Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Responding to a sharp increase in the number of illnesses linked to contaminated eggs, the U.S. Food and Drug Administration has introduced tougher safety requirements for large-scale egg producers. The agency says that the new rules can eliminate nearly 80,000 illnesses and save 30 lives every year. The measures target the spread of Salmonella Enteritidis bacteria throughout egg producing facilities. The salmonella bacteria frequently contaminate eggs and the products in which they are used.

Read the rest of this entry »

Federal regulatory agencies have come under fire recently for their “cozy relationships” with large corporations; the Food and Drug Administration, the National Highway Traffic Safety Administration, and the now-defunct Minerals Management Service have all been targeted for reform by the Obama Administration for their failure to enforce safety rules and regulations. Now the Federal Aviation Administration is being investigated for turning a blind eye on Northwest Airlines while it ignored federal safety regulations for more than a decade.

Read the rest of this entry »

Quality and security lapses identified during a Food and Drug Administration (FDA) investigation has led to the temporary suspension of production at Johnson & Johnson’s McNeill PPC drug manufacturing plant, located in Fort Washington, Penn., where children’s Tylenol, Motrin, Benadryl and Zyrtec were made. The investigation was followed by a recall of 1,500 lots of the brand name over-the-counter products distributed in the U.S. and internationally. The FDA says it is considering more actions against the company, including possible criminal penalties.

Read the rest of this entry »

The Food and Drug Administration (FDA) is warning consumers not to use a sexual enhancement capsule distributed by Natural Wellness because the product contains an undeclared ingredient that may cause serious, life-threatening conditions for some populations.

Read the rest of this entry »

Burning ear candles that manufacturers claim draw ear wax and “impurities” or “toxins” out of the ear canal should not be used because they may cause serious injury even if used according to manufacturers’ instructions, according to a warning from the Food and Drug Administration (FDA). Ear candles are hollow cones about 10 inches long and made from a fabric tube soaked in beeswax, paraffin or a mixture of the two. In ear candling, also called ear coning or thermal auricular therapy, a patient lies on his side while a candle is placed in the outer ear and lit.

Read the rest of this entry »

Dr. Margaret Hamburg, the newly appointed chief of the Food and Drug Administration (FDA), is flexing her muscles with drug makers over questionable product promotion, in an effort to live up to her promise to step up enforcement of oversight of drug makers, device manufacturers and other companies the agency oversees. Last year, the FDA issued 41 enforcement letters, twice as many as it issued in 2008.

Read the rest of this entry »

The Food and Drug Administration (FDA) is warning hospital risk managers, surgical service managers and infection control professionals that a device used in surgical and endoscopy suites for sterilizing or disinfecting medical devices has been modified, has not been approved by the FDA, and may not properly disinfect or sterilize instruments, which may pose a serious risk to patients and health care staff.

Read the rest of this entry »

The U.S. Food and Drug Administration is cracking down on manufacturers of alcoholic energy drinks, giving them 30 days to provide scientific evidence that their caffeinated crossover beverages are safe. FDA letters went out to nearly 30 manufacturers recently, representing the earliest stages in the government’s efforts to curb what researchers consider a dangerous trend: the mixing of alcohol and caffeine.

Read the rest of this entry »

A device used to block off the aorta, monitor aortic pressure, and deliver solution to stop the heart during cardiopulmonary bypass procedures has been recalled by the Food and Drug Administration (FDA) because the device’s balloon catheters may spontaneously rupture during surgery and may result in serious health consequences or death to patients.

Read the rest of this entry »

“We are now in a position never before experienced in the history of influenza,” said Dr. Margaret Hamburg, Commissioner of Food and Drugs, in a letter to health care providers about the safety and availability of the 2009 H1N1 influenza vaccine. Just as a new and serious virus is spreading widely around the country, causing hospitalizations and deaths, a vaccine is becoming available to help prevent infection and protect the public.”

Read the rest of this entry »