Pre-compliance

Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly,  how to avoid and/or mitigate such actions.  FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.

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ACE: Auditing Your Import History

In FY 2020 alone, U.S. Customs and Border Protection (“CBP”) import audits resulted in over $44.6 million being collected by CBP. Similarly, CBP collected over $20.1 million in FY 2020 from trade-related penalties and liquidated damages. Prior to CBP auditing you, there is a lot you can do to be proactive about import compliance. The first step is getting a clear picture of your imports by accessing and analyzing your import data on the Automated Commercial Environment (“ACE”). An ACE  audit can identify duty-saving opportunities and open risks.

To date, CBP has collected $87.8 billion in China 301 tariffs. If you have paid Section 301 China tariffs on Lists 3 and 4 and you have joined the landmark lawsuit demanding full refunds on these tariffs paid, it is critical that you understand the extent of China tariffs that you have paid, and proactively look out for liquidations. Proactively and comprehensively auditing your ACE import data is the first step.

Whether you are new to importing or a seasoned professional, this one-hour webinar is a must attend. Register today to hear directly from our Diaz Trade Law President Jennifer (Jen) Diaz about audit risks and duty-saving opportunities. Jen is a Chambers ranked, Board Certified International Attorney specializing in customs and international trade.

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REGISTER TODAY! NEI Accredited Webinar Importing 101 – Introduction to U.S. Customs

Webinar Importing 101 Introduction to US CustomsCo-Authored by Denise Calle

Whether you are new to importing or seasoned, this one-hour webinar is a must attend. Register today to hear directly from this specialized, expert trio on the “Top 10 Tips When Importing to Ensure Compliance” with real case studies:

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FDA Further Extends UFI Flexibility For Food Facility Registrations

Background on Food Facility Registration

The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. Food and Drug Administration (“FDA”). Additionally, the FDA Food Safety Modernization Act (“FSMA”) amended the food facility registration requirements in the  FD&C to require domestic and foreign facilities to submit certain additional new information to the FDA and renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.

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Anti-Circumvention, EAPA, Dumping Duties & the Spreadability of Cases

This one-hour webinar will provide an overview of AD/CVD, U.S. Customs and Border Protection’s enforcement actions and investigative process, as well as a review of EAPA regulations and provide insights on best practices to protect your company in this contentious area of U.S. Customs and Border Protection enforcement.

Background on EAPA

The Enforce and Protect Act of 2015 (EAPA) allows U.S. Customs and Border Protection (“CBP”) to investigate whether a company has evaded anti-dumping and countervailing (AD/CVD) duties in an on-the-record investigation. EAPA enforcement has increased considerably in recent years. In fact, in Fiscal Year 2020, CBP collected $287 million in duties via EAPA enforcement – this is a 500 percent increase since the beginning of the EAPA program in FY 2017.

On April 21, 2021 at 12:00 PM, Jennifer Diaz and David Craven will present a webinar on Anti-Circumvention/EAPA/Dumping Duties & the Spreadability of Cases.

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