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FDA Webinar on Human Drug Importations

posted by Jennifer Diaz March 2, 2021 0 comments

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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CBP Issues WRO on Cotton, Tomato, & Downstream Products Made in Xinjiang

posted by Jennifer Diaz February 18, 2021 0 comments

The United States has been increasing its efforts to combat forced labor around the world. During the Trump Administration’s final weeks, the United States not only banned the importation of Chinese Cotton, Tomatoes, among other products, but also explicitly recognized the situation in Xinjiang as a Genocide.

Importers not adequately auditing their supply chains for use of forced labor are at risk of administrative and criminal enforcement. Imported merchandise produced with forced labor is subject to the Department of Homeland Security (DHS) enforcement. Such enforcement includes U.S. Customs and Border Protection’s (CBP) right to detain, exclude, and/or seize imported goods and Homeland Security Investigation’s potential criminal investigation. China is not only the United States’ number one trading partner but also happens to be the world’s biggest forced labor violator.

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FDA Import Alert on Mexican Hand Sanitizer

posted by Jennifer Diaz February 4, 2021 0 comments

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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FTC issues a Record Breaking $1.2 Million Penalty

posted by Jennifer Diaz January 26, 2021 0 comments

Co-Authored by Denise Calle

Chemence Inc., a glue maker, is once again in a sticky situation with The Federal Trade Commission (FTC) for allegedly making deceptive claims that its products are made in the United States. In a proposed Consent Order, Chemence agreed to pay $1.2 million for its violation of the FTC Act for violating a 2016 federal court order to cease deceptive marketing tactics, as well as mandated an annual compliance report. The FTC now seeks Public Comment on the proposed consent agreement. The comment period closes on February 8, 2021. Thereafter, FTC will decide whether it should withdraw from the agreement or make it final and force Chemence to pay the $1.2 million penalty.

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U.S. Customs Targets Use of Forced Labor

posted by Jennifer Diaz January 21, 2021 0 comments

Bloomgberg Law Diaz Trade Law’s President, Jennifer Diaz, Associate Attorney, Denise Calle, and supporting Law Clerk, Zachary Kaufman, are enthusiastic to announce Bloomberg Law published another one of our articles, “U.S. Customs Targets Use of Forced Labor”! Below is the article reproduced with permission for your reading pleasure. We’d love to hear your feedback!

You can read the article here (where you’ll have the ability to access all of the great hyperlinks), please note you cannot click on the hyperlinks below.

We’d love to hear your feedback!

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US Imposes Additional Tariffs on EU Goods

posted by Jennifer Diaz January 19, 2021 0 comments

On Wednesday, January 6, 2021, the Office of the United States Trade Representative (USTR), announced the revision of its Section 301 Action: Enforcement of U.S. WTO Rights in Large Civil Aircraft Dispute (86 FR 674).

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Treasury Imposes Further Sanctions on Iran

posted by Jennifer Diaz January 12, 2021 0 comments

Co-Authored by Sharath Patil

Background on Iran Sanctions

The United States has imposed restrictions on activities with Iran under various legal authorities since 1979, following the seizure of the U.S. Embassy in Tehran following the Iranian Revolution. In October 2015, the United States, the United Kingdom, France, China, and Russia, as well as Germany (known collectively as the P5 +1) met with Iran and successfully negotiated the Joint Comprehensive Plan of Action (“JCPOA”). Pursuant to the JCPOA, Iran agreed to roll back parts of its nuclear program in exchange for relief from some sanctions. According to United Nations Security Council Resolution 2231, the JCPOA would result in “the comprehensive lifting of all UN Security Council sanctions as well as multilateral and national sanctions related to Iran’s nuclear program, including steps on access in areas of trade, technology, finance, and energy.” The few years of decreased economic sanctions towards Iran came to an end in May 2018 when the Trump administration unilaterally withdrew from the JCPOA. The return of increased U.S. sanctions towards Iran came into effect in November 2018.

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USTR Announces Special 301 Review – Comments Due January 28

posted by Jennifer Diaz January 7, 2021 0 comments

Co-Authored by Sharath Patil

Special 301 Report

The United States Trade Representative (“USTR”) conducts an annual evaluation known as the Special 301 review. In the review, USTR identifies countries that deny adequate and effective protection of intellectual property (“IP”) rights or deny fair and equitable market access to U.S. persons who rely on IP protection. As a result of this review, trading partners that present the most significant concerns regarding IP rights are placed in one of three categories: 1) the Watch List, 2) the Priority Watch List, and 3) Priority Foreign Countries.

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USDA National Organic Program – Enforcement & Compliance Overview

posted by Jennifer Diaz January 5, 2021 0 comments

Co-Authored by Sharath Patil

What’s the National Organic Program?

Established by Congress and announced in 2000, the U.S. Department of Agriculture’s (“USDA”) National Organic Program (“NOP”) is a federal regulatory program which develops and enforces uniform national standards for organically-produced agricultural products sold in the United States. NOP operates as a public-private partnership which accredits third-party organizations to certify that farms and businesses meet the national organic standards. By enforcing its standards, NOP ensures a level playing field for producers while protecting consumer confidence in the integrity of the USDA organic seal.

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New Developments in U.S. Aluminum & Steel – Import Monitoring

posted by Jennifer Diaz December 31, 2020 0 comments

Co-Authored by Sharath Patil

Background on Section 232 Investigations

There is significant discussion among the trade community about the future of the Section 232 aluminum and steel tariffs. Section 232 investigations, administered by the U.S. Commerce Department, are conducted to determine the imports of certain goods on national security. Historically, Section 232 investigations have been conducted regarding U.S. imports of crude oil and petroleum products and uranium, among other critical imports. Under the Trump administration, the Commerce Department initiated investigations of U.S. imports of aluminum and steel on April 27, 2017. The investigation resulted in an affirmative determination that such imports harm U.S. national security. The Commerce Department’s investigation reports found that:

The United States is the world’s largest importer of steel – with imports four times exports.
World steelmaking capacity is 2.4 billion metric tons, up 127% from 2000, while steel demand grew at a slower rate.
The recent global excess capacity is 700 million tons, almost 7 times the annual total of U.S. steel consumption. China is by far the largest producer and exporter of steel, and the largest source of excess steel capacity. Their excess capacity alone exceeds the total U.S. steel-making capacity.
Aluminum imports have risen to 90% of total demand for primary aluminum

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