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FDA Revises Import Alert for Spinach and/or Kakina from 2 Japan Prefectures

On April 15, 2011, the Food and Drug Administration updated its Import Alert (IA # 99-33) on detention without physical examination of certain milk, milk products, fruit, vegetables, and baby formula from Japan due to radionuclide contamination.

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Spinach, Kakina from 2 Prefectures no Longer Detained & Refused Admission under 801(a)(2)

The revision is necessary because on April 12, 2011, the Japanese government lifted its restriction on the distribution of spinach and kakina from the Gunma prefecture, and kakina from the Tochigi prefecture based on data received.

Therefore, FDA states that is no longer appropriate to detain these products under section 801(a)(2) of the Federal Food, Drug, and Cosmetic Act, under which products are detained and refused admission because they are forbidden or restricted in sale in the country in which they were produced or exported.

But Will Detain Under 801(a)(3), Only Enter if Free of Radionuclide Contamination

The import alert states that now, spinach and kakina from the Gunma prefecture and kakina from the Tochigi prefecture will be detained pursuant to Section 801(a)(3), which means they will be detained and refused admission, unless shown to be free from radionuclide contamination.

(See ITT’s Online Archives or 04/14/11, 03/25/11, 03/24/11, 03/22/11, and 04/14/11 news, 11041416, 10032522, 11032438, 11032225, and 11041416, for BP summaries of previous versions of Import Alert #99-33 and FDA’s Question and Answer document on the situation.)

FDA Q&A document, updated 04/11/11, available here