The U.S. Food and Drug Administration is continuing to take steps following the investigation of lead and chromium in apple cinnamon fruit puree pouches this past fall that was prompted by findings of elevated blood lead levels in children. While initial response activities to investigate the source of the contamination and prevent additional illnesses are completed, the Agency is continuing to explore prevention, compliance, and surveillance activities going forward.
Source: U.S. Food and Drug Administration
FDA Takes Additional Steps Following Investigation of Elevated Lead and Chromium Levels in Apple Cinnamon Puree Products
June 18, 2024
The U.S. Food and Drug Administration is continuing to take steps following the investigation of lead and chromium in apple cinnamon fruit puree pouches this past fall that was prompted by findings of elevated blood lead levels in children. While initial response activities to investigate the source of the contamination and prevent additional illnesses are completed, the Agency is continuing to explore prevention, compliance, and surveillance activities going forward.
One key post-response activity is highlighting the important responsibility that retailers have in effectuating a recall. The FDA is issuing this warning letter to Dollar Tree, Inc., because, at the time of the recall, the company failed to adequately remove recalled WanaBana apple cinnamon fruit puree pouches from its store shelves. In the weeks and months that followed the manufacturer’s voluntary recall of apple cinnamon fruit puree pouches, public health officials across many states reported continuing to see recalled WanaBana apple cinnamon fruit puree pouches on Dollar Tree store shelves. This warning letter is part of the Agency’s ongoing post-incident response activities.
Importantly, when a food is recalled, retailers play a crucial role in carrying out the recall by ensuring that recalled products are not available to consumers at their stores. The Agency is concerned with Dollar Tree’s capability to quickly remove unsafe products from its store shelves as necessary and as required during a public health threat, such as a recall. The FDA has asked the company to respond within 15 days of receipt of the warning letter stating the specific steps it has taken to address any violations and prevent the recurrence of violations or providing its reasoning and supporting information as to why the company believes it is not in violation of the law.
In addition, the FDA is continuing oversight of foreign firms and imported foods, including through increased and more targeted import screening. As such, the Agency has also placed Negasmart, doing business as Sanchez Obando Alexander Ricardo, the distributor of the cinnamon used in the contaminated applesauce products, on multiple import alerts, including Import Alert 99-47 regarding products that appear to be adulterated for economic gain and Import Alert- 99-42 for products that are contaminated with heavy metals and appear to be adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Import alerts are tools the FDA uses when the Agency has enough evidence to allow for Detention Without Physical Examination of products that appear to be in violation of the FD&C Act. While the FDA has no indication that Negasmart/Sanchez Obando Alexander Ricardo is attempting to import products, the import alerts will help ensure that any attempt by the firm to import products will be flagged for FDA reviewers prior to any shipments entering the U.S. and reaching consumers. Following the WanaBana apple cinnamon fruit puree pouch recall and FDA’s investigation, the FDA also added Austrofood S.A.S., the manufacturer of the apple cinnamon fruit puree pouches, to Import Alert 99-42.
The FDA’s priority is the health and well-being of U.S. consumers, which the Agency helps protect by providing guidance and oversight to industry, establishing and enforcing regulations that reduce foodborne illness, and strengthening partnerships and collaboration with stakeholders to ensure that our food is not contaminated at any point during its journey along the supply chain. Food safety is a shared responsibility that involves food producers, distributors, manufacturers, and retailers alike.
FDA WARNING LETTER TO DOLLAR TREE, INC.:
June 11, 2024
Dear Mr. Dreiling:
Beginning in October 2023, the U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC) and state and local partners, investigated elevated levels of lead linked to consumption of WanaBana Apple Cinnamon Fruit Puree pouches. As described below, laboratory analysis of multiple lots of WanaBana Apple Cinnamon Fruit Puree pouches, including finished product samples collected from Dollar Tree stores, detected extremely high concentrations of lead. The presence of these levels of lead causes these products to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(1)] in that they bear or contain an added poisonous or deleterious substance which may render them injurious to health.
On October 29, 2023, Wanabana USA initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree pouches. As a consignee of the recalled products, Dollar Tree Inc. (Dollar Tree or you) was notified in writing, on October 29, 2023, of Wanabana USA’s voluntary recall of Apple Cinnamon Fruit Puree pouches. Subsequent recall audit checks of your Dollar Tree and Family Dollar/Dollar Tree combination stores (collectively referred to as your “Dollar Tree stores”) revealed that you continued to offer the recalled WanaBana Apple Cinnamon Fruit Puree pouches on store shelves well after the recall was initiated, despite FDA’s numerous attempts to bring this serious issue to your attention. The receipt in interstate commerce of adulterated food, and the delivery or proffered delivery thereof for pay or otherwise, is a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)]. You can find the FD&C Act and its implementing regulations through links on FDA’s home page at https://www.fda.gov.
FDA and State Partner Testing of WanaBana Apple Cinnamon Fruit Puree Pouches
In October 2023, FDA was made aware of an investigation by the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) regarding four children with elevated blood lead levels, indicating potential acute lead toxicity. The NCDHHS investigation identified WanaBana Apple Cinnamon Fruit Puree pouches as a potential shared source of exposure. As part of their investigation, NCDHHS analyzed multiple lots of WanaBana Apple Cinnamon Fruit Puree pouches, detecting extremely high concentrations of lead. FDA and state partners also collected and analyzed additional product samples of fruit puree and applesauce pouches. FDA and Maryland Department of Health (MDH) detected extremely high concentrations of lead in WanaBana Apple Cinnamon Puree, the FDA has reviewed and supports MDH’s analytical findings. Specifically, (b)(4) parts per (b)(4) (ppm) lead was detected in an FDA sample and (b)(4) ppm lead was detected in an MDH sample of WanaBana Apple Cinnamon Puree collected from Dollar Tree stores.
The presence of these levels of lead causes the WanaBana Apple Cinnamon Fruit Puree pouches to be adulterated within the meaning of section 402(a)(1) of the FD&C Act [21 U.S.C. § 342(a)(1)] in that they bear or contain an added poisonous or deleterious substance which may render them injurious to health. Exposure to lead at the levels found in the WanaBana Apple Cinnamon Fruit Puree pouches could result in acute lead toxicity. Lead is toxic to humans and can affect people of any age or health status; children are particularly susceptible to lead toxicity due to their low body weight. Short term exposure to lead could result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. Longer term exposure could result in the following additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremor, and weight loss.
Receipt and Offer of Adulterated Foods
On October 29, 2023, Wanabana USA initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree pouches. As a consignee of the recalled product, you were notified in writing, on October 29, 2023, of the voluntary recall of Apple Cinnamon Fruit Puree pouches. In the weeks and months that followed, state and local partners in multiple states continued to report the presence of recalled WanaBana pouches on Dollar Tree store shelves with FDA requesting and working with partners to see such product removed or destroyed when found. The receipt in interstate commerce of adulterated food, and the delivery or proffered delivery thereof for pay or otherwise, is a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].
Following multiple reports from state and local partners of finding recalled WanaBana product on Dollar Tree store shelves well after you were informed of the voluntary recall by Wanabana USA, FDA initiated a Recall Audit Check (RAC) assignment to state and local partners to conduct at Dollar Tree stores. The purpose of FDA RACs is to determine if a recalling firm’s consignees received notification of the recall and followed the instructions listed in the notification. Based on FDA’s review of the RAC data from state and local partners, the agency determined that, through December 19, 2023, the recall was ineffective at the retail level due to Dollar Tree’s failure to adequately remove recalled product from Dollar Tree store shelves. RACs conducted by our state and local partners between November 10 and 30, 2023, identified an estimated (b)(4) Dollar Tree stores reporting not being notified of the recall by Dollar Tree headquarters. Furthermore, (b)(4) Dollar Tree stores that state and local partners visited between November 10 and December 19, 2023, still had recalled WanaBana product on shelves.
Despite numerous attempts to bring this serious issue to your attention, your firm continued to offer adulterated Apple Cinnamon Fruit Puree pouches on store shelves, leaving children at risk of exposure to these adulterated products. Specifically:
• On November 22, 2023, FDA held a call with Dollar Tree to discuss the ineffectiveness of your sub-recall. We asked Dollar Tree what actions you were willing to take to ensure recalled product was no longer available on store shelves. On November 27, 2023, in response to the call, you stated:
“(b)(4).”
Despite your assurance that all Dollar Tree stores had pulled the recalled product from store shelves and destroyed it, FDA continued to receive reports of recalled product being on store shelves at Dollar Tree stores. Further, merely locking recalled product from sale at your store registers (i.e., putting a stop sale in the system) is not an effective measure for removing the product from the market, as evidenced by a consumer complaint to the Kitsap Public Health District, which the Kitsap Public Health District brought to the attention of Dollar Tree stores in Kitsap County, WA on November 6, 2023. In this complaint, the consumer noted that they were shopping with their child at the Dollar Tree store and let their child eat a food pouch off the shelf before paying; the store had an active recall for the food (but had not taken the food off of the shelf) and would not let the consumer pay for the food because of the stop sale in place at the register.
• On November 28, 2023, you sent FDA an email with a copy of the notification you stated that you had sent to Dollar Tree stores on November 22, 2023, informing them to remove all units of the recalled product from the sales floor, identify them in the stockroom, and destroy them.
• On November 30 and December 1, 2023, you sent emails to FDA that included data from your store systems referencing dozens of attempted sales of recalled WanaBana products over the seven-day period from November 24 to 30, 2023, further demonstrating that the recalled product remained on store shelves.
• On December 1, 2023, due to the continued findings of product on store shelves, FDA held another call with Dollar Tree. This call was to inform you of reports of product still being offered on shelves at Dollar Tree stores in several locations. We acknowledge that after this call, Dollar Tree sent FDA an email stating that, on November 24, 2023, you stopped “(b)(4)” to Dollar Tree stores and that you “(b)(4).”
• On December 6, 2023, you provided FDA with the notice you stated that you had sent to Dollar Tree stores on December 2, 2023, regarding disposition of recalled products. As of December 7, 2023, FDA continued to receive reports from various state partners of finding recalled WanaBana product still on shelves at Dollar Tree stores. Due to the ongoing findings of recalled product, FDA held a call with Dollar Tree representatives on December 8, 2023, to discuss this failure to adequately effectuate the recall and continued offering of adulterated WanaBana Apple Cinnamon Fruit Puree pouches on Dollar Tree store shelves.
• On December 13, 2023, 45 days after your firm was notified in writing of the recall by Wanabana USA, the third-party auditor you engaged began conducting recall audit checks at the retail level.
• Through December 19, 2023, FDA and state and local partners continued to find recalled product on Dollar Tree store shelves.
• On December 18, 20, and 21, 2023, FDA again held calls with Dollar Tree to relay our concerns that your stores continued to have adulterated products on store shelves.
At various times following calls with FDA, you provided information regarding corrective actions and additional actions taken to effectuate this particular recall. However, to date, you have not provided FDA with any information demonstrating that long-term, sustainable corrections have been implemented throughout your organization to prevent adulterated food from being received in interstate commerce and subsequently offered for sale in the future.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with the food you receive and offer for sale at your establishments. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe you are not in violation of the FD&C Act, include your reasoning and any supportive information for our consideration.
Please send your reply to Food and Drug Administration, Attention: Andrew Howard Compliance Officer, Office of Human and Animal Foods Operations, Division East Two, Compliance Branch, 11155 Dolfield Boulevard, Suite 117, Owings Mills, Maryland 21117. If you have any questions regarding this letter, you may contact Andrew Howard via email at Andrew.Howard@fda.hhs.gov. Please reference CMS #674301 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Ann M. Oxenham, JD
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
Additional Resources:
- Warning Letter
- Post- Incident Response Activities: Elevated Lead and Chromium Levels in Cinnamon Applesauce Pouches
- Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce Pouches
- Import Alert 99-47 Detention Without Physical Examination of Human Food Products That Appear to be Adulterated for Economic Gain
- Import Alert 99-42 Detention Without Physical Examination of Foods Due to Heavy Metal (Toxic Element) Contamination
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