December 1, 2022

Volume XII, Number 335


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New Report Outlines FDA’s Strategy to Ensure the Safety of Imported Produce

  • On September 27, the FDA released “Activities to Enhance the Safety of Imported Produce,” a report which details how the Agency’s 2019 strategy for safeguarding imported food specifically applies to imported produce. For background on the FDA’s “Strategy for the Safety of Imported Food,” see our February 2019 blog.

  • The new report outlines how the agency is working to enhance the safety of fresh fruits and vegetables through four goals that were established in the 2019 strategy document. The report details how the FDA works to achieve each goal.

    • Goal 1 – Food Offered for Import Meets U.S. Food Safety Requirements

      • Specifically for Goal 1, the FDA relies on international inspections, use of verified foreign suppliers through effective implementation of the FSVP final rule, audits such as those conducted under FDA’s Accredited Third-Party Certification Program or other programs aligned with FDA produce safety requirements, incentivizes importers to use verified suppliers through the Voluntary Qualified Importer Program (VQIP), leverages oversight efforts of regulatory counterparts with strong food safety systems, and increases awareness and training of produce safety requirements.

    • Goal 2 – FDA Border Surveillance Prevents Entry of Unsafe Foods

      • Some of FDA’s activities for Goal 2 include enhancing and refining FDA’s import screening and entry review process, optimizing use of sampling of imported produce, utilizing import alerts and import certifications, improving testing methods and tools to determine admissibility of produce offered for import, and maximizing the benefit to border surveillance from state and other partnerships.

    • Goal 3 – Rapid and Effective Response to Unsafe Imported Food

      • For Goal 3, the FDA maximizes effectiveness of FDA’s response to an event involving imported produce, enhances the efficiency and effectiveness of recalls, and uses information sharing-opportunities to prepare for and respond to unsafe imported produce.

    • Goal 4 – Effective and Efficient Food Import Program

      • For Goal 4, the FDA has developed an improved understanding of the global inventory of produce facilities and farms and conducts performance assessments of the effectiveness of import activities.

Nicholas Prust, Frederick Stearns, and Emily Thomas also contributed to this article.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 271

About this Author

Lisa P. Alsobrook Attorney Keller Heckman DC Office

Lisa Alsobrook practices in the area of food and drug law. She advises domestic and foreign clients on regulatory requirements for foods, dietary supplements, cosmetics, and food and drug packaging in jurisdictions around the world. Her main focus is regulatory and compliance matters of the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture relating to human food, food packaging material, animal feed, food additives and ingredients, and dietary supplements.

Prior to attending law school, Lisa earned a master’s degree in Food Science. She worked as a...

Melvin S. Drozen, FDA, regulatory lawyer, Keller Heckman, law firm

Melvin S. Drozen joined Keller and Heckman in 1987.

Mr. Drozen advises clients on a broad spectrum of FDA, FTC, USDA and EPA (pesticides) regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, N.Y., and then an attorney in the General Counsel's Office of the Food and Drug Administration for seven...

Jill M Mahoney Associate Attorney Keller Heckman

Jill Mahoney advises clients on regulatory requirements for food, animal feed, food additives, dietary supplements, and cosmetics. She counsels clients on labeling and advertising compliance and claims substantiation issues, including nutrition labeling, ingredient declarations, nutrient content claims, structure function claims, and Country of Origin labeling. She assists food, animal feed, and dietary supplement manufacturers in preparing self-determined GRAS positions, GRAS Notifications for Food and Drug Administration (FDA) submissions, New Dietary Ingredient Notification submissions...

Richard Mann Partner Keller Heckman DC

Richard (Rick) Mann represents his clients in business and trade association disputes relating to food advertising, promotional and labeling claims, food safety and compliance issues, and general business and corporate law matters.

Rick works extensively with clients in the development of compliant advertising, promotional, and labeling claims and campaigns, and the development of appropriate support for such claims. His regulatory experience allows him to represent his clients in proceedings at the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the National...

Paula S. Pastuskovas San Francisco Food and Drug Attorney Keller and Heckman

Paula Pastuskovas counsels domestic and international clients on regulatory and compliance matters in food and drug law. She assists clients in obtaining regulatory clearances for food additives and food-contact materials from the U.S. Food and Drug Administration (FDA), Health Canada, and other comparable international agencies. She advises clients on food labeling, ingredient, and substantiation issues. 

As a resident of the firm’s San Francisco office, Paula also advises companies on compliance with California’s state and local laws. This...