• In November 2021, we reported on the dismissal of a case against Pepperidge Farm Inc. in the Southern District of New York. A similar case was filed against Pepperidge Farm Inc. on May 31, 2021, in the Southern District of Illinois.
  • In both cases, the plaintiff alleged that the product name “Golden Butter” crackers was deceptive because, though the crackers contained butter, they also included vegetable oils.  The plaintiff in the Illinois case also alleged that the vegetable oil enhanced the golden appearance of the product and that this was misleading as consumers expect the butter alone to provide the crackers’ golden hue.
  • On January 24, 2022, the court dismissed the Illinois case against Pepperidge Farm, holding that reasonable consumers were not likely to be misled. The court noted that the crackers contained butter as the second ingredient on the product label; thus, the use of “butter” in the name was descriptive and not false or misleading. Further, the court noted that the crackers were golden in color; thus, the word “golden” was also descriptive and not misleading.
  • On February 26, an Illinois resident, Rabia Hamidani, filed a proposed class action complaint against Bimbo Bakehouse LLC alleging the bakery manufacturer of selling misleadingly labeled Cheesecake Factory-branded bread (subscription to Law360 required). Specifically, Hamidani alleged the bread and bread label deceived buyers into believing the bread was healthier and contained more whole grains than it actually did based on the bread’s brown hue, a crust with visible grain pieces, and the claim “no artificial preservatives or flavors” declared on the label’s principal display panel.
  • According to the complaint, bran gives whole grain products a distinctive brown coloring, whereas refined grains are white in color. Hamidani argued that the brown color of the Cheesecake Factory-branded bread came from dried molasses and caramel color, and not whole grains, given that enriched wheat flour was the most predominant ingredient and whole wheat flour was third. Further, it was asserted that the product’s name “Brown Bread” “takes advantage of consumer assumptions and beliefs about the darker color of whole grain products.”
  • Hamidani argued that consumers increasingly prefer whole grain products because they are nutritionally superior to non-whole grain products. She further stated that the product’s appearance and name misled consumers into believing the bread was more nutrient-dense than similar products, and caused consumers to pay a premium for the “Brown Bread.”
  • Hamidani argued the company violated the Illinois Consumer Fraud and Deceptive Business Practices Act through false and misleading statements and omissions regarding the “absolute and relative amount of whole grains compared to refined grains” within the product. She also claimed negligent misrepresentation, fraud, and unjust enrichment, among others. Keller and Heckman will continue to monitor any developments in this litigation.
  • On February 24, 2022, FDA released PFAS test results from samples that were collected for the FY2021 regional collection of the Total Diet Study (a program to monitor nutrients and contaminant levels in foods). 89 of the 92 tested food samples had no detectable levels of PFAS and, while PFAS was found in three seafood samples (tilapia, cod, and shrimp), given the limited sample size, no conclusions could be drawn about PFAS levels in seafood in the general food supply.
  • PFAS (i.e., per- and polyfluoroalkyl substances) are a diverse group of widely used, long lasting chemicals that do not easily breakdown and can accumulate in the environment and human tissues with potential negative health consequences. They are authorized for certain food contact uses by FDA, although FDA and industry have agreed to voluntarily phase out certain types of PFAS (6:2 FTOH) and a number of states have also passed laws to phase out the use of PFAS.
  • This is the fifth set of general food supply testing conducted by FDA and, of the 532 total samples tested, only 10 have had detectable PFAS. Based on this data, there is currently no evidence that indicates that certain foods should be avoided based on PFAS levels.

Costco Artificial Flavoring Is A Lie, Court Told (Law360 Subscription Required)

  • A federal class action complaint, filed September 3, 2021, alleges the words “black raspberry flavor” and pictures of black raspberries on the label, together with the dark red color of the beverage render the omission of “artificially flavored” deceptive on Costco’s label for Kirkland brand carbonated, flavored water drink.  In a January 24, 2022 motion to dismiss, Costco disputes the plaintiff’s allegations of noncompliance with FDA’s labeling regulations, highlights that the product does not contain any express “no artificial” claims, and argues that any reasonable consumer understands “black raspberry” as a flavor designator, not an ingredient claim, and could not make any reasonable assumptions based on the use of coloring about the amount of any ingredient that is present in the product.
  • In a memorandum filed on February 23, 2022, the plaintiff opposes Costco’s motion to dismiss by reasserting allegations of noncompliance with food labeling laws and arguing that where the use of natural flavors in such a product is plausible, as evidenced by other products on the market, it is not unreasonable for consumers to assume that the Kirkland carbonated, flavored water would not contain artificial flavoring and would have more black raspberry ingredients than it does.  The memorandum also notes that Costco did not present evidence that “malic acid,” an ingredient which the plaintiff’s testing demonstrates is D-malic acid, a non-naturally occurring isomer, is used only to control pH, rather than to mimic the tart taste of raspberries.  The plaintiff additionally distinguishes “raspberry flavor” from “raspberry flavored,” arguing that the former phrase was used on the label for the purpose of misleading consumers with respect to the artificial nature of the flavor ingredients.
  • While no extrinsic evidence of consumer deception has been offered, this is not necessarily required to survive a motion to dismiss under a permissive plausibility standard.  Keller and Heckman will continue to monitor any developments in this litigation.
  • On February 16, 2022, the Food Safety and Inspection Service (FSIS) published its proposed pathogen reduction performance standards to address Salmonella in raw comminuted pork and raw pork cuts.
  • FSIS notes that there have been several outbreaks of Salmonella attributed to pork, suggesting that raw pork is a continuing health concern. Since 2013, FSIS has committed to a 25% reduction in annual cases of salmonellosis attributed to the products it regulates.
  • The agency is proposing two pathogen reduction standards – one for raw comminuted pork and another for intact and non-intact raw pork cuts, as sampling suggests that the two classes differ in Salmonella contamination. FSIS intends to collect and analyze 52 samples per year for each establishment that is subject to the performance standards. Beginning one year after the standards are finalized, FSIS will post each establishment’s performance category based on the most recent 52 Salmonella sample results.
  • FSIS is seeking input on the proposed standards and will accept comments until April 18, 2022.
  • On February 16, New York Attorney General Letitia James issued a demand letter to HolleUSA to stop making false or misleading claims about their baby food products. The demand letter specifically alleges that HolleUSA has been offering for sale various baby foods that are marketed as having “[n]o detectable traces of heavy metals” and as being “lead free.” However, the Office of the Attorney General (OAG) tested several products and found that they do, in fact, contain detectable levels of heavy metals, such as lead, cadmium, and arsenic.
  • The letter orders the removal of all false and misleading claims relating to the products being free of heavy metals from the website, sales materials, and virtual store fronts. It applies to both explicit statements (e.g., “lead free”) as well as any labels or graphics that imply a product is lead free (e.g., “Pb” with a line through it).
  • In terms of federal regulatory requirements, the FDA has not established any lead, arsenic, or cadmium limits for virtually any category of baby food products. However, the FDA’s Closer to Zero action plan, which was published in response to the February 2021 Congressional report on the level of heavy metals in baby foods, will propose action levels aimed at reducing exposure to toxic elements in foods. Notably, the levels of heavy metals that were detected by the OAG in the HolleUSA products did not exceed the EU standards, which is where the brand is based.
  • In a press release announcing the demand letter, Attorney General James stated that “New York parents should never have to second guess the safety of the products meant for their children. […] These false or misleading claims prey upon parents’ concerns about the continuing problem of toxic heavy metals in their children’s food, and they must end. We will continue to hold accountable any company that misrepresents its products to New York consumers.”

USDA Asks 9th Circ. To Affirm ‘Organic’ Hydroponics Label – [ 1465000-1465037-https-ecf-ca9-uscourts-gov-n-beam-servlet-transportroom-servlet-showdoc-009033262160.pdf]

  • The U.S. Department of Agriculture (USDA) has asked the Ninth Circuit to uphold a California federal judge’s finding that it may continue to permit hydroponic growers to label their products as “organic,” assuming that they meet relevant USDA requirements for “organic” certification.   In 2019, the Center for Food Safety (CFS) submitted a petition to USDA for a proposed rulemaking that would exclude hydroponic produce from “organic” certification because the products are not grown in soil. USDA denied the 2019 petition, stating that the Agency’s practices fully comply with the federal Organic Foods Production Act (OFPA), which doesn’t explicitly prohibit certification of hydroponically grown food.
  • In 2020, a group of consumer interest advocates, including CFS and traditional organic farmers, sued USDA in the Federal District Court for the Northern District of California, claiming that organic certification of hydroponic operations that do not work with or build soil is prohibited under OFPA. The US Court held that USDA could continue with the practice of allowing hydroponic growers to be certified and label their products “organic.” CFS has appealed the Ninth Circuit decision, arguing that, “[t]he Organic Foods Production Act (OFPA)’s language is plain and mandatory: organic crop producers ‘shall . . . foster soil fertility, primarily through the management of the organic content of the soil through proper tillage, crop rotation, and manuring.’ 7 U.S.C. § 6513(b).”
  • USDA counters that the statute does not clearly proscribe the organic certification of hydroponic crop production, noting that, “[t]here is no reason to conclude, and certainly no reason the department was required to conclude, that Congress forbade the organic certification of an entire category of crop production in that roundabout way.”  USDA posits that the soil requirement outlined in the CFS appeal is naturally read to apply to producers that do use soil in growing crops, not limiting organic certification and labeling to crops that are grown in soil.  As a result, USDA has requested that the Ninth Circuit affirm the District Courts decision that the Agency may continue to allow hydroponic growers to label hydroponically grown food as organic, assuming that the other OFPA requirements are met.
  • Keller and Heckman will continue to monitor this and similar issues.
  • On February 17, 2022, the U.S. District Court of the Southern District of New York dismissed a lawsuit against Mars Wrigley Confectionery US, LLC (Mars) which alleged that Mars’ chocolate-coated vanilla ice cream bars (called Dove bars) deceived consumers by including vegetable oils in the bars while also making representations regarding the milk chocolate content of the bars.
  • Specifically, the labels of Dove bars stated that they were “made with milk chocolate” and that the vanilla ice cream had been dipped in milk chocolate. Plaintiff alleged that, based on these representations, consumers would not expect the product to contain “lower quality chocolate substitutes” such as coconut oil and palm oil.
  • The court dismissed these allegations as conflating the content of the milk chocolate ingredient with the content of the milk chocolate coating. As disclosed on the ingredient list, the predominant ingredient in the Dove bars was milk chocolate made with cocoa butter, and it was the chocolate coating, not the milk chocolate itself, which contained the vegetable oils. Nothing in the product labeling, including the “made with milk chocolate representation” indicated to a consumer that the product was made exclusively with milk chocolate and there was also no indication that the vegetable oils had been used to replace cocoa butter in the milk chocolate.
  • As previously reported, the Environmental Protection Agency (EPA) published a final rule on August 30, 2021 that revoked all tolerances for the pesticide chemical chlorpyrifos on raw agricultural commodities; the rulemaking was driven by toxicity concerns, primarily concerning exposure in children. The tolerances are set to expire on February 28, 2022, effectively banning the use of chlorpyrifos on food crops. In light of the expiration, FDA published a guidance document to assist food producers and processors that handle foods which may contain chlorpyrifos restudies.
  • In October of 2021, agriculture stakeholders submitted formal written objections and a request to stay the tolerance revocations to EPA. More than 80 stakeholders signed the document, arguing that significant harms would result from banning chlorpyrifos and urging the agency to stay implementation of the rule until objections were formally addressed by EPA.
  • Agriculture stakeholder groups are now seeking a court injunction against EPA’s ban on chlorpyrifos. On February 10, 2022, agricultural trade groups representing thousands of members filed a lawsuit against EPA before the Eight Circuit Court of Appeals, alleging that the agency ignored its own scientific findings regarding 11 high-benefit and low-risk crop uses for chlorpyrifos and that the revocation will cause irreparable damage. It remains to be seen how EPA will respond to the lawsuit.
  • For a comprehensive overview of the applicable statutory and regulatory framework for foods, check out our Practical Food Law Seminar happening in San Francisco on May 3–5, 2022.
  • On February 15, the U.S. Senate confirmed Dr. Robert M. Califf as Commissioner of the Food and Drug Administration. As our readers know, Dr. Califf is internationally recognized as an expert in clinical trial research, health disparities, healthcare quality, and cardiovascular medicine, and also served as the FDA Commissioner under former President Barack Obama from February 2016 until January 2017.
  • During a December 14 hearing, Dr. Califf stated that his top priority would be the ongoing COVID-19 pandemic and the agency’s preparation for future outbreaks: “The FDA must continue to be a strong partner in battling COVID-19, taking into account lessons learned from the pandemic so we can apply them to the ongoing current pandemic, and so we are ready for the next one.”
  • Dr. Califf will replace Dr. Janet Woodcock, who has been serving as the Acting FDA Commissioner since January 20, 2021. In a statement posted to Twitter following Dr. Califf’s confirmation, Dr. Woodock stated she will become Principal Deputy Commissioner, essentially FDA’s second-in-command.
  • President Biden nominated Dr. Califf in November 2021, and was expected to have a swift confirmation process based on the bipartisan support he received in 2016. However, Dr. Califf’s nomination faced significant opposition, as evidenced by the narrow confirmation vote of 50-to-46, largely due to Dr. Califf’s prior work with the pharmaceutical industry.