Short answer: an FDA food facility registration did not protect this Ecuadorian manufacturer when its hazard analysis and supplier verification failed to control lead in cinnamon. The public record shows that 39 lots — 2,998,088 individual fruit-puree and applesauce pouches — were recalled after regulators detected extremely high lead concentrations.
This article summarizes public FDA enforcement records. The companies named in those records are not identified as FDABridge clients.
What happened in the Ecuador cinnamon applesauce case?
Beginning in October 2023, FDA, CDC, and state partners investigated elevated blood-lead reports associated with WanaBana apple cinnamon fruit puree and related private-label applesauce pouches. The products were manufactured by AUSTROFOOD S.A.S. in Ecuador. WanaBana USA initiated the recall on October 29, 2023, and FDA later classified it as a Class I recall.
FDA's August 9, 2024 warning letter reported lead results ranging from 1.44 parts per million to 6.43 parts per million in tested finished pouches. Testing of cinnamon collected at the Ecuador facility found 2,270 ppm and 5,110 ppm lead, plus high chromium. FDA stated that additional analysis identified lead chromate in the cinnamon, which was indicative of economic adulteration.
Why did FDA cite the manufacturer?
FDA said the facility's hazard analyses did not identify lead in cinnamon as a hazard requiring a preventive control. The facility had a written supply-chain program, but the warning letter stated that it did not implement its own requirement for an annual onsite audit of the Ecuadorian cinnamon supplier. A desk audit was performed instead.
The enforcement lesson is broader than cinnamon. Under the FSMA preventive-controls framework, a foreign food manufacturer must identify known or reasonably foreseeable biological, chemical, and physical hazards. When a hazard is controlled by a supplier, the manufacturer needs a risk-based supply-chain program with approved suppliers, suitable verification activities, documented review, and corrective action.
What should foreign food manufacturers do differently?
- Treat spices, botanicals, colors, and mineral ingredients as potential chemical-hazard inputs instead of relying only on microbiological specifications.
- Match supplier-verification frequency and method to the hazard, product, supplier history, and vulnerability of the intended consumer.
- Define representative sampling, validated analytical methods, acceptance criteria, and lot-release authority in writing.
- Verify the laboratory and the certificate of analysis; a supplier-issued COA is evidence, not a complete control program.
- Make sure the US importer addresses the same hazards in its Foreign Supplier Verification Program.
Quick answers for exporters
Did the FDA registration itself fail?
No. Registration identifies the facility; it does not approve the food, validate the food-safety plan, or prevent enforcement when a product is adulterated.
Can finished-product testing replace supplier controls?
Not by itself. FDA's warning letter emphasized a risk-based supply-chain program and questioned whether the proposed sampling and analytical procedures were sufficiently defined and implemented.
Verified public sources
- FDA warning letter to AUSTROFOOD S.A.S., August 9, 2024: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/austrofood-sas-679052-08092024
- FDA post-incident response for elevated lead and chromium in cinnamon applesauce: https://www.fda.gov/food/outbreaks-foodborne-illness/post-incident-response-activities-elevated-lead-and-chromium-levels-cinnamon-applesauce-pouches
If you export foods containing spices or other high-risk ingredients, FDABridge can review the FDA registration, label, and market-entry file before shipment. Start at fdabridge.com/food or fdabridge.com/contact.
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