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  • On June 14, 2018, the Kellogg Company voluntarily recalled impacted packages of Honey Smacks cereal following an announcement by the FDA and the Centers for Disease Control and Prevention (CDC) of a multistate outbreak of salmonellosis that could be traced to Kellogg’s Honey Smacks cereal produced at Kerry Inc’s Gridley, Illinois facility.  According to the CDC outbreak summary, 135 people, in 36 states, were infected with Salmonella Mbandaka and 34 of these people were hospitalized.  No deaths were reported. 
  • In a February 3, 2023 press release, the United States Department of Justice (DOJ), announced that Kerry Inc. pled guilty to a misdemeanor count of distributing adulterated cereal marketed as Kellogg’s Honey Smacks.  According to the plea agreement, Kerry’s routine environmental testing detected Salmonella in its Gridley facility on approximately 81 times between June 2016 to June 2018 and employees at the Gridley facility routinely failed to implement corrective and preventative actions (CAPAs) to address positive Salmonella tests.  Per the plea agreement, Kerry has agreed to pay a criminal fine and forfeiture amount totaling $19.228 million.  If the guilty plea is accepted by the court, Kerry’s fine and forfeiture will overtake the penalty of $17.25 million from the Bluebell ice cream listeriosis settlement, discussed here, as the largest-ever criminal penalty following a criminal conviction in a food safety case. 
  • In a related federal action, as we previously reported, Kerry’s former Director of Quality Assurance, Ravi K. Chermala, pleaded guilty on October 21, 2022 to three misdemeanor counts of causing the introduction of adulterated food into interstate commerce.  Chermala admitted that he directed subordinates to not report certain information to Kellogg about conditions at the Gridley facility and to alter the plant’s program for monitoring for the presence of pathogens in the plant, limiting the facility’s ability to accurately detect insanitary conditions.  Sentencing dates for Chermala and Kerry Inc. are set for February 16, 2023 and March 14, 2023, respectively. 
  • EMA occurs when someone intentionally leaves out, removes, or substitutes a valuable ingredient in a food or when a substance is added to a food to make it appear better or of greater value.
  • The sampling was designed to identify products that contained less expensive undeclared added sweeteners, such as corn and cane syrups.
  • FDA collected and tested 144 samples of imported honey from bulk and retail shipments from 32 countries.  FDA found 10% of samples to be violative and refused entry of these violative shipments into the U.S.  The associated companies and products have been placed on an import alert.
  • Violative samples are subject to agency action, such as recall and import refusal and, where appropriate, FDA may consider pursuing criminal investigations.
  • You can refer to this FDA Guidance for more information on proper labeling of honey and honey products.
  • On November 15, FDA announced a finalized rule to more effectively trace contaminated food through the food supply sourced both domestically and internationally. Foodborne illness affects millions of Americans each year. FDA’s action progresses its commitment to better protect the public by ensuring a safe and wholesome food supply through enhanced recordkeeping requirements which will allow for fast identification and removal of contaminated food from the US market.
  • The final rule, entitled “Requirements for Additional Traceability Records for Certain Foods,” establishes additional traceability recordkeeping requirements for entities that manufacture, process, pack, or hold certain food types.
  • Working closely with industry, FDA will be able to more effectively identify the origin and route of travel of certain contaminated foods to prevent or mitigate foodborne illness outbreaks, address credible threats of serious adverse health consequences or death, and minimize overly broad advisories or recalls that implicate unaffected food products.
  • “This rule lays the foundation for even greater end-to-end food traceability across the food system that we’re working on as part of the New Era of Smarter Food Safety initiative,” shared Frank Yiannas, FDA’s duty commissioner for food policy and response.
  • The traceability recordkeeping requirements purport to create a universal and harmonized approach to tracing certain foods included on the Food Traceability List (FTL). In determining what foods to include on the FTL, FDA has developed a risk-ranking model for food tracing based on the factors that Congress identified in Section 204 of the FDA Food Safety Modernization Act. Examples of identified food categories include, but are not limited to, fresh leafy greens, melons, peppers, nut butters, fresh fruits, and crustaceans.
  • The final rule, which will go into effect on November 21, 2022, includes the following key features:
    • Tracking specific points in the supply chain – such as the harvesting, cooling, initial packing, receiving, transforming, and shipping FTL foods;
    • Instituting traceability plans that contain information essential to help regulators understand an entity’s traceability program, including a description of the procedures used to maintain required records, descriptions of procedures used to identify foods on the FTL, descriptions of how traceability lot codes are assigned, a point of contact for questions regarding the traceability plan, and a farm map for those that grow or raise a FTL product;
    • Requiring industry to maintain records as original paper or electronic records, or true copies, provide requested records to the FDA within 24 hours of a request (or within a reasonable time to which the FDA has agreed), and offer records in an electronic spreadsheet when necessary to assist the FDA during an outbreak, recall, or other threat to public health.
  • Keller and Heckman will continue to provide updates on this final rule and its applications to the food industry
  • Maine’s Department of Environmental Protection (DEP) recently published a second “concept draft” rule to implement Maine’s sweeping PFAS in consumer products legislation; comments are due tomorrow, November 10, on the second “concept draft.” Readers may recall that in July 2021, Maine passed “An Act to Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution,” which implements reporting requirements for intentionally added PFAS in consumer products.  The law also prohibits PFAS in carpets, rugs, and fabric treatments, and institutes a total ban on intentionally added PFAS by January 1, 2030.  Once Maine settles on proposed implementing regulations to advance to the Board of Environmental Protection, a formal comment period will open, likely sometime in December based on recent public statements from Maine DEP personnel.  Although the rulemaking process is still ongoing, key updates are provided below:
    • Beginning January 1, 2023, the law requires manufacturers to notify the state of any products sold or distributed in Maine that contain intentionally added PFAS. Products that contain intentionally added PFAS and which are not reported are prohibited from sale or distribution in the state.  Importantly for food companies, DEP has stated that it interprets the statute as applying to food packaging.
    • DEP does not currently have a formal system in place to report products that contain intentionally added PFAS, but DEP will accept notifications via mail or email at PFASProducts@maine.gov. Maine is currently working with the Interstate Chemicals Clearinghouse to develop a reporting database that will ultimately be made public.  The statute provides that the notification must include the following:

(1) A brief description of the product;

(2) The purpose for which PFAS are used in the product, including in any product components;

(3) The amount of each of the PFAS, identified by its CAS registry number, in the product, reported as an exact quantity determined using commercially available analytical methods or as falling within a range approved for reporting purposes by the Maine DEP;

(4) The name and address of the manufacturer, and the name, address and phone number of a contact person for the manufacturer; and

(5) Any additional information established by the department by rule.

  • Exemptions: The statute provides for two exemptions from the reporting requirement. First, “Products for which federal law governs the presence of PFAS in the product in a manner that preempts state authority” are theoretically exempt.  However, DEP has stated that it is not aware of any federal law or regulation that would apply under this exemption.  The second exemption applies to a “product subject to Title 32, chapter 26-A or 26-B” of the Maine Revised Statutes.  Although Chapters 26-A (32 M.R.S. § 1731-1738) and 26-B (38 M.R.S. § 1741-1747) do apply to food packaging generally, DEP has stated that it will interpret this language narrowly.  An FAQ page on DEP’s website states that food packaging is only “subject to” chapter 26-A when the Department prohibits its sale by rule (which it has not yet done) and is only subject to Chapter 26-B if it contains a chemical designated as a “priority food contact chemical” by DEP’s Commissioner (which has not yet happened).  Thus, our readers should be aware that DEP does not interpret these exemptions as applying to food packaging.
  • Waivers and Extensions: Maine’s DEP is accepting requests for extensions to the reporting deadline on a case-by-case basis. Requests for extensions must be made by or on behalf of specific named manufacturers in advance of the January 1, 2023 reporting deadline.  If a manufacturer does not know if their products contain intentionally added PFAS and/or if the manufacturer cannot provide sufficient information to comply with the detailed reporting requirements listed above, that manufacturer can submit an extension request to PFASproducts@maine.gov.  Readers should be aware that all companies that are granted an extension will be listed on a publicly available document.
  • Penalties and Enforcement: Maine’s PFAS prohibition in consumer products directs DEP to adopt rules as necessary for the administration and enforcement of the statutes.  In the concept draft rule, DEP indicated that any violations are subject to DEP’s enforcement authority under 38 M.R.S. §§ 347–349.  A person who violates the provisions of the PFAS statute/reporting obligations may be subject to an investigation resulting in an administrative consent agreement, an enforcement hearing on the alleged violation, or a civil or criminal action brought by the Attorney General.  Civil penalties can be up to $10,000 per day of violation unless the violation relates to hazardous waste, in which case the person shall pay the state a penalty to be determined by a court of not more than $25,000 per day of violation.  In addition, criminal penalties (Section 349) can be up to $25,000 per day of violation.  (Section 349 indicates that violations of the provisions administered by the Maine DEP are considered a Class E crime, which is punishable up to six months incarceration and a $1,000 fine).
  • Keller and Heckman will continue to monitor and provide updates on Maine’s PFAS draft regulations.
  • According to the Department of Justice’s October 21 press release, a former quality assurance director for food manufacturer Kerry Inc. plead guilty to three misdemeanor offenses related to the manufacture of a breakfast cereal linked to an outbreak of Salmonella poisoning in 2018.
  • Kerry Inc.’s former Director of Quality Assurance oversaw the sanitation programs at various Kerry manufacturing plants, including a facility in Gridley, Illinois that primarily manufactured Kellogg’s Honey Smacks breakfast cereal for Kerry’s customer, the Kellogg Company.
  • In June 2018, FDA and CDC announced that an ongoing outbreak of Salmonella cases in the United States could be traced to Kellogg’s Honey Smacks cereal produced at Kerry Inc.’s Illinois facility. In response, Kellogg’s voluntarily recalled all Honey Smacks manufactured at the plant since June 2017. In July 2018, Kerry Inc. received a Warning Letter from FDA, which detailed how Agency investigators found “serious violations” of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation as detailed in 21 CFR Part 117. The present charges against Kerry Inc.’s former QA director stem from the 2018 multistate outbreak of Salmonella infections from Honey Smacks cereal, which sickened 135 people in 35 states.
  • In pleading guilty, the former QA director admitted that between June 2016 and June 2018, he directed subordinates to not report certain information to Kellogg’s about conditions at the Gridley facility. In addition, he admitted that he forced subordinates at the Gridley facility to alter the plant’s program for monitoring for the presence of pathogens, thus limiting the facility’s ability to accurately detect insanitary conditions and bacterial contaminations. “Food safety professionals cannot conceal potentially dangerous problems from customers or government regulators,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division.
  • Special Agent Lynda M. Burdelik of the FDA Office of Criminal Investigations also said that this prosecution “reinforces that if an individual violates food safety rules or conceals relevant information, [FDA] will seek to hold them accountable. The health of American consumers and the safety of our food are too important to be thwarted by the criminal acts of any individual or company.”
  • The sentencing date is scheduled for January 30, 2023. Further information about the case will be posted to the Department of Justice’s Information for Victims in Large Cases website, available at https://www.justice.gov/largecases.

Gerber Gets Baby Food Heavy Metals Suit Tossed (Law360 Subscription Required)

  • We reported on the April 25, 2022 dismissal by a New Jersey federal judge of a putative class action lawsuit against baby food producer Sprout Foods, Inc. after finding the alleged harm was “simply speculative” without the reported levels of heavy metals in the baby food being linked to any particular harm or risk to the plaintiffs.  In contrast, on January 10, 2022, a California federal judge refused to dismiss similar claims against Plum Organics, finding the claims are not preempted by federal law and that the suit plausibly alleges a reasonable consumer could be induced to pay more by the alleged omission of disclosures of potential toxins in the baby food (subscription to Law360 required).
  • On October 17, 2022, a Virginia federal judge followed the approach in the Sprout Foods case, dismissing claims against Gerber Products Co. by plaintiffs alleging economic harm from having purchased Gerber baby food products that were overpriced because Gerber failed to disclose the risk of containing harmful heavy metals on its packaging, inadequately tested for heavy metals, and failed to adhere to internal standards.  The case was dismissed on grounds of standing and federal preemption.
    • On the issue of standing, the court concluded the baby food products were safe “as to” the plaintiffs, finding the complaint discusses the dangers of heavy metal exposure to human health generally but does not allege the baby food products were adulterated, recalled, or the cause of any reported injuries, or that their children are at imminent risk of developing any specific ailment in the future because they consumed the baby food products.
    • The court also ruled against the plaintiffs on an alternative theory of economic injury based on allegations of having paid a “price premium,” finding the plaintiffs failed to allege any facts substantiating their conclusory allegations that would permit the court to determine the economic value of their alleged lost benefit without resorting to mere conjecture; thus, finding the plaintiff failed to demonstrate they did not get the benefit of their bargain or did not receive the full value of their purchase, the court found the plaintiffs lack standing
    • The court also noted that the plaintiffs have not identified an affirmative duty or legal obligation, under the Federal Food, Drug and Cosmetic Act or any other law, requiring the disclosure of the presence of heavy metals in baby food products.
    • On federal preemption arguments, the court found that FDA has primary jurisdiction to determine whether the amounts of heavy metals in baby food products is harmful.
  • Keller and Heckman will continue to monitor and report on litigation involving heavy metals in baby food, as well as FDA’s regulatory activities following two congressional reports (discussed here) that raised alarm regarding the levels of heavy metals— including arsenic, lead, cadmium, and mercury— reportedly found in baby foods.

 

  • On October 20, FDA issued final guidance that describes the actions, behaviors, and statements by a foreign food establishment or foreign government that the FDA considers to be a refusal of an inspection. As our readers may recall, FDA published its draft guidance concerning refusal of inspections back in December 2017.
  • Food for importation into the United States comes from all over the world.  One way that the FDA protects the U.S. food supply is by conducting inspections of foreign food facilities to identify potential food safety concerns. The Food Safety Modernization Act (FSMA) gives FDA authority to refuse entry of food offered for importation into the United States if the foreign food establishment or foreign government has refused to permit the FDA to inspect the foreign establishment that produced the food. The guidance issued yesterday provides examples of situations that FDA may consider as constituting refusal.
  • A non-exhaustive list of example situations in which FDA would consider a foreign food establishment to have “refused” an inspection include when an operator, agent, or owner in charge:
    • Does not respond to FDA during the 24-hour period after submission by FDA of a written inspection request;
    • Stops communicating with FDA at any time after the owner, operator, or agent in charge initially responds to FDA’s request to schedule an inspection;
    • Agrees to an inspection start date and then requests a later date without giving a reasonable explanation;
    • Refuses to permit entry to the establishment;
    • Sends staff home for the day, without a reasonable explanation, and tells the FDA investigator that the establishment is not producing any product;
    • Does not answer telephone calls from the FDA investigator who is present at the establishment and unable to gain entry to the establishment;
    • Bars the FDA investigator from an area of the establishment where food is grown, harvested, manufactured, processed, prepared, packed, or held;
    • States that direct observation of an establishment, in whole or in part, must be limited to an unreasonably short amount of time;
    • Makes statements, actions, and passive behaviors intended to avoid inspection or to mislead or deceive the FDA investigator in a manner that prevents the investigator from conducting the inspection;
    • Refuses to allow the FDA investigator to collect evidence to document potential violations (e.g., to take photographs as necessary; to collect samples; talk to pertinent staff; or to collect food labels and labeling);
    • Leaves the FDA investigator in a non-production area of the establishment (e.g., conference room) without access to records, to a responsible individual, or to other areas of the establishment that would be subject to inspection for an unreasonable period of time.
  • The final guidance is scheduled to be published in the Federal Register on October 21 and can be reviewed here.
  • In a 16-page order, U.S. District Judge William H. Orrick dismissed with prejudice customer Angela Kennard’s putative class action she filed last year against Kellogg Sales Co. over its use of the term “veggie” in several of its MorningStar Farms line of meatless products such as its burgers, hot dogs, chicken nuggets, patties, sausage links, bacon stripes, chicken wings and more. As our readers may recall, we reported on the Morningstar Farms “veggie” product labeling suit in April after Kellogg moved to dismiss the amended suit, citing several decisions in similar false labeling suits, such as the opinion issued by the Ninth Circuit in Becerra v. Dr Pepper/Seven Up Inc., where the panel ruled no reasonable customer would believe the company’s use of the term “diet” promised weight loss or management.
  • Plaintiff Kennard alleged Kellogg’s Morningstar Farms “veggie” products mislead consumers because the word “veggie” indicates that the main or only ingredients in the products are vegetables or made from vegetables, adding that customers she surveyed said they largely understood “veggie” to refer to vegetable-based products. Plaintiff accused the food and beverage company of violating California’s False Advertising and Unfair Competition laws, as well as a myriad of federal rules regulating the labeling of food products, and breaching warranties. However, on September 15, the  Northern District of California decided that Kellogg’s use of the term “veggie” on its labels is, at most, ambiguous and could refer to meat substitutes.
  • Judge Orrick said he didn’t think the term “veggie” on the products’ labels was false, misleading or misbranded or that it violates any federal food labeling requirements or state laws. The term “veggie” is ambiguous in the way it is used on the packaging, and the photos and information on the packaging doesn’t convey the product uses any particular vegetables. “I agree that the [Plaintiff’s’] allegations are implausible and do not support a reasonable inference that some significant portion of consumers would be misled into thinking the VEGGIE products are made primarily of vegetables as opposed to being vegetarian meat substitutes made from grains, oils, legumes, or other ingredients,” Judge Orrick maintained. Additionally, the product packaging features items that imitate meat, and consumers can readily identify the actual ingredients in the products on the packaging, the judge said.
  • In recent years, laws have been passed all over the country that restrict the use of the term “meat” in product labeling, including in Missouri, Arkansas, Oklahoma and others. For example, Missouri passed a law in 2018 prohibiting a seller or advertiser from “misrepresenting a product as meat that is not derived from harvested production livestock or poultry.” Similarly, many of these other states’ laws require that only foods derived from food-producing animals may contain labels with terms like “meat, “burger,” “sausage” and the like.
  • In light of these recent labeling lawsuits and related legislation, marketers must be mindful of any representations they are making — whether in words or pictures — that might convey claims about a product’s contents. Keller and Heckman will continue to follow and report developments relating to the growing number of labeling claims challenges.
  • On September 27, the FDA released “Activities to Enhance the Safety of Imported Produce,” a report which details how the Agency’s 2019 strategy for safeguarding imported food specifically applies to imported produce. For background on the FDA’s “Strategy for the Safety of Imported Food,” see our February 2019 blog.
  • The new report outlines how the agency is working to enhance the safety of fresh fruits and vegetables through four goals that were established in the 2019 strategy document. The report details how the FDA works to achieve each goal.
    • Goal 1 – Food Offered for Import Meets U.S. Food Safety Requirements
      • Specifically for Goal 1, the FDA relies on international inspections, use of verified foreign suppliers through effective implementation of the FSVP final rule, audits such as those conducted under FDA’s Accredited Third-Party Certification Program or other programs aligned with FDA produce safety requirements, incentivizes importers to use verified suppliers through the Voluntary Qualified Importer Program (VQIP), leverages oversight efforts of regulatory counterparts with strong food safety systems, and increases awareness and training of produce safety requirements.
    • Goal 2 – FDA Border Surveillance Prevents Entry of Unsafe Foods
      • Some of FDA’s activities for Goal 2 include enhancing and refining FDA’s import screening and entry review process, optimizing use of sampling of imported produce, utilizing import alerts and import certifications, improving testing methods and tools to determine admissibility of produce offered for import, and maximizing the benefit to border surveillance from state and other partnerships.
    • Goal 3 – Rapid and Effective Response to Unsafe Imported Food
      • For Goal 3, the FDA maximizes effectiveness of FDA’s response to an event involving imported produce, enhances the efficiency and effectiveness of recalls, and uses information sharing-opportunities to prepare for and respond to unsafe imported produce.
    • Goal 4 – Effective and Efficient Food Import Program
      • For Goal 4, the FDA has developed an improved understanding of the global inventory of produce facilities and farms and conducts performance assessments of the effectiveness of import activities.
  • Keller and Heckman will continue to monitor and report on any developments that impact produce safety requirements.
  • On June 14, 2022, the Senate Health, Education, Labor, and Pensions (HELP) Committee passed the FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348) which proposes various changes to the regulation of dietary supplements and cosmetics. The legislation was originally introduced by Sen. Patty Murray (D-WA) on May 26, 2022 and would amend Chapter IV of the Federal Food, Drug, and Cosmetic Act.
  • Specifically, in regard to dietary supplements, the Act would require that companies list their products with the FDA.  The information required to be submitted in connection with the listing includes the name of the supplement; the name and address of the manufacturer, packer, or distributor appearing on the label, and contact information for the owner or operator; the business name and mailing address of all locations in which the dietary supplement is manufactured, packaged, labeled, or held; a list of all ingredients in each supplement; the number of servings per container; directions for use; warnings, notice, and safe handling statements; allergen statements; any health or structure/function claims; and the dietary supplement product listing number. Subject to limited exceptions, this information would be made publicly available in a searchable electronic database.
  • The Act also proposes changes to the regulation of cosmetics. These include (1) adverse event reporting requirements; (2) the establishment of good manufacturing practices (GMPs) for cosmetics facilities; (3) registration and product listing requirements; (4) requirements to maintain records supporting the safety of the cosmetic product; (5) a labeling requirement to include contact information for adverse event reporting; (6) requirement to have records accessible to FDA if there is a reasonable belief that the product (or ingredients therein) presents a threat of serious adverse health consequences; and (7) a mandatory recall authority. In establishing GMP regulations, FDA is directed to consider the size and scope of the cosmetics manufacturer, the risks to public health, and to provide flexibility for different types of facilities. Currently, there is a GMP checklist for cosmetics manufacturers to follow for inspections, but no regulations have been promulgated.
  • Mandatory listing requirements for dietary supplement companies and strengthening of dietary supplement regulation have previously been considered by the FDA. Keller and Heckman will continue to monitor this legislation and report on any further updates.