Shehadeh Giannamore
FDA Approval Required for Company Enjoined from Marketing Products
On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with…
Court Finds FDA Exceeded Authority in Device Reclassification
On September 26, 2014, The United States Court of Appeals for the District of Columbia Circuit ruled that the FDA…
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…
FDA Releases Proposed Rules under FSMA
On September 19, 2014, the U.S. Food and Drug Administration (FDA) released revisions to four proposed rules, opening them up…
FDA Inches Closer to New Nutrition Facts Panel Rules
On August 1, 2014, the U.S. Food and Drug Administration (FDA) closed its comment period for a proposed rule that…
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…
Permanent Injunction Sought after Cheese Manufacturer Fails to Respond to FDA Warning Letter
On August 8, 2014, the U.S. Food and Drug Administration ("FDA") filed a Complaint for Permanent Injunction against a Michigan…
Gluten Free Labeling Now Being Enforced by FDA
On August 5, 2014, the U.S. Food and Drug Administration ("FDA") regulations regarding “gluten free” labeling came into effect. Last…
FDA Seeks Injunction against Company for Misbranding Drug Products
On June 25, 2014, the U.S. Department of Justice ("DOJ"), in response to a request made by the U.S. Food…
FDA Warning Issued Regarding Weight Loss Products
On April 7, 2014, the U.S. Food and Drug Administration ("FDA") released an advisory, warning consumers not to use bee…