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Tag: Disease Claims

FDA Warning Letters for Alzheimer’s Supplement Claims

Dietary Supplements, Disease Claims, fda warning letters, Labeling, Warning LettersFDA

On February 11, 2019, the U.S. Food & Drug Administration (“FDA”) published a warning to the public entitled “FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease” (“FDA Warning”). Found here, the FDA Warning notifies …

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FDA Warning Issued to Fraudulent and Unapproved Flu Products

Disease Claims, Drug, Drugs, Enforcement, FDA, fda warning, Guidance, Labeling, Warning LettersFDA

On March 2, 2018, the U.S. Food & Drug Administration (“FDA”) published a warning to the public entitled “FDA warns of fraudulent and unapproved flu products (“FDA Warning”). Found here, the FDA Warning is aimed at notifying the public of …

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FDA Untitled Letters: FDA Warnings with a Twist

Disease Claims, Enforcement, FDA, Labeling, W, Warning LettersFDA

The U.S. Food and Drug Administration (“FDA”) has recently been issuing letters to companies that are distinct from traditional FDA Warning Letters. Referred to as FDA Untitled Letters, these letters must be taken seriously, as the terms of FDA Untitled …

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Cosmetic Products and the FDA

color additives, Cosmetics, Disease Claims, FDA, imports, LabelingFDA

FDA Regulation of Cosmetics Products Importers introducing cosmetic products into the United States must be mindful of FDA regulations, which can present a barrier to market entry if the appropriate steps are not taken to ensure compliance. The U.S. Food …

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District Court sides with Industry on Dietary Supplement Substantiation

Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Structure-Function Claims, SubstantiationFDA, FTC

A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held in contempt for alleged violations of a 2007 consent decree regarding the marketing of its Phillip’s Colon Health (PCH) product. …

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US Marshals Seize Topical Products Deemed Drugs by FDA

Disease Claims, Drugs, Enforcement, FDAFDA

On April 16, 2015, U.S. Marshals seized what the U.S. Food & Drug Administration (“FDA”) classified as unapproved prescription drugs from Stratus Pharmaceuticals, Inc. of Miami, Florida. Stratus purchased these unapproved prescription drugs, worth over $1.5 million, from Sonar Products, …

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Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics

Cosmetics, Disease Claims, Drugs, Enforcement, FDA, Labeling, Structure-Function Claims, Warning LettersFDA

On March 31, 2015, Attorney Katherine Giannamore, of The Law Office of Katherine Giannamore, P.A., was interviewed by Ryan Nelson of “The Rose Sheet” about the challenges that companies face when marketing cosmetic products. “The Rose Sheet” is one of …

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FDA Warns of Marketing Cosmetics with Drug Claims

Cosmetics, Disease Claims, Drug, Drugs, Enforcement, FDA, Labeling, Structure-Function Claims, Warning LettersFDA

The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin line. However, the differences in regulation between the two are stark. The Federal Food Drug and Cosmetic Act (The Act) …

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FDA Stops Company from Marketing Unapproved New Drugs

Disease Claims, Drugs, Enforcement, FDA, Injunction, Labeling, NDA, Warning LettersFDA

On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted a consent decree of permanent injunction against Laclede, a U.S.-based manufacturer in connection with the marketing of unapproved new drugs. …

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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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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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