Seizure

FDA Approval Required for Company Enjoined from Marketing Products

FDA Disease Claims, Drug, Drugs, Enforcement, FDA, FDA Approval, Injunction, Labeling, Marshalls, NDA, Seizure

On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with the U.S. Food & Drug Administration (“FDA”) and entered a consent decree for permanent injunction against Ascend Laboratories, LLC. As we previously reported, Ascend had been targeted in connection with the marketing and sale of certain products, deemed drugs by the FDA, without first obtaining formal FDA approval. As explained in FDA’s announcement of the injunction, the Company is now enjoined from marketing these products until they first secure FDA approval and post bond to recover the seized products. As…

Marshals Seize Supplements with Undeclared Drug Ingredients

FDA CGMP, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Seizure, Warning Letters

On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters of Globe All Wellness, LLC, a dietary supplement manufacturer based in Hollywood, Florida. Marshals seized what are alleged to be tainted dietary supplements, believing the products to be unsafe, as they may contain an undisclosed active pharmaceutical ingredient. Marshals noted that several of the products that were seized contain sibutramine hydrochloride (sibutramine), which is the active ingredient in Meridia, an obesity drug. Meridia was pulled from the market in the United States in December of 2010, after clinical trials determined…