• The U.S. District Court for the Southern District of New York has dismissed with prejudice a class-action lawsuit that alleged that Annie Inc’s Bunny Fruit Snacks – Tropical Treat (the “Fruit Snacks”) mislead consumers with non-functional slack fill.
  • By way of background, pursuant to Section 403(d) of the Food, Drug, and Cosmetic Act (codified at 21 U.S.C. § 343), a food may be deemed misbranded if its container is “so made, formed, or filled to be misleading.” A container is “considered to be filled as to be misleading” if it “does not allow the consumer to fully view its contents” and “it contains nonfunctional slack-fill.” (See 21 C.F.R. § 100.100). “Slack-fill” is defined as the “difference between the actual capacity of a container and the volume of product contained therein” and is prohibited by FDA as “nonfunctional slack-fill” unless it is present for any of the reasons listed in Section 100.100 (e.g., it protects the package or is required by the packaging machine).
  • The box in which the fruit snacks were packaged allegedly contained 60% non-functional empty space (slack fill). However, the front of the box also included a disclosure which provided the number of fruit packages in the box, the weight of each package, and the net weight of the box. The accuracy of these disclosures was not challenged.
  • Notably, the Court did not reach the issue of whether the slack-fill was non-functional. Instead, the Court held that as a matter of law a reasonable consumer could not be misled by the alleged non-functional slack fill because the contents of the package were clearly disclosed. Accordingly, it dismissed the deceptive practices claims.
  • Last week, the U.S. Department of Agriculture announced that it will be making changes to its school nutrition standards for the 2022-2023 school year (SY 2022-2023), seeking to reinstate health goals that were rolled back during the pandemic.  The USDA issued a new final rule ­ Child Nutrition Programs: Transitional Standards for Milk, Whole Grains, and Sodium –which will establish transitional standards to support the transition of school meal nutrition standards as schools respond to and recover from the pandemic and while USDA engages in notice-and-comment rulemaking to update the meal pattern standards to more comprehensively reflect the Dietary Guidelines for Americans 2020-2025.
  • The new final rule establishes the following requirements beginning SY 2022-2023:
    • Milk: Schools and child care providers serving participants ages six and older may offer flavored low-fat (1%) milk in addition to nonfat flavored milk and nonfat or low-fat unflavored milk;
    • Whole Grains: At least 80% of the grains served in school lunch and breakfast each week must be whole grain-rich; and
    • Sodium: The weekly sodium limit for school lunch and breakfast will remain at the current level in SY 2022-2023. For school lunch only, there will be a 10% decrease in the limit in SY 2023-2024. This aligns with the U.S Food and Drug Administration’s recently released guidance that establishes voluntary sodium reduction targets for processed, packaged, and prepared foods in the U.S.
  • All other nutrition standards, including fruit and vegetable requirements, will remain the same as the 2012 standards. However, the USDA intends to issue a proposed rule in fall 2022 that moves toward updating long-term nutrition standards.  USDA is required to update school nutrition standards based on recommendations from the latest Dietary Guidelines for Americans. As such, USDA will prioritize seeking input from schools, industry and others to inform the final rule process for school nutrition standards. USDA expects to finalize that rule with enough time for schools to plan for SY 2024-2025.
  • Keller and Heckman will continue to monitor and report on similar school nutrition developments
  •  The Food Safety Modernization Act of 2011 (FSMA) directs FDA to establish a program for the testing of food by accredited laboratories.  We reported on FDA’s Final Rule which became effective on December 1, 2021 and provides eligibility requirements and procedures on how FDA will oversee a new Laboratory Accreditation for Analyses of Foods (LAAF) program.  Under the LAAF program, FDA will recognize accreditation bodies that will, in turn, accredit laboratories, which will test food and provide results directly to FDA.  Testing by a LAAF-accredited lab will be required to support removal of a food from an import alert or admission of an imported food detained at the border; to address an identified or suspected food safety problem with shell eggs, sprouts, and bottled drinking water; to address an identified or suspected food safety problem in certain, rare circumstances; and in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention.
  • On February 11, 2022, FDA announced the launch of the LAAF application portal (with User Guide) where interested accreditation bodies may apply for recognition under the LAAF program.  Once the FDA has recognized a sufficient number of accreditation bodies, the agency will announce that laboratories may apply to the recognized accreditation bodies for LAAF-accreditation.  When there is sufficient LAAF-accredited laboratory capacity for the food testing covered by the final rule, the agency will publish a document in the Federal Register giving owners and consignees 6 months’ notice that they will be required to use a LAAF-accredited laboratory for such food testing.
  • There is no way of predicting when the first LAAF-accredited laboratories will be available for food testing.  FDA anticipates that LAAF-accredited laboratory capacity may become available at different times for various types of food testing described in the final rule, e.g., testing for biological, chemical, physical, radiological hazards, or, most commonly, microbiological hazards.
  • On February 9, 2022 FDA announced that it had published a guidance document to assist food producers and processors that handle foods which may contain residues of the pesticide chemical chlorpyrifos. The guidance document is based on FDA’s Channels of Trade provision in the Food, Drug, and Cosmetic Act.  As background, the Environmental Protection Agency (EPA) published a final rule on August 30, 2021 that revoked all tolerances for chlorpyrifos. The tolerances are set to expire on February 28, 2022. The guidance document provides FDA’s enforcement policy on foods containing chlorpyrifos residues after the tolerances expire.
  • FDA has a two-phase enforcement approach on findings of chlorpyrifos residues that will apply to raw agricultural commodities and processed foods, as follows:
    • Stage 1: For a time period ranging from 6-24 months (depending on the specific food commodity) FDA intends to exercise enforcement discretion by not requesting documentation to show that chlorpyrifos residues are present as a result of lawful application.
    • Stage 2: FDA will accept documentation to demonstrate that lawful application of chlorpyrifos occurred before February 28, 2022. The end of this period is anticipated to be August 28, 2026 – the last date that FDA anticipates that food made from lawfully treated commodities will remain in the channels of trade.
  • Public comments on the guidance will be accepted at any time. Public comments may be submitted electronically to https://www.regulations.gov/ using Docket ID: FDA-2016-D-4484.
  • A proposed class action lawsuit filed on February 4 alleged that Poland Spring sparkling water, owned by BlueTriton Brands, Inc., misled consumers with the claim “a twist of lemon” because the water lacked “the amount and type of lemon ingredients expected by plaintiff and consumers” (subscription to Law360 required). As alleged in the complaint, customers expect the lemon flavor to come from lemon oil, lemon extract, or lemon juice, instead of natural flavors.
  • The plaintiff, Timothy Alexander, argued that the claim “a twist of lemon” refers to the “literal twisting of the outer portion of a lemon round,” and would cause a consumer to believe that the water contained actual lemon juice. However, as estimated in the complaint, the water likely only contained approximately 0.1 mL of lemon ingredients.
  • In addition to the “a twist of lemon” claim, the label also declared a characterizing flavor statement, or as referred to in the complaint as a “disclaimer.” Alexander argued that the “disclaimer” (i.e., “naturally flavored spring water with other natural flavors and CO2”) is “used so extensively on labeling that is has become the equivalent of a labeling tic, affixed to a majority of products with added flavoring,” and thus does not inform consumers that the product does not contain an appreciable amount of lemon.
  • The complaint stated that the value of the water purchased by Alexander was materially less than the value represented by BlueTriton, and that more water was sold at higher prices than would have been had the “a twist of lemon” claim not been declared on the label. Alexander seeks to represent customers in Illinois under the state’s customer fraud and deceptive practices law, as well as customers in Iowa, Arizona, Ohio, Alabama, Louisiana, West Virginia, Michigan, Texas, Arkansas, Virginia, and Oklahoma as part of a separate consumer fraud multistate class.
  • Keller and Heckman will continue to monitor and report on the outcome of the Poland Spring lawsuit as well as other labeling claim challenges.
  • Citing a decline in COVID-19 cases, the FDA resumed conducting domestic surveillance inspections across all commodities yesterday, February 7. The agency will also proceed with previously planned foreign surveillance inspections that have received country clearance and that are within CDC’s Level 1 or Level 2 COVID-19 travel recommendations; other foreign surveillance inspections will be rescheduled.
  • By way of background, on December 29th FDA had announced that it would postpone routine domestic and foreign inspection inspections in light of the spread of the omicron variant and then extended the pause on January 18th.
  • Throughout this period, FDA has continued to conduct “mission critical” foreign and domestic inspections as well as remote foreign supplier verification program activities for human and animal foods. It has also leveraged other tools, including remote assessment and import operations surveillance.  Additionally, state inspections under FDA contract have had, and continue to have, the discretion to make inspection decisions based on local information.
  • California’s Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65 (Prop 65), prohibits knowingly exposing any individual to a listed chemical without first providing a “clear and reasonable warning” to such individual.  Lead is listed as causing cancer and reproductive toxicity with a current Prop 65 No Significant Risk Level (NSRL) of 15 μg/day for oral exposure and a Maximum Allowable Dose Level (MADL) of 0.5 μg/day.  By comparison, the US Food and Drug Administration (FDA) has a provisional total tolerable intake level (PTTIL) for lead by small children of 6 μg/day.
  • In a February 2, 2022 Press Release, California Attorney General (AG) Rob Bonta, along with 10 district attorneys, announced a settlement with Perrigo Company and two of its subsidiaries (Perrigo) of a 2018 Prop 65 lawsuit that sets a target lead level for all Perrigo infant and toddler formula products sold in California of 4 parts per billion (ppb), with a maximum lead level of 7 ppb for soy-based formulas and 5 ppb for all other covered products.  Perrigo, a manufacturer for store brands of infant and toddler formula, also agreed to civil penalties of $72,500 and additional fees for costs.  The California AG characterized the lead limits under the settlement as “more than ten times below current federal guidance levels” and indicated his office may target other companies that fail to either reduce the lead levels in their infant and toddler products or provide a warning.
  • California’s AG is among a coalition of 23 Attorneys General, which as discussed here, petitioned FDA on October 21, 2021 to expedite setting heavy metal standards for baby foods.  Keller and Heckman will continue to monitor this matter and report on any developments.
  • On January 31, 2022, the Center for Science in the Public Interest (CSPI), together with the American Health Association and the American Public Health Association, petitioned the U.S. Department of Agriculture (USDA) to set added sugar standards for foods in school meal programs and sold on school premises.  The petition also asks the agency to ban the use of aspartame, saccharin, acesulfame-K and sucralose in school foods, citing fears that the manufacturers may rely on them to meet new standards.
  • Federal law requires school food programs and sales to follow the Dietary Guidelines for Americans that is published by USDA and the Department of Health and Human Services. CSPI’s petition asks USDA to set standards for added sugars that are consistent with the 2020-2025 edition of the guidelines, which recommends that Americans limit their added sugar intake to less than 10% of calories consumed. USDA’s current standards for school meal programs and foods sold at schools were set in 2012 and 2013, before added sugars were required on Nutrition Facts labels.
  • Separately, CSPI, together with Consumer Reports and a Harvard Medical physician and researcher, filed a petition urging the U.S. Food and Drug Administration (FDA) to require chain restaurants to disclose added sugars of its foods to consumers upon request. CSPI notes that FDA generally harmonizes mandatory disclosures at chain restaurants with what is required on Nutrition Facts labels and the Dietary Guidelines for Americans. CSPI argues that it should be non-controversial for FDA to require added sugar disclosures at chain restaurants.
  • It remains to be seen how USDA and FDA will respond to these requests. Keller and Heckman will continue to monitor and report on developments.
  • On January 31, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics that are a priority to complete during the next 12 months. The list is an update on the guidance agenda that the agency published in June 2021 and includes many of the same documents including:
    • Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders;
    • Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications; Draft Guidance for Industry;
    • Best Practices for Convening a GRAS Panel: Guidance for Industry;
    • Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and/or Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry; and
    • Labeling of Plant-based Milk Alternatives; Draft Guidance for Industry
  • Notably, the FDA expects to publish many of these guidance documents by January 2023, which is a 6-month extension from the original expected publication date of June 2022.
  • The FDA added the following guidance topics to be published by January 2023:
    • Testing Methods for Asbestos in Cosmetic Products Containing Talc; Draft Guidance for Industry;
    • New Dietary Ingredient (NDI) Notifications and Related Issues:  NDI Notification Procedures and Timeframes; Guidance for Industry;
    • Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry;
    • Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry; and
    • Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
  • Public comments on the list, including suggestions for alternatives or recommendations on the topics FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA-2021-N-0553. Please contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • Yesterday FDA released a video presentation summarizing the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act which adds sesame as the 9th “major food allergen.”
  • Specifically, the presentation includes an overview of the definition of a “major food allergen” (21 USC 321 (qq)) and the labeling requirements for such allergens on packaged foods, including dietary supplements, regulated by FDA (21 USC 343 (w)). The Food Allergen Labeling and Consumer Protection Act (FALCPA), which was passed in 2004, provided the regulatory framework for allergen labeling of “major food allergen,” which was defined to only include milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. By adding sesame as the 9th major food allergen, the FASTER Act extends the allergen labeling requirements to sesame as well. The effective date for the FASTER Act is January 1, 2023. Therefore, all FDA regulated packaged foods and dietary supplements containing sesame (or an ingredient derived from sesame) introduced or delivered for introduction into interstate commerce on or after this date must declare sesame as an allergen (either by declaring the food source in the ingredient list or with a separate “contains” statement).
  • Additionally, food facilities subject to the cGMP and preventive controls regulations in 21 CFR Part 117 must implement cGMP to prevent cross-contamination of major food allergens (if a major food allergen is present in the facility and cross-contact is reasonably likely to occur) and must also conduct a hazard analysis and implement a food safety plan which may consider allergen issues. After January 1, 2023, sesame would have to be considered in the implementation of these regulations as well.
  • The presentation also states that while FDA is not required to implement any new regulations (like FALCPA, FASTER is self-implementing), it will update guidance documents on an as-needed basis. FDA’s guidance document on voluntary labeling of sesame as an allergen will remain in effect until January 1, 2023 (at which point, labeling would no longer be voluntary). Furthermore, the presentation states that FDA plans to release a draft guidance related to its approach to evaluating the health and safety effects of other allergens (those that are not defined as “major food allergens”) by the end of June 2022. FDA also continues to work with other Health and Human Services (HHS) Agencies (ie., NIH and CDC) on a FASTER-mandated report to Congress which will include, among other things, recommendations for further modifications to the regulation of allergens.