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Tag: Recalls

Court Issues Injunction after FDA Warning Letter Issues Persist

CGMP, Dietary Supplements, Enforcement, FDA, Injunction, Recalls, Warning LettersFDA

On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its products until the company meets certain U.S. Food & Drug Administration (“FDA”) regulations and mandated standards (Current Good Manufacturing Practices …

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FDA Food Allergen Labeling

Allergens, FDA, Food, Gluten-Free, Labeling, RecallsFDA

When consumers with food allergies are purchasing food products, they normally examine the food labels to make sure a product does not contain any ingredients that would cause them to have an adverse reaction. Milk, eggs, fish, shellfish, nuts, wheat, …

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FDA Releases Proposed Rules under FSMA

Food, Food Facility Registration, Food Safety Modernization Act, Recalls, RulemakingFDA

On September 19, 2014, the U.S. Food and Drug Administration (FDA) released revisions to four proposed rules, opening them up for public comment. When these four rules are finalized in 2015, they will implement portions of the FDA Food Safety …

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Food Seasonings Recalled Due to Undeclared Allergens

Allergens, Dietary Supplements, FALCPA, FDA, Food, Labeling, RecallsFDA

On February 15, 2013, the DeCoty Coffee Company of San Angelo, Texas announced that it was recalling its 1.25 pound and 5.75 pound DeCoty Taco Seasoning products. Prompting this recall are labeling concerns, specifically that the products contain an undeclared …

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FDA Actions Highlight New Authority under FSMA

FDA, Food, Food Facility Registration, Food Safety Modernization Act, FSMA, Recalls, SalmonellaFDA

On November 26, 2012, the U.S. Food and Drug Administration (“FDA”) suspended the food facility registration of Sunland, Inc., a New Mexico-based peanut butter plant. Sunland, Inc. has been in the headlines throughout much of 2012 due to a number …

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Jimmy Dean Initiates Recall for Failure to Declare Allergens

Allergens, FDA, Food, Labeling, RecallsFDA

On November 10, 2012, Jimmy Dean issued a Press Release, explaining how the Company is initiating a voluntary recall of certain of its products due to a labeling error that resulted in undeclared allergens. In particular, the Company is recalling …

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Listeria-Laden Onions Spur Recalls throughout United States

FDA, Food, Listeria, onions, RecallsFDA

On July 28, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release notifying consumers of a voluntary recall initiated by GH Foods CA, LLC. The recall covers a variety of products containing certain onions distributed by Gills …

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FDA Notifies Consumers of Supplement Recall after Discovery of Undeclared Drug Ingredients

Dietary Supplements, Drug, Drugs, FDA, RecallsFDA

On May 18, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release announcing the voluntary recall of certain dietary supplements marketed as male enhancements. West Coast Nutritionals, Ltd., the firm responsible for the supplements, initiated the recall …

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FDA and FAAN Aim to Educate Public during Food Allergy Awareness Week

Allergens, FDA, Food, Labeling, Recalls, Warning LettersFDA

This week (May 13 – May 19, 2012) is recognized as Food Allergy Awareness Week (“FAAW”). FAAW was created by the Food Allergy & Anaphylaxis Network (“FAAN”), a non-profit organization dedicated to promoting awareness food allergies and those who suffer …

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FDA Warns of Recall Due to Undeclared Milk Derivatives in Several Beverage Products

Allergens, Beverages, FDA, Food, Labeling, Milk, RecallsFDA

On May 10, 2012, the U.S. Food and Drug Administration (“FDA”) posted a press release on its website notifying consumers of a recent recall of various fruit beverages. Jonlly Fruits Inc., the manufacturer of the beverages, opted to initiate the …

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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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