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Regulatory Requirements › Imports › New Regulations

Morgan Lewis - Well Done

FDA Updates Food Labeling Compliance Program: What It Means for Food Manufacturers

Morgan Lewis - Well Done on

In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This program guides FDA inspectors...more

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

Ropes & Gray LLP on

In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

Quarles & Brady LLP on

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

Mayer Brown

Brazil Introduces Regulations on the Importation of Solid Waste and Tailings

Mayer Brown on

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

Arnall Golden Gregory LLP

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

Arnall Golden Gregory LLP on

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

Hogan Lovells

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

Hogan Lovells on

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

Husch Blackwell LLP

Further Changes to Shipments under $800 from China

Husch Blackwell LLP on

On April 2, 2025 we reported that imports from China valued at $800 or less would no longer qualify for de minimis treatment starting May 2, 2025. On April 9, 2025 we reported the increase in tariffs and fees for imports of...more

Miller Canfield

New U.S. Regulations on Vehicle Connectivity and Automated Driving Systems: Compliance Starts Now!

Miller Canfield on

Starting today, March 17, 2025, new U.S. regulations impose sweeping restrictions on the importation and sale of connected vehicles (CV) and related components with ties to China and Russia....more

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