FDA Import Alert Removal
What is an FDA Import Alert?
An FDA Import Alert is an FDA enforcement tool to keep potentially dangerous products from entering the U.S. marketplace. It allows FDA to detain, without physically examining, products that either have or potentially could violate FDA regulations (based on prior violative shipments), alerts FDA field staff that the agency has enough evidence to automatically refuse admission of future shipments of imported articles, and shifts the burden to the importer after repeat violations to demonstrate product compliance via analytic testing/sampling.
Importantly, it means that future shipments of a product will not be allowed U.S. entry, unless the importer demonstrates product compliance. This can be extremely costly, cause delays, upset business flow, and question where you will source products/ingredients.
Who does it affect?
Import Alerts can affect manufacturers, shippers, growers, importers, or an entire geographic area of a specific country.
Why is my company or supplier on Import Alert?
You, or your company, may have been placed on Import Alert for a variety of reasons. This includes having a history of importing the violative products, that the products may appear violative, that there may have been issues raised during inspections of a manufacturing site or flags raised as a result of product recalls, or other information indicating that future and ongoing shipments may “appear” violative.
Examples of Import Alerts:
- 99-08 DWPE of Processed Human and Animal Foods for Pesticides
- 66-41 DWPE of Unapproved New Drugs Promoted in the U.S.
- 53-06 DWPE of Cosmetics that are Adulterated and/or Misbranded due to Color Additive Violations
- 36-01 Adulteration of Honey
Will I always be on Import Alert, or is there a way to resolve placement?
The longer-term resolution and more “permanent” fix is to Petition FDA to remove the company from Import Alert. This involves a detailed legal and regulatory submission to the FDA, which documents corrective actions and supporting records to address the root cause of the Import Alert placement and to show that non-compliant practices have been resolved.
How Garg Law Can Help:
Whether you are a distributor with a supplier who is on Import Alert, a manufacturer on Import Alert, or a region that has geographic placement on an Import Alert, removing your company from the “Red List” is the only way to resolve the issues more permanently. With our specific expertise in Import Alert removals, Garg Law can assist you with the following:
- Understanding the parameters of an Import Alert placement, and identifying and developing a game plan for removal
- Assisting with document drafting and assessing supportive records for the Petition
- Drafting and filing the Petition for Removal from Import Alert
- Representing and liaising with the appropriate FDA staff to resolve your matter
While each case is different, and prior success does not guarantee results, we are proud to report our proven track record of success. With our knowledge of the process and our legal and regulatory expertise, please contact us to discuss your case further.
