• 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.
  • Today, August 24, 2023, China announced it is banning imports of all seafood from Japan in response to Tokyo’s decision to begin releasing radioactive waste water from the Fukushima nuclear plant. 
  • The discharge began at 1:00PM local time, according to state-owned electricity firm Tokyo Electric Power Company (TEPCO).  TEPCO stated that it expects to discharge only around 200 or 210 cubic meters of treated wastewater.  From Friday, it plans to then release 456 cubic meters of treated wastewater over a 24-hour period and a total of 7,800 cubic meters over a 17-day period.  TEPCO also stated that the operation would be suspended immediately and an investigation conducted if any abnormalities are detected in the discharge equipment or the dilution levels of the treated wastewater. 
  • Japan’s devastating 2011 earthquake and tsunami caused water within the Fukushima nuclear plant to be contaminated with highly radioactive material.  The wastewater has been continually treated over the years to filter out harmful elements and will be heavily diluted with clean water to minimize concentrations of radioactive material when it is finally released.
  • The ban was aimed at preventing “the risk of radioactive contamination of food safety caused by Japan’s Fukushima nuclear contaminated water discharge,” and to protect the health of Chinese consumers, according to a statement released by the Chinese customs department.
  • In response to the release, Ministry of Commerce spokesperson Shu Jueting called it “extremely selfish and irresponsible” and said it would “cause damage and harm to the global marine environment that cannot be predicted.”
  • The total ban on Japanese seafood expands on previous regulations that had already halted imports from Fukushima and nine other regions in Japan.  Hong Kong has also announced a similar ban on food imported from parts of Japan.  Mainland China and Hong Kong represent Japan’s top two biggest export markets for seafood, according to Japanese customs data.
  • Keller and Heckman will continue to follow and report on these developments.
  • On August 9, Real Kosher Ice Cream voluntarily recalled soft serve on the go ice cream and sorbet cups due to potential contamination with Listeria monocytogenes, an organism which can cause serious infections in young children, the elderly, and individuals with weakened immune system. The ice cream products were distributed in over 19 states nationwide through canteens, grocery and convenience stores.
  • To date, two cases of illness have been reported in this outbreak in New York and Pennsylvania. Both individuals were hospitalized but no deaths have been reported to date. On August 23, FDA confirmed that Listeria matching the sick people’s samples was found in an unopened sample of the implicated ice cream during testing by the Pennsylvania Department of Agriculture. In addition, the New York Department of Agriculture and Markets found the outbreak strain of Listeria in five finished samples of “Soft Serve On the Go” ice cream cups collected from the company’s manufacturing facility.
  • Keller and Heckman will continue to monitor and report on food recalls in the US.
  • Last year we blogged about a decision in which the Court of Appeals of Georgia dismissed a deceptive product (dietary supplement) labeling case on primary jurisdiction grounds. That decision was subsequently appealed to the Supreme Court of Georgia which upheld the decision without explanation. However, in a concurrence (Law360 subscription required) authored by Justice Pinson (and joined by 2 other of the 9 Georgia Supreme Court justices), Justice Pinson raised questions about the applicability of one species of the primary jurisdiction doctrine in Georgia state courts.
  • In particular, Justice Pinson distinguished between two forms of primary jurisdiction. He characterized the first as “simply a species of statutory interpretation” in which courts have determined that “the governing statutory scheme put the issues within the exclusive jurisdiction of the agency.” Statutory construction is of course a necessary tool of any court, so there is no question that Georgia courts would apply this species of primary jurisdiction (whether interpreting federal or state law).
  • However, the other species of primary jurisdiction which has emerged in federal courts and percolated to state courts is based on prudential considerations. In such cases, courts applying primary jurisdiction have deferred to an agency’s concurrent jurisdiction based on considerations such as the agency’s technical expertise (often reflected in multi-factor balancing tests). Justice Pinson’s concurrence noted that the application of that species of primary jurisdiction “has to be answered by reference to Georgia law,” and that it was not obvious that such a law existed, at least in all cases.
  • Notably, these issues were not raised on appeal and so were not considered in relation to this case, but Justice Pinson wrote that “review of these questions may well be warranted in an appropriate case.” We will continue to monitor and report on whether the questions raised by the concurrence are explored elsewhere.

Splenda Maker Falsely Touts Diabetes Benefits, Suit Says (subscription to Law360 required)

  • As our readers may recall, a defamation lawsuit was filed on August 8, 2023 by TC Heartland LLC, the producer of a sucralose product sold as Splenda, against Dr. Susan Schiffman, the lead author of a May 29, 2023 scientific paper reporting potentially concerning toxicological and pharmacokinetic properties of sucralose-6-acetate (S6A), which the paper describes as an intermediate and impurity in the manufacture of sucralose.  In addition to attacking the research paper itself, Heartland’s complaint alleges that Dr. Schiffman made demonstrably false toxicology claims to the press about Splenda (which the company says does not contain detectable levels of S6A). 
  • On August 17, 2023, a proposed class action was filed in the Northern District of California against Heartland by a Type II diabetes patient accusing the company of false advertising and other consumer protection law violations by marketing Splenda-brand “diabetes care” shakes, zero calorie sweetener packets, sweet teas and multi-use syrup products to health-conscious consumers, including those with Type 2 diabetes, as a healthy sugar alternative even though sucralose has been shown to worsen diabetes, among other alleged harms.  As support for the plaintiff’s contention that Splenda products made with sucralose are neither healthy nor suitable for the claimed purposes of helping to manage blood sugar and aiding in diabetes care, the complaint cites the 2023 Schiffman paper and other published scientific articles, as well as the World Health Organization’s (WHO) May 15, 2023 guidelines urging against the long term consumption of sucralose and other nonnutritive sweeteners to achieve weight loss or to avoid non-communicable disease. 
  • While Heartland has not yet responded to the immediate lawsuit, the company’s press releases dispute claims in the 2023 Schiffman paper and other papers that would raise safety concerns for sucralose, highlighting alleged flaws in the research or conclusions of these papers.  Another press release objects to even the limited scope of WHO’s guidance, framing it as based on evidence with a “low certainty” level.  Heartland has also pointed to other favorable, and purportedly more convincing scientific studies, as well as reviews by FDA and international food regulatory authorities that support the safety of sucralose.  Keller and Heckman will continue to monitor any developments in the cases involving Splenda.
  • On July 26, the FDA responded to a January 30, 2023 citizen petition filed by the Center for Science in the Public Interest (CSPI) regarding sesame allergen labeling by denying two of CSPI’s petition requests and granting one request. See Docket FDA-2023-P-0342.
  • Specifically, CSPI’s petition requests were as follows:
    • Request 1. “Issue a notice to manufacturers, similar to [FDA’s] June 1996 “Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers,” declaring that companies cannot meet their obligation to control allergen cross-contact risks by adding major food allergens intentionally to foods;”
    • Request 2. “Finalize [FDA’s] “Draft Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)”…to likewise reflect the policy that companies cannot add major food allergens to mitigate cross-contact risks;” and
    • Request 3. “Clarify in guidance that while cross-contact risks can be declared voluntarily in a ‘may contains’ advisory statement, they cannot be declared by naming the allergen in the ‘Contains’ statement or ingredient list, as these are reserved for declaring actual ingredients.”
  • Regarding Requests 1 and 2, CSPI stated that certain manufacturers are intentionally adding sesame to products instead of implementing allergen preventive controls and included examples of companies who have either publicly or privately shared that they have added sesame to their products in response to the FASTER Act. CSPI argued that this practice is illegal and violative of both the law and the intent of FDA’s food safety rules because it “further elevates the risk to consumers by increasing potential exposure to the food allergen.” In response, FDA denied Requests 1 and 2. The Agency stated that they expect firms to adhere to good manufacturing practices and preventive controls, and that the Agency does not encourage the intentional addition of sesame to foods where it is not normally an ingredient, but that such a practice is not violative.
  • As for Request 3, CSPI asked the FDA to clarify that declaring an ingredient or allergen in the ingredients list when it has not been intentionally added to food is a prohibited practice and renders the food misbranded. FDA granted CSPI’s third request and stated that “the laws and regulations do not permit the addition of “sesame,” or any other major food allergen, on the label in the ingredient list or the “Contains” statement if that major food allergen is not an ingredient used to make the food.” FDA recently addressed the practice of using allergen advisory statements in a final guidance entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Final Guidance for Industry,” which notes that allergen advisory statements are not a substitute for adherence to current good manufacturing practices or, when applicable, food allergen preventive controls. The guidance also states that any allergen advisory statement must be truthful and not misleading. Further, in May of 2023, FDA announced the availability of draft compliance policy guide (CPG) entitled “Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact,” in which the Agency states that “Major food allergens unintentionally incorporated into a food are not to be declared in the ingredient list or the “Contains” statement.
  • In the conclusion to their response, FDA stated that while the Agency is not taking action with respect to Requests 1 and 2, they are “actively looking into and engaging on this practice of companies intentionally adding sesame to foods that, prior to the passage of the FASTER Act, did not contain sesame.” Keller and Heckman will continue to monitor for FDA’s engagement on this practice and report any updates.