• The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the FDA Safety and Landmark Advancements Act of 2022 (FDASLA) to introduce policies in response to the infant formula crisis. Sen. Patty Murray (D-WA), who chairs the HELP committee, introduced the bill in May.
  • The HELP Committee added sections 909 and 910 to address the breakdowns that led to a nationwide shortage of infant formula. Specifically, section 909 would require FDA to report to Congress on its mailroom policies and procedures, including quarterly reports on how the agency handles common carrier packages and correspondence. Section 910 would introduce a long list of requirements, including requiring FDA to monitor infant formula manufacturers more closely, increase the resiliency of the formula supply chain, work with other countries to “harmonize regulatory requirements” for formula, and provide flexibility in the infant formula premarket submission process during supply chain disruptions.
  • The formula shortage occurred due to food safety concerns that shut down a formula production plant in mid-February. The plant reopened June 4, but the shortage is expected to continue into the summer.
  • Keller and Heckman will continue to monitor this legislation.
  • On June, 6 2022, FDA released an online resource page for human and animal food producers who may be affected by flooding and severe weather incidents.  It identifies federal and state resources available to those who may be harvesting, mixing, storing, or distributing grains and other foods.
  • For example, FDA highlights that crops harvested from flood waters may be contaminated and unacceptable for consumption, as flood waters may contain sewage, pathogenic organisms, and chemical waste.  In addition, a concern for flood-impacted crops includes mold growth and the potential for the development of mycotoxins that have the potential to remain in the food throughout the production process and can cause serious illness or death when consumed by animals or humans.
  • FDA notes that some crops that are unsuitable for human use may be salvaged for animal food. FDA considers reconditioning requests on a case-by-case basis. FDA’s compliance policy guide for reconditioning requests can be found here.
  • A proposed consumer class action lawsuit was filed against Beyond Meat, Inc. on June 10, alleging that the plant-based meat manufacturer embellished the amount of protein contained in its line of plant-based sausages, breakfast patties, meatballs, ground beef, and chicken products. [Subscription to Law360 required].
  • In the complaint, plaintiff Mary Yoon alleges that Beyond Meat falsely labels and advertises its products as providing “equal or superior protein” to animal-derived meat. Her claim is based on the fact that “two different U.S. laboratories have independently and separately conducted testing on a wide range of Beyond Meat products. The test results were consistent with each other: the results of both tests show that Beyond Meat products contain significantly less protein than what is stated on the product packaging.”
  • Plaintiff Yoon alleges that Beyond Meat’s quantitative declaration of protein and percent Daily Value (%DV) are false and misleading because the quantitative amount was calculated using the nitrogen method. According to the complaint, “the nitrogen method is not the most accurate way to describe protein content” and that “[b]y law, Beyond Meat is required to use the PDCAAS calculation for the products rather than some other less-sophisticated method.”
  • In opposition to plaintiff Yoon’s claims, 21 CFR 101.9(c)(7) specifically provides for two different methods to determine protein values, including the nitrogen method. The FDA recently issued a clarifying Q&A supporting the use of either method to calculate protein content (i.e., nitrogen or PDCAAS), but noted that manufacturers are still obligated to include a %DV when protein claims are made and that %DV should be adjusted for protein quality.
  • Keller and Heckman will continue to monitor this litigation, as well as other protein related lawsuits.
  •  As many of our readers (and fellow peanut butter consumers) are likely aware, on May 20th J.M. Smucker Co. issued a voluntary recall of its JIF peanut butter products due to potential Salmonella contamination linked to a manufacturing facility in Lexington, Kentucky.
  • Class-action lawyers wasted no time in holding J.M. Smucker accountable and at least two class-actions have been filed against the company alleging various causes of action, including negligence and breach of warranties, for actions resulting in the production of potentially contaminated product that was sold to plaintiffs and other similarly situated consumers. The law firm of Akim represents the Plaintiff in both lawsuits and the complaints are substantially similar to one another.
  • The recall is still being investigated by FDA, CDC, and other state partners. It presents a particularly interesting question of legal liability since the Salmonella strain associated with illness in the current outbreak is the same one which was found in an environmental sample during a 2010 FDA inspection. Keller and Heckman will continue to monitor this litigation and the results of the outbreak investigation.
  •  Mark McAfee, a dairy farmer who wishes to sell raw, unpasteurized butter beyond his home state of California, and a co-plaintiff, the Farm-to-Consumer Legal Defense Fund, appealed FDA’s February 27, 2020 denial of McAfee’s 2016 citizen petition for a rulemaking by FDA to exclude butter from the requirement under 21 CFR 1240.61 that “milk products” in interstate commerce must be pasteurized.
  • In a June 10, 2022 opinion, No. 21-5170, the U.S. Court of Appeals for the District of Columbia Circuit upheld a lower court’s decision against the plaintiffs, rejecting McAfee’s argument on appeal that a rulemaking is necessary because FDA’s regulation banning interstate sale of raw butter violates the statutory definition of butter, fully agreeing with the district court and finding the challenge meritless.  By way of background, in a May 24, 2021 Memorandum Opinion, the U.S. District Court for the District of Columbia found that the raw butter ban was a “straightforward” exercise of FDA’s authority under the Public Health Service Act (PHSA), which gives FDA broad authority “to make . . . regulations . . . necessary to prevent the introduction, transmission, or spread of communicable diseases,” and that requiring butter to be pasteurized to eradicate disease-causing pathogens poses no conflict with the standard of identity of butter, which is defined in the Food, Drug, and Cosmetic Act (FDCA) in terms of permitted ingredients and milk fat content, but without mention of pasteurization.  The district court also rejected McAfee’s arbitrary-and-capricious challenges, finding that FDA presented a “great deal of scientific evidence” in support of its judgment that raw butter presents a food safety risk.
  • This ruling in the McAfee case does not impact intrastate sales of raw, unpasteurized milk products, including butter, in the states where this is permitted.  Further, in its February 2022 guidance on Food Safety and Raw Milk, while urging consumers to understand the health risks involved, FDA affirmed that it does not intend to take enforcement action against an individual who purchased and transported raw milk across state lines solely for his or her own personal consumption.
  • The United States District Court of the Eastern District of New York received a class action complaint on May 31, 2022 regarding the usage of the term “natural” in Nordic Naturals’ dietary supplement products. Plaintiffs allege that use of “natural” for said products constitutes false advertising as the products contain synthetic ingredients, including but not limited to gelatin, soy lecithin, riboflavin, citric acid, and more. Plaintiffs argue that knowledge of the synthetic nature of the ingredients would require “a scientific investigation” beyond the knowledge of the reasonable consumer and that the average consumer would have a reasonable expectation that the dietary supplement products contained only natural ingredients.
  • “Natural” claims in food and dietary supplement labeling have often been a target for class action litigation. Our site has previously covered “natural” cases involving the term’s usage to describe lunch meats and bacon, apple sauce, vanilla flavoring in soy milk, and other products.
  • While FDA has never formally defined “natural” by regulation, the Agency has traditionally taken the position that term means 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 to be in that food.” In response to several citizen petitions, as well as references in various Federal Court decisions requesting that the agency provide more formal guidance in this regard, FDA requested comments on the use of the term “natural” on food labeling in 2015.  The Agency received over 7,000 comments but has taken no formal action since the close of the comment period in May of 2016. Keller and Heckman will continue to monitor this case, as well as further action by FDA for any developments.
  • As previously reported, in January 2021 California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed limits on the use of the Proposition 65 short-form version of the safe harbor warning. The short-form warning became an option in 2016 and does not require manufacturers to disclose the chemical name(s) in the warning. OEHHA sought to limit the short-form warning by proposing various changes, including limiting the circumstances under which the short-form warning can be used and requiring the name of at least one chemical per relevant toxicity endpoint. In December 2021, OEHHA modified the short-form warning proposal as a result of comments it had received. The proposed modifications broadened the circumstances under which the short-form warning could be used and provided additional warning language.
  • On May 20, 2022, OEHHA announced that it would allow the rulemaking on the short-form warning to lapse. Under the Administrative Procedure Act, a rulemaking must be completed within one year of the date it was first noticed to the public. This period was temporarily extended due to the COVID-19 pandemic, but OEHHA was still unable to complete the rulemaking process in the allotted time.
  • OEHHA has stated that it intends to restart the rulemaking process within the next several weeks. We will continue to monitor any developments.
  • On June 6, consumer interest advocacy groups and various organic farmers, including the Center for Food Safety (CFS) and Swanton Berry Farms, Inc., filed an appellants’ reply brief against the USDA’s request that the Ninth Circuit uphold a California federal judge’s finding that it may continue to allow hydroponic growers to label their goods as “organic.” [Subscription to Law360 required]
  • As background, in 2019, 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 petition. As a result, the group of consumer interest advocates and organic farmers sued the USDA in district court, claiming organic certification of hydroponic operations that do not work with soil is prohibited under the Organic Foods Production Act (OFPA). The district court rejected the plaintiffs’ challenge, and CFS appealed the decision to the Ninth Circuit. Summaries of the suit can be found here, here, and here.
  • In the 40-page reply brief, CFS argues that the USDA took an “unreasonable interpretation” of the OFPA and disregarded requirements that all organic crop production foster soil fertility. CFS further alleges that accepting the USDA’s interpretation of the OFPA undermines Congress’ intent and that finding in favor of the USDA would set precedent and allow the Agency to “chip away and/or eliminate OFPA’s other prohibitions and restrictions on organic crop production.”
  • A hearing on the appeal is scheduled to be held before a three-judge panel in San Francisco on July 27. Keller and Heckman will continue to monitor and provide updates on this lawsuit.
  • The White House Office of Management and Budget (OMB) received FDA’s proposed guidance on “Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements” on March 31, 2022. The draft guidance, which has not been publicly released, comes several years after the FDA requested comments from the public regarding the labeling of plant-based dairy alternatives and the standards of identity for dairy products.
  • In response, a group of bi-partisan lawmakers has sent a letter to OMB which urges the agency to reject the draft guidance to the extent that it “asks plant-based milk to identity differences without doing the same for animal milk.” For example, it would appear that the lawmakers would object to a guidance that adopted (to any degree) the Center for Science in the Public Interest’s suggestion that non-nutritionally equivalent plant-based dairy products bear a front-of-pack labeling disclosure or the National Milk Producers Association’s petition requesting “imitation” labeling for nutritionally inferior dairy alternatives. Notably, the lawmakers’ letter appears to take as a given that non-dairy alternatives will include qualifying plant-based terms (e.g., soymilk) and cites to a 9th Circuit decision which held that such qualifiers mitigated concerns about consumer confusion.
  • The last several years have included legal actions at all levels including in the courts (see e.g., above-cited 9th Circuit decision and Mikoyo’s vegan butter decision), in state legislatures (see e.g., Virginia and Wisconsin), and in Congress (see Dairy Pride Act). Whether FDA action, including issuance of the draft guidance, will resolve these issues or simply prompt further litigation and/or Congressional action remains to be seen. We are not aware of any timetable for OMB’s review, but we will continue to monitor and report on the guidance and related issues, which are of vital importance to many of our clients.

 Kellogg Escapes Class Action Over Fudge Ingredients (Law360 Subscription Required)

  • We reported on three substantively identical class action lawsuits filed in district courts in Illinois that allege products containing vegetable oils in place of dairy fats (i.e., butter and/or milk) are falsely and misleadingly described as “fudge.”  The lawsuits, which are all filed by Sheehan & Associates, P.C., target Kellogg Sales Company’s “Frosted Chocolate Fudge Pop-Tarts,” Bimbo Bakeries USA, Inc.’s “Chocolate Fudge Iced Cake,” and the Hershey Company’s “Hot Fudge.”  Fudge is not the subject of a formal standard of identity under FDA regulations.
  • On June 2, 2022, the claim under the Illinois Consumer Fraud and Deceptive Business Practices Act (ICFA), as well as claims of breach of warranty, negligent misrepresentation, fraud, and unjust enrichment against Kellogg were dismissed.  The judge found that the lead plaintiff failed to back the assertion that an average consumer would expect a fudge ingredient to contain milk fat.  While the plaintiff provided some evidence that credible third parties believe that milkfat is the central component of fudge, Molly Mills, an authority put forward to support the plaintiff’s interpretation, actually included numerous recipes that do not include milkfat in her book of fudge recipes.  While the plaintiff was granted 14 days to amend the complaint, the judge noted that in a similar, heavily cited Strawberry Pop-Tarts case (discussed here), which was also dismissed without prejudice, the plaintiff chose not to pursue the claims.
  • While no decision has been reported yet in the other “fudge” class action lawsuits, the outcome in favor of Kellogg indicates that for a case like this to ultimately succeed, where an ingredient name can be said to merely designate the flavor or taste of the product at issue, the plaintiff will most likely need to provide a well-designed market study as extrinsic evidence of consumer deception.