Importers Can Start Applying for FDA Expedited Review Program Oct. 1

The Food and Drug Administration has announced that the application portal for the Voluntary Qualified Importer Program will open Oct. 1, three months earlier than originally scheduled, to allow importers to submit their notices of intent to participate and completed applications early for the fiscal year 2020 benefit period.

VQIP is a voluntary fee-based program that provides expedited review and importation of human and animal foods for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. To participate, importers must meet certain eligibility requirements, which include ensuring that the facilities of their foreign supplier are certified under the accredited third-party certification program. One certification body has been accredited so far.

Interested importers should first submit a notice of intent to participate in VQIP. The FDA has indicated that it may only assess up to 200 applications in the first year, and ST&R attorney Shelly Garg says filing a notice of intent to participate will theoretically reserve an importer’s place in the queue. Notices must be resubmitted each year.

Garg also notes that preparing and submitting VQIP applications can be a time-consuming process. The FDA has said importers should have at least a three-year history of importing food into the U.S. and be in compliance with supplier verification and other responsibilities under the Foreign Supplier Verification Program and the juice and/or seafood Hazard Analysis and Critical Control Points regulations, if required. However, VQIP requires that importers go one step further to establish additional controls over their supply chains; e.g., creating quality assurance programs, which include written policies and procedures regarding safety and security and show compliance with criteria related to transportation and food defense. Garg says thoroughly reviewing and meeting the application requirements can help improve the chances an importer’s application is approved.

This article was originally published in the Sandler, Travis & Rosenberg Trade Report on September 25, 2018.

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