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    • District Court sides with Industry on Dietary Supplement Substantiation
    • FDA “Natural” Food Labeling
    • FDA Clears Device via De Novo Process
    • What’s in a Name? Everything, for “Standard” FDA Food Labeling
    • FDA Bans Trans Fats
    • FDA Issues Tobacco Warning Letters for Tobacco Retailer Inspection Violations
    • Potential Changes to FDA Regulation of Homeopathic Drugs
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    • Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics
    • FDA Warns of Marketing Cosmetics with Drug Claims
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Tag: Seizure

FDA Approval Required for Company Enjoined from Marketing Products

Disease Claims, Drug, Drugs, Enforcement, FDA, FDA Approval, Injunction, Labeling, Marshalls, NDA, SeizureFDA

On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with the U.S. Food & Drug Administration (“FDA”) and entered a consent decree for permanent injunction against Ascend Laboratories, LLC. As …

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Marshals Seize Supplements with Undeclared Drug Ingredients

CGMP, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Seizure, Warning LettersFDA

On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters of Globe All Wellness, LLC, a dietary supplement manufacturer based in Hollywood, Florida. Marshals seized what are alleged to be …

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510(k) Adverse Events Allergens Beverages CDRH CGMP Cosmetics Dietary Supplements Disease Claims Drug Drugs Enforcement FDA Food Food Facility Registration Food Safety Modernization Act FSMA FTC Gluten-Free GRAS Guidance imports Injunction Labeling Listeria mad cow Medical Devices NDA Nutrition Facts off-label promotion off-label use Orphan Designation Orphan Drug PMA post-marketing studies Recalls Rulemaking Salmonella Structure-Function Claims Substantiation Tobacco Control Act Tobacco Products Tobacco Warning Letter USDA Warning Letters

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Recent Posts

  • FDA Halts Voluntary Cosmetic Registrations Amidst Overhauls      
  • Congress Increases Minimum Tobacco Sales Age to 21
  • FDA Warns JUUL, Alleging Marketing Violations
  • FDA Warning Letters for Alzheimer’s Supplement Claims
  • FDA Considers Changing Major Food Allergen Labeling Requirements
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