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Category: FDA

Permanent Injunction Sought after Cheese Manufacturer Fails to Respond to FDA Warning Letter

CGMP, Enforcement, FDA, Food, Warning LettersFDA

On August 8, 2014, the U.S. Food and Drug Administration (“FDA”) filed a Complaint for Permanent Injunction against a Michigan Cheese Manufacturer and its owners under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 332. The FDA seeks …

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FDA Seeks Injunction against Company for Misbranding Drug Products

Disease Claims, Drug, Drugs, Enforcement, FDA, Labeling, Warning LettersFDA

On June 25, 2014, the U.S. Department of Justice (“DOJ”), in response to a request made by the U.S. Food and Drug Administration (“FDA”), filed a complaint seeking a permanent injunction against Laclede, Inc. of Rancho Domingo California and the …

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FDA Warning Issued Regarding Weight Loss Products

Dietary Supplements, Drugs, Enforcement, FDA, imports, Labeling, Warning LettersFDA

On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) released an advisory, warning consumers not to use bee pollen capsule marketed under the name Zi Xiu Tang Bee Pollen. The purpose for the advisory, previously reported here, was …

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FDA Publishes Food Allergen Labeling Guidelines

Allergens, Beverages, Dietary Supplements, Enforcement, Food, Guidance, LabelingFDA

On May 8, 2014, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.” The draft guidance represents current thinking on the topic as previously discussed through the release of …

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FDA Seizes Topical Creams Deemed Drugs

Disease Claims, Drug, Drugs, Enforcement, Labeling, NDAFDA

On May 16, 2014, the U.S. Food and Drug Administration (“FDA”), with assistance by the U.S. Attorney for the Southern District of Ohio, seized unapproved drugs valued at more than $11 million, which were marked by Ascend Laboratories of Montvale, …

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FDA Halts Production at New York Cheese Company

Enforcement, FDA, Listeria, Warning LettersFDA

On April 28, 2014, the U.S. Food and Drug Administration (“FDA”) prevailed in federal court in its action against Nancy Taber Richards and the company she co-founded, Trumansburg, N.Y.-based Finger Lakes Farmstead Cheese Company, LLC. In particular, the Western District …

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FDA to Regulate New Tobacco Products, E-Cigarettes

e-cigarettes, FDA, imports, Labeling, Rulemaking, Tobacco ProductsFDA

On April 24, 2014, the U.S Food and Drug Administration (FDA) announced its publication of newly proposed regulations pertaining to new tobacco products, as permitted by the Family Smoking Prevention and Tobacco Control Act of 2009. The products covered under …

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FDA Publishes Draft Guidance on Honey Labeling

Enforcement, FDA, Food, Guidance, imports, LabelingFDA

On April 11, 2014, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled “Draft Guidance for Industry: Proper Labeling of Honey and Honey Products” (“Guidance”). The Guidance provides industry with guidelines on how to properly label …

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FDA Advises Consumers to Avoid Using Dietary Supplements with Undeclared Drug Ingredients

Adverse Events, Dietary Supplements, Enforcement, FDAFDA

On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which are promoted as body forming, weight loss dietary supplements. According to the FDA, the Company’s dietary supplements …

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FTC Prevails Against Marketers of Medical Foods

Advertising, Disease Claims, FDA, FTC, Substantiation, Warning LettersFDA, FTC

On March 7, 2014, the Federal Trade Commission (“FTC”) reported that the Agency had prevailed in federal court in its action against the Wellness Support Network. In particular, the U.S. District Court for the Northern District of California entered a …

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    Katherine L. Giannamore
    Rated by Super Lawyers


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    FDA Legal Topics

    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

    Note that Information shared on this Website and Blog are for informational purposes only and may not provide the most up-to-date legal and regulatory information, as we do not provide updates to individual articles after publication. Any commentary or legal analysis herein is for general informational purposes and not to be relied upon for individual legal advice and does not establish an attorney-client relationship.

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