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  • On February 26, 2024, Family Dollar Stores LLC agreed to pay $41.675 million after pleading guilty to storing food and drugs in unsanitary conditions in a rodent-infested warehouse. In addition to monetary penalties, Family Dollar and Dollar Tree stores must “meet robust corporate compliance and reporting requirements for the next three years.”
  • Family Dollar began receiving reports of rodent issues in its West Memphis, Arkansas, warehouse and in store deliveries in 2020, and by January 2021, employees were aware of the unsanitary conditions in the warehouse that caused FDA-regulated products to become adulterated. However, the company continued to ship the products until January 2022 when an FDA inspection revealed live rodents, dead and decaying rodents, rodent feces, urine, odors, and evidence of gnawing and nesting. Fumigation following the investigation resulted in the extermination of more than 1,200 rodents. In February 2022, the company initiated a recall of all drugs, medical devices, cosmetics, and human and animal food products sold since January 1, 2021, in the 404 stores that received shipments from the infested warehouse.
  • Family Dollar was sued over the rodent problem in a class action (Law360 subscription required) on February 23, 2022, following FDA’s investigation of the warehouse. The complaint alleged that Family Dollar knowingly omitted information about the infestation from advertising and promotion of its products and continued to ship products to its stores from the warehouse in violation of state consumer protection laws and deceptive trade and practice statutes. The complaint also alleges breach of implied warranty, unjust enrichment, and negligence.
  • DOJ officials commented that consumers “have the right to expect that the food and drugs on the shelves have been kept in clean, uncontaminated conditions” and that the DOJ will hold accountable companies that violate laws designed to keep consumers safe. Knowingly selling adulterated products both put public health at risk and eroded consumer trust in the safety of products they purchase. An FDA official commented that “When companies put themselves above the law and distribute food that has been held under extremely insanitary conditions, putting the public’s health at risk, we will see that they are brought to justice.”
  • Dollar Tree announced that it has created new compliance and safety roles and plans to open a “fully reimagined and refreshed distribution center” in West Memphis.  
  • The attorneys general from 20 states sent a letter to FDA urging the agency to take official notice of three documents relating to lead in baby food in support of a 2022 petition for reconsideration requesting actions on heavy metals in food for babies and young children. The group of attorneys general filed a citizen petition on October 21, 2021, which FDA denied. The group then filed a reconsideration petition on June 1, 2022. That petition is still pending.
  • The 2021 petition urged FDA to drive down the levels of lead, inorganic arsenic, cadmium, and mercury in food intended for babies and young children, including by issuing guidance on finished product testing. According to the petition, this testing would amount to a “preventive control” that should be performed by food manufacturers. Now, the attorneys general say that a January 2023 guidance document on lead action levels, FDA’s public notices relating to the investigation into elevated lead levels in applesauce, and a December 2023 report on the inspection of the applesauce manufacturer provide additional support for the reconsideration petition.
  • According to the attorneys general, these documents “make it evident that some manufacturers and distributors of baby foods in the U.S. currently lack a clear understanding of the proper way to apply preventive controls to avoid adulteration of finished baby food products.” In the documents, FDA reported that the baby food products contained more than 200 times the maximum acceptable concentration of lead under the proposed action levels, yet there was no finished product testing prior to the recall. The harm to children demonstrated in the documents reinforces the need for required toxic element testing in finished products for babies and young children.
  • The letter requests FDA take official notice of the documents without reopening the administrative record since the documents are official and reliable FDA publications.
  • As our readers are likely aware, in November of last year, WanaBana voluntarily recalled apple cinnamon fruit pouches which were linked to acute lead toxicity in children. The products were sold under the WanaBana, Schnucks, and Weis brand names. The subsequent investigation traced the contamination to cinnamon from Austrofoods, an Ecuadorian food distributor. Cinnamon at the Austrofoods’s facility was also found to contain elevated levels of chromium, although it was not clear from the testing whether it contained chromium III, or the more toxic chromium VI. Considering the very high levels of lead and chromium, FDA raised the possibility of intentional economic adulteration.
  • The contaminated (ground) cinnamon was supplied to Austrofoods by Negasmart (also known as Negocios Asocidos Mayoristas S.A.), which sourced the cinnamon sticks from Sri Lanka but had the sticks processed by Carlos Aguilera. Both Negasmart and Carlos Aguilera are also Ecuadorian companies.
  • In the most recent update, released yesterday (February 6th), FDA announced that Ecuadorian officials have reported that the cinnamon sticks from Sri Lanka were found to be uncontaminated and that the cinnamon processor, Carlos Aguilera, is the most likely source of contamination. Per the report, Carlos Aguilera is “not in operation at this time.”
  • The recall highlights the complexity of modern supply chains and the difficulty in orchestrating a response when the issue crosses borders. FDA cannot take direct action against companies that do not export products to the United States including, in this case, Negasmart and Carlos Aguilera.
  • 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 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.
  • James Jones, the newly appointed Deputy Commissioner for Human Foods, released a statement on October 19 outlining his commitment to Commissioner Robert Califf’s framework for the proposed Human Foods Program (HFP). Jones said that he is “committed to upholding and executing this framework guided by the principle of protecting and promoting the health and wellness of all U.S. consumers.” The framework contains three priority areas: preventing foodborne illness, decreasing diet-related chronic disease, and safeguarding the food supply.
  • Under the foodborne illness prevention prong of the framework, FDA is proposing to set up an Office of Critical Foods, which will regulate infant formula and medical foods. This office is intended to work with industry to avoid recalls and shutdowns, particularly in infant formula manufacturing. The HFP will also use FDA’s New Era of Smarter Food Safety blueprint to further progress to regulate the food supply under the Food Safety Modernization Act.
  • To aid in decreasing diet-related chronic diseases, the HFP will prioritize reducing sodium in food, creating more accessible food labels, promoting healthy habits, and supporting innovation. On November 16, the Agency is co-hosting a public meeting with the Reagan-Udall foundation to hear input on front-of-package labeling and from November 6-8 will hold virtual public meeting and listening sessions regarding strategies to reduce added sugar consumption.
  • The HFP will also work to safeguard the food supply by reducing exposure to contaminants and other harmful chemicals in foods. FDA is working on a proposed rule regarding Brominated Vegetable Oil in food, as well as continuing its work on the Closer to Zero initiative, which we have covered previously, to reduce exposure to heavy metals in foods for babies and young children.
  • Keller and Heckman will continue to follow and report on the HFP.
  • On August 30, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to three infant formula manufacturers as part of the Agency’s recent push to enhance regulatory oversight in the infant formula industry.  The warning letters, which were issued to ByHeart Inc., Mead Johnson Nutrition, and Perrigo Wisconsin, LLC, allege violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations.
  • At the time of FDA inspections of the facilities, the Agency issued inspectional observations and exercised oversight of each firm as they initiated recalls (in December 2022, February 2023 and March 2023) to remove product potentially contaminated with Cronobacter sakazakii from the marketplace. 
  • Importantly, FDA does not advise consumers to discard or avoid purchasing any particular infant formula at this time.  These warning letters are not associated with any current recalls and therefore, FDA does not anticipate any impact to the availability of infant formula on the market.  Consumers should know that the U.S. infant formula supply is healthy with in-stock rates at 85% or higher since the beginning of 2023.
  • FDA states that it is issuing these letters now “as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulations.”  Each company will have 15 working days to respond to the FDA to explain what corrective actions they are taking.
  • Last week FDA announced that it had signed a regulatory partnership arrangement (RPA) with Ecuador’s seafood regulatory authority (the Vice Ministry of Aquaculture and Fisheries or VMAF) to enhance the safety of shrimp imported from Ecuador. Shrimp is the most consumed seafood product in the United States and Ecuador is the second largest exporter of shrimp to the United States (following India).
  • The partnership will increase collaboration between the agencies, including by facilitating information sharing, improving recall notification and response, promoting training on relevant food safety topics such as HACCP (hazard analysis critical control points) and good aquaculture practices, and facilitating joint participation in shrimp inspections, audits, and investigations. Earlier in the month, the agencies announced the signing of a confidentiality agreement to allow for the sharing of confidential information such as inspection and sampling records. FDA also examined various aspects of Ecuador’s regulatory framework for shrimp and VMAF’s capabilities, concluding that it was “confident that Ecuador has key components of a food safety oversight system for shrimp and shrimp products intended for export to the U.S.”  
  • The partnership advances core goals of FDA’s New Era of Smarter Food Safety plan, including by facilitating outbreak response and prevention through information sharing. If successful, the pilot program may lead to other similar partnerships with important U.S. food suppliers. We will monitor and report on any developments in this space.

Splenda Maker Falsely Touts Diabetes Benefits, Suit Says (subscription to Law360 required)

  • As our readers may recall, a defamation lawsuit was filed on August 8, 2023 by TC Heartland LLC, the producer of a sucralose product sold as Splenda, against Dr. Susan Schiffman, the lead author of a May 29, 2023 scientific paper reporting potentially concerning toxicological and pharmacokinetic properties of sucralose-6-acetate (S6A), which the paper describes as an intermediate and impurity in the manufacture of sucralose.  In addition to attacking the research paper itself, Heartland’s complaint alleges that Dr. Schiffman made demonstrably false toxicology claims to the press about Splenda (which the company says does not contain detectable levels of S6A). 
  • On August 17, 2023, a proposed class action was filed in the Northern District of California against Heartland by a Type II diabetes patient accusing the company of false advertising and other consumer protection law violations by marketing Splenda-brand “diabetes care” shakes, zero calorie sweetener packets, sweet teas and multi-use syrup products to health-conscious consumers, including those with Type 2 diabetes, as a healthy sugar alternative even though sucralose has been shown to worsen diabetes, among other alleged harms.  As support for the plaintiff’s contention that Splenda products made with sucralose are neither healthy nor suitable for the claimed purposes of helping to manage blood sugar and aiding in diabetes care, the complaint cites the 2023 Schiffman paper and other published scientific articles, as well as the World Health Organization’s (WHO) May 15, 2023 guidelines urging against the long term consumption of sucralose and other nonnutritive sweeteners to achieve weight loss or to avoid non-communicable disease. 
  • While Heartland has not yet responded to the immediate lawsuit, the company’s press releases dispute claims in the 2023 Schiffman paper and other papers that would raise safety concerns for sucralose, highlighting alleged flaws in the research or conclusions of these papers.  Another press release objects to even the limited scope of WHO’s guidance, framing it as based on evidence with a “low certainty” level.  Heartland has also pointed to other favorable, and purportedly more convincing scientific studies, as well as reviews by FDA and international food regulatory authorities that support the safety of sucralose.  Keller and Heckman will continue to monitor any developments in the cases involving Splenda.
  • On August 7, 2023, FDA issued a draft guidance which is intended to assist industry in navigating the new facility registration and product listing requirements of the Modernization of Cosmetic Regulations Act 2022 (MOCRA) (see p. 1389 of 1653).
  • MOCRA requires that persons who own or operate a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the U.S. register their facility. This registration requirement is subject to a small business exception and an exception for facilities that manufacture cosmetics regulated as drugs. Furthermore, in the case of contract manufacturers, the guidance indicates that either the contract manufacturer or the person whose name appears on the label (i.e., the “responsible person”) may register and that only a single registration is required. See draft guidance for the information required to register a facility and also optional information that FDA requests but cannot require via guidance.
  • MOCRA also requires that the responsible person for each cosmetic product submit a product listing (also subject to the same small business and drug product exceptions referenced above). However, a single listing submission may include multiple cosmetics with identical formulations or formulations that differ only in respect to colors, fragrances or flavors, or quantity of contents. See draft guidance for the information required in a product listing and also optional information that FDA requests but cannot require via guidance.
  • FDA is developing an electronic portal for registration and listing submissions which will be available in October 2023 (a paper submission process will also be available but is discouraged).
  • Cosmetic manufacturing/processing facilities must be registered by December 29, 2023, if that facility was owned or operated by the responsible person on December 29, 2022. If the facility was not owned or operated by that date, then it must be registered by the later of: (i) within 60 days after manufacturing/processing begins or (ii) February 27, 2024. The responsible person must also submit a cosmetic product listing by December 29, 2023, unless the product was marketed after December 29, 2022, in which it must be submitted by the later of: (i) within 120 day of marketing the product or (ii) within 120 of December 29, 2023.
  • The product listing number, registration number, and brand names under which the cosmetic products are sold will not be publicly disclosed. All other information is available for public disclosure consistent with the Freedom of Information Act (FOIA).
  • FDA currently administers establishment registration and product listing requirements for drugs, medical devices, and tobacco products and registration (but not product listing) for food facilities.  If FDA implements cosmetic registration and listing only via guidance without issuing regulations (as the Agency appears to be doing), FDA will be limited to requiring only the statutory elements while asking for optional elements, such as the DUNS number and electronic submission.     
  • Comments to the draft guidance are due by September 7, 2023. A broader discussion of the changes to cosmetic regulation under MOCRA, including FDA’s new recall authority, the added safety substantiation requirements, and adverse event reporting requirements, can be found in this Keller and Heckman article. Keller and Heckman will continue to monitor developments in the implementation of MOCRA.