This update includes FDA and USDA updates, FDA warning letters, lawsuits, and other articles of interest, including pasteurization to kill H5N1 in dairy products, a move to ban artificial dyes in school foods, misleading labeling, and more.
FDA Updates
FDA Files Color Additive Petition
August 5: The FDA announced that it filed a petition, submitted by GNT USA, LLC, proposing that the color additive regulations be amended to provide for the safe use of spirulina extract in foods generally in amounts consistent with good manufacturing practice. comments on the petitioner’s environmental assessment must be submitted by October 4, 2024. More information can be found here.
FDA Collecting Information on Food and Cosmetic Export Certificate Application Process
August 8: The FDA announced a collection of information to help support the implementation of laws and regulations governing the export of certain FDA-regulated products, as outlined in section 801 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart E. Some countries require manufacturers to provide certificates for FDA-regulated products they wish to export. Firms can request these certificates electronically via the Export Certification Application and Tracking System (eCATS) or Certificate Application Process (CAP), or by contacting the FDA. This collection specifically pertains to export certificates for human food and cosmetic products, with respondents being firms interested in exporting these products to countries that require such certificates. The comment deadline is September 9, 2024. More information can be found here.
FDA to Hold Public Meeting on the Development of an Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food
August 12: The FDA is developing a systematic process for post-market assessments of chemicals, including generally recognized as safe (GRAS) ingredients, food additives, color additives, food contact substances, and contaminants. This process is intended to guide future post-market assessments and includes a transparent method for identifying and prioritizing food chemicals currently for safety reviews. This project is part of a broader approach to enhance food chemical safety. The FDA will host a public meeting on September 25, 2024 from 12:30 – 4:30 PM ET to discuss this process and gather stakeholder feedback on this proposal. Comments must be submitted on or before December 6, 2024. To register for the public meeting, visit the registration page. More information can be found here and the Federal Register Notice with instructions for comments can be found here.
FDA Advances Sodium Reduction Efforts and Issues Draft Guidance
August 15: The FDA issued new voluntary sodium reduction targets in a draft guidance, marking Phase II of its sodium reduction efforts. The new targets build on 2021 Phase I voluntary sodium reduction goals to further reduce diet-related diseases linked to high sodium intake. The draft guidance contains three-year sodium reduction targets for 163 food categories that are commercially processed and packaged, or prepared in food service establishments, which account for over 70% of sodium intake in the U.S. The targets are intended to help address the excess intake of sodium in the U.S. The new voluntary targets will support reducing sodium intake to about 2,750 milligrams/day, a 20% reduction from pre-Phase I levels. The FDA will assess progress every three years and is accepting comments on the draft guidance until November 14, 2024. This initiative is part of the White House National Strategy on Hunger, Nutrition, and Health and aligns with the Healthy People 2030 goal. More information can be found here and here.
NACMCF to Hold Public Meetings on Genomics and Cronobacter Updates in September 2024
August 28: The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will hold a public meeting of the full Committee and Subcommittees from September 24, 2024, to September 26, 2024. The NACMCF will provide updates on FSIS’ Genomics charge and the FDA’s Cronobacter spp. in Powdered Infant Formula charge. The full Committee will hold an in-person and virtual public meeting on Tuesday, September 24, 2024, from 10:00 a.m. to 12:00 p.m. and on Thursday, September 26, 2024, from 4:00 p.m. to 5:00 p.m. The Subcommittees on Genomics and on Cronobacter spp. in Powdered Infant Formula will hold concurrent Subcommittee meetings on Wednesday, September 25, 2024, from 1:00 p.m. to 5 p.m. The Subcommittee meetings are open to members of the public by virtual attendance only. Attendance to all meetings is free but pre-registration is requested by Wednesday, September 18, 2024. More information can be found here.
FDA Warning Letters
Cinnamon Products: The FDA issued a warning letter to Austrofood, the manufacturer of recalled apple cinnamon fruit puree pouches, citing Austrofood for violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. The FDA alleges that Austrofood failed to conduct a proper hazard analysis to identify lead in cinnamon as a hazard requiring preventive control. The letter states that the presence of lead adulterates the product under the Federal Food, Drug, and Cosmetic Act (FD&C Act). More information can be found here.
Adulterated Bean Sprouts: The FDA issued a warning letter to a Pennsylvania bean sprout farm after an investigation revealed several violations of the FD&C Act at the farm’s sprouting facility, including evidence of rodents where packaging material is stored and other conditions that may result in the sprouts contacting contaminated surfaces. The FDA determined that bean and soybean sprout products are adulterated in that they have been prepared, packed, or held under insanitary conditions.
A database of warning letters can be found here.
USDA Updates
FSIS Proposes New Rule to Combat Salmonella in Poultry Products
August 7: The Food Safety and Inspection Service (FSIS) issued a proposed rule and determination to reduce Salmonella contamination and illnesses associated with raw poultry products. The proposed rule would make it illegal to sell chicken, chicken parts or ground chicken and turkey if it is found to be contaminated with certain types of Salmonella. The proposal would establish final product standards to prevent raw chicken carcasses, chicken parts, ground chicken, and ground turkey products that contain any type of Salmonella at or above 10 colony forming units (CFU) per gram/ml and any detectable level of at least one of the Salmonella serotypes of public health significance from entering commerce. The proposed rule would also require poultry establishments to develop a microbial monitoring program to prevent pathogen contamination throughout the slaughter system. Comments on the proposed rule must be received by October 7, 2024. More information and instruction for submitting comments can be found here.
NACMPI Virtual Meeting on Inspection Program Updates and Tech Integration
August 16: FSIS will hold a virtual meeting of the National Advisory Committee on Meat and Poultry Inspection (NACMPI) on September 16-17, 2024. The Committee will advise on meat and poultry inspection programs, review establishment size definitions, and discuss technology’s role in inspections. The meeting runs from 10 a.m. to 4 p.m. EDT and requires pre-registration for access. More information can be found here.
FSIS to Begin H5N1 Monitoring in Dairy Cows at Slaughter
August 16: FSIS will begin monitoring H5N1 influenza A in dairy cows at slaughter starting September 16, 2024. This will be integrated into the existing National Residue Program, using PCR testing on muscle samples. Carcasses will be held pending test results, with no additional holding time required. If H5N1 is detected, the USDA will ensure the carcass does not enter the food supply. This initiative builds on three previous USDA studies, and FSIS will update stakeholders on the results. More information can be found here.
FSIS Updates Guidelines for Animal-Raising and Environmental Claims on Meat Labels
August 28: The FSIS released an updated guideline to improve documentation for animal-raising and environment-related claims on meat and poultry labels. The Guideline on Substantiating Animal-Raising or Environment-Related Labeling Claims includes revisions from sampling data, petitions, public comments to petitions and feedback received from a wide range of stakeholders. Animal-raising and environment-related claims, such as “Raised Without Antibiotics” and “Climate-Friendly,” are voluntary and require FSIS approval. The guideline encourages third-party certification to ensure these claims are truthful. It also recommends routine testing for “negative” antibiotic claims. A recent FSIS study found antibiotic residues in 20% of samples from the “Raised Without Antibiotics” market, prompting FSIS to enforce stricter measures against false claims. The agency plans to publish a detailed study and may implement further testing and rulemaking. Comments on the guideline are due by November 12, 2024. More information can be found here and here.
Other Articles of Interest
FDA’s Ban on Brominated Vegetable Oil: Implications for Food Manufacturers
August 5: The FDA recently finalized a rule to revoke the use of brominated vegetable oil (BVO) as a food additive due to concerns about its potential health effects. This rule, effective from August 2, 2024, provides companies a one-year period to reformulate, relabel, and discontinue sales of products containing BVO, with enforcement expected to begin on August 2, 2025. BVO has been used primarily in citrus-flavored beverages to stabilize flavoring oils, but many companies have already begun phasing it out in favor of alternatives such as sucrose acetate isobutyrate (SAIB), glycerol ester of wood rosin, modified cellulose, acacia gum, and locust bean gum. The suitability of these substitutes depends on specific product requirements, and manufacturers must evaluate options to maintain product quality. The transition away from BVO presents challenges for manufacturers, including the complexity and cost of reformulating products to maintain flavor and stability. Reformulation involves expenses such as turbidity tests, consumer focus groups, production scale-up testing, and relabeling. These costs are necessary to ensure that the reformulated products comply with the law and remain acceptable to consumers. More information can be found here.
FDA Confirms Pasteurization Kills H5N1 in Dairy Products
August 16: The FDA completed a second round of testing that confirmed pasteurization effectively kills the H5N1 avian virus in milk and dairy products, making them safe for consumption. However, raw milk remains a risk. The survey, coordinated with the USDA, tested 167 dairy products, including pasteurized and raw milk products, and found no viable H5N1 virus. These results support previous findings that pasteurization inactivates the virus. The survey results will be published in a peer-reviewed journal. Since 2022, the U.S. has reported 14 human avian flu cases, with no cases linked to dairy consumption. The CDC reports no unusual influenza activity, but more poultry outbreaks are expected as wild birds migrate. More information can be found here.
California Moves to Ban Artificial Dyes in School Foods
August 30: California lawmakers have passed a bill banning six artificial dyes from foods in public schools, pending the governor’s approval. The bill, introduced by Assembly member Jesse Gabriel and supported by Consumer Reports and the Environmental Working Group, targets synthetic colorings linked to neurobehavioral issues in some children. If signed by Governor Gavin Newsom, the law will take effect in December 2027, making California the first state to implement such a ban. The bill, known as the California School Food Safety Act (Assembly Bill 2316), seeks to replace dyes like Red 40 and Yellow 5 with natural alternatives. While the FDA hasn’t confirmed a link between these dyes and behavioral problems, a 2021 review by California’s EPA found associations with adverse effects in sensitive children. More information can be found here.
Lawsuits
Class Action Filed Against Albertsons for Misleading ‘100% Juice’ Labeling on Fruit Products
August 2: A proposed class action lawsuit has been filed against Albertsons Companies Inc., alleging that the company’s fruit products contain synthetic additives that contradict their labeling as being packed in 100% juice. The complaint, filed in the US District Court for the Northern District of California, claims that Albertsons’ “Signature Select” brand, specifically its sliced peaches and mandarin orange fruit cups, contain ascorbic and citric acids, which are synthetic additives. The plaintiff argues that these additives are used to mimic naturally occurring substances, thus misleading consumers. The lawsuit seeks to establish a nationwide class and a California subclass of consumers who purchased these products, which are sold across Albertsons’ grocery chains, including Safeway and Jewel-Osco. The legal claims include breach of express warranty and violations of California consumer protection, competition, and false advertising laws. The plaintiff is seeking various forms of relief, including compensatory, statutory, and punitive damages, as well as injunctive relief and attorneys’ fees. A copy of the complaint can be found here.
Class Action Against Kroger’s ‘Farm Fresh’ Egg Label Dismissed
August 7: A federal judge dismissed a proposed class action against Kroger Co., which alleged that the “farm fresh” label on some of its private-label eggs was misleading because the eggs came from hens in cages and industrial confinement. The plaintiff, Adam Sorkin, argued that the label was deceptive as it suggested imagery of hens living freely on farms. However, the US District Court for the Northern District of Illinois ruled that Sorkin failed to demonstrate that his interpretation of “farm fresh” matched the expectations of a reasonable consumer. The judge stated that the term “Farm Fresh Eggs” pertains to origin and timing, not the living conditions of the hens, and that Sorkin’s complaint did not support the notion that reasonable consumers would be misled to believe the eggs came from idyllic farm settings. The judge noted that other terms like “cage-free,” “free range,” and “pasture-raised” explicitly address the living conditions of hens. More information can be found here.
D.C. Circuit Denies Standing for Animal Group in USDA Poultry Labeling Suit
August 9: The D.C. Circuit Court ruled that the Animal Legal Defense Fund (ALDF) lacks standing to sue the U.S. Department of Agriculture (USDA) over allegedly misleading labels on Perdue poultry products. The court upheld a lower court’s decision, stating that the ALDF failed to demonstrate the necessary associational standing. The case centered on Marie Mastracco, an ALDF member, who claimed injury from the misleading packaging. However, the court found that Mastracco could not prove her injury was ongoing or imminent, as there was no evidence of other poultry products with similar misleading graphics. The ALDF’s lawsuit, initiated in mid-2021, argued that the USDA’s Food Safety and Inspection Service neglected its duty by approving labels that used graphics suggesting chickens were raised outdoors, contrary to their actual conditions. The court did not address the merits of the ALDF’s claims about the USDA’s label approval process, as the appeal focused solely on the issue of standing. A copy of the Court’s decision can be found here.
Ralphs Grocery Co. Faces Class Action Over Misleading Smoked Gouda Labeling
August 12: Ralphs Grocery Co. faced a setback in its attempt to dismiss a proposed consumer class action regarding its sliced smoked gouda product, which is alleged to be misleadingly labeled due to the use of added liquid smoke for flavoring. The U.S. District Court for the Central District of California determined that the issue of whether Ralphs should have disclosed the added flavor on the front label is not appropriate to resolve on a motion to dismiss. The judge noted that the smoked flavor might be classified as an artificial flavor, which would require a label declaration under federal regulations. The court also found that the state law claims were not preempted, as they were grounded in California’s Sherman Food, Drug, and Cosmetics Law, which aligns with federal labeling standards. Federal regulations mandate that flavored cheeses must declare the flavors or spices that characterize the product. The case is identified as Grimes v. Ralphs Grocery Co., C.D. Cal., No. 2:23-cv-09086.
Judge Dismisses Microplastics Mislabeling Lawsuit Against Ice Mountain Bottled Water
August 12: In the case of Slowinski et al. v. BlueTriton Brands Inc., a federal judge in the US District Court for the Northern District of Illinois dismissed a lawsuit claiming that Ice Mountain bottled water, labeled as “100% Natural Spring Water,” is misleading due to the presence of microplastics. The plaintiffs argued that the presence of microplastics rendered the labeling false. However, US District Judge Seeger ruled that the complaint is preempted by the Food, Drug, and Cosmetic Act, as it challenges the FDA’s definition of “spring water,” which does not address microplastics. The judge emphasized that no reasonable consumer would expect a guarantee at the molecular level and that the plaintiffs failed to demonstrate any intent to defraud, or specific injuries suffered. The court found that the plaintiffs lacked standing for an injunction since they did not intend to purchase the water again, but they could pursue injury claims. The judge noted that the plaintiffs did not test the water for microplastics and that the presence of such particles does not negate the natural spring water label. The court allowed the plaintiffs to amend their complaint within two weeks, although Judge Seeger expressed skepticism about their ability to strengthen their case. A copy of the court order can be found here.
Class Action Lawsuit Filed Against LesserEvil LLC Over Lead Content in Toddler Snacks
August 13: A class action lawsuit has been filed in the US District Court for the District of Connecticut against LesserEvil LLC alleging that the company failed to disclose excessive levels of lead in its Lil’ Puffs snacks for toddlers. The complaint claims that the health food brand did not inform consumers about the harmful lead content on the product packaging. The class is seeking damages, restitution, and class certification, asserting that LesserEvil violated Connecticut and Illinois consumer protection laws, as well as the federal Magnuson-Moss Warranty Act. The plaintiff contends that the company misrepresented the safety of its products by marketing them as suitable for children, despite independent lab tests showing lead levels exceeding California’s legal limits. The lawsuit also notes that LesserEvil has received multiple notices of violation from California regarding lead content, indicating the company’s awareness of the issue. The proposed class includes all US residents outside California who purchased the snacks within the statute of limitations, as well as a subclass of Illinois residents. The case is Augustine v. LesserEvil LLC , D. Conn., No. 3:24-cv-01309 and a copy of the complaint can be found here.
Upside Foods Sues Florida Over Cultivated Meat Ban
August 14: Upside Foods, represented by the Institute for Justice, has filed a lawsuit against Florida officials in the U.S. District Court for the Northern District of Florida, challenging a new state law that bans the production, distribution, and sale of cultivated meat. Upside Foods produces meat from animal cells without raising and slaughtering animals, offering a cruelty-free alternative that has been approved by the FDA and USDA for safety and quality. The lawsuit argues that Florida’s law SB 1084, signed by Governor Ron DeSantis and effective from July 1, is unconstitutional because it violates the Commerce Clause by favoring in-state businesses over out-of-state competitors, thus undermining the national common market. The complaint highlights that the law is protectionist, shields local meat producers from competition, and is not based on safety concerns. The lawsuit also alleges that the law breaches the Supremacy Clause because it is expressly preempted by federal regulations on meat and poultry products. More information can be found here.
Class Action Filed Against The Giant Co. Over BVO in Orange Soda
August 14: A proposed consumer class action has been filed against grocery chain The Giant Co. in the US District Court for the Middle District of Pennsylvania, alleging that the company’s orange soda is defective due to the inclusion of toxic brominated vegetable oil (BVO) as a flavoring stabilizer. The complaint argues that Giant should have been aware of BVO’s toxicity, as other soda brands have removed the ingredient and its use has been restricted by various governments. The FDA recently banned BVO in foods following findings that it could cause adverse health effects, including thyroid problems. Lead plaintiff Shavonne Daniels claims she purchased a defective product, asserting that no reasonable consumer would expect a citrus-flavored beverage to cause neurological symptoms, hypothyroidism, and depression. The complaint emphasizes that Giant had a duty to disclose the potential health risks associated with BVO and brings claims of unjust enrichment, negligence, failure to warn, fraudulent concealment, breach of warranties, and strict products liability. The case is titled Daniels v. The Giant Co. LLC, case number 1:24-cv-01363, and a copy of the complaint can be found here.
Kroger and Ralphs Sued for Proposition 65 Violations Over Lead and Cadmium in Food Products
August 14: A complaint filed by Consumer Advocacy Group Inc. in Los Angeles County Superior Court accuses The Kroger Co. and Ralphs Grocery Co. of violating California’s Proposition 65 by selling roasted seaweed snacks and ground cinnamon containing cadmium and lead without providing the required consumer warnings. Proposition 65 mandates that businesses in California must provide “clear and reasonable warnings” before exposing consumers to chemicals known to cause cancer and reproductive harm, such as lead and cadmium. The lawsuit alleges that the defendants knowingly exposed consumers to these harmful chemicals through products like SeaSnax and Kroger’s private label ground cinnamon, which reportedly contains lead levels exceeding the FDA’s advisory limit. The plaintiff seeks a permanent injunction to enforce compliance with Proposition 65, civil penalties of up to $2,500 per day per violation, and reimbursement for attorney fees and costs. The case highlights the potential health risks associated with seaweed snacks, which are often perceived as healthier alternatives, due to their ability to absorb heavy metals. The complaint emphasizes the importance of consumer awareness and the right to make informed choices about product safety.
Judge Dismisses Claims Against Prime Hydration for Marketing Caffeinated Drinks to Children
August 15: Consumers alleging that Prime Hydration LLC, a beverage company founded by YouTubers Logan Paul and KSI, improperly marketed highly caffeinated drinks to children failed to plead their claims with enough specificity to proceed, according to a federal judge. The US District Court for the Western District of Kentucky stated that many claims were based on allegations of false and misleading statements and are subject to heightened pleading standards that the consumers did not meet. The judge also dismissed the public nuisance claim, noting that such claims in Kentucky are limited to real property-based issues. The consumers argued that Prime Hydration’s market largely consists of customers under 24, including minors who are at health risk from consuming high-caffeine energy drinks. Prime Hydration is also facing similar litigation in New York over caffeine content. The case is Kennedy v. Prime Hydration LLC, W.D. Ky., No. 3:23-cv-00476 and a copy of the Court’s order can be found here.
Judge Dismisses Most Claims in Hershey’s Heavy Metals Lawsuit
August 16: A federal judge for the US District Court for the Southern District of California dismissed most claims in a lawsuit against Hershey Co. for allegedly failing to disclose lead and cadmium in its dark chocolate bars. Judge Anthony J. Battaglia ruled that the plaintiff, Eva Grausz, did not demonstrate that the metals posed an unreasonable safety hazard. The judge noted that Grausz failed to provide specific amounts of the metals that would create a safety risk simply asserted that lead and cadmium are carcinogens. This marks the third dismissal of the plaintiff’s claims. However, the judge allowed misbranding and implied warranty claims against Hershey’s to proceed. The case is Grausz v. Hershey Co., S.D. Cal., No. 3:23-cv-00028 and a copy of the Court’s decision can be found here.
Gatorade Protein Bars Deceptive Marketing Lawsuit Proceeds
August 16: A federal judge for the US District Court of the Northern District of California partially upheld a consumer class action against PepsiCo, alleging PepsiCo created a “deceptive health halo” around its Gatorade brand protein bars. The plaintiffs claimed the bars were misleadingly marketed as healthy despite high sugar content. PepsiCo argued that consumers wouldn’t equate “protein” with “healthy” or “low sugar” and that their labeling complied with federal law. However, the judge found that the plaintiffs plausibly alleged consumer deception, particularly with marketing claims like “Backed by Science” and “Used by the Pros,” which aren’t preempted by federal law. The judge allowed the case to proceed but dismissed claims for injunctive and equitable relief, permitting an amended complaint within 21 days. The case is Ian McCausland et al. v. PepsiCo Inc. and more information can be found here.
Class Action Targets Protein Labeling on Erin Baker’s Products
August 26: A proposed class action alleges that Baker’s Breakfast Cookies Inc., doing business as Erin Baker’s Wholesale Baked Goods, failed to include the percent daily value for protein in its granola and breakfast cookie products. The complaint, filed in the US District Court for the Northern District of California, claims the packaging prominently displays protein content but omits the required daily value percentage. The lead plaintiff argues that the main protein source is oats which is a low-quality protein, and proper calculation would show only 45% of the advertised protein is digestible. The suit claims this omission violates FDA regulations and misleads consumers. The plaintiff in the case Brown v. Baker’s Breakfast Cookies Inc., N.D. Cal., No. 3:24-cv-05809, seeks to represent a nationwide class and a California subclass, alleging violations of California consumer protection laws, fraud, and unjust enrichment, and seeks damages and an injunction.
Class Action Alleges Misleading ‘No Salt’ Labeling on Kinder’s Seasonings
August 28: A class action lawsuit claims P.K. Kinder Co. misleads consumers by labeling seasoning products as “No Salt” despite containing potassium chloride. The complaint, filed in US District Court for the Northern District of California, argues that potassium chloride is a recognized salt substitute. The complaint noted that though “salt” in food typically means sodium chloride or table salt, the FDA issued guidance about potassium chloride in 2020. The FDA’s 2020 guidance allows “potassium salt” labeling to inform consumers, aligning with efforts to reduce sodium intake and prevent chronic diseases. The suit brings claims under California consumer protection statutes as well as claims for breach of warranty and unjust enrichment. A copy of the complaint can be found here.
This Regulatory Update covers information from August 2024.
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