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FDA Issues Draft Guidance on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

The United States Food and Drug Administration (FDA) recently issued Draft Guidance for Industry entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C” (the Draft Guidance). 1/ As FDA Associate Commissioner...more

FDA Commissioner Gottlieb and Deputy Commissioner Yiannas Issue Statement on New Steps to Strengthen FDA’s Food Safety Program for...

FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand...more

National Academies Release Dietary Reference Intakes for Sodium and Potassium

The National Academies of Sciences, Engineering and Medicine (NASEM) recently released updated Dietary Reference Intakes (DRIs) for sodium and potassium. For the adequate intake of sodium, the report reaffirms the existing...more

FDA Releases Strategy for the Safety of Imported Food

The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of...more

FDA Announces Qualified Health Claim for Consuming Oils with High Levels of Oleic Acid to Reduce Coronary Heart Disease Risk

The U.S. Food and Drug Administration (FDA) last month announced it would exercise enforcement discretion over two qualified health claims characterizing the relationship between the reduced risk of coronary heart disease...more

FDA Releases Plant and Animal Biotechnology Innovation Action Plan

The U.S. Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan (“Action Plan”). The Action Plan provides an overview of the key priorities FDA expects to pursue through...more

USDA and FDA Announce Joint Oversight Over Cell Cultured Products

On Friday, November 16, 2018, the U.S. Department of Agriculture (USDA) Secretary Perdue and U.S. Food and Drug Administration (FDA) Commissioner Gottlieb announced a joint regulatory framework to oversee cell cultured...more

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