• A class-action lawsuit filed by Spencer Sheehan which alleged that Whole Foods deceptively labeled its “Oats & Flax Instant Oatmeal” (sold under the 365 Everyday Value brand) has been dismissed without prejudice.
  • The lawsuit brought a variety of causes of action against Whole Foods based on alleged consumer deception related to (1) the labeling of an ingredient as “dehydrated cane juice solids” instead of sugar and (2) the whole grain content of the oatmeal.
  • Specifically, in regard to the first alleged deception, Plaintiffs argued that they purchased the product believing that the “dehydrated cane juice” referred to a fruit juice ingredient and not sugar. The front of the package contained a picture of a bowl of oatmeal with a few raspberries sprinkled on top and lying to the side of the bowl. The Court rejected this claim because there was no representation regarding the sugar content of the oatmeal on the front box (e.g., sugar free) and because any consumers that did not recognize the ingredient listing of “dehydrated cane juice solids” as synonymous with sugar could readily view the sugar content of the product on the adjacent and much larger nutrition facts panel. The court also stated that there was no reason to believe that a reasonable consumer would interpret cane juice to mean fruit juice and that to the extent that the raspberries on the front cover implied that the product contained real raspberries, this notion would be quickly dispelled by the ingredient list.
  • Plaintiffs also alleged that the statement “100% Whole Grain – 18g or more per serving” on the front display panel was misleading because it implied that the product was entirely made up of whole grains. The court dismissed this allegation as frivolous because it was inconsistent with the other allegation (a product containing sugar cannot be completely whole grain), the product name included flax, which is an oilseed and not a grain, and the “18 g or more per serving” clarified that the 100% whole grain content referred to just that portion of the product. The case is another reminder that courts will view allegations of consumer deception in the context of all the information available to consumers.

 

  • FDA’s definition of “dietary fiber” at 21 CFR 101.9(c)(6)(i) identifies seven soluble, isolated or synthetic non-digestible carbohydrates (NDCs) that have been determined by FDA to have physiological effects that are beneficial to human health and, thus, may be declared as dietary fiber on Nutrition and Supplement Facts labels.  In 2018, FDA issued guidance which, as discussed here, identifies eight additional NDCs that may be declared as dietary fiber under FDA’s enforcement discretion pending rulemaking to revise 21 CFR 101.9.  As of January 10, 2020, with the addition of “glucomannan,” as discussed here, FDA had recognized a total of ten isolated or synthetic NDCs that may be used subject to regulatory discretion in response to citizens petitions requesting addition of the substances to the definition of dietary fiber.
  • On December 17, 2021, FDA announced that it intends to propose that “Acacia (Gum Arabic)” also known as gum acacia, be included in the definition of dietary fiber at 21 CFR 101.9(c)(6)(i).  Based on available evidence, FDA determined that the scientific evidence suggests that gum acacia can help reduce blood glucose and insulin levels after it is eaten with a meal containing a carbohydrate that raises blood glucose levels.  With the addition of gum acacia, there are now 18 categories of isolated or synthetic NDCs which are either included in the definition of dietary fiber (i.e., beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, hydroxypropylmethylcellulose) or may be included in the dietary fiber declaration on the Nutrition and Supplement Facts labels under FDA’s continuing exercise of enforcement discretion until FDA completes rulemaking to add additional fibers to the regulatory definition of dietary fiber (i.e., mixed plant cell wall fibers, arabinoxylan, alginate, inulin and inulin-type fructans, high amylose starch (resistant starch 2), galactooligosaccharide, polydextrose, resistant maltodextrin/dextrin, cross linked phosphorylated RS4, glucomannan, acacia (gum arabic)).  FDA will continue to evaluate citizen petitions that could result in the recognition of additional substances as dietary fiber.
  • Keller and Heckman assisted in the submission of the citizen petition to expand the list of substances considered by FDA to fall within the definition of dietary fiber to include gum acacia.
  • As previously reported, on January 8, 2021 California’s Office of Environmental Health Hazard Assessment (OEHHA) published a proposed rulemaking to limit the use of the short-form version of the Proposition 65 safe harbor warning.  Short-form warnings, which do not require the disclosure of chemical name(s) in the warning, have been widely used by manufacturers since they became an option in 2016.
  • On December 13, 2021, OEHHA published a notice of modification to the proposed amendments on short-form warnings.  As a response to comments received during the proposed rulemaking, OEHHA has modified the proposed regulation to make the following changes:
    • Increase the maximum label size for short-form warnings from 5 square inches to 12 square inches.
    • Allow the use of short-form warnings to be used on internet or catalog warnings, when the short-form warning is being used on the product label.
    • Provide the additional signal word options of “CA Warning” or “CALIFORNIA WARNING” to make clear that the warning is being given pursuant to California law (whereas the original language only permitted the signal word “WARNING”).
    • Provide additional warning language options including: “Exposes you to [name of chemical], a [carcinogen and/or reproductive toxicant] -www.P65Warnings.ca.gov.” and “Exposes you to [name of chemical], a carcinogen, and [name of chemical], a reproductive toxicant – www.P65Warnings.ca.gov.”
  • OEHHA is accepting comments on the proposed modifications through January 14, 2022. We will continue to monitor any developments.
  • On December 7, U.S. Representatives Chellie Pingree (D-Maine) and Dan Newhouse (R-Washington), and U.S. Senator Richard Blumenthal (D-Connecticut), reintroduced the bipartisan Food Date Labeling Act in both the House and Senate (H.R. 6167; S.3324). The bill is designed to end consumer confusion around food date labeling and increase the consumption and donation of safe, edible food. According to its sponsors, the Act will reduce food waste by standardizing date labels on food products.
  • Government estimates indicate that Americans waste 40% of the overall food supply on an annual basis, much of it caused by confusing and conflicting information around food date labels. Meanwhile, as per Rep. Pingree’s press release, more than 38 million Americans are food insecure and the climate crisis is worsening, in part, due to food waste. “It is estimated that if all food waste represented an individual country, it would be the third largest emitter of greenhouse gases globally.” Federal law does not regulate the use of date labels on food products, with the exception of infant formula. In the absence of federal regulation, 41 states have developed their own date labeling requirements that use varying and inconsistent language, such as “sell by,” “use by,” “freshest on,” and “expires by.”
  • The Food Date Labeling Act will establish date labeling language that clearly differentiates between quality and safety: “best if used by” communicates that the qualify of the food product may begin to deteriorate after the date, and “use by” communicates the end of the estimated period of shelf life, after which the product should not be consumed. Under the legislation, food manufacturers will decide which food products carry a quality or discard date. The legislation will also allow food to be sold or donated after its labeling quality date.
  • H.R 6167 was assigned to the House Energy and Commerce Committee as well as the Agriculture Committee; S. 3324 was sent to the Senate Health, Education, Labor, and Pensions Committee. Provisions to standardize food date labeling were also included in Rep. Pingree’s Agriculture Resilience Act, which was reintroduced in April 2021. Additionally, in September, Reps. Pingree and Newhouse, along with Congresswoman Suzanne Bonamici (D-Oregon) reintroduced the School Food Recovery Act, which would create a new program at the USDA to support schools working on food waste reduction projects.
  • The United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) worked collaboratively with the Food and Drug Administration’s Center for Food Safety and Applied Nutrition (FDA/CFSAN) in consultation with the Centers for Disease Control and Prevention (CDC) and received input from industry, academic institutions, and consumer advocacy group stakeholders to conduct an “Interagency Risk Assessment: Listeria monocytogenes in Retail Delicatessens” as described in FSIS’s September 2013 Technical Report.  FSIS incorporated the key findings into its 2014 FSIS Best Practices Guidance for Controlling Listeria monocytogenes (Lm) in Retail Delicatessens Compliance Guidelines (Retail Lm Guidance).  In January 2016, FSIS launched a multi-year nationwide pilot project to collect surveillance data to assess whether retail delicatessens are using the recommendations in the Retail Lm Guidance.
  • In a December 10, 2021 Constituent Update, FSIS announced that as of September 30, 2021, it discontinued its retail Lm surveillance because data analysis has shown that retailers have consistently followed a high percentage of the recommendations.  Since the pilot project was launched in 2016, FSIS investigators completed a total of 7,114 questionnaires in retail delis to determine the adoption rate of the recommendations.  In the fourth quarter of FY 2021, FSIS reviewed 155 questionnaires completed by investigators in retail delis.  The agency exceeded its voluntary compliance targets with the retailers following 93% of the 33 recommendations (target 92%) and with 75% of retailers following all eight of the most important guidelines (target 64%).
  • Moving forward, FSIS will continue steps to educate the industry on its Retail Lm Guidance and associated best practices.  FSIS intends to broaden its reach by partnering with retail trade associations and state regulatory authorities to assist in the distribution of educational materials for this initiative.

Ill. Judge Trims Fraud Suit Targeting Barilla Pasta Sauce (subscription to Law360 required)

  • A proposed class action lawsuit filed against Barilla America Inc. in October 2018 alleges that consumers in Illinois, California, and Kansas were misled by the claim “no preservatives” on jars of pasta sauce containing citric acid as an ingredient.  The plaintiffs assert that Barilla’s pasta sauce is deceptively labeled as containing no preservatives because the U.S. Food and Drug Administration (FDA) recognizes citric acid as a preservative that delays rancidity, prevents spoilage, and slows certain other changes in food.
  • On December 10, 2021 a federal judge in the Northern District of Illinois ruled from the bench that consumer fraud, breach of warranty, and unjust enrichment claims can proceed against Barilla over the allegedly deceptive labeling.  The judge ruled against the plaintiffs on implied warranty and negligent misrepresentation claims, although leave to amend was granted.  The judge also denied injunctive relief, finding that plaintiffs’ future harm is conditional, being dependent on their choosing to purchase the pasta sauce again as opposed to purchasing a different brand or making their own pasta sauce.
  • As discussed here, a similar false advertising lawsuit brought by the same attorneys was dismissed last year against Kraft Heinz Food Co. concerning its Capri Sun juice products containing citric acid.  The more succinct “no preservatives” labeling on the pasta sauce, however, may be distinguished from “no artificial preservatives” labeling on Capri Sun where the plaintiffs’ case was doomed by problems drawing a connection between the common industry practice used to artificially manufacture citric acid and the actual practice used by Kraft.
  • As a part of its work to implement the Food Safety Modernization Act and New Era of Smarter Food Safety initiative, FDA has released its Foodborne Outbreak Response Improvement Plan (“Improvement Plan”).  This Improvement Plan is designed to help FDA and its partners enhance the speed, effectiveness, and communication of foodborne outbreak investigations.  To create this Improvement Plan, the Agency collaborated with the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS), Centers for Disease Control and Prevention (CDC), state health officials, industry and consumer foodborne outbreak experts, and FDA leadership and staff.
  • FDA will also work with the University of Minnesota’s School of Public Health to assess the Agency’s capacity to support, join, or lead multistate outbreak investigations and to provide recommendations in an independent public report.  This report, “An Independent Review of FDA’s Foodborne Outbreak Response Processes,” provides an objective assessment of the Agency’s structural and functional capacity to respond to multistate foodborne illness outbreaks.  According to FDA, the report played an instrumental role in the development of the Improvement Plan.
  • The Improvement Plan focuses on improving four specific priority areas, which FDA believes will have the most impact on outbreaks associated with human food.
    • Tech-enabled product traceback: a digital resource to collect voluntarily provided consumer purchase data to better facilitate and expedite how FDA receives outbreak data.
    • Root-cause investigations (RCIs): a set of protocols and procedures to help standardize and expedite the release of outbreak investigation data to industry and the public.
    • Strengthen analysis and dissemination of outbreak data: FDA will work with CDC, USDA’s FSIS, and other partners to strengthen data sharing among the agencies, which should help identify reoccurring, emerging, and persistent strains of pathogens
    • Operational improvements: the Agency will focus on improving its performance measures to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities
  • Keller and Heckman will continue to monitor and report on this and similar matters.
  • On August 10, 2021, Prollergy Corporation (Prollergy) submitted a notification to FDA regarding health claims related to the introduction of allergenic foods to infants and the reduction in the risk of developing food allergies. Under the Federal Food, Drug and Cosmetic Act, as amended by the FDA Modernization Act (FDAMA), a manufacturer may submit to FDA a notification for a health claim based on an authoritative statement from a scientific body of the US Government or the National Academy of Sciences; in this case, the authoritative statement Dietary Guidelines for Americans 2020-2025 and 2020 Dietary Guidelines Advisory Committee.
  • On December 8, 2021, FDA announced that it had completed reviewing Prollergy’s notification, concluding that manufacturers may use the following claims on the label of any food product that qualifies for the claims:
    • “If a baby has severe eczema, egg allergy or both, introducing age-appropriate, peanut-containing foods as early as 4 months may reduce the risk of developing a peanut allergy. Caregivers should check with the baby’s healthcare provider before feeding the baby peanut-containing foods.”
    • “For babies with an increased risk of peanut allergy (babies with severe eczema, egg allergy or both), introducing age-appropriate, peanut-containing foods as early as 4 months may reduce the risk of developing a peanut allergy. Caregivers should check with the baby’s healthcare provider before feeding the baby peanut-containing foods.”
  • Companies are permitted to start using the approved claims as of December 8, 2021.  These claims are in addition to a qualified health claim that FDA acknowledged in 2017, which was also related to the link between early peanut introduction and the reduced risk of developing peanut allergies.
  • On December 2, a bipartisan group of U.S. Representatives introduced the “CBD Product Safety and Standardization Act of 2021” which would establish federal standards and require the FDA to regulate cannabidiol (CBD) in foods and beverages. The Act was introduced by Rep. Kathleen Rice (D-NY), along with Reps. Angie Craig (D-Minn.), Morgan Griffith (R-VA.), and Dan Crenshaw (R-Texas).
  • The Act would allow FDA to regulate CBD as a food additive. If passed, it would require the Agency to issue regulations specifying the maximum amount of CBD derived from hemp per serving, labeling and packaging requirements, and conditions of intended use.
  • In a press release, Representative Rice stated that “CBD products are exploding in popularity, but the lack of federal regulation surrounding them has put consumers at risk and left businesses looking for clarity. The bipartisan CBD Product Safety and Standardization Act will establish the clear regulatory framework needed to provide stability for business and ensure unsafe products stay off the shelves.”
  • In support of the Act, the U.S. Hemp Roundtable, the hemp industry’s national advocacy organization, stated “[t]he hemp industry is grateful to Reps. Kathleen Rice, Morgan Griffith, Angie Craig and Dan Crenshaw for their introduction of the CBD Product Safety and Standardization Act. We strongly support requiring the FDA to regulate hemp extracts like CBD as food and beverage ingredients.”
  • We have previously blogged about the General Administration of Customs China’s (GACC’s) publication of registration requirements applicable to all foreign food companies that manufacture, store, or process food exported to China. The regulations (Decree 248 – Regulations on Registration and Administration of Overseas Manufacturers of Imported Food) will take effect on January 1, 2022. An English translation of the regulations is available here.
  • Yesterday, FDA announced the steps that it is taking to help industry comply with the new requirements. By way of background, Articles 7 and 8 of the Decree require that the countries’ competent authorities recommend registration of facilities involved in the export of the following categories of food: (1) Meat and meat products, (2) Aquatic products, (3) Dairy products, (4) Bird nests and bird nest products, (5) Casings, (6) Bee products, (7) Eggs and egg products, (8) Edible oils and fats, (9) Stuffed wheaten products, (10) Edible grains, (11) Milled grain industry products and malt, (12) Fresh and dehydrated vegetables and dried beans, (13) Condiments, (14) Nuts and seeds, (15) Dried fruits, (16) Unroasted coffee beans and cocoa beans, (17) Foods for special dietary purposes, and (18) Functional food.
  • GACC has indicated that existing registrations for the first four categories of products will continue to be recognized. Further, FDA already facilitates registration of seafood, dairy, and infant formula, and firms that are already certified by FDA to export these products to China need not take further action with regard to facility registration; however, all other requirements mandated under Decree 248, e.g., declaring the facility registration number on the food package, must be followed. Additionally, Article 9 of Decree 248 mandates that facilities that manufacture, process, or store all food other than those in the 18 categories referenced above must self-register.
  • In contrast, all U.S. establishments that manufacture, process, or store products in categories five through eighteen for export to China may now submit an application via FDA’s Export Listing Module (ELM) to facilitate registration of these facilities with China; step-by-step instructions are available. Applications to the ELM should be submitted by December 17, 2021.