• On September 2, a coalition of consumer groups, foodborne illness survivors, poultry industry, academic scientists, and other food safety leaders sent a letter to USDA Secretary Tom Vilsack requesting a meeting to discuss the Agency’s regulatory approach to ensuring the safety of poultry. Consumer groups, the Center for Science in the Public Interest (CSPI), Consumer Federation of America, Consumer Reports, and Stop Foodborne Illness joined poultry producers, Butterball, Perdue Farms, Tyson Foods, and Wayne Farms to ask for modernized, science-based USDA poultry food safety standards that are objective, risk-based, and flexible enough to adapt to evolving science.
  • Foodborne pathogens are a significant threat to public health in the US. Salmonella and Campylobacter, which are commonly found in poultry, account for over 70% of all foodborne illnesses tracked by the CDC. Those two pathogens account for approximately 3 million illnesses in the US annually, and cost over 6 billion dollars.
  • According to the letter, reduction in foodborne illness has been at a standstill even though recognized best practices for the pathogens have advanced. In order to make progress and to achieve the Healthy People 2030 targets, the letter’s undersigned parties urged FSIS to make significant changes to its regulatory program and food safety standards, guided by the following principles and conclusions:
    • Modernized standards should be objective, risk-based, achievable, enforceable, and flexible enough to adapt to emerging evidence and the latest science.
    • A modernized Hazard Analysis and Critical Control Point (HACCP) framework should address risk reduction across the full production process from raw material to finished packaging, including defining responsibility of poultry processors to consider pre-harvest practices and interventions in their HACCP plans.
    • Salmonella and Campylobacter should be addressed in parallel but separate proceedings as larger knowledge gaps exist for Campylobacter than Salmonella and different timelines and risk mitigation approaches may be necessary.
    • Ongoing research is needed to support continued progress towards reducing Salmonella and Campylobacter, including epidemiologic data and analysis to improve attribution of illness to specific commodities and products
  • Keller and Heckman will continue to monitor this matter and report on any updates.
  • On September 3, 2021, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) published an advanced notice of public rulemaking (ANPR) to solicit comments and information regarding the labeling of cell-cultured meat and poultry products.
  • By way of background, in 2019, FSIS and the U.S. Food and Drug Administration (FDA) agreed to jointly oversee the production of cell-cultured products from animals traditionally under FSIS jurisdiction (livestock, poultry, and catfish). Under the agreement, FDA is charged with overseeing cell collection, growth and differentiation, while FSIS is responsible for cell harvesting, processing, packaging, and labeling. FDA is also entirely responsible for the regulation of cell-cultured seafood products other than catfish (as these foods are traditionally regulated by FDA), although the agencies agreed to develop joint principles for labeling to ensure a consistent approach. To that end, the ANPR states that FSIS will consider comments submitted in response to FDA’s Request for Information (RFI) on the labeling of cell-cultured seafood. (See RFI Blog Post).
  • Through the ANPR, FSIS is seeking comment on a broad range of questions related to labeling of cell-cultured meat and poultry products, including the foundational question of whether labeling should differentiate cell-cultured products from traditionally slaughtered products, and if so, what terms should be used.  A detailed list of questions regarding cell-cultured labeling options for which FSIS is soliciting comments can be found in the ANPR. Additionally, FSIS is requesting economic data and consumer research so that it can better understand the animal cell culture industry. Questions of particular interest to FSIS (e.g., expected number of market entrants) can again be found in the ANPR.
  • FSIS will review the labels of any cell-cultured meat or poultry products that are marketed before rulemaking is completed and ensure that the cell-cultured products are clearly differentiated from slaughtered meat and poultry products, although such labels may need to be changed once final regulations are implemented.  Comments to the ANPR are due by November 2, 2021.  Please let us know if you are interested in submitting comments in response to this ANPR.
  • On August 20, 2021, an Iowa federal judge dismissed a May 2021 lawsuit filed in Iowa federal district court by the Iowa Pork Producers Association (“IPPA”) and three Iowa pork companies, challenging the constitutionality of California’s Proposition 12 (“Prop 12”), California’s animal welfare law affecting food producing animals.  The U.S. District Court for the Northern District of Iowa granted California’s motion to dismiss after concluding that Iowa pork producers failed to establish that the court had personal jurisdiction over the California state officials named in the case.  Additionally, the court concluded that the complaint failed because Prop 12 applies generally to pork and veal production without regard to the state of origin.
  • As a recap from our 2019 blog post on Prop 12, California voters passed this law as a ballot initiative in the November 2018 election.  The new law established the standard for confinement of certain farm animals and bans the sale of eggs, veal, and pork products that do not comply with the new confinement standards.  The 2018 law amended the existing California Health and Safety Code provisions for Farm Animal Cruelty, regulating the treatment of farm animals.  Meat producers, farmers, and agricultural associations have repeatedly challenged the constitutionality of Prop 12, arguing that it violates the Constitution’s commerce clause by placing an undue burden on interstate commerce.
  • The dismissal in Iowa is another loss for the animal agricultural industry, as the courts dismissed a similar lawsuit in May 2020.  In addition, the North American Meat Institute (NAMI) failed to convince the U.S. Court of Appeals for the Ninth Circuit to ban the implementation of Prop 12 in late 2020, and the Supreme Court declined to hear an appeal of the NAMI case.  Prop 12 challenges continue, as Senators from Kansas, Iowa, Mississippi, and Texas recently introduced a bill, the Exposing Agricultural Trade Suppression Act (EATS Act), in August 2021, but the bill has yet to reach the Senate.
  • Keller and Heckman will continue to monitor this matter and report any updates.
  • On August 31, the Ninth Circuit decertified a class of consumers that claimed Coca-Cola falsely labeled its drinks as having no artificial flavors when they contained phosphoric acid (subscription to Law360 required). This decision reversed a class certification order from a California federal judge, and agreed with Coca-Cola that the consumers lacked standing to pursue injunctive relief because they have not shown that they are at risk of suffering future harm.
  • The consumers alleged they were misled by Coke’s labels that claimed they had “no artificial flavors” and “no preservatives added” “since 1886” because the labels did not disclose the addition of phosphoric acid, which can be used as both a preservative and artificial flavor. That being said, several of the named plaintiffs stated that they were not actually concerned with the use of phosphoric acid, but were worried that Coca-Cola was not truthful on its product labels. In fact, those consumers stated that they would be interested in purchasing Coke gain if the labels were accurate, regardless of whether the product contained phosphoric acid.
  • According to the Ninth Circuit, the desire for Coca-Cola to truthfully labels its products was not enough to demonstrate any future harm. In the decertification memorandum, the court found that “[n]one of the plaintiffs in this case allege a desire to purchase Coke as advertised, that is, free from what they believe to be artificial flavors or preservatives, nor do they allege in any other fashion a concrete, imminent injury. Instead, as plaintiffs explained in their brief, they have ‘each stated that if Coke were properly labeled, they would consider purchasing it.’ Under governing law, such an abstract interest in compliance with labeling requirements is insufficient standing alone.”
  • Three class-actions lawsuits filed in district courts in Illinois allege that products containing vegetable oils, and not dairy fat, are falsely and misleadingly described as “fudge.” (See Reinitz v. Kellogg Sales Company, Bartosiake v. Bimbo Bakeries USA, Inc., and Lederman v. The Hershey Company).  The lawsuits, which are all filed by Sheehan & Associates, P.C. and are substantively identical, have targeted Kellogg Sales Company’s “Frosted Chocolate Fudge,” Bimbo Bakeries USA, Inc.’s “Chocolate Fudge Iced Cake,” and the Hershey Company’s “Hot Fudge” respectively.
  • The lawsuits allege that fudge is a candy made from the mixing of sugar, butter, and milk, and that the replacement of dairy fats (butter and/or milk) with vegetable oils in each of the three products at issue constitutes deceptive advertising.  In support of these claims, Plaintiff cites a hodgepodge of sources including three recipes from around the turn of the 20th century, a Wikipedia entry, Molly Mills, who is apparently “one of today’s leading authorities on fudge,” and a 1982 Bulletin from the International Dairy Federation.
  • Plaintiffs have not, however, provided any extrinsic evidence of consumer deception (e.g., market studies), and such information will almost certainly have to be produced for such a case to ultimately succeed. We have previously reported on several other class actions which allege that the replacement of dairy fat with vegetable oil is misleading to consumers (see here and here), and we will continue to monitor and report on the outcomes of these cases.

Frito-Lay’s ‘Hint of Lime’ Chips Have No Lime, Buyers Say (subscription to Law360 required)

  • A proposed class action filed against Frito-Lay on August 25, 2021 in the U.S. District Court for the Central District of California claims that the company’s “Hint of Lime” Tostitos tortilla chips are misleadingly labeled because they contain only “Natural Flavors” and not appreciable amounts of whole lime juice.  The claims are based on alleged violations of California consumer protection laws, federal warranty law, federal trade law, and unjust enrichment.
  • As we previously reported, Frito-Lay faces similar claims in Illinois that likewise hinge largely on the product containing an image of a lime and the statement “Here’s Another Hint – Squeeze in More Flavor With Some Salsa,” which allegedly imply that lime has been squeezed into the product.  Both lawsuits also make much of the fact that a statement, “Flavored Tortilla Chips,” which the plaintiffs characterize as a “disclaimer,” appears at the bottom corner where crumpling of the package hides it from view.  Under federal flavor labeling regulation, however, a lime flavored product can be flavored only with “natural flavoring” derived from lime with no disclaimer required where the product is not purported to contain lime for nutritive value (e.g., vitamin C content).
  • The California lawsuit additionally alleges that after receiving notice of the plaintiffs’ allegations, Frito-Lay “engaged in label changes on its website” by adding the parenthetical, “including natural lime flavor,” after “Natural Flavor” in the list of ingredients.  The potential significance of this new factual allegation is not elucidated in the complaint.
  • Keller and Heckman will continue to monitor and report on the outcome of these “Hint of Lime” cases as well as the many other flavor labeling challenges brought by plaintiffs’ lawyers claiming harm to consumers from allegedly misleading food labeling.
  • FDA released per- and polyfluoroalkyl substances (PFAS) testing results yesterday from its first survey of nationally-distributed processed foods collected for the Total Diet Study (TDS). 164 of the 167 tested foods did not contain detectable levels of PFAS. FDA’s update states that the three samples that do contain detectable PFAS levels do not present a human health concern.
  • The comprehensive analysis of the results published online provides more information on the tested foods that did contain detectable levels of PFAS: perfluorooctanesulfonic acid (PFOS) and perfluorononanoic acid (PFNA) were found in frozen fish sticks/patties, PFOS and perfluorodecanoic acid (PFDA) in canned tuna, and PFOS in protein powder. The substances were detected at concentrations below 150 ppt.
  • While the sample sizes are limited and the results do not provide an accurate description of PFAS levels in the general food supply, FDA’s TDS studies will help the agency determine if additional sampling is needed for any foods. As we reported last month, FDA has also published results from its testing of 94 food samples, including in raw fruits and vegetables, meats, poultry, and fish. Of these PFAS were detected in a single sample of cod but not at levels that indicated a human health concern. FDA has stated it plans to conduct a targeted survey of PFAS in commonly-consumed seafoods.
  • An Illinois consumer has filed a class action lawsuit against Kellogg in federal court, claiming that Frosted Strawberry Pop-Tarts’ packaging is misleading because the product contains less strawberry than implied by the packaging.  The complaint highlights that the ingredient declaration indicates that the product “contains 2% or less” of dried strawberries, pears, and apples and speculates that apple and pear could be more prominent than the strawberry component. In addition, the complaint notes that the product contains Red 40 as an ingredient, which allegedly misleads the consumer into thinking there is more strawberry in the product.
  • The plaintiffs in this case raised that the Pop Tarts are not described as being strawberry flavored.  The complaint compared the label of the Frosted Strawberry Pop-Tarts to other brands’ strawberry toaster pastries, like Great Value and Clover Valley, which describe the products on the front of the package as being “artificially and naturally flavored.” The Pop Tarts are described as being “Frosted Strawberry” without reference to being flavored.
  • The newly filed complaint is similar to our previous post on a similar complaint concerning Kashi Strawberry Bars.  Kellogg has yet to respond but will be able to draw from the motion to dismiss it filed earlier this year in response to an analogous Sheehan & Associates complaint concerning Strawberry Pop Tarts filed in New York District Court in the fall of 2020.
  • FDA recently published the guidance document “FDA Export Certification: Guidance for Industry,” which is intended to provide a general description of the FDA’s export certification to industry and foreign governments. Companies exporting products from the US are often asked by foreign customers or governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act and other statutes administered by the Agency.
  • FDA export certification provides information concerning a product and/or establishment’s regulatory or marketing status, based on available information at the time FDA issues the certification (including attestations provided by the person seeking the export certification). For some Agency Centers, if a product has received approval or clearance from FDA, it is indicated on the export certification and/or a copy of approved labeling is appended, as appropriate. FDA issues several types of export certificates, including “Certificate of Free Sale” for human food, animal food/drugs, and cosmetics, “Health Certificate,” “Certificate of a Pharmaceutical Product,” “Non-Clinical Research Use Only Certificate,” “Certificate to Foreign Government,” and “Certificate of Exportability.”
  • This guidance supersedes previous versions that were issued in July 2004, April 2005, and February 2019. The FDA is accepting comments on the guidance document electronically via docket ID: FDA-2013-S-0610. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • As we have previously reported, in September 2020, Mexico and Canada signed a Statement of Intent (SOI), which expanded the countries’ partnership in dealing with food safety issues. Among other things, the 2020 SOI expanded the partnership to include all foods traded between the countries and encouraged the development and use of new technologies to improve food safety.
  • On August 20, 2021, FDA and its regulatory counterparts in Mexico (Cofepris and SENASICA) held the first Food Partnership Annual meeting in which they discussed the accomplishments and goals of the partnership. The discussion was summarized in a recent press release by Frank Yiannis, FDA Deputy Commissioner for Food Policy and Response. (See also Constituent Update)
  • Specifically, Mr. Yiannis stated that the agencies were continuing to work on four strategic priorities: (1) foodborne illness prevention, (2) enhanced coordination for outbreak response, (3) regulatory laboratory coordination, and (4) food safety training opportunities for industry. The agencies’ efforts included sharing analytical methods and laboratory protocols to improve detection and reduce exposure to food illness pathogens, sharing outbreak data to improve outbreak response communications, and working to revise a coordinated outbreak response protocol. Mr. Yiannis also announced progress in training industry on best agricultural practices, including the training of 90% of the Mexican papaya industry on papaya growing best practices.
  • Keller and Heckman will continue to monitor and report on developments in the regulation of food safety.