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Manufacturers › Food and Drug Administration (FDA) › FDA Warning Letters

Holland & Knight LLP

FDA Enforcement Against Dental Lab Could Have Broader Implications

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) recently published a warning letter (Warning Letter) targeting a dental laboratory after a lengthy inspection found that the dental laboratory's operations, which offer...more

Orrick, Herrington & Sutcliffe LLP

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

Orrick, Herrington & Sutcliffe LLP on

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

Troutman Pepper Locke

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

Troutman Pepper Locke on

In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

Troutman Pepper Locke

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

Troutman Pepper Locke on

In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Troutman Pepper Locke

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

Troutman Pepper Locke on

The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more

Jackson Walker

Mid-Year FDA Update: What’s New for Dietary Supplements?

Jackson Walker on

The U.S. Food and Drug Administration (“FDA”) regulates both finished dietary supplements (e.g., the “multi-vitamin” tablets that you might buy at the grocery store) and dietary ingredients (e.g., the B vitamins contained in...more

Oberheiden P.C.

FDA Warning Letter Response Strategies (Step-By-Step)

Oberheiden P.C. on

FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more

Harris Beach Murtha PLLC

FDA and FTC Take Action Regarding Pandemic-Related Products

Harris Beach Murtha PLLC on

In response to the COVID-19 pandemic, numerous manufacturers and distributors of products ranging from CBD, to herbal products and supplements, to ingestible silver, began to market their products as those that could...more

Wilson Sonsini Goodrich & Rosati

FDA Announces Unprecedented Recall of Dietary Supplements

Wilson Sonsini Goodrich & Rosati on

Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more

Mintz - Health Care Viewpoints

Consumer Product Regulatory Priorities in 2019: An Ever-Shifting Landscape for FDA

Mintz - Health Care Viewpoints on

This is our third year-end post for 2019 related to the Food and Drug Administration (FDA), focusing on the agency’s activities in the widely divergent area of “consumer products.” In taking a wide-lens view of the past year,...more

Wilson Sonsini Goodrich & Rosati

Court Holds the FDA Cannot Classify an Imaging Agent Medical Device as a Drug

Wilson Sonsini Goodrich & Rosati on

The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more

Seyfarth Shaw LLP

FDA Stresses CBD Safety Concerns in 15 Warning Letters and Revised Consumer Update

Seyfarth Shaw LLP on

In its largest mass enforcement action involving cannabidiol (CBD) yet, the U.S. Food & Drug Administration (FDA) announced on November 25 the issuance of 15 warning letters to various companies for illegally selling products...more

Bradley Arant Boult Cummings LLP

The Beginning of the End or the End of the Beginning? The FDA Issues 15 New Warning Letters to CBD Companies - Cannabis Industry...

Bradley Arant Boult Cummings LLP on

The U.S. Food and Drug Administration (FDA) sent a shot across the bow of the cannabidiol (CBD) industry on November 25. The FDA disclosed that it issued warning letters to 15 companies “for illegally selling products...more

Carlton Fields

CBD Health Claims Spur FDA Warning & Product Seizure Threats

Carlton Fields on

The 2018 Farm Bill gave cannabis businesses around the country a legal path to market and sell hemp and hemp-derived products. Despite the groundbreaking law, several regulatory uncertainties remain. The FDA has been a source...more

Mintz - Health Care Viewpoints

Update on FDA’s Comprehensive Regenerative Medicine Policies and Enforcement Activities

Mintz - Health Care Viewpoints on

Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by...more

Akin Gump Strauss Hauer & Feld LLP

A Client’s Guide to FDA Recalls

Akin Gump Strauss Hauer & Feld LLP on

Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more

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