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Tag: Guidance

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 Directed to Enforce Dairy Labeling Requirements

Beverages, Dairy Labeling, FDA, Food, Guidance, LabelingFDA

On March 23, 2018, President Trump signed the Congressional Spending Bill, directing, among other things, the U.S. Food and Drug Administration (“FDA”) to take action against imitation dairy foods and enforce dairy labeling regulations. The National Milk Producers Federation (NMPF) …

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Guidance Issued on Proper FDA Labeling of Honey and Honey Products

Enforcement, FDA, fda labeling, Food, Guidance, imports, LabelingFDA

In February 2018, the U.S. Food & Drug Administration (“FDA”) published a guidance document entitled “Proper Labeling of Honey and Honey Products: Guidance for Industry (“Guidance”). Found here, the Guidance is aimed at explaining to industry FDA labeling for honey …

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FTC Issues Multi Level Marketing (MLM) Guidance

Cosmetics, Dietary Supplements, Enforcement, FTC, Guidance, mlmFTC

On January 4th of 2018, the Federal Trade Commission (FTC) issued a document, entitled “Business Guidance Concerning Mutli-Level Marketing.” This Guidance relates to Multi-Level Marketing (MLM) practices and addresses how these businesses can ensure their compliance with the FTC Act. …

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FDA Guides on General Wellness and Low Risk Devices

CDRH, FDA, Guidance, Labeling, Medical DevicesFDA

On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current position on low risk devices and general wellness products. This guidance document directs the Center for Devices and Radiological Health …

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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 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’s CFSAN Announces Plan for Program Priorities

Beverages, CFSAN, Cosmetics, Dietary Supplements, FDA, Food, Food Safety Modernization Act, Gluten-Free, Guidance, LabelingFDA

On September 4, 2013, the Center for Food Safety and Applied Nutrition (CFSAN or the Center), a public health regulatory center in the U.S. Food and Drug Administration (FDA), published its 2013-2014 Plan for Program Priorities. The plan outlines certain …

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FDA Updates Draft Guidance on Medical Foods

FDA, Food, Guidance, Labeling, Medical FoodsFDA

On August 13, 2013, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Frequently Asked Questions about Medical Foods; Second Edition.” The first edition of this guidance was previously issued in May 2007. The draft provides …

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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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    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

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