• On December 10, 2020, the FDA finalized guidance document CVM GFI #262, Pre-Submission Consultation Process for Animal Food Additive Petitions (FAPs) or Generally Recognized as Safe (GRAS) Notices, to facilitate consultations between FDA and stakeholders prior to submitting an animal FAP or GRAS notice for an animal food ingredient. The guidance includes recommendations from the FDA Center for Veterinary Medicine (CVM) on the information that should be included with (1) pre-petition consultations prior to animal FAPs; (2) pre-submission consultations for animal food GRAS notifications; and (3) Food Use Authorization (FUA) requests to use, in human or animal food, products derived from animals that have been administered an investigational substance intended for use in animal food.
  • The guidance, which was first drafted in February 2020, details non-binding recommendations for submissions to investigational food additive (IFA) files and FDA’s review process for IFA submissions, use of foreign data in submissions, the circumstances under which a stakeholder should submit their study protocols, and how to best communicate with FDA regarding regulatory submissions. The guidance encourages early communications between stakeholders and CVM in the FAP or GRAS notice process and emphasizes that stakeholders should email CVM as questions arise to improve the quality of submissions.
  • New appropriations in the last year have allowed CVM to improve its capacity for animal food ingredient reviews, and it is working to reorganize the Division of Animal Feeds to expedite reviews and improve the process’s efficiency. This guidance furthers its goals of facilitating better communications with stakeholders to bring safe new animal food ingredients to the market. Keller and Heckman is well-versed in assisting with animal FAPs and GRAS notice reviews and will continue to monitor changes to these processes.
  • On December 8, 2020, United States District Court Northern District of California William H. Orrick ruled on Big Heart Pet Brands, Inc.’s (“Defendant”) motion to dismiss plaintiff’s amended complaint and held that plaintiff’s amended complaint against the dog food manufacturer satisfies that standards for standing and can go forward.
  • In the amended complaint, the plaintiff alleged that the Defendant falsely markets its Grain Free Easy to Digest Salmon Sweet Potato & Pumpkin Recipe Dog Food as “Grain Free,” “No Corn,” and “No Soy Protein” even though independent testing confirmed that the product contains significant amounts of both corn and soy.
  • In response to Defendant’s motion to dismiss, Judge Orrick concluded that the plaintiff had standing to pursue the case, as she relied on the labeling of the dog food and its assurance that it contained no grain, corn, or soy, and would not have bought the food if she would have known that it was false.  In its motion, Defendant argued that the amended complaint provides a report that shows the bag of food tests was not the one purchased by the plaintiff; however, Judge Orrick found that this fact did not impact the plaintiff’s standing at the motion to dismiss stage, as it is enough to allege that an example of the dog food contains grain, corn, or soy.
  • Judge Orrick also rejected Defendant’s argument that the case must be dismissed because there are alternative possible explanations for the tested bag to contain grain, corn, or soy.  In its motion to dismiss, Defendant stated that one alternative explanation for plaintiff’s allegations is that the product she purchased did not actually contain corn, or soy protein, and instead one sample bag, not purchased by her, may have inadvertently contained corn and soy DNA due to possible cross-contamination.  However, Judge Orrick noted that a possible alternative explanation does not destroy the plausibility of plaintiff’s claims.  Judge Orrick also stated that other courts have permitted consumer claims in nationwide class actions regarding product mislabeling to move forward based on limited testing, including a single test on a single sample of the product at issue.  We will continue to monitor any developments.
  • On December 6, a complaint was filed in the Southern District of New York against the owners of PopChips, VMG Partners LLC. The proposed class action alleges that the labeling of “Cheddar and Sour Cream” PopChips is misleading to consumers. Named plaintiff, John Salony, told the court that when consumers see the flavors “cheddar & sour cream” on a label without qualifiers like “naturally flavored,” “other natural flavors,” or “artificially flavored,” consumers expect the product to be primarily, if not entirely, flavored by the actual characterizing ingredients.
  • Salony stated that while the product contains some cheddar cheese, it also contains added cheddar cheese flavor as indicated by the listing of “natural flavors” in the ingredient list.  According to the complaint, “natural flavors” are added because the amount of cheddar cheese is insufficient to independently provide the product with a cheddar taste, and therefore, the front label should have disclosed the added cheddar flavoring in accordance with FDA’s flavoring labeling at 21 CFR 101.22(i)(1)(i).
  • Additionally, Salony alleged that the label failed to disclose that the product contained no real sour cream, thereby misleading consumers who “want real sour cream because even when consumed in small amounts, it contributes to beneficial health effects.” The complaint listed the following sour cream health benefits: helps to establish and maintain beneficial intestinal bacterial flora and reduce lactose intolerance; has high mineral content (i.e., phosphorus and calcium); contains Vitamin B12 which helps preserve nerve cells and maintain red blood cells; and contains Vitamin A which helps promote eye health, and increases the body’s immunity.
  • The complaint states that PopChips’s branding, marketing, and packaging is designed to deceive, mislead, and defraud consumers, and that VMG Partners sold more of the product and at higher prices because of the deceit. In the suit, Salony intends to represent all buyers of PopChips who live in New York, and brings claims under the state’s consumer protection statutes, as well as claims for negligent misrepresentation, breach of express and implied warranty, fraud, and unjust enrichment. Notably, Salony’s attorney, Spencer Sheehan, is representing another consumer making similar claims against Frito-Lay’s Ruffles Cheddar & Sour Cream Flavored Potato Chips.

Keller and Heckman will continue to monitor any developments.

  • On December 4, 2020, the 9th Circuit affirmed the District Court’s dismissal of a complaint brought by a consumer against Diamond Food, Inc. for claims arising out of her purchase of a popcorn product which contained partially hydrogenated oils (PHOs).
  • By way of background, in 2015 the FDA made a final determination that PHOs, which are the primary dietary source of artificial trans fat in processed foods, are not Generally Recognized as Safe (GRAS). Manufacturing of foods with PHOs was banned for most uses of PHOs after June 18, 2018, with food manufactured with PHOs prior to this date allowed to remain in the market until January 1, 2020. See PHO Final Determination Guidance.
  • Plaintiff alleged that she had been economically and physically harmed by purchasing popcorn with PHOs. The 9th Circuit disagreed and found that she had not alleged an injury, and that therefore she lacked standing to bring the action. In particular, the Court held that she had not been economically harmed because the labeling disclosed the presence of trans fat. Therefore, she could not have been said to have bargained for a product that was free of trans fat, nor, given the “firmly established” risk of trans fat at the time of her purchase, could she have been said to have paid more than the product was worth. The Court also rejected her arguments regarding her alleged past physical injury and prospective risk of physical injury from exposure to trans fat as speculative and unsupported by the evidence, in particular in light of the small quantities of trans fat that she alleged she consumed from the popcorn.
  • Keller and Heckman will continue to monitor and report on developments in food litigation.

 

  • Our blog discussed the filing on August 9, 2020 of a class action lawsuit alleging the marketing of “Carrot Cake Mini-Donuts” violates various New York consumer protection laws.  Specifically, the plaintiff alleged a qualifying term is prescribed by FDA’s flavoring regulation (e.g. “flavored, naturally flavored, artificially flavored”) and that the absence of a qualifier led consumers to expect the product to contain real carrots, whereas, based on the ingredient statement’s disclosure of “natural and artificial flavor,” without listing carrots, it was apparent that the product did not contain any real carrots.
  • As reported by Law360 (subscription required), Hostess Brands, LLC and Hostess Brands, Inc. (Hostess Brands) argued, in a motion to dismiss on December 1, 2020, that “carrot cake” refers to the taste of the donuts, rather than the presence of carrots as an ingredient, and that the absence of carrots in the ingredient statement, along with there being no picture of carrots on the label, shows there are no actual carrots in the pastries.  The defendants further argued that claims of deception due to the absence of a disclaimer in the product name are undermined by the plaintiff’s admission of having begun purchasing the donuts before a “naturally and artificially flavored” disclaimer was temporarily removed for a brief period in 2020.
  • It is not clear whether the defendants concede that a disclaimer is required by the Federal Food, Drug, and Cosmetic Act’s (FDCA) food labeling requirements since their brief to the court did not directly address this aspect of the plaintiff’s allegations.  Keller & Heckman will continue to monitor and provide updates regarding food flavoring class-action litigation.
  • On December 1, 2020, the United States District Court Northern District of California granted Westbrae Natural, Inc.’s (“Defendant”) motion to dismiss the plaintiff’s lawsuit.  In the complaint, the plaintiff alleged that the use of the word “vanilla” on the label of Defendant’s organic unsweetened vanilla soymilk misrepresents to consumers that the soymilk’s vanilla flavor is derived exclusively from the vanilla bean plant.  The plaintiff also claimed that the soymilk is made with no or negligible amounts of natural vanilla and should be labeled “artificially flavored.”
  • In the motion to dismiss, Defendant argued that the plaintiff failed to allege that a reasonable consumer would be deceived by the “vanilla” label into believing that the soymilk’s vanilla flavor is derived exclusively from the vanilla bean.  The court agreed with the Defendant and stated that the “label does not contain any other words or pictures that suggest the vanilla flavor is derived exclusively from the vanilla bean.”
  • As support for his allegations, the plaintiff presented a 2020 survey in the complaint, which allegedly showed that 69.5% of 400 consumers believed that the “vanilla” representation on the label meant that the soymilk’s flavor comes exclusively from the vanilla bean.  The court stated that the results of the 2020 survey do not make plaintiff’s claims plausible and that a survey, alone, does not satisfy the reasonable consumer test.  The court gave plaintiff 20 days to refile his complaint to address its shortcomings.
  • This lawsuit follows several lawsuits filed in 2020 where plaintiffs accused businesses of misrepresenting the vanilla flavoring in multiple food and beverage products.  We will continue to monitor any developments.
  • On November 30, 2020, plaintiffs filed the latest in a series of consumer class actions against coffee companies alleging false and deceptive advertising.  The complaint, filed in the U.S. District Court for the Northeastern District of Illinois against The Folger Coffee Company (“Folgers”) and its parent, The J.M. Smucker Company, alleges that Folgers overstates the number of cups of coffee its ground coffee canisters will yield, causing economic injury to the class members.
  • The complaint asserts Folgers carried out a “classic and unlawful bait-and-switch scheme that causes unsuspecting consumers to spend more money for less than the advertised amount of coffee they believe they are purchasing,” violating state consumer protection laws and the Magnuson-Moss Warranty Act.  Pointing to a 30.5-ounce canister of Folgers Classic Roast as an example, the complaint explains that while the product’s label says it yields 240 6-ounce servings of coffee,  the product only has enough ground coffee to produce approximately 173 6-ounce servings when following the instructions on the label.
  • This lawsuit is the latest of several class actions based on similar facts filed in the last year against Folgers and other coffee companies.  A class action against distributors of Great Value, Food Lion, Hannaford, Market Pantry, and other ground coffee brands settled in July 2020.  Carlson Lynch, LLP, the firm representing consumers in the action discussed above, has represented plaintiffs in at least three similar class actions. Two of these have since been voluntarily dismissed without prejudice (a May 2020 suit against Folgers and an August 2020 suit against Walmart, both filed in the U.S. District Court for the Southern District of California).  A third suit in the Western District of Pennsylvania against Kraft Heinz for its Maxwell House brand has been stayed until January 2021 to allow time to settle.  Kraft Heinz faced a separate July 2020 class action in Florida state court that has since been transferred to federal court.  Krogers also faces a suit in the Central District of California.  We will continue to monitor any developments.
  • On December 1, the FDA published an updated guidance that explains how to comply with FDA’s requirement to provide a Unique Facility Identifier (UFI) recognized as acceptable by FDA when submitting a food facility registration or renewal. The guidance also provides information on what to do if a facility is unable to timely obtain a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number prior to the end of the biennial renewal period on December 31, 2020.
  • As a reminder, beginning October 1, 2020, a facility’s UFI must be submitted with the registration information. 21 CFR 1.232(a)(2). The UFI will be used to verify that the facility-specific address associated with the UFI is the same address associated with the facility’s registration. To date, the FDA recognizes the DUNS number as an acceptable UFI.
  • According to the guidance, in order to address stakeholder concerns, FDA intends to allow registrants who anticipate that they will be temporarily unable to provide a DUNS number with their registration or renewal to enter “PENDING” in the UFI field of their registration. This temporary entry will allow for registrations and renewals to be submitted even if the registrant has not yet provided a DUNS number. Upon submission, the registrant will have 90 calendar days to update their registration with their DUNS number. Failure to update the registration with a valid DUNS number within 90 calendar days will result in cancellation of the registration.
  • As our readers know, domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with FDA. Registered facilities are required to renew the registrations by December 31, every even-numbered year commencing with 2012.
  • A class action lawsuit filed in the U.S. District Court for the District of New Mexico against Diestel Turkey Ranch alleges that much of the advertising of its turkeys is false and designed to mislead consumers into purchasing products that they believe are sourced from animals that have been raised with the highest standards of care.
  • In particular, Defendant’s turkey products, which are sold at major retailers such as Whole Foods, are marketed to provide consumers the comfort of knowing that the products are sourced from turkeys that are raised humanely in open pasture on a small family run ranch in the Sonora, California region. For example, among other representations, Diestel advertises its products as “[t]houghtfully raised on sustainable family farms with plenty of fresh air and space to roam” and as raised under the welfare standards of the Global Animal Partnership (GAP) Welfare Certified Program.
  • Plaintiff alleges that, in stark contrast to these representations, the vast majority of turkeys are raised in abysmal conditions at factory farm operations outside of California. And, while some of Defendant’s products are in fact certified under the highest GAP standard (< 1%), Plaintiff notes that the GAP auditors visit every 15 months and the turkey life cycle is only 4 months, so many flocks sold as GAP were never visited by a third-party auditor. Further, Plaintiff also notes that while USDA-FSIS reviews and requires some substantiation for animal raising claims, it does not independently verify claims through on-site inspections and, as a result, many such labels contain inaccurate statements.
  • The lawsuit follows several years after the Washington Post and the Wall Street Journal reported on abuses at Diestal Turkey Ranch farms and a month after a similar lawsuit was filed in the U.S. District Court for the Northern District of California.

 

  • Our readers may recall that a lawsuit filed June 26, 2020 against The Hain Celestial Group, involving Organic Plus Vanilla Soy Milk, avoided some of the pleading issues that doomed some of the numerous class action lawsuits, filed mostly by a single firm, involving other products that are claimed to contain deceptive and misleading information on their labels regarding vanilla.  Plaintiffs alleged that the disclosure of “Vanilla Flavor With Other Natural Flavors” in the soy milk’s ingredient list indicated that the product contained non-vanilla flavor and that this non-vanilla flavor contained vanillin.  The plaintiffs also alleged that because vanilla is governed by standards of identity (see 21 CFR 169.175 (“Vanilla extract); 21 CFR 169.177 (“Vanilla flavoring”)), the general flavoring rules of 21 CFR 101.22, including the designation of “with other natural flavors,” do not apply and any non-vanilla flavor must be disclosed as an artificial flavor.
  • A November 23, 2020 memorandum filed in support of The Hain Celestial Group’s motion to dismiss, (subscription to Law360 required), characterizes the plaintiffs’ case as one of “over 91 other lawsuits their counsel have filed against producers of vanilla-containing products” and asserts they are attempting to “hold-up” food companies for expensive settlements based on what “they believe is a technical violation of FDA flavoring regulations.”  In addition to arguing that the plaintiffs’ false advertising claims are preempted to the extent they assert that the product labeling does not comply with the Federal Food, Drug, and Cosmetic Act’s (FDCA) food labeling requirements and is, therefore, automatically deceptive, the defendant’s memorandum directly attacks the plaintiffs’ conclusion that “vanilla” in the product name violates FDA’s food labeling regulations, arguing that under FDA’s regulations, the statement of identity in the product’s name is “Soymilk” and “Vanilla” is a flavor designation, not subject to the standards of identity cited by the plaintiffs.
  • It is yet to be seen whether the New York federal court hearing this case will reach the issue of whether the soy milk labeling complies with the FDCA and FDA’s characterizing flavor regulations.  FDA has not issued any warning letters that would clarify the matter of product labeling involving vanilla.  Keller & Heckman will continue to monitor and provide updates regarding vanilla products and other class-action litigation in the food industry.