Keyword: fda
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LET me start by saying I’m a fan of generic drugs. They save Americans billions of dollars each year and give us access to wonderful drugs at affordable prices. I’ve recommended generics in this column many times and use them myself when possible. But there is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts. The problem is not pervasive, but it’s something consumers should be aware of — especially now that more insurers insist that patients take generic medications when they are available. Let me also......
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A proposal to enable the importation of cheaper prescription drugs could endanger the U.S. medicine supply and would be difficult to implement, the Food and Drug Administration said Tuesday These criticisms from Margaret Hamburg, President Barack Obama’s FDA commissioner, could prove damaging to an effort by a broad coalition to enact the longstanding goal of easing consumers’ access to prescription drugs from countries such as Canada, where the prices are generally lower than in the United States. Sen. Byron Dorgan (D-N.D.) introduced his amendment to the healthcare bill on Tuesday with the support of 19 other senators, including four Republicans,...
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The chemical Bisphenol A, which has been used for years in clear plastic bottles and food-can liners, has been restricted in Canada and some U.S. states and municipalities because of potential health effects. The Food and Drug Administration will soon decide what it considers a safe level of exposure to Bisphenol A (BPA), which some studies have linked to reproductive abnormalities and a heightened risk of breast and prostate cancers, diabetes, and heart disease. Now Consumer Reports' latest tests of canned foods, including soups, juice, tuna, and green beans, have found that almost all of the 19 name-brand foods we...
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http://www.youtube.com/watch?v=0IDRSkBOuuc
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NaturalNews) The U.S. Government Accountability Office (GAO) recently released a report indicting the U.S. Food and Drug Administration (FDA) for allowing health professionals convicted of crimes to perform research for the agency and to supervise patients' safety during clinical trials. The FDA is required by law to disqualify from positions within its organization doctors that have been convicted of fraud or other crimes. Yet the GAO is publicizing that it takes an average of four years for criminals to be disbarred from their positions. In one case, a doctor who was convicted of 53 counts of criminal offense was allowed...
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Raw Emotions Over Raw Oysters The FDA's proposal to treat raw oysters had sparked an outcry among diners. Legend has it that raw oysters are good for love — but they're also worth fighting over, as the Food and Drug Administration has learned. Facing political pressure from the Gulf Coast oyster industry, the FDA has backed off a plan to require raw oysters from the Gulf of Mexico to be treated to rid them of Vibrio vulnificus, a potentially deadly bacteria found in warm-water oysters. Harvesters and politicians had warned that the plan could devastate the industry. The outcry was...
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ENID, Oklahoma (Reuters) - To the untrained eye, Pollard Farms looks much like any other cattle ranch. Similar looking cows are huddled in similar looking pens. But some of the cattle here don't just resemble each other. They are literally identical -- clear down to their genes. Of the 400-some cattle in Barry Pollard's herd of mostly Black Angus cattle there are 22 clones, genetic copies of some of the most productive livestock the world has ever known. Pollard, a neurosurgeon and owner of Pollard Farms, says such breeding technology is at the forefront of a new era in animal...
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This is the seventh installment of a nine-part series excerpting the chapter on medical care from the new edition of economist Thomas Sowell's "Applied Economics." All parts of the series can be seen at IBDeditorials.com.It is illegal for a pharmaceutical company to begin selling a drug without prior approval by the Food and Drug Administration. The drug-approval process tries to reduce the risks of new and untried medicines before they are made available to the general public. In addition to being reasonably safe for most people, pharmaceutical drugs must also be shown to be effective for whatever medical conditions they...
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A Food and Drug Administration decision to impose draconian new rules on oysters harvested from the Gulf of Mexico could wreck Louisiana's $300 million-a-year industry and restrict the diets of raw oyster lovers here and elsewhere for most of the year -- all in a misguided effort to prevent a serious but rare health threat. The FDA announced guidelines, to go into effect in 2011, that would require all Gulf oysters harvested from April through October to undergo a sterilization process before they can be sold. That could double or even triple the cost of Louisiana oysters for consumers and...
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At the small warehouse tucked away in the back side of the French Quarter, the shuckers at P&J Oyster Co. have arrived before daybreak for 133 years. Their in-shell and shucked oysters have been on the menus of generations of restaurateurs, from oysters on the halfshell at Acme Oyster House and Casemento’s to the seafood gumbo at Dickie Brennan’s Steakhouse. In less than two years, the tradition could become obsolete for seven months out of the year, based on newly announced oyster guidelines from the Food and Drug Administration. In an effort to reduce cases of a rare, but potentially...
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NEW ORLEANS -- Federal officials plan to ban sales of raw oysters harvested from the Gulf of Mexico unless the shellfish are treated to destroy potentially deadly bacteria.
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NEW ORLEANS – Federal officials plan to ban sales of raw oysters harvested from the Gulf of Mexico unless the shellfish are treated to destroy potentially deadly bacteria — a requirement that opponents say could deprive diners of a delicacy cherished for generations. The plan has also raised concern among oystermen that they could be pushed out of business. The Gulf region supplies about two-thirds of U.S. oysters, and some people in the $500 million industry argue that the anti-bacterial procedures are too costly. They insist adequate measures are already being taken to battle germs, including increased refrigeration on oyster...
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WASHINGTON – The Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn't extend patients' lives, say congressional investigators. A report due out Monday from the Government Accountability Office also shows that the FDA has never pulled a drug off the market due to a lack of required follow-up about its actual benefits — even when such information is more than a decade overdue. (excerpted)
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egislation granting the Food and Drug Administration new powers to oversee the nation's food supply has elbowed its way onto Congress' crammed calendar with bipartisan support and rare agreement between consumer groups and an industry stung by product recalls. The legislation, sponsored by Sen. Richard J. Durbin (D-Ill.), would require the FDA to step up inspections of food facilities and to issue new rules to improve the quality of imported food and to combat contaminants in fresh produce. The measure also would give the agency authority to recall products on its own, instead of relying on industry cooperation. "Hardly a...
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(NaturalNews) Health freedom attorney Jim Turner is filing a lawsuit in Washington D.C. mid-day Friday in an urgent effort to halt the distribution of the swine flu vaccine in America. On behalf of plaintiffs Dr. Gary Null and other licensed health care workers of New York State, the lawsuit charges that the FDA violated the law in its hasty approval of four swine flu vaccines by failing to scientifically determine neither the safety nor efficacy of the vaccines. "The suit will seek an injunction against the FDA from approving the vaccine," attorney Jim Turner told NaturalNews on Thursday evening's Natural...
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Synovi was recently taken off the shelves and made unavailable. When the company was called, they were evasive and just said there were some issues and the such, but made no mention of the plant closure until I did an internet search. Please get the word out to any dog owners who may be using Synovi glucosamine. FDA closes Teva Animal Health plant
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Tobacco Control Expert Dr. Michael Siegel Calls for a Scientific, Not Ideological or Political Response to the Electronic Cigarette Issue (EMAILWIRE.COM, September 08, 2009 ) BOSTON – An article in this week's issue of the Journal of the American Medical Association (JAMA) reports that the Food and Drug Administration (FDA) has now acknowledged receiving 98 reports of suicides and 188 reports of suicide attempts that appear to be linked to use of Chantix, a prescription medication for smoking cessation. In addition, the FDA has received reports of patients taking the drug being involved in motor vehicle crashes. At the same...
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URGENT! Sign the Petition to the FDA to Defeat Mandatory Swine Flu Vaccinations !!! Click Here to Sign the Petition ! > Read the Petition Below for more Information: Before the United States of America Food and Drug Administration In the Matter of the A-H1N1-09 “Swine Flu” Vaccines } FDA Docket No. __________ To: Dockets Management Branch } PETITION Food and Drug Administration Room 1061 } With Request for Emergency Relief: 5630 Fishers Lane HFA-305 Temporary Stay of all Pending Rockville, MD 20852 } “Swine Flu” Vaccine Approvals Dated: August 17, 2009 Pursuant to the Constitution of the United States...
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For the first time, the U.S. Food and Drug Administration has publicly admitted that politics has trumped science. The agency acknowledged yesterday that it approved a device to help with knee-replacement surgeries—a device the agency’s own scientists said often failed—only after it received pressure from a cohort of Democratic congressmen from New Jersey, where the device’s manufacturer is located. The $3000 device was known as the Menaflex, a “collagen scaffold” that supported a damaged meniscus in the knee. It failed its initial reviews but received approval in December of last year anyway, during the waning days of the Bush Administration....
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The Food and Drug Administration's new leaders issued a scathing report about the approval of a knee device last December, saying "extreme" pressure from Democrats on Capitol Hill damaged the integrity of the process. The FDA said it is reconsidering its decision on ReGen Biologics Inc.'s Menaflex device. A page-one Wall Street Journal article in March first raised questions about the decision and reported that the FDA's then-device chief overruled objections of FDA scientists in clearing Menaflex... ...Four Democrats from New Jersey -- Sens. Frank Lautenberg and Robert Menendez, and Reps. Steve Rothman and Frank Pallone Jr. -- contacted the...
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Thursday's raid followed a two-year criminal investigation into the company and corporate officers, including founder Ryan DeLuca, by the U.S. Food and Drug Administration, according to search warrants filed in U.S. District Court. The searches were conducted at Bodybuilding.com's headquarters at 2026 S. Silverstone Way, Meridian, and its warehouse off Gowen Road in south Boise, after two warrants were signed by U.S. Magistrate Judge Candy W. Dale, said Wendy Olson, an assistant U.S. attorney in Boise. DeLuca could not be reached for comment, but a spokeswoman said the company is cooperating fully in the investigation. "We are not the manufacturers...
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By John Gever, Senior Editor Military doctors can use a portable polymerase chain reaction (PCR) testing device to diagnose novel H1N1 flu infections in troops overseas, the FDA announced. The emergency authorization was approved "to better protect our troops," said FDA Commissioner Margaret A. Hamburg, MD, in a statement. The device, called JBAIDS (Joint Biological Agent Identification and Diagnostic System), is a rugged, suitcase-sized instrument that can run PCR-based molecular diagnostic tests. It has been under development for several years by a consortium of military health research centers, the CDC, and academic medical laboratories. The development program began in the...
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I sat at a picnic table listening to various mothers discussing their hectic schedules trying to keep up with teenage daughters, all on the same sports team. When one mother told of squeezing in an appointment that morning to get her daughter the HPV shot that her doctor recommended, the conversation turned to the necessity to "protect" their girls in such troubling times. I stayed quiet, hoping to learn the values guiding these parents' decisions. Predictably, they had not thought through the issues, nor did they know the facts. Those mothers were merely following doctors' recommendations and that of all...
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WASHINGTON -- The Food and Drug Administration tapped a Veterans Affairs official with a long history of public-health experience to head the agency's new tobacco division. Lawrence Deyton was the chief public-health officer at the VA and initiated smoking-cessation programs that lowered smoking rates among veterans. He has served in the National Institutes of Health, started a community-based AIDS service organization in Washington, D.C., and was a legislative aide with the House Subcommittee on Health and the Environment in the 1970s. His experience at building public-health initiatives should come in handy as the FDA grapples with how to regulate the...
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I did everything I could—including risking life in prison. Back in the 1980s-1990s, the Life Extension Foundation® crusaded to enlighten Americans about the economic ruination that would occur if this country’s corrupt drug regulatory structure was not abolished. At the behest of pharmaceutical interests, the FDA brutally retaliated against us. What I am about to divulge is a shocking revelation about why prescription drugs cost so much. I want to remind readers what happens when an apathetic public allows archaic government regulations to rule the marketplace. In the 1940s, Argentina was the ninth wealthiest country in the world. At one...
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Despite some really eloquent speeches to the contrary, our “for sale” House of Representatives passed the Food Fascism Act….euphemistically called a food safety act, by a margin of about 140 over the naysayer’s. True to form, Rosa DeLauro spoke about things she knows nothing about and couldn’t care less; Rosa just loves her some Monsanto! And that exclusion for farms??? Gone! And that includes you organic idiots who thought you had kissed enough behinds to have your industry excluded. The newly revised bill that appeared overnight after the original was defeated 29th of July, now includes all those farms we...
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The FDA recently went public with misleading information about the safety of electronic cigarettes and the marketing of the devices, not only using its clout but recruiting other prominent organizations to demonize a product that has great public health benefit potential. A group of prominent doctors and tobacco researchers, including Dr. Michael Siegel at the Boston University School of Public Health, Dr. Joel Nitzkin of the AAPHP Tobacco Control Task Force, and Dr. Brad Rodu, Endowed Chair, Tobacco Harm Reduction Research University of Louisville, challenge the FDA to provide the full quantitative data of the study upon which the FDA...
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*[EXCERPTED]* "...The Family Smoking Prevention and Tobacco Control Act allows the FDA to...control an industry ... Opponents from...N. Carolina argued that the FDA had proved through a series of food safety failures that it was not up to the job of regulation..."
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The Food and Drug Administration—which has struggled to fulfill its mission of regulating food, drugs and other consumer goods that make up nearly a quarter of the U.S. economy—does not have the expertise to forecast its own budget needs, according to congressional investigators. While many lawmakers and consumer advocates have long complained that the agency lacks the staff and equipment to accomplish its mission, the Government Accountability Office says the agency doesn't even have "the data to develop a complete and reliable estimate of the resources it needs." FDA officials acknowledged the problems uncovered by the GAO, saying they are...
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And another piece of legislation involving, surprise surprise, Waxman. Read the full text of H.R. 2749: Food Safety Enhancement Act of 2009.
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The cancer establishment now has a 50-year history of vast corruption, incompetence and organized suppression of cancer therapies which actually work. A little over one year ago, a UK cancer survivor advertised a natural anti-cancer pill along with proven scientific research results via a link into the US Government database for medical research on cancer. Proving to the public of a cover-up he was arrested by the UK Medicines Healthcare Regulatory Authority (MHRA).
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Government experts are scheduled to vote on whether Nyquil and other combination cold medications should be pulled from the market to help curb deadly overdoses. The Food and Drug Administration has assembled more than 35 experts for a two-day meeting to discuss and vote on ways to prevent overdose with acetaminophen — the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications. Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. There are...
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The Washington Times ran an editorial about the Food and Drug Administration's recent warning to General Mills, Inc. about two claims the company has placed on its Cheerios boxes. The marketing copy for Cheerios Toasted Whole Grain Oat Cereal says that "Cheerios is clinically proven to reduce cholesterol 4 percent in 6 weeks" and that, "Cheerios can help reduce the risk of coronary heart disease, by lowering the 'bad' cholesterol." So what's wrong with that? Well, according to the FDA, that means Cheerios will now be categorized as drugs, and regulated as such. Susan Cruzan of the FDA's press...
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A Nestle plant linked to an outbreak of illness has been shut temporarily, and the company said Monday that it expects to lay off more than 200 workers as a result. Preliminary results "indicate a strong association with eating raw prepackaged cookie dough," the CDC says. "It's likely that we're going to have some temporary layoffs at that facility," Nestle spokeswoman Roz O'Hearn said of the Danville, Virginia, facility that was churning out refrigerated cookie-dough products until Thursday. About 550 people work at the factory, but only about half of them work on cookie dough, she said. The rest work...
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President Barack Obama signed into law Monday an anti-smoking bill that will give the Food and Drug Administration unprecedented authority to regulate tobacco. Obama, who has struggled to quit smoking, signed the Family Smoking Prevention and Tobacco Control Act during an event Monday in the Rose Garden. "I know how difficult it can be to break this habit," Obama said.
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WASHINGTON (AP) — President Barack Obama is set to sign into law an anti-smoking bill that will give the Food and Drug Administration unprecedented authority to regulate tobacco. Obama is scheduled to sign the Family Smoking Prevention and Tobacco Control Act during an event Monday in the Rose Garden. The law allows the FDA to reduce nicotine in tobacco products, ban candy flavorings and block labels such "low tar" and "light." Tobacco companies also will be required to cover their cartons with large graphic warnings.
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The latest verdict from the Food and Drug Administration is that Cheerios is a drug. Parents, then, must be drug pushers. The FDA sent a warning to Cheerios maker General Mills Inc. that it is in serious violation of federal rules. "Based on claims made on your product's label, we have determined that your Cheerios Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease" the FDA letter said. "[Cheerios] may not be legally marketed with the above claims...
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President Obama isn't just rewriting rules regulating the environment and the financial markets -- he is also going after the food industry. Target and example No. 1: Cheerios. "Based on claims made on your product's label," the FDA said in a letter to manufacturer General Mills, "we have determined (Cheerios) is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation and treatment of disease."
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A new food safety bill is on the fast track in Congress-HR 2749, the Food Safety Enhancement Act of 2009. The bill needs to be stopped. HR 2749 gives FDA tremendous power while significantly diminishing existing judicial restraints on actions taken by the agency. The bill would impose a one-size-fits-all regulatory scheme on small farms and local artisanal producers; and it would disproportionately impact their operations for the worse. HR 2749 does not address underlying causes of food safety problems such as industrial agriculture practices and the consolidation of our food supply. The industrial food system and food imports are...
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Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell, federal health regulators said Tuesday. The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration's announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs. The FDA says about 130 consumers have reported a loss of smell after using Matrixx Initiatives' Zicam products since 1999. Shares of the Scottsdale, Ariz.-based company plunged to a 52-week low after the FDA announcement, losing...
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Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell. The action is an early indication that the Obama administration is likely to take far more aggressive enforcement actions against drug companies than the Bush administration did.
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The FDA says consumers should stop using Zicam Cold Remedy nasal gel and related products immediately. All the over-the-counter products contain zinc. Scientists say that ingredient may damage nerves in the nose needed for smell.
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Associated Press-June 12, 2009 "Today Congress sent legislation to the Whte House which woul give the Federal Government vast new powers to regulate and restrict cigarettes..."
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The FDA to the Rescue; You're Children are now Safe! The Senate approved legislation Thursday that would give the Food and Drug Administration authority to regulate tobacco for the first time." Feel any better now? I am quite confident that when this bill is passed and the FDIC has authority over "big Tobacco" - this endeavor will be hugely successful. That is if you define success by the number of billions of dollars that will be siphoned off into the back pockets of the elected imbeciles and their cronies over a period of years. How?..."
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Arizona Sen. John McCain voted for a bill Thursday allowing the U.S. Food and Drug Administration to regulate tobacco, while fellow Sen. Jon Kyl said no. The bill would give the FDA the power to regulate tobacco and cigarettes for the first time. The Senate voted 79 to 17 Thursday for the Family Smoking Prevention and Tobacco Control Act. President Barack Obama supports the bill. Obama and Congress approved a large increase to the federal tobacco tax earlier this year to fund expansion of the State Children’s Health Insurance Program, which provides health coverage to uninsured minors.
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Years in the Making, Senate Votes to Give FDA Power to Regulate TobaccoTimes have changed now that even tobacco states have smoking bans. Today, after two weeks of wrangling and a decade of considering the change, the U.S. Senate endorsed increased regulation of tobacco. Senators voted 79-17 to regulate tobacco in the same way the government regulates everything else you put in your body -- from Froot Loops to aspirin. Watch "World News With Charles Gibson" tonight at 6:30 ET for the full report. At Campaign for Tobacco-Free Kids, organization president Matthew L. Myers called the vote "a truly historic...
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After 11 years, three presidents and millions of dollars in lobbying by worried cigarette makers, Congress is poised to put the tobacco industry under the regulation of the Food and Drug Administration. Passage of the tobacco legislation will mark a big victory for Altria Inc., parent of Philip Morris USA, because it includes new restrictions on advertising and packaging that will make it difficult for other companies to gain attention for their brands. Smaller companies such as Lorillard Inc. and Reynolds American Inc. contend that the legislation will create a new barrier of FDA red tape and make it difficult...
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The Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon because of high levels of disease-causing bacteria found during a recent inspection. Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, issued a voluntary recall of some skin sanitizers and skin protectants marketed under several different brand names, the FDA said in a statement. Consumers should not use any Clarcon products and should throw them away, the FDA said.
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"Without any assurance that intellectual property will be respected and protected, not only drug makers, but other companies as well, will avoid investing in developing new products since they risk having their investments effectively expropriated by the government”
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Sen. Tom Coburn, who is also a medical doctor, is calling for an outright ban on the sale of cigarettes and other tobacco products. "What we should be doing is banning tobacco," the Oklahoma Republican declared on the Senate floor during a debate on a tobacco regulation bill. "Nobody up here has the courage to do that. It is a big business. There are millions of Americans who are addicted to nicotine." The battle against tobacco use has been ongoing. Earlier this year Congress passed legislation that included an increase in the federal tax on cigarettes of more than 60...
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