Entries by admin_fidj

U.S. Attorney Seeks $7 Million In Forfeiture Trial Of Privately Printed “Liberty Dollars”

On April 4th, federal prosecutors will resume the forfeiture trial of approximately $7 million in precious metals used to create “Liberty Dollar” coins, a privately minted and distributed currency which prosecutors believed was designed to compete with US currency in violation of federal law. The forfeiture trial comes after the March 18, 2011 conviction of the Liberty Dollar’s creator, Bernard von NotHaus, on multiple charges including making coins resembling US currency, issuing and passing Liberty Dollars coins intended for use as “current money,” and conspiracy.

FDA allows Pharmacy Compounding of Preterm Labor Drug

On Wednesday, March 30, 2011, the U.S. Food and Drug Administration (FDA) issued a statement to compounding pharmacies regarding FDA’s enforcement discretion with regard to compounded versions of Makenaâ„¢, KV Pharmaceutical’s branded preterm labor drug. As we previously reported, the FDA approved KV Pharmaceutical’s Makenaâ„¢ (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women.

FDA Delays Federal Menu Nutritional Labeling Guidelines

As we previously posted (here, here, and here), the Patient Protection and Affordable Care Act (“PPACA”) contains a provision that requires chain restaurants with at least 20 locations in the United States and vending machine operators who own or operate 20 or more vending machines to post calorie, fat, and other nutritional information of menu items.

Harsh sentences coming for strict liability FDA misdemeanor offense

The FDA has recently expressed that it intends to bring more criminal prosecutions for strict liability offenses under the Food, Drug & Cosmetic Act (FDCA) under the “Park” Doctrine. As we previously discussed, the FDCA makes it a criminal misdemeanor to violate the FDCA even if a person had no knowledge of a violation, did not commit fraud, and did not intend to violate the law. This is known as a “strict liability” misdemeanor, as opposed to criminal offenses that require a defendant to knowingly commit an offense.

FDA Updates the Import Entry Review Process for Medical Devices

On March 24, 2011, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released a Letter to Industry regarding recommendations to improve medical device import entry review processes in an effort to expedite entry of foreign medical devices into the United States. The Letter to Industry states the Agency’s concern with the increasing “number of imported medical devices that do not have sufficient entry data.” The lack of sufficient entry data means more review time for the FDA to make a decision about admissibility at the port of entry.

US Government Audit Reveals Government Waste in Catfish Regulation

In 2008, the U.S. catfish industry convinced Congress to require tougher federal inspections on just one species of fish—catfish—by transferring regulation of domestic and imported catfish from the Food & Drug Administration (FDA) to the Department of Agriculture (USDA). The U.S. catfish industry supported these tougher inspections by the USDA not because it supported tougher regulation on catfish, but because it believed they would be a roadblock to imports from Vietnam and other countries.