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Tag: Dietary Supplements

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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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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FDA Investigates Illnesses Linked to Energy Drinks and Supplements

Adverse Events, Beverages, Dietary Supplements, Energy Drinks, FDA, FoodFDA

On November 16, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the Agency’s ongoing investigation of reported illnesses and deaths linked to energy drinks and energy shot supplements. Found here, the Statement details the FDA’s efforts …

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FDA Warns Dietary Supplement Firms for Marketing Concussion Treatments

Dietary Supplements, Disease Claims, Drugs, Food, Labeling, Structure-Function Claims, Warning LettersFDA

On September 6, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to two dietary supplement companies in connection with promoting unapproved products as drugs. According to the FDA, the firms cited by the Agency, PruTect Rx and …

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FDA Warns Makers of RockStar Coffee & Energy Products

Beverages, Dietary Supplements, Enforcement, Labeling, RockStar, Warning LettersFDA

On May 23, 2012, the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter to the manufacturers of the widely popular RockStar energy products, Rockstar , Inc. (“the Company”). Found here, the Letter contains various allegations that the Company’s …

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Marshals Seize Misbranded Drug Products at Maine Facility per FDA’s Request

Dietary Supplements, Drug Products, Drugs, Enforcement, FDA, Labeling, Warning LettersFDA

On June 6, 2012, the U.S. Food and Drug Administration (“FDA”) announced the seizure of various drug products from a Portland, Maine facility. According to the FDA, U.S. Marshals seized the drug products upon the Agency’s request after it was …

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FDA Alerts Consumers of an Array of Dangers Associated with Reumofan Plus Supplement

Dietary Supplements, Enforcement, FDA, imports, Labeling, Reumofan PlusFDA

On June 1, 2012, the U.S. Food and Drug Administration (“FDA”) issued an alert to consumers on the product Reumofan Plus. Purportedly marketed as a dietary supplement, Reumofan Plus is manufactured in Mexico by the company Riger Naturals. According to …

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FTC May Have Won Battle with POM Wonderful but Industry Appears to Have Won the War

Beverages, Dietary Supplements, Enforcement, Food, FTC, SubstantiationFTC

On May 21, 2012, the Federal Trade Commission (“FTC”) announced that it has prevailed in its claim against POM Wonderful LLC (“The Company”) pursuant to a recent ruling by Chief Administrative Law Judge (“ALJ”), D. Michael Chappell. In an Order …

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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 Warns Companies Marketing Supplements Containing DMAA

Dietary Supplements, Enforcement, FDA, NDI, Supplements, Warning LettersFDA

On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to several dietary supplement manufacturers in connection with their alleged improper marketing of supplements containing dimethylamylamine (“DMAA”). DMAA, also referred to as geranium extract, is an …

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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

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  • FDA Warning Letters for Alzheimer’s Supplement Claims
  • FDA Considers Changing Major Food Allergen Labeling Requirements
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