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Enforcement Actions Manufacturers

McDermott Will & Schulte

Cooperate, protect, and challenge: Responding to dawn raids conducted by EU competition authorities

Dawn raids conducted by antitrust authorities are stressful events. Among other issues, the ensuing investigations consume significant time and effort and often result in high fines for the companies involved. It is therefore...more

Holland & Knight LLP

PFAS in Cosmetics: State-Led Regulatory Surge Demands Proactive Compliance

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States are rapidly enacting and implementing bans and reporting requirements for per- and polyfluoroalkyl substances (PFAS) in cosmetics, creating a complex and evolving compliance environment for manufacturers, distributors,...more

Barnea Jaffa Lande & Co.

European Commission Tightens Law Enforcement on Pharmaceutical Cartels

In July 2025, the European Competition Commission imposed a EUR 489,000 fine on Alchem International Pvt. Ltd. and its Hong Kong subsidiary for their involvement in a pharmaceutical cartel involving the active ingredient used...more

Hinch Newman LLP

Essential Guide to FTC Made in USA Advertising Do’s and Don’ts | FTC Made in USA Attorney

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The Federal Trade Commission recently enacted the Made in USA Labeling Rule and updated its “Complying with the Made in USA Standard” business guidance. Both reinforce the “all or virtually all” standard...more

Orrick, Herrington & Sutcliffe LLP

Will FDA’s Warning Letter to WHOOP Put a Chill on Wearables?

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more

Cozen O'Connor

The State AG Report – 07.24.2025

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: • Latest Texas AG Food Probe Puts Mars in a Sticky...more

Cozen O'Connor

OSHA Renews Focus On Amputations In Manufacturing

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OSHA recently renewed its national emphasis program focused on preventing amputations in manufacturing, effective June 27. The national emphasis program will remain in place for five years, and programmed inspections may...more

Cozen O'Connor

Latest Texas AG Food Probe Puts Mars in a Sticky Situation

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Texas AG Ken Paxton announced that he is investigating Mars, Inc., the maker of products like M&M’s and Skittles, for allegedly engaging in deceptive trade practices in violation of state consumer protection laws when...more

Conn Maciel Carey LLP

Don’t Get Caught Off Guard: OSHA Renews Its Machine Safety (Amputations) National Emphasis Program

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OSHA announced that it is renewing its National Emphasis Program (NEP) to Address Amputations in Manufacturing. The renewed NEP will replace the previous version which expired on June 27 and will remain in place for five...more

Kelley Drye & Warren LLP

FTC Warns Manufacturers and Retailers About Made in USA Claims

As we noted earlier this month, FTC Chairman Andrew Ferguson designated July as ​“Made in USA” Month. Because Hallmark still hasn’t printed greeting cards to commemorate the month, the FTC celebrated by sending warning...more

Cozen O'Connor

The State AG Report – 07.17.2025

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Democratic AGs Oppose Washing Away Appliance Efficiency...more

Gardner Law

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

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Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more

Cozen O'Connor

Bipartisan Coalition of AGs Secures $720 Million Settlement with Opioid Manufacturers

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Virginia AG Jason Miyares, along with a bipartisan coalition of eight other AGs, announced a $720 million settlement with eight opioid drug manufacturers to resolve allegations that they contributed to the opioid epidemic....more

Wiley Rein LLP

Wiley Consumer Protection Download (July 15, 2025)

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FTC Sends Warning Letters Regarding Potential Noncompliance With “Made in USA” Requirements. On July 8, the FTC sent letters to a flagpole retailer, footwear maker, football equipment company, and personal care products...more

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

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On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

McGuireWoods LLP

FTC Signals Continued Enforcement of “Made in USA” Labeling Rule and Guidance

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The Federal Trade Commission was quiet in its role as the Made in USA enforcement authority during the first few months of the Trump administration. But July left little doubt that the current FTC will continue the robust...more

Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

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The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Mintz

[Podcast] Health Law Diagnosed – Best Practices for Communicating with the FDA

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In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more

MG+M The Law Firm

Wisconsin Supreme Court Ruling on PFAS Leaves Businesses Vulnerable and Overextends Agency Power

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In a contentious 5–2 decision, the Wisconsin Supreme Court has dealt an unprecedented blow to the state’s business and manufacturing sector by ruling that the Department of Natural Resources (DNR) can force cleanup of PFAS...more

Kelley Drye & Warren LLP

FTC (and NAD) Celebrate ​“Made in USA” Month

On July 1, 2025, FTC Chairman Andrew Ferguson designated July as ​“Made in USA” Month. Chairman Ferguson noted that in a recent poll, 61% of Americans stated that whether a product was ​“Made in USA” played a factor in their...more

Skadden, Arps, Slate, Meagher & Flom LLP

OIG Issues Unfavorable Advisory Opinion: Provision of Free Services to Referral Sources Creates Kickback Risk

Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...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

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

Air Enforcement: U.S. Environmental Protection Agency and Willow Island, West Virginia Industrial Coatings Manufacturer Enter into...

The United States Environmental Protection Agency (“EPA”) and Allnex USA Inc. (“Allnex”) entered into a June 11th Consent Agreement (“CA”) addressing alleged violations of an Air Permit. See Docket No. CAA-03-2025-0036....more

Littler

OSHA Renews its National Emphasis Program on Amputations in the Manufacturing Industry

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The U.S. Department of Labor’s Occupational Safety and Health Administration renewed its National Emphasis Program on Amputations in Manufacturing Industries (NEP) on June 27, 2025, superseding the prior version. This new NEP...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

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