Tag Archives: IMPORT

FDA Issues First Warning Letter to Food Importer Under FSVP

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On August 13, FDA announced the issuance of the first warning letter to a U.S. food importer under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP).  As our readers may know, FSVP generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance … Continue Reading

FSVP Follow-up

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With little fanfare, FDA issued a new Import Alert (IA 99-41) to prevent the importation of foods by importers who are not in compliance with the Foreign Supplier Verification Program (FSVP) Regulation.  The FSVP regulations require importers to evaluate and document their suppliers and the steps taken to ensure the safety of food being imported.  … Continue Reading

FDA Announces FSMA Third-Party Certification Program User Fee Rates for Fiscal Year 2020

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On July 23, 2019, FDA published a notice in the Federal Register announcing the fiscal year 2020 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized by the Third-Party Certification Program, as authorized by the 2011 Food Safety Modernization Act (FSMA). Under … Continue Reading

FDA’s Outlines Plans to Modernize Oversight of Imported Food

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The U.S. Food and Drug Administration (FDA) discusses how the Agency is integrating new tools, that are a result of the passage of the Food Safety Modernization Act (FSMA),  with existing ones to improve the safety of imported foods in a newly released publication, “Strategy for the Safety of Imported Food.” (For background information on … Continue Reading

Fishy Business: Seafood Fraud in New York State

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As previously reported on this blog, the seafood industry has continued to deal with the issue of seafood fraud, which includes the substitution of cheaper species for more expensive ones. In December 2016, the National Oceanic and Atmospheric Administration published a final rule establishing a “Seafood Import Monitoring Program,” which included permitting, reporting and recordkeeping … Continue Reading

FDA Expands ANAB Recognition under the Accredited Third-Party Certification Program

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The Food Safety Modernization Act (FSMA) established the Accredited Third-Party Certification Program, which is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies have the authority to accredit third-party “certification bodies,” otherwise known as third-party auditors. In turn, the certification bodies (1) conduct consultative and/or regulatory food safety … Continue Reading

FDA Encourages Importer Preparation for Next VQIP Application Cycle

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As previously discussed on this blog, the Food Safety Modernization Act (FSMA) established a voluntary, fee-based program for the review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program … Continue Reading

Shrimp and Abalone to be Included in SIMP

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As previously reported on this blog, the National Marine Fisheries Service’s (NMFS) National Oceanic and Atmospheric Administration (NOAA), Commerce Department, issued a final rule on December 9, 2016 (81 FR 88975), that established the Seafood Import Monitoring Program (SIMP). The goal of the program is to prevent illegal, unreported, and unregulated (IUU) seafood from entering … Continue Reading

FSMA Update: More Clarification on FSVP from FDA

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As previously reported on this blog (see here, here and here), the U.S. Food and Drug Administration (FDA) has issued guidance documents, fact sheets, and a Q&A document on how to comply with the foreign supplier verification program (FSVP) final rule, under the Food Safety Modernization Act (FSMA). The FSVP regulation establishes requirements relating to: the … Continue Reading

USDA Broadens Netherlands’ Access to U.S. Market for Raw Veal

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Meat, poultry, and egg products imported to the United States fall under the jurisdiction of the U.S. Department of Agriculture’s Food Safety & Inspection Service (FSIS). FSIS administers requirements that seek to ensure these products are produced under standards equivalent to the U.S. inspection system.  For nearly 2 decades, Dutch veal was banned from the … Continue Reading

Seafood Traceability Rule to Remain in Place, Says Court

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As reported previously on this blog, concerns about illegal, unreported and unregulated (IUU) seafood fraud, led to a proposed rule to establish a traceability program for certain seafood species. The final rule establishing the Seafood Import Monitoring Program was published by the National Oceanic and Atmospheric Administration (NOAA), National Marine Fisheries Service (NMFS), Department of … Continue Reading

Questions (and Answers) on FSVP

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As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017 (for a summary of which importers are covered by the general compliance date, see here). The U.S. Food and Drug Administration recently issued additional guidance for importers on … Continue Reading

Fishy Business: NOAA Finalizes Seafood Traceability Rule

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For years, the seafood industry has grappled with the issue of “seafood fraud,” which includes the substitution of cheaper species for more expensive ones.  As previously covered on this blog, on February 5, 2016, the Commerce Department’s National Oceanic and Atmospheric Administration (NOAA) issued a proposed rule to establish a new traceability program for certain seafood … Continue Reading

Import(er) Alert: E-Filing Proposed Rule

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FDA proposes e-filing requirements to facilitate product imports. FDA and the U.S. Customs and Border Protection Agency (CBP) work together to facilitate the admission of imported products into the U.S.  The Automated Commercial Environment (ACE) is a commercial trade processing system operated by CBP that helps automate and expedite the processing of imports and exports. Earlier … Continue Reading

FDA Guidance: Prior Notice

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FDA issues third edition of guidance regarding prior notice for imported food. Under Section 801(m) of the Federal Food, Drug, and Cosmetic Act, FDA requires the submission of “prior notice” in advance of an article of food arriving at the U.S. border.  “Food” is defined broadly to include finished foods, ingredients, and raw materials.  The … Continue Reading

FSMA Flash: Upcoming Public Meetings

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FDA hosting three public meetings to focus on FSMA import provisions. With FSMA implementation in full swing, FDA has announced that it will be hosting three one-day public meetings in different regions to focus on the import provisions of the FDA Food Safety Modernization Act (FSMA). Specifically, the meetings will focus on import safety programs, (i.e. … Continue Reading

Import Refusal Trends

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Newly-issued report describes trends in FDA import refusals. FDA is responsible for overseeing the safety of the U.S. food supply, which includes significant quantities of imported food.  Due in part to resource constraints, FDA inspects only a fraction of the foreign facilities that produce food for the U.S. and physically examines only a small percentage … Continue Reading

Caveat Importer

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Recent FDA public meeting addressed FSMA import implications. The FDA Food Safety Modernization Act (FSMA) includes several import-focused components, such as the Foreign Supplier Verification Program (FSVP) and the still-under-development Voluntary Qualified Importer Program (VQIP).  The general compliance date for the FSVP is May 28, 2017.  The VQIP is expected to be open for applications … Continue Reading

Sounds Fishy: New Seafood Traceability Program

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NOAA proposes new traceability program for certain types of seafood. For years, the seafood industry has grappled with the issue of “seafood fraud,” which includes the substitution of cheaper species for more expensive ones.  Data from one of the largest seafood fraud investigations in the world indicate that snapper and tuna were mislabeled most frequently, … Continue Reading

Imports: Risky Business?

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Survey of FDA import data suggests food imported from low-GDP countries may pose higher risks. Particularly now that FDA has issued a final rule to implement the Foreign Supplier Verification Program (FSVP) under the FDA Food Safety Modernization Act (FSMA), the food industry is more engaged than ever in the analysis of risks associated with foods … Continue Reading

Accreditation Activity

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FDA issues a proposed rule and draft guidance to implement its third-party accreditation program under FSMA. The FDA Food Safety Modernization Act (FSMA) directs FDA to establish a program for accrediting third parties to conduct food safety audits and issue certifications for facilities and food.  The Agency may use certifications:  (1) as a condition of … Continue Reading

Where’s the Beef?

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USDA to permit beef imports from Argentina and Brazil. The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is tasked with protecting the United States from animal and plant pests that could threaten the domestic agricultural market and the food supply.  Regulations in 9 CFR Part 94 prohibit or restrict the … Continue Reading

Import(er) Alert

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FDA Releases Draft Guidance on Voluntary Qualified Importer Program. Under the FDA Food Safety Modernization Act (FSMA), FDA is required to establish a voluntary, fee-based program for the review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. On June … Continue Reading
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