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Keyword: fda

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  • FDA announces review of birth control pills over serious blood clot risks [Bayer with 7000 lawsuits]

    06/04/2011 12:18:15 PM PDT · by GonzoII · 8 replies
    Life Site News ^ | June 1, 2011 | Peter J. Smith
    FDA announces review of birth control pills over serious blood clot risks by Peter J. Smith Wed Jun 01 5:32 PM EST WASHINGTON, D.C., June 1, 2011 (LifeSiteNews.com) – Federal drug regulators are now reviewing studies that say some modern birth control pills may pose a serious risk of clots to women who take them. The US Food and Drug Administration (FDA) announced Tuesday that they were conducting a safety review of birth control products containing drospirenone, a synthetic female sex hormone or progestin. German pharmaceutical maker Bayer’s oral contraceptives Yaz, Yasmine, Safyral, Beyaz, and their generics are part...
  • Feds seize elderberry juice from Kansas winery

    06/04/2011 6:29:25 AM PDT · by ruralvoter · 61 replies
    The Kansas City Star ^ | 6/3/11 | Roxana Hegeman
    Federal authorities have seized bottles and drums of elderberry juice concentrate from a Kansas winery, contending that the company's claims of its benefits for treating various diseases make the product a drug. (snip) The government contends the juice concentrate is an unapproved and misbranded drug because the winery claims it is used to treat diseases such as the flu, cancer and AIDS. "Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments, Dara Corrigan, the FDA's associate commissioner for regulatory affairs, said in a news release. "The FDA is committed to protecting...
  • Government Death Panels Won’t Kill You – Unless You’re Sick And Weak

    05/26/2011 7:25:16 AM PDT · by Slyscribe · 28 replies
    IBD's Capital Hill ^ | 5/26/2011 | David Hogberg
    ObamaCare supporters fervently believe that science will prevail in systems that are controlled by politicians. It is usually the unstated assumption behind their arguments defending the Independent Payment Advisory Board. They seem to believe it so blindly that they can’t see evidence to the contrary even when it is right in front of their noses.
  • The Four Loko Effect (situational specificity of tolerance)

    05/23/2011 12:31:20 PM PDT · by decimon · 14 replies
    The popular, formerly caffeinated, fruity alcoholic beverage, Four Loko, has been blamed for the spike in alcohol-related hospitalizations, especially throughout college campuses. Initially, caffeine was deemed the culprit and the Food and Drug Administration ordered all traces of caffeine to be removed from Four Loko and all other similar beverages. However, according to an upcoming evaluation in Perspectives on Psychological Science, a journal of the Association for Psychological Science, caffeine might not be the primary cause of the spike in hospitalizations. “Four Loko didn’t have the extraordinary intoxicating effect because of caffeine, but rather because of the phenomenon of situational...
  • Mothers crying over raw milk

    05/17/2011 5:36:05 PM PDT · by Tolerance Sucks Rocks · 113 replies
    The Washington Times ^ | May 16, 2011 | Stephen Dinan
    Four weeks after the government moved to shut down Amish farmer Dan Allgyer for selling fresh, unpasteurized milk across state lines, angry moms who made up much of his customer base rallied on the Capitol’s grounds Monday to demand that Congress rein in the food police. The moms milked a cow just across the street from the Senate and served up gallons of fresh milk, playfully daring one another to drink what, if sold across state lines, would be considered contraband product. “The FDA really screwed up this time. They got between a mom and a farmer,” said Mark McAfee,...
  • Creeping Tyranny Meets Creeping Sovereignty

    05/12/2011 7:06:34 AM PDT · by Bed_Zeppelin · 14 replies · 1+ views
    BlackListedNews ^ | May 9, 2011 | Tony Caratlucci
    Like a single worn edge of a roof tile on a windy day, the town of Sedgwick, Maine invites the winds of change to tear off entirely the roof of the federal government's growing tyranny over every aspect of our daily lives. Sedgwick decided to go to the literal root of the matter, declaring "food sovereignty" over agriculture and it's trade locally. Thrusting the responsibility and liability on sellers and buyers - as would be indicative of any free society - Sedgwick's new ordinance undermines entirely state and federal licensing and regulatory regimes. Few could argue that we as informed...
  • FDA clears first test to quickly diagnose and distinguish MRSA and MSSA

    05/09/2011 7:09:21 PM PDT · by neverdem · 6 replies
    FDA NEWS RELEASE ^ | May 6, 2011 | NA
    For Immediate Release: May 6, 2011Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.govConsumer Inquiries: 888-INFO-FDAFDA clears first test to quickly diagnose and distinguish MRSA and MSSA The U.S. Food and Drug Administration today cleared the first test for Staphylococcus aureus (S.aureus)  infections that is able to quickly identify whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA).There are many different types of Staphylococci bacteria, which cause skin infections, pneumonia, food and blood infections (blood poisoning). While some S.aureus infections are treated easily with antibiotics, others are resistant (MRSA) to commonly prescribed antibiotics such as penicillin and amoxicillin. The KeyPath MRSA/MSSA...
  • Many New Drugs Did Not Have Comparative Effectiveness Information Available at Time of FDA Approval

    05/04/2011 6:45:44 AM PDT · by TennesseeGirl · 12 replies
    Science Daily ^ | May 03, 2011 | Science Daily Staff
    Only about half of new drugs approved in the last decade had comparative effectiveness data available at the time of their approval by the U.S. Food and Drug Administration, and approximately two-thirds of new drugs had this information available when alternative treatment options existed, according to a study in the May 4 issue of JAMA. http://www.sciencedaily.com/releases/2011/05/110503161400.htm
  • Amish Milk: The Latest Target of the Obama Regulatory State

    05/01/2011 11:36:53 AM PDT · by Tolerance Sucks Rocks · 29 replies
    The Foundry (Heritage Foundation Blog) ^ | April 30, 2011 | The Heritage Foundation
    Milk might do a body good, but if it’s unpasteurized milk sold by an Amish farmer across state lines, it’s a whole other story… or at least according to the Food and Drug Administration (FDA). The Washington Times reports: A yearlong sting operation, including aliases, a 5 a.m. surprise inspection and surreptitious purchases from an Amish farm in Pennsylvania, culminated in the federal government announcing this week that it has gone to court to stop Rainbow Acres Farm from selling its contraband to willing customers in the Washington area.The product in question: unpasteurized milk.It’s a battle that’s been going on...
  • Feds sting Amish farmer selling raw milk locally

    A yearlong sting operation, including aliases, a 5 a.m. surprise inspection and surreptitious purchases from an Amish farm in Pennsylvania, culminated in the federal government announcing this week that it has gone to court to stop Rainbow Acres Farm from selling its contraband to willing customers in the Washington area. The product in question: unpasteurized milk. It’s a battle that’s been going on behind the scenes for years, with natural foods advocates arguing that raw milk, as it’s also known, is healthier than the pasteurized product, while the Food and Drug Administration says raw milk can carry harmful bacteria such...
  • Feds Take Down Amish Farmer... Over Milk

    04/29/2011 8:46:52 AM PDT · by therightliveswithus · 47 replies
    Pundit Press ^ | 4/29/11 | Aurelius
    Our government at work. A year-long sting operation came to an end this week. In that time, the government used fake names and surprise inspections all to nab the people at Rainbow Acres Farm in the D.C. area. The reason: they were selling milk. Unpasteurized milk, to be exact. Asked for comment, the government released this statement: “It is the FDA’s position that raw milk should never be consumed.” Therefore, the Amish farmers at Rainbow Acres had to be brought down. Asked for comment, one Washington resident stated, “I look at this as the FDA is in cahoots with the...
  • E-cigarettes will get FDA oversight as tobacco products

    04/26/2011 3:10:05 AM PDT · by Tolerance Sucks Rocks · 25 replies
    The Los Angeles Times ^ | April 25, 2011 | Melissa Healy
    The Food and Drug Administration announced Monday that it will act to ensure the government's right to impose marketing, manufacturing and safety restrictions on "electronic cigarettes," a nicotine delivery device widely billed as an alternative to cigarettes for those trying to quit and for smokers who can't light up. In a letter posted to the FDA's website Monday, Dr. Lawrence R. Deyton, director of the FDA's Center for Tobacco Products, said the agency will act to regulate e-cigarettes as tobacco products. To shore up its authority to do so, the agency will propose new regulatory language that would specifically define...
  • US to regulate electronic cigarettes as tobacco

    04/25/2011 11:46:02 PM PDT · by bruinbirdman · 25 replies
    The Telegraph ^ | 4/26/2011
    The U.S. Food and Drug Administration's announcement came after the U.S. Court of Appeals for the D.C. Circuit issued a decision which said that electronic cigarettes are not drugs or devices unless they are marketed for therapeutic purposes. In 2009, the FDA was given the authority to regulate tobacco products that are not drugs or devices. Electronic cigarettes, marketed under names such as NJOY, mimic the act of smoking and include nicotine, but do not emit the same type of odour or ash. In December, three judges from the appellate court ruled that the FDA could regulate the products as...
  • Small Businesses Fret Over Food-Safety Rules

    04/22/2011 1:17:29 PM PDT · by Qbert · 8 replies
    WSJ ^ | 4/22/2011 | STEPHANIE GLEASON
    When Congress revamped food-safety laws last year, small farmers and food producers won a victory when they were excluded from many of the new rules. Now, as the Food and Drug Administration implements the new Food Safety Modernization Act, the small businesses are hoping they aren't snagged by the new rules anyway. The legislation, which updates 100-year-old food-safety regulations, does not apply to meat, eggs or dairy products, which are regulated by the U.S. Department of Agriculture. Despite the exemption, it's still unclear how small food producers will be affected, said Robert Guenther, senior vice president of public policy for...
  • Obama Health Bill Sends "Yankees" Peanut Factory Packing (FDA regs required $40 M factory update)

    04/21/2011 6:18:45 PM PDT · by Qbert · 21 replies
    Gothamist.com ^ | 4/21/2011 | Garth Johnston
    The FDA Food Safety Modernization Act that President Obama signed into law this year didn't just bring us a fancy new FDA recall page. It also is sending the 125-year-old A.L. Bazzini Co., which makes the “official peanut of Yankee Stadium,” out of New York and into the loving embrace of Pennsylvania. The firm, which moved from TriBeCa to Hunts Point in 1997, says the new regulations would require them to perform a $40-million-dollar update to their production facility. And since they have this "state of the art" plant in Allentown (thanks to their recent purchase of the chocolate company...
  • Rx Drug Shortages Hit All-Time High

    04/20/2011 4:15:05 PM PDT · by bvw · 87 replies · 1+ views
    MedPage Today ^ | March 28, 2011 | Emily P. Walker
    WASHINGTON -- The number of prescription drugs in short supply has more than tripled since 2005 and shortages are now more frequent than ever, [] Premier Healthcare Alliance -- a performance improvement alliance of more than 2,500 U.S. hospitals -- surveyed 311 pharmacy experts at hospitals and other facilities, such as surgery centers and long-term care facilities, about shortages during a six month period in 2010. The survey found that 89% had experienced shortages that may have caused a medication safety issue or error in patient care. Eight out of 10 times a shortage occurred, the patient's care was delayed...
  • Senator urges FDA to ban menthol-flavored cigarettes

    04/20/2011 6:19:54 PM PDT · by Tolerance Sucks Rocks · 49 replies · 1+ views
    The Hill ^ | April 19, 2011 | Josiah Ryan
    Sen. Richard Blumenthal (D-Conn.) is calling on the Food and Drug Administration (FDA) to ban menthol-flavored cigarettes. In a letter addressed Monday to the FDA, Blumenthal said the agency should ban menthol cigarettes because they encourage young people to smoke. “The dangers of menthol tobacco products in general, and to our youth in particular, are highly concerning, and provide abundant grounds for FDA to develop a plan that will result in the removal of menthol from tobacco products to protect public health,” Blumenthal wrote in the letter, addressed to FDA Commissioner Margaret Hamburg. Blumenthal is seeking a ban identical to...
  • Obama tries to obstruct executions

    04/17/2011 6:33:51 PM PDT · by SmithL · 30 replies
    San Francisco Chronicle ^ | 4/17/11 | Debra J. Saunders
    President Obama well may have begun another undeclared war - this time on states that try to enforce their own death penalty laws - on the dubious grounds that the Food and Drug Administration has not approved drugs intended to kill convicted killers. On March 15, the Drug Enforcement Administration seized Georgia's supply of sodium thiopental, the first drug given under the three-drug lethal injection protocol used in most of the country's 34 death-penalty states. The DEA also asked Kentucky and Tennessee for their sodium thiopental to aid its investigation. Why? The DEA referred me to the Department of Justice,...
  • Free Speech in Health Science May Become a Reality (Proposed law to curb FDA limits on speech)

    04/06/2011 12:59:50 AM PDT · by UnwashedPeasant · 4 replies
    Today, the Free Speech about Science Act of 2011 was introduced in Congress by Rep. Jason Chaffetz (R-UT) and Rep. Jared Polis (D-CO). Please tell Congress how important this bill is!As we reported last week, a new bill in Congress promises to revolutionize the way Americans get access to scientific research on the health benefits of foods and supplements. The Free Speech about Science (FSAS) Act, HR 1364, would change FDA regulations so that legitimate, peer-reviewed scientific studies can be referenced without changing the food’s regulatory category to an unapproved drug. This will protect access to scientific information, and will...
  • FDA Headbangs With Condoms, Not Cigs

    03/28/2011 8:00:26 AM PDT · by Kaslin · 18 replies · 1+ views
    Townhall.com ^ | March 28, 2011 | Katie Kieffer
    If young people have casual sex, they’re rock stars, as long as they use condoms. If they casually smoke cigarettes, they’re borderline criminals. According to the FDA, that is. The FDA takes a hypocritical and overly invasive stance on two adult products: Condoms and cigarettes. The FDA’s inconsistent and excessive regulation of these adult products hurts free enterprise and represents an inappropriate extension of government in our daily lives. This month, The Associated Press reported that condom maker Graphic Armor Inc. is releasing the first line of FDA-compliant condoms with full-color advertising graphics directly on the latex. The graphics will...