• In a September 16 opinion, U.S. District Judge John P. Cronan denied the majority of Starbucks’ motion to dismiss a proposed class action lawsuit related to the allegedly misleading names of their “Refreshers” products (subscription to Law360 required). Named plaintiffs Joan Kominis and Jason McAllister alleged that Starbucks advertises its Refreshers beverages as containing fruits like mango, passionfruit, and acai, but that the beverages do not actually contain said fruits. The plaintiffs argued that had they been aware that the Refreshers did not contain the named fruits, they would not have purchased the products or would have paid significantly less for them.
  • In their motion to dismiss, Starbucks argued that consumers understand that the product names refer to flavors, not the ingredients, and that its advertising accurately represents the products’ fruit content. However, Judge Cronan held that, based on the context of the menu and advertising images of drinks with fruit pieces, a significant portion of the general consuming public could reasonably believe that the products contain the named fruits.
  • Out of eleven causes of action, Judge Cronan only granted the dismissal of unjust enrichment and common law fraud. In his opinion, Judge Cronan stated that the plaintiffs adequately alleged that a significant portion of the general public could be misled by the product names. Judge Cronan held that the pleading of unjust enrichment failed because it is duplicative of the New York General Business Law claims and because it cannot be brought under California law in conjunction with an express warranty claim. Further, Judge Cronan held that plaintiffs failed to sufficiently plead scienter to support the fraud claim. The claim of unjust enrichment was dismissed with prejudice, and the claim with respect to fraud was dismissed with leave to amend.
  • Today, FDA announced an update on its work to advance its strategy to help prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula, including:
    • Continuous collaboration with industry, coalitions, academia, and consumer groups to better understand and explore ways to enhance the safety of powdered infant formula.
    • Issuance of a letter to the powdered infant formula industry to share current safety information and a call to industry to take prompt action to improve processes related to the safe production of powdered infant formula.
    • Initiation of hiring to establish a dedicated cadre of investigators to conduct infant formula inspections. 
    • Initiation of hiring of staff to support the new Office of Critical Foods. 
    • Supporting the Council of State and Territorial Epidemiologists (CSTE) position on elevating Cronobacter to a nationally notifiable disease, which was successfully adopted by the CSTE on June 29, 2023.
    • Updating and reorganizing infant formula related materials on FDA.gov to provide both consumers and industry with more accessible information, including:
    • Initiating work with the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) to address knowledge gaps regarding Cronobacter. 
  • The updated prevention strategy webpage includes a full list of actions that have been taken to date. In addition, FDA has continued to undertake additional steps to enhance its regulatory oversight of the infant formula industry, including the recent issuance of three warning letters to infant formula firms in August 2023 and requirement that manufacturers to develop, maintain and implement risk management plans to identify and evaluate risks to the supply of the critical food, such as infant formula, and ways to mitigate such risks, as mandated by Congress.
  • Keller and Heckman will continue to monitor and report on issues relating to infant formula.
  • On September 12, 2023, a group Senators, including proponents of the previously introduced Dairy Pride Act, wrote to FDA, again urging the agency to enforce the standards of identity (SOI) for dairy products, which define milk (and related products) as from a cow (although notably do not mention milk from other animal sources, such as goats). See e.g., 21 CFR 131.110. The letter also warns FDA of a “new, additional perpetrator – Cell-based dairy imitation products,” which the Senators alleged were also in violation of FDA’s SOIs and frequently nutritionally inferior.
  • FDA has not yet issued any guidance on the labeling of cell-based dairy products (i.e., dairy products grown from mammary cells), although USDA recently approved labels for cell-grown meat which will use the term “cell-cultivated.”
  • Based on FDA’s draft guidance, Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements, there appears to be no appetite in the agency for banning the use of the term “milk” in the names of products that are not from cows. Indeed, several courts have found that such attempts by states were unconstitutional. However, the draft guidance recommends that plant-based milk alternatives using the term “milk” disclose nutritional differences from milk.
  • We will continue to monitor and report on development in the labeling of plant and cell-based alternative meat and dairy products.
  • On September 11, the California Senate passed AB-418, The California Food Safety Act. As our readers know, if signed into law, AB-418 would prohibit the manufacturing, selling, delivering, distributing, holding, or offering for sale a food product that contains brominated vegetable oil, potassium bromate, propylparaben, and Red dye 3.
  • As of just last week, titanium dioxide was removed from the list of prohibited substances. Brian Ronholm, director of food policy at Consumer Reports, stated earlier this week that supporters of the bill “would have preferred not to take out titanium dioxide” but that “having the four that are in there now […] certainly is a welcome development.” Those in opposition to AB-418, like the American Chemistry Council, believe the bill is “an overly broad and unnecessary burden on consumers, manufacturers, and regulators.”
  • AB-418 passed the Senate in a 33 to 3 vote and is now sent to Governor Gavin Newsom to be signed. Governor Newsom has not indicated where he stands on AB-418. If signed, the bill would go into effect on January 1, 2027.
  • Keller and Heckman will continue to monitor and report on any developments.
  • According to research posted on September 13, 2023 in Public Health Nutrition, restaurants posting their menus on third party platforms such as DoorDash, Uber Eats, and Grubhub are not consistently complying with federal regulations requiring calorie disclosures.
  • Federal law requires chain restaurants to post calorie counts on menus, and those calorie counts must be visible to consumers while making food selections, whether online or in the restaurant.  The U.S. Food and Drug Administration (FDA) paused enforcement of menu labeling requirements in April 2020 due to COVID-19, but has since promised to resume enforcement as of November 2023.  However, FDA has stated publicly that third party platforms (TPPs) themselves are not covered by federal menu labeling laws [see https://www.washingtonpost.com/business/2021/04/01/food-delivery-apps-calorie-labeling/]. FDA has made no indication that it might provide labeling requirements for TPPs, despite public interest groups urging the Agency to do so.
  • Researchers examined food and drink items posted by restaurants representing the top 75 restaurant chains in four US cities and found that 60% of menus on restaurant websites or apps posted calories for every menu item reviewed.  Only 27% of menus on DoorDash, 19% of menus on Uber Eats, and only 6% of menus on Grubhub had consistent calorie information.  The researchers have called on FDA to clarify whether the chain restaurants can be held accountable for menus they post on the platforms.
  • 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.