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301 INVESTIGATIONSBest PracticesChinaChina Trade WarCOVID-19Customs ExpertEnforcementHTSImportInternational BusinessInternational TradeSpecial 301Trade PolicyU.S. Customs and Border Protection (CBP)U.S. Trade Representative (USTR)

301 Exclusion Extensions for COVID-19 Related Products

posted by Jennifer Diaz April 13, 2021 0 comments

On March 10, 2021, via Federal Register Notice ( 86 FR 13785), the United States Trade Representative (USTR) announced that 99 medical product exclusions will be extended from March 31, 2021, to September 30, 2021. This action extends a previous USTR action which extended these exclusions from December 31, 2020, to March 31, 2020 (85 FR 85831). Continue Reading

Best PracticesCustoms ExpertEnforcementExportInternational BusinessInternational LawInternational TradePre-complianceU.S. Food and Drug Administration (FDA)

OTC Drug Manufacturers are Required to Pay FDA Facility User Fees by May 10, 2021

posted by Jennifer Diaz April 8, 2021 0 comments

Co-Authored by Denise Calle.

On March 26, 2021, Food and Drug Administration (FDA) published the Federal Register Notice, “Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing the OTC Monograph Drug user fee program fee rates for FY 2021. This is the first year FDA has expanded user fees to OTC Drug Manufacturers and submitters of OTC monograph order requests.

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Best PracticesChinaChina Trade WarCustoms ExpertEnforcementExportImportImport AlertInternational BusinessInternational LawInternational Trade

Future of First Sale Rule in Question

posted by Jennifer Diaz April 6, 2021 0 comments

On March 1, 2021, the Court of International Trade (CIT) denied Meyer Corporation’s claim for duty-free treatment under its attempted use of the first sale valuation and the Generalized System of Preferences (GSP), in Meyer Corporation, U.S. v. United States, Court No. 13-00154 (Meyer). This case sent a ripple through the trade-community as many speculate whether the decision signals an end of first sale for non-market countries.

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301 INVESTIGATIONSEnforcementImportInternational TradeInvestigationTrade PolicyU.S. Trade Representative (USTR)

Proposed 25% Tariffs on Section 301 Digital Service Taxes – Comment Now

posted by Jennifer Diaz April 1, 2021 0 comments

Digital economy and society in the EU

Background on Section 301 Digital Service Taxes

In 2020, the United States Trade Representative (“USTR”) initiated Section 301 investigations with respect to certain Digital Service Taxes (“DSTs”) being adopted or under consideration by a number of countries. DSTs are taxes on revenues that certain companies generate from providing certain digital services to users in those jurisdictions. According to USTR, available evidence suggests that DSTs are expected to target large, U.S.-based technology companies.

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AD/CVDBest PracticesChina Trade WarCustoms ExpertEnforcementExportImportInternational LawInternational TradeU.S. Customs and Border Protection (CBP)

New AD/CVD Petition Against Imports of Certain Chinese Mobile Access Equipment

posted by Jennifer Diaz March 25, 2021 0 comments

Co-Authored by Sharath Patil

Background on AD/CVD Investigations

Antidumping duty (“AD”) and countervailing duty (“CVD”) investigations are brought jointly by the U.S. International Trade Commission (“USITC”) and the U.S. Department of Commerce (“Commerce”). AD investigations are triggered when a domestic industry alleges that it has been injured by competing imports of particular goods from specific countries being sold at less than a fair value. Meanwhile, CVD investigations are triggered when a domestic industry alleges that it has been injured by competing imports that are being unfairly subsidized by their governments. The domestic industry initiating the investigation is known as the petitioner while the foreign industry participating in the investigation is known as the respondent.

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Best PracticesCustoms ExpertEnforcementEventsInternational LawInternational TradeLabelingU.S. Food and Drug Administration (FDA)

Cleaning for COVID-19 – Importing Cleaning Products: Who Regulates You?

posted by Jennifer Diaz March 15, 2021 0 comments

Co-Authored by Denise Calle

A year into the COVID-19 pandemic, the U.S. Environmental Protection Agency (EPA) and The Food and Drug Administration (FDA) are in full enforcement mode carefully monitoring novel products claiming to treat, mitigate, or “kill” COVID-19. Compliance advisories issued at the beginning of the pandemic are now being replaced with enforcement advisories. Manufacturers, importers, distributors, and others engaged in the production or sale of products claiming to mitigate or “kill” COVID-19 should be more cautious than ever when developing product claims for both product labels and marketing material or alternatively, confirm products comply with the numerous regulations governing COVID-19 cleaning products.

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Best PracticesChina Trade WarCustoms ExpertEnforcementEventsExportImportImport AlertInternational BusinessInternational LawInternational TradeU.S. Customs and Border Protection (CBP)

Biden Executive Order Strengthens Buy American Government Procurement Laws

posted by Jennifer Diaz March 9, 2021 0 comments

Co-Authored by Sharath Patil

Biden Signs Executive Order Strengthening Buy American Laws

Buy American laws are a set of statutes, regulations, rules, and Executive Orders that require that the U.S. federal government require or provide preferences for purchasing goods produced in the United States. Buy American laws were created and continue to be amended with the intention of promoting economic and national security, stimulating economic growth, creating good jobs at decent wages, and supporting the U.S. manufacturing and defense industrial bases.

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Best PracticesCustoms ExpertEnforcementEventsExportImportInternational BusinessInternational LawInternational TradeSupply ChainU.S. Customs and Border Protection (CBP)U.S. Food and Drug Administration (FDA)

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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Best PracticesChina Trade WarCustoms ExpertEnforcementExportForced LaborImportImport AlertInternational BusinessInternational LawInternational TradePre-complianceU.S. Customs and Border Protection (CBP)

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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COVID-19ExportImportInternational TradeTrade PolicyU.S. Customs and Border Protection (CBP)U.S. Department of State (DOS)U.S. Food and Drug Administration (FDA)

Biden Administration Commits to Modernizing Regulatory Review

posted by Jennifer Diaz February 9, 2021 0 comments

Co-Authored by Sharath Patil

Background on Regulatory Review

U.S. federal laws come from a wide array of sources. They are generally organized under the following order of authority:  1) the U.S. constitution, 2) statutes passed by Congress, 3) treaties ratified by Congress, 4) case law, 5) executive orders, 6) regulations, and 7) agency guidance. After Congress has provided a federal agency with a policy mandate, an agency is empowered to promulgate regulations to provide detailed and binding rules on those matters.

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