• Spencer Sheehan is an extraordinarily prolific plaintiff’s lawyer who works primarily in the food space. By his own count, he filed 440 class actions between 2020 and spring 2023. He monopolized the field of filing lawsuits against vanilla flavored products for a period, and was the subject of an NPR profile featuring his suit against Strawberry Pop-Tarts (alleging that they were mostly apple and pear) as well as other high-profile articles.
  • As one judge in the Northern District of Illinois put it in May, Sheehan has a habit of pushing the same legal theories “time and again, in case after case, without much success.” The judge admonished Sheehan that his “losing streak should tell you something” and ordered him to file a spreadsheet showing every case he had filed based on a similar legal theory since 2020. Finally, noting the significant amounts of attorney’s fees Sheehan had caused companies to run up with his frivolous filings, the judge ordered Sheehan to show cause why he should not have to pay the defendant’s legal fees. The court has not taken any further action in the case since.
  • Instead, in July, the Northern District of New York noted frivolous cases filed by Sheehan in that district, in addition to two admonitions directed at him by judges in the Southern District of New York concerning the same conduct. In addition to the court’s allegations, Sheehan also had to face an amicus filing by another company he had targeted. According to that filing, Sheehan had responded to the company’s threats of a sanctions motion by saying, “So go file your rule 11 motion I hear such sanctions threats from people like you all day long.” The court issued its order holding him in contempt last week, but reserved decision on the nature of the final sanctions Sheehan will face.
  • Keller and Heckman will continue to follow and be available to assist with defending against class actions in the food and packaging space.
  • As a direct response to California’s Proposition 12, Missouri Senator Josh Hawley has introduced the Protecting Interstate Commerce for Livestock Producers Act with the goal of protecting farmers from state regulations that some critics have claimed will hurt their business and drive up costs for consumers.
  • As we have previously blogged, the U.S. Supreme Court in May upheld California’s Proposition 12, which requires that eggs, veal and pork products sold in California must be from animals raised in enclosures meeting certain minimum size requirements, regardless of where the animals were raised. It is estimated that California accounts for 13% of all pork consumption in the US.
  • Senator Hawley’s bill aims to “protect family farms from going bankrupt and consumers from shouldering higher costs at the grocery store,” according to the senator’s press release.  He states that, “Missouri’s livestock producers keep food on the table across America and they shouldn’t be burdened by costly laws – made by other states – that disrupt interstate commerce, drive-up costs, and impose crippling regulations.”
  • To ensure that no state can mandate animal welfare standards in another state, the bill proposes to accomplish the following:
    • Preempt states and local governments from regulating the raising, production, and importation of livestock or livestock-derived good from another state or local government;
    • Allow states to regulate the importation of livestock in the event of animal disease; and
    • Protect farmers from states implementing laws that are preempted by this bill.
  • Keller and Heckman will continue to monitor this bill and will relay any developments.
  • On November 29, 2023, USDA’s Agricultural Marketing Service (AMS) published a final rule updating the National Bioengineered Food Disclosure Standard’s (the Standard) List of Bioengineered (BE) Foods (the List) by adding “sugarcane (Bt insect-resistant varieties)” and amending “squash (summer)” to “squash (summer, coat protein-mediated virus-resistant varieties).”
  • AMS is required to review the List on an annual basis. We have previously blogged about earlier versions of these proposed updates to the List (in the form of a request for comments and a proposed rule) and the final form of these updates includes more precise descriptions which is intended to capture only BE foods.
  • The presence a food ingredient on the List (or an ingredient derived from one on the List) in a food establishes a presumption that the food is a BE food requiring a BE disclosure. If a food is on the List, but is not a BE food, then records must be kept rebutting the presumption of its BE status. However, conversely, a food may be a BE food even if it is not on the List, and in all cases a BE disclosure is required if a regulated entity has actual knowledge that a food is BE.
  • The effective date of this final rule is December 29, 2023, but per the Standard, regulated entities have 18 months from the effective date to comply.
  • On November 30, 2023, FDA announced that it had released a third wave of tools and FAQs to inform stakeholders about requirements for the Food Traceability Rule and to help covered entities become compliant with the rule. These new resources are available on FDA’s food traceability webpage.  
  • This update includes a new webpage explaining traceability lot codes, a video highlighting technological components of product tracing systems, example traceability plans, new supply chain examples for deli salads, and information on applying for a waiver or exemption. FDA also added to the FAQ page, with questions and answers now encompassing topics throughout the supply chain, including packing and shipping, farms, retail establishments and restaurants, recordkeeping, importing, and more.  
  • As previously reported, the Rule is one of nine major finalized rules intended to implement the Food Safety Modernization Act to reduce the prevalence of foodborne illness. Issued in November 2022, the Rule is intended to facilitate rapid identification and removal of potentially contaminated food from the market. The new FAQs and tools can help covered entities prepare to meet the requirements by the compliance date of January 20, 2026.
  • The U.S. Food and Drug Administration (FDA) has announced the recall of various stone fruit linked to an outbreak of Listeria monocytogenes.  Specifically, HMC Farms is voluntarily recalling conventional (non-organic) peaches, plums, and nectarines sold in retail stores from May 1, 2022 through November 15, 2022 and from May 1, 2023 through November 15, 2023.  The recalled fruit was sold at retail stores such as Publix, Walmart, Sam’s Club, Sprouts Farmers Market, and Albertsons nationwide in bags or as individual pieces of fruit with PLU stickers, under multiple brand names.
  • Additionally, the recalled fruit was sold to other manufacturers who may have frozen and/or relabeled the recalled fruit for resale under another brand.  The recalled fruit is past expiration and no longer available for sale in retail stores, but could have been frozen by consumers.
  • Symptoms of Listeriosis (Listeria infection) usually start within two weeks after eating food contaminated with Listeria, but may start as early as the same day or as late as ten weeks after.  Mild symptoms may include a fever, muscle aches, nausea, tiredness, and vomiting.  If the more severe form of listeriosis develops, symptoms may include headache, stiff neck, confusion, loss of balance, and convulsions.
  • FDA’s investigation is ongoing to determine the source of contamination and if additional products are linked to illness.
  • FDA and the Center for Disease Control and Prevention (CDC) are also investigating an ongoing Salmonella outbreak linked with recalled cantaloupe products that has caused at least 99 illnesses and two deaths in 32 states.
  • Keller and Heckman will continue to monitor and report significant food safety developments.
  • On November 21, 2023, Senators Edward J Markey and Senator Cory Booker introduced the Ensuring Safe and Toxic-Free Foods Act, which would end the legal entitlement to market foods based on a self-determined generally recognized as safe (GRAS) position and would instead require notification to FDA and provision of supporting information. Currently, the GRAS Notification program is completely voluntary.
  • The bill would also:
    • Require that the notice and supporting information be available on FDA’s website and subject to public comment for 90 days.
    • Prohibit carcinogenic substance from receiving GRAS designation (this is already prohibited by the Federal Food, Drug, and Cosmetic Act).
    • Prohibit substances that show evidence of reproductive or developmental toxicity from receiving GRAS designations.
    • Prohibit people with conflicts of interest from serving as experts in reviewing and evaluating scientific data with regard to GRAS designations.
    • Create a new office within the FDA which would reassess whether existing food additives, food contact substances, color additives, and GRAS substances are safe, and establish a new committee to advise on standards, processes, and methods necessary for reassessment of substances.
  • The full text of the bill does yet appear to be available online, but virtually identical legislation under the same name was introduced in 2022. While the likelihood of passage is uncertain, we will continue to monitor and report on updates to this legislation.
  • On November 22, 2023, FDA released a one-page fact sheet answering questions regarding the redundancy risk management plan requirement in the Food and Drug Omnibus Reform Act of 2022. The fact sheet is intended to provide information to manufacturers of critical foods, which FDA defines as any infant formula or medical food. The redundancy risk management plan requirement was established in response to the 2022 infant formula shortage caused by insanitary conditions at a formula plant that led to a voluntary recall and temporary production stoppage.
  • The fact sheet describes the requirements for a redundancy risk management plan, which every critical food manufacturer is required to develop, maintain, and implement. According to FDA, a risk management plan may identify and evaluate risks to critical foods, as well as mechanisms to mitigate supply chain disruptions. A separate plan is needed for each manufacturing facility, but not for each product that is manufactured within the same facility.
  • Additional safety information for consumers and manufacturers is available on FDA’s infant formula landing page. Keller and Heckman will continue to monitor and report on issues relating to infant formula.
  • On November 17, the FDA updated its Leafy Green STEC Action Plan (LGAP). FDA first released the LGAP in 2020 following recurring outbreaks linked to leafy greens caused by Shiga toxin-producing E. Coli (STEC). 
  • The update provides additional information on sampling assignments, method developments, and a status update on FDA’s long term longitudinal studies in Arizona and California. The Agency also released a new fact sheet: Adjacent and Nearby Land Uses and their impact on the safety of produce grown nearby. 
  • The LGAP is part of the FDA’s yearslong efforts, in collaboration with partners in the public and private sectors, to enhance the safety of leafy greens. Per FDA, this work has included “prioritized inspections, focused sampling, stakeholder engagement and collaboration, data sharing, root cause investigations, and advancements in the science of detection and prevention.”
  • FDA also noted that the Agency intends to discuss their vision for produce safety efforts after the transition to the Human Foods Program in early 2024.

The Daily Intake is taking a break for the Thanksgiving holiday and will return on November 27. We wish you a wonderful Thanksgiving holiday!

  • The Consumer Federation of America (CFA), a non-profit consumer advocate organization, submitted a petition to FDA on November 8, 2023, requesting that the agency amend the flavoring regulation at 21 CFR 101.22 to replace the use of “natural flavor” with “added flavor” or “added flavoring.”
  • Under 21 CFR 101.22, “natural flavor” and “natural flavoring” are those flavors/flavorings derived from natural (i.e., plant or animal) sources. Specifically, the regulation defines these terms to mean “the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.”  Artificial flavors/flavorings are defined inversely; they are flavors which are not derived from these sources.
  • The petition argues that there are often few distinctions between natural and artificial flavors, both of which are frequently highly processed. It also raises questions about the safety and healthfulness of highly processed flavors, including concerns that they may induce overeating.
  • The petition is careful to note that it does not seek to erase the distinction between “artificial” and “natural flavors” and that the proposed revision would still distinguish between the two. Furthermore, a manufacturer seeking to promote the natural quality of its flavor could still use the ingredient’s common or usual name (e.g., mint extract).
  • Keller and Heckman will follow and report on the agency’s response, if any, to this petition. 
  • A salmonella outbreak traced to cantaloupe imported from Mexico has spread through several U.S. states and Canada. As of November 17, 2023, at least 43 people in the U.S. and eight people in Canada had been infected with Salmonella linked to the same cantaloupes. At least 17 of those people required hospitalization.
  • On November 15, 2023, Sofia Produce, LLC issued a recall of all fresh cantaloupes it distributed in packages labeled with the “Malichita” brand between October 16 and 23, 2023. The cantaloupes were distributed directly to Arizona, California, Maryland, New Jersey, Tennessee, Illinois, Michigan, Wisconsin, Texas, Florida, and Canada, and may have reached consumers through retail outlets outside of those areas.
  • The outbreak also includes Vinyard brand pre-cut cantaloupes and ALDI brand whole and pre-cut cantaloupes. Sofia Produce is contacting each of its buyers to advise them of the recall. Consumers should check to see if they have recalled products, which should not be consumed. If consumers are unsure whether they have purchased a recalled product, they are advised to contact their retailer.
  • Keller and Heckman will continue to monitor and report on food recalls in the U.S.