Category: FDA

  • FDA, Advocacy Groups Agree to Stay Lawsuit Over Menu Labeling Compliance Delay

    The U.S. Food and Drug Administration (FDA), the Center for Science in the Public Interest (CSPI) and the National Consumers League have filed a joint motion to stay a lawsuit intended to compel the agency to implement the delayed menu labeling rule required by the Affordable Care Act. Ctr. for Sci. in the Pub. Interest v.…

  • FDA Announces Final FSMA Produce Safety Rule

    The U.S. Food and Drug Administration (FDA) has announced that the produce safety rule of the Food Safety and Modernization Act of 2010 (FSMA) is now final, establishing minimum standards for the growing, harvesting, packing and holding of raw produce for human consumption. Compliance dates are staggered but will affect large operations first. The key…

  • FDA to Permit Baby Food Allergy-Reduction Claims

    The U.S. Food and Drug Administration (FDA) has announced the approval of a qualified health claim that baby food with ground peanuts can reduce the development of peanut allergies. On the labels of foods suitable for infant consumption that contain ground peanuts, companies can now include the claim that “for most infants with severe eczema…

  • FDA Seeks Comment on Regulation Changes for “Meaningful Burden Reduction”

    Implementing an executive order titled “Reducing Regulation and Controlling Regulatory Costs,” the U.S. Food and Drug Administration (FDA) has opened a comment period to identify “existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health…

  • “Competing Priorities” Keep FDA From Ruling on Food Names Petition

    The U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition has notified the Good Food Institute (GFI) that the agency has been unable to reach a decision on the advocacy group’s March 2017 petition requesting recognition for commonly used—if technically inaccurate, per FDA definitions—food names such as “almond milk,” “soymilk,” “almond…

  • Shook Attorneys Explore Limits on Photography During FDA Inspections

    Shook Partners Lindsey Heinz and Katie Gates Calderon, with Associate Hillary Nicholas, have authored an article for Law360 discussing regulations related to the use of photography during a U.S. Food and Drug Administration (FDA) inspection of a production facility. “Despite the void of statutory authority, the FDA continues to instruct its inspectors to ‘not request…

  • Intentional Adulteration Guidance for Small Businesses Available

    The U.S. Food and Drug Administration has made available industry guidance titled “Mitigation Strategies to Protect Food Against Intentional Adulteration: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide.” Comments on the guidance may be submitted at any time.   Issue 645

  • FDA Issues Guidance for Use of Ultrafiltered Milk in Cheese

    The U.S. Food and Drug Administration (FDA) has announced the availability of industry guidance titled, “Ultrafiltered Milk in the Production of Standardized Cheese and Related Cheese Products: Guidance for Industry.” The guidance advises manufacturers that FDA intends to exercise enforcement in the use of fluid ultrafiltered milk in cheese products.   Issue 645