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ArentFox Schiff

As the (Customs and Trade) World Turns: September 2024

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Welcome to the September 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and...more

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

Perkins Coie

FDA and AAFCO Updates for Animal Food Ingredient Oversight

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FDA’s Center for Veterinary Medicine (CVM) recently announced the upcoming expiration of its longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO). This MOU—which has...more

IR Global

Forced Labor Questionnaires: Another Helpful Hint

IR Global on

In February 2024, Customs and Border Protection (CBP) began taking a new approach to Uyghur Forced Labor Prevention Act (UFLPA) enforcement—questionnaires. Once again, the solar industry is among the first targets, vanguards...more

Gardner Law

FDA Drafts Guidance on Correcting “Misinformation”

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The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...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

ArentFox Schiff

DHS’ Second UFLPA Strategy Update: Aluminum, PVC, and Seafood Enter the UFLPA’s Purview for Scrutiny and Enforcement

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Since the inception of the Uyghur Forced Labor Prevention Act (UFLPA), importers globally have started to become acutely aware of potential forced labor risks hidden beneath intricate supply chains....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

Morrison & Foerster LLP

EPA May Now Pursue PFOS and PFOA Manufacturers and Users under CERCLA

Effective as of yesterday, July 8, 2024, two widely used per- and polyfluoroalkyl substances (PFAS)—perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) are deemed hazardous substances under the Comprehensive...more

Hinch Newman LLP

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

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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

Davis Wright Tremaine LLP

Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA

Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...more

ArentFox Schiff

The 340B ‘Saga’ Continued: HRSA, States, and Drug Manufacturers Contest 340B Contract Pharmacy Restrictions in Court

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In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more

K&L Gates LLP

The European Commission Sends Strong Signal Against Parallel Import Restrictions

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On 23 May 2024, the European Commission (Commission) imposed a €337.5 million fine to one of the world’s leading manufacturers of chocolate, biscuits, and coffee products for restricting cross-border trade in these product...more

Greenberg Glusker LLP

Will Makeup Get a Makeover?: Titanium Dioxide in Cosmetics

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UPDATE: On June 12, 2024, the U.S. District Court for the Eastern District of California entered a preliminary injunction in The Personal Care Products Council v. Bonta....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

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

Robinson+Cole Manufacturing Law Blog

PFOA and PFOS Are CERCLA Hazardous Substances – Now What?

EPA recently issued its long-awaited rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances under the Comprehensive Environmental Response, Compensation and Liability...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

Sheppard Mullin Richter & Hampton LLP

FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests

Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will phase out the Agency’s previous...more

A&O Shearman

Increased Focus on Forced Labor in the US and EU

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U.S. Customs authorities impounded thousands of vehicles, showing risks to imports linked to forced labor. The U.S. government detained thousands of luxury vehicles deemed to contain a small electronic component sourced from...more

Gardner Law

FDA’s Center for Drug Evaluation and Research (CDER) Issues FY2023 Annual Report

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In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more

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

OSHA Enforcement: Commerce, Georgia, Electric Vehicle Battery Manufacturing Facility Cited for Alleged Violations

The Occupational Safety and Health Administration (“OSHA”) issued a January 17th news release stating it was proposing to assess penalties against SK Battery America Inc. (“SK”) for alleged violations. SK is described as a...more

Braumiller Law Group, PLLC

[Webinar] Forced Labor/Slave Labor/Uyghur Labor - The latest on human rights violations and CBP enforcement - January 4th, 11:30...

Join Braumiller Law Group Senior Counsel Bruce Leeds for the second presentation in a monthly series regarding Hot Topics in International Trade Compliance Forced Labor/Slave Labor/Uyghur Labor - The latest on human rights...more

Foley & Lardner LLP

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

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In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...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

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