On November 26, 2012, the U.S. Food and Drug Administration (“FDA”) suspended the food facility registration of Sunland, Inc., a New Mexico-based peanut butter plant. Sunland, Inc. has been in the headlines throughout much of 2012 due to a number …
FDA Investigates Illnesses Linked to Energy Drinks and Supplements
On November 16, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the Agency’s ongoing investigation of reported illnesses and deaths linked to energy drinks and energy shot supplements. Found here, the Statement details the FDA’s efforts …
Jimmy Dean Initiates Recall for Failure to Declare Allergens
On November 10, 2012, Jimmy Dean issued a Press Release, explaining how the Company is initiating a voluntary recall of certain of its products due to a labeling error that resulted in undeclared allergens. In particular, the Company is recalling …
FDA Warns Company for Marketing Medical Device
On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a Tennessee-based company in connection with the Company’s alleged violations of the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to …
FDA Targets Online Pharmacies in International Efforts
On October 4, 2012, the U.S. Food and Drug Administration (“FDA”) announced that it has taken action as part of an international campaign to protect consumers from illegal online pharmacies. Found here, the FDA’s announcement explains its involvement in the …
FDA Approves MS Drug, Noting Boxed Warnings
On September 12, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of the drug Aubagio (teriflunomide). Manufactured by Sanofi Aventis, Aubagio is a once-a-day tablet for the treatment of relapsing forms of multiple sclerosis (“MS”) in adults. …
FDA Approves First Drug Specifically Formulated to Treat Pediatric Tumors
On August 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced the Agency’s approval of a new drug formulated specifically to treat children with a rare type of brain tumor, known as subependymal giant cell astrocytoma (SEGA). Manufactured by …
FDA Approved Combination Pill for HIV Treatment
On August 27, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of Stribild, a drug intended to treat the HIV-1 infection in adult individuals who have not previously received treatment for the infection. Manufactured by Gilead Sciences, …
Listeria-Laden Onions Spur Recalls throughout United States
On July 28, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release notifying consumers of a voluntary recall initiated by GH Foods CA, LLC. The recall covers a variety of products containing certain onions distributed by Gills …
FDA Proposes New Unique Identifier System for Medical Devices
On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced its intention to require most medical devices in the United States to bear a Unique Device Identifier (“UDI”). According to the FDA, this UDI system could potentially improve …