FDA

President Obama used his weekly radio address last weekend to talk about an urgent matter for all Americans. Which one? It could have been any of a half dozen, but it was one that received essentially no attention from the last administration: food safety. He also officially announced his nominations for the two top spots at FDA, Dr. Margaret (Peggy) Hamburg and Dr. Josh Sharfstein. Both are public health experts and intimately familiar with urban health problems, Hamburg as Commissioner of the New York City health department, Sharfstein as head of the Baltimore health department. Both are…
My problem with The Onion is that sometimes their pieces are so good I can't figure out how to extract pull quotes. I just want to reprint the whole damn thing and that's not exactly "fair use." So if want to read it all you'll have to go there (link with pull quote after the jump). Here's a piece that is at once so grotesque and so spot on it's scary: WASHINGTON—Calling it "perfectly safe for the most part," and "not nearly as destructive or fatal as previously thought," the Food and Drug Administration approved the enterobacteria salmonella for human consumption this week. FDA director…
I might be an atheist but I'm glad when the food industry "gets religion." How observant they will be is another question, but for now, they are making noises to suggest they know which side their bread is peanut-buttered: The Grocery Manufacturers Association (GMA) issued the following statement from GMA President and CEO Pam Bailey regarding the FDA Food Safety Modernization Act cosponsored by U.S. Senators Richard J. Durbin of Illinois and Judd Gregg of New Hampshire. Additional cosponsors include: Edward M. Kennedy of Massachusetts, Richard Burr of North Carolina, Christopher J. Dodd of…
The Supreme Court ruled yesterday that if the FDA approves a drug, it doesn't mean you don't have to keep the labeling up to date if you should warn people. So that settles one question about FDA approval. The FDA put its stamp of approval on the drug Vioxx, too, but approved or not, Vioxx was not OK. Some unfortunate people traded their arthritis pain for a heart attack. Not a good trade. So the maker of Vioxx got sued. When the regulatory agencies don't do their job, that's about the only remedy left. More important, it is the only way to change the behavior of companies whose negligence…
The plant in Blakely, Georgia that was the apparent source of the salmonella peanut butter outbreak didn't make peanut butter for retail consumption. It made bulk peanut butter and peanut butter paste which became an ingredient in many other products. The number of products is now around 2000, the largest product recall in US history. So if you bought peanut butter retail you're safe, right? Not so fast. The Peanut Corporation of America (RIP; filed for Chapter 7 bankruptcy Friday) owned another plant in the Texas panhandle. Maybe you didn't know that. Neither did the Texas authorities,…
Another death to add to the nine already attributed to the peanut cum salmonella affair. This one is the company itself and the jobs of its employees. The Peanut Corporation of America (PCA) is going belly up. I don't mean Chapter 11 (reorganizing under the bankruptcy laws). I mean Chapter 7, as in liquidating. I wonder if this is an effort to wring as much private cash out of the business as possible before it gets its nuts sued off of it. So one company, many jobs, the deaths of 9 people and the illness of more than 600 others, half of them children. In dollar terms there's also the lost…
People who make products containing peanut butter are seeing a dramatic drop in sales because of the salmonella problem (other posts here, here, here, here, here, here, here). That includes jarred peanut butters found in supermarkets (down 22% over the same period last year), although none are known to be contaminated. The Peanut Corporation of America (PCA) only sold peanut butter in bulk, to institutions and as an ingredient (peanut paste). Consumers aren't differentiating. This seems like a fairly prudent behavior, since everyday new products are being recalled, now surpassing a stunning…
The peanut butter with a side of salmonella story just keeps getting worse (other posts here, here, here, here, here, here). The toll so far is 8 dead, 575 confirmed salmonella cases (and undoubtedly many more never reported) and 1550 products recalled, one of the largest recalls in US history. The Peanut Corporation of America (PCA) plant in Blakely, Georgia, sold peanut butter in bulk to institutions (like nursing homes and schools) and peanut paste and similar ingredients to many other companies. And even as it did so, its own and government agency records showed there was a problem. The…
The financial industry (what's left of it) now knows what the food industry is learning (or never learned; take your pick). Effective regulation is good for business. Or rather, poor regulation is (very) bad for business. Latest exhibit: the gigantic recall of peanut products (international in scope: here's a long list of newly recalled Canadian products) after a relatively modest player (less than 1% of peanut products in US) ran a sloppy operation (for years), wasn't caught and now is dragging down everyone: The economic wallop from a salmonella outbreak in peanut products continues to…
The peanut butter/peanut paste ingredient based salmonella outbreak has been in the news lately and we've discussed it here (and here, here, here, here, here). There are now about 500 reported cases and six deaths. That's a case fatality ratio of just over 1%. So what if there were a disease outbreak of 100,000 cases with a case fatality ratio of 20%? I think we'd be pretty alarmed. But it happened in 2005. And it happened in 2006 and 2007 and last year, 2008 And it's happening, now, too. It isn't salmonella or or even HIV/AIDS, although it is estimated to kill more people in the US than both…
PetSmart's Grreat Choice Dog Biscuit isn't such a great choice for fido because they contain peanut paste with salmonella. It may also not be so Grreat for fido's owners: Dr. Stephen Sundlof, a veterinarian who is the director of the FDA's Center for Food Safety and Applied Nutrition, said that the risk to animals is minimal but that people who handle contaminated treats could come in contact with the salmonella bacteria. "It's especially important that children wash their hands after feeding treats to pets" because the bacteria could be on the surface, Sundlof said. (CNN) PetSmart has…
While we were busy with the pageant of the new administration, we are still cleaning up the messes from past administrations (not just Bush although Bush was the examplar of incompetence). Past messes like a broken food safety system. The latest example, of course, is the peanut butter and peanut paste salmonella debacle (see here, here, here), which just keeps getting worse. Bulk supplied institutional peanut butter containers were the first to be implicated and the connection was first made from nursing homes that used these. Supermarket peanut butter sold to consumers wasn't implicated.…
The four month old salmonella outbreak (here, here) that has already claimed at least five lives seems now to be an "ingredient" affair. The ingredient is peanut butter made in a Georgia plant of the Peanut Corporation of America (PCA) and sold to food distributors in bulk for use in institutions and not to consumers but also as as a peanut paste ingredient used other foods like cookies, crackers, cereal, candy, ice cream, baked goods or cooking sauces that are sold to consumers. As a result, CDC is now advising consumers to postpone eating products that contain peanut butter (such as cookies…
Rolling deadlines have kept me from the blogging desk, but I can occupy it long enough now to call out a few items that either haven't received as much coverage as they might have -- or that have gotten several interesting hits. ⢠At Huffpost, Jeanne Lenzer and Shannon Brownlee offer the FDA a three-step program: Step One: Admit that you are currently powerless over the industry you are supposed to be regulating. You have let Big Pharma take over your life. You have become dependent on drug company money that comes from the Prescription Drug Fee User Act (PDUFA) of 1992, and over the…
DemFromCt's excellent post at DailyKos alerted us to the fact that this year's vaccine appears to have a mismatched influenza B component. Each year vaccine makers try to anticipate the strains that will be circulating 6 months hence, based on surveillance data. They have been fairly good with their guesses but things seem to be getting more complicated in recent years and mismatched strains are becoming more common, that is, the vaccines don't protect as well or at all against the strains that are actually circulating. There are three strains in the yearly "flu shot," two influenza A strains…
You may be surprised to learn (I was) that the US is having a large (almost 400 people) multistate (42) salmonella outbreak (S. typhimurium, often but not always associated with poultry and dairy products). So far 67 hospitalizations, with patients spanning the age spectrum (ages 1 to 103).DNA fingerprinting has established all cases are related (a common source or sources). Oh, and one more thing. It didn't just begin. Apparently it's been going on since sometime in September. Like the plat du jour, this is the salmonella outbreak du jour. Last summer we were treated to the tomatoes-cilantro…
This post by Science's Jennifer Couzin at ScienceInsider suggests how much serious overhaul the FDA needs. Looks like some scientists at the Food and Drug Administration are doing what they can to influence president elect Obama's choice of their new boss. Nine scientists have written to Obama's transition team pleading with him to restructure the agency and lamenting manipulation of scientific data there. The biggest worry cited in the letter is around review of medical devices. Obama reportedly has his eye on some candidates who would likely shake up the FDA, including agency critic…
Ezra Klein relays Jim Manzi's worry that public funding of drug trials exposes you to the inverse problems of the current system. Namely, "bureaucrats and politicians tend to have enormous career risk from an unsafe drug introduction, but almost none from a rejected drug that would have been effective had it been introduced...[it] would likely result in fewer new drugs being brought to market." There's a bit to this. But it misses something important: The biggest problem with the present system may not be that deeply unsafe drugs are approved but that too many drugs that carry modest safety…
Seventeen days left in the Bush administration. With the fiscal crisis it isn't clear some urgent matters will be attended to right away by the Obama folks, but one can hope. Urgent matters like getting the Food and Drug Administration back on track protecting our food supply. Consider this FDA Press Release from yesterday: FDA Prevents Two Dairies from Adulterating Animal Drugs and Food The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene…
One can understand why a government might be reluctant to release information to the public about the list of illegal food additives it has found in food products made within its borders when you read this: China Releases List of Illegal Food Additives As part of its long-term effort to improve food safety, China's Ministry of Health recently made public a list of illegal food additives that have been used in food production. Among insecticides, drain cleaners, and industrial dyes are included boric acid, an insecticide that was added to noodles and meatballs to increase elasticity, and…