• On March 29, 2021, the U.S. District Court for the Eastern District of California granted the California Chamber of Commerce’s (CalChamber) preliminary injunction to temporarily bar the State of California and any private litigants from enforcing Proposition 65 against businesses that do not warn consumers that acrylamide in food is known to the State of California to cause cancer.
  • In the lawsuit, CalChamber argued that warnings for acrylamide constitute false and misleading compelled speech that violates the First Amendment of the United States Constitution because there is a lack of reliable scientific evidence suggesting a causal relationship between acrylamide in food and cancer risk.  The court concluded that stating acrylamide is known to cause cancer is not factual or free of controversy, as most studies suggest naturally forming acrylamide in food products does not cause cancer in humans.
  • By way of background, acrylamide is a naturally occurring compound that develops when starches and sugars are cooked at high temperatures.  According to California’s Office of Environmental Health Hazard Assessment, it is present in foods including “French fries, potato chips, fried and baked snack foods, roasted asparagus, canned sweet potatoes and pumpkin, canned black olives, roasted nuts, roasted grain-based coffee substitutes, prune juice, breakfast cereals, crackers, some cookies, bread crusts, and toast.”
  • In its decision, the court stated that “if a business decides not to use the safe harbor warning, it risks expensive and lengthy litigation against private enforcers or the state, and defendants carry heavy evidentiary burdens if they attempt to show their products contain permissibly small quantities of acrylamide.”  The court clarified that the preliminary injunction has no impact on preexisting consent decrees, settlements, or other agreements related to Proposition 65 warning requirements.
  • On March 25, Congressmembers introduced The Baby Food Safety Act of 2021 to amend the Federal Food, Drug, and Cosmetic Act (FDCA) to limit the presence of toxic elements in infant and toddler food. Within a year of the Act coming into effect, manufacturers of infant formula and toddler food for kids up to 36 months would be required to adhere to the following initial maximum levels:
    • Inorganic arsenic: 10 ppb for infant and toddler food (except cereal) and 15 ppb for infant and toddler food that is cereal
    • Cadmium: 5 ppb for infant and toddler food (except cereal) and 10 ppb for infant and toddler food that is cereal
    • Lead: 5 ppb for infant and toddler food (except cereal) and 10 ppb for infant and toddler food that is cereal
    • Mercury: 2 ppb
  • Within 3 years of the date of enactment, the Secretary must set final regulatory limits that are lower than those mentioned above to levels protective of infant and toddler neurological development. Every 5 years afterwards, the established levels must be reviewed, and if needed, lowered by regulation. The Act also permits the Secretary to establish interim action levels and regulatory limits for toxic elements in infant and toddler food.
  • The Act was introduced by Representatives Raja Krishnamoorthi. In an announcement with Representative Tony Cardenas, Senator Amy Klobuchar, and Senator Tammy Duckworth, Rep. Krishnamoorthi stated that the Act was introduced “to dramatically reduce toxic heavy metals in baby food, educate parents about the risks, and invest in cutting edge farming technology to reduce any economic barriers to making baby foods safe for consumption.” As our readers know, the Act follows a February report from the House Oversight and Reform Subcommittee on Economic and Consumer Policy that reported on the levels of heavy metals found in baby foods produced by seven of the largest baby food manufacturers in the U.S.
  • On March 24, 2021, the U.S. District Court for the Northern District of California dismissed (subscription to Law360 required) a consumer class action lawsuit against McDonald’s which had alleged various causes of action relating to McDonald’s sale of vanilla ice cream that the plaintiff alleged derived some portion of its vanilla flavor from vanillin rather than vanilla bean.
  • The Court found that the Plaintiffs had not established that their claim—that consumers were misled by the vanilla flavor labeling—was plausible as required to survive a motion to dismiss. Specifically, the court found that the allegations of consumer deception were merely conclusory and did not establish that it was “probable that a significant portion of the general consuming public or of targeted consumers, acting reasonably in the circumstances, could be misled.” The court noted the labeling regulations that govern the retail sale of vanilla ice cream added no support for Plaintiffs’ claims because they indisputably did not apply to sales at fast-food establishments. Additionally, and serving as an independent grounds for dismissal, the court found that Plaintiffs’ had not established that they had paid a premium for the vanilla ice cream; rather the court found it to be “counter-intuitive” in the market context presented.
  • We have reported on a variety of vanilla flavoring class action lawsuits, many of which have not survived the motion to dismiss stage. This case is another demonstration of the difficulty that plaintiffs have had in convincing the court that consumers expect vanilla flavored products to contain not only the flavor of vanilla but also the ingredient vanilla bean. An amended complaint may be filed within 30 days of the order.
  •  FDA recently posted a March 5, 2021 Warning Letter to Panther James LLC for the manufacture of untreated juices without a Hazard Analysis and Critical Control Point (HACCP) plan and the required 5-log reduction of the pertinent microorganism that are required under the Juice HACCP regulations at 21 CFR Part 120.  The same violations were the subject of a February 1, 2019 Warning Letter involving Apple Lemon Ginger, Beet #1, Beet #2, Beet #3, Green #1, Green #2, Green #3, Green #4, Carrot Orange Beet, Ginger Shot, Turmeric Shot, Immunity Potion and other juices manufactured at the company’s Berkley, MI facility and sold onsite and at its four retail establishments in the Detroit metro area, as well as distributed wholesale, under the “DROUGHT” brand name, to non-related business entities.
  • While noting that the exemption from Juice HACCP for a “retail establishment” does not apply here because juice from Panther James’ Berkley facility is sold to other business entities, FDA explains that if it was exempt from Part 120 and not also exempt from registering as a food facility, it would be subject to the preventive control requirements of 21 CFR Part 117, which would require essentially the same food safety plan and hazard control measures as Juice HACCP.  Additionally, FDA’s letter explains how the different definition of “retail food establishment” under Part 117, as compared to “retail establishment” under the Juice HACCP regulations, means that the Berkley facility would not fall within the retail food establishment exemption from the requirement to register, even if sales to outside businesses were eliminated.
  • FDA’s recent action highlights how the Agency’s regulations allow only very limited exemptions from the requirement for a 5-log reduction of the pertinent microorganism in juices.  Although it is difficult to gauge the likelihood of further FDA enforcement action against DROUGHT juices, where no illnesses have been reported and no pathogens have been detected, any products that FDA has determined are not prepared, packed, or held in compliance with Juice HACCP, are presumed by law to be unsafe (adulterated per se).
  • As we previously reported, the National Milk Producers Federation (NMPF) filed a citizen petition with FDA in February 2019 requesting that the agency (1) enforce existing “imitation” labeling requirements against non-dairy substitutes for dairy foods and (2) codify FDA policies to permit the name of a standardized dairy food (like “milk,” “yogurt,” or “cheese”) to be used under limited circumstances. In particular, the petition proposes amending 21 C.F.R. § 101.3(e), FDA’s imitation foods regulation, to require the word “imitation” in product identity statements for non-dairy substitutes unless the product is nutritionally equivalent to the referenced dairy product.
  • On March 19, 2021, the Good Food Institute submitted a comment arguing against the petition, saying that the NMPF’s proposed regulation contravenes the Federal Food, Drug and Cosmetic Act, interpretative case law, and current regulations on “imitation” foods and violates the free speech clause of the First Amendment. Specifically, the comment characterizes the proposal as “needlessly complex and protectionist” and emphasizes its view that plant-based products are not “imitation” products that claim nutritional equivalence under current regulations but are instead alternative or substitute products, using the example that cow’s milk is to soy milk as is canola oil to soybean oil.
  • In addition to a handful of consumer comments, the Plant Based Foods Association had filed a comment also advocating against the amendments proposed by NMPF. Other industry stakeholders had filed comments, which we summarized here, regarding nomenclature concerns with plant-based dairy alternatives in response to an FDA Request for Comments in early 2019.
  • FDA has not yet responded to the comments it received on its 2019 request or NMPF’s citizen petition. We will continue to monitor this issue and report on any developments.
  • Mexico’s Federal Consumer Attorney’s Office (PROFECO) and other Mexican agencies have recently agreed to provide the food industry with more flexibility to comply with requirements in the Official Mexican Standard NOM-051 (“NOM-051”) that become effective on April 1, 2021.  NOM-051 sets forth new warning labeling requirements for all prepackaged food and non-alcoholic beverages sold within Mexico.
  • As we have reported in the past, in late 2020, Mexico’s NOM-051 began requiring manufacturers to place octagonal warning symbols in consumer products that state “Excess Calories,” “Excess Saturated Fat,” “Excess Sugars,” and “Contains Caffeine – Avoid in Children.” NOM-051 imposed a number of other requirements that were slated to become effective on April 1, 2021.  For example, prior to the PROFECO announcement, Clause 4.2.2.1.8 (requiring that all added sugar ingredients be grouped in the ingredient list) and Clause 4.1.5 (prohibiting prepackaged products with FOP warnings from bearing cartoon characters, animations, celebrities, athletes or pets, interactive elements (e.g., such as space games or digital downloads) that appeal to children) were to become effective on April 1, 2021.
  • PROFECO has stated that between April 1, 2021 to May 31, 2021, Mexican authorities will allow companies’ products that comply with already-effective FOP labeling requirements to continue to be marketed even if they do not comply with other requirements that would have otherwise become effective April 1, 2021.
  • On March 17, Utah Governor Spencer J. Cox signed Senate Bill (SB) 147 into law, which requires that egg-laying hens be kept in cage-free systems by 2025. Senator Scott D. Sandall (D-Box Elder) sponsored SB 147 with Representative Joel Ferry (R-Box Elder); both are members of Utah’s farm-rancher community.
  • Beginning on January 1, 2025, a farm owner or operator may not knowingly confine egg-laying hens in an enclosure that is not a cage-free housing system or that has less than the amount of usable floor space per hen as required by the 2017 edition of the United Egg Producers’ Animal Husbandry Guidelines, which establish 1 to 1.5 square feet of floor space per hen. The bill prohibits egg producers from confining hens to cages, and also requires farmers to provide hens perches, next boxes, scratching areas, and other amenities that allow them to “exhibit natural behaviors.” Battery cages, enriched colony cages, modified cages, convertible cages, furbished cages, and other such cage systems are prohibited. However, a farm with fewer than 3,000 egg-laying hens is exempt.
  • With the passage of SB 147, Utah is the eighth state to implement cage-free housing requirements, and joins Michigan, Oregon, Washington, Massachusetts, California, Rhode Island, and Colorado in banning battery cages. According to the USDA’s Agricultural Marketing Serving, nearly 30% of the industry is cage-free.
  • Last week the FDA issued warning letters to Honest Globe, Inc. (March 15, 2021) and Biolyte Laboratories, LLC (March 18, 2021) for selling products containing cannabidiol (CBD) in violation of the Federal Food, Drug and Cosmetic Act (the “Act”).
  • A principle issue addressed by FDA in the letters is the sale of the CBD containing products as unapproved drugs. The CBD products at issue claimed to provide pain relief as well as a variety of other beneficial effects (e.g., anti-inflammatory, anxiety and depression treatment).  Examples of claims include: “Elixicure pain relief with CBD”, “Deep-penetrating natural pain relief . . . non-addictive pain relief”, “relieving depression, lowering anxiety, lowering blood pressure, lowering intestinal inflammation and more”, “demonstrates antiviral, antibacterial, and antifungal effects for virtually every surface and tissue in the body”, “for temporary relief of occasional . . . minor aches and pains . . . Stiffness of muscles, joints and tissues.”  Therefore, consistent with the definition of drug,  the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the body. Both letters also state that the products do not meet the requirements under section 505G of the Act which would allow them to be marketed without an approved new drug application. Specifically, among other shortcomings, the active ingredient, CBD, was not an active ingredient in any applicable final monograph or tentative final monograph (TFM). Further, even if CBD was considered an inactive ingredient, the products would still not qualify for the 505G exception because CBD does not conform with the general requirement that it be safe and suitable since it has known pharmacological activity with demonstrated risks.
  • The letters also address a number of other deficiencies and violations, including failure to comply with current good manufacturing practices.
  • As we have previously reported, FDA taken the position that CBD is not a lawful dietary ingredient or dietary supplement, but has focused its enforcement efforts on Warning Letters against companies making unsubstantiated health claims. These letters are consistent with that policy. We will continue to monitor and report on any development in CBD regulation and enforcement.

 Candy Maker Accused of Fudging Amounts in Packages (subscription to Law360 required)

  • A putative class action complaint was filed in the U.S. District Court for the Northern District of Illinois on March 18, 2021 against Kilwins Quality Confections, a Michigan-based company with internet sales and franchises in 25 states that make various sweets on-site.  The named plaintiff alleges that a variety of candy,  was mislabeled under state consumer protection laws and food labeling statutes because it contained fewer servings and a higher caloric content than declared.
  • The complaint seeks more than $5 million in compensation for overpayment by consumers over a 5-year period before Kilwins purportedly corrected the alleged labeling violations.  As one example, the plaintiff claims to have paid $16.99 for a jar of Sea-Salt Caramel Topping bearing a label which stated that the jar contained 20 servings of 2-TBL and 110 calories per serving, but actually contained only 16 servings with 140 calories per serving.
  • The claims at issue appear to involve gross misstatements  of the net weight and caloric content on products in a niche market and, therefore, may not portend a new area of scrutiny for class action lawsuits.  Moreover, net weight lawsuits centered on violations of state laws sometimes raise complex preemption issues where different results would follow under a less complicated sampling plan under FDA’s Compliance Policy Guide which calls for selecting a sample of 48 units, and considers the sample to be in compliance if the mean of the sample is within 1% of the declared contents.
  • By way of background, in November 2020, a class action lawsuit was filed asserting various causes of action against Mowi USA, LLC and Mowi Ducktrap, LLC (collectively “Mowi”) arising out of their alleged misrepresentations in marketing smoked salmon products sold under the brand name Ducktrap River of Maine. Specifically, the lawsuit alleged that the salmon products, while represented as sustainable, natural, and sourced from Maine, were in fact the products of unsustainable and environmentally unfriendly industrial farming, not natural because the farmed salmon were treated with antibiotics and pesticides, and sourced from international waters rather than off the coast of Maine.
  • On March 16, 2021, Plaintiffs requested that the Court approve a proposed settlement between the parties. By the terms of the proposed settlement, a fund of $1.3 million would be established to reimburse consumers who had purchased the salmon products between March 1, 2017 and the [yet undetermined] date of entry of the preliminary settlement approval. The class representative plaintiffs would be paid a total of $9000 from this fund and claimants would be reimbursed $2.50 per product purchased, with a $25 limit on reimbursement without proof of purchase. In addition, under the proposed terms, Mowi would pay $360,000 in attorney fees and would be prohibited from using the phrases “sustainably sourced,” “all natural,” and “Naturally Smoked Salmon FROM MAINE” on any Ducktrap product for two years from the date of entry of the judgment.
  • Plaintiffs argued that the court should approve the settlement, in part because the compensation of $2.50 per claim represents a significant increase over the estimated $1.06 premium that the various representations at issue allowed the products to be sold for. Plaintiffs’ motion has been opposed by two intervenors in the litigation who allege that the proposed settlement is driven by attorneys’ fees and does not sufficiently advance the class interests.
  • This case serves as a reminder to substantiate all labeling claims and to tread cautiously when making natural claims, which the FDA has still not yet defined. Keller and Heckman will continue to monitor this case as well as other food consumer class action lawsuits.