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Warning Letters

FDA Untitled Letters: FDA Warnings with a Twist

The U.S. Food and Drug Administration (“FDA”) has recently been issuing letters to companies that are distinct from traditional FDA…

FDA Regulation of Aromatherapy and Essential Oil Products

Aromatherapy and essential oil products are becoming more popular by the day, and marketing these products in compliance with federal…

FDA Issues Tobacco Warning Letters for Tobacco Retailer Inspection Violations

The U.S. Food and Drug Administration (FDA) has been ramping up their enforcement efforts against tobacco retailers in recent months…

Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics

On March 31, 2015, Attorney Katherine Giannamore, of Shehadeh Giannamore, PLLC, was interviewed by Ryan Nelson of “The Rose Sheet”…

FDA Warns of Marketing Cosmetics with Drug Claims

The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin…

FDA Stops Company from Marketing Unapproved New Drugs

On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted…

Court Issues Injunction after FDA Warning Letter Issues Persist

On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its…

FDA HACCP Enforcement Sandwiches Food Company between a Rock and a Hard Place

On November 21, 2014, the U.S. Food & Drug Administration (“FDA”) filed for a permanent injunction in the Eastern District…

FTC-FDA Warning Letter Issued to Company Marketing Ebola Cure

On September 23, 2014, the U.S. Food & Drug Administration ("FDA"), in conjunction with the Federal Trade Commission ("FTC"), issued…

Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

On August 8, 2014, the U.S. Food and Drug Administration ("FDA") obtained a court order from the United States District…