International Business

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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FTC issues a Record Breaking $1.2 Million Penalty

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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US Imposes additional tariffs on EU goods

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

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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USDA National Organic Program – Enforcement & Compliance Overview

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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