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FDA issued updated guidance regarding manufacture of alcohol-based hand sanitizerAs reports of hand sanitizer shortages have circulated and consumers have taken to using even Tito’s Vodka as a replacement (yes, on their hands), FDA has stepped in to provide clarity.  Last Friday, FDA issued updated guidance regarding manufacture of alcohol-based hand sanitizer.

The first guidance document, Temporary Policy for Preparation of Certain Alcohol-Based Hand

FDA Releases Industry Guidance Regarding Adverse Event Reporting During COVID-19On March 19, the Food and Drug Administration (FDA) released guidance providing recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic, including COVID-19. The guidance revises and replaces final guidance released in 2012 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary

Vigorous food safety enforcement for basic violations continues under the leadership of new FDA Commissioner, Dr. Scott Gottlieb. On June 20, on the heels of an adverse FDA inspection, FDA announced that the U.S. Marshals Service had seized the food products held by Professional Warehouse and Distribution, Inc., at a food warehouse facility in St. Paul, Minnesota. The related complaint filed by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the District of Minnesota alleges that the products are adulterated under the Federal Food, Drug, and Cosmetic Act in reliance on 21 U.S.C. §342(a)(4). The seized products are worth approximately $73,000 and include barley flour, spices, pasta, dried beans, tea and cookies.

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