• 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.
  • The U.S. Food and Drug Administration (FDA) has provided an update regarding the cinnamon applesauce pouches that have been recalled.  FDA’s investigation began on November 9, 2023, when WanaBana USA voluntarily recalled all lots of WanaBana Apple Cinnamon Fruit Puree pouches, Schnucks-brand cinnamon flavored applesauce pouches, and Weis-brand cinnamon applesauce pouches due to reports of elevated levels of lead.
  •  As of January 8, 2024, FDA has received 87 confirmed complaints/reports of adverse events potentially linked to the recalled product.
  • CDC’s National Center for Environmental Health is currently conducting case finding efforts in collaboration with state and local health departments.  As of January 5, 2023, CDC has received reports of 86 confirmed cases, 209 probable cases, and 26 suspected cases, totaling 321 cases from 38 different states through their reporting structure.
  • FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses.  Because of the products’ long shelf life, cases are still being reported.
  • Keller and Heckman will continue to monitor and relay any developments in the investigation.
  • 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 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.
  • 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.
  • Center for Drug Evaluation and Research (CDER) researchers recently conducted a study titled, The effect of food vehicles in vitro performance of pantoprazole sodium delayed release sprinkle formulation, to better understand the oral drug effectiveness when sprinkled onto or into certain foods.  “Sprinkling” a drug into food vehicles is a common alternative for patients who have difficulty swallowing solid foods or medications.  Previous research has shown that mixing incompatible foods and drugs may impact the drug’s rate of dissolution in the gastrointestinal tract, potency, and may even lead to undesired side effects.
  • Researchers focused on pantoprazole sodium (antacid), which patients are currently advised to mix with applesauce or apple juice, as supported by in vivo data described in the labeling.
  • The study evaluated several food vehicles and their effect on the in vitro performance (i.e., the process of dissolving in the body) of the drug.  Researchers chose apple juice and applesauce, as well as pudding, yogurt, and milk.  The foods differed in their viscosity (thickness), pH level (or how acidic/basic an item is), and water content. 
  • In the study, the researchers sprinkled the pantoprazole sodium granules on the food vehicles for different amounts of contact time (30, 60, or 120 minutes).  Then they placed the mixture into a dissolution apparatus for in vitro dissolution testing and took samples after various time periods.
  • Researchers found that the food’s pH and the length of time it was mixed with the drug affected drug performance.  When researchers mixed the drug into low pH food vehicles, such as applesauce or apple juice, the drug performed similarly to the control group.  Conversely, high pH food vehicles, such as milk, with a long contact time (e.g., 120 minutes) caused premature drug release, drug degradation, and loss of performance.  In conclusion, researchers confirmed that an in vitro assessment can detect the effect of the food vehicle on drug performance, which has implications for evaluating drug safety and efficacy.
  • On October 6, 2020, a California judge dismissed an amended complaint alleging that apple juice and applesauce products sold by Mott’s, LLP (a subsidiary of Dr. Pepper Snapple Group, Inc.) were falsely advertised as “Natural” and/or “All Natural Ingredients” where they contained trace amounts of the acetamiprid, a neonicotinoid pesticide.
  • The amended complaint was virtually identical to the original complaint (which was dismissed), but for the addition of two generic surveys which Plaintiff alleged demonstrated that consumers did not expect “natural” products to contain trace amounts of pesticides. One 2019 study reported that 68.1% of consumers did not believe that crops sprayed with synthetic pesticides were natural, while a 2015 study reported that 63% of respondents thought that natural labeling meant that “no toxic pesticides were used.”
  • Relying on precedent dealing with nearly identical issues (even the same two surveys were involved), the Court rejected Plaintiff’s argument and held that the surveys were not enough to demonstrate that a reasonable consumer would believe that a “natural” food product would contain no residual pesticides, even in trace amounts. Specifically, the Court found that the 2019 study was not persuasive because it related to crop production and not food labeling, while the 2015 study did not define important terms like “natural” and “toxic,” and arguably undermined Plaintiff’s claims by suggesting that the term “natural”  was “essentially meaningless.”
  • The case is a part of a continuing trend of litigation targeting “natural” claims even amidst the regulatory uncertainty regarding the use of the term. (In 2015, the FDA solicited comments regarding the use of the term, but has yet to take any action.) Keller and Heckman will continue to monitor and report on “natural” litigation and regulatory efforts to define the term.