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This update includes FDA updates, FDA warning letters, USDA updates, lawsuits, and other articles of interest, including increased certification fees for color additives, grants for AI-driven food safety research, alleged misleading mac & cheese advertising, and more.

FDA Updates

FDA Issues Final Guidance on Histamine Control in Fishery Products
November 4:  The FDA released a final guidance document titled “Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and Histamine (CPG 7108.24) Compliance Policy Guide.” This compliance policy guide (CPG) is intended to provide FDA staff guidance on adulteration associated with decomposition and/or histamine identified during surveillance sampling and testing of fish and fishery products susceptible to histamine formation. More information can be found here.

FDA Extends Comment Period for Draft Guidance on Voluntary Sodium Reduction Goals in Processed Foods
November 4:  FDA is extending the comment period for the draft guidance titled “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2).” This guidance outlines the next voluntary goals for sodium reduction over a three-year period in various food categories. The goals are intended to reduce excessive sodium intake, improve public health, and promote health equity. Comments must be submitted by January 13, 2025. More information can be found here.

FDA and EPA Approve First Antimicrobial Treatment for Pre-Harvest Agricultural Waste
November 4:  The FDA and EPA announced the registration of the first antimicrobial product for pre-harvest agricultural water using a revised efficacy protocol. This approval allows the treatment of foodborne pathogens like Salmonella and E. coli in water used to grow produce, setting a new standard for food safety. Previously, chemical treatments were limited to managing algae, biofilm, or produce rot. This new product provides farmers with an important tool to reduce the presence of human pathogens in agricultural water, enhancing produce safety. More information can be found here.

FDA Releases Supplement to 2022 Food Code with Updated Safety Guidelines
November 4: The FDA published the 2022 Food Code Supplement, incorporating recommendations from the 2023 Biennial Meeting of the Conference for Food Protection. This Supplement, along with the Food Code, offers practical, science-based guidelines to help reduce the risk of foodborne illness in various retail and foodservice establishments. It is the model for retail food regulations in all 50 states, the District of Columbia, and territories. The Food Code and its Supplement are collaborative efforts by the FDA, CDC, and USDA-FSIS. The next complete revision of the Food Code will be published in 2026. More information can be found here. More information can be found here.

FDA Seeks Public Input on Export Certification Process for Human Food Products
November 7:  The FDA is seeking public input on its approach to managing certification for the export of human food products. Exporters often need FDA certification to meet foreign requirements, which provides an official attestation of a product’s regulatory or marketing status. The FDA issues these certifications in the form of certificates or export lists. The Request for Information intends to gather feedback from stakeholders to help the FDA Human Food Program improve the export certification process. This includes addressing challenges, experiences with listing requirements, and suggestions for implementing fees to cover operational costs. Comments must be submitted by January 7, 2025. More information can be found here.

FDA Increases Certification Fees for Color Additives
November 8:  The FDA issued a final rule to amend the color additive regulations, increasing the fees for certification services. The new fees include a $0.10 per pound increase for straight colors, including lakes. There are similar increases for repacks of certified color additives and color additive mixtures. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, certain color additives must be certified by the FDA before they can be used in food, drugs, cosmetics, and certain medical devices. Manufacturers pay fees for these certification services, which support the FDA’s color certification program. The final rule took effect on December 8, 2024. More information can be found here.

FDA Updates VQIP Guidance to Enhance Flexibility and Efficiency
November 14:  The FDA released updated guidance for the Voluntary Qualified Importer Program (VQIP), part of the FDA Food Safety Modernization Act (FSMA). The revisions streamline processes, increase flexibility, and improve program efficiency. Updates include a new inspection approach that may reduce user fees, the ability for participants to add suppliers and foods throughout the year, and an extended deadline for enrollment steps. More information can be found here and the VQIP Guidance for Industry can be found here.

FDA Seeks Public Input on PFAS in Seafood
November 20:  The FDA issued a request for information to help fill data gaps that remain regarding per- and polyfluoroalkyl substances (PFAS) in seafood. The purpose of this request is to help increase our understanding of the potential for PFAS exposure from seafood. They intend to use the information submitted in response to this request to help inform future activities to reduce dietary exposure to PFAS that may pose a health concern. Comments on this notice must be submitted by February 18, 2025. More information can be found here.

FDA Requires Accredited Mycotoxin Testing for Imported Foods Starting December 2024
November 22:  Beginning December 1, 2024, owners and consignees of certain imported foods must conduct mycotoxin analyses by accredited laboratories under the Laboratory Accreditation for Analysis of Foods (LAAF) program. Detailed information on the LAAF final rule and to access the LAAF Dashboard  can be found here.  Additional information can be found here.

FDA Expands E. Coli Recall for Grimmway Farms Organic Carrots
November 26:  The FDA updated the advisory for the outbreak of E. coli linked to whole and baby organic carrots from Grimmway Farms. On November 21, 2024, the recall was expanded to include additional bag sizes for organic whole carrots under the following labels: Bunny Luv 50-lb, Cal-Organic 15-lb and 50-lb, and Good & Gather 1-lb. These products are likely no longer available for sale in stores but could be in people’s homes. A full list of recalled products is on Grimmway Farms’ expanded recall announcement.  More information can be found here.

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FDA Warning Letters

Misbranded Cookies: The FDA issued a warning letter to Stew Leonard’s Holdings LLC following an inspection that found significant violations of the Federal Food, Drug, and Cosmetic Act. Following a consumer complaint about an anaphylactic death linked to Stew Leonard’s Florentine Cookies, the company recalled the cookies. The cookies contained peanuts and eggs, but the labels did not declare these allergens. The FDA identified that the Florentine Cookies were misbranded because the labels fail to list peanuts and eggs as required.

A database of warning letters can be found here.

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USDA Updates

FSIS Leadership Changes
November 21:  The FSIS announced changes to the agency’s leadership team. These changes reflect the agency’s continual effort to protect public health through science-based regulation, strong enforcement, and advancement of its prevention-first approach to eliminating foodborne illness. Dr. Denise Eblen, previously Assistant Administrator for the Office of Public Health Science (OPHS), is now the agency Administrator. Paul Kiecker will become Assistant Administrator in the Office of Investigation, Enforcement and Audit (OIEA). Dr. Kis Robertson Hale is named Acting Assistant Administrator for OPHS, and Melissa Moore will serve as Acting Office of Field Operations (OFO) Assistant Administrator. Paul Wolseley will transition to the role of Executive Associate for Regulatory Operations (EARO) within OFO. These changes take effect on December 9, 2024. More information can be found here.

FSIS Holds Public Meetings on Salmonella Framework for Raw Poultry Products
November 22:  FSIS is hosting two virtual public meetings to give stakeholders an opportunity to discuss the Salmonella Framework for Raw Poultry Products proposed rule and proposed determination. The first meeting will cover the proposed final product standards under Component Three of the proposed framework, while the second will focus on regulatory amendments in Component Two to improve process control monitoring. The virtual public meetings were held on December 3, 2024 and December 5, 2024. More information can be found here.

FSIS Sets Uniform Compliance Date for Food Labeling Regulations
November 27:  FSIS established January 1, 2028, as the uniform compliance date for new meat and poultry product labeling regulations that will be issued between January 1, 2025, and December 31, 2026. FSIS periodically announces uniform compliance dates for new meat and poultry product labeling regulations to minimize the economic impact of label changes. All meat and poultry food products that are subject to labeling regulations issued between January 1, 2025, and December 31, 2026, will be required to comply with these regulations on products introduced into commerce on or after January 1, 2028. More information can be found here.

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Other Articles of Interest

The Growing Importance of Traceability in Agriculture
November 17:  As consumer demands for transparency and safety grows, agricultural businesses must adapt by implementing traceability systems. Labels play a crucial role in tracking products, and with label design software, businesses can create, manage, and track labels that meet the highest standards of safety, compliance, and consumer trust. More information can be found here.

USDA Awards Grants for AI-Driven Food Safety Research
November 17:  Professors at Florida State University have received $300,000 in grants from the USDA’s National Institute of Food and Agriculture for food safety research involving artificial intelligence. Hailey Kuang, Ph.D. was awarded $150,000 to develop an AI-powered, portable sensor to detect antimicrobial-resistant pathogens in meat and fresh produce. Her project seeks to address global food safety challenges and could lead to an educational program for future food safety leaders. Prashant Singh, Ph.D. was awarded $150,000 to develop a digital PCR test for quantifying Salmonella in beef samples. He is working to improve reproducibility and simplify DNA isolation protocols, with potential applications beyond ground beef. More information can be found here.

CDC Declares End to Boar’s Head Listeria Outbreak
November 25:  The Centers for Disease Control and Prevention (CDC) declared the multistate listeria outbreak linked to Boar’s Head deli meat officially over. The outbreak affected 61 people across 19 states, resulting in 60 hospitalizations and 10 deaths. The CDC noted that the actual number of illnesses might be higher. All products involved are now past their shelf life. Despite the outbreak being over, investigations and lawsuits are ongoing. The USDA is reviewing the situation, and systematic reviews are being conducted at Boar’s Head facilities. A class action lawsuit filed in August was settled in November, but several wrongful death lawsuits are still pending. The outbreak, first reported on July 19, led to recalls of about 7.2 million pounds of product. Inspection reports revealed numerous noncompliance issues at the Virginia plant, which has since been permanently closed. The Boar’s Head listeria outbreak has significantly reduced demand for cold cuts across the industry. Experts caution that sales may remain low for a year or more as consumers continue to worry about contaminated deli meat. More information can be found here and here.

Trump Administration Nominees
November 26:  President-elect Trump has nominated Robert F. Kennedy Jr. as Secretary of Health and Human Services. John Hopkins surgeon, Dr. Marty Makary, was nominated as head the FDA. Makary has criticized the use of pesticides on food and the industry turning against “natural fat”. Florida congressman, Dave Weldon, was nominated to take over the Centers for Disease Control and Prevention. Brooke Rollins, who heads think tank America First Policy Institute in Austin, TX, was nominated as Secretary of the Department of Agriculture. More information can be found here and here. 

Congress Members Urge FDA Ban on Red 3
November 27:  Two dozen Members of Congress, led by Rep. Rosa DeLauro, are urging the FDA to ban the carcinogenic food dye FD&C Red No. 3 (Red 3) in food. California banned Red 3 in 2023, making it the first U.S. state to do so. Lawmakers argue that a ban on Red 3 is both required and feasible, citing the availability of alternatives. The FDA banned Red 3 in cosmetics in 1990 due to its carcinogenic effects in rats, and various health organizations have confirmed its cancer-causing properties. California also found it causes neurobehavioral issues in children. The FDA is reviewing a petition from 24 organizations and scientists to ban Red 3 in food but has not yet ruled on it. Lawmakers emphasize the need for the FDA to act to ensure food safety, especially for products marketed to children. A copy of the congressional letter can be found here.

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Lawsuits

Evian Microplastics Lawsuit Dismissed Over ‘Natural’ Labeling Claims
November 6:  Danone Waters of America LLC successfully convinced a federal judge to dismiss a proposed class action lawsuit alleging that the company falsely advertises its Evian spring water as “natural” despite the bottles leaching microplastics into the water. The US District Court for the Northern District of Illinois ruled that the FDA’s regulation of “spring water” does not impose requirements related to microplastics. The judge stated that the terms “natural” and “spring water” are inseparable, as the regulation uses “natural” to describe the source of the spring water. The plaintiffs argued that the presence of microplastics in the water contradicts the “natural” label. However, the court found that consumer protection claims attempting to impose a different requirement for the term “natural” go beyond the regulatory requirements and are preempted. The judge noted that any claim imposing requirements beyond using “natural” to identify the water source is preempted by federal regulations. The case is Daly v. Danone Waters of Am., LLC.

Olly Faces Partial Dismissal in Dosage Mislabeling Lawsuit
November 13:  Olly Public Benefit Corp. successfully convinced a federal judge to dismiss misrepresentation and warranty claims from a proposed class action lawsuit alleging deceptive dosage advertising for nine products. The judge for the US District Court for the Central District of California ruled that dosage details on the back panel do not constitute fraud. However, the company could not dismiss consumer protection claims under California laws. The plaintiff argued that the labels mislead buyers by not clarifying that the dosage is per serving, not per unit. The judge agreed that reasonable buyers could be misled and allowed these claims to proceed. The case is Tarvin v. Olly Public Benefit Corp.

Kraft Heinz Faces Lawsuit Over Alleged Misleading Mac & Cheese Advertising
November 14:  Kraft Heinz Co. failed to convince a federal judge to dismiss a proposed class action alleging the company falsely advertised its macaroni and cheese products as free from artificial flavors, preservatives, and dyes, despite containing citric acid and sodium phosphate. The US District Court for the Northern District of Illinois found that the plaintiffs sufficiently connected the use of artificial citric acid and sodium phosphates to Kraft Heinz’s practices. The judge also noted that the consumers provided evidence that these ingredients function as preservatives, citing FDA guidance and other sources. However, the court dismissed the consumers’ claims for an injunction, as they are aware of the alleged deceptive practices and are not at risk of future harm. The case is Hayes v. Kraft Heinz Co.

Van Leeuwen Faces Class Action Over Misleading ‘Honeycomb’ Ice Cream Labels
November 15:  Brooklyn-based Van Leeuwen Ice Cream LLC is facing a proposed class action lawsuit for allegedly misleading customers into believing that their “honeycomb” labeled ice creams contain actual honey or honeycomb, which they do not. The lawsuit, Ozuzu v. Van Leeuwen Ice Cream, LLC, filed in the US District Court for the Southern District of New York, claims that the high-priced products, such as Honeycomb, Peanut Butter Brownie Honeycomb, Honeycomb Fudge Ripple, and Honeycomb Caramel Ice Cream Sandwich, are falsely advertised. The plaintiffs argue that these products are priced significantly higher than average ice creams reflecting their positioning as luxury items. They also point out that other premium brands, like Tillamook, use honey in their formulations, and Van Leeuwen’s accurate labeling of other flavors like Pumpkin Cheesecake and Black Cherry Chip shows they know how to label correctly but chose not to for the honeycomb products. A copy of the complaint can be found here.

This Regulatory Update covers information from November 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 updates, FDA warning letters, lawsuits, and other articles of interest, including a streamlined process for FDA complaints, PFAS limits for bottled water, an update on the salmonella outbreak linked to eggs, and more.

FDA Updates

FDA’s Unified Human Foods Program Reorganization Goes into Effect
October 1:  The FDA launched the Unified Human Foods Program, marking the largest reorganization in its history. This new program seeks to enhance public health by preventing foodborne illnesses, reducing diet-related chronic diseases, and ensuring food safety. The reorganization impacts over 8,000 employees and includes restructuring the Office of Inspections and Investigations to improve collaboration and efficiency.  Additionally, the FDA will pilot a new online consumer complaint form to better handle public health risks. The goal is to build a stronger, more integrated, and modernized agency to better meet public health goals. More information about FDA’s reorganization can be found here.  A webpage dedicated to FDA’s Human Foods Program can be found here.

FDA Streamlines Complaint Process for Food and Supplements
October 4:  The FDA Human Foods Program announced a new, streamlined approach for processing complaints, including whistleblower complaints related to FDA-regulated products. Complaints can be about health issues or defects in food, dietary supplements, or cosmetics. The public will be able to direct complaints about foods and dietary supplements to the Human Foods Program through online reporting forms, and by phone to 1-888-SAFEFOOD. More information can be found here.

Listeria Outbreak Leads to Injunction Against Rizo Lopez Foods Following FDA Investigation
October 8:  The U.S. District Court for the Eastern District of California issued a consent decree against Rizo Lopez Foods Inc. and its co-owners, prohibiting them from manufacturing and selling certain products until they comply with federal laws. This follows an investigation by the FDA, in collaboration with state and local partners, into a Listeria outbreak linked to their cheeses, which resulted in 26 illnesses, 23 hospitalizations, and two deaths across 11 states. The FDA found Listeria in their facility, leading to a recall of all dairy products. The consent decree requires corrective actions and FDA approval before resuming operations. More information can be found here.

Update on Salmonella Outbreak Linked to Eggs
October 18:  The CDC declared the Salmonella outbreak linked to eggs from Milo’s Poultry Farm LLC over and the FDA’s investigation is complete.  As previously reported, the FDA issued an advisory regarding a Salmonella outbreak linked to eggs from Milo’s Poultry Farm LLC. The eggs were distributed to retailers and foodservice distributors in Wisconsin, Illinois and Michigan. Milo’s Poultry Farm voluntarily recalled all eggs supplied by their farm and all eggs should now be off the market and beyond shelf life.  More information can be found here.

FDA Considers PFAS Limits for Bottled Water Industry
October 24:  The FDA is evaluating whether to regulate PFAS levels in bottled water, following a new EPA rule limiting the chemicals in tap water, potentially affecting the $62 billion bottled water industry. The FDA must decide by April 2029 whether to regulate PFAS in bottled water. The decision will be based on findings from recent studies and surveys. If PFAS are found in the water used for bottling, the FDA’s regulations must align with the EPA’s standards for public health.  Recent studies indicate that PFAS, particularly PFOA and PFOS, are prevalent in bottled water globally, although most levels are below health risk thresholds.  However, some samples did exceed these limits, highlighting the need for monitoring. The International Bottled Water Association (IBWA), representing about 73% of the market, has already set its own PFAS limits and is preparing to comply with upcoming EPA regulations. They argue that the FDA’s decision will have minimal impact on their members, who are already taking steps to address PFAS contamination. The FDA’s upcoming decision could significantly affect bottled water safety and regulation, especially as many Americans rely on groundwater that may contain these chemicals.

FDA Responds to Objections on Phthalate Food Contact Uses
October 29:  The FDA responded to objections on its final rule that eliminated authorized food contact uses of most phthalates because these uses were abandoned by the industry. After reviewing the objections, the FDA concluded they did not warrant changes to the rule. However, the agency is conducting an updated safety assessment of the remaining authorized uses and is considering new information received through a request for information. Phthalates are also included in the FDA’s list of select chemicals under review.  More information can be found here and here.

FDA’s Human Foods Program Unveils FY 2025 Priority Deliverables
October 30:  The FDA’s Human Foods Program (HFP) has released its 2025 Priority Deliverables, outlining key activities for its first year following a major reorganization that began on October 1, 2024. This initiative seeks to enhance public health through three main risk management areas:

1. Microbiological Food Safety: Collaborating with various stakeholders to prevent foodborne illnesses.
2. Food Chemical Safety: Ensuring the safety of food chemicals and advancing dietary supplement safety.
3. Nutrition: Promoting nutrition science and policies to combat diet-related chronic diseases and ensure safety of infant formula.

These deliverables are designed to strengthen regulatory oversight, advance scientific understanding, and foster partnerships. The HFP is also working to fully operationalize its program, including enhanced risk modeling and regulatory workforce development. More information can be found here.

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FDA Warning Letters

Adulterated Ice Cream Products: FDA issued a warning letter to Ice Cream House LLC for violations of the Current Good Manufacturing Practice and Preventive Controls regulations following an inspection of its ready-to-eat ice cream manufacturing facility in Brooklyn, NY.   Samples collected by the FDA during the inspection revealed the presence of Listeria monocytogenes at the facility. As a result, the FDA determined that the ice cream products are adulterated due to being prepared under insanitary conditions. 

Marketing of Infant Formula: The FDA issued a warning letter to Healthwest Minerals, Inc. dba Mt. Capra Products alleging that their Goat Milk Formula Recipe Kit met the definition of an infant formula under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA claimed the product was marketed as mimicking breast milk and an alternative to commercial baby formula. Since Mt. Capra had not previously manufactured an infant formula, they were required to make a submission under the FD&C Act before introducing the product into interstate commerce.

A database of warning letters can be found here.

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Other Articles of Interest

FDA Launches Webpage on Microplastics and Nanoplastics in Foods
October 1:  FDA recently published a webpage containing information about microplastics and nanoplastics in foods. According to the FDA, microplastics and nanoplastics may be present in food, primarily through environmental exposure but there is no sufficient scientific evidence to show that microplastics and nanoplastics from plastic food packaging migrate into foods and beverages. Although microplastics and nanoplastics have been found in various foods, current research does not indicate that they pose a significant health risk. The FDA is actively monitoring this issue.  The FDA’s microplastics and nanoplastics webpage can be found here.

Serious Health Risk Prompts Class 1 Recall of Wisconsin Eggs Amid Salmonella Outbreak
October 7:  The FDA has upgraded a recall of eggs from Milo’s Poultry Farms in Bonduel, Wisconsin, to “Class 1 status,” indicating a serious health risk. This follows a multistate salmonella outbreak linked to the farm, with 65 people falling ill across nine states, including 42 in Wisconsin. No deaths have been reported, but 24 people were hospitalized. The recall affects eggs with expiration dates of Oct. 12 or earlier from brands like Milo’s Poultry Farms, M&E Family Farms, Tony’s Fresh Market, and Happy Quackers Farm. Consumers are advised not to eat, sell, or serve the recalled eggs and to clean any surfaces they have touched. Cases of salmonella have also been reported in California, Colorado, Iowa, Illinois, Michigan, Minnesota, Utah, and Virginia. More information can be found here.

Bimbo Bakeries Challenges FDA Allergen Labeling Warning
October 10:  Bimbo Bakeries USA is resisting an FDA warning to change its allergen labeling for certain Sara Lee and Brownberry products. Despite the FDA’s concerns, Bimbo maintains its labeling of sesame as an ingredient to prevent accidental consumption, citing a conservative approach for consumer safety. The FDA warned that Bimbo could face recalls, fines, and criminal charges if it doesn’t comply. However, Bimbo did clarify its labeling around tree nuts, changing the labels to inform consumers that the product includes hazelnut, rather than “tree nuts.”  A copy of Bimbo’s response to FDA’s warning letter can be found here. More information can be found here.

Updates on California’s Revised SB 54 Packaging Regulations
October 16:  California’s SB 54 extended producer responsibility for packaging was open for public comment again until October 29.  This follows a previous 61-day comment period and a public hearing earlier this year.  Changes include updated definitions and reorganization of sections. The rules specify reuse and refill criteria, requiring items to be reused multiple times to reduce plastic waste. Items must be returnable at the purchase location or within a mile, and returns should not impose extra burdens on consumers. Additional details were added regarding exemptions, recycling rates, and the treatment of chemical recycling. The rules also clarify responsibilities for producers and set a registration deadline of July 1, 2025.  More information can be found here.

FDA and Purdue University Collaborate to Combat Salmonella in Southwest Indiana
October 21:  The FDA initiated a multi-year study in collaboration with Purdue University and the Indiana produce industry to investigate human pathogens, particularly Salmonella, in the Southwest Indiana agricultural region. This follows several Salmonella outbreaks linked to cantaloupe from the area, where no specific contamination source was identified.  The study will assess how Salmonella is distributed and survives in the environment, focusing on factors like water quality, soil, dust, and animal intrusion. Research teams will collect samples from various environmental sources to better understand the persistence and transfer of pathogens. The findings will help inform effective food safety practices and enhance the safety of food produced in this region. More information can be found here.

FTC’S Rule Banning Fake Consumer Reviews Goes Into Effect
October 21:  The Federal Trade Commission (FTC) issued a final rule to combat fake reviews and testimonials which went into effect on October 21, 2024. The rule prohibits the sale or purchase of fake reviews and allows the FTC to seek civil penalties against violators. The rule bans reviews that misrepresent the reviewer’s identity or experience, including AI-generated reviews. It prohibits compensating for reviews with specific sentiments.  It requires disclosure of reviews by company insiders and prohibits undisclosed insider reviews. It also bars using threats or false claims to suppress negative reviews and prohibits buying or selling fake social media influence indicators.  More information can be found here.

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Lawsuits

Judge Allows Class Action Against Snapple Over ‘All Natural’ Labeling to Proceed
October 14:  A consumer, Albert Fried, filed a class action in the US District Court for the Southern District of California against Snapple Beverage Corp. claiming that the “All Natural” labeling on its teas and juices is misleading because they contain manufactured citric acid. Fried also alleged that the false labeling of the products as “All Natural” allowed Snapple to charge more. Snapple tried to dismiss the case, but the judge allowed the claims regarding citric acid to proceed, stating it was plausible consumers could be deceived. However, the judge dismissed claims about the use of juice concentrates for color, as the product labels clarified their use, and no reasonable consumer would be misled by the “All Natural” label in that context.

Court Dismisses Deceptive Advertising Claims Against Sun-Maid Over Yogurt-Covered Raisins
October 14:  A consumer’s lawsuit against Sun-Maid Growers of California alleging deceptive advertising of its “yogurt-covered” raisins was dismissed because they are preempted by federal regulations. The US District Court for the Southern District of California said the FDA clarified in 2021 that “yogurt-covered” products do not need live cultures but must contain yogurt powder. The court ruled that the plaintiff’s claims do not violate the Federal Food, Drug, and Cosmetic Act. The court dismissed the suit without prejudice, allowing the plaintiff until October 22 to amend the complaint.

Walmart Wins Dismissal of Fish Oil Heart Heath False Advertising Lawsuit
October 21:  Walmart Inc. defeated a proposed consumer class action alleging it deceptively advertised its Spring Valley Fish Oil Omega-3 supplements as beneficial for heart disease prevention. The US District Court for the Northern District of California ruled that the “heart healthy” claims on the packaging were preempted by federal regulations as function claims, not implied health claims. The plaintiff, Pearl Magpayo, did not provide specific evidence to support her claims of misleading labeling. The judge noted that the heart symbol and “supports heart health” statement were a “close call” but pointed out disclaimers on the packaging. The claims were dismissed without prejudice, allowing for potential amendment. Walmart’s request to stay the case was denied, as the FDA has already provided guidance on such claims.

Class Action Against Campbell Soup Co. Proceeds Over Misleading Preservative Claims
October 23:  Campbell Soup Co. failed to convince a federal judge to dismiss a class action alleging false advertising of its Cape Cod chips as free from artificial preservatives, despite containing citric acid.  A judge for the US District Court for the Northern District of California ruled that whether citric acid acts as a preservative in the chips is a question of fact unsuitable for dismissal at this stage. The plaintiffs’ claims under New York and California laws were allowed to proceed, as they sufficiently alleged potential consumer deception. However, the plaintiffs request for an injunction was dismissed, as there’s no ongoing threat of deception due to the ingredient list.

Martian Sales Challenges FDA’s Warning on O.P.M.S. Black Liquid Kratom
October 24:  Martian Sales Inc., the trademark owner of O.P.M.S. Black Liquid Kratom, is challenging the FDA’s warning that its product is linked to serious health effects, including death. The company filed a complaint in the US District Court for the District of Columbia, claiming the FDA acted unlawfully by issuing an “unwarranted sanction” and falsely characterizing its product. Martian Sales argues that the FDA’s warning lacks scientific evidence and is based on an anonymous report without specific information linking their product to the alleged death. The company seeks a court declaration that the FDA acted unlawfully, an injunction against the agency’s actions, and other appropriate relief.

Chubby Snacks Faces Class Action Over Alleged Sugar Mislabeling
October 25:  Chubby Snacks Inc. is facing a proposed class action lawsuit for allegedly misrepresenting the sugar content in its crust-less sandwiches. The complaint, filed in the Northern District of California, claims the company’s peanut butter and grape sandwich nutrition labels state the product contains three grams of sugar, while independent tests show over six grams. Plaintiff Ifonia Gelin alleges she overpaid for the product due to these misrepresentations. The lawsuit includes claims of false advertising, unjust enrichment, and breach of warranties, seeking damages for California and nationwide consumer classes.

LA County Sues PepsiCo and Coca-Cola Over Misleading Recycling Claims
October 31:  Los Angeles County filed a lawsuit against PepsiCo and the Coca-Cola Company, in the Los Angeles County Superior Court, accusing them of misleading consumers about the recyclability of their plastic bottles. The county claims these companies are major plastic polluters and have promoted recycling as a sustainability strategy, despite many plastics being non-recyclable or only recyclable once. The lawsuit alleges that the companies use recycling to distract from real solutions like reducing plastic use and investing in sustainable materials. It also accuses them of unfair competition and false advertising, seeking to stop misleading practices and impose penalties. The American Beverage Association denies these allegations, citing California’s high recycling rates and industry efforts.  More information can be found here.

Deep River Snacks Reaches $4 Million Settlement Over Misleading Non-GMO Claims
October 31:  Old Lyme Gourmet Co., operating as Deep River Snacks, reached a $4 million settlement with consumers over deceptive advertising claims. The lawsuit alleged that the company misled consumers by using a “non-GMO” graphic similar to the Non-GMO Project’s certification. Magistrate Judge Taryn A. Merkl of the US District Court for the Eastern District of New York recommended preliminary approval of the settlement. Consumers with proof of purchase can claim $5 for the first product and $0.50 for each additional product, up to $10. Class counsel plans to seek over $1.3 million in attorneys’ fees.

This Regulatory Update covers information from October 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 unintended milk in ‘dairy-free’ chocolate products, movement toward bans of cultivated meat, FDA’s new Human Foods Program, and more.

FDA Updates

FDA Enhances Food Traceability Efforts with New Resources and Public Meeting
September 4:  The FDA issued an update on its efforts to enhance food traceability. Deputy Commissioner Jim Jones highlighted online resources and roundtables with the Reagan-Udall Foundation to aid industry with implementation of the Food Traceability Rule. Insights from these discussions were further explored in a public meeting on October 7. Stakeholders are encouraged to provide feedback by October 25, 2024. For more details, visit the Foundation website.  More information can be found here.

FDA Releases Pesticide Residue Monitoring Report
September 4:  The FDA released its annual Pesticide Residue Monitoring Program Report for Fiscal Year 2022, summarizing findings from the FDA’s testing of human and animal foods for 757 different pesticides and selected industrial compounds from October 1, 2021, through September 30, 2022. The findings show that the levels of pesticide chemical residues in the U.S. food supply are generally in compliance with EPA pesticide tolerances.  More information and a summary of findings can be found here.

FDA Issues Advisory on Salmonella Outbreak Linked to Eggs
September 6:  The FDA issued an advisory regarding a Salmonella outbreak linked to eggs from Milo’s Poultry Farm LLC. As of September 6, 2024, 65 cases have been reported across nine states. The eggs were traced to Milo’s Poultry Farms, LLC of Bonduel, WI. The FDA conducted an inspection and collected samples at Milo’s Poultry Farms.  The FDA found the outbreak strain in samples from the farm, leading Milo’s Poultry Farm to voluntarily recall all their eggs, including eggs labeled as “Tony’s Fresh Market”, in Wisconsin, Illinois and Michigan. More information can be found here.

FDA Finds Unintended Milk in ‘Dairy-Free’ Chocolate Products
September 17:  The FDA, along with Pennsylvania and Michigan state agencies, tested “dairy-free” dark chocolate products for unintended milk in 2022-2023. Out of 210 samples, 13 tested positive for milk, with one sample containing a high level. The products had advisory labels about potential milk presence. Two manufacturers removed “dairy-free” claims, and a third agreed to do so pending further investigation. The likely source of milk was identified as the dark chocolate supplier. The FDA will continue monitoring dark chocolate products labeled as “dairy-free” for the presence of milk because it can cause serious health consequences to consumers with milk allergy. More information can be found here.

FDA Updates Compliance Guide for Small Entities on Agricultural Water Standards
September 24:  The FDA released an updated guidance document entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide” to help small businesses comply with revised regulations concerning agricultural water. This guide is part of the broader “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” regulation. The update helps small entities comply with revised pre-harvest agricultural water requirements for covered produce (excluding sprouts) under the Produce Safety Rule. It reflects changes from the May 2024 final rule. Compliance dates start on April 7, 2025, and vary based on farm size. More information can be found here.

FDA Withdraws Chlorine Dioxide Food Additive Petition
September 26:  The FDA announced the withdrawal, without prejudice to a future filing, of a food additive petition proposing that the food additive regulations for chlorine dioxide be amended to provide for an additional method for producing the additive.  More information can be found here.

FDA Updates Mycotoxins in Domestic and Imported Human Foods Compliance Program
September 26:  The FDA updated the Mycotoxins in Domestic and Imported Human Foods Compliance Program to include monitoring of additional mycotoxins of regulatory interest in human foods, specifically T-2/HT-2 toxins and zearalenone. The new data gained by the compliance program update will support enforcement actions, risk assessments, and international activities, as well as provide information on mycotoxin incidence, extent of contamination, and co-occurrence.  More information can be found here.

FDA Releases Guidance Video on Importing Safe and Compliant Seafood
September 27:  The FDA released a video titled “Importing FDA-Regulated Products: Seafood” to guide importers, suppliers, and brokers on importing safe and compliant seafood into the U.S. It covers essential topics like product content, handling, packaging, and associated hazards, as well as compliance with FDA seafood regulations. This video is the third in a series. The first video, outlining the general FDA admissibility process for imports, was released in March 2022. The second video, “Importing FDA-Regulated Products: Human Foods,” was released in September 2023.

FDA Food Facility Registration Now Open until December 31, 2024
September 27:  Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing, processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2024. Registration expires if not renewed by December 31, 2024, with no associated fee.  Renewals must be submitted electronically unless a waiver is granted. This registration helps the FDA trace foodborne illness sources and requires biennial renewals.  More information can be found here.

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FDA Warning Letters

Milk Misbranding/Labeling: The FDA issued a warning letter to Graceleigh, Inc. dba Sammy’s Milk.  Based on an inspection and review of Sammy’s Milk’s website and social media, FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Sammy’s Milk is marketed as an infant formula, but FDA alleges it is a new product that has not met the required FDA submission process. Despite a voluntary recall and some changes to Sammy’s Milk online presence, concerns remain about misleading representations.  The FDA also alleges the product was misbranded due to false claims about testing for Cronobacter.

Adulterated Bottled Water:  The FDA issued a warning letter to Waiakea Bottling Inc. after an inspection revealed significant violations of federal Processing and Bottling of Bottled Drinking Water Regulations.  The FDA determined that the bottled water products processed at the facility are adulterated under the FD&C Act because they have been prepared, packed, or held under insanitary conditions.   

A database of warning letters can be found here.

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USDA Updates

FSIS Releases Guideline on Substantiating Animal-Raising or Environment-Related Labeling Claims
September 10: The Food Safety and Inspection Service (FSIS) announced the availability of an updated version of its guideline on documentation needed to support animal-raising or environment-related claims on meat or poultry product labeling. Official establishments submit this documentation to the Agency when they apply for approval of labels with animal-raising or environment-related claims. The updated guideline includes changes made in response to updated scientific information, FSIS sampling data, askFSIS questions, public comments, petitions, and other meetings with Agency stakeholders. FSIS will accept comments on the guideline until November 12, 2024.  More information can be found here and here.

FSIS Rules on Labeling Petitions
September 11:   FSIS issued final rulings on the following four food safety petitions. 

1. 2016 Animal Welfare Institute Petition: Requested amendments to poultry labeling for “free range” claims. FSIS decided not to codify the proposed definitions, citing evolving consumer expectations and the impracticality of fixed definitions.
2. 2022 PETA Petition: Sought to stop FSIS review of animal-raising claims. FSIS denied the petition but updated guidelines to encourage third-party certification and documentation for claims like “Pasture-Raised.”
3. 2023 Perdue Farms Petition: Partially granted. FSIS updated guidelines to differentiate “pasture-raised” from “free range,” encouraging documentation to substantiate claims.
4. 2023 Environmental Working Group’s “Low Carbon” Petition: Requested prohibition of “Low-Carbon Beef” claims. FSIS denied the petition, maintaining that claims must be truthful and not misleading, without requiring third-party verification.

More information can be found here.

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Other Articles of Interest

States Move to Ban Cultivated Meat: A Growing Trend in Food Regulation
September 6:  Several states in the U.S. are taking steps to restrict or ban the sale and labeling of cultivated (lab-grown) meat. Florida, Alabama, and Iowa have enacted laws restricting or banning cultivated meat. Florida’s law prohibits manufacturing or selling cultivated meat. Alabama’s ban takes effect on October 1. Iowa prohibits labeling lab-grown food as meat. Nebraska is working on similar legislation, with an executive order already limiting state spending on lab-grown meat. Illinois is considering a bill for 2025 to ban alt-meat.  Cell-cultivated meat is developed from animal cells without slaughter. In 2023, the FDA and USDA approved the first U.S. sales of cell-cultivated chicken from GOOD Meat and UPSIDE Foods. The U.S. and Singapore are the only countries allowing consumer sales. The industry has received significant funding for research and development.  More information can be found here.

Study Reveals Widespread PFAS Presence in Wisconsin Residents with Links to Locally Caught Fish and Microwave Popcorn
September 6:  A study by the University of Wisconsin School of Medicine and Public Health found that PFAS, including PFOA, are present in the blood of most Wisconsin residents. Analyzing samples from over 600 adults, the study revealed that more than 96% had detectable PFAS levels. Older, non-Hispanic white males and those with higher incomes showed higher levels. The study linked higher PFAS levels to consuming microwaved popcorn and locally caught fish. However, the lead researcher cautioned that these findings don’t definitively establish risk, as the data didn’t cover all potential PFAS sources, indicating a need for further research.  More information can be found here.

Boar’s Head Closes Plant and Ends Liverwurst Production Amid Listeria Outbreak
September 13:   Boar’s Head is closing its Jarratt, VA, plant indefinitely and discontinuing liverwurst production due to a Listeria outbreak that sickened 57 people and killed nine. The company apologized and is taking measures to prevent future incidents. The contamination was linked to a specific process at the Jarratt facility used only for liverwurst. Boar’s Head initiated a recall of liverwurst and expanded it to include 7 million pounds of other meat and poultry products. The USDA had previously noted serious issues at the plant. Boar’s Head is enhancing food safety measures, appointing a new Chief Food Safety Officer, and forming a Food Safety Council to improve industry standards.  More information can be found here.

Food Survey Reports Decline in Consumer Confidence
September 26:   The 2024 IFIC Food & Health Survey reports a decline in consumer confidence regarding food safety, the lowest in a decade. The IFIC Spotlight Survey highlights concerns about foodborne illnesses and heavy metals, with the presence of E. coli in ground beef and heavy metals and arsenic in baby food being top worries. Consumers avoid ultraprocessed foods, dyes, and sugar substitutes, as well as MSG, bioengineered/GMO ingredients, nanoplastics and preservatives. Trust in food safety is linked to the presence of an ingredient rather than quantity. The survey emphasizes the need for factual information to help consumers make informed choices. Data was collected from 1,000 Americans, with a margin of error of ±3.1%. More information can be found here.

FDA Launches New Human Foods Program on October 1
September 26:   The FDA implemented a reorganization on October 1, 2024 to enhance its oversight of the human food supply. The reorganization involves creating a unified Human Foods Program (HFP) by merging functions from the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and parts of the Office of Regulatory Affairs (ORA). The restructuring also includes renaming ORA to the Office of Inspections and Investigations (OII), focusing on inspections, investigations, and imports to ensure product safety and quality. The FDA’s restructuring will improve efficiency and adaptability to new food technologies, globalization, and climate change. More information can be found here.

Study Identifies Poultry as Main Source of U.S. Drug-Resistant Campylobacter Infections
September 27:   A new study by the Ineos Oxford Institute for Antimicrobial Research has identified poultry as the primary source of human Campylobacter infections in the U.S., with 68% of cases from 2009 to 2019 linked to contaminated poultry. The study, published in the Journal of Infection, used machine learning to analyze genomic data from human and animal sources. It highlights significant concerns about rising antibiotic resistance in bacteria found in the food chain, particularly in poultry strains, which poses a public health threat. More information can be found here.

California Bans Artificial Dyes in School Food
September 30:   California has become the first state to ban six artificial dyes in school cafeterias due to health concerns. Governor Gavin Newsom signed Assembly Bill 2316, the California School Food Safety Act, which prohibits Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3 in public school meals. The law responds to studies linking these dyes to hyperactivity and neurobehavioral issues in children. Although the FDA hasn’t confirmed a causal link, a 2021 California review found associations with behavioral problems. The law, effective December 31, 2027, requires manufacturers to use natural alternatives. More information can be found here.

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Lawsuits

Campbell Soup Co. Wins Dismissal of ‘Air Fried’ Kettle Chips Deception Lawsuit
September 3:  Campbell Soup Co. defeated a proposed class action  alleging deceptive advertising of Kettle Brand “air fried” potato chips. The plaintiff claimed the chips were misleadingly marketed as being cooked solely by air frying when they were cooked in oil. The U.S. District Court for the Northern District of California ruled that the front label’s disclosure of “kettle cooked” was sufficient to inform consumers of the cooking method. The judge noted that the phrase “Kettle Cooked Air Finished” indicated a multi-step cooking process involving both kettles and air. The back label, which included a diagram and an ingredients list showing vegetable oils, further clarified the cooking method. The court found it implausible that reasonable consumers would believe the chips were cooked exclusively by air frying and denied the plaintiff’s request to amend the complaint.

Judge Allows Lindt Dark Chocolate Lawsuit Over Lead Contamination to Proceed
September 9:  A judge U.S. District Court for the Eastern District of New York allowed a lawsuit against Lindt & Sprüngli (USA) Inc. to proceed, alleging that the company’s dark chocolate bars contain significant amounts of lead and were falsely advertised as safe and high-quality. The court ruled that packaging statements could mislead consumers into believing the chocolate was free of unsafe levels of lead. This lawsuit is part of a broader wave of litigation following a Consumer Reports article on high levels of lead and cadmium in chocolate. The plaintiffs claim they overpaid for the chocolate, believing it to be free of harmful contaminants. The judge rejected Lindt’s argument that their packaging statements were mere puffery, stating that consumers could interpret them as implying quality and an absence of lead. The court also noted the health risks associated with lead and cadmium.

Prime Hydration Wins Partial Dismissal in PFAS Deception Lawsuit
September 10:  A judge for the US District Court for the Northern District of California dismissed most claims in a class action lawsuit against Logan Paul’s Prime Hydration LLC, which alleged deceptive marketing of its Grape Sports Drink as healthy despite containing PFAS chemicals. The judge ruled that phrases like “refresh, replenish, or refuel” are too vague to mislead reasonable consumers. However, a claim for breach of implied warranty was allowed to proceed. The plaintiff, Elizabeth Castillo, argued that the drink’s health benefits are falsely advertised due to the presence of PFAS chemicals, which are linked to health risks. The court found that the drink’s label, listing artificial ingredients, would dispel any belief that it is entirely healthy. Castillo’s claim under the Magnuson-Moss Warranty Act was dismissed, but her breach of implied warranty claim remains, as she alleged the PFAS levels exceeded federal limits.

Class Action Over Misleading Protein Claims in Nature’s Path Cereals Moves Forward
September 12:  A judge for the U.S. District Court for the Northern District of California has allowed a class action lawsuit against Nature’s Path Foods Inc. to proceed. The lawsuit claims the company misrepresented the amount of usable protein in its cereals. The judge ruled that the claims are not preempted by federal protein label regulations because the claims are not dependent on how the amount of protein is calculated. The plaintiff, Ian Miller, argued that the cereals advertised 5 grams of protein per serving, but this was misleading because not all the protein is usable by the human body. The judge also noted that the cereals did not include a quality-adjusted percent daily value, which is required by both FDA regulations and California law. Nature’s Path’s arguments that the claims were preempted and that consumers would know plant-based proteins are incomplete were rejected by the court. More information can be found here.

SkinnyPop Faces Class Action Lawsuit Over Misleading Popcorn Packaging Claims
September 13:   The makers of SkinnyPop Popcorn are facing a federal class action lawsuit for allegedly misrepresenting the amount of popcorn and calorie content in their bags. The lawsuit, filed in the US District Court for the Southern District of California, claims the product’s bags contain up to 43% less popcorn than advertised. The plaintiffs, Cade Bogren, Michelle Bogren, and Jeremiah Tills, accuse the defendants of misleading consumers and violating federal and California laws and seek to represent a class of California consumers who purchased the snack foods with the last four years.

Judge Allows Class Action Over Misleading Fireball Cinnamon Mini Bottles to Proceed
September 13:   A federal judge denied Sazerac Co.’s motion to dismiss a class action lawsuit claiming that miniature bottles of Fireball Cinnamon mislead consumers into thinking they are whisky when they are actually malt-based. The U.S. District Court for the Middle District of Florida found that reasonable consumers could be misled, especially since the mini bottles are sold in non-liquor stores like gas stations. The court noted that the packaging is nearly identical to the original Fireball whisky, which could confuse consumers.  Additionally, the judge stated that even technically true labels can be misleading. The complaint also included social media evidence showing consumer confusion, supporting the claim of potential deception. The mini Fireball product is described by Sazerac as a malt-based and wine-based beverage, allowing broader retail distribution than Fireball Whisky.

Class Action Targets SunButter for Alleged False Advertising and High Cadmium Levels
September 16:  SunButter LLC is facing a proposed class action for allegedly falsely advertising its sunflower butter products as healthy and non-toxic, despite containing harmful cadmium levels. Plaintiffs John Boyd and Jana Rabinowitz claim that testing showed SunButter’s products exceeded California’s Proposition 65 cadmium limits. The lawsuit, filed in the Central District of California, accuses SunButter of false advertising, unfair business practices, and breach of implied warranty under California and New York consumer protection laws. The plaintiffs seek injunctive relief, restitution, disgorgement of profits, and damages for affected consumers in California and New York who purchased the sunflower butter products.

Food Lion Hit with Lawsuit Over Alleged Misleading Labeling of Cereal Bars
September 18:  A proposed consumer class action alleges that Food Lion LLC’s Fruit and Grain Cereal Bars mislead buyers by claiming to be “Naturally Flavored” and “Made With Real Fruit Filling,” despite containing synthetic DL-malic acid as a flavoring agent. The complaint, filed in the US District Court for the Eastern District of North Carolina, argues that federal regulations require products with DL-malic acid to be labeled as artificially flavored. The plaintiff, Kathy Applegate Bates, claims she wouldn’t have purchased the bars if she had known this and seeks damages under North Carolina law for consumer protection, unjust enrichment, and breach of warranty. A copy of the complaint can be found here.

Tyson Faces Lawsuit Over ‘Climate-Smart Beef’ and Net-Zero Emission Plan
September 18:  A lawsuit filed against Tyson Foods Inc. alleges the company misleads consumers about its environmental impact and commitment to achieving net-zero emissions by 2050. The Environmental Working Group claims Tyson lacks a concrete plan to meet these goals and that its “climate-smart beef” program is vague and ineffective. The lawsuit, filed in the Superior Court of the District of Columbia, accuses Tyson of violating consumer protection laws by making misleading marketing claims. Tyson, while not commenting on the litigation, asserts its commitment to sustainable practices. The group seeks an injunction to correct consumer misconceptions. A copy of the complaint can be found here.

Aldi Faces False-Ad Suit Over Alleged Mislabeling of Avocado Oil
September 19:  A proposed class action filed in the US District Court for the Southern District of New York accuses Aldi Inc. of falsely advertising its Simply Nature avocado oil as “100% Pure” when it allegedly contains cheaper oils. Plaintiff Maggie Frost claims the product’s labeling is misleading, as tests show the oil’s fatty acid profile doesn’t match pure avocado oil. The lawsuit alleges violations of consumer protection laws, breach of warranty, and fraud, seeking damages and class certification. A copy of the complaint can be found here.

Judge Dismisses Lawsuit Over Slack Filled Packaging of Yogurt Raisins
September 23:  A judge for the US District Court for the Eastern District of Missouri dismissed a lawsuit against Mariani Packing Co. regarding its yogurt-covered raisins. The plaintiff, Kimberly Diesel, claimed the bags were 58% empty, but the judge ruled she failed to show economic injury or deception. The packaging accurately represented the quantity, and the slack fill was deemed functional to prevent damage. The judge noted that consumers could feel the bag to assess its contents. Diesel’s claim under the Missouri Merchandising Practices Act was rejected, granting Mariani summary judgment.

This Regulatory Update covers information from September 2024.
Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for
additional information on regulatory issues that
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