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Tag: Warning Letters

FDA Issues Warning Letters to Companies Marketing Illegal Diabetes Drugs

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

On July 23, 2013, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to 15 domestic and foreign companies that were deemed to be unlawfully marketing diabetes products in violation of the Federal Food, Drug, and …

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FDA Issues Warning Letters to Online Cigarette Companies

Cigarettes, FDA, Labeling, Tobacco Products, Warning LettersFDA

In April 2013, the U.S. Food and Drug Administration (FDA) issued warning letters to certain online cigarette retailers, finding many of their products adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). One of the …

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Company’s Operations Halted for Violating FDA Food Labeling Rules

Enforcement, FDA, Food, Labeling, Misbranding, Nutrition Facts, Warning LettersFDA

On March 13, 2013, the U.S. Food and Drug Administration (“FDA”) announced that a federal judge has signed a consent decree of permanent injunction, enjoining a New Jersey-based food company’s operations. In particular, Butterfly Bakery Inc. (“the Company”) is prohibited from processing …

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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/FTC Issue Joint Warning Letter to Company Marketing Flu Remedy

Disease Claims, Drugs, Enforcement, FDA, FTC, Labeling, Substantiation, Warning LettersFDA, FTC

On January 24, 2013, the U.S. Food and Drug Administration (“FDA”) and the U.S. Federal Trade Commission (“FTC”) issued a joint warning letter to Flu & Cold Defense, LLC (“the Company”), a Florida company, for unlawfully marketing its “GermBullet” inhaler …

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FDA Enjoins Beverage Maker’s Operations until it Complies with the FDCA

Beverages, CGMP, Food, HACCP, Injunction, Labeling, Warning LettersFDA

On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it has entered into a consent decree of permanent injunction with Jonlly Fruits, Inc. (“Company”) and its President, Bartolo Pérez Román. Jonlly Fruits is a frozen fruit, …

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FDA Warns Online Cigarette Retailers for Marketing Violations

FDA, Guidance, Tobacco Products, Warning LettersFDA

In January 2013, the U.S. Food and Drug Administration (”FDA”) sent out several warning letters to online retailers of cigarettes, detailing certain marketing or product statements made that are in violation of federal laws that govern the practice. Several companies …

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FDA Warns Company for Marketing Medical Device

510(k), Disease Claims, FDA, Labeling, Medical Devices, PMA, Warning LettersFDA

On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a Tennessee-based company in connection with the Company’s alleged violations of the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to …

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FDA Targets Online Pharmacies in International Efforts

Drugs, Enforcement, FDA, Medical Devices, Warning LettersFDA

On October 4, 2012, the U.S. Food and Drug Administration (“FDA”) announced that it has taken action as part of an international campaign to protect consumers from illegal online pharmacies. Found here, the FDA’s announcement explains its involvement in the …

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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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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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