On May 23, 2012, the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter to the manufacturers of the widely popular RockStar energy products, Rockstar , Inc. (“the Company”). Found here, the Letter contains various allegations that the Company’s …
House Oversight Committee Finds that FDA Actions Cause Drug Shortages
On June 15, 2012, the U.S. House of Representatives Committee on Oversight and Government Reform issued a Staff Report, detailing the problem of drug shortages for key lifesaving drugs. According to the Report, the shortages are largely affecting the availability …
Marshals Seize Misbranded Drug Products at Maine Facility per FDA’s Request
On June 6, 2012, the U.S. Food and Drug Administration (“FDA”) announced the seizure of various drug products from a Portland, Maine facility. According to the FDA, U.S. Marshals seized the drug products upon the Agency’s request after it was …
U.S. Marshals Seize Products from California Firm upon FDA ’s Repeated Finding of Violations
On May 22, 2012, the U.S. Food and Drug Administration (“FDA”) announced that U.S. Marshals, acting at the requests of the Agency, had seized certain products deemed to be unapproved new drugs. HybriSil (methylprednisolone acetate 1% in silicone gel), the …
FDA and FAAN Aim to Educate Public during Food Allergy Awareness Week
This week (May 13 – May 19, 2012) is recognized as Food Allergy Awareness Week (“FAAW”). FAAW was created by the Food Allergy & Anaphylaxis Network (“FAAN”), a non-profit organization dedicated to promoting awareness food allergies and those who suffer …
FDA Warns Companies Marketing Supplements Containing DMAA
On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to several dietary supplement manufacturers in connection with their alleged improper marketing of supplements containing dimethylamylamine (“DMAA”). DMAA, also referred to as geranium extract, is an …
FDA Enters into Consent Decree with Seafood Processor over Alleged Manufacturing Deficiencies
On April 11, 2012, the U.S. Food and Drug Administration (“FDA”) announced that, with the aid of the Department of Justice, it has entered into a consent decree with a California seafood processor. The consent decree precludes the company from …
FDA Enters Into Consent Decree of Permanent Injunction with Cheese Producer Due to Listeria Contamination
On April 9, 2012, the U.S. Food and Drug Administration (“FDA”) announced it has entered into a consent decree with a Washington State cheese producer. The company, Del Bueno, which processes and distributes cheeses, and its owner Jesus Rodriguez, agreed to …