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Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
The U.S. Food and Drug Administration (FDA) recently issued two guidance documents – one final and one draft – related to the new nutrition labeling requirements. The final guidance is an update to the previous draft guidance...more
Silverman Publishes “In Search of the Reasonable Consumer: When Courts Find Food Class Action Litigation Goes Too Far” - Shook Partner Cary Silverman has authored an article for the University of Cincinnati Law Review...more
On September 26, 2018, the Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA’s commitment to disclose retailer information for certain food recalls to improve consumer safety....more
FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more
On December 1, 2014, the Food and Drug Administration published its final rule on Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, 79 FR 71156. This rule requires restaurants...more