• As we have previously blogged, the U.S. Supreme Court upheld California’s Proposition 12 (Prop 12) on May 11, 2023, which bans the sale of pork in California unless breeding pigs (sows) are allowed at least 24 sq. ft. of space and the ability to stand up and turn around in their pens.  The decision has left the pork industry with many questions regarding implementation, including how to market and advertise pork products as Prop 12 compliant.
  • Prop 12 does not contain any explicit language that addresses Prop 12 disclaimers to be marketed to consumers.  The only explicit language discussed is in section 1322.4(a), which states that shipping documents shall include the statement “Pork CA Prop 12 Compliant,” to be affixed to bulk shipping containers sent to retailers.  California’s Animal Health and Food Safety Services Division (AHFSS) has not promulgated any regulations that demonstrate what kinds of advertising phrases would be acceptable.  The Final Statement of Reasons also does not speak on advertising language.
  • While federal agencies are not subject to Prop 12 requirements, the U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) will review Prop 12 compliance/exemption claims as voluntary labeling claims.  Through AskFSIS, FSIS stated that it considers Prop 12 claims to be special claims that require FSIS label approval before they can be used on labels in commerce (9 CFR § 412.1).  FSIS will not approve labels with a statement such as “California Prop 12 Complaint” without further explanation on the label.  Information related to animal raising conditions may be a claim that FSIS could approve, provided the label explains the meaning of the claim and adequate supporting documentation is submitted with the label approval.  Further explanation on the label is also needed for Prop 12 exemption claims.
  • Keller and Heckman will continue to monitor and relay the developments of Prop 12 regulations and implications.
  • On May 2, during the Petfood Forum 2023, members from the Pet Food Institute (PFI) proposed recommendations to create a comprehensive and uniform federal system for regulating pet food. PFI’s concern over the present system is that a patchwork of varying state pet food regulations creates challenges for selling pet food products across state lines. Currently, state agencies work independently under state law in partnership with FDA to ensure pet food safety in the U.S.
  • PFI’s proposal calls for a new center to be developed at FDA which would focus solely on regulating cat and dog food and treats. On May 11, the American Feed Industry Association (AFIA) issued a response to PFI’s proposal, arguing that the proposal will impact ingredient suppliers’ ability to enter the market due to dual registration requirements at the state and federal level.
  • On May 30, the Association of American Feed Control Officials (AAFCO) released a statement on PFI’s proposal, stating that a “federally regulated approach is not in the best interest of pets or pet owners” because a federal system would decrease the number of qualified inspectors in the marketplace and eliminate routine state-led inspections which evaluate pet food ingredients and products for potential contaminants or adulterants. Eliminating these inspections can result in a risk to animal health and an erosion of consumer confidence. Thus, AAFCO believes that state feed programs for inspections, sampling, and oversight of labeling and marketing claims are more accessible and better equipped to regulate pet food and that state agency collaboration with FDA and AAFCO is already a sufficiently integrated pet food system.
  • Keller and Heckman will continue to monitor developments that impact the regulation of pet food.
  • Last month, the American Beverage Association (ABA), a trade organization whose members consist of manufacturers of both dairy milk and plant-based milks, submitted comments on FDA’s draft guidance titled Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements. The draft guidance, which was published in February of this year, proposes a voluntary framework for the labeling of plant-based milk alternatives (PBMAs) that allows the term “milk” in PBMAs provided that the plant-source of the beverage is disclosed and nutritional differences from milk are disclosed on the principal display panel (PDP).
  • ABA supports the FDA’s decision to allow for the use of term “milk” in PBMAs but requests that the agency reconsider the recommendation to disclose nutrient differences on the PDP. ABA argues that disclosing nutrient differences on the PDP is without precedent and could create greater consumer confusion. Instead, ABA believes that a statement on the PDP referring consumers to the nutritional facts panel would better serve consumer interests.
  • ABA also urges the FDA to revise the guidance to allow for the generic descriptor “plant-based” in the name of PMBAs. ABA argues that there are products “with multiple synergistic ingredients” and without a uniquely characterizing plant source that would be better served by a general descriptor.
  • ABA notes that the guidance is particularly important because it is likely to have implications in other plant-based product categories (e.g., plant-based meats) and because Plaintiffs’ lawyers are likely to allege that products which do not follow the recommendations of the guidance are misleading, making the recommendations “tantamount to requirements.” Comments to the draft guidance are due by July 31, 2023.
  • The Center for Disease Control and Prevention (CDC) is currently investigating Salmonella infections in at least six states that may be linked to raw cookie dough sold at Papa Murphy’s. 
  • Residents in Washington, Oregon, Idaho, Utah, California, and Missouri reported illnesses from February 27 to May 2, after eating raw cookie dough sold at Papa Murphy’s Take ‘N’ Bake pizza stores.  The pizza company has temporarily stopped selling their raw chocolate chip cookie dough and s’more bars dough, and the items have been removed from its website.
  • So far, 18 Salmonella infections have been reported.  No deaths have been reported, though there have been two hospitalizations.  CDC officials say that the number of sick people is likely higher than the number reported and that the outbreak could extend to other states.
  • Keller and Heckman will continue to monitor this area and will report any significant developments.
  • On May 19, Coca-Cola filed a motion to dismiss in an Illinois federal court, requesting the judge to throw out a proposed class action alleging it misleads consumers into thinking its Fresca brand of soda water contains real fruit with no added sweetener. See Letoski et al. v. The Coca-Cola Co., case number 1:23-cv-00238, in the U.S. District Court for the Northern District of Illinois.
  • Earlier this year, consumers filed suit against Coca-Cola, alleging that its Fresca products’ “Grapefruit” and “Black Cherry” flavor descriptions, which are accompanied by vignettes of the relevant fruits, caused them to believe the soft drinks contain “non-negligible amounts” of “fruit ingredients.” Although the products contain “concentrated grapefruit juice,” the complaint alleges that the amount must necessarily be “de minimis” because (1) there is less grapefruit juice than “citric acid”; and (2) “based on industry estimates of the use of citric acid in carbonated beverages” the Fresca products probably contain “roughly 0.60 grams of citric acid.” This is deceptive, the complaint alleges, because the products contain only “fruit flavoring.”
  • Further, the plaintiffs allege that the term “soda water” caused them to think that Fresca is simply “carbonated water” without any “added sweeteners or flavorings,” when the Fresca products contain aspartame, a non-nutritive sweetener.
  • In its motion to dismiss, Coca Cola contends that the product labels are in full compliance with FDA’ food labeling regulations, arguing that the characterizing flavor regulation at 21 CFR 101.22(i) do not require real fruit ingredients to be in a product bearing fruit-related terms and vignettes, but rather must be accompanied only by a disclosure about the source(s) of the product’s flavoring ingredients (e.g., “natural flavors,” “other natural flavors,” or “artificial flavors”). Thus, according to the defendant, the ““Black Cherry Citrus Flavor with Other Natural & Artificial Flavors” designation and fruit vignette on Fresca communicates that the beverage contains black cherry flavors, not actual cherry ingredients. Additionally, the Fresca products contain “concentrated grapefruit juice,” a fruit-based ingredient.
  • Additionally, Coca Cola argues that plaintiffs have no basis to conclude the term “soda water” promises consumers a product with no added sweeteners, claiming the use of the artificial sweetener aspartame in Fresca is properly disclosed on product labeling. The company reasoned that a reasonable consumer interested in knowing about the presence of sweeteners in product can find the ingredients declared on the product ingredient list.
  • Keller and Heckman will continue to monitor consumer class actions regarding challenges to food label claims.
  • The FASTER Act, which went into effect on January 1st of this year, made sesame the 9th major food allergen, thereby triggering allergen labeling obligations for foods containing sesame or an ingredient derived from sesame. (21 USC 343(w)). These labeling obligations can be met by either by declaring the allergen (sesame) in the ingredient list in a way that includes the word “sesame” or in a “contains” statement immediately after or adjacent to the ingredient list. There is no mandatory labeling for the presence of unintentional allergens (from cross-contact), although the use of a voluntary “may contain” statement is common.
  • Implementation of the law has proved challenging for manufacturers that produce both sesame-containing and sesame-free products at the same facility. Good manufacturing practices (GMPs) which are used to prevent cross-contact with other allergens have proved to be insufficient in the case of sesame, which poses unique challenges because of the small size of the sesame seed which is easily dispersed in a facility and difficult to completely remove. This challenge is more significant in the case of sesame seeds than it is with the other major allergens.
  • Indeed, the risks of cross-contamination are so high that industry does not believe that a “may contain [sesame]” statement sufficiently apprises a consumer of the risk. However, FDA does not permit for the affirmative declaration of the ingredient unless it is intentionally added to the product. Thus, in order to be able to include sesame on the ingredient list and therefore apprise consumers of its presence, some members of the baking industry have been intentionally adding small amounts of sesame to their products. However, an unintended consequence has been that sesame-allergic individuals are consuming familiar products that have been reformulated in this way without reading the ingredient list and therefore are being exposed to higher levels of sesame.
  • This approach has drawn the ire of a bipartisan group of 8 congressmen, who in a letter to the American Bakers Association earlier this month, chastised the industry for making a change that they argue “undercut[s] the purpose and intent” of the law and endangers consumers. In applauding the “fourteen brands that have confirmed their facilities are dedicated free of sesame,” (bold added) the letter unwittingly summarized the crux of the issue: current GMPs appear to be insufficient to prevent sesame-cross contact. The novel issue calls for novel solutions – either in the law (or its interpretation) or in the food processing space.
  • Those who manufacture, process, pack, or hold foods that are on FDA’s Food Traceability List (FTL), including certain cheeses, shell eggs, nut butters, various fresh fruits and vegetables, finfish, crustaceans, mollusks (bivalves), and ready-to-eat deli salads, as well as foods containing non-transformed FTL foods, are subject to further recordkeeping requirements in addition to the traceability requirements that are generally applicable to other foods.  On November 21, 2022, FDA published the FDA Food Safety Modernization Act (FSMA) Final Rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule), discussed here, which requires these entities to maintain records containing information known as key data elements (KDEs) that are associated with critical tracking events (CTEs) in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods.  When requested, these records must be provided to FDA within 24 hours or some reasonable time to which FDA has agreed. 
  • On May 18, 2023, FDA published a Small Entity Compliance Guide (SECG) to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule as established in 21 CFR part 1, subpart S.  The SECG defines key terms of the Food Traceability Rule and, in addition to providing detailed guidance on how to comply with each part of the rule, offers guidance for determining whether an entity may be exempt from the rule and instructions on petitioning for a modification, waiver, or exemption from various requirements of the rule.  The SECG also notes that violation of any recordkeeping requirement under FSMA section 204, including any Food Traceability Rule violation, is prohibited under the Federal Food, Drug, and Cosmetic Act, except when such violation is committed by a farm, and that articles that appear not to comply with the requirements of the Food Traceability Rule are subject to refusal of admission to the U.S. 
  • The compliance date for all persons subject to the recordkeeping requirements of the Food Traceability Rule is Tuesday, January 20, 2026. 
  • On May 16, FDA released a draft Compliance Policy Guide, “Sec. 555.250: Major Food Allergen Labeling and Cross-contact,” to provide guidance for FDA staff on the Agnecy’s enforcement policy regarding major food allergen labeling and cross-contact. When finalized, the police guide is expected to replace the existing CPG 555.250 for FDA staff.
  • Among other things, the draft CPG describes the labeling requirements for major food allergens, as well as the proper use of the ingredient list and the “Contains” statement for major food allergen declarations. It also describes requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact pursuant to good manufacturing practices. 
  • The draft CPG directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations, reflecting FDA’s risk-based and science-based approach for the evaluation of potential allergen violations. FDA’s policy regarding cross-contact explains that a food is not adulterated as a result of cross-contact unless the product is injurious to health and that is determined based on a case-by-case review. If the product bears an allergen advisory statement (e.g., “may contain sesame”) but there is evidence of inadequate allergen cross-contact controls, then the product could still be adulterated.
  • In FDA’s Constituents Update, it recognized the fact that some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence. While the draft CPG does not specifically address the issue of industry adding sesame to products that did not previously contain it, the draft CPG does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame. FDA recognizes that this practice may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume-an outcome that the FDA does not support.
  • FDA requests that interested parties submit either electronic or written comments on this draft guidance by July 17, 2023. The link to upload comments can be found here.
  • Keller and Heckman would be happy to assist in submitting comments. We will continue to monitor and report on developments in the food allergen space.
  • California Assembly Bill 418 (AB 418) has a received a favorable 54-11 Assembly vote, which is a first-in-the-nation ban on brominated vegetable oil, potassium bromate, propylparaben, Red Dye No. 3, and titanium dioxide in candy, cereals, and other processed food.  The bill will now be heard and voted on by the California Senate.
  • If passed, this bill, commencing January 1, 2025, would prohibit a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale, in commerce, a food product that contains any of the specified substances.  Violations would be punishable by a civil penalty up to $5,000 for a first violation, and up to $10,000 for each subsequent violation.
  • Titanium dioxide is a powder used as a white colorant or to give a smooth texture in candies and other processed foods.  Potassium bromate is added to baked goods to strengthen dough and its ability to rise.  Brominated vegetable oil is used in some beverages to keep citrus flavoring well mixed, rather than rising to the top of the beverage.  Propylparabens are used for antimicrobial food preservation.  Red Dye No. 3 is used in many popular candies as a colorant.
  • This law, if passed, would seek to ban substances that are duly approved in the US and poses a direct challenge to the preemptive authority of the U.S. Food and Drug Administration (FDA) to regulate foods in the US. Keller and Heckman will continue to monitor this area and relay any developments.
  • On May 11, 2023, the U.S. Court of Appeals for the 9th Circuit affirmed the District Court’s grant of summary judgment in favor of Walmart and International Vitamin Corporation (Defendants) in a class-action lawsuit which alleged that Defendants had incorrectly labeled certain of their dietary supplement products as glucosamine sulfate or glucosamine sulfate potassium chloride (the decision does not distinguish between these alternative names). The decision was based on the fact that Plaintiffs’ allegations relied on different test methods than those prescribed by the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations and that the use of such methods was preempted by the FDCA.
  • Under the relevant provisions of the FDCA and its implementing regulations, a food (including dietary supplement) is misbranded if it is offered for sale under the name of another food, or if it does not include certain mandatory nutrition information, including a declaration of each dietary ingredient by its common or usual name. Compliance with the nutrition labeling requirements, including the common or usual name requirement, is determined by specified testing protocols, which provide in part that testing should be conducted by an AOAC official method or, if one is not available, alternate methods that have been appropriately validated.
  • Plaintiffs alleged that true glucosamine sulfate potassium chloride consists of a single crystal composed of glucosamine, sulfate, potassium, and chloride, and that their testing revealed that the Defendants’ products contained a blend of glucosamine hydrochloride and potassium sulfate, which they alleged should be labeled as glucosamine hydrochloride. However, the test methodology which Plaintiff’s expert used was neither an AOAC method nor had it been appropriately validated. Furthermore, Plaintiffs’ expert acknowledged that other validated methods characterized the blended product as glucosamine sulfate potassium chloride (i.e., the validated methods did not distinguish between glucosamine sulfate potassium chloride in its blended or crystal form).
  • Accordingly, the Court held that Plaintiffs sought to impose a labeling requirement which was different than federal law and that their claims were therefore preempted by the FDCA.