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Tag: Food

FDA Imports: Foods and Cosmetics

Cosmetics, FDA, FDA Imports, Food, imports, Labeling, Prior Notice, VCRPFDA

Do you ever wonder how your favorite exotic cheese, foreign cookies, or champagne make it to the United States? As it turns out, importing food and cosmetics into the United States is not as simple as putting it in boxes …

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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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FDA Inches Closer to New Nutrition Facts Panel Rules

Beverages, FDA, Food, Labeling, Nutrition Facts, RulemakingFDA

On August 1, 2014, the U.S. Food and Drug Administration (FDA) closed its comment period for a proposed rule that would make significant changes to food labeling requirements, particularly nutrition facts panels. Per the Administrative Procedure Act, the FDA is …

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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 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On May 8, 2014, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.” The draft guidance represents current thinking on the topic as previously discussed through the release of …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FDA Publishes Draft Guidance on Honey Labeling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On April 11, 2014, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled “Draft Guidance for Industry: Proper Labeling of Honey and Honey Products” (“Guidance”).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 Moves to Update Nutrition Facts Label for Foods

Beverages, Dietary Supplements, FDA, Food, LabelingFDA

On February 27, 2014, the U.S. Food and Drug Administration’s (“FDA”) moved to update nutrition facts labels (“Nutrition Facts Panels”) on packaged foods and dietary supplements. The proposal was prompted by recent scientific findings that suggest there is a direct …

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FDA Issues Guidance on Distinguishing Liquid Dietary Supplements from Beverages

Beverages, Dietary Supplements, FDA, Food, GRAS, Labeling, Structure-Function ClaimsFDA

On January 16, 2014, the U.S. Food & Drug Administration (“FDA”) published a guidance document entitled “Distinguishing Liquid Dietary Supplements from Beverages” (“Guidance”). Found here, the Guidance is aimed at explaining to industry how dietary supplements and beverages differ. Beverages …

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FDA Acts to Ban Trans Fat in Foods

FDA, Food, food additives, GRAS, Labeling, trans fatFDA

On November 7, 2013, the U.S. Food and Drug Administration (“FDA”) published an announcement, entitled “Tentative Determination Regarding Partially Hydrogenated Oils,” announcing its preliminary determination that Partially Hydrogenated Oils (“PHOs”), which are the primary source of trans fatty acids (trans …

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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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    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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