News & Analysis as of

Enforcement Actions Regulatory Requirements Manufacturers

Holland & Knight LLP

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

Holland & Knight LLP on

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

Hinch Newman LLP

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

Hinch Newman LLP on

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

Conn Maciel Carey LLP

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

Conn Maciel Carey LLP on

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

Gardner Law

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

Gardner Law on

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

Wiley Rein LLP

Wiley Consumer Protection Download (July 15, 2025)

Wiley Rein LLP on

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

Mintz

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

Mintz on

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

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

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

Littler

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

Littler on

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

Gardner Law on

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

Morrison & Foerster LLP

CPSC Issues Weekly Record Level of Product Safety Notices

As noted in our recent client alert, the U.S. Consumer Product Safety Commission (CPSC) continues to aggressively pursue enforcement actions for violations of the Consumer Product Safety Act (CPSA) against foreign...more

Goodwin

State Drug Transparency Laws - 2025 Update

Goodwin on

We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more

Gardner Law

Staying Prepared Amid FDA Changes

Gardner Law on

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Foley & Lardner LLP

CPSC Announces “Record-Breaking Week” of Enforcement Actions Against Chinese Manufacturers

Foley & Lardner LLP on

On May 15, 2025, the Consumer Product Safety Commission (CPSC or Commission) announced a “record-breaking week” of enforcement actions against “foreign violators.”[1] Namely, the Commission announced 28 separate product...more

Arnall Golden Gregory LLP

Surprise, Surprise: FDA Announces Plans to Increase Number of Unannounced Inspections at Foreign Manufacturing Facilities

In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more

McGuireWoods LLP

FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

McGuireWoods LLP on

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more

MG+M The Law Firm

Zeldin's EPA Weakens Biden-Era PFAS Rules Despite Upholding Core Standards

MG+M The Law Firm on

On May 14, 2025, the US Environmental Protection Agency (EPA), under Administrator Lee Zeldin, announced its decision to retain the national enforceable drinking water standards for two of the most scrutinized per- and...more

Cooley LLP

FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

Cooley LLP on

On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...more

Akin Gump Strauss Hauer & Feld LLP

EPA Speaks on PFAS: What Manufacturers Need to Know

After addressing a number of other programs over the first 100 days of the new administration, on April 28, 2025, the Environmental Protection Agency (EPA) finally addressed PFAS. Administrator Lee Zeldin outlined a number of...more

Hudson Cook, LLP

California Regulator Signals New Era in Privacy Enforcement

Hudson Cook, LLP on

In March, 2025, the California Privacy Protection Agency announced a consent order with an auto manufacturer alleging multiple violations of the California Consumer Privacy Act and imposing a $632,500 fine for alleged failure...more

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

OSHA Enforcement: Penalty Assessment Addressing Conyers, Georgia Biolab

The Occupational Safety and Health Administration (“OSHA”) issued a news release stating that it is proposing to impose penalties against Bio-Lab Inc. (“BLI”). The news release states that OSHA determined that the BLI...more

Hogan Lovells

AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...more

Foley & Lardner LLP

Prop 65: Changes to Short-Form Warnings Will Cause Long-Term Impacts

Foley & Lardner LLP on

The California Office of Environmental Health Hazard Assessment (OEHHA) recently amended its regulations concerning requirements for consumer product warnings to qualify for “safe harbor” protection from enforcement actions...more

Hogan Lovells

Why medical device companies must prioritize compliance with DOJ's Data Security Program

Hogan Lovells on

This regulation is designed to protect U.S. national security by restricting the transfer of bulk sensitive data to foreign entities associated with “countries of concern,” including China, Russia, Iran, North Korea, Cuba,...more

48 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide