• A Consumer Reports study found high lead levels in vegetable puffs made from cassava that are marketed as snacks for young children, with one puff containing more lead than any of the 80 baby foods the group has tested since 2017.
  • Reducing heavy metal contamination in foods for babies and young children is a priority for FDA, as we have previously reported. In January 2023, FDA released draft guidance on action levels for lead in baby foods as part of the Closer to Zero initiative, establishing action levels of 10 parts per billion (ppb) for fruits, vegetables, mixtures, yogurts, custards/puddings, and single ingredient meats; 20 ppb for root vegetables; and 20 ppb for dry infant cereals. The report urges FDA to also consider exposure to lead from baby snack foods.
  • Consumer Reports measures lead as a percentage of California’s maximum allowable dose level (MADL) of 0.5 µg/day, or 0.5 ppb. According to the study, Lesser Evil Lil’ Puffs Intergalactic Voyager Veggie Blend contained 112% of the MADL, and another flavor from the same brand contained 60% of the MADL. Serenity Kids Tomato & Herbs, Bone Broth flavor contained 53% of the MADL. 
  • Cassava is a root vegetable, and because lead occurs naturally in the soil, it can accumulate in a plant’s roots. Lead can be further concentrated when cassava is processed into flour for snack foods. This could also be the case for any root vegetable, such as sweet potatoes, carrots and beets.
  • Keller and Heckman will continue to monitor heavy metals in foods for babies and young children.  
  • On June 5, 2024, FDA announced preliminary findings from a nearly 5-year study of E. coli, including Shiga toxin-producing E. coli (STEC), and Salmonella pathogens in the Southwest agricultural region. The study was conducted in conjunction with a number of partners in the region and in the leafy green industry.  
  • These pathogens are a major cause of food-born illness in leafy greens and the study was launched following a major food-born illness outbreak in Yuma, Arizona which was linked to E. coli 0157:H7 (a STEC serotype). Over the course of the study (May 2019 – April 2024), more than 5000 samples were collected from a variety of potential environmental reservoirs, including water, soil, sediment, air, animal fecal material, and wildlife. Whole genome sequencing was performed on samples to determine their genetic relatedness and distribution.
  • The study found that positive results increased with proximity to concentrated animal feeding operations and the data suggests that air, dust, and wind play a role in pathogen transfer. However, birds and other wildlife do not appear to be a significant source of STEC.
  • Continued analysis of the data and its implications is planned and additional details will be presented at the International Association for Food Protection meeting on July 14-17, 2024.
  • Last month Health Canada announced a proposal to remove brominated vegetable oil (BVO) as a permitted food additive. It is currently authorized for use as a density adjusting agent in flavors used in beverages containing citrus or spruce oil at a maximum level of 15 ppm as consumed. (List of Permitted Food Additives with Other Accepted Uses (Lists of Permitted Food Additives).
  • The Health Canada proposal follows FDA’s proposed revocation of 21 CFR 180.30 (“Brominated vegetable oil”). Health Canada’s decision is based on the same study which prompted FDA’s action. The study, which was conducted by FDA in collaboration with the National Institutes of Health (NIH), reported adverse effects in rats fed BVO at lower levels compared to previous studies.
  • Although Health Canada’s assessment concluded that there was not sufficient support for the continued use of BVO as a food additive, it also did not identify an immediate health concern and it intends to allow for a 1 year transition period once the change is published.
  • Comments to the proposal are due by July 30, 2024, and may be submitted to the address listed in the proposal or to food.ibr-ipr.aliments@hc-sc.gc.ca with subject line “brominated vegetable oil P-FAA-24-0.” 
  • The 2025 Dietary Guidelines Advisory Committee held its fifth meeting May 29-30, 2024. The Committee is charged with reviewing current nutrition science to develop a scientific report with independent, science-based advice for HHS and USDA to consider when developing the 2025-2030 Dietary Guidelines for Americans.
  • The Dietary Guidelines are developed through a five-step process beginning with identifying scientific questions. The Committee is then appointed to review scientific evidence, and finally HHS and USDA develop and implement the guidelines. The 2025-2030 scientific questions include the relationship between dietary patterns and certain health conditions and life stages, including the effect of ultra-processed foods; specific dietary pattern components, such as added sugars and saturated fats; and strategies related to diet quality and weight management. Two priority topics that are not on the list of questions to be examined are alcoholic beverages and sustainability. HHS will lead a separate examination of alcoholic beverages, which require significant, specific expertise; HHS and USDA will address the complex relationship between nutrition and climate change separate from the Committee’s process.
  • The Committee is appointed every five years and comprises 20 members who “examine the relationship between diet and health across all life stages” through a health equity lens. The fifth Committee meeting included presentations from each of the subcommittees, as well as full Committee deliberations. In particular, the Committee discussed the role of dairy products, considering that about 36 percent of people in the U.S. are lactose-intolerant. The presentation slides and video recordings will be posted to the Dietary Guidelines website when they are available, which could take up to one month.
  • The final Committee meeting is slated for September 25-26, 2024. The Committee will release its scientific report in late 2024, and the 2025-2030 Dietary Guidelines for Americans will be released in 2025. Keller and Heckman will continue to monitor and share updates regarding the development process.
  • A California federal judge has certified a class action (Law360 subscription required) alleging that Barilla falsely labels its pasta as being made in Italy. We previously blogged on this case when Barilla’s motion to dismiss was denied because the plaintiffs plausibly alleged that the phrase “Italy’s #1 Brand of Pasta” is misleading despite Barilla arguing that the phrase represents the “Company’s Italian roots.”
  • The plaintiffs allege that the claim on the front panel of Barilla’s packaging “is misleading to reasonable consumers and tricks them into thinking the products are made in Italy or with ingredients sourced from the country.” According to the plaintiffs, this claim is reinforced through graphics using the Italian flag’s colors. However, the products are not made in Italy or using ingredients sourced from Italy.
  • Barilla argued that the class was not properly defined and the product labels have been revised since filing, so the class should not be certified. According to the judge, though, certification is proper because, among other things, the plaintiffs adequately alleged the defendants suffered common harm based on consumer deception. The consumers in the class relied on the challenged claim and understood it to mean the products were authentic Italian pastas that they would not have purchased if they knew the products were not made in Italy. In addition, the plaintiffs submitted evidence that Barilla marketed its products as “authentically Italian” understanding that an Italian connection is a material consideration to potential purchasers.
  • Keller and Heckman will continue to monitor this case and other food litigation developments.
  • USDA’s Agriculture Marketing Service (AMS) recently solicited public information about possible amendments to the electronic or digital link option for disclosing a bioengineered food. 
  • By way of background, the National Bioengineered (BE) Food Disclosure Standard regulations (BE regulations) currently provide that a BE disclosure may be made by on-package text, on-package symbol, electronic or digital link, or text message. 7 CFR 66.100(b).
  • However, as we have previously reported, in September 2022, a district court held that USDA had exceeded its statutory authority in authorizing the text message option as a standalone means of disclosure. The law which the BE regulations implement (7 USC 1639 et seq.) instructed USDA to provide “additional and comparable” options to the electronic or digital link if it determined that consumers would not have sufficient access to the BE disclosure. However, the Court determined that the text message was not an “additional” option and did nothing to cure the issues which USDA identified with the digital or electronic link disclosure. Accordingly, the Court ordered USDA to reconsider both the text message and electronic or digital link disclosure methods, although both remain in place pending the reconsideration. 
  • Pursuant to the Court order, last month USDA requested public input on the effectiveness and usage of the electronic or digital link disclosure, potential “additional and comparable options,” and other questions related to the BE disclosure methods more generally. The detailed questions can be found in 89 Fed. Reg. 25187 (Apr. 10, 2024). Comments are due by June 10, 2024.
  • Earlier this month, Judge Bobay of Allen County Superior Court in Indiana has ruled that tacos and burritos are technically Mexican-style “sandwiches” as part of his ruling in a zoning case. 
  • The case stems from a neighborhood association agreement which stipulated that only establishments that do not have a drive-thru, outdoor seating, or alcoholic beverages, and that specifically serve “made-to-order” or “Subway-style” sandwiches, could operate in a particular strip mall.  The plaintiff intended to open a restaurant that served tacos, burritos, and other made-to-order Mexican items, but the commission determined the restaurant proposal did not meet the sandwich-related criteria.  The judge wrote that the “Court agrees with Quintana that tacos and burritos are Mexican-style sandwiches, and the original Written Commitment does not restrict potential restaurants to only American cuisine-style sandwiches.”
  • The question of what foods are considered “open-face sandwiches” or “closed-face sandwiches” adds to the debate further because the answer impacts which federal agency has jurisdiction over the product.  Closed-face sandwiches are under FDA labeling jurisdiction and do not require USDA FSIS label approval, although the meat in the closed-face sandwich must be from a USDA inspected facility.  USDA defines closed face sandwiches as ”ready-to-serve, hand-held products consisting of a meat or poultry filling between two slices of bread, a biscuit, or a bun.”  On the other hand, USDA regulates “open-face sandwiches,” where the product includes at least 50% cooked meat, and “dinners containing a sandwich type product” (e.g., hamburgers).
  • The culinary question of what foods are considered sandwiches has been a popular debate throughout media and industry.  The National Hot Dog and Sausage Council has even weighed in, declaring that hot dogs are not in fact sandwiches.  New York law considers burritos to be a sandwich for taxing purposes, though USDA does not.  One court, in White City Shopping Ctr., LP v. PR Restaurants, LLC, held that Mexican products like burritos, quesadillas, and tacos, do not fit the definition of a sandwich.
  • On May 21, 2024, the California Assembly passed AB 2316, ordering it to the Senate. If enacted, the bill would prohibit public schools from offering, selling, or otherwise providing food and beverages containing the color additives Blue 1, Blue 2, Green 3, Red 40, titanium dioxide, Yellow 5, and Yellow 6, as well as beverages with added caffeine.
  • According to the Assembly’s Floor Analysis, the bill is intended to protect the health and wellbeing of children by preventing “the serving of school foods with additives that are linked to cancer, hyperactivity, and neurobehavioral harms.” A 2021 report by the California Environmental Protection Agency’s Office of Environmental Health Hazard assessment found that synthetic food dye consumption can result in hyperactivity and neurobehavioral problems in children, who have varying sensitivities to the dyes. The report found that safe levels for dye intake established by the FDA are not sufficient to protect health. The analysis claims that the bill will only affect 4.2% of school meal products and 2.5% of a la carte foods and that it is unclear how commodity products, such as mozzarella cheese provided through federal nutrition programs, will be affected.
  • AB 2316 follows the California Food Safety Act, which passed in September 2023. That law banned the use of brominated vegetable oil, potassium bromate, propylparaben, and Red 3. Notably, the bill initially included titanium dioxide. However, it was removed from the list of prohibited substances shortly before the bill passed.
  • Keller and Heckman will continue to monitor AB 2316.
  • 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.