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Tag: Labeling

FDA Warning Letters for Alzheimer’s Supplement Claims

Dietary Supplements, Disease Claims, fda warning letters, Labeling, Warning LettersFDA

On February 11, 2019, the U.S. Food & Drug Administration (“FDA”) published a warning to the public entitled “FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease” (“FDA Warning”). Found here, the FDA Warning notifies …

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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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La Croix Sued Over “Cockroach Killer”

Beverages, GRAS, la croix, Labeling, naturalFDA

On October 5, 2018, the internet went abuzz with news that La Croix, a refreshing favorite to millennials and soccer moms alike, was targeted with a high-profile class action suit. Arguing that La Croix’s labeling failed to live up to …

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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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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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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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Cosmetic Products and the FDA

color additives, Cosmetics, Disease Claims, FDA, imports, LabelingFDA

FDA Regulation of Cosmetics Products Importers introducing cosmetic products into the United States must be mindful of FDA regulations, which can present a barrier to market entry if the appropriate steps are not taken to ensure compliance. The U.S. Food …

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    Katherine L. Giannamore
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