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Compliance Reporting Requirements Manufacturers

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Shook, Hardy & Bacon L.L.P.

Material Concerns: Legal Updates on Substances of Emerging Concern

First effective in 2024, the Act bans the sale or distribution of various products that contain intentionally added PFAS chemicals. On January 1, 2026, as part of the product phase-out timeline, the new law bans the sale or...more

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

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Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more

Kelley Drye & Warren LLP

Reminder: Federal Communications Commission – July and August Filings - 2025

Manufacturers of wireless handsets that are used in the delivery of digital commercial mobile radio service within the scope of FCC Rule 20.19 are required to file information annually regarding their compliance with the...more

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

DLA Piper

Single-Use Plastics Fund Act: Original Reporting Deadline Passed – Act Now for Extended Date

DLA Piper on

Germany’s Single-Use Plastics Fund Act (EWKFondsG) requires manufacturers to report 2024 data on single-use plastic products. The original 15 May 2025, deadline has passed, but the Federal Environment Agency (UBA) has...more

Kelley Drye & Warren LLP

Reminder: Federal Communications Commission – June and July Filings

Carriers and providers of interstate and international telecommunications that seek to revise their May 1, 2025, Form 499-Q filing must do so within 45 days of the Form 499-Q filing deadline, i.e., by June 16, 2025 (because...more

BakerHostetler

FDA Issues Draft Guidance on Replacing Color Additives in Drug Products

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On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more

Morrison & Foerster LLP

Proactivity in Product Safety: Best Practices for Compliance

Consumer product companies are facing unprecedented scrutiny as the Consumer Product Safety Commission (CPSC) intensifies its regulatory oversight. With heightened civil penalties, increased monitoring of e-commerce...more

Foley & Lardner LLP

Reese’s Law: The Evolving Regulatory and Enforcement Landscape for Consumer Products Containing Button Cell or Coin Batteries

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Share on Twitter Print Share by Email Share Back to top Over the past year, manufacturers, importers, distributors, and retailers of consumer products containing button cell and coin batteries (or products intended to contain...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Hazardous Waste Enforcement: Tennessee Division of Solid Waste Management Proposed Order and Assessment Addressing Ripley...

The Tennessee Division of Solid Waste Management (“TDSWM”) issued a February 7th Proposed Director’s Order and Assessment (“Order”) to SRG Global Coatings, LLC (“SRG”). See Case No. HWM 24-0024. The Order provides that...more

Alston & Bird

Brave New World of Extended Producer Responsibility: Compliance Considerations for Affected Industries

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Our Environment, Land Use & Natural Resources and Food & Beverage Groups examine the growing industry compliance impact of states’ extended producer employer production responsibility (EPR) laws....more

Blake, Cassels & Graydon LLP

Canada Publishes Phase 1 Guidance for the Reporting of Plastics

Introduction - On December 31, 2024, the Government of Canada published a guide for reporting to the Federal Plastics Registry (Registry). As discussed in our previous bulletin, the Government of Canada established the...more

Littler

Cal/OSHA Approves Final Respirable Crystalline Silica Regulation, While Other Potential Limits on Engineered Stone Remain Under...

Littler on

On December 19, 2024, the Cal/OSHA Standards Board unanimously approved a proposal to make permanent amendments to its regulation regarding occupational exposures to respirable crystalline silica (RCS) in the general industry...more

Alston & Bird

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

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Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more

Warner Norcross + Judd

A New Year Brings New PFAS Regulations and Reporting Requirements

2025 promises to be a busy year for companies that use — or previously used — per- and polyfluoroalkyl substances (PFAS) in their supply chains. The U.S. Environmental Protection Agency (EPA) and various state governments...more

Alston & Bird

D-Day for the EU Cyber Resilience Act

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Our Privacy, Cyber & Data Strategy Team discusses the new Cyber Resilience Act (CRA) that affects manufacturers and distributors of connected devices that are in use anywhere in the European Union....more

Gardner Law

LDT Compliance: Countdown to May 2025

Gardner Law on

We previously reported on the FDA’s laboratory-developed test (LDT) rule published on May 6, 2024, which classifies LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This shift marks the end...more

Clark Hill PLC

PFAS “Lookback” Reporting: Delayed in the US, Moving Ahead in Canada

Clark Hill PLC on

As regulatory activity and litigation concerning per- and polyfluoroalkyl substances (“PFAS”) continue to pick up across the U.S. and around the world, recent developments in North America highlight one of the challenges...more

Nilan Johnson Lewis PA

PFAS Reporting Requirements at the Federal and State Level – How Will Manufacturers Respond? – Part 4 of 10

Part 4. PFAS Reporting Requirements at the Federal and State Level – How Will Manufacturers Respond? Per- and polyfluoroalkyl substances, known by the acronym PFAS and better known by the moniker “forever chemicals,” are...more

Barnea Jaffa Lande & Co.

Israel: Increased Enforcement of Packaging Law

Recently there has been a significant increase in administrative enforcement proceedings, warning letters and motions to certify class actions in relation to the Processing of Packaging Law. The law, enacted back in 2011,...more

Alston & Bird

PFAS Primer Quarterly Update: 2024 Q2 – Setting the PFAS Standard

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In the latest edition of the PFAS Primer Quarterly Update, our roundup of regulatory, litigation, and scientific actions involving PFAS, the EPA announces drinking-water regulations, states continue to fight firefighting...more

Baker Donelson

Who's Who under the EU AI Act: Spotlight on Key Actors

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Who will play the leading role if we make a new series about AI? If you interview Steven Spielberg, Sundar Pichai, and Sam Altman, you might receive three distinct ideas ranging from the 2001 classic "AI: Artificial...more

Holland & Knight LLP

2023 PFAS Year in Review: EPA Policy and Aqueous Film-Forming Foam Litigation Updates

Holland & Knight LLP on

2023 was a busy year for folks following legal developments related to per- and polyfluoroalkyl substances (PFAS). In December, the U.S. Environmental Protection Agency (EPA) issued its Second Annual Progress Report. Some of...more

McGlinchey Stafford

Environmental Justice and Impact on Manufacturers

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In recent weeks, the U.S. Environmental Protection Agency (EPA) released the draft 2023 Environmental Justice Guidance Document (Guidance), a revision of the EPA’s “Technical Guidance for Assessing Environmental Justice in...more

Perkins Coie

EPA Finalizes PFAS Reporting Rule

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The U.S. Environmental Protection Agency (EPA) published a final reporting rule under the Toxic Substances Control Act (TSCA) on October 11, 2023, which requires manufacturers of per- and polyfluoroalkyl substances (PFAS) and...more

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