Disease Claims
District Court sides with Industry on Dietary Supplement Substantiation
A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held…
US Marshals Seize Topical Products Deemed Drugs by FDA
On April 16, 2015, U.S. Marshals seized what the U.S. Food & Drug Administration (“FDA”) classified as unapproved prescription drugs…
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…
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…
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…
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…