News & Analysis as of

Food and Drug Administration (FDA) Imports Enforcement Actions

Morgan Lewis - Well Done

FDA Updates Food Labeling Compliance Program: What It Means for Food Manufacturers

In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This program guides FDA inspectors...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

Troutman Pepper Locke

FDA and CBP Seize Nearly $34M Worth of Illegal E-Cigarettes in Joint Operation

Troutman Pepper Locke on

In the first major enforcement action involving the importation of illegal tobacco products by the new administration, and on the heels of the appointment of the new acting director of the U.S. Food and Drug Administration...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

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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

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

Cozen O'Connor

Bipartisan AGs to Disposable E-Cigarette Companies: You’re Blowing Smoke

Cozen O'Connor on

A bipartisan group of ten AGs announced separate, coordinated efforts to take regulatory and enforcement action against companies allegedly importing, distributing, selling, and marketing flavored disposable e-cigarettes....more

DLA Piper

Food and Beverage News and Trends - September 2024 #2

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape....more

Morgan Lewis

FDA Places Mexican-Made Hand Sanitizers on Import Alert Due to Toxin Risks

Morgan Lewis on

The Food and Drug Administration (FDA) issued a press release on January 26 announcing a countrywide import alert on all alcohol-based hand sanitizers manufactured in Mexico due to their potential methanol content. The press...more

American Conference Institute (ACI)

[Virtual Event] Advanced Legal, Regulatory and Compliance Forum on Over the Counter Drugs - February 26th, 9:00 am - 5:45 pm EST

A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Wilson Sonsini Goodrich & Rosati

First FSVP Warning Letter Issued by the FDA

In a signal to industry that the period for education and enforcement discretion related to the Foreign Supplier Verification Programs (FSVP) may be concluding, the Food and Drug Administration (FDA) recently issued its first...more

Hogan Lovells

FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Russian

ANTICORRUPTION DEVELOPMENTS – Canadian Mining Company Settles with SEC over FCPA Charges – On March 26, Kinross Gold Corporation settled with the Securities and Exchange Commission (SEC) over its alleged failure to...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Chinese

ANTICORRUPTION DEVELOPMENTS – Canadian Mining Company Settles with SEC over FCPA Charges – On March 26, Kinross Gold Corporation settled with the Securities and Exchange Commission (SEC) over its alleged failure to...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - March 2018

ANTICORRUPTION DEVELOPMENTS – Canadian Mining Company Settles with SEC over FCPA Charges – On March 26, Kinross Gold Corporation settled with the Securities and Exchange Commission (SEC) over its alleged failure to...more

Weintraub Tobin

New FDA Strategy Document for FSMA, Food Safety Modernization ACT

Weintraub Tobin on

The USDA has issued a new “strategy” document that outlines the agency’s direction with regard to implementing the Food Safety Modernization Act (“FSMA”). The document is intended to “to guide the next phase of FSMA...more

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