• At the end of March, U.S. federal Judge Brian A. Jackson issued a decision in Turtle Island Foods v. Strain, which blocked a Louisiana labeling law for violation of commercial free speech guarantees.  Judge Jackson concluded that the Louisiana labeling law encroached on protected commercial speech with its extensive list of prohibited language.  Commercial speech is protected by the U.S. Constitution, but the protection is more limited than other forms of speech.  When a complaint is filed for violation of commercial free speech, the party seeking to uphold the speech restriction must demonstrate that the government has a legitimate interest in restricting particular types of commercial speech, and the subject law or regulation is the least restrictive manner to regulate such speech.
  • In June 2019, the Louisiana Legislature passed the “Truth in Labeling of Food Products Act.”  The Act prohibited labeling that misrepresents a food product as an agricultural product.  In particular, the Act applied to a range of agricultural products, including, but not limited to meat.  The Act provided definitions for, and restricted the use of terms like “meat,” “beef,” “pork,” “poultry,” and “rice.” Notably, the law prohibited plant-based products from using the term “meat,” non-rice products from using the term “rice,” and sugar alternatives from using the term “sugar.”  The Act also preemptively prohibited cell-cultured meat by excluding the term from the definition of “meat.”
  • The Act became effective on October 1, 2020, and Turtle foods filed a complaint less than a week later. The company based its complaint on First Amendment freedom of speech guarantees, as well as the Fourteenth Amendment’s Due Process Clause.  The company also alleged that the purpose of the Act was to prohibit “current and intended speech.”  Although Louisiana has not taken any enforcement action against food producers, Judge Jackson concluded that the risk of enforcement is substantial.  The law provides that violators may be fined $500 per day, per offense.
  • 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.
  • As previously reported, on February 9, 2018, the US Cattlemen’s Association filed a petition with the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS), requesting that the Agency limit the definition of “meat” and “beef” to products derived from animals born, raised and harvested in the traditional manner.  The petition was meant to prevent these terms from being used for cell-cultured products.
  • FSIS denied the petition on September 16, 2021.  In its response FSIS discussed its denial in the context of both cell-cultured products and other products. For cultured products, the Agency stated that it intends to address the issues through the advanced notice of proposed rulemaking (ANPR) regarding the labeling of cell-cultured products that was published on September 3, 2021.  For other products (such as plant-based alternatives to meat), FSIS pointed to a 2013 announcement in which it said that it would not be adding new entries to its Food Standard and Labeling Policy Book; therefore, FSIS indicated it could not now add the terms “meat” or “beef” as requested.  Further, FSIS noted that this issue would fall in FDA’s jurisdiction as these products are not amenable to the Federal Meal Inspection Act or Poultry Products Inspection Act.
  • Harvard’s Animal Law and Policy Program also filed a petition with FSIS requesting a labeling approach for cell-based meats and poultry that would not require new standards of identity and would not ban the use of common or usual meat or poultry terms or other product terms specified in current codified standards of identity.  The petition asserts that FSIS should wait to establish speech restrictions until the Agency has a better understanding of the compositional and safety characteristics of finished cell-based meat products and until it has had the opportunity to review proposed labels.
  • In FSIS’s September 16, 2021 response to Harvard Animal Law’s petition, the Agency stated that it intends to address the issues through the ANPR and that it is “actively expanding its knowledge of cell-based meat and poultry products so that it can effectively oversee the safety and labeling of such products.”
  • On May 10, Texas state lawmakers passed a bill that would prohibit plant-based, cell-based, or insect-based food products that do not contain meat from slaughtered animals from using terms like “meat,” “beef,” “pork,” or “poultry product” on food labels.
  • House Bill (HB) 316 states that a food advertised or labeled as a livestock or poultry product, analogue product, or cell-cultured product shall be considered misbranded if, among other requirements, it is an imitation of another food, unless its label bears the word “imitation” in prominent type. Meat and poultry analogue products and cell-based products are deemed misbranded unless they declare qualifying terms or disclaimers on the product label, such as “meatless,” “plant-based,” “made from plants,” “cell-cultured,” or other similar phrases that clearly communicate to the consumer the contents of the product.
  • HB 316 was introduced on November 9, 2020 by State Representative Brad Buckley (R), and was passed on May 10, 2021. There is a companion bill in the Senate, SB883, which was referred to the Senate Business & Commerce committee on March 11.
  • Of HB316, Rep. Buckley stated “[t]his is for those who choose to eat meat, but it’s also for those who choose to not eat meat” and that the goal “is to have clear and accurate labeling so the consumer has no doubt what they’re purchasing.” The bill gained support from the Texas & Southwestern Cattle Raisers Association, Texas Poultry Federation, Texas Pork Producers Association, and other livestock companies. However, the bill is opposed by organizations like the Plant Based Foods Association and the Alliance for Plant Based Inclusion. Several state lawmakers have also expressed concern. State Rep. Gene Wu (D) argued that the bill may cause Texas to be subject to unnecessary litigation and State Rep. Kyle Biedermann (R) stated “[t]here shouldn’t be a need to have to legislate more regulation of these other companies when it seems their packaging is pretty clear.”
  • Keller and Heckman will continue to monitor any developments.
  • The Wisconsin State Assembly Committee on Agriculture recently approved two bills that would restrict terms such as “milk,” “cheese,” and “yogurt” to products derived from lactating hooved animals, regardless of whether the terms are qualified by phrases like “plant-based,” “vegan,” or “dairy free.” Assembly Bill (AB) 73 covers the labeling of dairy foods, and AB 74 discusses the labeling of milk products. Both passed the Assembly by executive action on April 7.
  • Both bills include a provision that states that “the prohibition in the bill applies only if at least 10 states out of a group of 15 states listed in the bill enact a prohibition similar to this bill by June 30, 2031.” In other words, the prohibition against use of such terms does not take effect unless at least 10 other named states enact a similar prohibition. The group of states is composed of Illinois, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Dakota, North Carolina, Ohio, South Dakota, Tennessee, Virginia, and West Virginia.
  • The committee also passed a third bill, AB 75, that prohibits the labeling of a meat product as “meat” or a similar term unless the product is derived from an edible part of the flesh of an animal or any part of an insect, and does not include cultured animal tissue that is produced from animal cell cultures. In short, the bill prohibits cell cultured meat from being labeled as “meat.”
  • The bills’ sponsors allege that they drafted the bills because consumers are confused by plant-based milk, cheese, and meat labels. However, in a statement to FoodNavigator-USA, Michael Robbins of the Plant Based Foods Association (PBFA) argued that the bills are “anti-competitive, anti-free market” and “present a misguided attack on innovation and all food producers’ free speech rights to use words and phrases that consumers understand.”
  • On January 23, 2021, plaintiffs filed a putative class action complaint in the United States District Court Southern District of New York against Icelandic Provisions, Inc. (“Company”), which sells Skyr, a traditional Icelandic cultured dairy product.  Plaintiffs allege that the Company’s marketing and advertising misleads consumers to believe that the Skyr is made in Iceland when actually it is produced in Batavia, New York.
  • The complaint alleges fraud, negligent misrepresentation, unjust enrichment, and violation of state consumer-protection statutes.  Plaintiffs claim that the depiction of the Icelandic countryside with a snow covered backdrop, the statement “Traditional Icelandic Skyr,” and Company’s name, “Icelandic Provisions” misleads consumers to believe that the product is made in Iceland.  Additionally, the plaintiffs claim that Company’s inclusion of “Developed in partnership with MS Iceland Dairies, Reykjavik, ISL” is misleading because it furthers the impression that the Skyr is made in Iceland.
  • The plaintiff’s counsel is Sheehan & Associates, a firm that has become known in recent years for its pursuit of class action litigation claiming harm to consumers from allegedly misleading food labeling.  The Sheehan firm has represented a number of class action plaintiffs in recent flavor labeling challenges.  Origin and geographic claims have drawn scrutiny from the Federal Trade Commission, state regulators, and most recently, class action plaintiffs’ lawyers.
  • On July 13, the FDA announced its 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 represents achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. The Blueprint builds on the work that FDA has already implemented through FSMA and also outlines a partnership between government, industry, and public health advocates to create a modern approach to food safety.
  • The Blueprint is centered around four core elements:
    • Tech-enabled Traceability – FDA wants to utilize new technologies and integrate data streams to identify outbreaks and trace the origin of contaminated food to its source in minutes.
    • Smarter Tools and Approaches for Prevention and Outbreak Response – The Blueprint includes plans to strengthen the FDA’s procedures and protocols for conducting root cause analyses that can identify how a food became contaminated and figure out how to help prevent contamination from happening again. The need for greater traceability and predictive analytics is seen in the Agency’s most recent efforts to improve the safety of romaine and other leafy greens.
    • New Business Models and Retail Modernization – FDA is also examining new business models for the production and delivery of food, while ensuring that those foods continue to be safe for consumers. New business models include novel ways of producing foods and ingredients, such as cell-cultured food products. FDA is also committed to exploring new approaches of food safety that go beyond traditional training and inspection for retail establishments and restaurants.
    • Food Safety Culture – The Blueprint also focuses on fostering the growth of and strengthening the food safety culture on farms and in food facilities all over the world. For instance, in order to make dramatic reductions in foodborne disease, the Agency believes they must do more to influence and change human behavior, as well as to address how employees think about food safety and educating consumers.
  • FDA originally intended to publish the Blueprint in March, but was forced to postpone and turn attention to addressing the public health emergency posed by the COVID-19 pandemic. However, as explained by the FDA, the pandemic has made it even more clear that the actions outlined in the Blueprint are essential to protect and promote food safety.

 

  • Missouri was the first among many states, including Arkansas, Louisiana, Mississippi, North Dakota, Oklahoma, South Carolina, South Dakota, and Wyoming, to enact laws restricting plant-based and cell-cultured products from being labeled as “meat.”  As reported here, Turtle Island Foods (Tofurkey brand), in conjunction with non-profit advocacy groups, filed a lawsuit on August 28, 2018, which is the date Missouri’s law took effect, alleging First Amendment violations.  The plaintiffs requested a preliminary injunction on October 30, 2018.  Before a ruling was made on the injunction request, litigation was suspended for negotiations but then resumed in July 2019 after settlement discussions failed.
  • AP News reported on October 4, 2019 that U.S. District Judge Fernando Gaitan Jr. of the Western District of Missouri denied the request for a preliminary injunction because Tofurkey will not be affected by the law in question.  Specifically, as Missouri is not expected to prosecute where a non-meat product label using a defined “meat” term also bears a qualifier, such as “vegetarian,” “plant-based,” or “cell-based,” the Judge found there is no risk of prosecution for the plaintiff and no burden from having to change labels because the current labels disclose that Tofurkey products are plant-based.  A reported statement from Jessica Almy, an attorney in the case and the Director of Good Food Institute (GFI), a co-plaintiff, however, indicates that GFI has appealed the ruling.  In contrast, other plaintiffs in a similar situation will consider dropping a lawsuit in Mississippi upon adoption of a proposed regulation permitting “meat” terms in that state on labels that also use qualifiers.
  • In addition to plant-based products that are the subject of ongoing litigation in Missouri and other states, cell-based products derived from muscle tissue cultured in vitro from animal cells are also targeted by states’ meat labeling laws.  Cell-based products remain in the research and development phase and, thus, are not truly represented in the current litigation against state meat labeling laws.  It is likely, however, that yet-to-be developed federal labeling regulations will ultimately preempt the state laws.  In this regard, we have reported that five cell-based meat and seafood companies have formed a coalition to represent the industry’s interest amidst regulatory uncertainty.
  • As previously reported on this blog, the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) have announced an agreement to share regulatory oversight over cell-based or cell-cultured meat. As part of the agreement, FDA will conduct premarket consultation to evaluate the manufacture of these products, including oversight of tissue collection, cell lines and banks, and all components of inputs.
  • The agencies have previously agreed that no additional legislation would be necessary to effectuate the joint agreement. No additional guidance or proposed regulations have been published by either FDA or USDA at this time.
  • In light of this regulatory uncertainty, five cell-based meat and seafood companies have formed a coalition to represent the industry. The coalition, Alliance for Meat, Poultry & Seafood Innovation (AMPS Innovation) includes five founding member companies, BlueNalu, Finless Foods, Fork & Goode, JUST, and Memphis Meats. These companies are currently in the research and development phase but expect to make products available in the next several years. In a joint statement, members noted the purpose of the coalition is to “speak with a unified voice as we emerge as a viable, impactful partner in the overall food and agriculture sector.”
  • Like countless other states, earlier this year, Mississippi passed SB 2922, which stipulates that cell-based, plant-based, or insect-based foods cannot be labeled as “meat” or “a meat food product” (e.g., “hamburgers,” “hot dogs,” “sausages,” “jerky”, etc.). Specifically, SB 2922 amended Section 75-35-15(4) of the Mississippi Code to state “[a] food product that contains cultured animal tissue produced from animal cell cultures outside of the organism from which it is derived shall not be labeled as meat or a meat food product. A plant-based or insect-based food product shall not be labeled as meat or a meat food-product.” Such products still run afoul of the law even if the labels include claims like “100% vegan,” “plant-based,” or “meatless.”
  • SB 2922 came into effect on July 1, 2019. On that same day, vegan “meat” producer, Upton’s Naturals Co. and the Plant Based Foods Association (PBFA) filed suit in federal court against Mississippi’s Governor and Commissioner of the Department of Agriculture and Commerce arguing that the label restrictions violate their First Amendment right to free speech, among other claims. Upton’s and PBFA are seeking a declaratory judgment that SB 2922 violates the First and Fourteenth Amendments to the U.S. Constitution, a preliminary injunction prohibiting enforcement of SB 2922 throughout the duration of the litigation, a permanent injunction, and an award of nominal damages in the amount of $1.00.
  • Mississippi’s Department of Agriculture and Commerce, along with the state’s cattle and poultry associations, supported the state law. Indeed, in response to the lawsuit, the Department said it has a “duty and obligation to enforce the law” and that it wanted to ensure the consumer has “clear information on the meat and non-meat products they purchase.” However, supporters of the lawsuit, like the Good Food Institute, argued that “Mississippi is acting as word police” and that the law is a “slippery slope” that could open the door to restrictive labeling.

 

The Daily Intake is taking a break for the Fourth of July holiday and will return on July 8, 2019.  We wish you a wonderful Fourth of July holiday!