The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan.
The consent decree permanently prohibits/stops the company, Ahmed, and Khan from manufacturing and distributing drug products until Deltex’s manufacturing operations and products are in compliance with federal law and the terms of the consent decree.

At the request of the U.S. Food and Drug Administration, the U.S. Department of Justice today filed a complaint for permanent injunction against a Jamaica, N.Y.-based beverage company to prevent it from processing and distributing juice and other products. (DSK)

U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized all dental devices from Rite-Dent Manufacturing Corporation, located in Hialeah, Fla. (DSK)

Agency strategy caps maximum at 325 milligrams to reduce risk of liver toxicity.

The U.S. Food and Drug Administration today announced it is issuing its first warning letters to retailers for the illegal sale of tobacco products to minors in violation of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Using state inspectors who have been commissioned by the agency, the FDA visited 493 different retail establishments in Mississippi over the past three months and issued 25 warnings.

The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of a continued international extortion scam.

Enrollment in REMS program required for health care professionals

The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) to help companies and others save time and resources in their interactions with the agency.

The U.S. Food and Drug Administration announced today that any tobacco product introduced or changed after Feb. 15, 2007 must be reviewed by the agency. In FDA guidance published today, the agency outlines a pathway for marketing a product whereby the company marketing the product must prove that it is “substantially equivalent” to products commercially available on Feb. 15, 2007.

• PRock Marketing LLC, of Kissimmee, Fla., is recalling all lots of Fruta Planta and Reduce Weight Fruta Planta. This is a single product marketed under two brand names.