Enforcement
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…
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…
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…
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 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…
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…