• On September 29, 2021, the United Kingdom (UK) announced plans to pave the way for gene editing technologies to be used for crops raised in the UK.  While the European Union (EU) regulates organisms modified by gene editing as genetically modified organisms, the UK is choosing to take a different approach to gene editing.  As a first step, the government will change rules relating to gene editing to facilitate research and development.
  • The UK’s Department for Environment, Food, and Rural Affairs (DEFRA) noted that gene editing is different from genetic modification because it does not result in the introduction of DNA from other species, but rather creates new varieties that are similar to those that could be produced by natural breeding processes.
  • DEFRA takes the position that gene editing will make plant breeding more efficient and will be able to develop crops that are more nutritious, more resistant to pests and disease, and more beneficial to the environment.  To that end, DEFRA notes that gene edited foods will only be permitted to be marketed if they do not present a health risk, do not mislead consumers, and do not have lower nutritional value than their non-genetically edited counterparts.
  • On September 27, agriculture industry groups, including the National Pork Producers Council (NPPC) and American Farm Bureau Federation (AFBF), petitioned the U.S. Supreme Court to review the Ninth Circuit’s decision to uphold California’s Proposition 12, which is a ballot initiative that was passed by California voters in November 2018 and established new standards of confinement of certain farm animals and bans the sale of eggs, veal, and pork products that do not comply with those standards (subscription to Law360 required).
  • As our readers know, in July of 2021, the U.S. Court of Appeals for the Ninth Circuit ruled against the NPPC and AFBF in their challenge to Prop 12. In a unanimous decision, the Ninth Circuit affirmed the dismissal of the groups’ challenge to the law, stating that the law correctly regulates in-state and out-of-state actions in the same way. The panel also noted that precedent dictates a state law can only be found to violate the dormant commerce clause in “narrow circumstances” and the law’s alleged “upstream effects” on out-of-state producers do not qualify.
  • The NPPC and AFBF state that the district and appeals courts’ decisions should be overturned. NPPC President Jen Sorenson said “We’re asking the Supreme Court to consider the constitutionality of one state imposing regulations that reach far outside its borders and stifle interstate and international commerce.”
  • Notably, this is not the first challenge to Proposition 12 to go before the U.S. Supreme Court. The North American Meat Institute (NAMI) previously petitioned the Court to hear its case regarding the constitutionality of Prop 12, arguing that the Ninth Circuit’s decision in its case conflicts with holdings by other appellate courts and the U.S. Supreme Court. However, the Supreme Court denied the request for review on June 28 and offered no explanation for its decision.
  • Keller and Heckman will continue to monitor challenges to California’s Proposition 12 and report on any updates.
  • A class-action lawsuit filed in August against Hormel Foods alleges that the company’s Black Label Center Cut Bacon  (Center Cut Bacon) is falsely labeled as containing “25% Less Fat Than Our Regular Bacon.”
  • Plaintiffs allege that the claimed reduction in fat content is based on a smaller serving size rather than an actual decrease in fat content, and that the Center Cut Bacon did not contain 25% less fat than any other bacon product sold by Defendant when accounting for serving size. Furthermore, Plaintiffs allege that the labeling misleads consumers by failing to identify the reference food as required by federal regulation when a claim comparing nutrient levels to a reference food is made (i.e., a “relative claim”). See 21 CFR 101.13(j)(2)(ii). While Plaintiffs surmised that the reference food was Original Bacon, Center Cut Bacon contained only 14% less fat Original Cut Bacon when the serving size was accounted for (by computing fat content on a per gram basis).
  • More broadly, Plaintiffs allege that the practice of using different serving sizes for similar bacon products confused consumers and made it more difficult for them to verify the truthfulness of the fat reduction claim. This case is a good example of how nutrient content claims even on meat products regulated by USDA FSIS can be targeted in class action lawsuits.

Aldi Freed From False-Ad Claims Over ‘Vanilla’ Almond Milk (subscription to Law360 required)

  • On September 21, 2021, the U.S. District Court for the Southern District of New York dismissed with prejudice the first amended complaint in a consumer class action lawsuit against the Aldi grocery chain.  The named plaintiff alleged the word ‘vanilla’ in the product name of Friendly Farms, Organic, Unsweetened Vanilla Almond Milk is misleading because the product’s vanilla flavor is not derived exclusively or predominantly from vanilla beans or vanilla extract.
  • Citing recent decisions in other vanilla flavoring class action lawsuits by the same counsel, the court found in favor of Aldi as follows:
    • The term ‘vanilla’ on vanilla-flavored products merely indicates flavor and not an ingredient source.
    • Design flaws render a 2020 survey commissioned by the plaintiff’s counsel practically useless, rather than proving as the plaintiff purports that 69.5% of 400 consumers believed the ‘vanilla’ representation on the label meant that the product’s flavor comes exclusively from vanilla bean.
    • Even if the plaintiff were correct about federal labeling regulations, there is no inference that the disputed labeling standards align with consumer perceptions.
    • Dictionary definitions of vanilla do not assist the plaintiff in demonstrating that consumers believe the vanilla flavor comes exclusively from ingredients derived from the vanilla plant.
  • We have reported on a variety of vanilla flavoring class action lawsuits, many of which have not survived the motion to dismiss stage.  We will continue to monitor any developments.

 

 

  • 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.”
  • As our readers may recall, in July of 2019, the USDA’s Food Safety and Inspection Service (FSIS) issued a notice of availability and a request for comment on a new guideline for establishments producing multi-component kit products that contain meat or poultry products. On September 21, FSIS announced updates to the guideline and responded to comments received in 2019. FSIS intends for the guideline to help establishments and other food handling facilities determine whether the kit product needs to be prepared under FSIS inspection and how to label a kit product that contains fully labeled meat or poultry components.
  • FSIS received 15 comments on the guideline, mainly from firms that prepare kits and trade associations that represent the meat and retail industries. Comments, and FSIS responses, covered a range of topics, including:
    • One comment requested that FSIS provide a clearer definition of a kit and clarify whether Agency policy distinguishes between a kit and a meal kit. FSIS reiterated that a kit product consists of individually packaged meat or poultry components and other food components sold together as a single unit. FSIS policy does not distinguish between the terms “kit” or “meal kit.”
    • One comment sought clarification on whether FSIS inspection and label approval requirements apply to firms that receive and further process bulk product as part of final kit assembly. FSIS updated the guideline to clarify that Agency guidance on the preparation of kit products without FSIS inspection does not apply when the meat or poultry component is processed, including portioned or packaged, by the firm assembling the kit.
    • One FSIS employee commented to ask for clarification whether a kit may be assembled under voluntary inspection and bear a USDA inspection legend. FSIS confirmed that the assembly of a kit product is eligible for voluntary inspection as a food inspection service under 9 CFR 350.3(c).
  • FSIS noted that the guideline represents the Agency’s current thinking on multi-component kit products and will be updated as necessary.
  • On September 20, 2021, the American Association of Feed Control Officials (AAFCO) released a press statement in which it detailed its updated position on the regulation of hemp and hemp byproducts in animal food, urging more research to be conducted and for unified regulatory action at the national level.
  • Under the Federal Food, Drug, and Cosmetic Act it is illegal to introduce hemp and hemp products (containing CBD or THC) as food or animal feed. FDA continues to review the safety of such products and potential regulatory pathways for their introduction. As a result, many efforts have been made to gain approval for such uses at the state level (see e.g., New York), threatening a patchwork of conflicting state regulations under the umbrella of a federal prohibition.
  • AAFCO is urging the industry to continue to conduct research supporting the safety of hemp and hemp products in animal feed and to submit applications to AAFCO and FDA for review and approval at the national level (AAFCO and FDA work together to review a new AAFCO ingredient definition submission).
  • AAFCO believes that further research is needed to demonstrate that hemp can be safely fed to all animal species and that it is safe to consume food from food-producing animals fed hemp. Currently only data regarding the use of hempseed cake in laying hens has been submitted to AAFCO and the data is still under review. Further, AAFCO believes that the approval of hemp as a feed ingredient at the state level could result in trade barriers between states and the loss of market opportunities for farmers if their suppliers are unwilling to accept the risk of purchasing products that have not been federally approved.
  • Delta-8 tetrahydrocannabinol (Delta-8 THC), as found in many popular products, is a compound that can be made by chemical conversion of cannabidiol (CBD) extracted from hemp.  Delta-8 THC is an isomer of Delta-9 THC and has similar psychoactive and intoxicating effects.  Both THC isomers are found at very low levels in “hemp” (as defined in the 2018 Farm Bill).  There was very little regulatory focus on Delta-8 THC until an array of new products, including gummies, brownies, and cookies, began popping up on-line and in gas stations, convenience stores and other retail outlets in late 2020.
  • A September 14, 2021 consumer update from the Food and Drug Administration (FDA), titled “5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC,” was issued in reaction to multiple factors, including an uptick in adverse event reports, finding Delta-8 THC products marketed to children, and contamination concerns from potentially unsafe manufacturing methods.  FDA’s public notification covers five things to know about Delta-8 THC products as follows:
  1. Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put public health at risk, including variable Delta-8 THC concentrations, non-standardized formulations, misleading labeling, other cannabinoid and terpene content, and unauthorized claims for therapeutic or medical use.
  2. FDA has received adverse event reports involving 22 patients who experienced vomiting, hallucinations, trouble standing, and/or loss of consciousness following the ingestion of Delta-8 THC products, with 19 such patients having consumed food products containing Delta-8 THC.  National poison control centers have reported 661 exposure cases of Delta-8 THC, with 660 occurring between January 1, 2021 and July 31, 2021, and 39% involving mostly unintentional exposures in pediatric patients less than 18 years of age.
  3. Delta-8 THC has psychoactive and intoxicating effects, similar to Delta-9 THC, the component responsible for the “high” that may be experienced from using cannabis.  FDA is also concerned that Delta-8 THC products likely expose consumers to much higher levels of the substance than are naturally occurring in hemp cannabis raw extracts or from the historical use of cannabis.
  4. Because of the very low concentration of Delta-8 THC naturally present in hemp, manufacturing Delta-8 THC products often involves the use of potentially harmful chemicals to synthetically convert CBD, derived from hemp, into Delta-8 THC.  In addition to such chemicals presenting manufacturing hazards, or possibly remaining at unsafe levels as contaminants in finished Delta-8 THC products, ubiquitous amateur production methods result in uncertainty with respect to other potential contaminants that may be present or produced depending on the composition of the starting raw material and by-products created during synthesis.  Unsanitary manufacturing conditions may also lead to safety concerns for some Delta-8 THC products.
  5. Delta-8 THC products should be kept out of the reach of children and pets.  Many Delta-8 THC products are packaged and labeled in ways that may appeal to children and are sold by retailers that may not impose age restrictions for purchasing the products.

FDA reports that it is actively working with federal and state partners to further address the concerns related to Delta-8 THC products and is monitoring the market for product complaints, adverse events, and other emerging cannabis-derived products of potential concern.

  • Keller and Heckman will continue to monitor developments with CBD derivatives.
  • Earlier this year we reported on FDA’s launch of the FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge. The public challenge sought to encourage the development of affordable, tech-enabled traceability tools to protect people and animals from contaminated foods. The public challenge ran from June 1, 2021 to July 31, 2021.
  • On September 13, 2021, FDA announced the winners of the challenge. FDA selected 12 winners representing the United States, Canada and New Zealand from over 90 submissions from around the world.  FDA stated that it “is committed to and will continue to do its part to help ensure that companies of all sizes, including small to midsize ones, can use and benefit from new tracing technologies.”
  • FDA will host a webinar on Tuesday, September 28 at 11 a.m. ET, in which the winning teams will present their solutions and take questions during a live Q&A session.
  • The District of Columbia Court of Appeals has revived a case filed in 2016 by the Animal Legal Defense Fund (ALDF) accusing Hormel Foods of falsely advertising lunch meats and bacon as a “Natural Choice.” The court’s decision to reverse the trial court’s judgment and remand for further proceedings has already been described by animal rights activists as a “watershed ruling for consumer protection of all types.”
  • In the original lawsuit, the ALDF argued that Hormel’s national advertising campaign “Make the Natural Choice” was false and misleading because “there is nothing natural about the way Hormel’s Natural Choice products are produced.” The ALDF alleged that reasonable consumers would expect meat products labeled as “natural” to “be derived from animals who were provided access to the outdoors, were given opportunities to graze or forage,” and not fed artificial growth hormones.
  • The District of Columbia Court of Appeals disagreed with the trial court and determined that the ALDF does have standing to bring the case and that federal labeling laws do not preempt ALDF’s claims, which only focus on Hormel’s advertisements, and not the labels themselves. According to the court, although the USDA may have approved the Natural Choice product labels, that does not mean that “whatever claims pass USDA scrutiny for labeling purposes are necessarily fair game to broadcast in all manner of advertisements.”
  • The court’s ruling means the case may now move forward on procedural grounds, but the court has not yet ruled on the merits of the case. Keller and Heckman will continue to monitor and report on any developments.