On August 25, 2011, U.S. Marshals seized various seafood products from a manufacturing facility in California. Prompting the seizure, the U.S. Food and Drug Administration (FDA) requested the marshals take action against Meiko Food Co. after finding the company’s operations were not compliant with the federal Food, Drug, and Cosmetic Act (FDCA) and accompanying FDA regulations.
On August 25, 2011, the Office of Foreign Assets Control (“OFAC”) of the United States Department of the Treasury announced that it had reached a settlement with JPMorgan Chase Bank, […]
On August 22, 2011, Del Monte Fresh Produce N.A., Inc. (Del Monte) brought suit against the U.S. Food and Drug Administration (FDA), seeking to invalidate an import alert the agency placed on cantaloupes imported from Guatemala. The challenged Import Alert, found here, was issued after the FDA concluded that cantaloupes being imported from Guatemala were the source of a Salmonella Panama outbreak that left several people ill. In its complaint, Del Monte alleges the FDA had insufficient evidence that Del Monte’s cantaloupes were the source of this outbreak.
On August 15, 2011, Facebook changed its policy regarding public comments on the Walls of pharmaceutical companies’ Facebook pages. In the past, Facebook granted pharmaceutical companies the privilege of disabling comment Walls on their company pages, which prevented the public from posting or viewing comments.
On August 16, 2011, five tobacco companies filed a complaint against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia challenging the Agency’s rule requiring new textual and graphic warning labels on cigarette packaging and advertisements. As we reported here earlier this year, the FDA issued a final rule pursuant to the Family Smoking Prevention and Tobacco Control Act (the “Act”) that requires each cigarette package and advertisement to bear one of nine new textual warning statements and an accompanying graphic image (see FDA’s approved images here).
On August 15, 2011, the U.S. Department of Treasury and Internal Revenue Service (IRS) issued temporary regulations (T.D. 9544) and proposed regulations (REG-112805-10) regarding the annual fee imposed on certain branded prescription drugs.
On August 18, 2011, Fredda Branyon, a naturopathic physician in Arizona, entered into a plea agreement with the U.S. Attorney‘s Office in Houston, Texas regarding charges of illegally selling stem cells.
Stemming from the recent crackdown on unapproved cough and cold drugs, the U.S. Food and Drug Administration (FDA) recently denied two citizen petitions for reconsideration of the Agency’s action. Submitted by the pharmaceutical companies ECR Pharmaceuticals (ECR) and Laser Pharmaceuticals, LLC (Laser), the requests sought review of the FDA’s decision to rid the market of these products without permitting the companies the opportunities for hearing and asked the Agency to stay future enforcement action, allowing their products to remain on the market until the issues were resolved. In what ultimately resulted in a dismissal based on procedural grounds, the FDA reaffirmed both its hard-line stance against these over-the-counter (OTC) unapproved medicines as well as the narrow grounds on which the Agency will allow an administrative appeal of its actions.
On August 9, 2011, the U.S. Department of Agricultures (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule to establish a mandatory livestock tracking system in order […]
In 2004, the U.S. Department of Justice (DOJ) Office of the Inspector General (OIG) began investigating Janssen Pharmaceutica Inc. (Janssen), a subsidiary of Johnson & Johnson (J&J), concerning the marketing […]
