misrepresentation arguing that even though each of the alleged sweeteners comes from a plant, they undergo extensive industrial processing before being used as a sugar substitute and therefore are not natural. 

Barilla Italian Pasta Label Suit Gets Class Certified
May 29:    A federal judge for the U.S. District Court for the Northern District of California granted class certification to consumers alleging Barilla America Inc. deceived them into believing some of their pastas were made and sourced in Italy, because of packaging labels that said, “Italy’s #1 Brand of Pasta.”  The Consumers sued Barilla in 2022 over the Italy statement as being deceptive because the pastas are made in Iowa and New York.  The judge previously denied Barilla’s motion to dismiss the class action lawsuit, ruling that the plaintiffs had standing to sue the company.  More information can be found here.

This Regulatory Update covers information from May 2024. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.

This update includes FDA and USDA updates, FDA warning letters, lawsuits, and other articles of interest, including an update on the safety of the country’s commercial milk supply, reports of adulterated and misbranded food, and new technology to help Prepare for FDA’s traceability rule.

FDA Updates

FDA Collecting Information on Food Calorie and Nutritional Labeling Requirements
April 11: FDA announced a proposed collection of information pertaining to calorie labeling of food items in vending machines and nutrition labeling of standard menu items in restaurants and similar retail food establishments. This information collection supports statutory and regulatory requirements that govern food labeling, and information collection recommendations discussed in associated Agency guidance. Respondents to the collection of information are manufacturers, packers, and distributors of food products, as well as certain food retailers such as supermarkets, vending machine operators and restaurants, subject to food labeling requirements. Comments on this information collection are due May 13, 2024. More information can be found here.

FDA Announces Information Collection for Food Allergen Labeling and Reporting
April 11: FDA announced a proposed collection of information to ensure accurate labeling of ingredients derived from major food allergens. Respondents to this information collection are manufacturers and packers of packaged foods sold in the U.S. subject to the labeling requirements and prohibitions found in section 403 of the federal Food, Drug, and Cosmetic Act. Comments on this information collection are due May 13, 2024. More information can be found here.

FDA Releases Draft Guidance on NDIN Master Files for Dietary Supplements
April 4: The FDA issued a draft guidance document to help industry comply more easily with the new dietary ingredient notification (NDIN) requirement by providing recommendations on the submission and use of Master Files which contain identity, manufacturing, or safety data that can be used to support a NDIN. New dietary ingredient Master Files are submitted solely at the discretion of the Master File owner and are not required by statute or regulation. Written comments on the draft guidance are due by June 3, 2024. More information, as well as a link to the draft guidance document can be found here.

Update on FDA PFAS Investigation in Food Supply Reveals Low Dietary Risk
April 18: The FDA released an update that outlines its recent activities and approach to managing PFAS-related risks. The FDA has been testing exposure to PFAS substances in the general food supply since 2019. To date, the FDA tested nearly 1,300 samples from a wide range of foods, as part of the Total Diet Study (TDS), to assess dietary exposure to PFAS. Recent test results reveal that out of 95 samples from a regional TDS collection, PFAS was detected in 8 beef and seafood samples. Overall, the rate of detection has been low, with PFAS found in less than 3% of TDS samples tested so far. The FDA concluded that the PFAS levels detected are not likely to be a health concern for either young children or the broader population. More information can be found here.

FDA Reports Improvement in Honey Adulteration Rates Following Recent Import Tests
April 8: The FDA released data from a sampling assignment carried out in 20223 and 2023 to test imported honey for adulteration aimed at economic gain. FDA sampled imported honey for the presence of cheaper sweeteners not declared on the label, a practice known as economically motivated adulteration (EMA). Out of 107 honey samples, 3% were found to be non-compliant. This is a decrease from the previous year’s violation rate. When violations were detected, the FDA denied entry of the products into the U.S. and placed the associated company and product on Import Alert. More information can be found here.

FDA Finalizes Guidance on Veterinary Feed Directive
April 29: The FDA announced that is has finalized Guidance for Industry (GFI) #120: Veterinary Feed Directive Regulation Questions and Answers, to provide guidance to industry on the requirements of the veterinary feed regulations (i.e., the Veterinary Feed Directive (VFD) final rule). The VFD final rule outlines the process for authorizing the use of approved animal drugs intended for use in or on the feed of food-producing animals that require veterinary oversight, including medically important antimicrobials when needed for specific animal health purposes. This final guidance also serves as a Small Entity Compliance Guide to aid industry in complying with the requirements of the VFD final rule. More information can be found here.

FDA Releases Guidance on Revocation of Partially Hydrogenated Oils in Foods
April 29: The FDA announced the availability of a guidance for industry entitled “Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide”. The compliance guide is intended to help small entities comply with FDA regulations after the FDA revoked specific requirements pertaining to the use of partially hydrogenated oils in certain foods or as a direct or indirect food substance. More information can be found here.

FDA Files Food Additive Petition from Environmental Defense Fund, et al.
April 26: The FDA announced that it filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove fluorinated polyethylene. The petitioners state that the fluorinated polyethylene manufactured consistent with § 177.1615 can produce polymeric per- and poly-fluorinated alkyl substances that can migrate to food and are not safe pursuant to section 409(c)(5) of the Food Drug &Cosmetic Act. The FDA is seeking comments, additional scientific data, and other information related to the issues raised by this petition. Comments must be submitted by June 25, 2024. More information can be found here.

FDA Considering Warning Labels on Foods
April 30: The FDA is considering requiring food manufacturers to put new labels on the front of packages to flag certain health risks, such as high levels of salt, sugar or saturated fat. It may be some time before such labels appear in stores, as the FDA is still determining the best approach. However, the food industry disputes the effectiveness of such labels in altering consumer behavior and argues that some proposed label designs are confusing. More information can be found here.

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FDA Warning Letters

Misbranded Food: FDA issued a warning letter to Lipari Foods Operating Company alleging that its walnuts, filberts, and cashews labels did not declare a major food allergen.

Adulterated Seafood: Upon inspection of Euro USA’s seafood processing facility, FDA issued a warning letter for violations of the seafood Hazard Analysis and Critical Control Point regulation involving packaging products under insanitary conditions.

Imported Food: FDA issued warning letters to two California companies for failure to develop, maintain and follow a Foreign Supplier Verification Program for imported produce and snacks.

Adulterated Animal Feed: FDA issued a warning letter to Appleton City Feed Service LLC for violations of Veterinary Feed Directive requirements and for using a new animal drug that is adulterated. FDA also issued a warning letter to Hi-Pro Feeds for adulterated goat feed.

Adulterated Soybean Sprouts: FDA issued a warning letter Korean Food, Inc. for violations of the sprouts and the food labeling regulations alleging that the company’s soybean sprouts products are adulterated because they were prepared, packed, or held under insanitary conditions.

A database of warning letters can be found here.

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USDA Updates

USDA Issues Order Requiring Mandatory Testing and Reporting Requirements for Livestock
April 25: The U.S. Department of Agriculture is implementing new measures to safeguard the U.S. livestock industry from the highly pathogenic H5N1 avian influenza. As of April 29, 2024, the Animal and Plant Health Inspection Service (APHIS) will enforce a Federal Order with requirements for mandatory testing for interstate movement of dairy cattle and mandatory reporting. The Federal Order aims to widen the understanding of H5N1’s behavior, particularly its movement between wild birds and dairy cows, and to control its spread by mandating reporting of positive tests. More information can be found here.

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Other Articles of Interest

Potential Snack and Candy Ban Due to Cancer Concerns
April 18: Several states are considering or have enacted laws to ban common snacks and candies because they contain ingredients that could cause cancer. The list of potentially banned products includes cereals like Lucky Charms and Fruit Loops, various candies such as Skittles and M&M’s, and snacks like Flamin’ Hot Cheetos and Doritos. This move is due to concerns about certain food and color additives, which, while preserving food, may pose health risks. Supporters of the legislation argue that these ingredients are harmful and should be eliminated. Meanwhile, some states have refused to pass similar bans, citing a lack of “scientific basis”. More information can be found here.

Shareholder Criticizes General Mills Over Use of Plastic Packaging
April 16: General Mills Inc. is under scrutiny from Green Century Funds (Green Century), a shareholder, for not adequately addressing sustainable packaging, despite a resolution passed two years ago with majority support from shareholders for the company to establish plastic waste reduction goals and provide progress reports. Green Century has filed a new plastics-focused resolution for General Mills’ annual meeting later this year. Although General Mills claims significant progress towards making packaging recyclable or reusable by 2030, with a current rate of 93% recyclable packaging by weight, Green Century remains skeptical and critical of the pace of change. Problems have arisen with the shuttering of Myplas, a Minnesota-based plastic facility backed by General Mills, which was part of the company’s plastic strategy.

FDA Commissioner Wants Congressional Action on Hemp-Derived CBD
April 11: During a U.S. House of Representatives Oversight Committee hearing, FDA Commissioner, Dr. Robert Califf, expressed that the FDA did not consider hemp-derived CBD safe for legal sale as a dietary supplement. He advocated for Congress to establish a regulatory framework for CBD. The FDA has consistently maintained that it would not develop rules to allow CBD to be sold in dietary supplements or foods. Califf said that CBD does not fall under the FDA’s regulatory scheme. According to Califf, the existing policies in place governing food and dietary supplements are insufficient to manage the risks associated with CBD. Califf was also concerned about the potential harms of CBD exposure that could cause liver damage over time. Read Califf’s testimony here.

Get Ready: New Technology Available to Help Prepare for FDA’s Traceability Rule
April 12: The new traceability rule (Rule 204 under the Food Modernization Act) finalized in November 2022 will be enforced beginning January 20, 2026, with routine inspections anticipated to start in 2027. Frank Yiannas, a former FDA official involved in drafting the rule, advises companies to start preparing now. He cautions against the use of Advanced Shipping Notices (ASNs) as a compliance shortcut, suggesting that ASNs are insufficient for the specific food safety traceability intended by Rule 204. Yiannas suggests that companies should instead concentrate on improving the tracking of shipping and receiving records through the use of technology that can track shipments more accurately without manual scanning, providing instant and retrievable data for compliance with Rule 204’s requirements. More information about technology available to prepare for the new traceability rule can be found here. More information about the new traceability rule and how businesses can prepare for it can be found here.

Surge in Food Recalls Since Before Pandemic
April 25: Last year saw food recalls reach the highest levels since the pre-pandemic period, with significant outbreaks causing illness in 1,100 people and resulting in six deaths, according to a report by the Public Interest Research Group (PIRG). Recalls rose by 8% in 2023, with dangerous bacteria like Listeria, Salmonella, and E. coli causing a quarter of these incidents. 49% of the recalls stemmed from undeclared allergens, partly due to new requirements for manufacturers to list sesame as an ingredient. More information can be found here.

FDA Says U.S. Commercial Milk Supply is Safe
April 24: Recent cases of highly pathogenic avian influenza (HPAI) in U.S. dairy herds have prompted the FDA and USDA to reassert that the nation’s commercial milk supply remains safe. This assurance is based on two critical components of the federal-state milk safety system: the pasteurization process, which eliminates pathogens, and protocols to either divert or destroy milk from cows that are ill. More information can be found here.

FDA Calls on Congress to Establish National Food Lead Testing Requirements
April 23: Due to concerns about toxic heavy metals in baby food and related products, FDA Commissioner Robert Califf went before Congress to request new laws for lead testing in food, emphasizing the need to protect young children and babies from lead poisoning. This action follows incidents like the Wanabana applesauce pouch recall in October, which contained high lead levels and has since been connected to numerous poisoning cases across the U.S. Califf argued for increased FDA authority to test food for lead and set heavy metal limits, citing the lack of federal requirements for such testing beyond a few exceptions. More information can be found here.

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Lawsuits

$5 Million Missouri Raisin Packaging Class Action Certified
April 19: A federal judge in Missouri has granted class certification to consumers suing Mariani Packing Company Inc. for allegedly deceptive packaging of vanilla yogurt raisins. The lawsuit, led by Kimberly Diesel, alleges that Mariani sold its raisins in packaging that contained only 42% of raisins, with the remainder being empty space, known as slack-fill. The Plaintiffs claim this is a violation of the Missouri Merchandising Practices Act (MMPA), as it deceives consumers about the quantity of the product. A copy of the Court’s Order can be found here.

Kraft Sued Over Lead in Lunchables
April 18: A lawsuit was filed against Kraft Heinz Co. in the US District Court for the Eastern District of New York, by Vince Palmeri, alleging deceptive advertising of Lunchables products. The complaint alleges that Lunchables packaging, which promises “100% Freshness Guaranteed,” is misleading because it suggests the products are safe for consumption. Palmeri claims that Kraft Heinz Co. failed to disclose the presence of lead, thus making the value of Lunchables worthless. He accuses the company of negligence and violations of New York’s General Business Law and is seeking damages, as well as seeking to represent a class of purchasers nationwide. Kraft maintains that their products are safe, attributing the presence of lead to its natural occurrence in the environment, and plans to defend against the allegations. The case references a Consumer Reports article which found significant levels of lead in several lunch and snack kits, exceeding California’s regulatory limits. Similar lawsuits have been initiated against Hershey Co. and Walmart Inc. following reports of heavy metals in food. A copy of the complaint can be found here.

Bimbo Bakeries All Butter Cake Lawsuit Dismissed
April 15: Bimbo Bakeries USA Inc. successfully defeated a class action lawsuit alleging deceptive advertising of its “All Butter” Entenmann brand cake, which included vanillin, a synthetic ingredient for flavoring. The US District Court for the District of Maryland ruled that federal law preempted the state-law claims of deception and warranty breach, and the complaint did not convince that a reasonable consumer would interpret “All Butter” to mean the flavoring was exclusively from natural butter. The suit, brought by Candice Bradby, argued the cake’s labeling and ingredient list failed to adequately disclose artificial flavoring, leading her to pay a premium price under a false impression. The court found the claims to be invalid under the Food Drug and Cosmetic Act (FDCA), which sets federal standards for food labeling and supersedes non-identical state regulations. The Court also noted complaint failed to allege facts showing reasonable consumers would be misled about the source of the butter flavor, particularly given the presence of “artificial flavors” on the ingredients list. More information can be found here.

Splenda Maker Faces Class Action Over “100% Natural” Claims
April 12: TC Heartland LLC, the producer of Splenda Naturals Stevia, was sued over its “100% Natural” labeling, which the plaintiff claims is misleading due to the product’s synthetic ingredients. The class action filed in the US District Court for the Eastern District of New York alleges that such marketing misleads consumers who are inclined to pay extra for products deemed “natural”. The complaint claims that Splenda Naturals Stevia contains erythritol and stevia leaf extract, which are not naturally occurring substances and subjected to synthetic chemical processing. The plaintiff asserts he was deceived into buying a product that did not meet his expectations of naturalness and seeks to represent classes of consumers from across the nation who have purchased Splenda under the pretext of it being entirely natural. The lawsuit is based on allegations of deception, fraud, and breach of warranty. While a Splenda representative has stated that the disputed “100% Natural” label is discontinued, the plaintiff alleges that the product’s packaging is still widely available and advertised. More information can be found here.

Court Advances Deceptive Advertising Claims Against Coca-Cola Over “100% Recyclable” Bottles
April 9: A US District Judge for the Northern District of California has allowed claims to proceed against the Coca-Cola Co. for allegedly misleading consumers with the assertion that its water bottles are “100% Recyclable.” The allegations presented in the latest complaint are that Coca-Cola’s bottles are not fully recyclable due to the plastic film material used on the product labels, which are not processed by California recycling facilities, and are consequently discarded. The complaint’s focus on the non-recyclability of the labels due to the material’s incompatibility with recycling plants led the Judge to find it plausible that the “100%” claim could be misleading and thus denied the defendants’ motion to dismiss the complaint. A copy of the Judge’s Order can be found here.

Dole’s “Healthy” Labeling Claims Remain Intact Amid Dismissal of Class Action
April 9: Dole Packaged Foods LLC defeated a proposed class action that challenged the health claims on its fruit products. The lawsuit, filed in the US District Court for the Northern District of California, alleged that Dole’s labels deceptively market fruit products as “healthy and nutritious”, despite the high sugar content in products like fruit parfaits, cups, and beverages. The court dismissed the claims, citing preemption by federal law and the implausibility of consumer deception. The court noted that nutrition claims relating to vitamin C levels fall under implied nutrition standards and are subject to the Food Drug and Cosmetic Act, which mandates uniform nutrition labeling and hence preempts the plaintiffs’ state law-based claims. Furthermore, the court found that the challenged statements about “good nutrition” and “goodness and nutrition” were mingled with marketing language, such as references to sunshine and upbeat, whimsical imagery. This, the court implied, would signal to a reasonable consumer that the claims were not to be interpreted in a literal, factual way. The Judge said because the nutrition statements aren’t health representations, Dole wasn’t obligated to address the negative health effects of sugar. More information can be found here.

Licorice Maker Wins Deceptive Labeling Lawsuit
April 23: KLN Enterprises Inc., the maker of Wiley Wallaby Very Berry Licorice, successfully defended against a proposed class action that claimed the company mislabeled the candy as naturally flavored while it contained synthetic malic acid. The U.S. District Court for the Southern District of California dismissed the case on the grounds that the plaintiff, Mark Trammell, did not adequately allege that the malic acid was artificial nor that it was used as a flavoring agent. Trammell alleged that labels stating the licorice was “Naturally Flavored” and free of artificial colors and flavors was deceptive. He brought consumer protection claims under California laws and additional claims for breach of warranty and unjust enrichment. The Court noted the insufficiency of Trammell’s allegations and highlighted that the product’s label did not claim to be all-natural or free of artificial ingredients. Moreover, Trammell was not considered to have standing to seek an injunction as he did not convincingly claim an intention to purchase the licorice again. Consequently, the lawsuit was dismissed in full.

This Regulatory Update covers information from April 2024. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.