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Compliance 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 -
Clark Hill PLC

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

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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

Gardner Law

Kickbacks and Consequences: Lessons from the Innovasis Settlement

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On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...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

Thomas Fox - Compliance Evangelist

The Boeing Monitorship: Memo to Attorney General Garland and Kelly Ortberg

Gentlemen - I have written blog posts and articles about the proposed Plea Agreement negotiated between Boeing and the Department of Justice (DOJ). As the leaders of both organizations, I wanted to address you both...more

Venable LLP

Food and Color Additives - Is the Patchwork Here?

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State legislatures are actively pursuing bans on food and color additives.  California’s landmark Food Safety Act (Act), effective January 2027, bans the manufacture and sale of products containing brominated vegetable oil...more

Foley & Lardner LLP

2024 Has Been a Big Year for EPA with Significant Implications for Manufacturers as EPA Executes on its PFAS Strategic Roadmap  

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In 2021 the Environmental Protection Agency (“EPA”) issued its strategic roadmap to address a broad group of thousands of manmade chemicals known as per- and polyfluoroalkyl substances (“PFAS”), pledging to use “every tool in...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

Pillsbury Winthrop Shaw Pittman LLP

The EU’s AI Act: A Review of the World’s First Comprehensive Law on Artificial Intelligence and What This Means for EU and Non-EU...

The agreed text of the AI Act was published on July 12, 2024, essentially starting the clock on the legal deadlines contained in it. Its obligations will apply in tiered phases, with the first key obligations being enforced...more

Williams Mullen

Hotter Than Blue Blazes! OSHA Issues New Heat Hazard Rules for Companies Operating Outdoor and Indoor Workplaces

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The Occupational Safety and Health Administration (OSHA) has issued a Proposed Rule that could expose employers to liability when employees suffer heat illnesses in outdoor or indoor workplaces. This Rule will affect...more

Thomas Fox - Compliance Evangelist

Boeing: Accept the Omnibus Monitor Approach

I recently wrote a series of blog posts and articles on why the Department of Justice (DOJ) should think big and go big with a completely new approach to the monitorship for Boeing under its agreement to take a guilty plea....more

Hinch Newman LLP

FTC Made in USA Labeling Rule Compliance and Defense Lawyer on Refreshed Agency U.S. Origin Claim Guidance

Hinch Newman LLP on

On July 2, 2024, the Federal Trade Commission announced a “refreshed version” of the agency’s Complying with the Made in USA Standard guidance document. The refreshed guidance document includes, without limitation, updated...more

Wilson Sonsini Goodrich & Rosati

FDA Signals to Industry to Prepare for Compliance with the LDT Final Rule Despite Looming Legal Challenge

The U.S. Food and Drug Administration (FDA) is reaffirming its plans to actively regulate certain laboratory developed tests (LDTs) that the FDA has historically treated with enforcement discretion. On June 25, 2024, the FDA...more

K&L Gates LLP

Ten Things Consumer Packaged Goods Companies Should Do to Manage Co-Manufacturer Relationships

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Many consumer packaged goods (CPG) companies’ contract with other companies to manufacture goods sold under the CPG companies’ label or brand. These arrangements are called “co-manufacturing” or “contract manufacturing.”...more

Baker Donelson

Six Sizzling Ways to Beat the OSHA Heat This Summer

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The summer heat is in full swing and so are ramped-up compliance efforts from OSHA. This alert provides you with six quick tips to help avoid and minimize any "heat" from OSHA this summer....more

Venable LLP

Event in Review: The Modernization of Cosmetics Regulation Act of 2022

Venable LLP on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. ...more

Searcy Denney Scarola Barnhart & Shipley

Understanding the Manufacturing Process of Eye Drops and How Contamination Can Occur

The U.S. Food and Drug Administration (FDA) has recently identified several brands of eye drops that were sold with contaminants. These contaminants—which were introduced into the affected eye drops during the manufacturing...more

Gardner Law

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

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The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more

Venable LLP

Accelerating Privacy Scrutiny: Key Developments for the Auto Industry

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Recent U.S. developments indicate a growing focus on regulating and investigating the data privacy practices of companies in the automotive sector. The Federal Trade Commission (FTC) recently highlighted in a blog post its...more

Adams and Reese LLP

International Compliance Digest – May 2024

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May saw the long-awaited release of the USTR’s Section 301 review. USTR confirmed that the Trump-era tariffs will remain in place, and raised those tariffs by another $18 billion on manufacturing, critical minerals, solar...more

Womble Bond Dickinson

Federal Trade Commission Strikes Against “Crafted in America” Language

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As previously reported by Home Textiles Today, the Federal Trade Commission (FTC) has announced a “record civil penalty” of $3.175 million against a retailer who failed to tell the truth about whether the products it sells...more

Holland & Knight LLP

EPA Designates 2 PFAS Compounds as Hazardous Substances

Holland & Knight LLP on

The U.S. Environmental Protection Agency (EPA) on April 19, 2024, announced its Final Rule designating two per- and polyfluoroalkyl substances (PFAS) compounds – perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid...more

Foley & Lardner LLP

What Food & Beverage Companies Need to Know About the U.S. Consumer Product Safety Commission

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Food and beverage companies may be surprised to learn that the U.S. Food and Drug Administration (“FDA”) is not the exclusive regulatory authority over the safety of foods and beverages. Indeed, other governmental authorities...more

Pillsbury - PFAS Observer

French Parliament Unanimously Approves a Bill Banning Certain PFAS Products

As regulation of the use of PFAS in consumer products continues to develop at a rapid pace in the United States, businesses that manufacture or sell products internationally should also keep their fingers on the pulse of...more

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

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