News & Analysis as of

Regulatory Requirements Imports

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

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In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

BakerHostetler

FDA-Regulated Products Supply Chain Disruptions: Policy Shifts

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Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more

Holland & Knight LLP

EPA Proposes 2026-2027 Renewable Fuel Standard Volume Mandates

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The U.S. Environmental Protection Agency (EPA) on June 13, 2025, issued a proposed rule, "Renewable Fuel Standard (RFS) Program: Standards for 2026 and 2027, Partial Waiver of 2025 Cellulosic Biofuel Volume Requirement, and...more

Braumiller Law Group, PLLC

Hot Topics in International Trade - Let's Be Serious-Supply Chain Audits

When was the last time you conducted an audit of your supply chain classifications? Did you know, that if Customs comes knocking, for a specific reason, they can go back up to five years in your data....more

DLA Piper

VAT Public Clarification VATP044

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On 26 May 2025, the UAE Federal Tax Authority (FTA) issued Public Clarification VATP044, confirming that UAE-based recipients of Concerned Services are not required to self-issue tax invoices if they retain valid invoices or...more

DLA Piper

Customs Agent Ordered to Pay GBP1m in Import VAT Relating to its Customer's Imports

DLA Piper on

Roseline Logistics Ltd (Roseline) acted as a Customs agent for QP Trading Limited (QPTL) and made 32 import declarations between January and May 2022. Roseline claimed postponed VAT accounting (PVA) on QPTL's behalf in each...more

Clark Hill PLC

New presidential proclamation doubles tariffs on steel and aluminum imports

Clark Hill PLC on

On June 3, President Trump issued a proclamation doubling tariffs on imports of steel and aluminum articles and derivative steel and aluminum articles from 25% to 50%, effective at 12:01 a.m. EDT on June 4. This action, taken...more

A&O Shearman

UK will permanently retain its UK+ exhaustion regime to allow continued supply of medicines into the UK

A&O Shearman on

The government has published its response to the consultation on the exhaustion regime for IP rights. The overall conclusion is that the UK will permanently maintain its UK+ IP exhaustion regime, the bespoke (and...more

Troutman Pepper Locke

FDA and CBP Seize Nearly $34M Worth of Illegal E-Cigarettes in Joint Operation

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In the first major enforcement action involving the importation of illegal tobacco products by the new administration, and on the heels of the appointment of the new acting director of the U.S. Food and Drug Administration...more

Bergeson & Campbell, P.C.

Chemical Coalition Withdraws TSCA Section 21 Petition Seeking Revisions to TSCA 8(a)(7) PFAS Reporting Rule

As reported in our May 4, 2025, blog item, on May 2, 2025, a coalition of chemical companies petitioned the U.S. Environmental Protection Agency (EPA) for an amendment of the Toxic Substances Control Act (TSCA) Section...more

Mayer Brown

Brazil Introduces Regulations on the Importation of Solid Waste and Tailings

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The Brazilian government published Decree No. 12,451/2025 (the “New Decree”), which regulates Article 49, §1 of the National Solid Waste Policy (Law No. 12,305/2010), establishing exceptions to the ban on importing solid...more

Jones Day

EU Commission Publishes The Risk Classification Under The EUDR

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On May 22, 2025, the EU Commission adopted an implementing regulation to the EU's Deforestation Regulation ("EUDR") in which it identified the risk classification of countries as “low, standard or high risk” required under...more

Bergeson & Campbell, P.C.

EC Announces Low- and High-Risk Countries under the EUDR

The European Commission (EC) released on May 22, 2025, the identity of the countries that present a low or high risk of deforestation in producing seven commodities (cattle, cocoa, coffee, palm oil, rubber, soy, and wood)...more

Foley & Lardner LLP

CPSC Announces “Record-Breaking Week” of Enforcement Actions Against Chinese Manufacturers

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On May 15, 2025, the Consumer Product Safety Commission (CPSC or Commission) announced a “record-breaking week” of enforcement actions against “foreign violators.”[1] Namely, the Commission announced 28 separate product...more

Ropes & Gray LLP

Two Bills Targeting Forced Labor in Chinese Supply Chains Reintroduced in US Congress

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Over the last several weeks, two bills targeting Chinese supply chains were reintroduced in Congress. Although different in their approach, the COBALT Supply Chain Act and TASK Act both seek to address goods from China...more

Arnall Golden Gregory LLP

Surprise, Surprise: FDA Announces Plans to Increase Number of Unannounced Inspections at Foreign Manufacturing Facilities

In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more

McGuireWoods LLP

FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

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On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more

MG+M The Law Firm

EPA Issues Interim Final Rule Extending TSCA PFAS Reporting Deadlines

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On May 12, 2025, the US Environmental Protection Agency (EPA) issued an interim final rule significantly extending the reporting deadlines for PFAS reporting under Section 8(a)(7) of the Toxic Substances Control Act (TSCA)....more

Robinson+Cole Environmental Law +

EPA Delays PFAS Reporting Deadlines, Again: Implications for Manufacturers and Importers

On May 12, 2025, the U.S. Environmental Protection Agency (EPA) announced an amendment delaying the data submission period for the Toxic Substances Control Act (TSCA) PFAS reporting rule, which will now begin on April 13,...more

The Volkov Law Group

Episode 369 -- Stepping Into the Enforcement Spotlight -- Customs and Border Patrol and Import Enforcement

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What if your next import shipment becomes the centre of a federal enforcement action — not because of criminal intent, but because of a mistake? In today’s episode, Michael Volkov breaks down the expanding power and reach of...more

Warner Norcross + Judd

Manufacturers and Importers Win More Time as EPA Again Extends TSCA PFAS Reporting Deadlines

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The U.S. Environmental Protection Agency (EPA) has issued a direct final rule that delays the opening of the data‑reporting window for per‑ and polyfluoroalkyl substances (PFAS) required under Section 8(a)(7) of the Toxic...more

Cooley LLP

FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

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On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...more

Vorys, Sater, Seymour and Pease LLP

US EPA Delays TSCA PFAS Reporting and Hints at Revisions

US EPA again revised the reporting deadlines for manufacturers and importers of PFAS under the Toxic Substances Control Act (TSCA) Section 8(a)(7) rule. Like the prior extension, US EPA states that it needs additional time to...more

Hogan Lovells

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

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On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more

Morgan Lewis

From Offshore to Onshore: Considerations for Pharmaceutical Industry Stakeholders Amid New Domestic Drug Manufacturing EO

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The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more

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