Keyword: fda
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Will it be enough to rein in FDA’s outrageous power grab? ANH-USA, together with a number of supplement trade organizations, went to Capitol Hill to plead our case about the FDA’s profoundly flawed NDI (new supplement) draft guidance in the offices of two powerful senators and longtime friends of natural health, Sen. Tom Harkin (D-IA) and Sen. Orrin Hatch (R-UT). Our visit was preceded by all the letters you have been sending to Congress, which have immeasurably increased the visibility of this issue. As you know, if this draft guidance stands, it would allow FDA to arbitrarily deny the sale...
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A contentious relationship between drug manufacturers and the Drug Enforcement Agency may cause a continuing shortage of the attention deficit medication Adderall, which the FDA just added to its official drug shortages list, the New York Times reported. As of 2007, about 9.5 percent, or 5.4 million, of school-aged children were diagnosed with Attention Deficit Hyper Disorder, according to the Centers for Disease Control and Prevention. Adderall prescriptions went up 13.4 percent from 2009 to 2010, and more than 18 million prescriptions were written for the drug, Reuters reported. As demand for the drug grows, more and more patients have...
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TRENTON, N.J. (AP) -- The number of new prescription drug shortages in 2011 shot up to 267, well above the prior record and about four times the number of medication shortages in the middle of the last decade. Figures just released by the University of Utah Drug Information Service, which tracks national drug shortages, show there were 56 more newly reported drug shortages in the U.S. last year than in 2010, when there were 211. By contrast, there were only 58 drug shortages reported in 2004. As the drug shortages worsen, so does their impact on patient care, particularly...
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Yesterday, my entire afternoon got eaten by my panic over shortages of Adderall, the drug that changed my writing life from daily torture that I slogged through because I'm a hard worker to sometimes-hard work I love. Instead of writing, I wasted my time on the phone to a bunch of local pharmacies, and emailing my very good-natured doctor multiple times ("Can you prescribe in Mexico?"), and searching for Canadian pharmacies -- maybe one in Windsor where maybe I could get Gregg to pick me up 10 or 20 or maybe even 30 pills...in all the spare time he has....
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Brad Rogers, Sheriff of Elkhart County, Indiana, is withstanding FDA bureaucrats who are harassing citizens in his county. The Complete Patient reports,The U.S. Justice Department has withdrawn its subpoena of Indiana raw dairy farmer Richard Hochstetler to appear before a federal grand jury. He was scheduled to testify tomorrow in Detroit, in connection with an outbreak of illnesses linked by public health officials, including the U.S. Food and Drug Administration, to the milk of his Forest Grove Dairy. But yesterday he received a certified letter saying that his subpoena was being withdrawn.The withdrawal came after Roger’s Sheriff’s Department told the...
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Left 'speechless' as Sebelius overrules FDA on access to morning-after pillBy Sam Baker - 12/07/11 06:28 PM ET In a decision steeped in 2012 politics, President Obama’s top health official on Wednesday overruled government scientists to block wider access to the so-called “morning-after pill.” The decision to leave in place a requirement that women younger than 17 get a prescription for the drug was a huge surprise to liberal groups and advocates for the Plan B contraceptive, some of whom said they were left “speechless” by Health and Human Services Secretary Kathleen Sebelius’s involvement. It came a day after Sebelius...
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This past year, I started writing a health and fitness column through Creators.com, titled "C-Force." It is no surprise that in researching for that column, I've discovered repeat offenses of food and beverage tampering by the federal government. But arsenic in apple juice?Dr. Oz received significant flak when he reported in September that "some of the best-known brands of apple juice contain arsenic." Since then, however, Oz has been redeemed and his claims substantiated!After Oz's initial comments, Dr. Richard Besser, a 13-year veteran of the Centers for Disease Control and Prevention and ABC News' chief health and medical editor, publicly...
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The FDA has issued a proposed mandate that represents the greatest threat to dietary supplements since 1994. Back in the early 1990s, consumers were so alarmed by FDA bullying that they staged a massive revolt. The result was that Congress passed a law prohibiting the FDA from banning popular nutrients (as the agency had threatened to do). There was, however, a loophole in the 1994 law. The FDA was given authority to regulate ingredients introduced after October 15, 1994. It has been 17 years, but the FDA just issued draconian proposals as to how it intends to regulate what it...
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Cigar smokers are mad as hell, and they aren’t going to take it anymore. Faced with an unprecedented assault on their guilty pleasure from President Barack Obama's Food and Drug Administration, aficionados and industry insiders told The Daily Caller that they’re picking up their torch lighters and revolting. Usually divided by their preferences for mild, medium and full-bodied smokes, they're uniting against regulations that threaten to make cigars prohibitively expensive, shut down scores of small cigar shops, jeopardize tens of thousands of jobs and erase the traditionally bright line between Camels and Cohibas. Cigar lovers are also recruiting members of...
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A U.S. judge sided with tobacco companies on Monday, granting a temporary injunction blocking rules requiring new warning labels that use graphic images like a man exhaling cigarette smoke through a hole in his throat.
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SILVER SPRING, Maryland, November 2, 2011 – They escaped arrest. The “raw milk freedom riders” who illegally transported raw milk from a farm in Pennsylvania to FDA headquarters in Silver Spring, Maryland and then drank it and distributed it to a crowd rallied in support of their efforts got away with their crime.As reported yesterday in this column, this group of raw milk activists planned the ride and rally to protest government restrictions on the sale of raw milk and the spending of taxpayer money to raid and bankrupt small family farms.The rally began at noon as the swelling crowd...
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First time posting. Wanted to inform and start a discussion on the FDA and National Cancer Institute's motivations for FIGHTING a proven cancer cure...
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President Obama couldn't wait to trample over the legislative process again. This week, he issued his 98th executive order on an irresistibly exploitatable policy issue: prescription drug shortages. Soon, "One a Day" won't just be a multivitamin. It'll be the rate of White House administrative fiats. Federal officials darkly suggest that selfish industry "stockpiling" is endangering Americans' lives. "If we find out that prices are being driven up because shortages are being made worse by manipulations of companies or distributors," the White House further threatened, "agencies will be empowered to stop those practices. And the FDA and the Department of...
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Shortages have more than tripled since 2005, according to the University of Utah's Drug Information Service, and by the end of the year more than 300 products are likely to be back-ordered, in short supply or totally unavailable. Some are anesthetics and pain therapies, others emergency room "crash cart" drugs. But most—about 70% in 2010—belong to the class of drugs known as "sterile injectables" that are mainstays of the chemotherapy arsenal, such as paclitaxel or cytarabine.
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Here are some highlights from HHS Secretary Kathleen Sebelius's conference call with reporters Monday morning to talk about President Obama's new executive order, which is intended to provide more medicine to treat deadly diseases: -- Obama "felt the executive order was the most appropriate way to highlight the problem and actually call for a collaborative approach to solve the problem on behalf of patients in this country," Sebelius said. -- "Within the drug shortage program itself, we are planning to effectively double the staff, and we expect that they will be kept busy working on the additional information that we...
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Acting once again without Congress, President Obama on Monday was directing the Food and Drug Administration to take steps to reduce drug shortages that administration officials say have placed patients at risk and led to price gouging. The president signed an executive order -- his fifth in a week -- instructing the FDA to take action absent congressional approval. Last year, the FDA reported 178 drug shortages -- mainly cancer drugs, anesthetics, electrolytes and emergency room drugs -- and the agency says it continues to see an increase in shortages this year. The White House also announced Obama's support for...
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President Obama signed his latest executive order this afternoon, saying of the initiative to address a drug shortage that "we've got to go ahead and move forward." He concluded, somewhat awkwardly: "All right. With that, I'm going to sign this bill -- or this executive order -- excuse
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Eat the Old: Could Mass Cannibalism Solve a Future Food Shortage? The global human population is set to hit 7 billion on Oct. 31, and by century's end it will stand at 10 billion, according to the United Nations. That's a lot more mouths to feed. There's a very good chance that generating food from traditional farming and livestock practices will not be able to keep pace with this boom. What if a worldwide food shortage were to become so terribly dire that people resorted to eating . . . people? In such a dreadful event, the most-sensible first choice...
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A chemist with the Food and Drug Administration pleaded guilty Tuesday to using a confidential drug database to earn nearly $3.8 million by trading the stock of companies with new drug applications.
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Sen. Jim DeMint is trying to stop the federal government from banning a popular over-the-counter asthma inhaler, introducing an amendment that would yank funding for the ban set to go into effect in January. The Food and Drug Administration rule would take off the shelves the epinephrine asthma inhaler known as Primatene Mist. The product is currently the only FDA-approved over-the-counter inhaler and is being banned because it uses something called chlorofluorocarbons (CFCs) as a propellant -- the substance is considered harmful to the ozone layer.
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PER WEBSITE: FDA regulations will force manufacturers to spend upwards of six-figures just to get new a blend approved. Your favorite boutique cigar brands will wither and die, leaving only the largest manufacturers to introduce a new blend or two per year. Don't expect to sample those new blends, either: free samples will be illegal, as well as cigar events. And even if you're brave enough to buy a box sight unseen, the FDA is likely to mandate near-zero levels of nicotine. How do you suppose THAT cigar will taste? Surely the Founding Fathers are spinning in their graves! When...
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Just got an email from Famous that is essentially reproduced at the link. Basically they say the FDA is looking to get into the business of "regulating" cigars and legislation is needed to prevent this. I followed their link to a CRA (Cigar Rights of America) site which allows one to craft messages to be sent to your Senators and Congressman. I just did this. If you agree with me that the FDA shouldn't be regulating cigars I urge you to do the same. ML/NJ
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Hundreds of thousands of asthma sufferers who use an over-the-counter inhaler will be compelled to seek a more costly prescription device by the end of the year, when the federal government plans to ban them over environmental concerns. The Food and Drug Administration last week began a media push to get the word out about the looming phase-out. After Dec. 31, the epinephrine asthma inhaler known as Primatene Mist will no longer be available. The product is currently the only FDA-approved over-the-counter inhaler and is being taken off the shelves because it uses something called chlorofluorocarbons (CFCs) as a propellant...
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A few weeks ago, I wrote to you about the FDA’s proposed new policy on dietary supplements that could make it impossible or very expensive for you to purchase the natural products you rely on to support your health. The open comment period on the FDA’s proposed guidelines ends on September 30, so NOW is the time to act and let your voice be heard if you want to retain your right to access supplements. (Scroll down to the bottom of this article to learn how you can get involved.) If the FDA has its way, all vitamins, herbs and...
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Obama Administration to Ban Asthma Inhalers Over Environmental Concerns 3:00 PM, Sep 23, 2011 • By MARK HEMINGWAY Single Page Print Larger Text Smaller Text Alerts Remember how Obama recently waived new ozone regulations at the EPA because they were too costly? Well, it seems that the Obama administration is would rather make people with Asthma cough up money than let them make a surely inconsequential contribution to depleting the ozone layer: Asthma patients who rely on over-the-counter inhalers will need to switch to prescription-only alternatives as part of the federal government's latest attempt to protect the Earth's atmosphere. The...
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More than an hour into last night’s debate, Rep. Michele Bachmann attacked Gov. Rick Perry on the HPV vaccination controversy — or more accurately pseudo-controversy. It stems from an executive order issued by Perry in 2007 that required all Texas girls to receive Gardasil, a vaccine against the most common strains of human papilloma virus, before entering the sixth grade. However, Texas lawmakers blocked that mandate. Some critics argued that the vaccine was too new to have been confirmed safe, while others said that Perry’s order would preempt parental rights or give girls a false sense of security, possibly causing...
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When the FDA answered FTCLDF (Farm to Consumer Legal Defense Fund) in the interstate shipment of raw milk suit, they stated four fully repugnant things. That you have no right to, nor does your child have a right to any particular food, you have no right to bodily or physical health, that you have no right to contract, and that they are “rationally” fulfilling their public health mission. It appears that they forgot to include that you have no right to privacy or free association along with no right of contract. With the recent actions against Rawesome, sting operations against...
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As Texas governor, GOP presidential hopeful Rick Perry has presided over 234 executions. It's a record number, which, The Washington Post reported last week, bestows on Perry "a law-and-order credential that none of his competitors can match -- even if they wanted to." Watch how pundits will try to turn that statistic into a political negative -- and paint Perry as the governor with blood on his spurs -- even though American voters overwhelmingly support the death penalty. The temptation to tout Texas' status as the state with the most executions will prove too seductive. It won't matter that, as...
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http://rjjrdq.com/2011/07/24/fda-declares-walnuts-a-drug/ This is old news but it is wise to keep informed in what the Obama regime is up to.
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FORT WORTH, Texas - If your dog has heartworms it will be harder to get a cure. The only company producing the parasite-killing drug has run out and veterinarians don’t know when they’ll get more. Veterinarians across the country are in a quandary because Immiticide is the only FDA-approved drug available to treat dogs with heartworms. Drug company Merial said its supply is gone and it can’t produce any more because it can’t get the drug’s active ingredient in the United States. The FDA has been hesitant to allow overseas suppliers to fill American orders. Vets are working with what...
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COLUMBIA, S.C. (AP) - Four of the five largest U.S. tobacco companies sued the federal government Tuesday over new graphic cigarette labels that include the sewn-up corpse of a smoker and a picture of diseased lungs, saying the warnings violate their free speech rights and will cost millions of dollars to print. The companies, led by R.J. Reynolds Tobacco Co., Lorillard Tobacco Co., said the warnings no longer simply convey facts to allow people to make a decision whether to smoke. They instead force them to put government anti-smoking advocacy more prominently on their packs than their own brands, the...
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Sen. Orrin Hatch blasted a new bill that health experts are calling a government takeover of the vitamin industry. New legislation proposed by Sen. Dick Durbin, D-Ill., earlier this month would crack down on the testing, labeling, and sale of dietary supplements nationwide. The increased regulation almost certainly will deny many Americans easy, affordable access to the natural health products they rely on daily, experts warn. Sens. Durbin and Richard Blumenthal, D-Conn., quietly submitted the Dietary Supplement Labeling Act of 2011 over the July 4th weekend. Despite its innocuous title, the bill would force a massive reclassification of food additives...
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Well that didn’t take long. Yesterday, in a post discussing a New York Times op-ed that called for heavy taxation on “unhealthy” foods, I asked, “How long before some starry-eyed but angry-faced Democrat proposes legislation to force ‘healthy food’ advertising?” Now The Daily Caller reports that food producers could face government regulations requiring “healthy” composition profiles for foods marketed to children two to seventeen years old.If enacted, new regulatory criteria will reclassify many foods which the FDA presently considers healthy as off limits for advertising to children. In the present formulations, eighty-eight of the top 100 most-consumed foods will be...
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Life Extension® has published 57 articles that describe the health benefits of walnuts. Some of this same scientific data was featured on the website of Diamond Foods, Inc., a distributor of packaged walnuts. Last year the FDA determined that walnuts sold by Diamond Foods cannot be legally marketed because the walnuts “are not generally recognized as safe and effective” for the medical conditions referenced on Diamond Foods’s website. According to the FDA, these walnuts were classified as “drugs” and the “unauthorized health claims” cause them to become “misbranded,” thus subjecting them to government “seizure or injunction.” Diamond Foods capitulated and...
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Seen any walnuts in your medicine cabinet lately? According to the Food and Drug Administration, that is precisely where you should find them. Because Diamond Foods made truthful claims about the health benefits of consuming walnuts that the FDA didn’t approve, it sent the company a letter declaring, “Your walnut products are drugs” — and “new drugs” at that — and, therefore, “they may not legally be marketed … in the United States without an approved new drug application.” The agency even threatened Diamond with “seizure” if it failed to comply. Diamond’s transgression was to make “financial investments to educate...
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New FDA Report: Abortion Drug Kills 14 Women, Injures 2,200 Washington, DC -- The Food and Drug Administration has quietly released a new report about the deaths of and injuries to women from the dangerous RU 486 abortion drug and the Obama administration has done nothing to make the information available to women. http://www.lifenews.com/2011/07/12/new-fda-report-abortion-drug-kills-14-women-injures-2200/
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A Food and Drug Administration panel today voted 6-0 to halt the use of cancer drug Avastin for the treatment of breast cancer, saying studies have failed to show Avastin is effective for that purpose. The recommendation came after two days of testimony from patients, doctors, and advocacy groups. The panel faced several tearful accounts of women, young and old, who believed Avastin saved their lives.
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WASHINGTON, DC, June 28, 2011 (LifeSiteNews.com) - If homosexual activists at the U.S. Department of Agriculture (USDA) have their way, a radical “gay sensitivity” training program developed by the department could soon be coming to every federal agency, the Washington Times reported Sunday. According to an internal newsletter published for employees, the Office of Personnel Management (OPM), the agency that oversees federal employment issues, has met with officials at USDA responsible for developing the program. The newsletter, which calls the program “groundbreaking,” reports that the goal of collaboration with OPM is to spread USDA’s “LGBT Special Emphasis Program” across the...
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Tony the Tiger, some NASCAR drivers and cookie-selling Girl Scouts will be out of a job unless grocery manufacturers agree to reinvent a vast array of their products to satisfy the Obama administration’s food police. Either retool the recipes to contain certain levels of sugar, sodium and fats, or no more advertising and marketing to tots and teenagers, say several federal regulatory agencies. The same goes for restaurants. It’s not just the usual suspected foods that are being targeted, such a thin mint cookies sold by scouts or M&Ms and Snickers, which sponsor cars in the Sprint Cup, but pretty...
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AUSTIN, TX - The U.S. Department of Agriculture (USDA) is expected to issue its new proposed rule for mandatory animal traceability very shortly. While USDA already has traceability requirements as part of existing animal disease control programs, the proposed framework goes much further to require animal tagging and tracing even absent any active disease threat. The framework has raised significant concerns among family farm and ranch advocates, who criticize the agency for failing to provide a coherent, factual explanation for the new program’s necessity. “USDA brags about the success of past programs, but has abandoned the principles that made them...
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And with that budget hit, the so-called “food safety” law can’t be implemented—and no money to approve Frankenfish! This is huge! Last week the House of Representatives passed the agriculture funding bill for fiscal year 2012, and the bill included a gigantic cut in FDA’s budget. This is particularly significant because they were tasked with implementing most of the provisions of the Food Safety Modernization Act that Congress passed last year. The Congressional Budget Office estimated that the cost of implementing the Food Safety act would be $1.4 billion over five years. The whopping $285 million budget cut makes it...
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The federal government has a growing interest in the eating habits of Americans for the same reason it has an interest in tobacco consumption, said Kathleen Sebelius, the secretary of the Department of Health and Human Services. The reason is money, because three-quarters of medical-spending is driven by chronic diseases, such as obesity and tobacco-related diseases, she said. Sebelius’ comments came at the tail-end of Tuesday’s White House press conference where officials showcased nine new photos that must be carried on cigarette packs. Officials used a survey of 18,000 people to find the images that would have the most distressing...
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Dozens of new designs were made, but a winner has been chosen! All kidding aside, I mentioned last November that large labels like the one above are coming... Beginning September 2012, FDA will require larger, more prominent cigarette health warnings on all cigarette packaging and advertisements in the United States. These warnings mark the first change in cigarette warnings in more than 25 years and are a significant advancement in communicating the dangers of smoking. From the FDA "These warnings mark the first change in cigarette warnings in more than 25 years." It would be frightening if boredom with the...
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June 20, 2011 (LifeSiteNews.com) – U.S. scientists reported last week they have been able to develop potentially “self-healing” lasers that could be used in the human body for treating diseases such as cancer. The lasers, however, use human embryonic cells in a controversial experiment that has not yet been approved by the FDA. The experiment findings were published this month in the Nature Photonics journal, by physicists Malte C. Gather and Soek Hyun Yun of the Wellman Center for Photomedicine at the Massachusetts General Hospital. “This is the first time that we have used biological materials to build a laser...
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RICHMOND, Va. (AP) - In the most significant change to U.S. cigarette packs in 25 years, the Food and Drug Administration on Tuesday released nine new warning labels that depict in graphic detail the negative health effects of tobacco use. Among the images to appear on cigarette packs are rotting and diseased teeth and gums and a man with a tracheotomy smoking. Also included among the labels are: the corpse of a smoker, diseased lungs, and a mother holding her baby with smoke swirling around them. They include phrases like "Smoking can kill you" and "Cigarettes cause cancer" and feature...
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RICHMOND, Va. (AP) - Coming to a store near you: nine more reasons not to smoke. The Food and Drug Administration on Tuesday is set to release nine new graphic health warning labels for U.S. cigarette packs, representing the most significant change to cigarette packs in more than 25 years. The new labels will take up half of a pack of cigarettes and also will appear on advertisements. Cigarette makers have until the fall of 2012 to comply. Mandates for new warning labels were part of a 2009 law giving the FDA authority to regulate tobacco. The announcement follows reviews...
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How many of you have not been able to get a drug you needed to properly deliver anesthesia to a patient?” I asked. Every hand in the room went up. “How did that affect your patients?” I asked. “Two of our patients died,” one woman answered. I was speaking to a group of nurse anesthetists, enrolled in a business management program at Marshall University in West Virginia. I wish I could say their experience is unusual. It isn’t. About 90 percent of all the anesthesiologists in the country report they are experiencing a shortage of at least one anesthetic. Drug...
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This is a link to a free viewing of a very interesting documentary about a doctor in Texas who seems to have discovered an amazingly effective tool to fight cancer. I am in the middle of watching it, but just watched an undeniable Atlas Shrugged moment that moved me to post it here.... It will only be free to view until midnight tonight. Thought provoking stuff here, and I will be interested to hear what ya'll think.
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Senator Snowe said a proposed rule by the U.S. Department of Agriculture (USDA) limiting total servings of starchy vegetables (potatoes, corn, green peas, and lima beans) to one cup per week and eliminating these vegetables from breakfast meals is not grounded in scientific data and does not make economic sense. In letters to First Lady Michelle Obama, founder of the Let’s Move campaign, and USDA Secretary Tom Vilsack, Senator Snowe urged reevaluation of the nutritional and economic impacts of this proposal. Senator Snowe recently joined her colleagues in calling on President Obama to resolve a discrepancy within the Administration regarding...
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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...
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