• FDA published a report on June 11 that expresses concerns with farm animal operations located nearby fields growing produce. The report focuses on a 2020 Salmonella enteritidis outbreak in peaches that affected 101 people across 17 states and explains FDA’s testing and traceback processes from the outbreak.
  • The report explains that FDA connected pathogen samples from peaches and peach tree leaves to a strain of Salmonella on an adjacent chicken operation using whole-genome sequencing on chicken isolates from the same period as the outbreak. The results prompted additional testing around the company’s orchards where other strains of Salmonella were connected to genetically identical pathogens found in beef and cattle isolates from an adjacent cattle feedlot. The findings helped FDA quickly identify and prioritize investigations at certain peach packing and holding operations and other peach orchards.
  • The report states these findings underscore FDA’s concern about the potential impact adjacent land uses have on produce safety, including the potential impact of dust exposure. Past outbreaks have been linked at least in part to animal feeding operations, including a 2018 E. coli outbreak in romaine lettuce. FDA encourages collaboration between neighboring farms to identify areas of concern and tailor their land management to the specific practices and conditions on individual farms.
  • The Consumer Brands Association, The Safe Food Coalition, and The Association of Food and Drug Officials published a joint letter to Janet Woodcock, FDA’s Acting Commissioner of Food and Drugs, expressing their support for FDA’s compliance with the inspection frequency mandates required by the Food Safety Modernization Act (FSMA) and encouraging FDA to utilize state officials to help carry the burden.
  • The letter expresses concerns with FDA’s recently published Resiliency Roadmap for FDA Inspectional Oversight, which states that FDA seeks to work with Congress to allow the agency more flexibility in conducting inspections, specifically it seeks to conduct inspections on a risk-based frequency rather than a congressionally-mandated timeline.  The organizations note that they disagree Congress should step in to revisit the FSMA inspection frequency mandate for domestic food facilities, highlighting that FDA’s existing risk-based inspection strategy is consistent with the FSMA inspection mandate and that inspections are a “critical component of managing foodborne illness risk.” The organizations also suggest FDA lead a stakeholder engagement series to obtain feedback on ways to meet the domestic inspection frequency mandates and gather ideas on how to modernize inspections.
  • By way of background, FSMA requires FDA to inspect domestic food facilities (such as manufacturers/processors) at specified frequencies based on two broad categories of risk. FDA must inspect high-risk U.S. food facilities at least once every three years and  non-high-risk U.S. food facilities at least once every five years. The Resiliency Roadmap showed that FDA is not on track to meet its inspection mandate, in large part because lower-priority inspections were postponed during the COVID-19 pandemic.
  • On June 11, 2021, the FDA will issue its final rule to revoke the standards of identity (SOIs) for lowfat and nonfat yogurt, and amend the SOI for yogurt. The final rule regulates lowfat and nonfat yogurts under the general SOI for yogurt at 21 CFR § 131.200 and 21 CFR § 130.10 (“Requirements for foods named by use of a nutrient content claim and a standardized term”).  This action is in response to a citizen petition filed by the National Yogurt Association (NYA) in 2000 and is part of FDA’s Nutrition Innovation Strategy.  FDA states that the final rule modernizes the yogurt standard “by allowing for greater flexibilities and technological advances in yogurt production.”
  • The final rule permits the use of any optional safe and suitable milk-derived ingredient to increase “milk solids not fat content,” as well as safe and suitable emulsifiers, flavors, color additives, preservatives, cultures, stabilizers, and nutritive carbohydrate sweeteners.  FDA decided to retain reference to “nutritive carbohydrate sweeteners” instead of referring to “sweeteners” to exclude nonnutritive sweeteners.  FDA explained that, to comply with FDA’s regulatory framework under the Nutrition Labeling and Education Act (NLEA), nonnutritive sweeteners may only be added to yogurt under § 130.10 with a corresponding nutrient content claim (e.g., “reduced calorie yogurt”).  The final rule also optionally permits fortification with vitamins A (at a minimum of 10% of the daily value per serving) and vitamin D (at a minimum of 25% of the daily value per serving) and within the limits of current good manufacturing practices.
  • The final rule establishes minimum amounts of live and active cultures for yogurt products to bear the optional labeling statement, “contains live and active cultures.” To bear the label, yogurt must contain at least 107 CFU/g of live and active cultures at the time of manufacture and a reasonable expectation of 106 CFU/g throughout the product’s assigned shelf life.  If dairy ingredients are treated after culturing to inactivate viable microorganisms, the final rule requires a statement of “does not contain live and active cultures” on the label (§ 131.200(f)(1)(ii)). The statement must appear in letters not less than one-half of the height of the letters used in the product name.
  • The final rule is effective on July 11, 2021 and has a compliance date of January 1, 2024.
  • On Friday, June 4, U.S. District Judge James Lorenz denied preliminary approval (subscription to Law360 required) of a General Mills class action settlement due to signs of collusion. The California federal judge said the deal raises questions about whether class counsel really had the consumers’ interests in mind, as the deal offers no money to the class, but a large payout to the attorneys.
  • In December 2017, consumers filed a class action lawsuit against General Mills, claiming that its fruit-flavored snacks (Fruit Roll-Ups) were intentionally mislabeled as all natural. The suit alleged that the products were advertised as “naturally flavored” and containing “no artificial flavors” but contained malic acid.
  • General Mills and the class of consumers recently reached a settlement agreement which would require minimal label changes to the product’s packaging. Under the proposal, General Mills would display an asterisk next to the “no artificial flavors” claim, with the asterisk directing consumers to the company’s website where it would be mentioned that the product may “contain synthetic malic acid or other acidulants” and that “malic acid is intended for use not as a flavor or to impart the characterizing flavor of these products, but is a substance the FDA approves for multiple uses including a flavor enhancer, a flavoring agent or adjuvant, or as a pH control agent.” The settlement would provide no money to class members and instead provide a $725,000 payout to the attorneys for fees and costs. Such an agreement strays far from the class’s original request for monetary relief. The court ultimately found that the settlement falls short of a fair and adequate settlement to resolve the class claims and denied the proposed deal.
  • A class action lawsuit (law360 subscription required) filed against Burt’s Bees, Inc. alleges that the company misleadingly labels its dog shampoos as “99.7% natural” when in fact they contain mostly synthetic ingredients.
  • The front of the shampoo bottles also tout the specific natural ingredients included in the shampoos, e.g., “with Colloidal Oat Flour & Honey.” In contrast, Plaintiff alleges that the products contain only minute quantities of natural ingredients and are composed largely of the following synthetic ingredients:  coco betaine, coco glucoside, glyceryl oleate, disodium cocoyl glutamate, glycerin, xanthan gum, potassium sorbate, and sodium benzoate.
  • The dog shampoos are not regulated by the FDA; they are not cosmetics because they are not marketed for human use and are not animal drugs because they do not claim to diagnosis, cure, mitigate, treatment, or prevent disease or to affect the structure or any function of the body. However, the products, which are classified as grooming aids (the animal equivalent of cosmetics), are still subject to Federal Trade Commission (FTC) regulation of false advertising claims. To that end, Plaintiff references FTC guidance which states that products making 100% natural claims cannot contain any synthetic or artificial ingredients and that “companies can’t misstate the extent to which any product contains natural or synthetic components [and] can’t make misleading claims about ingredients or composition.”
  • As we have reported on previously, natural claims are often targeted in food litigation. FDA has not engaged in rulemaking to define the term but, like FTC, considers it to mean that the product contains nothing artificial or synthetic, and is considering further action to define the term in food labeling.  We will continue to monitor and report on any developments in this “natural” litigation space, in food and otherwise.
  • A class-action lawsuit brought on behalf of a proposed group of California consumers alleges that Purely Elizabeth, LLC’s products, including granola, oats, and waffle and pancake mixes, are misbranded and deceive consumers by making false claims related to their protein content.
  • Specifically, Plaintiffs allege that the products contain up to 25% less protein than declared. Some of the products’ statements of identity advertise them as protein products, i.e., “Grain-Free Protein + Collagen Pancake & Waffle Mix,” and all include a statement on the principal display panel declaring the protein content.  Plaintiffs also allege that the protein content declaration constitutes a protein claim which would require that the percent daily value (%DV) of protein that the product provides be declared. (See 21 C.F.R. §  101.9(c)(7); California has adopted all of federal food labeling regulations).  Furthermore, the protein content used to compute the %DV must be corrected for by PDCAAS score, a measure of protein digestibility. The products allegedly do not declare the %DV of protein and contain proteins with low PDCAAS scores (i.e., less digestible proteins) such as collagen and amaranth that would further reduce the %DV of protein that they provide.
  • This is the second class-action lawsuit related to protein content that has been filed recently. Food companies should remember that a protein claim triggers a mandatory protein %DV declaration which must take into account the PDCAAS score of the protein source(s).

 

 

Two recently-filed class actions target Pepperidge Farm butter-flavored crackers and Nestlé vanilla-flavored coffee creamer:

  • Pepperidge Farm Butter Crackers (Law360 subscription required): A class of consumers filed suit against Pepperidge Farm, Inc. on May 31, 2021 in the U.S. District Court for the Southern District of Illinois claiming that the company’s “Golden Butter” crackers are misleadingly labeled because the product does not contain a meaningful amount of butter and uses primarily synthetic substitutes like vegetable oils. The claims are based on alleged violations of Illinois consumer protection law, federal warranty law, and unjust enrichment. As we previously reported, Pepperidge Farm faces a lawsuit based on similar claims in New York.
  • Nestlé Vanilla-Flavored Coffee-mate (Law360 subscription required): A class of consumers filed suit against Nestlé USA in the U.S. District Court for the Northern District of California on June 2, 2021 alleging that its natural vanilla-flavored Coffee-mate products are misleadingly labeled because the products purport to contain natural vanilla flavor when they instead contain primarily artificial vanilla flavor. The claims are based on alleged violations of California consumer protection law and unjust enrichment. Vanilla flavoring remains a popular target for class actions.

Two other cases in the consumer class action space have recently settled:

  • Pressed Juicery “Greens Juice” Settlement: Pressed Juicery, Inc. reached a $695,000 settlement agreement with a class of plaintiffs that sued claiming the company’s “Greens Juices” product contained sugary fruit juices as the primary ingredients instead of the green vegetables represented on the labels. Consumers that purchased qualifying product between May 1, 2014 and May 19, 2021 are eligible to file a claim and receive $1 per product purchased for up to 10 products. Claimants need not show proof of purchase. Final approval of the settlement is scheduled for October 8, 2021.
  • Blue Diamond Vanilla Flavoring Settlement: Blue Diamond Growers reached a $2.6 million settlement with a class of plaintiffs that sued claiming “Almond Breeze” brand nut-based dairy-alternative products that referenced vanilla flavor did not use real vanilla. Consumers that purchased qualifying products between April 15, 2014 and May 17, 2021 are eligible to file a claim and receive $0.50 per product without proof of purchase, or up to $1 per product with proof of purchase, for up to 10 products. A fairness hearing is scheduled for August 25, 2021, and claims must be submitted by November 23, 2021.
  • Last year we reported on FDA’s New Era of Smarter Food Safety Blueprint, which outlines the Agency’s plan to create a safer food system over the next decade. The Blueprint focused on tech-enabled traceability, smarter tools and approaches for prevention and outbreak response, new business models and retail modernization, and promotion of food safety culture.
  • On June 1, the FDA launched a public challenge in tangent with the New Era of Smarter Food Safety initiative to encourage the development of affordable, tech-enabled traceability tools to protect people and animals from contaminated foods.  The FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge aims to develop scalable traceability hardware, software, or data analytics platforms that are low- or no-cost to the end user, while promoting innovation.  Entries will be evaluated on the following criteria:
    • Ability to address the needs of the targeted segment of the food supply chain.
    • Uniqueness and innovativeness of the technology developed.
    • Likelihood of utilization and ease of navigation.
    • Affordability to enable inclusive and viable traceability approaches.
    • Scalability and interoperability for the solution to be used by a majority of the targeted segment of the food supply chain.
  • FDA’s Office of Food Policy and Response is overseeing the public challenge, which runs from June 1, 2021 to July 30, 2021.  Up to 12 entrants will be announced as challenge winners, with their respective video submissions posted to FDA’s website and shared at an FDA webinar.  Entrants are not required to transfer any intellectual property rights to FDA nor provide an open source code.
  • On June 1, the FDA published a press release announcing that Real Water Inc., a Nevada-based bottled water manufacturer, agreed to cease operations until they can comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.
  • As our readers may recall, the FDA has been investigating an outbreak of acute non-viral hepatitis of unknown cause in Nevada. The consumption of Real Water brand alkaline water was the only known common link between five cases of acute liver failure in children that occurred in November and December 2020. An additional 11 cases of acute non-viral hepatitis in adults, including one death, have since been identified as possibly linked to the consumption of Real Water brand alkaline water.
  • According to a complaint filed by the Department of Justice (DOJ) on behalf of the FDA, defendants violated the FD&C Act by operating facilities that failed to meet preventive controls requirements to control food hazards, and also failed to follow current good manufacturing practice (cGMP) requirements for bottled water. The Real Water Inc. products were also deemed adulterated within the meaning of the FD&C Act because they were prepared, packed, or held under insanity conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.
  • U.S. District Judge Jennifer A. Dorsey entered a consent decree of permanent injunction between the US and AffinityLifestyles.com Inc. (a majority shareholder of Real Water Inc.), Real Water Inc., Brent A. Jones (president of Real Water Inc.), and Blain K. Jones (vice president of Real Water Inc.). The consent decree requires defendants to cease operations until they complete corrective actions, including hiring a qualified independent expert to inspect their facilities. Further, defendants may not resume operations until procedures are implemented to ensure continuing compliance with food safety requirements.
    • On May 24, 2021, the consumer protection groups Food & Water Watch and Empire State Consumer Project, Inc. (ESCP) requested (via letter) that the FDA take action to address the allegedly high levels of arsenic and lead found in many vinegar products.
    • ESCP tested 24 samples of major brands of vinegars or vinegar reductions or glazes and found that 11 contained arsenic or lead and 7 contained both. And, of the 11 products, 10 were balsamic products and all were imported from Italy, Greece, or Spain. Arsenic levels in contaminated products ranged from 70 parts per billion (ppb) to more than 1,040 ppb, which means at maximum levels, one tablespoon serving of vinegar would exceed FDA’s maximum allowable level of 0.01 mg arsenic in one liter of drinking water (equivalent to 10 ppb arsenic). Lead levels ranged from 68.6 to 127 ppb, which exceeded the 34 ppb safe harbor level for balsamic vinegars under California’s Proposition 65.
    • Citing to the dangers of arsenic and lead exposure, particularly to developing fetuses, the letter requests FDA to perform product testing and establish limits and warnings addressing lead and arsenic in vinegars and vinegar reductions or glazes.
    • This letter comes in the wake of the fallout from the Congressional report on heavy metals (including arsenic and lead) in baby foods, which has prompted FDA’s Closer to Zero Plan as well as proposed legislation in Congress, both aimed at reducing heavy metals levels in baby foods. Keller and Heckman will continue to monitor any developments in the regulation of heavy metals in food.