• The UK Office for Sanitary and Phytosanitary Trade Assurance commissioned the Foods Standards Agency (FSA) to profile the potential risks of importing oysters into the United Kingdom in the hopes of mitigating possible issues.  The study comes after FSA assessed the public health risk of raw oysters earlier this year to help develop risk management options during norovirus outbreaks.
  • Chemical and microbiological hazards were identified, which include heavy metals, natural biotoxins, viral and bacterial pathogens, and persistent organic chemicals.  Allergens and physical hazards were excluded. 
  • The UK currently imports approximately 350,000 kilograms of oysters per year.  The main exporters to the UK include South Korea, France, and New Zealand.  Although consumption surveys indicate that the general population rarely eats oysters, oysters are considered a high risk product.  This is largely due to their filter feeding, which allows bioaccumulation of hazards and likelihood for raw consumption.
  • The main hazards identified in the supply chain were Vibrio parahaemolyticus; marine biotoxins (such as amnesic, paralytic, and lipophilic toxins); hepatitis A virus (HAV), norovirus and Salmonella; heavy metals like cadmium mercury and lead; and diseases caused by other Vibrio species.
  • Control measures at different stages of the supply chain will vary with hazard type.  Control measures during harvest can include suspension of activity, transfer of live animals to cleaner sites, or altering onward processing requirements.  During processing, purification can be achieved through re-immersion in clean water.  At the consumption phase, there are various options to help reduce risk: labeling and traceability, education of workers on cold chain breaches and contamination, and advice on avoiding raw products by vulnerable groups.
  • FDA is continuing to investigate the elevated lead levels in cinnamon used in applesauce pouches that were recalled beginning October 31, 2023. Most recently, inspectors collected samples that the cinnamon supplier sold to the applesauce manufacturer, finding extremely high levels of lead contamination at 5,110 parts per million (ppm) and 2,270 ppm. For context, the Codex Alimentarius Commission is considering adopting 2.5 ppm as the maximum level for lead in cinnamon, among other similar spices.
  • To date, there have been approximately 65 reported cases of children displaying symptoms of lead toxicity related to the applesauce pouches. FDA has not found evidence that any other products, including pouches from the same brands that do not contain cinnamon, are related to the recall. The pouches implicated in the recall have been traced back to a manufacturer and cinnamon supplier in Ecuador, and FDA is working closely with Ecuadorian officials who are conducting their own investigation.
  • FDA has theorized that lead may have been intentionally added to the cinnamon in a case of economic adulteration. Nevertheless, FDA is continuing its investigation and has provided a timeline that it will continue to update as the investigation progresses.
  • Keller and Heckman will continue to monitor and provide updates on this investigation.
  • On December 13, 2023, the U.S. Food and Drug Administration (FDA) provided a reorganization proposal for the unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model.  The proposed reorganization package is currently under review at the U.S. Department of Health and Human Services (HHS).  FDA hopes implementation of the plans will occur sometime in 2024.
  • In addition to previous announcements, FDA’s proposed reorganization package includes the following new updates:
    • Making the FDA’s HFP and product Centers solely responsible for receipt, triage, and closing consumer and whistleblower complaints, rather than this role being split between Centers and field Offices.
    • Renaming ORA as the Office of Inspections and Investigations (OII) and solidifying its role as the frontline of FDA’s field-based inspection, investigation, and import operations.
    • Establishing an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner to strengthen central coordination of cross-agency medical issues, including special populations such as people with rare diseases and children.  This includes a new Office of Public Health Preparedness and Response to support medical countermeasure policy, emergency preparedness work, and medical product shortage coordination across the agency.
    • Merging the Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) to form a new office; both offices are currently housed within the FDA’s Office of the Chief Scientist (OCS).
    • Creating an Office of Enterprise Transformation, which will work across FDA to drive high-priority cross-cutting business process improvement efforts.
  • Before the proposal is implemented, it must be reviewed by the Office of Management and Budget.  FDA must also provide Congress with a 30-day notification period, issue a Federal Register notice, and engage in all necessary negotiations with Union representing impacted staff
  • Keller and Heckman will continue to monitor this reorganization process and will relay any developments.
  • Today FDA announced an update to its Menu Labeling Supplemental Guidance which addresses implementation of menu nutrition labeling requirements. The menu labeling rules only apply to standard menu items offered by “covered establishments,” which are defined as restaurants and similar retail food establishments with 20 or more locations doing business under the same name and offering for sale substantially the same menu items, as well as restaurants and similar retail establishments that register to voluntarily subject themselves to the menu labeling requirements. (21 CFR 101.11).
  • The menu labeling regulations require disclosure of calories on menu and menu boards, and require that other nutrition information (e.g., fat, sugar, protein) be available in written form on the premises and provided to the customer upon request. Notably, the menu labeling regulations do not require disclosure of “added sugars” as is now required on packaged foods.  
  • The draft update includes two new Q&As which (1) clarify that nutrition information can be provided on third party platforms (TPPs) through which food is ordered and delivered and (2) that added sugars may voluntarily be declared.
  • Although FDA accepts comments on any guidance at any time, comments on the draft new Q&As are due by February 12, 2024, to ensure they are considered before FDA begins work on final versions.
  • On December 7, 2023, several members of the House of Representatives introduced the Innovative Feed Enhancement and Economic Development Act (Innovative FEED Act). The bill was also introduced in the Senate earlier this year.
  • If approved, the Act will amend the Federal Food, Drug and Cosmetic Act (FDCA) to add a new category of animal feed ingredients that do not fit neatly into the current categories of animal drug or animal food. “Zootechnical animal food substances” would be defined as substances added to the food or drinking water of animals intended to “lower food pathogens, reduce byproducts for animals, or affect its gut microbiome.” These substances should achieve their intended affect by “acting solely within the gastrointestinal tract of the animal.” The ingredients would follow FDA’s existing food additive petition process, and the bill would add specific petition requirements to Section 409 of the FDCA. In addition, the bill would establish labeling requirements for zootechnical food substances.
  • According to a press release from Congressman Greg Pence, one of the representatives who led the introduction of the bill, zootechnical animal food substances will provide more tools for farmers, reduce FDA review times of feed additives, and spur innovation in feed ingredients. The bill has received support from various industry groups that have recognized it as a tool for a modernized feed ingredient approval framework and a driver for nutritional innovation.
  • Keller and Heckman will continue to monitor this bill.
  • 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.