Recordkeeping Under Food Safety Modernization Act

Posted by Lisa Capote | Mar 14, 2012 | 0 Comments

The Food Safety Modernization Act was signed a little over a year ago and FDA continues to make strides in implementing all the new FDA laws required under the Congressional mandate. The latest proposed FDA law issued February 2012 addresses establishment, maintenance, and availability of records: Amendment to Record Availability Requirements. Under the proposed FDA law, FDA officials that have a reasonable belief that an article or any other food that may be affected in a similar manner will be permitted access to records to pertaining to these food products.

Under the current FDA law, an FDA official may request records of a specific food product where there is reason to believe it is adulterated. The new regulations will expand FDA's powers to review records. As an example, an importer of papaya from Mexico will automatically be detained under an Import Alert currently in place. If in the same container a different fruit, say mangos, are being shipped there is the potential that FDA officials “reasonably believe” the mangos, simply for being shipped with the papayas, can be adulterated. At that point, FDA can request documentation from the importer or supplier to confirm the status and safety of the product. The FDA law requires that these documents must be made available as soon as possible, but not to exceed 24 hours from the time of receipt of the request.

Although the new FDA law is only a proposed law, there is a potential it will become regulation after the prescribed notice and comment period. Importers and suppliers, alike, need to be prepared to turn over any and all documentation related to their food products on a moment's notice that establishes the safety of the product.

About the Author

Lisa Capote

Ms. Capote is the founder and Managing Partner of Capote Law Firm. She founded the minority, woman owned law firm in 2006 with the goal to provide quality service to FDA regulated companies. Since that time her practice has grown to include other US federal agencies as well as an international trade component.


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