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For the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration, refusing Wednesday to allow emergency contraceptives to be sold over the counter, including to young teenagers. [more inside]
posted by DWRoelands on Dec 8, 2011 - 323 comments

But beyond the disgust element was another more important question concerning borax: was it actually safe to eat? This troubling issue was the reason why squad members were imbibing the compound at Christmas, the reason for the Poison Squad experiments themselves. Established by a famously outspoken, crusading chemist from the U.S. Department of Agriculture, Harvey Washington Wiley, the squads were also meant to answer another, larger question: were manufacturers actually poisoning the food supply?
posted by liketitanic on Jul 12, 2011 - 19 comments

Based on a lack of evidence for efficacy, "an FDA panel unanimously voted to revoke its approval of Avastin (bevacizumab) for breast cancer. The decision evoked cheers from some groups and jeers from others. At least one group derided the decision as the work of a 'death panel'". An interesting article on the withdrawal of a "miracle" drug from a section of the market, explaining the reasoning behind the decision and discussing the reaction from patients, many of whom believe -- despite the evidence -- that the drug was actually helping them. [more inside]
posted by metaBugs on Jul 1, 2011 - 11 comments

Flu Warning: Beware the Drug Companies! (snyrbl)
posted by Sticherbeast on May 10, 2011 - 42 comments

Should you be allowed unrestricted knowledge of your own genetic makeup? Or should your doctor be the one to decide how much you can know about your own genes? Currently direct-to-consumer (DTC) genetic testing companies (such as 23andMe) allow consumers to discover which genes they have inherited. But some influential people are arguing that the general public is harmed by the ability to freely access this type of information. The American Medical Association is urging the FDA to make it so that genomic information is only available to a person through a personal physician or medical counselor. As a counterpoint the geneticists at the Genomes Unzipped website provide a six point statement on why People Have A Right To Access Their Own Genetic Information. [more inside]
posted by Jason Malloy on Mar 13, 2011 - 98 comments

Progesterone caproate injections have been used to reduce the likelihood of premature births in at-risk pregnant women for years. Up until now, the drug was custom-compounded by wholesale and specialist pharmacies, legally, but without federal approval. These injections cost between $5 and $15 a dose and were regularly reimbursed by insurance companies and Medicaid. Last month, the FDA announced their approval of a commercially produced version of the compound, to be marketed under the brand name Makena by a company called KV Pharmaceuticals. No stranger to controversy and trouble, KV barely survived a rash round of layoffs and wrongful termination lawsuits. Their former chief executive now faces criminal charges surrounding the company's failure to notify the FDA that they were producing oversized morphine tablets. (He could also do for a shave, it appears.) Now, KV has announced that the new drug will be available at a cost of $1,500 per dose, bringing the total pregnancy term cost of treatment to $25,000-$30,000, from its former cost of $250-$300, a 100-fold increase—but it gets worse... [more inside]
posted by disillusioned on Mar 9, 2011 - 63 comments

Toxic Waste is toxic.
posted by ardgedee on Jan 14, 2011 - 43 comments

The FDA has unveiled new graphic warnings for cigarette packages, including for the first time images that might depict dead bodies, cancer patients and diseased lungs. You can see all 36 new images here. (13MB PDF). [more inside]
posted by Mister Fabulous on Nov 10, 2010 - 190 comments

POM Wonderful may not be so wonderful, but that might not be so surprising, given the history of Stewart and Lynda Resnick. The couple are involved with much more than pomegranate juice: they own Fiji Water, pesticide manufacturer Suterra, Paramount Agribusiness (source of citris, well-known pistachios and other nuts), and former owners of the Franklin Mint. This round with the Resnicks started in February 2010, with a warning from the FDA, which lead to a confusing bit of restraining order requested, then soon after requested to be withdrawn (with fears of pushing the First Amendment too far). That phase is past, but POM Wonderful is now stating they believe "very strongly in its first amendment rights to communicate the promising results," results which look similar to placebos taken by control subjects. The FTC is not impressed.
posted by filthy light thief on Sep 28, 2010 - 29 comments

A lack of federal rules has made the nation the dumping ground for cheap, adulterated and even dangerous oils. With many consumers in the U.S. becoming ill after consuming "olive oil", the USDA is finally moving to create standards defining what is "virgin olive oil". These are supposed to come out in the fall. Except 'the new rules are voluntary — not mandatory — so the prospect of more slick shenanigans continues'. Meanwhile, the FDA 'which oversees most food-label accuracy issues, said the agency does not regularly test olive oils for adulteration, and that it relies on tips about problems from the public, trade groups and others'. [more inside]
posted by VikingSword on Jul 8, 2010 - 74 comments

The New York Times reports that anime-style "Circle" (or "Big Eye") lenses are currently gaining in popularity, thanks to Lady Gaga's Bad Romance video. [more inside]
posted by zarq on Jul 3, 2010 - 59 comments

Should we start doing medical research on pregnant women? In the wake of the H1N1 epidemic, in which pregnant women had a disproportionately higher risk of death, the question of including pregnant women in clinical trials has begun to be tentatively breached. [more inside]
posted by KathrynT on Jun 21, 2010 - 22 comments

Are the Rules That Determine Who Can Donate Blood Discriminatory? Canadian AIDS researchers Dr. Mark Wainberg and Dr. Norbert Gilmore say that while the ban on blood donation from men who have sex with other men may have been ethically and scientifically justified in the 1980's, it no longer makes sense. (CMAJ.) Even though the US FDA reaffirmed their long-standing ban in 2007, they plan to revisit the policy in June. [more inside]
posted by zarq on May 26, 2010 - 69 comments

"Starting Friday, Walgreens' shoppers can buy an over-the-counter genetics test from Pathway Genomics at 7,500 stores across the country. Priced at $20 to $30, the kit claims to offer information on users' possibility of developing conditions like Alzheimer's disease, breast cancer, or diabetes. Access to the scientific analysis online, however, costs another $79 to $179"* [video | 02:31]. "But doctors and geneticists fear the worst for this new over-the-counter access to genetic testing. With no physician to interpret the results of the test, and no FDA regulation of how results are processed or delivered, there is the potential for consumers to misinterpret what their risk really means for their health and their lifestyle."* [more inside]
posted by ericb on May 11, 2010 - 47 comments

"Con men used to travel town to town hawking medical remedies said to be made of Chinese snakes. Snake oil was useless and dangerous. So the FDA was created to put a stop to it and other food and drug scams. But, today, quack medicine has never been bigger. In the 21st century, snake oil has been replaced by bogus therapies using stem cells. Stem cells may offer cures one day, but medical charlatans on the Internet are making outrageous claims that they can reverse the incurable, from autism to multiple sclerosis to every kind of cancer."* Video Part 1 [13:15] || Part 2 [11:49]. [more inside]
posted by ericb on Apr 18, 2010 - 33 comments

The FDA has yet to approve stem cell therapies for general use in medicine, but that hasn’t stopped doctors in Colorado from providing them anyway. [more inside]
posted by zarq on Mar 17, 2010 - 50 comments

Ammonia-injected centerfuged fatty trimmings = pink slime + E. Coli. Eight years ago, federal officials were struggling to remove potentially deadly E. coli from hamburgers when an entrepreneurial company from South Dakota came up with a novel idea: injecting beef with ammonia.
posted by cytherea on Jan 1, 2010 - 90 comments

Raw Milk is milk that has not been pasteurized or homogenized. Raw milk is legal in England, but not in Scotland. Similarly, it's legal in South Carolina and illegal in Georgia. Enter MeFi's Own® ewagoner of Athens Locally Grown. [more inside]
posted by Medieval Maven on Nov 2, 2009 - 144 comments

You may know it as acetaminophen, paracetamol, APAP, or ... Tylenol. Today an FDA advisory panel recommended banning prescription drugs that contain acetaminophen, such as vicodin and percocet. The panel of experts also voted to give acetaminophen a black box warning, and reduce the maximum dosage of over-the-counter formulations. Acetaminophen is a popular painkiller by itself and, in combination with opiates, is the most commonly prescribed medication in the US. [more inside]
posted by borborygmi on Jun 30, 2009 - 117 comments

The House passed H.R. 1256, the Family Smoking Prevention and Tobacco Control Act a few days ago. The bill would put regulation of tobacco under the jurisdiction of the F.D.A. Some are critical of this bill, pointing out that Philip Morris is behind it. But the bill does contain many positive elements. Manufacturers would be required to disclose product ingredients to the F.D.A. and marketing to children would be further restricted. [more inside]
posted by formless on Apr 7, 2009 - 35 comments

The US Food and Drug Administration started regulating the labeling of food, beverages, and medicines after the passage of the 1906 Pure Food and Drug Act, and added food coloring and cosmetics with the 1938 Food, Drug, and Cosmetic Act. They have just released a new website, the FDA Notices of Judgment Collection, 1906-1963, containing data from thousands of cases of mislabeled or misadvertised products and drugs, available in multiple forms (text, PDF, metadata XML, .TIF image, etc.), with searchable archives. Poking around in the data will yield information on cases ranging from misbranding methamphetamine tablets, to quack "Film-O-Sonic" devices, to bacteria-laden unproven abortifacients sold over the counter, to purported "4-way" cures for baldness, to hunks of radium sold for putting in your drinking water to "stimulate the sex organs" (judged against for stating an unproven use, not for actual danger of product). Organized by the FDA's history office, the new database is a fascinating resource for historians, public safety advocates, researchers, and librarians.
posted by Asparagirl on Apr 6, 2009 - 28 comments

"Libertarians Are Dumb, or Why We Eat Heinz Ketchup"
posted by expriest on Mar 16, 2009 - 180 comments

FDA says your company's medical device isn't safe to market? No problem. Just hire a lobbyist. Afraid of being sued? Don't worry. The Supreme Court says you are immune.
posted by expriest on Mar 6, 2009 - 40 comments

Foodies, gourmands, and gluttons! Courtesy of those muckrakers at the New York Times, consider this recent op-ed piece. For those still pissed about the Times cheerleading us into Iraq, skip it and just dig this handbook from your federal watchdogs to determine just how much rat shit may have been in those beanie-weenies you enjoyed cold from the can last night at 1:34a.m. Handy alphabetization makes finding your favorite processed foods easy as pie.
posted by barrett caulk on Feb 14, 2009 - 23 comments

Maybe outsourcing is the answer. Canadian importers detected the salmonella tainted peanut products, and, prior to eight Americans dying from it, informed the US FDA. "The FDA failing to follow up after this incident, does that mean that products that are not good enough for a foreign country are still good enough for the USA? That's a double standard that has deadly consequences for our citizens." [more inside]
posted by orthogonality on Jan 30, 2009 - 49 comments

Towards responsible use of cognitive-enhancing drugs by the healthy - a commentary in Nature that says, "we call for a presumption that mentally competent adults should be able to engage in cognitive enhancement using drugs". Farkesque debate here. [more inside]
posted by daksya on Dec 8, 2008 - 57 comments

The single-shot Palm Pistol... The U.S. Food and Drug Administration has accepted a conceptual, ergonomic 9mm handgun — designed for people crippled by arthritis, muscular dystrophy, or similar conditions that render them too weak to operate normal handguns — as a Class 1 Medical Device.... doctors could eventually write prescriptions for it and then be reimbursed by Medicare.
posted by blaneyphoto on Dec 8, 2008 - 61 comments

Bisphenol A. Canada is banning it in baby bottles, while the California State Senate recently passed a bill to ban it in child care products. Even the US Senate is getting in on the action. Bill Moyers thought it was interesting enough to run this Expose story. In addition to the previously discussed cancer risk, it may also cause obesity. Is this pointless overreaction, or is it an example of government's failure to act [PDF] in the face of industry pressure? The FDA, was, after all, tasked with screening such endocrine disruptors over ten years ago. Previously on the blue and green.
posted by wierdo on May 25, 2008 - 58 comments

The blood substitute PolyHeme has been previously discussed on MetaFilter, but new evidence shows that PolyHeme actually raises the chances of death by nearly 30%. PolyHeme was notable mostly for the reaction to its clinical trials, which, controversially, did not require patient consent.
posted by scrump on Apr 29, 2008 - 19 comments

Our Decrepit Food Factories. Michael Pollan on what sustainability is really about. [Via Gristmill.]
posted by homunculus on Dec 18, 2007 - 27 comments

A nation of outlaws. A century and a half ago, another fast-growing nation had a reputation for sacrificing standards to its pursuit of profit, and it was the United States.
posted by Kirth Gerson on Aug 27, 2007 - 18 comments

Dying for Lifesaving Drugs: Will desperate patients destroy the pharmaceutical system that produces tomorrow's treatments?Reason Magazine
posted by BrotherCaine on Jul 26, 2007 - 43 comments

In January 2006, small amounts of genetically engineered rice turned up in a shipment that was tested ... by a French customer of Riceland Foods, a big rice mill based in Stuttgart, Ark. Testing revealed that the genetically modified rice contained a strain of Liberty Link that had not been approved for human consumption. What's more, trace amounts of the Liberty Link had mysteriously made their way into the commercial rice supply in all five of the Southern states where long-grain rice is grown. Aventis Crop Science had contracted with a handful of farmers to grow the rice, which was known as Liberty Link because its genes had been altered to resist a weed killer called Liberty, also made by Aventis. Then, the French pharmaceutical giant that owned Aventis Crop Science decided to sell the U.S. biotech unit and abandon the very emotional business of reengineering the foods we eat. "We didn't want to take any chances," says a former Aventis executive. "We burned and buried enough rice to feed 20 million people." Last November, the USDA retroactively approved the Liberty Link rice for human consumption.
posted by Kirth Gerson on Jul 23, 2007 - 92 comments

First hundreds of pets were killed by the poisonous food additive, melamine, from China. Then it turns out that this poison got into the human food chain leading to humans. Then there was the flap about cough syrup killing thousands of people. Then, there was that warning a couple days ago about imported monkfish actually being deadly puffer fish. And now the FDA has issued warnings that toothpaste imported from China has ethylene glycol in it. Yes, the same ethylene glycol that keeps your engine running in the winter. China responds to the warnings by saying "Hey, we printed the ingredients on most of the labels, it's not our fault if antifreeze kills you."
posted by dejah420 on Jun 4, 2007 - 73 comments

Melamine found in almost half of all Chinese food imports now on the banned list. The Food and Drug Administration is enforcing a new import alert that greatly expands its curtailment of some food ingredients imported from China, authorizing border inspectors to detain ingredients used in everything from noodles to breakfast bars. The FDA has also announced that melamine laced products have found their way into the human consumption cycle via poultry and pork. Interesting to note that the budget for FDA inspections is at it's lowest level ever, and that only 1% of all imports actually get inspected.
posted by dejah420 on May 1, 2007 - 75 comments

Europeans love to bash American chocolate - especially Hershey's - almost as much as the like to bash, erm, America in general (apparently, it tastes like doggie treats). Recently, Big Chocolate have asked the FDA if they can stop using real cocoa butter in the chocolate-making process, which can only make it taste even worse. I often wonder how many so-called chocoholics know that most of the chocolate they eat was probably picked by slave labour in West Africa. Child slaves, even. Meh, they probably don't care: research indicates that chocolate is 'four times better than kissing'. Never trust a junkie.
posted by chuckdarwin on Apr 23, 2007 - 128 comments

FDA approves meat and milk from cloned animals, no labels necessary.
posted by knave on Dec 27, 2006 - 91 comments

TSA Alert: US Bans Vegemite. Is it because this yeast extract tastes bad? Do the Marmite^ people have some sinister influence? Has Australia offended our government somehow? How is it that a product that has been around for 80 years suddenly becomes forbidden? Who would ban a product that can help prevent neural tube defects (e.g., spina bifida)? Blame the FDA, whose has ruled that folate (folic acid) "should be kept under 1 mg per day ... because higher intake may complicate the diagnosis of pernicious anemia, one form of vitamin B12 deficiency, which especially affects older people." Of course pernicious anemia is rare (less than 10-20 cases/100,000 people per year in the US), as is the Vegemite market. But when has logic ever dictated policy. The international fallout has already started:
"I am never going to America", vows Xochiquetal, while a commenter at Geelong blogger Bernie Slattery’s site foresees US regulators going even further down the road to absurdity, "Americans don’t know what they’re missing … they’ll be banning Tim Tams next."
If the government wanted to ban something Australian, the least they could have done is started here.
posted by scblackman on Oct 23, 2006 - 47 comments

Feeling sick and thinking of buying over-the-counter cold medicine like Sudafed or Claritin-D? Be prepared to wait in line at the pharmacy counter, show a photo ID, and sign a log book. The nationwide restriction of medication containing pseudoephedrine or ephedrine begins this weekend. Why? Those 2 ingredients are used to make meth.. (NPR audio piece).
posted by jaimev on Sep 27, 2006 - 136 comments

[NewsFilter] A partial victory for public health over politics. Amazingly, the FDA has finally, after 3 years of wrangling, approved over-the-counter sale of Plan B, an emergency contraceptive pill. The victory is partial because you need to be 18 or older to purchase it without a doctor's note. If you're under 18, you need to still have documentation from your physician (or nurse practitioner). The politics behind the approval process were laid bare in this (sincerely) fascinating GAO report [note: links to .pdf file]. I also hope that OTC approval will avoid this.

Plan B previously discussed on MeFi here.
posted by scblackman on Aug 24, 2006 - 65 comments

"In 2006, the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) distributed a 38-question survey to 5,918 FDA scientists to examine the state of science at the FDA. The results paint a picture of a troubled agency: hundreds of scientists reported significant interference with the FDA’s scientific work, compromising the agency’s ability to fulfill its mission of protecting public health and safety."
posted by daksya on Jul 20, 2006 - 25 comments

The new lies about women's health (image slightly NSFW) according to Glamour. More on why every egg is sacred to the Bush administration. [via Wired's Sex Drive Daily]
posted by boost ventilator on Jun 3, 2006 - 90 comments

FDA re-opens probe into benzene contamination of soft drinks US food safety authorities have re-opened an investigation closed 15 years ago into soft drinks contaminated with cancer-causing chemical benzene, following evidence the industry has failed to sort out the problem.
posted by mlis on Feb 15, 2006 - 25 comments

This is not good news. U.S. health officials have issued a warning about possible birth defects in infants born to women who take the antidepressant Paxil during the first trimester of pregnancy.
posted by lilboo on Sep 29, 2005 - 38 comments

Pharmaceutical company seeks approval for controversial heart drug BiDil for blacks only, even though the connection of a nitric oxide deficiency to the genetic makeup of the African-American population is an unsubstantiated hunch, in the words of the drug's own developer — and the drug had already once been denied approval. Is the FDA doing good science or ignoring science under the pressure of big business wanting to sell BiDil to a US$1Bln demographic?
posted by Rothko on Jun 16, 2005 - 27 comments

Your mother was right. You can go blind from doing that. Federal health officials are examining rare reports of blindness among some men using the impotence drugs Viagra and Cialis. Since it doesn't actually do anything, Enzyte should still be safe.
posted by hipnerd on May 27, 2005 - 20 comments

FDA to ban sperm donations from homosexuals. Claims the rate of HIV among gay men is statistically high enough to warrant the exclusion. Gay community suggests discrimination. See also: Gay blood ban (in effect since 1985).
posted by Civil_Disobedient on May 5, 2005 - 204 comments

Singaporean scientists genetically modify zebra fish to detect water pollutants by turning fluorescent. An American company realizes there's a consumer market for novelty glow-in-the-dark fish, and starts selling the US's first genetically modified pet. While the FDA, which oversees GM animals, 'finds no reason to regulate', California's Fish and Game Commission bans sales in the state over ethical concenrns, and a coalition of watchdog groups files suit to support a national ban.

A year later, GloFish are still on sale, and California's reconsidering its sales block. With the first GM pet quietly swimming into homes, and others (like hypo-allergenic cats) close behind, are we ready for a designer pet invasion?
posted by thomascrown on Dec 20, 2004 - 51 comments

Chemical heads Your hair is drab. Dull. Needs more volume. Needs less frizz. It needs something. Maybe it needs cetyl alcohol. Mixed with a dash of propylene glycol, and how about a little butane, or acrylamide? Once upon a time, people lathered, rinsed, never repeated, and went on their merry bad-hair days. Then, science and chemistry specialized the way folks condition and shine. Companies began creating new compounds so they could design products for specific hair types. Now, some consumer groups worry about the mix of chemicals: they point to incomplete labeling and little government oversight of the cosmetics and hair industry, accusations the Food and Drug Administration does not deny. "The FDA needs to define what is safe to put in these products, and come up with standards," says Tim Kropp, a senior scientist with the Environmental Working Group, a nonprofit consumer organization in Washington that helped produce a study on problem ingredients in everyday products. "There are no safety standards in place." (to access main link, a little help from BugMeNot). More inside.
posted by matteo on Oct 4, 2004 - 18 comments

Bush administration seeks to block consumer drug suits. White House says injury claims undermine FDA.
Gee. I don't know why we might need some legal recourse against drug manufacturers?
Weasels!
posted by jpburns on Jul 25, 2004 - 35 comments

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