News & Analysis as of

Manufacturers Enforcement Actions

Morgan Lewis

US Department of Justice Establishes Trade Fraud Task Force to Counter Tariff Evasion

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In late August 2025, the US Department of Justice announced the formation of a cross-agency Trade Fraud Task Force that will specialize in tariff-related investigations. DOJ positioned the new task force as an extension of...more

Morgan Lewis - As Prescribed

Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?

On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more

ArentFox Schiff

Federal Court Blocks Prop 65 Warning for Titanium Dioxide in Cosmetics

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In an order filed on August 12, the US District Court for the Eastern District of California ruled that California’s Proposition 65 cancer warning requirement for certain listed forms of titanium dioxide (airborne, unbound...more

Health Care Compliance Association (HCCA)

UPICs May Audit Skin Substitutes Twice; Are Lawsuits Against Manufacturers Coming?

As the audits and investigations of wound care procedures with skin substitutes march on, providers who were audited once by a CMS unified program integrity contractor (UPIC) should prepare for a second round. And if the UPIC...more

Hinch Newman LLP

How to Avoid Scrutiny When Advertising or Labeling Made in USA

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In 1997, following consumer research and public comments, the FTC published an Enforcement Policy Statement on U.S. Origin Claims to guide marketers and manufacturers that want to make an unqualified Made in USA claim under...more

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

Hazardous Waste Enforcement: U.S. Environmental Protection Agency and Ladson, South Carolina Vehicle Assembly Plant Enter into...

The U.S. Environmental Protection Agency (“EPA”) and Mercedes-Benz Vans, LLC, (“MBV”) entered into a June 16th Consent Agreement (“CA”) addressing alleged violations of the Hazardous Waste Regulations. See Docket No....more

Greenberg Glusker LLP

Counting to 10: Simpler in Kindergarten than in Proposition 65

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California’s Proposition 65 (“Prop. 65”) requires businesses to provide warnings for any products that contain certain levels of chemicals determined by the State of California to cause cancer or reproductive harm. Prop. 65...more

Nelson Mullins Riley & Scarborough LLP

FTC Advertising Compliance for Foreign Manufacturers Entering the U.S. Market

As your company prepares to enter the U.S. market, it is essential to understand and comply with the Federal Trade Commission’s (FTC) advertising and labeling regulations. These rules are designed to protect consumers from...more

BCLP

What is the European Accessibility Act and What Impact Will It Have on Your Business?

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The European Accessibility Act (EAA) came into force on 28 June 2025. It requires that all in-scope products and services placed on the market or provided after that date in the EU must meet specified accessibility...more

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

Cozen O'Connor on

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

Cozen O'Connor on

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

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