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

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

Rivkin Radler LLP

FDA Warns That Topical Pain-Relief Products Containing CBD Violate FD&C Act

Rivkin Radler LLP on

This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a ...more

Womble Bond Dickinson

Insight into Medical Foods and the Scope of FDA Regulation

Womble Bond Dickinson on

The FDA has issued warning letters to manufacturers of products marketed as medical foods to treat a range of medical conditions, including fibromyalgia, autoimmune disorders, irritable bowel syndrome, arthritis, asthma,...more

Epstein Becker & Green

Federal Courts Say They Will Decide Cases Against CBD Product Manufacturers When the Smoke Clears

Epstein Becker & Green on

The cannabidiol (“CBD”) consumer product marketplace is booming. And, while FDA has maintained its position that CBD, even hemp-derived CBD, may not be included as an ingredient in conventional foods or dietary supplements,...more

Mintz - Consumer Product Safety Viewpoints

FDA Ratchets Up Pressure on Homeopathic Drug Manufacturers

On May 14, FDA announced that it issued five Warning Letters to companies that manufacture and market homeopathic drugs for human use. Four of the letters were issued to four companies that jointly manufacture and package...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Therapeutic Products, Part 2

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - October 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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