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Arnall Golden Gregory LLP

Made in America? What Developers Need to Know About U.S. Supplement Facilities

Introduction - “Made in America” has strong consumer appeal, but in the dietary supplement industry, reality is far more complex. Roughly 75-80% of raw nutraceutical ingredients (like vitamin C, fish oils, amino acids, and...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

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Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

Dorsey & Whitney LLP

New EU Packaging Rules Impact Manufacturers

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The Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40), the European Union’s new regulation concerning the packaging of products placed on the European market (PPWR), came into force on 11 February 2025....more

Venable LLP

FDA Regulatory Updates for Summer 2025: Food, Supplements, and Cosmetics

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Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be...more

Barnea Jaffa Lande & Co.

Israel’s Import Reform: “What’s Good for Europe Is Good for Israel”

The “What’s Good for Europe Is Good for Israel” reform came into effect at the beginning of 2025, with considerable. This reform allows importers to import diverse products to Israel in a new standardization track, based on...more

Jones Day

The EU's Deforestation Regulation: Will There Be Further Changes?

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The EU's Deforestation Regulation (EUDR), designed to ensure that no products that contribute to deforestation are sold in, or exported from, the EU, continues to be criticized by EU Member States and major market players....more

Morgan Lewis

EPA Extends PFAS Reporting Deadline Under Toxic Substances Control Act Once More

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EPA’s May 13 interim final rule, which extended the start and end dates of the PFAS Toxic Substances Control Act Section 8(a)(7) reporting period for all manufacturers by nine months, was EPA’s second such extension to the...more

Beveridge & Diamond PC

EPA Continues Focus on Antimicrobial Pesticide Enforcement in 2025

Key Takeaways - What Happened: EPA continues to assess significant penalties against manufacturers and distributors of antimicrobial products under the new administration....more

Ropes & Gray LLP

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

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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

Gardner Law

What to Do When FDA Detains Your Shipment

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When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice...more

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

[Podcast] 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

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

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

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

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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