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  • The U.S. District Court for the Eastern District of California has entered a consent decree of permanent injunction against Rizo Lopez Foods and the company’s co-owners.  Among other requirements, the consent decree prohibits Rizo Lopez Foods from manufacturing and selling certain food products until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other federal regulations.  The consent decree requires the defendants to make corrective actions and receive FDA approval from the U.S. Food and Drug Administration (FDA) before they may resume operations.
  • As we previously reported, FDA and the Centers for Disease Control and Prevention (CDC) investigated a multi-year, multistate outbreak of Listeria monocytogenes (Listeria) infections linked to queso fresco and cotija cheeses manufactured by Rizo Lopez Foods.  In February 2024, Rizo Lopez Foods voluntarily recalled its entire inventory of dairy products, regardless of the sell-by date of the product.
  • In total, the CDC outbreak investigation identified 26 illnesses, which occurred across 11 states and included 23 hospitalizations.  Two of the individuals subsequently died.  Four individuals were pregnant, including one who suffered a pregnancy loss.
  • FDA’s Human Foods Program is live as of today, October 1, 2024. We have previously blogged about FDA’s internal reorganization to realign functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and key functions of field operations in the Office of Regulatory Affairs into a unified Human Foods Program.
  • The Deputy Commissioner for Human Foods will report directly to the FDA Commissioner and will have authority over all components of the Human Foods Program. Fourteen offices will comprise the Human Foods Program, focusing on one of three functions:
    • Three offices with risk management functions will manage public health risks, including diet-related chronic diseases, health equity, infant formula, pathogen-related foodborne illness, chemical safety, dietary supplement safety, and ingredient innovation.
    • Four offices with strategic management functions will leverage data to prioritize activities and resources based on risk. This will include risk assessment, strategic planning, goal-setting, and business operations.
    • Seven offices with cross-cutting functions will support risk management priorities, including working with state and local regulators, carrying out compliance and enforcement actions, responding to food-related outbreaks and recalls, engaging with stakeholders, setting standards, engaging with international industry and regulatory counterparts, coordinating laboratory operations, and evaluating the effectiveness of programs and processes.
  • Notably, the Office of Nutrition and Food Labeling will retain its name and most of its functions. However, the premarket review team for infant formula will go to the Office of Critical Foods, which is under the Nutrition Center for Excellence.
  • The reorganization is intended to allow “a modernized FDA that optimizes resources to help the agency meet its public health mission; provide employees with clearer priorities and more career opportunities; and comply with recent legislation” establishing the Office of Critical Foods and ensuring the safety of cosmetics products.
  • Keller and Heckman will continue to report on the implementation of the Human Foods Program.
  • On August 9, 2024, FDA issued a warning letter to Austrofoods S.A.S., the Peruvian-based manufacturer that produced lead-contaminated apple cinnamon fruit puree pouches that were the subject of a recall last year.
  • The letter follows up on inspections that were conducted in December of last year and which “found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation” in 21 CFR Part 117.
  • The specific violations of these rules that were referenced include:
    • The failure to conduct an appropriate hazard analysis to identify and evaluate lead as a known or reasonably foreseeable hazard requiring a preventive control. FDA noted that lead is often found in spices and that children (the intended consumers) are particularly sensitive to it. Although lead was identified as a hazard, the plan concluded that no preventive control was required based on vague and faulty rationales like “supplier without historical precedents [of lead contamination].”Although the plan concluded that no lead control was required, it nevertheless required that cinnamon be purchased from an approved supplier with certificates of analysis (COA). However, the supplier approval plan was not properly implemented and no on-site audits were conducted. FDA recommended that COAs from labs using scientifically valid methods and procedures document that supplied ingredients (e.g., cinnamon) meet food-grade production standards for every major analytical parameter (e.g., heavy metals).
    • The plan for heavy metal monitoring in the finished product that was provided to FDA did not include critical information like what constituted a representative sample, what method would be used by the test lab, and how the company would assure that the method was properly followed.
  • The warning letter is part of FDA’s continued efforts to reduce the incidence of lead and other heavy metal contamination.   
  • USDA’s Food Safety and Inspection Service (FSIS) will begin testing products for the presence of allergens in its new allergen verification sampling program. The sampling will occur at establishments that produce ready-to-eat products with labeling that claims the absence of at least one of 14 food allergens, including soy, crustacean shellfish, eggs, peanuts, milk, almond, Brazil nut, cashew, coconut, hazelnut, macadamia, pine nut, pistachio, and walnut. FSIS will also test for gluten and intends to expand the program to include sesame.
  • According to the FSIS website, unreported allergens make up 37% of recalls of FSIS-inspected products, with 12 recalls for unreported allergens so far in 2024. FSIS is implementing this program to expand its industry compliance verification by significantly expanding and replacing the current soy testing program, broadening the scope to include multiple allergens. FSIS aims to ensure the accuracy of labeling claims in ready-to-eat products, which will enhance consumer safety.
  • FSIS intends to issue instructions to inspection program personnel by July 26, 2024. In addition to the new sampling program, USDA is working to increase allergen awareness with food safety and allergen tips for parents and caregivers.
  • Keller and Heckman will continue to monitor and provide updates on the allergen verification sampling program and other allergen awareness initiatives from USDA and FDA.
  • FDA has taken additional action related to the investigation into lead and chromium in apple cinnamon fruit puree pouches prompted by elevated blood lead levels in children in the fall of 2023. The Agency is prioritizing prevention, compliance, and surveillance activities by highlighting retailers’ responsibilities in recall situations and continuing oversight of foreign firms.
  • FDA issued a warning letter to Dollar Tree, Inc., because the company failed to adequately remove recalled products from its store shelves. Although the company was notified of the recall in writing on October 29, 2023, effectiveness checks showed that the recalled products remained on shelves at some stores through December 19, 2023. Further, as of the date FDA issued the warning letter, Dollar Tree had not provided the Agency with any information demonstrating sustainable corrective actions to prevent the future sale of adulterated food products.
  • FDA has also increased targeted screening of imported foods. Negasmart, the distributor of the cinnamon used in the contaminated applesauce pouches, has been placed on Import Alert 99-47 for products that appear to be adulterated for economic gain and Import Alert 99-42 for products contaminated with heavy metals. FDA has also placed Austrofood S.A.S., the manufacturer of the applesauce products, on Import Alert 99-42. The import alerts will help ensure these products are flagged for FDA review upon any attempt to import them into the U.S.
  • Keller and Heckman will continue to monitor and provide updates on the investigation into contaminated applesauce pouches.
  • Today FDA announced the publication of an assessment concluding that tara flour does not meet the criteria for generally recognized as safe (GRAS) status and that its use in food constitutes an unapproved food additive use which renders the food adulterated. The assessment comes almost 2 years after Daily Harvest’s June 2022 recall of a product containing tara flour following serious reports of adverse events, including liver toxicity and hospitalizations.
  • Tara flour is derived from the germ of the plant Tara spinosa (aka Caesalpinia spinosa or tara plant) and should not be confused with tara gum, which is derived from the endosperm of the tara plant and which FDA notes has a “well established” safety profile when used as a thickening agent/or stabilizer in food.  
  • FDA’s assessment concludes that there is little information describing the composition or effects of tara flour and that the few studies that do exist are not sufficient to support a GRAS conclusion based on scientific procedures. Indeed, one study on a non-protein amino acid in tara flour (baikiain) was suggestive of liver toxicity. Furthermore, the Daily Harvest recall, as well as other adverse event reports, are inconsistent with a GRAS conclusion. FDA also found no evidence that tara flour was consumed in food prior to 1958 which is necessary (but not sufficient) for a GRAS conclusion based on common use in food.  
  • Last September, the Canadian Food Safety Inspection Agency (CFIA) issued a similar notice, advising industry not to use tara flour because it was likely a novel food (i.e., a food without a safe history of use) and CFIA had not conducted a pre-market assessment as required for novel foods.  
  • Greenbrier International, Inc., the parent company of Dollar Tree, has been sued over alleged lead contamination in ground cinnamon (Law360 subscription required). The lawsuit follows recalls of lead-tainted ground cinnamon and cinnamon apple sauce products.
  • According to the plaintiff, Dollar Tree’s Supreme Tradition Ground Cinnamon, which was purchased for normal household use, contained hundreds of times more lead than the FDA’s proposed action levels for lead contamination suggest are safe. The plaintiff claims that the company violated New York State’s false advertising laws by labeling the product in a “way to impact consumer choices and gain market dominance” even though the company knew consumers “would be unwilling or less likely to buy the product if [they] knew the product contained lead.”
  • The plaintiff stated that Dollar Tree is responsible for ensuring its products are safe and not contaminated with dangerous substances and that the company and its cinnamon manufacturer should have measures in place to ensure the products are safe.
  • We have blogged previously about the lead-contaminated cinnamon and cinnamon products, as well as the related recalls. Keller and Heckman will continue to monitor this issue.
  • Earlier this month, the Federal Trade Commission (FTC) released a report which analyzes market factors contributing to the infant formula market disruptions that occurred in 2022 following the recall of infant formula manufactured at Abbot’s Sturgis, Michigan manufacturing facility due to potential bacterial contamination.
  • The report describes how the U.S. infant formula market has been highly concentrated among only a few manufactures for decades; primarily Abbot, Mead Johnson (owned by Reckitt Benckiser), Perrigo (owns PBM Holdings), and Nestle (which sold the U.S. and Canadian rights to Gerber Good Start brand to Perrigo along with its Wisconsin manufacturing facility). The report also discusses two principal factors which have contributed to market concentration.
  • One factor is the single-rebate system used in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program. The WIC program, which is administered by USDA through state agencies, offers assistance, including nutritional assistance, to certain at-risk individuals. In 2018 56% of the infant formula sold in the U.S. was purchased by WIC participants. Infant formula purchased through WIC is heavily discounted because individual states negotiate significant rebates (averaging 92% of the wholesale price of infant formula in 2013) in exchange for market exclusivity within the state’s WIC program. These WIC-exclusivity agreements have spill-over effects in the broader infant formula market and dramatic (≈ 90%) increases or decreases in market share have been seen following the gain or loss of a WIC contract.
  • The report also discusses FDA’s extensive regulation of infant formula as a second factor contributing to market consolidation by acting as a barrier to entry. Infant formula must be of “sufficient biological quality” and must support growth, demonstration of which typically requires a specific 15-week preclinical study. Among the other requirements, new infant formula submissions are also required at least 90 days before marketing the formula.
  • The report is written in a neutral manner which details the primary factors contributing to the consolidation of the infant formula market, but acknowledges that these factors also have positive impacts (e.g., lower infant formula prices for WIC participants), and does not offer any recommendations.
  • In January of this year, FDA testing revealed the presence of toxic yellow oleander (Thevetia peruviana) in a number of dietary supplements containing Crataegus mexicana, which the supplements refer to as tejocote root, and in one case as “brazil seed.” We note that Crataegus mexicana can also be referred to by other names such as “Mexican hawthorn,” although none of the products that have been identified as contaminated use that name. Many of these products are advertised as weight loss supplements. The FDA testing followed the lead of an earlier Centers for Disease Control (CDC) investigation, which also revealed yellow oleander contamination in tejocote supplements.
  • FDA continues to receive adverse event reports. Many of the sellers have not recalled their product, so there are significant concerns that some of these products remain on the market. FDA states that yellow oleander can cause severe, or even fatal, neurologic, gastrointestinal, and cardiovascular adverse health effects.
  • While FDA has mandatory recall authority where a product is adulterated or misbranded and there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death, it has not yet instituted any mandatory recalls and has instead worked to remove listings for these products and/or facilitate voluntary recalls.
  • On March 6, 2024, the U.S. Food and Drug Administration (FDA) sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the US, reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including ground cinnamon products.  The Agency also recommended the voluntary recall of certain ground cinnamon products sold by a number of brands at six different retail chains that were found to contain levels of lead.
  • This letter follows the recent incidents associated with certain cinnamon apple sauce pouches that resulted in lead poisoning in young children.  As we have previously blogged, FDA’s investigation into the contaminated apple sauce pouches traced the contamination back to a manufacturer and cinnamon supplier in Ecuador.
  • FDA notified the distributors and manufacturers of products found to contain elevated levels of lead and recommended that the manufacturers voluntarily recall these products because prolonged exposure to them may be unsafe.  The products were identified during an FDA-initiated sampling and testing effort to assess cinnamon sold across numerous retail stores.  No illnesses or adverse events have been reported to date related to the ground cinnamon products listed in this news release, but the FDA is concerned that, because of the elevated lead levels in these products, continued and prolonged use of the products may be unsafe.
  • Since the issuance of the letter, recipient companies El Chilar and Raja Foods, as well as Stonewall Kitchen and Colonna, have issued voluntary recalls for some of their cinnamon products.
  • FDA continues to work with the Center for Disease Control and Prevention (CDC), as well as state and local partners, to investigate elevated lead and chromium levels in individuals with reported exposure to apple cinnamon fruit puree pouches.  Keller and Heckman will continue to monitor and relay any developments in this area.