• USDA’s Agricultural Marketing Service (AMS) administers the National Organic Program (NOP) as authorized by the Organic Foods Production Act of 1990 (OFPA).  The USDA organic regulations, which were published on December 21, 2000, and became effective on October 21, 2002, govern the production, handling, labeling, and sale of organically produced agricultural products.  On August 5, 2020, in response to mandates in the Agriculture Improvement Act of 2018, as well as pressure from the industry and recommendations from the National Organic Standards Board (NOSB), USDA published a proposed rule called Strengthening Organic Enforcement (SOE) that is aimed at preventing loss of organic integrity—through unintentional mishandling of organic products and intentional fraud meant to deceive—and strengthening trust in the USDA organic label. 
  • On January 19, 2023, USDA published the SOE final rule.  The final rule includes clarifications and additional examples in response to comments received on the SOE proposed rule.  Key updates include:
    • Requiring certification of more businesses, like brokers and traders, at critical links in organic supply chains;
    • Requiring NOP Import Certificates for all organic imports;
    • Requiring organic identification on nonretail containers;
    • Increasing authority for more rigorous on-site inspections of certified operations;
    • Requiring uniform qualification and training standards for organic inspectors and certifying agent personnel;
    • Requiring standardized certificates of organic operation;
    • Requiring additional and more frequent reporting of data on certified operations;
    • Creating authority for more robust recordkeeping, traceability practices, and fraud prevention procedures; and
    • Specifying certification requirements for producer groups.
  • The compliance date for the SOE final rule is March 19, 2024, or 12 months after the effective date of March 19, 2023. 
  • On January 18, USDA published a final rule expanding the criteria of generic label approval for inspected meat, poultry, and egg products. The Expansion of Generic Labeling Rule is largely consistent with the proposed rule published in September 2020, which proposed to discontinue review of generically approved labels and expand the circumstances under which FSIS will generically approve food labels under its jurisdiction. Notably, the final rule does not eliminate the requirement to comply with USDA’s labeling regulations, but instead shifts the burden of compliance for generic labels onto the manufacturer.
  • Under the current regulations, FSIS evaluates sketches of some labels for approval, and approves others generically without submission to FSIS for sketch approval. To obtain sketch label approval, domestic meat and poultry establishments, egg product plants, and certified foreign establishments that are eligible to export product to the United States, or their representatives, are required to submit sketch labels to FSIS for evaluation, except when the label is generically approved by the Agency under 9 CFR 412.2. FSIS allows certain meat, poultry, and egg product labels that bear all required labeling features and that comply with the Agency’s labeling regulations to be generically approved (9 CFR 412.2(a)(1)). Generically approved labels do not need to be submitted to FSIS for sketch approval before they can be used on products in commerce. Generic label approval requires that all mandatory label features are prominent and conform to FSIS regulations. Although such labels are not submitted to FSIS for approval, they are deemed to be approved and, therefore, may be applied to product in accordance with the Agency’s prior label approval system.
  • The final rule will expand generic approval to products only intended for export that deviate from domestic labeling requirements and permit generic approval of the labels of products that receive voluntary FSIS inspection. It will also expand generic approval to:
    • (1) “Organic” claims that appear in a product label’s ingredients statement;
    • (2) Labels of products that receive voluntary FSIS inspection (e.g., exotic species);
    • (3) “Geographic landmarks” displayed on a product label (e.g., a foreign country’s flag, monument, or map); and
    • (4) “Negative” claims made on product labels that identify the absence of certain ingredients or types of ingredients (e.g., statements such as “No MSG Added,” “Preservative Free,” “No Milk,” “No Pork,” or “Made Without Soy”). However, the final rule does not include negative animal raising claims (e.g., “no antibiotics administered”).
  • As of the effective date, FSIS will no longer evaluate labels submitted to FSIS that are eligible for generic approval. FSIS will, however, continue to provide industry with relevant resources, including updated generic labeling guidance, and timely answers to generic labeling questions. FSIS has updated the FSIS Guideline for Label Approval and intends to update and reissue FSIS Directive 7221.1.
  • The final rule will become effective on March 20, 2023. Interested parties may submit comments on the revised FSIS Guideline for Label Approval on or before February 17, 2023 here. Keller and Heckman will continue to monitor and report on the USDA generic label approval rules.
  • On January 16, consumer plaintiffs filed a class action lawsuit against The Coca-Cola Company alleging that their Fresca Sparkling Soda Water misleads consumers to believe the beverages contain no added sweeteners, even though they contain aspartame and citric acid (subscription to Law360 required). In the complaint, named plaintiffs Mark Letoski and Roger Fox assert that, per the FDA, consumers understand the terms “sparkling water” or “soda water” to mean water with added carbonation but without sweeteners or flavorings. Thus, they argue that the presence of any food additives should be prominently disclosed on the principal display panel (PDP).
  • Notably, the product identity statements (PIS) do appear to declare the presence of flavorings. For example, two of the PISs are “Sparkling Soda Water Black Cherry Citrus Flavor With Other Natural & Artificial Flavors” and “Sparkling Soda Water Grapefruit Citrus Flavor With Other Natural Flavors.” But the plaintiffs argue the PIS should also identify the presence of sweeteners (e.g., “Artificially Sweetened Sparkling Soda Water”).
  • Further, the plaintiffs argue that the images of grapefruits and cherries on the product label lead consumers to believe that the beverages contain “non-negligible amounts” of real fruit ingredients, despite the characterizing flavor statements that are declared on the PDP (e.g., citrus flavor with other natural flavor & artificial flavors). The plaintiffs concede that although the products do contain grapefruit juice concentrate as an ingredient, the label is misleading because citric acid is present at a greater amount.
  • The case is Letoski et al v. The Coca-Cola Company, 1:23-cv-00238. The lawsuit alleges violations of the Illinois Consumer Fraud and Deceptive Business Practices Act, the Vermont Consumer Fraud Act, several state consumer fraud acts, plus breaches of express warranty, implied warranty of merchantability and the Magnuson Moss Warranty Act, and negligent misrepresentation, fraud, and unjust enrichment.
  • Keller and Heckman will continue to monitor this case and report on any notable developments.
  • Last year we reported on a class-action lawsuit which alleged that a product described as “brown bread,” and which contained oat and rye flakes on the crust and a “no artificial preservatives or flavors” label claim, deceived consumers by creating the appearance of a healthier product consisting primarily of whole grains. In reality, the product consisted primarily of refined enriched grains, although it also contained some whole grains.
  • Last week, the Court rejected Plaintiff’s fraud claims because the labeling made no reference to the quantity of whole grains, nor did it even refer to “whole wheat” or “whole grain.”
  • The Court also dismissed breach of warranty claims because no notice had been given to Defendant of the breach; a negligent misrepresentation claim because, absent certain exceptions the court deemed inapplicable, such a claim cannot stand on economic loss alone; and an unjust enrichment claim because it was premised on the fraud claims. Additionally, the Court dismissed for lack of standing Plaintiff’s request for injunctive relief because by bringing action, Plaintiff demonstrated awareness of the alleged deficiency in the product, and therefore was unlikely to sustain future harm.
  • Plaintiff’s claims, with the exception of the negligent misrepresentation claim, were dismissed without prejudice so Plaintiff may amend the complaint and refile by January 26, 2023.
  • On January 12, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) released two press announcements regarding the Agency’s continued effort in addressing heavy metals in foods pursuant to its Closer to Zero Action Plan.  As we have previously blogged, the Closer to Zero Action plan is FDA’s ongoing, multi-phase evaluation of toxic elements present in foods commonly eaten by babies and young children.  FDA’s goal is to make meaningful reductions in exposure to arsenic, lead, cadmium, and mercury from foods through research, setting action levels, and increasing targeted compliance and enforcement activities.
  • First, FDA announced that it will be co-hosting a virtual workshop, “Bridging The Biological And Communication Sciences On Nutrients And Environmental Contaminants In Foods To Support Child Development,” with the National Institute of Health on research in risk communication, environmental contaminants in food, and the role of nutrition in child development.  The workshop will take place on February 9-10, 2023, from 10:30 EST – 4:30 PM EST.  The description of the event provides that the workshop will cover a “wide range” of nutrition and toxicology topics, including the following:
    • Challenges in children consuming adequate nutrients and the role of exposure to environmental contaminants from foods.
    • The important role of nutrients from different foods groups in child development and helping to protect children from the health effects associated with exposure to contaminants.
    • Research opportunities in food, nutrients, and the effects of environmental exposure.
    • Federal agencies’ current and future risk communications.
  • Registration to the workshop is currently available and will close on February 10, 2023.
  • Second, FDA announced that the National Academies Committee is hosting its first public information-gathering session on January 19, 2023, in furtherance of its study “The Role of Seafood Consumption in Child Growth and Development.”  As we have previously blogged, FDA, National Academies of Science, Engineering, and Medicine (NASEM), and EPA have partnered to conduct the study which is focused on assessing the current evidence in nutrition and toxicology associations between seafood consumption and child growth and development with a particular emphasis on mercury in seafood varieties.
  • The session is scheduled to be webcast on January 19, 2023, from 2:00 PM EST – 3:15 PM EST.  
  • Keller and Heckman will continue to monitor and report on developments on the Closer to Zero Action Plan.
  • In December 2022, USDA’s Economic Research Service (ERS) published a report titled, “State Policies for Farm Animal Welfare in Production Practices of U.S. Livestock and Poultry Industries: An Overview.” The report analyzes the farm animal welfare laws enacted by states since 2002 to better understand the market impacts on livestock industries and the legislative circumstances surrounding the policies.
  • The report found that, while state policies may cover a smaller share of operations and production, the retail sale restrictions have a broader reach – expanding beyond state borders and affecting the market for U.S. imports and exports.  
  • The report also noted that legal challenges in response to state animal welfare policies have largely been unsuccessful. The report noted that the success of current policies may indicate that future legislation could expand the coverage of animal welfare policies. Indeed, the report found that recently proposed policies are beginning to target the dairy and beef industries, which until recently has received less attention than the poultry and pork industries.
  • An example of a representative state animal welfare policy is California’s Proposition 12, which potentially affects the production of covered pork, veal, and poultry products sold in California, regardless of where they are produced.  Proposition 12 is currently under review by the U.S. Supreme Court, and a decision is expected this summer. The decision could have wide-reaching effects and impact other state policies. Keller and Heckman will continue to monitor and report on these developments.
  • On January 10, the FDA issued a final guidance for the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. As our readers know, under the Food Safety Modernization Act (FSMA), FSVP requires that importers verify that the food which they import provides the same level of public health protection as the preventive controls or produce safety regulations (as appropriate) in the U.S. and to ensure that supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.
  • The guidance is intended to assist importers in developing and implementing FSVP records, and following FSVP requirements for each food they import. The guidance includes recommendations on the requirements to analyze the hazards in food; how to evaluate a potential foreign supplier’s performance and the risk posed by the food; ways to determine and conduct appropriate foreign supplier verification activities; and how importers of dietary supplements or very small importers can meet modified FSVP requirements.
  • The guidance finalizes a 2018 draft guidance, and addresses comments received regarding what food the FSVP regulation applies to, what information must be included in the FSVP, and who must develop and perform the FSVP activities.
  • A class action was filed (Law360 subscription required) on January 5, 2023, against Glanbia Performance Nutrition, Inc. d/b/a THINK!, alleging that the company deceived consumers by claiming that their protein bars contained no artificial sweeteners despite being sweetened by maltitol syrup.
  • Maltitol is a sugar alcohol, and the complaint describes how maltitol is produced to demonstrate that the ingredient is artificial; namely, maltose is hydrogenated in the presence of hydrogen gas and a metal catalyst. 
  • Although FDA does not specifically define “artificial” or “artificial sweetener” (it does, however, define “artificial” in other contexts like artificial flavoring or artificial color), it refers to many of the approved sweeteners as artificial sweeteners. See e.g., 21 CFR 145.131 (Requiring canned figs that are sweetened with saccharin and/or sodium saccharin to be labeled as “artificially sweetened”). The complaint alleges that the hydrogenation reaction chemically changes the natural starting material (maltose), is not a naturally occurring chemical reaction, and therefore renders the maltitol product artificial. We note that while there is no GRAS or food additive regulation for maltitol, it is marketed on the basis of a self-affirmed GRAS position and is referenced in FDA’s regulations as one of the sugar alcohols which qualifies as a noncariogenic carbohydrate sweetener for which certain health claims can be made. 
  • We will continue to monitor and report on this case and other litigation relating to natural and artificial (free) claims.
  • We reported on FDA’s July 30, 2020 release of a testing protocol for the development of new antimicrobial products that could be registered with EPA to treat preharvest agricultural water.  More specifically, the FDA protocol is for use in evaluating treatments for inactivating shiga toxin-producing E. coli (STEC), including E. coli O157:H7, and other pathogens that may contaminate water used on agricultural fields.  The protocol is an important part of FDA’s 2020 Leafy Greens STEC Action Plan.  It was formally updated on May 17, 2022 to reflect an April 2021 allowance for some data that do not comply with good laboratory practices (GLP) and an April 2022 amendment changing the maximum contact time from 1 minute to “up to 5 minutes.” 
  • On January 6, 2022, in agreement with EPA, FDA updated the protocol once again to remove Listeria monocytogenes from the organism test panel based on pilot studies finding that sanitizer treatments that will likely be effective for E. coli and Salmonella may be different from those that are most effective for L. monocytogenes.  The April 20, 2020, EPA memorandum shows this change to the protocol at page 2.  The agencies expect that removing L. monocytogenes from the test panel will facilitate the registration of antimicrobial treatments against STECs (and other E. coli) and Salmonella in pre-harvest agricultural water. 
  • FDA concurrently states that companies may continue testing against L. monocytogenes for inclusion in their registration with EPA at their option.   We will continue to monitor developments impacting FDA’s Leafy Greens STEC Action Plan. 
  • FDA announced in the Federal Register on December 30, 2022 that January 1, 2026 will be the uniform compliance date for final food labeling regulations that are issued in calendar years 2023 and 2024.  This action is not intended to change existing requirements for compliance dates contained in final rules published before January 1, 2023.
  • In line with its historical practice, FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of labeling changes on the food industry of having to respond separately to each labeling change.
  •  FDA encourages industry to comply with new labeling regulations as quickly as feasible.  However, all food products subject to the January 1, 2026, uniform compliance date must comply with the appropriate labeling regulations when initially introduced into interstate commerce on or after January 1, 2026.  For some food labeling regulations, the FDA will set a compliance date that differs from the uniform compliance date if special circumstances justify doing so. The specific compliance date is published when a final regulation is issued.
  • The final rule became effective this Tuesday, January 3, 2023.  FDA is accepting electronic and written comments until March 6, 2023 here.  For general food labeling and nutrition guidance documents and related regulatory information, please visit FDA’s website here.
  • Keller and Heckman will continue to track new food labeling regulations in 2023 and keep industry informed of the applicable compliance dates.