• An Illinois consumer has filed a proposed class action against The Wonderful Co. LLC, the bottler of Fiji Natural Artesian Water, claiming that the water contains microplastics. The claim alleges violations of the Illinois Consumer Fraud and Deceptive Business Practices Act, common law fraud, and unjust enrichment for intentionally labeling the products as Natural Artisan Water, even though the company knew or should have known the product contains microplastics.
  • The complaint cites a 2018 study on synthetic microplastic contamination in bottled water, which found that 93 percent of bottled water showed signs of contamination. An additional study in 2019 found that the microplastics in bottled water originated from mechanical stress caused by frequent opening and closing of the plastic cap on the bottles.
  • Microplastics have been shown to cause toxic effects in marine life, as well as mammals, including humans. While the full extent of these effects in humans is not fully understood, studies have shown that they can cause problems in the immune, gastrointestinal, endocrine, and cardiovascular systems.
  • The complaint notes that FDA has not defined the term “natural,” but has long considered it to mean that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected in that food.” The claim alleges that labeling the bottled water as “natural” is false and misleading and deprived plaintiffs of the ability to choose the quality of products they purchase and consume.
  • Keller and Heckman will continue to monitor this lawsuit and the issue of microplastics in bottled water.
  • Following a previous recall of its Chewy granola products in December, Quaker Oats has broadened its recall to its granola bars, snacks, and some varieties of its popular Cap’n Crunch cereal products sold nationwide due to possible Salmonella contamination.
  • The U.S. Food and Drug Administration (FDA) has provided a list of the affected products, which now include the following:  Quaker Chewy Granola Bars (Fruity Fun) Amazing Apple, Quaker Chewy Granola Bars (Fruity Fun) Amazing Apple and Splendid Strawberry Variety Pack, Quaker Chewy Granola Bars Yogurt Strawberry Flavor, Cap’n Crunch Treats Crunch Berries Cereal Bar, Quaker Chewy Granola Breakfast Cereal Strawberry, Cap’n Crunch Cinnamon Crunch Cereal, and Cap’n Crunch OOPS! All Berries Instant Oatmeal.
  • Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.
  • The listed products were sold throughout the US, Puerto Rico, Guam, and Saipan.  Consumers can scan the SmartLabel QR code on the product package to determine whether it has been recalled.
  • Keller and Heckman will continue to monitor and relay any updates regarding food safety.
  • Recently released documents indicate that FDA has recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from a Schedule I drug to a  Schedule III drug under the Controlled Substances Act. Schedule I drugs have a high potential for abuse, have no currently accepted medical use (CAMU), and there is a lack of accepted safety for their use under medical supervision. In contrast, Schedule III drugs, have a lesser potential for abuse than Schedule I and II drugs, have a CAMU, and their abuse may lead to moderate or low physical dependence or high psychological dependence. 21 U.S.C. § 812.
  • As to the first factor mentioned above (high potential for abuse), FDA noted that “marijuana is the most frequently abused federal illicit drug” and produces a wide range of responses, both positive and negative, but concluded that “it does not produce serious outcomes compared to drugs in Schedules I or II.” Notably, marijuana ranked at the very bottom of drugs when it came to a number of undesirable metrics including overdose, poisoning, emergency room visits, and hospitalizations.
  • As to the second factor mentioned above (currently accepted medical use), FDA concluded that that there is widespread experience with medical use of marijuana by licensed health care providers operating under state-authorized programs and that there was “some credible scientific support” for the use of medical marijuana to treat anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, chemotherapy induced nausea and vomiting, pain, and post-traumatic stress disorder.
  • On the third factor mentioned above (dependence liability), FDA concluded that marijuana can lead to low or moderate physical dependence in heavy users, and can produce psychic dependence, but that the probability of a serious outcome is low.
  • The DEA will ultimately be responsible for the decision. We will continue to monitor and report on developments.
  • Arizona state representatives have introduced two bills relating to the sale of cell-cultured meat in the state. HB2121 would prohibit the sale or production of cell-cultured animal products, and HB2244 would deem cell-cultured products labeled with traditional terms as misbranded.
  • Rep. David Marshall and four co-sponsors introduced HB2121, titled “Cell-cultured animal product; prohibition.” This bill would impose civil penalties on any person who offers to sell, sells, or produces a cell-cultured animal product for human or animal consumption. In addition, it would create a cause of action for any person or organization “whose business is adversely affected by a violation” of the prohibition. Legislative findings in the bill focus on Arizona’s cattle ranching history and include:
    • The regulation of cell-cultured animal products is a matter of statewide concern necessary to protect public health.
    • This state’s cattle ranching industry is integral to this state’s history, culture, values and economy.
    • Cattle is one of the five foundational pillars that have driven this state’s economy since territorial days.
    • The production and sale of lab-grown, cell-cultured animal product threatens to harm this state’s trust land beneficiaries and the highest and best use of state trust land, which includes the lease of state lands to ranchers for livestock grazing to fund public schools and other public institutions.
    • This act is necessary to protect this state’s sovereign interests, history, economy and food heritage.
  • Rep. Huang Nguyen and eight co-sponsors introduced HB2244. Rather than outright banning cell-cultured animal products, this bill would prohibit the use of terms that are “the same or deceptively similar” to terms historically used on meat and poultry products or otherwise representing cell-cultured or synthetically derived products as a meat or poultry product. The bill is intended to prevent cell-cultured or synthetic animal products from being labeled in a way that “misrepresents or misbrands” the products.
  • While FSIS and FDA have agreed to jointly regulate cell-cultured animal products in the United States, Italy has become the first country to ban cell-cultivated meat.
  • Keller and Heckman will continue to monitor laws relating to cell-cultured animal products.
  • The Federal Trade Commission (FTC) has announced that it will hold an informal hearing on its Proposed Rule on the Use of Consumer Reviews and Testimonials on February 13, 2024. Representatives of Fake Review Watch, the Interactive Advertising Bureau, and a group of three marketing professors requested in their comments on the proposed rule the opportunity to speak at an informal hearing and will be accorded the opportunity to do so. Briefly, Fake Review Watch’s comments expressed concerns that the rule does little to hold review platforms accountable; the Interactive Advertising Bureau expressed concerns that the rule’s definitions of deceptive activity sweep too broadly and threaten to violate the First Amendment, and the professors described their research in mechanisms for generating trust in review platforms and expressed their opposition to any amendments to the rule that would require disclosure of reviewers’ identities.
  • As discussed previously on our Consumer Protection Connection blog, the proposed rule would establish as deceptive (1) selling or obtaining fake consumer reviews or testimonials or false indicators of social media influence like fake followers or views; (2) repurposing a review of one product to apply to another, substantially different product (so-called “review hijacking”); (3) buying or otherwise incentivizing positive or negative reviews; (4) the writing of reviews of a company’s products by the company’s employees without disclosing the relationship; (5) a company’s controlling a website claiming to provide independent opinions about its own products; and (6) falsely presenting reviews as comprehensive if negative reviews have been suppressed, or using unjustified legal threats or other intimidation to suppress negative reviews.
  • The hearing follows on the heels of the FTC November 2022 Advanced Notice of Proposed Rulemaking (ANPR). At that time, Chair Khan asserted that the new rule was necessary for the agency to contend with the increasing importance of endorsements and reviews in the online marketplace and the limitations on its ability to seek monetary relief following the Supreme Court’s decision in AMG Capital. Commissioner Wilson, who was at the time the sole Republican commissioner and has since resigned, lamented that “The Rule-a-Palooza at the FTC has begun!” and dissented from the vote to publish the ANPR. While agreeing that fake and deceptive reviews and endorsements were unlawful, she pointed out that the Commission already had “a multi-pronged strategy in place to combat this issue” and argued that a rulemaking was not the best use of agency resources.
  • Keller and Heckman will continue to monitor the progress of this rulemaking, and be available to advise with optimizing use of endorsements and consumer reviews while managing legal risk.
  • The U.S. Food and Drug Administration (FDA) has provided an update regarding the cinnamon applesauce pouches that have been recalled.  FDA’s investigation began on November 9, 2023, when WanaBana USA voluntarily recalled all lots of WanaBana Apple Cinnamon Fruit Puree pouches, Schnucks-brand cinnamon flavored applesauce pouches, and Weis-brand cinnamon applesauce pouches due to reports of elevated levels of lead.
  •  As of January 8, 2024, FDA has received 87 confirmed complaints/reports of adverse events potentially linked to the recalled product.
  • CDC’s National Center for Environmental Health is currently conducting case finding efforts in collaboration with state and local health departments.  As of January 5, 2023, CDC has received reports of 86 confirmed cases, 209 probable cases, and 26 suspected cases, totaling 321 cases from 38 different states through their reporting structure.
  • FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses.  Because of the products’ long shelf life, cases are still being reported.
  • Keller and Heckman will continue to monitor and relay any developments in the investigation.
  • Last month, a California Superior Court dismissed a case against Gulf Pacific Rice Company which alleged that one of their brown rice products contained elevated levels of lead and failed to carry an appropriate warning as required by the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). 
  • Proposition 65 provides a safe harbor where it can be shown that the exposure to the chemical in question is low enough to pose no significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm.  These thresholds below which no warning is needed are referred to as “no significant risk levels” (NSRLs) in the case of carcinogens and “maximum allowable daily levels” (MADLs) for chemicals that cause reproductive harm.
  • The MADL for lead is 0.5 micrograms/day so the question at trial was whether the exposure to lead from consumption of the brown rice product exceeded this level.
  • The Court agreed with Defendant’s calculations indicating that expected exposure was only 0.01 micrograms/day, well within the safe harbor. In so doing, the Court concluded that:
    • It was appropriate to use the geometric mean rather than the arithmetic mean for all calculations, because the geometric mean reduces the effect of outliers and “is the generally accepted scientific method for the determination of the central tendency of a set of data.”  The geometric mean is always equal to or less than the arithmetic mean.
    • An exposure assessment under Proposition 65 should use consumption data from all groups “and is not limited to any specific subpopulation, ethnicity, gender or other subcategory.”
  • However, the Court did reject the Defendant’s constitutional challenges to Proposition 65 as well as the argument that Proposition 65 was preempted by the Federal Food, Drug, and Cosmetic Act. 
  • Keller and Heckman will continue to monitor and report on updates to Proposition 65.
  • FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network recently released its 2022 annual report summarizing investigations into foodborne outbreaks and adverse events. This is CORE’s first annual report since it was established in 2011.
  • In 2022, CORE evaluated 65 incidents, including potential and confirmed outbreaks and adverse events; initiated 28 responses to outbreaks that appeared to be caused by an FDA-regulated food; and issued 11 public health advisories to provide actionable advice about a food linked to an outbreak.
  • Of the responses linked to an identifiable product, 37 percent were related to produce, 32 percent were related to multi-ingredient foods, dairy, fish, and nuts and seeds, and 31 percent were related to other or unknown foods categories. The report highlights noteworthy outbreaks from 2022, including Enoki mushrooms, cantaloupe, and peanut butter.
  • CORE is a network of science, medicine, and public health experts with teams intended to evaluate and control outbreaks related to FDA-regulated foods. A list of active and past investigations is available on the outbreak table webpage.
  • Officials are urging a federal court to dismiss Tofurky’s challenge of Texas’s new food labeling law, arguing that the plant-based meat maker has only made “hypothetical” allegations and lacks standing.
  • Texas Senate Bill 664 asserts that analogues of meat, poultry, seafood and eggs will be deemed misbranded unless the product label “bears in prominent type equal to or greater in size than the surrounding type and in close proximity to the name of the product one of the following: ‘analogue’; ‘meatless’; ‘plant-based’; ‘made from plants’; or a similar qualifying term or disclaimer intended to clearly communicate to a consumer the contents of the product.”  For cultivated meat products, it imposes an identical labeling requirement with one of the following terms: “cell-cultured”; “lab-grown”; or something similar.
  • Tofurky claims that, “The law institutes an unreasonably burdensome and protectionist trade barrier that contravenes and is preempted by federal law and imposes vague standards on Tofurky and other plant-based meat producers who use words associated with meat products to describe products that are clearly marketed and packaged as 100% plant-based/vegan.”
  • In its motion to dismiss, Texas counters that the legal action is at best premature and that Tofurky lacks standing as to the law’s provisions related to cell-cultured, since the company is solely a plant-based organization.  “It cannot be overstated that Plaintiffs have not clearly and properly alleged what, if any, provisions of the Amendment they cannot meet,” according to Texas.
  • Keller and Heckman LLP will continue to monitor and relay any developments in the labeling and litigation space.
  • As we have previously blogged, in 2022 FDA denied a petition from Bonumose LLC which requested that the agency exempt D-tagatose from declaration as an added sugar. The petition argued that D-tagatose contributes less calories than traditional sugars (1.5 calories/g vs. 4 calories/g) and is not associated with the same health outcomes as traditional sugars (i.e., mono- and disaccharides, such as glucose, fructose, lactose, and sucrose), but FDA declined in part because even 1.5 calories/g could contribute non-negligible levels of what the Agency deemed empty calories.
  • Last month, FDA issued a supplemental response in which it indicated that it would exercise enforcement discretion in regard to the % daily value (DV) declaration of added sugars in products containing D-tagatose if the % DV calculation is based on a 1.5 calories/g contribution of D-tagatose. The DV for added sugars is 10% of total calories based on a 2000 calories diet (200 calories), which is 50 g for traditional sugars which metabolize at 4 calories/g.
  • The supplemental response represents only a minor change as the 2022 response indicated that the agency would not object to the use of 1.5 calories/g in the calculation of calories. FDA has maintained its position that D-tagatose should be included in the added sugars declaration.
  • The supplement was issued in response to an ongoing lawsuit challenging the response to the petition (Bonumose v. FDA, Civ. Action No. 23-645 (D.D.C.). We will continue to monitor and report on any changes to the declaration of D-tagatose and other non-traditional sugars.