The Food & Drug Administration (FDA) has begun to apply Import Alert 99-29, “Detention Without Physical Examination of All Vegetable Protein Products From China for Animal or Human Food Use Due to the Presence of Melamine and/or Melamine Analogs,” to imported finished pet foods from China with vegetable-based proteins that may contain melamine. This has never been covered before by this import alert. Melamine, an industrial chemical, and its related compounds have no approved use as an ingredient in animal or human food in the United States. We believe a recent uptick in detentions of pet food shipments from China is a predictor of more policy change to come. FDA field officials have recommended the alert be amended to explicitly cover finished pet foods from China that contain vegetable proteins.
In 2007, FDA discovered an outbreak of domestic animal illnesses and deaths associated with pet food manufactured with vegetable proteins contaminated with melamine and melamine-related compounds. This outbreak resulted in over 17,000 complaints and 17 Class I and II recalls based on samples collected. FDA collected samples of pet foods containing wheat gluten; 45% tested positive for melamine or melamine-related compounds. FDA also collected samples containing rice protein concentrate; 32% were found positive for melamine or melamine-related compounds. All of these positive samples were traced back to having been imported from China. Since then, the US has been closely monitoring imported animal food for melamine, with a closer eye still on Chinese imports.
To release shipments detained under Import Alert 99-92, importers need to provide evidence from a third-party laboratory analysis (of a representative sample from the whole shipment) that verifies the product does not contain melamine or cyanuric acid. Third-party laboratories may use any method found acceptable by FDA (meets method performance of LC-MS/MS).
Pet food processors who purchased vegetable-based protein materials from companies already on the 99-29 Green List (meaning that third-party lab results showed that the raw material consistently tested negative for melamine) are being asked to test a third time locally. Before, companies listed on Import Alert 99-29 were raw vegetable protein suppliers, not finished good processors. FDA is starting to detain finished goods which contain vegetable-based protein, reflecting that FDA’s policy may potentially change. It is vital for importers to understand and hold accountable each phase of their supply chain.
Importers seeking removal from automatic detention (aiming to be added to the Green List) need to adequately determine whether their suppliers and manufacturers have appropriate controls and processes to ensure the product’s quality. The company or shipper should provide the following information:
- Documentation showing that FDA has released a minimum of five consecutive non-violative shipments based on third-party laboratory analyses using FDA-recommended methods.
- Documentation that all shipments did not contain the presence of melamine and/or melamine analogs.
- Certificate indicating that an inspection of the manufacturer was conducted and adequate controls are in place.
Ben England, founder and CEO of FDAImports, said, “While the former administration focused on trade wars and tariffs, the new administration is more concerned about food and drug safety. Enforcement will likely be more strict in the coming years. Pet food manufacturers need to perform the required melamine testing and have protocols in place to avoid any detentions at the port.”
FDAImports assists companies in getting on the Green List or seeking removal from Red Lists. We can help; please feel free to contact us.
