FDA Backtracks on Labels, Big Tobacco Drops Its suit

6/9/2015 The FDA backtracks on labels, Big Tobacco drops its suit. America’s three largest tobacco giants, Phillip Morris USA (owned by Altria Group, Inc.), RJ Reynolds (owned by Reynolds American) and Marlboro, Camel & Newport (owned by Lorillard Tobacco) sued the FDA for overstepping its bounds by considering requiring approval for label changes such as

Viagra May Increase Melanoma Risk by 84%

6/8/2015 Viagra may increase melanoma risk by 84%. This is hard news to report, but something every man must understand: your “little blue pills” may end up giving you “little brown spots,” according to recent studies showing a correlation between Viagra use and incidence of melanoma skin cancer. At present, only one federal suit has

FBI Investigates the Cancer-Spreading Hysterectomy Device

5/28/2015 Last year a Johnson & Johnson medical device, the laparoscopic power morcellator, was removed from the market. This year the FBI investigates the cancer-spreading hysterectomy device. The power morcellator was a favorite of surgeons for doing minimally-invasive hysterectomies and removing uterine fibroids. The device worked by grinding up tissue that could then be removed

Medtronic Plc Agrees to Consent Decree with the FDA

5/1/2015 Pending approval from U.S. district court in Minnesota, Medtronic Plc agrees to consent decree with the FDA regarding its SynchroMed implantable drug pump. The company will correct problems that cause the pumps to deliver either too little or too much medication. The pumps are used for treating cancer and chronic pain patients and those

Food Safety Experts have done What with Big Tobacco?

In a landmark investigation released this week, the Center for Public Integrity (CPI) uncovered the alarmingly small and insular circle of experts who are used by food manufacturers to determine if a new ingredient is “Generally Regarded As Safe,” or GRAS. The investigation discovered that at least one of 10 particular consultants participated in over

Is the GRAS Food Safety process a Racket?

A 1958 law offers food companies who want to market new ingredients in their products a way to bypass extensive and costly FDA safety testing. The law provides the option for companies to demonstrate that the ingredient in question has been deemed “Generally Regarded As Safe” (GRAS) by a consensus panel of scientists and experts.