First FDA Voluntary Qualified Importer Program Application Period Begins October 1, 2018
The U.S. Food and Drug Administration (FDA) will begin accepting applications for its Voluntary Qualified Importer Program (VQIP) on October 1, 2018. In a September 2018 webinar, FDA stated it intends to review around 200 VQIP applications during Fiscal Year (FY) 2019.
What is VQIP?
VQIP allows eligible importers to pay an annual fee for expedited review and release of foods specified in an approved VQIP application. FDA will limit examination and sampling of these foods to situations where they are linked to a public health risk.
During the recent webinar, FDA estimated that participating importers may see their shipments released in as little as ten minutes. FDA compared this to an average release of 14.5 hours if manual review is needed, or 6.7 days if documentation or analysis is needed.
How Do I Participate In VQIP?
To take advantage of these benefits, importers may submit an application to FDA that covers aspects such as the foods they wish to import under expedited review, the suppliers of those foods, and a description of procedures used to ensure the safety of foods throughout the supply-chain. FDA may also examine the foods’ labels for compliance with certain requirements such as allergen labeling.
Among other requirements, VQIP-eligible importers must:
- have a three-year history of food importation into the U.S.
- be in compliance with applicable FDA food safety regulations (i.e. HACCP, HARPC, or FSVP)
- hold a current certification issued by an FDA-accredited third-party certification body for each foreign supplier listed in the VQIP application.
- not currently have compliance issues with FDA (i.e. Import Alerts, Class I recalls, Warning Letters, etc.) or have a history of significant non-compliance
What is the Cost to Participate in VQIP?
FDA estimates the VQIP user fee to be $16,400. The Agency states it will request payment of VQIP fees after an application has been approved. VQIP benefits for approved importers who have paid the fee will begin on October 1, 2019.
Registrar Corp offers a variety of services to help interested parties meet VQIP eligibility requirements. Our Regulatory Specialists can develop your FSVPs, write HARPC and HACCP plans for your suppliers, or review current plans for compliance. Registrar Corp can also help remove a supplier from Import Alert by developing a petition to FDA. Lastly, the Registrar Corp FDA Compliance Monitor provides a simple solution to supply-chain monitoring requirements.
For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.