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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FDA OPENS NEW 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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COVID-19’s Impact on 2020 Trade Flows

COVID-19’S IMPACT ON 2020 TRADE FLOWS

Diaz Trade Law’s President, Jennifer Diaz,  and Associate Attorney, Sharath Patil, are enthusiastic to announce that our article, “COVID-19’S IMPACT ON 2020 TRADE FLOWS” was published by the Customs and International Trade Bar Association (CITBA) in its Spring 2021 newsletter. Below is the article for your reading pleasure.

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ACE: Auditing Your Export History

Co-Authored by Sharath Patil

If a company or individual believes they have violated export control regulations and the U.S. government is unaware of this violation, proactively and voluntarily disclosing the potential wrongdoing can substantially reduce penalties. A key component of filing a successful voluntary self-disclosure (“VSD”) is uncovering and providing the correct data. Diaz Trade Law has significant experience analyzing ACE export data to evaluate your export compliance and submit successful VSDs that substantially mitigate penalties.

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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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