FDA Issues Archives | Customs & International Trade Law Blog

Customs and Trade Law Weekly Snapshot

Here is a recap of the latest customs and international trade law news:

Apparel

Nike has ended 2021 as the most valuable apparel firm globally. According to data presented by FinancePR.com, the American outfit achieved a $30.44 billion valuation in 2021, placing it at the helm of the top ten garment firms worldwide.

CBP

On November 30, 2021, U.S. Customs and Border Protection officers in Cincinnati seized a shipment containing counterfeit designer jewelry and scarves. The fakes, which came from China, would have been worth a total of $3.09 million had they been genuine.
On December 6, 2021, a garment importer based in downtown Los Angeles was sentenced to 12 months and one day in federal prison for scheming to undervalue imported garments and avoid paying duties to the United States, and failing to report income on tax returns and large cash transactions to the federal government.
On December 13, 2021, Chris Magnus was sworn in as Commissioner of United States Customs and Border Protection following his Senate confirmation last week. Magnus becomes the fifth confirmed CBP Commissioner since the law enforcement agency’s creation under DHS in 2003.
CBP has reorganized all Informed Compliance Publications (ICPs) on CBP.gov under each applicable Center of Excellence and Expertise.
U.S. Customs and Border Protection is modernizing the ACE Secure Data Portal over multiple phases in 2022. The modernization effort will entail the transition of existing functionality to an upgraded platform, offering […]

By Jennifer Diaz|2022-07-01T11:15:32-04:00January 14, 2022|ACE, China, China Trade War, HTS, Import, International Trade, Seizures, Snapshot, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA), U.S. Office of Foreign Assets Control (OFAC)|Comments Off

Food Importers: How to Import Food Compliantly & Survive a FSVP Audit

The U.S. Food and Drug Administration (FDA) is now auditing Foreign Supplier Verification Program (FSVP) Importers to ensure they comply with the FSVP program. To date, over 92 warning letters have been issued against companies for FSVP violations. If your business is importing food into the U.S., or wants to start, our one-hour, NEI accredited, webinar on “Importing Food in Compliance with U.S. FDA & Surviving A FSVP Audit” will provide best practices and TOP tips to comply with FDA regulations and avoid, navigate, and mitigate any potential FDA compliance action.

Register today to to hear directly from Senior Trade Advisor, Domenic Veneziano, DTL’s president, Jennifer Diaz, and Associate Attorney, Denise Calle, on the pathway to legally import food and best practices for surviving a FSVP audit.

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By Jennifer Diaz|2021-09-07T15:53:46-04:00September 6, 2021|Best Practices, Food, Import, International Trade, Labeling, Pre-compliance, U.S. Food and Drug Administration (FDA)|Comments Off

Don’t Let FDA Target Your Medical Device Company

Did you know FDA has issued 1,569 enforcement actions against medical device companies? Now is the time to ensure your medical devices are in compliance with FDA laws and regulations prior to importation. If your business is manufacturing, repackaging, relabeling, and/or importing medical devices into the U.S., or wants to start, our one-hour webinar on “Importing Medical Devices in Compliance with U.S. FDA” is for you. We will provide TOP tips to avoid U.S. Food and Drug Administration (FDA) enforcement action, and best practices to navigate and mitigate FDA enforcement.

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By Jennifer Diaz|2021-10-07T14:48:15-04:00August 10, 2021|COVID-19, Import, Import Alert, International Business, International Law, International Trade, Labeling, Medical Devices, PPE, Pre-compliance, Speaking, U.S. Food and Drug Administration (FDA)|Comments Off

FDA OPENS NEW FSVP PORTAL FOR IMPORTERS

The Foreign Supplier Verification Programs for Food Importers (FSVP), establishes guidelines for importers to vet their foreign manufacturers, ensuring that food products destined for the U.S. are safe for consumption. The FSVP was created under the Food Safety Modernization Act (FSMA). These standards of the FSVP are in line with the goals articulated in the U.S. Food and Drug Administration (FDA) Strategy for the Safety of Imported Food. The FDA seeks to ensure that foreign-manufactured food products are safe for consumption. Further, as discussed in Diaz Trade Law’s previously published blog, the FDA issued its first FSVP warning letter in September 2019, and since then has issued at least 60 more!

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By Jennifer Diaz|2021-10-07T14:53:51-04:00May 27, 2021|Best Practices, Food, Import, International Business, International Trade, Labeling, Pre-compliance, Supply Chain, U.S. Food and Drug Administration (FDA)|Comments Off

FDA Webinar on Human Drug Importations

On January 14, 2021, the United States Food and Drug Administration (FDA) kicked off the year with a set of Webinars for the trade community. Specifically, the Center for Drug Evaluation and Research (CDER) held its first annual Small Business and Industry Assistance (SIBA) Compliance Conference. The topics covered various areas dedicated to compliance including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance.

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By Jennifer Diaz|2022-07-07T12:33:06-04:00March 2, 2021|Best Practices, Customs Expert, Enforcement, Events, Export, Import, International Business, International Law, International Trade, Supply Chain, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

FDA Import Alert on Mexican Hand Sanitizer

For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers. FDA singled out importations of hand sanitizers from Mexico due to the frequent use of methanol.

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By Jennifer Diaz|2021-10-12T14:59:21-04:00February 4, 2021|Best Practices, COVID-19, Customs Expert, Enforcement, Export, Import, Import Alert, International Business, International Law, International Trade, Mexico, Seizures, Supply Chain, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

COVID FLEXIBILITY – FDA Announces Temporary Policy Regarding Certain Labeling Requirements for Foods

The U.S. Food and Drug Administration is issuing a guidance document to provide additional temporary flexibility in food labeling requirements to manufacturers and vending machine operators. The goal is to provide regulatory flexibility, where appropriate, to help minimize the impact of supply chain disruptions on product availability associated with the current COVID-19 pandemic.

Entitled “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines,” this guidance is one of several the FDA has issued to provide temporary flexibility to the food industry to help support the food supply chain and meet consumer demand during the pandemic.

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By Jennifer Diaz|2021-10-22T10:18:12-04:00May 27, 2020|Best Practices, Customs Expert, Food, Import Alert, International Trade, IPR, Trademarks and Logos, U.S. Food and Drug Administration (FDA)|Comments Off

USDA & CBP Combat Non-Compliant WPM

Diaz Trade Law’s President, Jennifer Diaz and Associate Attorney, Denise Calle are enthusiastic to announce that our article “USDA & CBP Combat Non-Compliant WPM “ was published by Bloomberg Law! Below is the article reproduced with permission for your reading pleasure. We’d love to hear your feedback! […]

By Jennifer Diaz|2022-04-25T16:50:10-04:00January 9, 2020|Best Practices, Bloomberg, Bloomberg Import, China Trade War, Counterfeits, Enforcement, Export, Import, International Business, International Law, International Trade, IPR, Trademarks and Logos, Penalty, Reasonable Care, Seizures, Supply Chain, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

A Year in Review!

DTL saved clients MILLIONS of dollars in 2019. It is with great joy that we finish off 2019 celebrating our fourth anniversary! We would like to thank each of you for being an integral part of making DTL a success.

This year has been filled with numerous achievements and accomplishments. We are grateful for the clients who have entrusted their trade and customs issues to us, and we look forward to assisting you in 2020!

Below we share some of our 2019 success stories with you.

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