• On September 4, 2024, the U.S. Food and Drug Administration (FDA) made available its annual Pesticide Residue Monitoring Program Report for Fiscal Year 2022 (FY 2022), which summarizes findings from FDA testing of human and animal foods for 757 different pesticides and selected industrial compounds from October 1, 2021, through September 30, 2022.
  • FDA’s pesticide residue monitoring program tests FDA-regulated foods shipped in interstate commerce to determine whether they comply with pesticide tolerances, or maximum residue levels, set by the Environmental Protection Agency (EPA).  FDA may take action if it is shown that the amount of pesticide residue on a food is over the tolerance, or when a pesticide is found and there is no tolerance established.  FY 2022 findings show that the levels of pesticide chemical residues in the U.S. food supply are generally in compliance with EPA pesticide tolerances.
  • Out of 2,800 total human food samples, 96.2% of domestic samples and 89.5% of imported samples were compliant were compliant.  No pesticide chemical residues were detected in 42.7% of domestic samples and 44.6% of imported samples.  In determining which products to sample, FDA may consider past problem areas, findings from state and federal monitoring, and foreign pesticide usage data.  Fruits and vegetables accounted for majority (75.5%) of domestic samples.
  • Spencer Sheehan is a Plaintiff’s attorney who has filed hundreds of class action lawsuits against food companies for allegedly deceptive labeling and marketing. A small percentage of these lawsuits survive the motion to dismiss stage, let alone succeed on the merits. Indeed, many of his losses are suffered many times over as he has a practice of refiling essentially identical lawsuits in different jurisdictions, even after unfavorable rulings.
  • His practices have increasingly drawn the ire of the courts, and this summer a United States District Court in Florida issued an order sanctioning him and making him responsible for attorney’s fees in the case.
  • Specifically, the Court applied Florida fee shifting statutes, one mandatory and one discretionary, to hold Plaintiff and Sheehan responsible for the legal fees. However, the Court went further and sanctioned Sheehan for bad faith conduct. The Court noted Sheehan’s practice of re-filing failed lawsuits in other jurisdictions after “collect[ing] consumer plaintiffs through social media advertising.” Particularly troublesome to the Court was the contention that Sheehan was not an attorney of record for the Plaintiff even when his name appeared on the pleadings. The Court found that this was part of a broader practice of flagrantly violating court rules and that Sheehan had not been admitted pro hac vice to any of the twelve cases in which he is involved that are currently pending in the same district.
  • Briefing in case continues as the Court decides on the final monetary award and whether or not to hold the local Florida counsel jointly responsible.
  • On August 29, 2024 (Law360 subscription required), the California State Legislature passed Assembly Bill 2316, the California School Food Safety Act, sending it to the governor. If signed, the bill will prohibit school districts, county superintendents of schools, or charter schools with kindergarten through 12th grade from serving Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3, which researchers have linked to serious health issues.
  • The California Assembly passed the bill in May 2024, finding that it is intended to protect the health and wellbeing of children. The bill was introduced following a 2021 report from the California Environmental Protective Agency that found that “consuming synthetic food dyes can lead to hyperactivity and other neurobehavioral problems in some children.” According to the report, the FDA’s acceptable daily intakes for the dyes are based on outdated studies that did not detect behavioral effects in children.
  • The California Assemblymember who introduced the “first-in-the-nation bill” stated that “California has a responsibility to protect our students from chemicals that harm children and interfere with their ability to learn.” The California State Superintendent of Public Instruction said the bill is “an important step forward to ensure that California’s schools are healthy and equitable learning environments for all.”
  • California Governor Gavin Newsom will have until the end of September to sign or veto the bill. If signed, it will go into effect on December 31, 2027.
  • On August 28, 2024, the U.S. Department of Agriculture (USDA) announced the availability of an updated guideline that makes recommendations to strengthen the documentation that supports animal-raising or environment-related claims on meat or poultry product labeling.  According to USDA, the intent is to protect consumers from false and misleading labels.
  • Animal-raising claims (e.g., “Raised Without Antibiotics,” “Grass-Fed,” “Free-Range”) and environment-related claims (e.g., “Raised using Regenerative Agriculture Practices,” “Climate-Friendly”) are voluntary marketing claims that highlight certain aspects of how the source animals for meat and poultry products are raised or how the producer maintains or improves the land or otherwise implements environmentally sustainable practices.  The documentation submitted by companies to support these claims is reviewed by USDA’s Food Safety and Inspection Service (FSIS) and the claims can only be included on the labels of meat and poultry products sold to consumers after they are approved by the agency.
  • In the updated guideline, FSIS strongly encourages the use of third-party certification and more robust documentation to substantiate animal-raising or environment-related claims.
  • Additionally, the updated guideline recommends that establishments using “negative” antibiotic claims (e.g., “Raised Without Antibiotics” or “No Antibiotics Ever”) implement routine sampling and testing programs to detect antibiotic use in animals prior to slaughter or obtain third-party certification that includes testing.
  • Public comments will be accepted and reviewed for 60 days after publishing in the Federal Register.
  • Keller and Heckman will continue to monitor and report on any rulemaking developments.
  • On August 9, 2024, FDA issued a warning letter to Austrofoods S.A.S., the Peruvian-based manufacturer that produced lead-contaminated apple cinnamon fruit puree pouches that were the subject of a recall last year.
  • The letter follows up on inspections that were conducted in December of last year and which “found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation” in 21 CFR Part 117.
  • The specific violations of these rules that were referenced include:
    • The failure to conduct an appropriate hazard analysis to identify and evaluate lead as a known or reasonably foreseeable hazard requiring a preventive control. FDA noted that lead is often found in spices and that children (the intended consumers) are particularly sensitive to it. Although lead was identified as a hazard, the plan concluded that no preventive control was required based on vague and faulty rationales like “supplier without historical precedents [of lead contamination].”Although the plan concluded that no lead control was required, it nevertheless required that cinnamon be purchased from an approved supplier with certificates of analysis (COA). However, the supplier approval plan was not properly implemented and no on-site audits were conducted. FDA recommended that COAs from labs using scientifically valid methods and procedures document that supplied ingredients (e.g., cinnamon) meet food-grade production standards for every major analytical parameter (e.g., heavy metals).
    • The plan for heavy metal monitoring in the finished product that was provided to FDA did not include critical information like what constituted a representative sample, what method would be used by the test lab, and how the company would assure that the method was properly followed.
  • The warning letter is part of FDA’s continued efforts to reduce the incidence of lead and other heavy metal contamination.   
  • Mondelēz International Inc. has been sued (Law360 subscription required) for allegedly using deceptive sustainability claims regarding its cocoa supply chain. According to the plaintiffs, Mondelēz’s supply chain “really contributes to ‘grievous and unsustainable labor abuses.’”
  • Mondelēz launched its “Cocoa Life” program in 2012 to “help make cocoa sourcing more sustainable in key cocoa-producing countries.” Mondelēz affixes the Cocoa Life logo on its products to represent that those products “protect the planet” and “respect the human rights of people within our own operations and in our value chain.” However, according to the complaint, farms in Mondelēz’s supply chains are linked to unfair labor practices, hazardous child labor, and deforestation; therefore, the products are not responsibly sourced or sustainable, and the Cocoa Life logo is misleading.
  • The product packaging directs consumers to the Cocoa Life website, which explains that the products “help enhance child protection systems” and improve communities and forests. The plaintiffs allege that these misrepresentations are false and deceptive because sustainability and ethical sourcing is important to consumers and “a majority of consumers would stop buying from brands they believe are unethical,” but that Mondelēz hides the unethical practices in its supply chain to sell products at higher prices.
  • This is the second suit this year alleging that Mondelēz “greenwashes” its products with deceptive labeling that “hides evidence of environmental degradation, child labor and child slavery in its supply chain.” The first complaint, filed in January 2024, is set for a dismissal hearing in November.
  • Keller and Heckman will continue to monitor this and other food labeling litigation.
  • French start-up, Gourmey, has submitted the EU’s first application for novel food approval of a cultivated meat product, duck foie gras, which it is offering in both a pâté “semi-cuit” form and as whole pieces ready for frying.
  • The European Commission (EC) will review before asking the European Food Safety Authority (EFSA) for a risk assessment, which the agency will start after verifying that the application contains all the required studies to prove that the product is safe for consumers to eat.
  • While the application should theoretically take about 18 months to review, it will most likely exceed this timeframe, as it is the first cultivated meat product application.
  • An EFSA approval may be controversial.  Italy in particular is opposed to cultivated meat and, in December 2023, banned lab-grown food from the Italian market.  The ban is arguably in breach of European law, since the Meloni government failed to respect EU standstill procedures, adopting the Italian bill before the end of the mandatory comment period, when a measure should be put on hold to allow other EU member states or EC to raise concerns.
  • If the Gourmey foie gras – or any other cultivated meat or fish – is authorized at EU level under the novel foods regulation, the decision will be binding on Italy and the government will have to allow the product on the Italian market.
  • Last week the United States Court of Appeals for the Second Circuit affirmed a grant of summary judgment for Defendants Walgreen Co. and International Vitamin Corporation (IVC) on preemption grounds in a case involving dietary supplement labeling. IVC manufactured and Walgreens sold a glucosamine dietary supplement product which Plaintiffs argued was misleadingly labeled in light of the product formulation.
  • Plaintiff alleged that Defendants should have declared the dietary ingredient as “glucosamine hydrochloride and potassium sulfate” (bold added) and not as “glucosamine hydrochloride potassium sulfate.” This argument hinged on the distinction between glucosamine sold as a single crystal form in contrast to a blended form. The single crystal form consists of a glucosamine-sulfate-potassium-chloride salt, while the blend consists of a mixture of a glucosamine-hydrochloride salt and potassium-sulfate salt. In an aqueous solution (as with the human body), both forms dissociate into the same glucosamine, sulfate, potassium, and chloride constituents.
  • Dietary ingredients like glucosamine for which FDA has not established a Reference Daily Value or a Daily Reference Value must be declared by their common or usual name which, the court stated, is to be determined by testing the ingredient with a validated method of identification. In the absence of appropriate AOAC methods, “other reliable and appropriate analytical procedures” may be used, although FDA has indicated that, where available, it expects official compendial methods such as the U.S. and European pharmacopoeias to be used.
  • It was uncontested that both forms of glucosamine (single crystal and blend) are consistent with the monographs for “Glucosamine Sulfate Potassium Chloride” in the U.S. and European pharmacopoeias. The Federal Food, Drug, and Cosmetic Act (FDCA) contains an express preemption provision which forbids states from establishing food labeling standards that are “not identical” to certain federal food labeling requirements, including the requirement that ingredients be identified by their common or usual names. Therefore, because the dietary ingredient declaration was consistent with the monographs in the pharmacopoeias, and such pharmacopoeias contained “reliable and appropriate analytical procedures” endorsed by FDA, the Court held that “glucosamine hydrochloride potassium sulfate” was the common or usual name under the federal regulations and that the name was insulated from legal challenge based on the FDCA’s labeling preemption provision.
  • On August 16, 2024, FDA issued Edition 2 of the Draft Guidance for Industry: Voluntary Sodium Reduction Goals covering target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods. The Guidance builds on Phase 1, which set initial targets to encourage the food industry to voluntarily reduce sodium levels in various processed, packaged, and prepared foods.
  • The Guidance is intended to provide voluntary goals to “reduce excess population sodium intake, while recognizing and supporting the important roles sodium plays in food technology and food safety.” More than 70% of total sodium intake is from sodium added during food manufacturing and commercial food preparation, with the average daily sodium intake at approximately 3,400 mg/day. The 2020-2025 Dietary Guidelines for Americans, however, advises individuals 14 and older to limit their consumption to 2,300 mg/day. The Guidance sets a goal to help reduce sodium intake to 2,750 mg/day, which, while higher than the Dietary Guidelines recommends, is “intended to balance the need for broad and gradual reductions in sodium and what is publicly known about technical and market constraints on sodium reduction and reformulation.”
  • Excess sodium consumption has been shown to be a contributing factor in the development of hypertension, which is a leading cause of heart disease and stroke. Decreasing population sodium intake is expected to reduce the rate of hypertension and lower blood pressure. Researchers estimate that broadly reducing sodium intake could prevent between 280,000 and 500,000 premature deaths over 10 years.
  • The Guidance sets voluntary goals for baseline, target mean, and upper bound sodium concentrations for several foods and food categories. The baseline is the “state of the market” for each category in 2022 based on information gathered from food labels and menus. The target mean concentration is the “desired average sodium concentration” and the voluntary upper bound is a standard that can be applied to every product in a category.
  • The initiative to reduce sodium is one of many nutrition initiatives FDA is working on to reduce diet-related chronic diseases, including an updated definition of “healthy” and a proposed rule for front-of-pack nutrition labeling.
  • Keller and Heckman will continue to monitor and provide updates on FDA’s sodium reduction goals and other nutrition initiatives.
  • On August 14, 2024, the Federal Trade Commission (FTC or Commission) announced its Final Trade Regulation Rule on the Use of Consumer Reviews and Testimonials (Final Rule) to rein in what it believes is the widespread practice of using fake reviews and testimonials to boost sales of products or services.
  • The long-awaited Final Rule was developed under the provisions of the Magnuson-Moss Warranty Act. Thus, it is the culmination of a two-year process that started in November 2022 with the publication of an Advance Notice of Proposed Rulemaking (ANPR), followed by a Notice of Proposed Rulemaking (NPRM) in July 2023, and a February 2024 informal public hearing.
  • The Final Rule reflects some changes from the proposed rule set out in the NPRM, including clarifications and limitations that were based on feedback received during the public comment period. For example, a previously proposed section addressing reuse of consumer reviews written for one product, so that the reviews appear written for a “substantially different product,” was omitted from the Final Rule following multiple comments, including a comment that raised a disputed issue of material fact.
  • The Commission decided not to finalize this provision at this time and reserved it for potential future rulemaking.
  • To read more, including key provisions of the Final Rule, click here.