News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) FDA Warning Letters Manufacturers

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

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

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

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

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

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...

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

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