• In a January 14 motion, Snapple Beverage Corp. asked a California federal court to dismiss a proposed class action lawsuit that alleges the “Sorta Sweet” label on its Straight Up Tea misleads consumers into thinking it is low in sugar. Snapple asserted that the label claim only refers to the drink’s taste, not sugar content. Indeed, Snapple stated “[n]o reasonable consumer goes through the mental gymnastics of redefining the puffery of ‘Sorta Sweet’ to mean ‘low in sugar’ while simultaneously ignoring the portions of the label that undo that implausible interpretation.”
  • According to the motion, the brand’s three different varieties (e.g., Sweet, Sorta Sweet, and Unsweetened) demonstrate that “Sorta Sweet” refers to the product taste and that a consumer looking at the varieties would understand that the “Sorta Sweet” tea has a different taste from the other two varieties. Snapple further argued that any question about the sugar content would be answered by the Nutrition Facts Panel on the bottles.
  • Snapple added that the complaint largely leans on a letter from the Center for Science in the Public Interest (CSPI) to the FDA, and does not make its own factual allegations. Snapple argued that “[a] plaintiff does not satisfy her pleadings burden by attaching an advocacy group’s letter to her complaint and saying ‘met too.’” A summary of the CSPI letter is available here.
  • Snapple asked for the complaint to be dismissed, but in the event the full complaint is not dismissed, Snapple urged the court to trim the claim for injunctive relief because the plaintiff is no longer at risk of harm.
  • Last month, the United States Court of Appeals for the 9th Circuit affirmed a grant of summary judgment in favor Target and other defendants in a class action lawsuit that alleged that Target’s Up&Up biotin dietary supplement violated various California consumer protection statutes because it claimed to  “help[ ] support healthy hair and skin.” Specifically, the Court held that (1) the statement was a “structure/function” claim governed by the Federal Food Drug and Cosmetic Act (the “Act”), (2) Plaintiff sought to impose different requirements from the Act, and (3) therefore, the claim was preempted.
  • By way of background, a “structure/function” claim is one that describes the function or role of an ingredient or nutrient in the human body. See Act § 403(r)(6); see also 21 C.F.R. 101.93 (f). Section 403(r)(6) of the Act authorizes such structure/function claims to be made provided that they (1) are  substantiated so that the statement is truthful and not misleading; (2) do not claim to diagnose, mitigate, treat, cure, or prevent a disease; and (3) include a mandatory disclaimer informing the consumer that the product has not been evaluated by the FDA and is not intended to treat or otherwise address disease.
  • Plaintiff had purchased the biotin product to battle hair loss and stimulate hair growth, but later learned that because he — like the majority of the population — was not deficient in biotin, supplementation would not increase his hair growth. Plaintiff alleged that because few consumers would see improvements in health of their hair or skin, the structure/function statement was false and misleading.
  • In rejecting this argument, the Court first found that structure/function claims were expressly preempted by the Act. The Court also found that the Act only required that there be substantiation for an ingredient’s function on the human body, and not the product’s impact on the general health of the population. The Court contrasted this to a disease claim which “speaks to the product’s effect on the consumer’s disease.” Therefore, because the only effect of the product on the consumer’s disease (i.e. hair loss) was challenged, and biotin’s role in supporting health and hair health was not, the statement was truthful and not misleading. Finally, the Court found that the Act’s other two requirements for structure/function claims were met; the product contained the mandatory disclaimer language and did not claim to treat or otherwise address disease.
  • The opinion underscores that structure/function claims that are properly substantiated and that otherwise meet federal requirements are not ripe targets for consumer class action lawsuits. Keller and Heckman will continue to report on interesting case law developments that impact foods and dietary supplements.
  •  We previously discussed a December 30, 2020 alert from FDA regarding recalls by Midwestern Pet Food, Inc. of nine total lots of Sportmix pet food products following reports of death and illness in dogs after consuming the products.  As discussed in an updated alert, the recall was expanded on January 11, 2021 to include all pet food products containing corn (more than 1000 lot codes of dog food and cat food) that were made in the firm’s Oklahoma plant and that expire on or before July 9, 2022.  As of FDA’s updated, January 26, 2021 alert, more than 110 pets have died and more than 210 pets are sick after have consumed certain pet food manufactured by Midwestern Pet Foods.  Another recent recall of dog food (September 2, 2020 by Sunshine Mills, Inc.) was triggered by a finding of elevated levels of aflatoxin in routine sampling of a single 4-pound bag of one lot of product but has not been associated with any deaths or illness.
  • On January 28, 2021, a group of consumers with dogs that died or became ill after consuming the now-recalled product from Midwestern Pet Foods have filed a proposed class action lawsuit (subscription to Law360 required) in the U.S. District Court for the Southern District of Indiana on behalf of a nationwide class and a California state class of buyers of Midwestern Pet Foods’ cat and dog foods.  The plaintiffs, who allege negligent misrepresentation, fraud, and unjust enrichment, seek restitution and over $5 million in damages to be determined in a jury trial.
  • It is yet to be seen how Midwestern Pet Foods will respond.  In earlier litigation following a pet food recall in 2005-2006 associated with aflatoxin contamination and involving a large number of deaths in dogs, it was reported that Diamond Pet Foods, Inc. agreed to pay $3.1 million dollars in a settlement with pet owners.
  • A proposed class of consumers filed a complaint (Law360 subscription required) against the grocery chain Aldi Inc. on January 26, 2021 in the Eastern District of New York alleging that Aldi’s “Smoked White Cheddar – Deli Sliced Cheese” product is mislabeled because it allegedly achieves its smoked flavor from natural flavorings rather than by smoking the cheese. The complaint asserts that while “natural smoke flavor” is listed as an ingredient, the front panel of the product violates FDA flavor labeling regulations by failing to use a product identity statement that shows the flavor is added and not obtained through smoking.
  • The Aldi suit closely follows claims in two previous cases filed in 2020 against Dietz & Watson Inc. in New York federal courts regarding smoked provolone and smoked gouda cheese products. Each case relies on the same FDA regulations, outlined in detail in our previous post, and highlights an FDA warning letter sent to Middlefield Original Cheese Co-op in 2017 that alleged that two Middlefield products were improperly labeled as “smoked cheese” when the flavor was obtained with added flavors rather than smoking the cheese.
  • In the Dietz & Watson smoked provolone case, plaintiffs filed to voluntarily dismiss the suit with prejudice earlier this month; settlement details have not been made public. To date, Dietz & Watson continues to advertise the smoked provolone, gouda, and other smoked cheeses on their website; the package labeling and product identity statement do not appear to have changed from those depicted in the original complaints.
  • The plaintiff’s counsel in the above three cases is Sheehan & Associates, a firm that has become known in recent years for its pursuit of class action litigation claiming harm to consumers from allegedly misleading food labeling. The Sheehan firm has represented a number of class action plaintiffs in the recent spate of flavor labeling challenges.
  • On January 13, 2021, California approved amendments to the state’s Proposition 65 warning regulations, which relate to the methods for providing warnings for alcoholic beverages purchased over the internet or through mobile applications.
  • As a result of the amendments, Section 25607.3(3)(A) now requires that a warning be provided to the purchaser or delivery recipient prior to or contemporaneously with the delivery of an alcoholic beverage in addition to any warning on the internet site or in a catalog.  A business must place warning meeting specified formatting requirements on either (i) the shipping container or delivery package or (ii) by email or text message as part of the electronically delivered receipt or confirmation for the applicable purchase.
  • The regulation, which becomes effective on April 1, 2021, makes available to all companies compliance options that the Attorney General provided in a January 2020 consent judgment with 13 alcoholic beverage delivery defendants.  Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Prop 65.  If you have any questions about the amendments to Article 6 or related matters, or would like assistance preparing comments, please email prop65@khlaw.com.
  • On January 26, FDA placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert in an effort to stop violative products from entering the US market until the Agency is able to review the products’ safety. See FDA’s Press Release. Under the import alert, FDA may detain shipments of the alcohol-based hand sanitizers from Mexico, and as part of the entry review, FDA will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured in accordance with US current good manufacturing practices (cGMPs). This is the first time the FDA has issued a countrywide import alert for any category of drug product.
  • Over the course of the ongoing COVID pandemic, the FDA has seen an increase in hand sanitizer products from Mexico that were labeled to contain ethanol, but tested positive for methanol. Methanol, or wood alcohol, can be toxic when absorbed through the skin and life-threatening when ingested and is not an acceptable ingredient in hand sanitizer or other drugs. The FDA is aware of methanol-contaminated hand sanitizer adverse events, including blindness, cardiac effects, effects on the central nervous system, hospitalizations, and death.
  • From April to December 2020, the FDA analyzed alcohol-based hand sanitizers imported from Mexico and found that 84% of the samples were not in compliance with FDA regulations. More than half were found to contain toxic ingredients, including methanol and/or 1-propanol.
  • Methanol-contaminated hand sanitizers are a serious safety concern for the FDA, and the Agency has been proactively working with companies to recall products and encourage retailers to remove violative products. Further, since July 2020, the FDA has issued 14 warning letters to manufacturers for distributing hand sanitizers with undeclared methanol, inappropriate ethanol content, and misleading claims.
  • Plaintiff, on behalf of a proposed class of buyers, and Defendant Frito Lays Inc., have asked a California District Court to voluntarily dismiss a false advertisement lawsuit that was filed in October 2020.
  • The complaint had alleged that Frito Lays’ potato crisps —sold under its “Ruffles” brand name and labeled as “Baked Lays Cheddar & Sour Cream Flavor” —were falsely advertised because they contained artificial diacetyl, which allegedly reinforced the sour cream flavor, but were not labeled as artificially flavored. On the contrary, Plaintiff had argued that the “Cheddar & Sour Cream Flavor” statement on the front label represented to consumers that the sour cream flavor was entirely naturally derived.
  • The complaint was very similar to a New York action against Frito Lays which we have previously covered. This action was voluntarily dismissed earlier this month according to court records.
  • The reason for the dropped suit, including the terms of any settlement between the parties, has not been disclosed. We have not yet seen a court decision address the merits of an artificial diacetyl flavoring lawsuit and will continue to monitor for any further developments in this area.
  •  As of a January 19, 2021 order dismissing false advertising claims against Topco Associates LLC’s ‘Vanilla Almond Milk’ (subscription to Law360 required), district court judges in the Southern District of New York have now rejected, as a matter of law, five cases attempting to claim that the word “vanilla” on food labeling falsely communicates to a reasonable consumer that the flavor of the respective ice cream and beverage products at issue derives entirely from real vanilla.  In each case, the court found it irrelevant that the product may perhaps not comply with the Food and Drug Administration’s (FDA) “complex” labeling regulations implementing the Federal Food, Drug, and Cosmetic Act (FDCA), finding “no extrinsic evidence that the perceptions of ordinary consumers align with these various labeling standards.”
  • As we have reported, a court in the Northern District of California, on December 1, 2020, granted a motion to dismiss in a similar case, involving Westbrae Natural, Inc.’s organic unsweetened vanilla soymilk.  In addition to making the same arguments as in the other ‘vanilla’ cases, the plaintiff in Westbrae offered a 2020 survey showing that 69.5% of 400 consumers believed that “vanilla” on the label meant that the soymilk’s flavor comes exclusively from the vanilla bean, but the court found that this survey alone does not satisfy the reasonable consumer test.
  • In a January 19, 2021 motion to dismiss (subscription to Law360 required), Trader Joe’s Company cites to the Westbrae decision for precedent and argues that reasonable consumers understand that “vanilla,” in the context of labeling for its ‘Vanilla Almond Clusters’ breakfast cereal, describes the product’s flavor, not its ingredients.  The grocery chain also notes that the plaintiff’s counsel, Spencer Sheehan, has filed 110 lawsuits over vanilla flavoring in 18 months, and further suggests that Mr. Sheehan rushed the Trader Joe’s lawsuit in an attempt to get ahead of dismissals in the “virtually identical” New York cases.
  • Based on the relevant court rulings, the Trader Joe’s lawsuit and others, including a proposed class action filed in California in September against McDonald’s vanilla ice cream (subscription to Law360 required), could be the last in a spate of class action lawsuits alleging deceptive and misleading labels on vanilla products.

 

  • President Biden’s list of planned executive actions included an order to reexamine chlorpyrifos, a controversial insecticide that is widely used to reduce insect damage to a variety of crops, including row crops, fruits, and vegetables. Chlorpyrifos has been the subject of several lawsuits and petitions that point to its potential adverse effects on human and wildlife health as reasons to ban its use in the United States.
  • The Obama administration had proposed a ban on the insecticide in its final months in 2016, but the Trump administration later reversed that decision, saying that more research was needed to determine the extent of chlorpyrifos’s risks. California and Hawaii are among the U.S. states that have joined the European Union in banning the chemical.
  • Reconsidering the use of chlorpyrifos is just one goal in a lengthy list of Trump administration actions that the Biden team plans to review. One other related rule that the team plans to review is the Trump administration’s decision to reduce buffer zones around fields that limit exposure to pesticides for farmworkers. Keller and Heckman will continue to monitor updates on the potential chlorpyrifos ban and other actions in the new presidential administration.
  • On January 15, 2021, the U.S. Food and Drug Administration (FDA) issued warning letters to ten companies that sell electronic nicotine delivery system (ENDS) products, including e-liquids.  FDA’s letters warned that any new tobacco product not in compliance with the premarket authorization requirements of the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, is adulterated and misbranded, and may not be marketed without FDA authorization.
  • By way of background, the premarket tobacco product application (PMTA) process ensures that new tobacco products will undergo a scientific evaluation by FDA to ensure that such products are appropriate for the protection of the public health.  Certain new tobacco products (g., ENDS on the market as of August 8, 2016, the effective date of FDA’s “Deeming Rule”) were required to complete and submit PMTAs by September 9, 2020 – a deadline established as a result of a federal district court order.  In compliance with that court’s order, FDA stated that companies that submitted applications by the deadline are allowed to continue selling those products for up to a year (i.e., until September 9, 2021), unless FDA rejects the PMTA filing, or uses its enforcement discretion to allow products sufficiently far along in the review process to remain on the market on a case-by-case basis. On January 19, 2021, four months after the submission deadline, FDA finalized its long-awaited “foundational rule” on PMTAs.
  • FDA also emphasized that it would continue to prioritize enforcement against companies that have not submitted a PMTA and that market ENDS, including e-cigarettes and products with a likelihood of youth use or initiation (g., cartridge or pod-based ENDS).
  • FDA requested that each company respond within 15 days of receiving the letter detailing how it will address FDA’s concerns, including the dates on which the company discontinued the sale and/or distribution of the tobacco products, and its plans for maintaining compliance.  FDA stated that the failure to address violations may result in a civil money penalty, seizure, and/or injunction.

To learn more about this and other tobacco-related topics, be sure to subscribe to our sister blog, The Continuum of Risk.  You can also register now for Keller and Heckman’s virtual E-Vapor and Tobacco Law Symposium on February 9-11, 2021.