FDA Expands Scope of Chinese Vegetable Protein Import Alert for Melamine

Jul 28, 2021 | China, FDA, Food, Imports, Imports from China, Law & Regulatory

In 2012 FDAImports represented a Chinese primary vegetable protein processor to obtain the first Green Ticket from the Food and Drug Administration’s (FDA) Import Alert (IA) #99-29. Since then, multiple other Chinese vegetable protein processors have obtained a Green Ticket, many with the help of FDAImports. However, the FDA has changed its policy and as a result, Chinese secondary processors of finished foods are going to be subject to this IA 99-29 as well. Recently, the FDA’s Center for Veterinary Medicine (CVM) (the office in FDA responsible for regulating animal food such as pet chews) has expanded the reach of IA 99-29 significantly. FDAImports has seen many finished, processed pet foods and pet chews from China that contain vegetable protein being detained under IA 99-29. This is a new policy at FDA, and it is still unpublished. Importers and Chinese secondary processors of animal food need to be aware of how these changes will affect their supply chain.

FDA issued 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” in 2007 when thousands of pets in the United States died due to the presence of Melamine in Chinese origin pet foods containing contaminated vegetable proteins.  Because FDA could not identify the specific manufacturers of the contaminated vegetable proteins, it created the countrywide Import Alert, leading to the automatic detention of every imported vegetable protein shipment from China. These vegetable proteins included Wheat Gluten, Rice Gluten, Rice Protein, Rice Protein Concentrate, Corn Gluten, Corn Gluten Meal, Corn Milled Protein, Soy Protein, Soy Gluten, Soy Meal, and Mung Bean Protein. However, never before had FDA applied this import alert to secondary processors of animal food using Chinese origin vegetable proteins.

Now, FDA is applying IA 99-29 to finished, imported, Chinese-origin animal food (such as pet food and pet chews) that contain vegetable protein. On its face, the Import Alert does not apply to finished animal food containing vegetable protein. FDAImports learned that FDA is amending IA 99-29 because it is too vague and fails to clarify that it applies to Chinese animal food containing vegetable proteins. This means many more of these finished products will be detained by FDA when they arrive in the US.  Although there are various solutions for obtaining release of these detained shipments (even without testing in the US), the best approach is for Chinese secondary processors to seek Green Ticket status on IA 99-29. Our CEO and Founder Ben England states, “The policy change will cast a wider net for CVM to automatically detain shipments of finished animal food that until now have not been affected IA 99-29. Luckily, we have a solution for clients – resulting in releases without testing.”

The first step is for importers to confirm their suppliers are Green Listed.  If they (or you) are not yet on the Green List, we can help. FDAImports and our Chinese subsidiary, ExportToUsa.com.cn, have aided numerous companies with obtaining removal from FDA Import Alerts. Contact us today for help.

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