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FDA

FDA Regulation of OTC Sunscreen Products

Have you ever wondered who ensures the safety of your sunscreen? With many people, including pregnant women and children, choosing…

FDA Stops Company from Marketing Unapproved New Drugs

On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted…

FDA Guides on General Wellness and Low Risk Devices

On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current…

Court Issues Injunction after FDA Warning Letter Issues Persist

On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its…

Overview of FDA’s Final Menu and Vending Labeling Rules

Menu and Vending Labeling Rules On November 25, 2014, the U.S. Food and Drug Administration (FDA) finalized two rules requiring…

FDA HACCP Enforcement Sandwiches Food Company between a Rock and a Hard Place

On November 21, 2014, the U.S. Food & Drug Administration (“FDA”) filed for a permanent injunction in the Eastern District…

FDA Food Allergen Labeling

When consumers with food allergies are purchasing food products, they normally examine the food labels to make sure a product…

FDA Imports: Foods and Cosmetics

Do you ever wonder how your favorite exotic cheese, foreign cookies, or champagne make it to the United States? As…

FDA Approval Required for Company Enjoined from Marketing Products

On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with…

Court Finds FDA Exceeded Authority in Device Reclassification

On September 26, 2014, The United States Court of Appeals for the District of Columbia Circuit ruled that the FDA…