• On September 11, 2023, a consumer class action lawsuit against Kroger for selling baby teething wafers with allegedly elevated levels of heavy metals was dismissed with leave to amend (Law360 Subscription required). 
  • Unlike several other heavy metal cases, the Court declined to invoke the “primary jurisdiction” doctrine. The Court found that an underlying reason for the application of primary jurisdiction is a “desire for uniformity,” and that the absence of any regulations on the subject indicated that FDA had not expressed such a desire. As to FDA’s Closer to Zero plan, the Court noted that the plan was announced more than two years ago and that it did not include a timeline for proposed or final regulations.
  • Nevertheless, the Court dismissed the claims. Several of the claims were dismissed for procedural reasons (e.g., failure to specify governing laws), while a claim under the Indiana Deceptive Consumer Sales Act was dismissed because, absent notice to the Defendant (which was not given), the Plaintiffs were required to show that the Defendant acted with an “intent to defraud or mislead.” No such allegations were made.
  • On the count alleging violation of the Washington Consumer Protection Act, which requires (among other things) an unfair or deceptive act or practice and an injury to plaintiff’s business or property, the Court held that no injury to property was shown; on the contrary, the wafers were bought and fed to children, who suffered no ill effects.
  • Notably, on this count, the Court found that Plaintiffs had met their pleading burden to identify an unfair or deceptive act (i.e., the omission of heavy metal warnings) even though Plaintiffs did not “provide actual test results” or “list who conducted the testing or when they conducted it.” The failure to include detailed test results in a complaint has doomed other lawsuits. Nevertheless, this count was dismissed based on the failure to show injury to property.
  • The California Food Safety Act (AB 418) was amended by the Senate to remove titanium dioxide from its list of prohibited substances. Four substances remain on the list: brominated vegetable oil, potassium bromate, propylparaben, and Red dye 3. The amendment was made just before the Legislature was to cast the final vote on AB 418, but it is now ordered to a third reading.
  • Additionally, in a July amendment, the effectiveness date was amended from January 1, 2025 to January 1, 2027, which would give affected parties two additional years to comply if AB 418 is passed.
  • As we have outlined in two previous posts (available here and here), AB 418 would prohibit manufacturing, selling, delivering, distributing, holding, or offering for sale a food product that contains any of the now four remaining substances. Anyone found to be in violation of the Act would be liable for a civil penalty not to exceed $5,000 for a first violation, and not to exceed $10,000 for each subsequent violation.
  • If passed, AB 418 would be the first law of its kind in the United States. Advocates of the bill, including Consumer Reports and the Environmental Working Group, argue that these substances have not been adequately reviewed by the FDA and view this bill as a necessary step to remove harmful chemicals from the food supply. The European Union has already imposed restrictions or bans on use of these substances in food.
  • Keller and Heckman will continue to monitor and report on any developments in this area.
  • On September 4, 2023, France released revised proposals banning the use of meat names for plant-based food made in the country in order to avoid “misleading claims” of some meat alternatives.  In its press release, France’s Ministry of Agriculture and Food Sovereignty stated that, “It is an issue of transparency and fairness which responds to a legitimate expectation of consumers and producers.”
  • The agency plans to ban the use of 21 meat terms, including “steak,” “ham,” and “spare ribs,” from labels on all plant-based food products.  Producers will be completely prohibited from using words associated with particular animal parts (i.e., rump, flank, loin, etc.) when marketing or describing processed products containing plant proteins.  A second list of 120 terms, including “bacon,” pastrami,” and “sausage” will be allowed by French authorities “to describe foodstuffs of animal origin which may contain plant proteins,” but only if the plant protein levels do not exceed a specified threshold, ranging between 0.5% and 6%.  “Burger” does not appear on the list of banned words.  If approved by the European Commission, producers will have three months to comply with the decree.
  • Previously, in June 2022,  France was the first European Union member state to attempt to impose such restrictions.  However, the measure was suspended by the country’s highest administrative court a month later, which argued that it was too vague and the timing too short.
  • Keller and Heckman will continue to monitor and relay any developments pertaining to this decree.
  • On August 31, FDA announced its 8th webinar in its ongoing series “Collaborating on Culture in the New Era of Smarter Food Safety” which explores food safety culture in partnership with the non-profit public health organization Stop Foodborne Illness. The upcoming webinar “Facing Food Safety Challenges through Culture and Persistence” will focus on the importance of a strong food safety culture and how it can help organizations address food safety challenges they may face. Guest speakers include representatives from the food industry and Conrad Choiniere, Director of the Office of Analytics and Outreach at the Center for Food Safety and Applied Nutrition, FDA.
  • FDA’s webinar series brings together experts from both the public and private sectors to exchange ideas and experiences regarding the importance of cultivating a robust food safety culture, ultimately contributing to safer food production. According to the FDA, food safety culture stands as a cornerstone in the FDA’s New Era of Smarter Food Safety blueprint which states that dramatic improvements in reducing the burden of foodborne illness cannot be made without doing more to influence the beliefs, attitudes, and the behaviors of people and the actions of organizations.
  • The webinar will take place on September 13, 2023, from 12 noon to 1:00 pm EST. Registration is available through the FDA website here.
  • Keller and Heckman will continue to report on FDA activities impacting food safety.
  • Last week FDA published an updated version of The Seafood List: FDA Guide to Determine Acceptable Seafood Names: Guidance for Industry, which is intended to be used in conjunction with FDA’s The Seafood List to determine acceptable market names (i.e., common or usual names) for seafood products.
  • The principles of the guidance document have not changed, but the document has been updated for ease of understanding and to add examples of acceptable seafood names, the most significant of which is the addition of “Kanpachi (Ocean-Farmed)” as an acceptable market name for Amberjack (Seriola rivoliana) as required by the 2023 consolidated appropriations act.
  • The Seafood List includes “acceptable market names,” as well as “common names,” which are established by accredited scientific fishery resources and recognized within U.S. commerce, “scientific names”, and “vernacular names.” Whereas “common names” are acceptable market names unless prohibited by law or regulation (indicated by a † symbol next to the common name in The Seafood List), vernacular names are generally not acceptable, and scientific names are not in themselves acceptable market names, although they can be used to supplement the market name in product labeling. The guidance establishes a hierarchy of principles though which acceptable market names for seafood products should be selected:  
    1. Use a name established by law or regulation.
    2. Use a nationally recognized and commonly used name.
    3. Use a “common name” (established by scientific fishery resources).
    4. Use an established international name or a name that is widely recognized and commonly used in the country of origin.
    5. Use a coined or fanciful name. 
  • The first available name at each step should be used, unless the name is false, misleading, or contrary to law or regulation, in which case the next step should be used to select a name.  In most cases, the selection of a seafood name should be a straightforward matter of selecting from the acceptable market names or common names (unless specifically prohibited) in The Seafood List. However, the guidance document is useful to understand the list and to select names in more difficult cases.
  • The Kraft Heinz Co. has agreed to settle in principle a proposed class action lawsuit that claims the MiO brand drink mixes falsely claimed to contain only natural flavors on their labels (subscription to Law360 required). Specifically, named plaintiff, Sandra Adams, alleged in the June 2022 complaint that The Kraft Heinz Co. was misleading consumers by advertising MiO as having no artificial flavors when it actually contained malic acid, which Adams called an “artificial petrochemical.”
  • The complaint sought to certify a class of consumers from Alabama, South Carolina, Tennessee, and Virginia, as well as a separate class for plaintiffs in Florida. Adams claimed all of the plaintiffs would not have paid the full price of the MiO products had they known the product contained malic acid. The Kraft Heinz Co. originally sought to dismiss the proposed class action and argued that Adams had not sufficiently shown that malic acid is an artificial flavor. However, the motion to dismiss was denied.
  • Details of the intended settlement have not been disclosed, nor has a settlement agreement been filed, but an order dismissing the case was filed on August 25.
  • On August 30, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to three infant formula manufacturers as part of the Agency’s recent push to enhance regulatory oversight in the infant formula industry.  The warning letters, which were issued to ByHeart Inc., Mead Johnson Nutrition, and Perrigo Wisconsin, LLC, allege violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations.
  • At the time of FDA inspections of the facilities, the Agency issued inspectional observations and exercised oversight of each firm as they initiated recalls (in December 2022, February 2023 and March 2023) to remove product potentially contaminated with Cronobacter sakazakii from the marketplace. 
  • Importantly, FDA does not advise consumers to discard or avoid purchasing any particular infant formula at this time.  These warning letters are not associated with any current recalls and therefore, FDA does not anticipate any impact to the availability of infant formula on the market.  Consumers should know that the U.S. infant formula supply is healthy with in-stock rates at 85% or higher since the beginning of 2023.
  • FDA states that it is issuing these letters now “as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulations.”  Each company will have 15 working days to respond to the FDA to explain what corrective actions they are taking.
  • Last week FDA announced that it had signed a regulatory partnership arrangement (RPA) with Ecuador’s seafood regulatory authority (the Vice Ministry of Aquaculture and Fisheries or VMAF) to enhance the safety of shrimp imported from Ecuador. Shrimp is the most consumed seafood product in the United States and Ecuador is the second largest exporter of shrimp to the United States (following India).
  • The partnership will increase collaboration between the agencies, including by facilitating information sharing, improving recall notification and response, promoting training on relevant food safety topics such as HACCP (hazard analysis critical control points) and good aquaculture practices, and facilitating joint participation in shrimp inspections, audits, and investigations. Earlier in the month, the agencies announced the signing of a confidentiality agreement to allow for the sharing of confidential information such as inspection and sampling records. FDA also examined various aspects of Ecuador’s regulatory framework for shrimp and VMAF’s capabilities, concluding that it was “confident that Ecuador has key components of a food safety oversight system for shrimp and shrimp products intended for export to the U.S.”  
  • The partnership advances core goals of FDA’s New Era of Smarter Food Safety plan, including by facilitating outbreak response and prevention through information sharing. If successful, the pilot program may lead to other similar partnerships with important U.S. food suppliers. We will monitor and report on any developments in this space.
  • We have observed that uncertainties about the levels of heavy metals in baby foods that are both safe and feasible could pose difficulties for plaintiffs in many of the consumer protection class action lawsuits that followed a February 4, 2021 report and September 29, 2021 supplement (discussed here) by the U.S. House of Representatives subcommittee on Economic and Consumer Policy that raised alarm over the levels of arsenic, lead, cadmium, and mercury reportedly found in U.S. baby foods.  Plaintiffs in personal injury litigation face related challenges in establishing that heavy metals in baby food consumed were sufficient to cause heavy metal toxicity and were a substantial cause of neurological disorders. 
  • In an August 24, 2023 hearing (Law360 subscription required), a California state judge said he would grant defense motions to exclude expert testimony that heavy metals in the baby food eaten by the plaintiffs’ son caused him to develop autism and attention deficit hyperactivity disorders (ADHD).  The judge ruled one expert’s calculation of the child’s exposure to heavy metals from the baby food was inadmissible, finding his methodology was constructed on assumptions.  Specifically, where no heavy metal was detected, the expert assumed the heavy metal was present at the level of detection and where the baby food was not tested, the expert assumed heavy metals were present at the maximum levels specified (whereas the actual levels of heavy metals in the baby food could be zero, or another level less than the assumed amount, in either case).  Other experts’ opinions were excluded because these experts could not have reached their purported opinions without relying on the same faulty heavy metal exposure assumptions. 
  • If problems calculating exposure to heavy metals can be fixed, the plaintiffs will face other causation questions raised by the ubiquity of heavy metals and uncertainties about their role in the development of neurological disorders.  As noted by the judge, “given that the heavy metals at issue here are found widely distributed throughout the environment from many sources — air, food, water, industrial product, and can cross the placenta — it seems a fact that virtually all neo-nates and infants are exposed to and have a dose of these metals in their bodies, yet not all children have these disorders.”  Keller and Heckman will continue to monitor and report on heavy metals baby food litigation and any relevant regulatory actions or developments. 
  • On August 25, the FDA published a proposed rule to revise the standard of identity and standard of fill of container for canned tuna. If finalized, the proposed rule would:
    • Replace the pressed cake weight method with the drained weight method to determine the standard of fill of container;
    • Clarify that the use of a packing medium is optional;
    • Remove provisions for specific flavorings and spices to avoid redundancy and allow the use of safe and suitable flavorings and spices as optional ingredients; and
    • Revise the language throughout the section to improve clarity and readability.
  • The proposed rule responds, in part, to a citizen petition filed by Bumble Bee Foods, LLC, StarKist Co., and Tri Union Seafoods, LLC (dba Chicken of the Sea International).
  • The canned tuna standards were established in 1957, and although the standards have been amended several times, it seems that certain requirements are outdated. FDA stated that the agency “aims to modernize food standards to maintain the basic nature and nutritional integrity of products while allowing industry flexibility for innovation to produce more healthful foods.”
  • Stakeholder comments must be submitted by November 24, 2023 to docket number FDA-2016-P-0147. Please contact fooddrug@khlaw.com for assistance preparing and submitting comments on the proposed rule.