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Tag: Enforcement

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FDA Considers Changing Major Food Allergen Labeling Requirements

Allergens, Dietary Supplements, Enforcement, FDA, Food, food allergen labeling, imports, LabelingFDA

In response to growing concerns over sesame allergies, the U.S. Food & Drug Administration (“FDA”) is reportedly considering adding sesame to the list of major food allergens. Since the enactment of the Food Allergen Labeling and Consumer Protection Act of …

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FDA to Review Standard of Identity for Dairy Products

Beverages, Dairy, Enforcement, FDA, Identity Labeling, Labeling, standard of identityFDA

On July 26, 2018, the U.S. Food & Drug Administration (“FDA”) announced that the Agency will be reviewing and modernizing established standards of identity for dairy products. A contentious issue among the dairy industry, dairy-alternative producers and consumers, FDA has …

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No Quiero Taco Bell: Recall Issued for Taco Bell Cheese Sauce

Allergens, Enforcement, FDA, Food, Food Safety Modernization Act, FSMA, Labeling, mandatory recall, mandatory recall authority, recallFDA

On July 24, 2016, Kraft Heinz Co. announced its issuance of a recall of Taco Bell cheese sauce, indicating that the products present a botulism risk. The recall notice, found here, indicates that this a voluntary recall, which is undertaken …

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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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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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Sample Response to FDA Tobacco Warning Letter

Enforcement, FDA, response to warning letter, tobacco, Tobacco Warning Letter, warning letter, Warning LettersFDA

No One-Size-Fits-All Approach, No Sample Response to a FDA Tobacco Warning Letter Getting a FDA Warning Letter for your tobacco business can be confusing. Responding to a FDA Tobacco Warning Letter can be even more confusing and time-consuming for a …

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FDA Untitled Letters: FDA Warnings with a Twist

Disease Claims, Enforcement, FDA, Labeling, W, Warning LettersFDA

The U.S. Food and Drug Administration (“FDA”) has recently been issuing letters to companies that are distinct from traditional FDA Warning Letters. Referred to as FDA Untitled Letters, these letters must be taken seriously, as the terms of FDA Untitled …

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District Court sides with Industry on Dietary Supplement Substantiation

Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Structure-Function Claims, SubstantiationFDA, FTC

A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held in contempt for alleged violations of a 2007 consent decree regarding the marketing of its Phillip’s Colon Health (PCH) product. …

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FDA Issues Tobacco Warning Letters for Tobacco Retailer Inspection Violations

Enforcement, FDA, Inspection Violations, Tobacco Control Act, Tobacco Retailer Inspections, Tobacco Warning Letter, Warning LettersFDA

The U.S. Food and Drug Administration (FDA) has been ramping up their enforcement efforts against tobacco retailers in recent months for compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) by issuing countless tobacco warning letters in connection …

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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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