News & Analysis as of

Manufacturers Civil Monetary Penalty

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

Stormwater Enforcement: U.S. Environmental Protection Agency and Seaford, Delaware Mulch Manufacturer Enter into Expedited...

The United States Environmental Protection Agency (“EPA”) and Mr. Mulch, LLC (“Mr. Mulch”) entered into a July 11th Expedited Settlement Agreement (“ESA”) addressing alleged violations of the Clean Water Act Stormwater...more

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

Hazardous Waste Enforcement: Alabama Department of Environmental Management and Refuse Truck Body Manufacturer Enter into Consent...

The Alabama Department of Environmental Management (“ADEM”) and the Heil Company, Inc. (“Heil”) entered into a June 12th Consent Order (“CO”) addressing alleged violations of the Alabama Hazardous Waste Regulations. See...more

Troutman Pepper

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

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In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

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

Air Enforcement: Alabama Department of Environmental Management and Mobile County Chemical Manufacturing Plant Enter into Consent...

The Alabama Department of Environmental Management (“ADEM”) and Evonik Corporation (“EC”) entered into a May 8th Consent Order (“CO”) addressing an alleged violation of an air permit. See Consent Order No. 24-XXX-CAP. The...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

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

Venable LLP

FTC Issues Record-Breaking Civil Penalty in “Made in USA” Case

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Tractor maker Kubota North America Corporation will pay a $2 million civil penalty for falsely labeling its replacement parts as “Made in USA,” the largest civil penalty ever in a Federal Trade Commission (FTC) Made in USA...more

Venable LLP

To Repair or Replace? California and New York Enact Right-to-Repair Laws

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Manufacturers need to be careful in the New Year to start complying with new laws in New York and California expanding consumers’ right to repair certain products. California joined the right-to-repair movement with the...more

Troutman Pepper

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

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The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more

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

Air Enforcement: Louisiana Department of Environmental Quality and Calcasieu Parish Styrene Manufacturing Facility Enter into...

The Louisiana Department of Environmental Quality (“LDEQ”) and Westlake Styrene, LLC (“Westlake”) entered into an October 18th Settlement Agreement (“SA”) addressing alleged violations of an air permit. See SA-AE-23-0032. ...more

Bass, Berry & Sims PLC

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

Bass, Berry & Sims PLC on

On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more

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

Air Enforcement: Arkansas Department of Energy & Environment - Division of Environmental Quality and Searcy Plastic Package...

The Arkansas Department of Energy & Environment – Division of Environmental Quality (“DEQ”) and The Bryce Company, LLC (“Bryce”) entered into an October 3rd Consent Administrative Order (“CAO”) addressing alleged violations...more

Harris Beach PLLC

Cochlear Implant Manufacturer Proposes to Provide Free Compatible Hearing Aids

Harris Beach PLLC on

This opinion addresses a proposed arrangement (“Proposed Arrangement”) by the manufacturer of cochlear implants (“Requestor”), where the Requestor would provide certain patients who receive one of their implants with a free...more

DarrowEverett LLP

Born in the USA? Product Origin Claims Nothing to Mess With

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The interconnectedness of the global economy has resulted in consumers being faced with a wide selection of substitute products from many different countries. A ”Made in the United States” claim could be, and often is, a...more

Sheppard Mullin Richter & Hampton LLP

OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies

On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more

Venable LLP

FTC Debunks Claim That Trunk Bunk Pads Were Made in the USA

Venable LLP on

​​​​​​​On August 30, the Federal Trade Commission announced a complaint and proposed order for Ohio-based Electrowarmth Products, LLC and its owner, alleging they improperly claimed that their heated fabric truck bunk...more

Hinch Newman LLP

FTC Made in USA Lawyer Discusses Latest Agency Enforcement Matter

Hinch Newman LLP on

A proposed FTC settlement that involves alleged false Made in USA representations and alleged deceptive COVID claims was recently filed by the Department of Justice on the FTC’s behalf against an individual and the two...more

ArentFox Schiff

OIG Issues Advisory Opinion Approving Biopharmaceutical Manufacturer’s Sponsorship of Free Genetic Testing and Counseling

ArentFox Schiff on

The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the...more

Bass, Berry & Sims PLC

Government Appeals Decisions in 340B Contract Pharmacy Litigation

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On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more

Lathrop GPM

FTC Warns Endorsements Could Lead to Civil Penalties

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Yesterday, the Federal Trade Commission issued a press release suggesting that the agency will be cracking down on allegedly deceptive practices in social media and online reviews, scrutinizing in particular reviewers who...more

Cozen O'Connor

Auto Parts Manufacturer Agrees To Pay $4 Million For Contamination Cleanup

Cozen O'Connor on

New York AG Letitia James and the New York State Department of Environmental Conservation (“DEC”) reached a settlement with auto parts manufacturer American Axle & Manufacturing, Inc. (“American Axle”) to resolve allegations...more

Bass, Berry & Sims PLC

OIG Issues Favorable Advisory Opinion (No. 21-01) on Free Drug Program

On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Free Drug Provided by Pharmaceutical Manufacturer to Patients

King & Spalding on

On March 18, 2021, OIG issued Advisory Opinion 21-01, addressing whether a pharmaceutical manufacturer may provide a personalized medicine made from a patient’s own cells as a one-time, potentially curative treatment (the...more

Morrison & Foerster LLP - Class Dismissed

Consumer Product Safety Enforcement To Heat Up Under Biden Administration

More aggressive enforcement actions and increased regulatory activities under the Biden Administration are here. In President Biden’s first weeks, he is making good on his promise to reverse course from the previous...more

Foley & Lardner LLP

Sunshine Act Reporting Update: De Minimis Amounts

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The Centers for Medicare & Medicaid Services (CMS) issued updated guidance on the thresholds that Applicable Manufacturers and Group Purchasing Organizations are required to report annually under the Sunshine Act (42 U.S.C. §...more

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