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U.S. food and drug administration 60 articles

Will Gottlieb’s Resignation from FDA Jeopardize Vaping Regulations?

U.S. Food and Drug Administration (FDA) chief Scott Gottlieb, whose leadership has been dominated in recent months by a crusade against the vape and tobacco industries, told his staff on Tuesday that he will resign in April. The surprise announcement casts a shadow over the bold initiatives Dr. Gottlieb spearheaded to combat the opioid addiction and youth vaping epidemics, both of which gripped the nation largely because of aggressive and sometimes illegal marketing and sales efforts by manufacturers. His bold efforts to beat back youth vaping and tobacco use have rankled many industry officials and Republican lawmakers, who have criticized ... Read More

Listeria Concerns Trigger New Blue Bell Ice Cream Recall

Blue Bell Ice Cream announced Wednesday that it is recalling two ice cream flavors over concerns they could be contaminated with listeria monocytogenes. The recall is the first the Brenham, Texas, ice cream manufacturer has launched since a listeria outbreak in April 2015 linked to its facilities and products nearly destroyed the company. The Blue Bell products recalled Wednesday are Blue Bell Chocolate Chip Cookie Dough half-gallon and pint sizes and half-gallon containers of Blue Bell Cookie Two Step. Both products contain cookie dough that could be contaminated with listeria. Although the new recall comes as Blue Bell continues to ... Read More

Nationwide fruit recall expanded over concerns of Listeria Monocytogenes contamination

A nationwide recall on nectarines, peaches, plums, and pluots potentially contaminated with the Listeria monocytogenes bacteria has been expanded to include additional retailers and store items made with the affected fruit. Cutler, Calif.-based Wawona Packing Co. voluntarily recalled the fruit on July 19 after an Australian importer’s test detected slight levels of the Listeria bacteria on three peaches. Wawona said in a statement that the Listeria it found fell “within tolerance levels” set by the Australian government. The U.S. Food and Drug Administration (FDA), however, has a zero-tolerance rule for listeria monocytogenes, prompting Wawona to retain a private laboratory to ... Read More

California fruit company issues nationwide recall after finding Listeria contamination

CUTLER, Calif. — A California fruit distributer has recalled several lots of nectarines, peaches, plums, and pluots sent out to retailers nationwide over fears that it could be contaminated with Listeria monocytogenes bacteria. Wawona Packing Co. President Brent Smittercamp said that the company was recalling the products after consultation with the U.S. Food and Drug Administration (FDA). Internal testing at Wawona’s Tulare County packing facility in central California found some of the fruit to be contaminated with Listeria, which can cause serious illness and may be fatal to young children the elderly, and people with weakened immune systems. Healthy individuals ... Read More

Consumer Reports finds excessive levels of carcinogen in Pepsi One

The U.S. Food and Drug Administration (FDA) said that it would conduct new studies on the safety of caramel coloring in food and drink after a Consumer Reports analysis found that Pepsi One contained excessive levels of a carcinogenic caramel coloring byproduct called 4-methylimidazole, also known as 4-Mel. 4-Mel forms in some caramel coloring during the manufacturing process. It is a known cancer-causing substance that can occur in trace amounts in certain food items when they are introduced to heat. Consumer Reports’ study, however, found that 4-Mel is present in more than just trace amounts in Pepsi One and another ... Read More

Government shutdown made food safety rule deadlines impossible to meet, FDA says

The U.S. Food and Drug Administration (FDA) asked the Ninth Circuit Court of Appeals on Friday to stall an order for a proposed food-safety rule, saying the government shutdown made it impossible for the agency to meet its Nov. 30 deadline. In June, a California federal judge ordered the FDA to propose a new rule to protect the nation’s food supply against a terrorist attack as part of the Food Safety Modernization Act, issuing the Nov. 30 deadline. The ruling was made in response to a lawsuit brought against the FDA by the Center for Food Safety and the Center ... Read More

Government shutdown becoming a health and safety risk for all Americans

The investigation of a salmonella outbreak that has sickened more than 270 people in 18 states has been severely hampered by the federal government shutdown, the latest example of how the safety and health of Americans are being threatened by partisan squabbling on Capitol Hill. The U.S. Centers for Disease Control and Prevention’s (CDC) limited staff is already monitoring more than 30 other outbreaks, but with much of its staff furloughed, the agency has had to cease monitoring for some foodborne pathogens, such as shigella and campylobacter, while slowing the pace on active investigations. Dr. Christopher Braden, director of the ... Read More

DePuy settles ASR metal hip complaint before trial start

Johnson & Johnson has settled a personal-injury lawsuit that accused its DuPuy Orthopaedics unit of manufacturing defective metal-on-metal hip replacement devices. The lawsuit had been selected as a bellwether case among several other cases DePuy faces over its ASR hip implants, and was destined for an October 15 trial in San Francisco Superior Court. In March, a Los Angeles jury ordered DePuy to pay Loren “Bill” Kransky, a retired prison guard, $8.3 million in damages for injuries he allegedly received from an all-metal ASR hip device made by DePuy. Mr. Krannsky’s case was chosen as the first of more than ... Read More

Rodent and insect activity prompt U.S. Marshals to shutter two Virginia food companies

Two Waynesboro, Va., food businesses have had their products seized by U.S. Marshals after U.S Food and Drug Administration (FDA) investigators found widespread and active rodent and insect infestation on the companies’ shared premises. Federal food safety officials effectively shut down Gourmet Provisions LLC, a manufacturer of ice cream cones under the name Matt’s Supreme Cones, and Royal Cup Inc., which provides coffee and tea services to businesses nationwide, on September 16 after a recent inspection uncovered dirty equipment, rampant  rodent and insect activity, and structural defects in the building.  The two businesses are located within the same Waynesboro, Va., ... Read More

Whistleblower asks court to reopen his Stryker pain pump lawsuit, citing changes in health care law

A whistleblower who sued medical device manufacturer Stryker Corp. and two other companies under the False Claims Act is seeking to have his lawsuit reopened after it had been tossed out by a federal judge in June. The plaintiff argues that the Affordable Care Act changes the terms on which his lawsuit was dismissed. Lonnie Paulos, an orthopedic surgeon and former Stryker consultant, alleged in his 2011 whistleblower lawsuit that Stryker, I-Flow Corp., and Orthofix International marketed their pain pumps for off-label purposes unapproved by the U.S. Food and Drug Administration (FDA) and then billed Medicare and other government-funded health ... Read More