Keyword: bhofda
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Knoxville vape companies are fuming mad after the FDA passed new regulations this month. They say this new law will put an end to the vaping industry. They are shocked at how far reaching the regulations are, and now they're afraid the new restrictions will destroy the industry. Hunter Allison with Tri State Vape Company will have to submit an application for each new product. He says that would come with a hefty price tag. Allison says, "The absolutely lowest price I've seen is $300,000 per product and that's $4.5 million for me and there's no possible way. He's already...
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Making Babies with 3 Genetic Parents Gets FDA Hearing A reproductive technology that taps three parents’ DNA as a way to eliminate hereditary diseases could reach clinical trials if the Food and Drug Administration gives the go-ahead. Reproductive technologies that marry DNA from three individuals will receive a trial in the court of public opinion this week. Such technologies may hold promise for averting certain genetically inherited diseases passed down via mutations to mitochondria, the cell’s battery pack. Scientists have already had successes with this type of reproductive approach in monkeys and in human embryos, and are now eager to...
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The Obama administration moved ahead Friday with the first major overhaul of the nation’s food-safety system in more than 70 years, proposing tough new standards for fruit and vegetable producers and food manufacturers. The long-awaited proposals by the Food and Drug Administration are part of a fundamental change aimed at preventing food-borne outbreaks — caused by everything from leafy greens to canteloupes to peanut butter — rather than simply reacting to them. Every year, contaminated foods sicken an estimated 48 million Americans and kill 3,000.
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President Barack Obama has not yet decided whether to go forward with a proposed regulation under the health care law he signed last year that would force Catholic individuals and institutions to act against the teachings of the Catholic church. In August, Health and Human Service Secretary Kathleen Sebelius proposed a regulation--that would take affect next fall--that would require all health care plans to cover sterilizations and all FDA-approved contraceptives, including abortifacients. The proposed regulation includes a very narrow religious exemption that does not cover individual Catholics, or Catholic universities, hospitals or charitable institutions.
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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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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,...
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This bill was considered in committee which has recommended it be considered by the Senate as a whole. Although it has been placed on a calendar of business, the order in which legislation is considered and voted on is determined by the majority party leadership. Keep in mind that sometimes the text of one bill is incorporated into another bill, and in those cases the original bill, as it would appear here, would seem to be abandoned.
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More Products, Including Tylenol Extra Strength and Rolaids, Recalled Due to Noxious Chemical Fears ### The U.S. Food and Drug Administration slammed Tylenol manufacturer McNeil Healthcare LLC during a media briefing this morning for what it called a slow response to problems at a facility in Puerto Rico that led to consumers becoming sickened by tainted pills. "McNeil should have acted faster," said Deborah Autor, director of the FDA's Office of Compliance, of the arm of Johnson & Johnson that manufactures Tylenol products, adding "When something smells bad, literally or figuratively, they must aggressively investigate and solve the problem." A...
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The Food and Drug Administration on Thursday began collecting millions in fees from the nation's tobacco companies to help fund the agency's newly granted authority to regulate the industry. The user fees, which will be collected quarterly, are based on each company's share of the U.S. tobacco market. The FDA will collect about $23 million for fiscal 2009. That will rise to $235 million in 2010 and grow to $712 million by 2019. The FDA would not disclose the assessments for specific companies. Stifel, Nicolaus & Co. analyst Christopher Growe said in a note to investors that Richmond, Va.-based Altria...
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My real interest is in the authors' third basis for regulation: market failure that ... results from time-inconsistent preferences (i.e., decisions that provide short-term gratification but long-term harm). This problem is exacerbated in the case of children and adolescents, who place a higher value on present satisfaction while more heavily discounting future consequences. Wow. This isn't socialism. It's sheer paternalism. This, according to the authors, is a market failure that justifies taxation to alter your behavior, totally apart from its impact on public health costs. This is what worries me about the crackdown on death sticks and edible crap. There's...
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Federal health officials banned sale of flavored cigarettes on Tuesday in the first major crackdown since the Food and Drug Administration was given the authority to regulate tobacco. The ban is intended to end sale of tobacco products with chocolate, vanilla, clove and other flavorings that lure children and teenagers into smoking. The agency will study regulating menthol products and hinted that it might soon take action against the far larger market of flavored small cigars and cigarillos. “These flavored cigarettes are a gateway for many children and young adults to become regular smokers,” Dr. Margaret A. Hamburg, commissioner of...
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Washington, D.C. (AHN) - Candy or fruit flavored cigarettes are no more. The Food and Drug Administration banned the products Tuesday as part of a campaign to reduce smoking.The flavored tobacco products could entice children into the smoking habit, said FDA Commissioner Dr. Margaret A. Hamburg. "Almost 90 percent of adult smokers start smoking as teenagers," she said. "These flavored cigarettes are a gateway for many children and young adults to become regular smokers."In a statement, the FDA said that studies have found that 17-year-old smokers are three times as likely to use flavored cigarettes as smokers over 25. About...
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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 House has passed a far-reaching food safety bill requiring more government inspections and imposing new penalties on those who violate the law, reacting strongly to an outbreak of salmonella in peanuts that killed at least nine people. The legislation would require greater oversight of food manufacturers and give the Food and Drug Administration new authority to order recalls. It also would require the FDA to develop a system for better tracing food-borne illnesses. Food companies would be required to create detailed food safety plans. President Barack Obama praised the bill soon after it was passed, calling it "a major...
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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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Not satisfied with its efforts to ban tobacco and demonize its users, the Food and Drug Administration (FDA) is now taking aim at a potentially healthier alternative to traditional cigarettes, electronic cigarettes. Electronic cigarettes (or e-cigarettes) are battery powered devices that emulate the look and feel of traditional cigarettes and deliver a vaporized nicotine solution directly to the lungs when smoked. The devices contain no tobacco and there is no combustion involved in their operation. They also contain far fewer carcinogens than other tobacco products, which may make them an excellent alternative to products like cigarettes, cigars and pipes. Despite...
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* HR 2749 would empower FDA to regulate how crops are raised and harvested. It puts the federal government right on the farm, dictating to our farmers. * HR 2749 would give FDA the power to order a quarantine of a geographic area, including "prohibiting or restricting the movement of food or of any vehicle being used or that has been used to transport or hold such food within the geographic area." Under this provision, farmers markets and local food sources could be shut down, even if they are not the source of the contamination. The agency can halt all...
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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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Last week, there was a fairly obscure story that was treated mostly with amusement. 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." If the government's enforcement action against Cheerios were to hold...
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The law will force cigarette packs to carry graphic warnings and forbid the use of terms like "mild" and "low tar" in tobacco advertisements. By July 2011, the top half of the front and rear panels of cigarette boxes will consist of warnings. Government getting into social behaviour??? Reminds me of the SURGEON GENERAL'S WARNING the government put into effect with the cigarette law by the FTC in 1973. Doesn't work! A colleague of mine was an FTC attorney who was one of the people responsible for enforcing the law. He told me at the time, "Of course nicotine is...
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