- On Monday, June 5, 2023, Saraya USA (Saraya) was denied its motion to dismiss a class action lawsuit that claimed it falsely advertises its granola as being “monk fruit sweetened” or “sweetened by monk fruit.” U.S. District Judge Orrick found that it was possible for consumers to believe monk fruit was the sole or predominant sweetener, since “no other sweetener is mentioned on the front of label.”
- In the complaint, the plaintiff Scott alleged that the granola product labels are deceptive because the granola is not entirely or predominantly sweetened with monk fruit and is instead predominantly sweetened with erythritol, which the complaint claims causes digestive problems and is linked to increased risk of heart attacks and stroke. Monday’s order stated that, “Scott has plausibly alleged that these statements, read alongside the statements ‘sugar free,’ ‘no sugar added,’ or ‘zero sugar’ also appearing on the products’ front labels, would mislead a reasonable consumer to believe that they were solely or predominantly sweetened with monk fruit.”
- Saraya, in its motion to dismiss, claimed that nowhere on the product label does it state the product is solely or predominantly sweetened by monk fruit, nor did it claim that the specific amount of monk fruit is in it. Saraya also claimed the ingredient list specifically said the granola contained monk fruit sweetener, erythritol, and monk fruit extract.
- Judge Orrick disagreed with Saraya’s argument, stating that, because no other sweetener was mentioned on the front of label, a consumer would reasonably be misled into thinking that monk fruit is the sole sweetener used.
- Keller and Heckman will continue to monitor and report on this case and similar class action challenges.
Bipartisan Lawmakers Seek to Remove Tariffs on Infant Formula with Proposed Formula 3.0 Act
- On June 1, a group of bipartisan lawmakers led by Senator Mike Lee, R-UT, introduced the Formula 3.0 Act which would permanently remove tariffs and other trade restrictions on imported infant formula base powder. This bill follows the expiration of the Formula Act, an emergency measure signed into law by President Biden in July 2022 that temporarily removed tariffs on infant formula in response to the nationwide infant formula shortage. Proponents of the bill said the Formula 3.0 Act aims to address vulnerabilities in the domestic infant formula market highlighted by the shortage last year.
- As our readers likely recall, FDA issued a recall of powdered infant formula originating from Abbott Nutrition’s facility in Sturgis, Michigan in February 2022. At the time, the Abbott facility supplied 40% of the nation’s infant formula. The recall and subsequent shutdown of the facility resulted in a monthslong infant formula supply shortage which drew attention to vulnerabilities in the domestic supply and to high tariffs and other obstacles imposed on imported infant formula.
- According to a 2022 report from the Congressional Research Service, imports of infant formula have increased substantially over the last decade, accounting for approximately 4.3 million kilograms (valued at $28.8 million) of domestic consumption in 2021. The most-favored-nation (MFN) tariff rate for these products typically ranges from 14.9% to 17.5%. Though tariffs were temporarily waived by the emergency measures enacted in July 2022, these measures have since expired.
- Keller and Heckman will continue to monitor developments on issues pertaining to infant formula.
FDA Issues Final Guidance for Inorganic Arsenic in Apple Juice
- On June 1, 2023, the FDA announced a final guidance for industry titled “Action Level for Inorganic Arsenic in Apple Juice.” The final guidance adopts an action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice, which is the same action level as initially proposed in the agency’s July 2013 draft guidance. The final guidance reflects FDA’s continued efforts to reduce levels of heavy metal contaminants in food commonly consumed by babies and young children.
- Inorganic arsenic is associated with adverse human health effects such as cancer, skin lesions, diabetes, detrimental birth effects, and cardiovascular and neurodevelopment toxicity. Although current FDA testing indicates an overall reduction of inorganic arsenic in apple juice, with many samples testing below 5 ppb, the agency considers a 10 ppb level to be protective of public health and widely achievable within the industry. The guidance is not legally binding and therefore if apple juice is found to contain inorganic arsenic above the action level, FDA will consider the level in addition to other factors, such as the agency’s “confidence in a measured analytical value,” to determine whether the food is adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)).
- Possible sources of inorganic arsenic in apple juice include “processing aids, prior use of arsenic based pesticides on land currently used for apple orchards, current use of arsenic-based pesticides in other countries, naturally high levels of arsenic in soil or water, atmospheric deposition from industrial activities” and “water used by manufacturers to dilute concentrate to prepare ready-to-drink juice.” FDA notes manufacturers may lower the level of inorganic arsenic in their apple juice by sourcing from apples or apple juice concentrates with lower inorganic arsenic levels, controlling the amount of inorganic arsenic in the water used to dilute concentrate, or changing filtering aids used to filter juices.
- Keller and Heckman will continue to monitor the developments in FDA’s efforts to reduce heavy metal levels in food.
FDA Webinar Reiterates a New Regulatory Pathway Created by Federal Legislation is Required for CBD
- A high-level internal working group that FDA convened to explore potential regulatory pathways for cannabidiol (CBD) products announced by way of a January 26, 2023 statement that existing regulatory pathways are not appropriate for CBD. As reported on this blog, the FDA working group examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies conducted and commissioned by FDA, and concluded it is “not apparent how CBD products could meet the safety standards for dietary supplements or food additives.” FDA’s January statement also announced that the Agency is prepared to work with Congress on legislation to create a new CBD-specific regulatory pathway that is necessary to move forward.
- On May 25, 2023, in the last of three webinars intended to address lingering questions following its January statement, FDA reiterated that it is up to Congress to create a legal status for CBD and other hemp-derived cannabinoids. FDA’s Stakeholder Webinar: “A New Way Forward for Cannabidiol (CBD) and Other Hemp Products” outline the factors that lead FDA to conclude statutory barriers prevent the regulation of these products as a food or dietary supplement. Specifically, FDA cited CBD’s inherent risk profile (e.g., liver injury, interactions with certain medications, and possible harm to the male reproductive system) and the limited risk management options for the food ingredient and dietary supplement pathways (i.e., the inability for FDA to weigh any potential benefits against the safety risks). FDA’s webinars advocate for the creation of a “harm reduction” approach for regulating CBD and other hemp-derived cannabinoids that would permit the Agency to set rules addressing known issues with current products, e.g., variable CBD content, incomplete ingredient labeling, contamination, and the risk of ingestion by children. While recognizing the growing popularity of CBD and other hemp products, FDA insists it can take the harm reduction approach only if Congress enacts legislation for a specific new regulatory framework.
- Although there has been bipartisan interest in breaking the current stalemate, the timing for any new legal framework for CBD is unclear. For the foreseeable future, FDA will continue to monitor the market and target enforcement efforts at products that pose the greatest risks. Examples noted in FDA’s webinar slides are unapproved new drugs that purport to contain CBD, products that have been associated with serious adverse events, and products that are packaged and labeled to resemble cereal, candy and cookies that appeal to children.
Marketing Implications of California’s Proposition 12
- 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.
AAFCO Comments on the Pet Food Institute’s Proposed New Federalized Regulatory System for Pet Food
- 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.
American Beverage Association Comments on Plant-Based Milk Guidance
- 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.
Salmonella Outbreak Linked to Papa Murphy’s Cookie Dough
- 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.
Coca-Cola Seeks Dismissal of Fruit Flavored Soda Water Consumer Class Action in Federal Court (Law360 Subscription Required)
- 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.
Implementation of FASTER Act Poses Challenge for Industry
- 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.