In the past week, the US FDA has issued import alerts for: • human and animal foods for pesticides • foods containing illegal and/or undeclared colors • seafood products due to the presence of salmonella • food products due to the presence of salmonella • honey and blended syrup due to unsafe drug residues • dried peppers from Mexico • papaya from Mexico The following is a summary of the information available from the FDA explaining what import alerts are. Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. The following are some reasons why a product or firm may be subject to DWPE. This list is not all inclusive: • The FDA has sampled your product and it tested violative for a pathogen • The FDA has sampled your product and it contains illegal colors or food additives • Your product contains pesticides that are not allowed or do not meet tolerance levels • The firm has not provided sufficient evidence to support adding them to the green list • Your product is an unapproved new drug • The foreign firm had a violative inspection by the FDA • The foreign firm has refused inspection by the FDA The purpose of import alerts are to: • Prevent potentially violative products from being distributed in the United States; • Free-up agency resources to examine other shipments; • Provide uniform coverage across the country; • Place the responsibility back on the importer to ensure that the products being imported into the United States are in compliance with the FDA’s laws and regulations. If a product is detained without physical examination, the company has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If evidence is not provided to the FDA, or if the information provided is not sufficient to overcome the appearance of the violation, the product is subject to refusal into the United States. The FDA provides details of their import alerts and they can be searched by company name, product, country of origin using the search function at: https://www.fda.gov/industry/actions-enforcement/import-alerts For further details, or if you face an import alert, get in touch on [email protected] |
FSMA’s Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration
This final rule of our series with Perigon Product Recall describes efforts made to prevent intentional adulteration. The rule under the Food Safety Modernization Act