Food Safety in the News: FDA Creates an Accelerated Path for Food Importers

Aug 21, 2015   

Friday, August 21st, 2015

The U.S. Food and Drug Administration (“FDA”) has established the Voluntary Qualified Importer Program (“VQIP”), which will allow participating importers to expedite review and importation of foods. The VQIP is in the draft guidance stage of implementation, meaning that the program is not binding on the FDA or the public until all public comments are received and the FDA finalizes the program. (To read the VQIP Draft Guidance please click here.) This program has been created as a result of the recently enacted Food Safety Modernization Act (“FSMA“), which “enables the [FDA] to better protect public health by helping to ensure the safety and security of the food supply.” Guidance at 3. The FSMA was signed into law to amend the Federal Food, Drug, and Cosmetic Act (“FD&C Act“) with the goal of protecting the United States food supply.
The FSMA implements safety standards importers must meet to import food into the United States. Pursuant to the FSMA, FDA is required to create a system through which food importers who have a proven food safety track record can expedite imports, and FDA created the VQIP to comply with that mandate. The VQIP is a voluntary, fee-based system allowing expedited review and importation of food for importers who have proven food safety track records and high levels of control over the supply chain.
The draft guidance lists the benefits of the program and the criteria importers must meet to become and remain eligible. Here are a few points of emphasis:

* Expedited entry into the United States for foods included and approved in the VQIP application. Therefore, qualified importers will enjoy the immediate release of their foods being imported into the United States.
* Examination limited to “for cause” situations, such as risks to public health or to audit the importer, instead of random, at will examinations.
* The VQIP importer can determine the location of the FDA examination mentioned immediately above.

* Food importers must have at least a three-year history of importing food into the United States;
* The importer, or any entity associated with the food, cannot be subject to an ongoing FDA investigation or action, or have a history of noncompliance.
* Importers must develop and implement food safety procedures -VQIP written policies –

for the entire supply chain, which ensures adequate safety and security over the entire chain.
Importers must be cognizant that they will experience a period of heighted FDA scrutiny prior to initial approval. However, once accepted, the importers will enjoy all the benefits of the VQIP program.
FDA expects this fee-based system to begin accepting importer applications on January 2018 and following the importers being accepted into the program, begin offering the benefits on October 1. FDA is accepting public comments until August 19, 2015 to allow the public to provide input on the draft guidance document, including the proposed $16,400 fee.
The attorneys in the Food, Drug, and Life Sciences practice group at Fuerst Ittleman David & Joseph, PL will continue to keep abreast of the developments with the new VQIP guidance. If you are an importer or within the industry and have questions or legal issues stemming from this guidance document, feel free to contact us at (305) 350-5690 or