• Earlier this month, Senators Amy Klobuchar and Tammy Duckworth announced the introduction of legislation (the “Baby Food Safety Act of 2024”) intended to increase the safety of certain foods, including baby and toddler foods, with respect to heavy metals and other contaminants.
  • In particular, the legislation calls on FDA to establish, through an administrative order process:
    • Limits for arsenic, cadmium, mercury, and lead in infant and toddler food (defined to include any food marketed for children up to 24 months) as well as food pouches made with fruit or vegetable juice or puree.
    • Limits for arsenic and lead in juice. We note that FDA has previously published draft action levels of 10 ppb lead in apple juice and 20 ppb lead in all other juice.
  • Proposed limits are required to be issued by December 31, 2025, for arsenic and lead, April 30, 2026, for cadmium, and April 30, 2028, for mercury.
  • The legislation would also require facilities manufacturing infant and toddler food, pouches with fruit or vegetable juice or puree, or juice to develop a control program for these contaminants (consistent with HARPC, or HACCP for juice, and with the mitigation against intentional adulteration regulations) and sample and test such contaminants pursuant to a sampling plan, the contours of which are to be set forth in a future FDA guidance (the sampling and testing requirements would not apply until 2 years from the date of enactment). Among the other provisions is a requirement that manufacturers of infant and toddler food develop an environmental monitoring program to monitor for the presence of environmental pathogens and heavy metals.
  • The proposed legislation also includes a broad preemption provision which prohibits any state from implementing legislation which is “different from, or in addition to, or not identical to” the provisions of the legislation.
  • If enacted, this would represent the first mandatory testing requirement for finished food products. We will continue to monitor and report on developments regarding this legislation.
  • On May 15, 2024, Iowa Governor Kim Reynolds signed the Iowa Meat Integrity Bill (SF 2391) to require specific labels for cell-cultivated, plant-based, and insect-based meat and egg alternatives, as well as prevent products deemed misbranded under the law from being sold to supplemental nutrition programs and schools. This follows bans on cell-cultivated meat in Alabama and Florida and moves by other states and Congress to restrict lab-grown meat sales, which we have previously blogged about.
  • Under the Iowa bill, a “manufactured-protein food product” will be deemed misbranded if the label does not contain a “conspicuous and prominent qualifying term in close proximity to an identifying meat term.” A “qualifying term” is defined as “a word, compound word, or phrase that would clearly disclose to a reasonable purchaser of meat products from a food processing plant that a food product is not a meat product” and includes words such as cell-cultivated, cell-cultured, fake, grown in a lab, imitation, insect, insect-based, insect-protein, lab-created, lab-grown, meat free, meatless, plant, plant-based, vegan, vegetable, vegetarian, or veggie.
  • The bill will require regulatory authorities to inspect food processing plants and grocery stores for compliance and allow them to issue a stop order or embargo order for violations.
  • The bill was led by Iowa Senator Dawn Driscoll and Representative Heather Hora, who said that “[l]ab-grown products are not the same as the high-quality meat raised by Iowa farm families.” According to the governor, the bill “prohibits companies from exploiting the trust consumers have with our livestock producers and misleading the consumers into buying products they don’t want.” While some legislators warned that the law could lead to national brands being unavailable to Iowa consumers, proponents argued that most major brands’ packaging is already within the bounds of the new law.
  • The bill goes into effect July 1, 2024.
  • On May 7, 2024, Alabama Governor Ivey signed SB 23 which bans the sale of cultivated meat in the state.  Specifically, the law will make it “unlawful for any person to manufacture, sell, hold or offer for sale, or distribute any cultivated food product” in the state.
  • The bill defines “cultivated food product” as “any food product produced from cultured animal cells.”  A violation of the ban by food sales establishments may result in civil penalties, or disciplinary actions, such as suspension or revocation of their food safety permits.  Violations are considered a Class C misdemeanor.  However, the bill does allow state research and development on cultivated products to continue.  The act will become effective October 1, 2024.
  • Alabama is now the second state in the US to sign this sort of ban into law.  As we previously reported, Florida Governor DeSantis signed SB 1084 on May 1, 2024, banning the sale of “cultivated meat.”
  • Keller and Heckman will continue to monitor and relay any developments in the cultivated food space.
  • Today FDA announced the publication of an assessment concluding that tara flour does not meet the criteria for generally recognized as safe (GRAS) status and that its use in food constitutes an unapproved food additive use which renders the food adulterated. The assessment comes almost 2 years after Daily Harvest’s June 2022 recall of a product containing tara flour following serious reports of adverse events, including liver toxicity and hospitalizations.
  • Tara flour is derived from the germ of the plant Tara spinosa (aka Caesalpinia spinosa or tara plant) and should not be confused with tara gum, which is derived from the endosperm of the tara plant and which FDA notes has a “well established” safety profile when used as a thickening agent/or stabilizer in food.  
  • FDA’s assessment concludes that there is little information describing the composition or effects of tara flour and that the few studies that do exist are not sufficient to support a GRAS conclusion based on scientific procedures. Indeed, one study on a non-protein amino acid in tara flour (baikiain) was suggestive of liver toxicity. Furthermore, the Daily Harvest recall, as well as other adverse event reports, are inconsistent with a GRAS conclusion. FDA also found no evidence that tara flour was consumed in food prior to 1958 which is necessary (but not sufficient) for a GRAS conclusion based on common use in food.  
  • Last September, the Canadian Food Safety Inspection Agency (CFIA) issued a similar notice, advising industry not to use tara flour because it was likely a novel food (i.e., a food without a safe history of use) and CFIA had not conducted a pre-market assessment as required for novel foods.  
  • Greenbrier International, Inc., the parent company of Dollar Tree, has been sued over alleged lead contamination in ground cinnamon (Law360 subscription required). The lawsuit follows recalls of lead-tainted ground cinnamon and cinnamon apple sauce products.
  • According to the plaintiff, Dollar Tree’s Supreme Tradition Ground Cinnamon, which was purchased for normal household use, contained hundreds of times more lead than the FDA’s proposed action levels for lead contamination suggest are safe. The plaintiff claims that the company violated New York State’s false advertising laws by labeling the product in a “way to impact consumer choices and gain market dominance” even though the company knew consumers “would be unwilling or less likely to buy the product if [they] knew the product contained lead.”
  • The plaintiff stated that Dollar Tree is responsible for ensuring its products are safe and not contaminated with dangerous substances and that the company and its cinnamon manufacturer should have measures in place to ensure the products are safe.
  • We have blogged previously about the lead-contaminated cinnamon and cinnamon products, as well as the related recalls. Keller and Heckman will continue to monitor this issue.
  • In a press release issued on May 8, 2024, the U.S. Department of Agriculture (USDA) announced that has developed a joint regulatory plan with the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) to update, streamline, and clarify their regulations and oversight mechanisms for biotechnology products.
  • The plan intends to address President Biden’s goals in Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Economy.”  The plan incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations.
  • The agencies have specifically identified five major areas of biotechnology regulation where the plan focuses:
    • Modified plants;
    • Modified animals;
    • Modified microorganisms;
    • Human drugs, biologics, and medical devices; and
    • Cross-cutting issues
  • USDA, FDA, and USDA noted the following joint efforts:
    • clarifying and streamlining regulatory oversight for genetically engineered (GE) plants, animals, and microorganisms;
    • updating and expanding their information sharing through an MOU to improve and broaden communication and coordination of oversight of modified microbes; and
    • undertaking a pilot project focused on modified microbes to explore and consider the feasibility and costs of developing a web-based tool that informs developers about which agency may regulate a given product category.
  • As the agencies begin to implement the plan, Keller and Heckman will be sure to relay any developments in this area.
  • Last week Florida Governor Ron DeSantis signed SB 1084 into law, making it “unlawful for any person to manufacture for sale, sell, hold, or offer for sale, or distribute cultivated meat in this state [Florida].” “Cultivated meat” is defined as “any meat or food product produced from cultured animal cells.” We note that this ban does not extend to plant-based meat imitation products.
  • Knowing violation of the law is a second-degree misdemeanor and the law provides for other punishments for businesses, including license suspension. The governor’s webpage indicates that the law represents Florida “fighting back against the global elite’s plan to force the world to eat meat grown in a petri dish or bugs to achieve their authoritarian goal.” The governor’s webpage links to another webpage by the World Economic Forum which touts the potential benefits of insect protein, but the law doesn’t ban insect protein, so it’s not clear why insect protein is mentioned.
  • The law is the first of its sort, but Alabama, Arizona, and Tennessee have considered similar laws. Like California’s recent food additive ban (AB-418), the law raises interesting questions about the authority of states to pass such bans, including questions  related to preemption and the (dormant) commerce clause.
  • On May 2, 2024, FDA published a final rule on agricultural water to enhance produce safety. The rule, titled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water, amends the agricultural water provisions of the 2015 produce safety regulation by replacing microbial criteria and testing requirements for pre-harvest water with a systems-based assessment approach.
  • As we have previously blogged, FDA issued the proposed rule in December 2021 followed by an announcement in January 2022 that the Agency would exercise enforcement discretion for agricultural water requirements for covered produce other than sprouts.
  • Specifically, the final rule:
    • Establishes requirements for agricultural water assessments that evaluate a variety of factors that are key determinants of contamination risks associated with pre-harvest agricultural water, including the water system, water use practices, crop characteristics, environmental conditions, potential impacts of water from adjacent and nearby land, and other relevant factors.
    • Includes testing pre-harvest agricultural water as part of an assessment in certain circumstances.
    • Requires farms to implement effective mitigation measures within specific timeframes based on findings from the assessments.
    • Adds new options for mitigation measures, providing additional flexibility in responding to findings from pre-harvest agricultural water assessments.
  • The rule also finalizes compliance dates as follows:
    • 2 years and 9 months after the effective date for very small farms;
    • 1 year and 9 months after the effective date for small farms;
    • 9 months after the effective date for all other farms.
  • The final rule is effective July 5, 2024.
  • On May 2, the Second Circuit upheld summary judgment in favor of KIND in a nine year old lawsuit challenging “All Natural” claims. In Re KIND LLC, No. 22-2684-cv (2d Cir. May 2, 2024). Although only time will tell, this Circuit decision, in favor of the defense, may finally change plaintiffs’ appetite for “natural” cases.
  • Over the many years of litigation, the lawsuit consolidated several class action filings from New York, Florida, and California into a single, multi-district litigation with several, different lead plaintiffs. All plaintiffs alleged that “All Natural” claims for 39 KIND granola bars and other snacks were deceptive. Id. at 3. Plaintiff had alleged that the following ingredients rendered the KIND bars not natural:  soy lecithin, soy protein isolate, citrus pectin, glucose syrup/”non-GMO” glucose, vegetable glycerine, palm kernel oil, canola oil, ascorbic acid, vitamin A acetate, d-alpha tocopheryl acetate/vitamin E, and annatto.
  • The Second Circuit found that, in such cases, the relevant state laws followed a “reasonable consumer standard” of deception. Id. at 10. Further, according to the Second Circuit, the “Ninth Circuit has helpfully explained” that the reasonable consumer standard requires “‘more than a mere possibility that the label might conceivably be misunderstood by some few consumers viewing it in an unreasonable manner.’” Id. (quoting McGinity v. Procter & Gamble Co., 69 F.4th 1093, 1097 (9th Cir. 2023)). Rather, there must be “‘a probability that a significant portion of the general consuming public or of targeted consumers, acting reasonably in the circumstances, could be misled.’” Id. To defeat summary judgement, the plaintiffs would need to present admissible evidence showing how “All Natural” tends to mislead under this standard.
  • The Second Circuit agreed with the lower court that plaintiffs’ deposition testimony failed to provide such evidence where it failed to “establish an objective definition” representing reasonable consumer understanding of “All Natural.” Id. at 28. While one plaintiff believed the claim meant “not synthetic,” another thought it meant “made from whole grains, nuts, and fruit,” while yet another believed it meant “literally plucked from the ground.” Id. The court observed that plaintiffs “fail[ed] to explain how a trier of fact could apply these shifting definitions.” Id.  The court next rejected as useful evidence a dictionary definition of “natural,” which stated,  “existing or caused by nature; not made or caused by humankind.” Id. at 29. The court reasoned that the dictionary definition was “not useful when applied to a mass-produced snack bar wrapped in plastic” – something “clearly made by humans.” Id.
  • The court, finally, upheld the lower court’s decision to exclude two other pieces of evidence the plaintiffs offered. First, the Second Circuit agreed that a consumer survey was subject to exclusion where leading questions biased the results. Id. at 21-22. The Second Circuit also agreed that an expert report by a chemist lacked relevance where it assessed “typical” sourcing of ingredients, not necessarily how KIND’s ingredients were manufactured or sourced. Id. at 22-24. Keller and Heckman will continue to monitor and report on class action cases that impact the food industry.
  • In yet another lawsuit filed by attorney Spencer Sheehan, Plaintiffs alleged that Aldi’s diced peaches products (“Yellow Cling Diced Peaches in 100% Fruit Juice”) violate FDA’s regulations and are falsely and deceptively labeled, in part because they are made from concentrate (the ingredient list identifies “white grape juice concentrate” and “lemon juice concentrate”) and contain the food additives ascorbic acid and citric acid. Plaintiffs claim these ingredients are inconsistent with a 100% juice declaration.
  • However, the lawsuit does not reference the fact that FDA’s regulations at 21 CFR 101.30(h)(1) provide that FDA is to calculate the percentage juice content of a reconstituted juice (i.e., a juice from concentrate) based on the Brix level (a measure of dissolved solids) of a reference single-strength (100%) juice. Thus, a reconstituted juice is not necessarily inconsistent with a 100% juice declaration. This point is also implicitly stated in paragraph (b)(3) which requires that other additives be declared when a 100% juice declaration is made, although for a 100% juice claim to be made such additives cannot result in a diminution of the “juice soluble solids” (i.e., Brix). 
  • Compliance or non-compliance with FDA’s regulations does not in itself provide evidence of consumer deception and the Court will have to decide whether a substantial portion of reasonable consumers would have been deceived under the circumstances. Nevertheless, compliance with FDA’s regulations likely will be a critical aspect of any preemption defense. In a case with some similarities, Bell v. Albertson Companies, Inc., No. 19-2741 (7th Cir. 2020), the 7th Circuit reversed a district court decision and held that Plaintiffs had plausibly alleged that a 100% grated parmesan cheese claim was deceptive when the product contained cellulose powder and potassium sorbate additives. Notably, a preemption defense was rejected because, while the additives were consistent with FDA’s standard of identity for parmesan cheese, the standard of identity did not address the 100% claim.