FDA Suggests Tightening Access To Painkillers Like Vicodin

Yesterday the U.S. Food and Drug Administration recommended that the rules regarding drugs with hydrocodone, which is often in painkillers like vicodin, be a lot tighter. It suggests that the drug be reclassified along the level of other opioid painkillers like oxycodone and morphine. [More]

Should An FDA Advisory Committee Chair Be Giving Drug Companies Tips On How To Get Approved?

Should An FDA Advisory Committee Chair Be Giving Drug Companies Tips On How To Get Approved?

It would be generous to label federal regulatory approval processes as merely byzantine, as some agencies require multiple layers of vetting, along with years of sitting around and waiting. Knowing how to navigate these waters is helpful information for anyone hoping to make it through in a timely fashion. But should those currently working for a federal agency like the FDA be actively giving advice to businesses about the best way to work the approval system? [More]

We Are In The Era Of “Nightmare” Bacteria And Nobody Seems To Care

We Are In The Era Of “Nightmare” Bacteria And Nobody Seems To Care

On March 5, 2013, the Centers for Disease Control issued a press released titled “Lethal, Drug Resistant Bacteria Spreading in U.S. Healthcare Facilities.” The warning that followed was dire. Drug-resistant organisms called carbapenem-resistant Enterobacteriaceae, or CRE, were not only spreading more rapidly through U.S. hospitals, they were becoming more resistant to so-called “last-resort” antibiotics. “CRE are nightmare bacteria,” said CDC Director Dr. Tom Frieden. How nightmarish? According to data from the CDC, 1 in 2 patients who contract a bloodstream CRE infection will die. That’s an ominous statistic, but it might not even be the scariest fact about CRE. [More]

(Brian Jackson Now)

FDA Needs Help Solving Outbreak Linked To Jerky Treats That’s Sickened Thousands Of Pets

There’s been a recent spate of pet deaths and illnesses connected to jerky treats made in China in the last few years — with almost 600 pets killed and 3,600 more sickened as of now — but federal animal health officials say they’re puzzled over exactly what’s actually causing the illnesses. [More]

OxyElite Pro

Health Officials Ask Stores To Yank Fat-Burning Supplement Linked To Liver Failure

Hawaii health officials are asking stores to stop selling the fat-burning supplment OxyElite Pro after an investigation linked it to cases of liver failure and acute hepatitis in 29 people. Two of those people had to undergo liver transplants and one has died, says the Hawaii State Department of Health. [More]

Is Anything Being Done To Prevent Exploding E-Cigarettes?


While concerns about health effects and youth-targeted marketing have the attorneys general of 37 states asking the FDA to regulate e-cigarettes much like the agency regulates the sale of tobacco, there are numerous reports of the devices “exploding” or catching fire, which can be significantly more dangerous than simply inhaling nicotine. [More]

"Tiger face" is not currently listed on the known side-effects of Perjeta.

FDA Approves First Pre-Surgical Breast Cancer Drug

While many of the hundreds of thousands of people who are diagnosed each year with breast cancer go through radiation or chemotherapy before surgery, until now drugs aimed at treating breast cancer were not FDA-approved for use in the pre-surgery stage. [More]

40 Attorneys General Agree: E-Cigarettes Need To Be Regulated Like Tobacco

Sort of famous actor Stephen Dorff is now a shill for a brand of e-cigarettes who aren't going to get any free advertising on this site.

The use of electronic cigarettes is growing rapidly, not just among tobacco users seeking a smoke-free alternative, but also among those who’ve never smoked but still want to experience the effects of nicotine. Concerned about this relatively unregulated (at least compared to tobacco) market, the attorneys general of 37 states — plus AGs for Puerto Rico, Guam, and the U.S. Virgin Islands — have written to the FDA asking for more regulatory controls on the sale and marketing of e-cigarettes. [More]

FDA Tests Confirm Presence Of Arsenic In Rice Products

FDA Tests Confirm Presence Of Arsenic In Rice Products

Almost exactly one year after our cohorts at Consumer Reports found arsenic in a wide range of rice products — from instant rice to baby food to rice milk to cereal — the Food and Drug Administration has released the results of its own research on the topic, effectively confirming CR’s findings and suggestion that consumers vary the types of grains they eat. [More]

Diethylstilbestrol is not something you want in your lunch.

Do Food Regulators Care If Foreign Farmers Use Veterinary Drugs Banned In The U.S.?

Later this week, the United Nations food standards agency will be meeting in Minneapolis to discuss, among other things, standards for ten veterinary drugs that are banned for use in the U.S. but not globally. Fearing that continued use of these drugs by farmers in other countries could result in these banned chemicals still reaching the American market, a group of consumer advocates have called on federal regulators to not only take a tougher stance, but to stop encouraging the use of these drugs elsewhere. [More]


August Food And Drug Recall Roundup – Ginger Lead Candies And Drug-Packed Supplements

Our monthly Recall Roundups have grown so expansive that we’ve had to separate them into two separate roundups: one for consumer goods, and one for consumables. [More]

Studies Link Plastic Food Packaging To Diabetes, Obesity Risks In Kids

Studies Link Plastic Food Packaging To Diabetes, Obesity Risks In Kids

Because there are apparently not enough studies to convince the Food and Drug Administration that controversial chemical Bisphenol-A (BPA) should not be used in just about every form of food packaging, yet another study has been published linking BPA to childhood obesity. Meanwhile, a separate study released today showed a possible connection between a widely used plasticizer and diabetes. [More]

(Morton Fox)

Salads Sold At Red Lobster & Olive Garden Linked To Cyclospora Outbreaks In Two States

Taking some of the guess-work out of figuring out why your stomach may currently be turned inside out, the Food and Drug Administration has confirmed that salads linked to a cyclospora outbreak that’s sickened at least 400 people have been tied to four restaurants in Iowa and Nebraska, including Olive Garden and Red Lobster. [More]


FDA Links Acetaminophen To Nasty, Possibly Fatal Skin Reactions (But Try Not To Freak Out)

Because no weekend can get started without news of a possible scary drug interaction, the FDA has issued a consumer alert warning that, in extremely rare cases, use of the popular over-the-counter painkiller acetaminophen (used in Tylenol and many others) can cause “rare but serious skin reactions,” including three serious skin diseases with symptoms like rash, blisters and widespread damage to the surface of skin. Yuck. [More]

(ktvorwald) None of that.

FDA Sets Rules For Gluten-Free Food Labels

In recent years much has been made of gluten — people with celiac disease can’t eat it and others simply want to keep their diets free of it. But until now, there hasn’t been any official word from on high regarding how to actually define what makes a gluten-free food. The Food and Drug Administration is changing that with a final rule on what characteristics a food must have in order to be really and truly gluten-free. [More]


FDA Finally Realizes Maybe It’s Time To Do A Better Job Of Improving The Safety Of Imported Foods

Perhaps your kitchen is only stocked with locally sourced organic food, but around 15% of what Americans eat — including half the fresh fruit, one-fifth of fresh veggies and 80% of fish — comes from around 150 different countries. So, finally getting around to implementing changes mandated by the 2011 Food Safety Modernization Act (FSMA), the Food and Drug Administration has proposed a couple rules aimed at beefing up controls on imported edibles. [More]


FDA Bans BPA From Infant Formula Packaging (Because Manufacturers Have Already Stopped Using It)

Fresh off patting itself on the back for only approving two new cigarette products (because they’re basically the same as the cigarettes already on the market), the Food and Drug Administration is continuing to show its willingness to take a timid stance on a controversial topic, by banning the use of the chemical bisphenol-A (BPA) in the packaging of infant formula… because packagers have all stopped using it anyway. [More]

(So Cal Metro)

Pepsi Scolded For Continued Use Of Controversial Caramel Coloring Considered A Carcinogen In California

A couple years back, the state of California declared that a caramel coloring agent, 4-methylimidazole (or 4-MEI), was a carcinogen and said that any beverages containing certain levels of 4-MEI would have to carry a warning label. With the most populous state in the nation effectively telling them to find another coloring agent, both Coca-Cola and Pepsi promised to change their respective formulas. But while Coke has made the switch nationally, Pepsi has only stopped using 4-MEI in California, says a new report. [More]