• The U.S. Food and Drug Administration (FDA) and the Center for Disease Control and Prevention (CDC) are renewing public health warnings that address the continuing hepatitis A outbreak traced to frozen, organic strawberries.  Although the outbreak has progressed slowly, public health officials are concerned that consumers may continue to be at risk due to the frozen product’s long shelf life.
  • As the FDA and CDC continue to investigate, various retailers have voluntarily recalled products that may be contaminated.  The strawberries in question have been found to have been imported by a common supplier from certain farms located in Baja California, Mexico.  FDA reported that, “the strain of hepatitis A virus causing illnesses this year is genetically identical to the strain that caused the outbreak of hepatitis A virus infections in 2022, which was linked to fresh organic strawberries imported from Baja California, Mexico, and sold at various retailers.”
  • Hepatitis A is a highly contagious, vaccine-preventable, liver infection caused by the Hepatitis A Virus (HAV).  Even if no symptoms are present, people can still transmit the infection.  Thus far, there have been 18 reported cases, resulting in 13 hospitalizations.  FDA has provided general food safety tips for consumers and retailers during an outbreak.
  • On May 3, FDA announced that it has filed a color additive petition (CAP 3C0325), submitted by the Environmental Defense Fund (EDF), the Center for Environmental Health (CEH), the Center for Food Safety (CFS), the Center for Science in the Public Interest (CSPI), and the Environmental Working Group (EWG). The petition proposes that FDA repeal the color additive regulation for titanium dioxide in 21 CFR 73.575, which permits its use in food products.
  • The petitioners assert that the intended use of this color additive no longer meets the safety standard under 21 CFR 70.3(i), and cite, as evidence, an opinion by the European Food Safety Authority (EFSA) entitled “Safety assessment of titanium dioxide (E171) as a food additive” that was published in May 2021. On January 14, 2022, the European Commission (EC) announced that it adopted a ban on the use of titanium dioxide as a food additive. To read more about EFSA’s 2021 titanium dioxide safety opinion, click here.
  • FDA also submitted notice of the color additive petition to the World Trade Organization’s Committee on Sanitary and Phytosanitary Measures on May 5 to request international input on the proposed titanium dioxide ban.
  • FDA is currently seeking comments, additional scientific data, and other information related to the safety of titanium dioxide in foods until July 3, 2023. Electronic comments can be submitted here.
  • Keller and Heckman would be happy to assist in submitting comments. We will continue to monitor developments regarding the permissive use of titanium dioxide as a color additive in foods.
  • Last month the Center for Science in the Public Interest (CSPI) and New York City’s Department of Health and Mental Hygiene (NYC DOHMH) petitioned FDA to issue voluntary guidance aimed at encouraging food manufacturers to lower added sugars in the food supply to amounts corresponding to less than 10 percent of total daily calorie intake within 10 years. 
  • The request is modeled off FDA’s voluntary sodium reduction guidance as well NYC DOHMH’s National Salt and Sugar Reduction Initiative, which is another voluntary program that aims to reduce the sugar and salt content of the food supply.    
  • The petition requests that FDA establish short-term (2.5-year), mid-term (5-year), and long-term (10-year) targets for added sugar content in processed and packaged food and beverages that contribute most to overall added sugar intake, with target reductions varying by food category. The petition also requests that FDA establish a public database of foods in the targeted categories with product information, including added sugar content, at baseline and at 2.5-year intervals, and that FDA provide public progress reports at 2.5-year intervals. Furthermore, the petition requests that FDA extent the scope of the guidance to cover prepared food and beverages (that most contribute to added sugar intake) if and when federal regulations are amended to require chain restaurants to declare added sugars (the subject of a separate CSPI petition).  
  • We will continue to monitor and report on this petition and other initiatives aimed at improving food nutrition. 
  • On April 26, House Energy Commerce Committee Member Pallone (D-NJ) and Senator Blumenthal (D-CT) introduced the Food Labeling Modernization Act of 2023 (FLMA). The bill would update front-of-package food labeling requirements, require updates to the ingredient list on packaged foods, and apply consumer friendly labeling requirements. As our readers may recall, a similar bill was introduced in the House in 2021.
  • FLMA’s initiative would direct FDA to establish a standard front-of-package nutrition labeling system for all of the packaged foods it regulates to complement the Nutrition Facts panel and clearly convey when high levels of sodium, added sugar, or saturated fat are present in foods. As reported by the Center for Science in the Public Interest, similar requirements have already been implemented in several countries, including Canada, Ecuador, and Chile.
  • FLMA would amend “standards of identity” to allow salt substitution across all packaged foods, which purportedly would enable the food industry to contribute to a national sodium reduction effort by swapping out sodium from standardized foods. FLMA would also update the labeling laws to require that the same Nutrition Facts, ingredient, and allergen information now on packages be available for online grocery items.
  • Further, FLMA includes several provisions aimed at addressing supposedly misleading claims that undermine health, such as whole grain, fruit, and vegetable claims. FLMA would additionally require clear disclosure for certain ingredients of public health importance such as caffeine in excess of 10mg per serving and gluten-containing grains.
  • Keller and Heckman will continue to monitor the status of FLMA and report with updates as they arise.
  • On May 2, The Association of American Feed Control Officials (AAFCO) announced the institution of its new repository, referred to as the Common Food Index (CFI), and implementation of a process by which items may be added for consideration by stakeholders and the general public. AAFCO is a non-profit organization that helps guide state, federal, and international feed regulators with ingredient definitions, label standards, and laboratory standards to support the health and safety of people and animals. The CFI provides for common foods that may be appropriate for use in animal food; however, it is not a substitute for the AAFCO process for new feed ingredient definitions delineated in the Official Publication.
  • Common foods are defined as food items commercially available and suitable for use in animal food but are not defined by AAFCO, including but not limited to certain whole seeds, vegetables, or fruits. Common food for animals may include common human foods that are known to be safe for the intended use in animal food. Manufacturers are responsible for determining whether a common food is safe and has utility for its intended use prior to commercial distribution as animal food.
  • AAFCO’s subcommittee of ingredient definition and label reviewers assessed and identified the first list to the most common and well-known ingredients. The proposed list of the initial 72 items can be found here.  
  • AAFCO is requesting stakeholders such as veterinarians, animal nutritionists, consumer groups, and the public to provide feedback on the initial CFI by June 2, 2023. AAFCO is not yet accepting proposals for additional common food items. Interested parties may submit their feedback using this virtual form.
  • Keller and Heckman would be happy to assist in submitting comments. We will continue to monitor and report on developments in the animal food industry.
  • On April 28, 2023, the U.S. Court of Appeals for the Ninth Circuit upheld a district court’s decision to dismiss a lawsuit against Kroger which alleged that the company falsely and misleadingly labeled its spreadable fruit products as “Just Fruit” because they contained ingredients which were not “fruit” in the form found in nature. However, all of the ingredients in the products (fruit syrup, pectin, calcium citrate, apple juice concentrate, and citric acid), were in fact derived from fruit. 
  • The Court held that the definition of “fruit” must be considered in the context of the product (a spreadable fruit) and that spreadable fruit products “necessarily contain ingredients other than the crushed ‘reproductive bod[ies] of a seed plant.’” (Merriam Webster Dictionary definition of a “fruit”). And, since each ingredient in the product was extracted and isolated from fruit, the claim was neither objectively false nor misleading under the reasonable consumer test (i.e., the label was not likely to mislead a significant portion of reasonable grocery shoppers).
  • The Court also rejected the argument that the descriptor “Just” (in “Just Fruit”) indicated an absence of added sweeteners. The statement said nothing about sugar content and a reasonable consumer would not think otherwise, especially given that most spreadable fruit products contain added sugars. 
  • We will continue to monitor and report on food litigation developments.

Coca-Cola Didn’t Deceive With Hard Seltzer ‘Margarita’ Labels (Law360 Subscription Required)

  • A proposed class action filed last year in the Southern District of New York asserts that Coca-Cola Company’s Topo Chico brand Margarita Hard Seltzer, made with fermented sugar alcohol and agave sweetener, is deceptively labeled as a cocktail containing tequila.  In support of her claims, the plaintiff asserts the terms “margarita” and “hard,” together with pictures of an agave plant on the case packaging, signal that the products contain tequila because tequila is a defining ingredient of a margarita cocktail and the term “hard” refers to distilled spirits (i.e., “hard liquor” such as tequila). 
  • In an April 21, 2023 opinion deciding a motion on the pleadings, the judge ordered the Topo Chico case dismissed with prejudice, finding a reasonable consumer viewing the product’s label as a whole would understand they were purchasing a hard seltzer made to taste like a margarita and not a margarita cocktail.  Noting that hard seltzer is a popular category of alcoholic beverages, the judge found that reasonable consumers would recognize Margarita Hard Seltzer as a product distinct from cocktails.  Unlike the Topo Chico product, canned margarita beverages noted in the plaintiff’s complaint are described as “premium cocktails,” are labeled as “Perfect Margarita” and “Sparkling Margarita,” without any qualifiers, and specify that they contain tequila.  The judge also found a reasonable consumer would understand the term “hard” in “hard seltzer” in the same way it is used in “hard cider” or “hard lemonade,” i.e., to indicate that the product contains alcohol, as distinguished from a non-alcohol version of the product.  In further support of his conclusions, the judge found it implausible that the plaintiff thought she was buying a product containing tequila when cursory observation would show the product surrounded in the grocery store by soft, drinks, beer, and hard ciders/lemonades/seltzers, but no hard liquor or cocktails because these cannot legally be sold in grocery stores in the state. 
  • This case is a reminder that context matters and a plaintiff’s selective interpretation of isolated terms on a product label will not be sufficient to show that reasonable consumers would be deceived. 
  • On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) released a proposed determination to declare Salmonella an adulterant in breaded stuffed raw chicken products when they contain more than minimal levels of Salmonella.  The announcement builds on FSIS’ proposed regulatory framework to reduce Salmonella infections linked to poultry products.
  • Under this proposal, FSIS would consider adulterated any breaded stuffed raw chicken products that include a chicken component that tested positive for Salmonella at 1 colony forming unit (CFU) per gram prior to stuffing and breading.  FSIS also proposes to carry out verification procedures, including sampling and testing of the chicken component of the relevant products prior to stuffing and breading.
  • In proposing to declare Salmonella an adulterant in breaded stuffed raw chicken products, FSIS based its decision on several factors, including the fact that since 1998, FSIS and its public health partners have investigated 14 Salmonella outbreaks and approximately 200 illnesses associated with these products.
  • FSIS is seeking public comments on the proposed determination and the proposed verification sampling program.
  • Keller and Heckman will continue to monitor this area and will relay any developments.
  • Today, FDA announced that it will be holding a virtual listening session on June 1, 2023 for interested parties to consult cosmetics manufacturers, including smaller businesses, contract manufacturers, consumer organizations, and other experts to help inform FDA’s efforts in developing regulations to establish good manufacturing practices (GMPs) for facilities that manufacture, or process cosmetic products distributed in the United States.
  • The event will include preliminary introductions and brief remarks on cosmetic product GMPs, followed by public comments on cosmetic GMPs.
  • To facilitate the discussion, FDA has developed topics covering the types of information the Agency seeks to obtain from industry, including:
    • Cosmetic GMPs
      • Identify any national or international standard and the extent to which it would be practicable for GMP regulations for cosmetic products;
      • Describe what constitutes sufficient flexibility within GMPs for cosmetic products to ensure regulations are practicable for all sizes and types of facilities;
      • Describe what constitutes simplified GMPs requirements for cosmetic products for smaller businesses to ensure regulations do not impose undue economic hardship; [and]
      • Describe appropriate compliance times for GMP regulations.
    • GMP Economic Impact
      • To what extent are manufacturers of cosmetic products already following a national or international standard for GMPs?  If an entity is not currently following a standard, what would the cost to implement GMPs consistent with such standard be?
      • Provide reports or examples of adverse events or recalls associated with a cosmetic product that were linked to manufacturing practices. How would implementing GMPs impact the likelihood of a recall of cosmetics products?  How would implementing GMPs impact the likelihood of consumers experiencing adverse events from the use of cosmetics products?  How would these impacts differ by type of cosmetic product?
  • Interested parties may register for the event at this link. The session will take place on June 1, 2023 from 10AM- 1PM EST.
  • Keller and Heckman will continue to monitor and report on FDA activity impacting the cosmetic industry.