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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, March 20, 2012

Court: Tobacco Health Lables Constitutional

 

United States - A U.S. law requiring large graphic health warnings on cigarette packaging and advertising does not violate the free speech rights of tobacco companies, a federal appeals court ruled on Monday.

Cigarette makers had sued to stop the U.S. Food and Drug Administration's new labeling and advertising requirements on grounds the rules violated their First Amendment right to communicate with adult tobacco consumers.

But the Cincinnati-based U.S. Court of Appeals for the 6th Circuit upheld the bulk of the FDA's new regulatory framework, including the requirement that tobacco companies include large warning images on cigarette packs.

The decision comes on the heels of a Washington, D.C., judge's ruling in a different, but related, case that rejected the FDA requirements and seems to set up a clash over the constitutionality of the FDA rules.

Floyd Abrams, a lawyer for Lorillard, noted the difference in tone in the two rulings and said the 6th Circuit case, the Washington case, or both, would likely end up in the U.S. Supreme Court.

The difference in the two cases is that the FDA had not introduced the specific images when the companies filed the 6th Circuit suit. While the Washington suit focused on the images, the appeals court addressed the larger issue of the FDA's regulatory power.

"There can be no doubt that the government has a significant interest in preventing juvenile smoking and in warning the general public about the harms associated with the use of tobacco products," Judge Eric Clay wrote for the three-judge 6th Circuit panel.

Congress passed the law in 2009 and ordered the FDA to adopt specific warning-label regulations. The labels must be in color, must cover the top 50 percent of a cigarette pack's front and back panels, and must cover the top 20 percent of print advertisements.

After tobacco companies, including R.J. Reynolds Tobacco Co and Lorillard Inc's Lorillard Tobacco Co, sued to block the law, the FDA unveiled nine images to go on cigarette packs, including graphic pictures of dead bodies, diseased lungs and rotting teeth. The companies accused the government of forcing them to disseminate an anti-smoking message in order to stigmatize and embarrass already-informed consumers.

The appeals court panel's two-judge majority disagreed with the companies on the label requirement, finding that the fact that the specific images might trigger disgust does not make the requirement unconstitutional.

The majority did note that it was only addressing the constitutionality of the statute on its face, and not the specific images that the FDA introduced after the suit was filed.

DISSENT ON IMAGES

Judge Clay, who wrote the main opinion upholding most of the FDA regulations, dissented, however, on the graphic label ruling. He called the rule "simply unprecedented." While the government can require a product manufacturer to provide truthful information, "it is less clearly permissible for the government to simply frighten consumers or to otherwise attempt to flagrantly manipulate the emotions of consumers as it seeks to do here," Clay wrote.

On February 29, D.C. district judge Richard Leon ruled that the FDA's images violated the tobacco companies' free-speech rights. He found that the warning labels were too big and that the government has numerous other tools at its disposal to deter smoking, such as raising cigarette taxes or including simple factual information on the labels rather than gruesome images.

The Obama administration appealed that ruling to the U.S. Court of Appeals for the District of Columbia Circuit on March 5.

Lorillard lawyer Abrams says Monday's appeals court decision does not necessarily conflict with the Leon's decision.

"The court made clear it was focusing on the statute as written, as opposed to the implementation of it," Abrams said.

The Department of Justice did not immediately provide comment.

The 6th Circuit also upheld other FDA regulations, including restrictions on the marketing of "light" cigarettes, on the distribution of free tobacco samples, and event sponsorship. The court struck down a rule barring the use of color and graphics in tobacco advertising.

"We are pleased the 6th Circuit Court of Appeal upheld the continued use of colors and imagery in our advertisements," said R.J. Reynolds spokesman Bryan Hatchell.

Thursday, March 15, 2012

Wisconsin to Ban Some Abortion Coverage, Re-focus Sex-education

Wisconsin - Wisconsin lawmakers have approved controversial measures to block the state's new health insurance exchange from covering abortions and require sex education classes to emphasize abstinence as the preferred method of birth control.


Both bills, which were voted through the Republican-controlled Assembly by 61-34 late Tuesday, now head to the desk of Republican Governor Scott Walker, who is widely expected to sign them.

The laws ban private insurers from offering abortion coverage in the plans they offer through the state-run exchange where thousands of Wisconsin residents will buy subsidized coverage under President Obama's healthcare overhaul.

Two Democrats, Peggy Krusick and Tony Staskunas, and one independent, Bob Ziegelbauer, joined Republicans in supporting the abortion bill, which opponents said would necessarily impair women's health by limiting access to abortions for those who require them.

A handful of Democratic representatives wore Planned Parenthood T-shirts as they voted unsuccessfully against the measure.

Also late Tuesday, the Assembly passed a bill that repeals the so-called "Healthy Youth Act" passed last session by Democrats that provided "comprehensive sex education."

Once Walker signs the measure, it will require schools that offer a human development and growth curriculum to emphasize abstinence as the preferred method of birth control and emphasize the role and "socioeconomic benefits" of marriage.

The measure would also remove information on contraceptive methods approved by the Food and Drug Administration from the required curriculum.

Democrats argued the bill would neglect science-based teaching and put children at risk from sexually transmitted diseases and teen pregnancy.

Last week, lawmakers in Utah passed a measure that would ban public schools from teaching contraception as a way of preventing pregnancy or sexually transmitted diseases.

Supporters of the measure in both Utah and Wisconsin argued that sex education was best left up to parents.

CDC Launching Graphic Anti-Smoking Ad Campaign

Atlanta - Tobacco taxes and smoking bans haven't budged the U.S. smoking rate in years. Now the government is trying to shock smokers into quitting with a graphic nationwide advertising campaign.

The billboards and print, radio and TV ads show people whose smoking resulted in heart surgery, a tracheotomy, lost limbs or paralysis. The $54 million campaign is the largest and starkest anti-smoking push by the Centers for Disease Control and Prevention and its first national advertising effort.

The agency is hoping the spots, which begin Monday, will persuade as many as 50,000 Americans to stop smoking.

"This is incredibly important. It's not every day we release something that will save thousands of lives," CDC Director Dr. Thomas Frieden said in a telephone interview.

That bold prediction is based on earlier research that found aggressive anti-smoking campaigns using hard-hitting images sometimes led to decreases in smoking. After decades of decline, the U.S. smoking rate has stalled at about 20 percent in recent years.

Advocates say it's important to jolt a weary public that has been listening to government warnings about the dangers of smoking for nearly 50 years.

"There is an urgent need for this media campaign," Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

The CDC was set to announce the three-month campaign on Thursday.

One of the print ads features Shawn Wright from Washington state who had a tracheotomy after being diagnosed with head and neck cancer four years ago. The ad shows the 50-year-old shaving, his razor moving down toward a red gaping hole at the base of his neck that he uses to speak and breathe.

An advertising firm, Arnold Worldwide, found Wright and about a dozen others who developed cancer or other health problems after smoking for the ads.

Federal health agencies have gradually embraced graphic anti-smoking imagery. Last year, the Food and Drug Administration approved nine images to be displayed on cigarette packages. Among them were a man exhaling cigarette smoke through a tracheotomy hole in his throat, and a diseased mouth with what appear to be cancerous lesions.

Last month, a federal judge blocked the requirement that tobacco companies put the images on their packages, saying it was unconstitutional.

Graphic ads are meant to create an image so striking that smokers and would-be smokers will think of it whenever they have an urge to buy a pack of cigarettes, said Glenn Leshner, a University of Missouri researcher who has studied the effectiveness of anti-smoking ads.

Leshner and his colleagues found that some ads are so disturbing that people reacted by turning away from the message rather than listening. So while spots can shock viewers into paying attention, they also have to encourage people that quitting is possible, he said.

The CDC campaign includes information on a national quit line and offers advice on how to kick the habit, CDC officials said.

Wednesday, February 29, 2012

Tobacco Health Labels Unconstitutional: U.S. Judge


By Jeremy Pelofsky

United States - A U.S. judge sided with tobacco companies on Wednesday, ruling that regulations requiring large graphic health warnings on cigarette packaging and advertising violate free-speech rights under the U.S. Constitution.

Cigarette makers challenged the U.S. Food and Drug Administration's rule requiring companies to label tobacco products with images of rotting teeth, diseased lungs and other images intended to illustrate the dangers of smoking.

"The government has failed to carry both its burden of demonstrating a compelling interest and its burden of demonstrating that the rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech," U.S. District Judge Richard Leon said in the ruling.

The judge granted a preliminary injunction last year blocking the new label requirement from taking effect in 2012, a decision the Obama administration has already taken to the U.S. Court of Appeals for the District of Columbia Circuit.

The government is also likely to appeal the new ruling.

While educating the public about the dangers of smoking "might be compelling, an interest in simply advocating that the public not purchase a legal product is not," Leon wrote in a 19-page ruling.

Further, Leon noted the warning labels were too big to pass constitutional muster and that the government has numerous other tools at its disposal to deter smoking such as raising cigarette taxes or including simple factual information on the labels rather than gruesome images.

Congress passed a law in 2009 ordering the FDA to adopt the label regulation, which requires color warning labels big enough to cover the top 50 percent of a cigarette pack's front and back panels, and the top 20 percent of print advertisements.

The FDA released nine new warnings in June to go into effect in September 2012, the first change in U.S. cigarette warning labels in 25 years. Cigarette packs already carry text warnings from the U.S. Surgeon General.

Tobacco companies, including Reynolds American Inc's R.J. Reynolds unit, Lorillard Inc, Liggett Group LLC, Commonwealth Brands Inc, which is owned by Britain's Imperial Tobacco Group Plc, and Santa Fe Natural Tobacco Co Inc challenged the rule, arguing it would force them to engage in anti-smoking advocacy against their own legal products.

"Unfortunately, because Congress did not consider the First Amendment implications of this legislation, it did not concern itself with how the regulations could be narrowly tailored to avoid unintentionally compelling commercial speech," Leon wrote.

A spokesman for the Justice Department, which represented the FDA in the case, had no comment. Representatives for the tobacco companies involved in the litigation were not immediately available for comment.

Tobacco companies have said it would cost them millions of dollars to comply and also argued the graphics offer no information that could not be accomplished through messages similar to warnings already on cigarette packages and ads.

The Centers for Disease Control and Prevention estimates some 45 million adults smoke cigarettes, which are the leading cause of preventable deaths in the United States.

The ruling "ignores decades of First Amendment precedent that support the right of the government to require strong warning labels to protect the public health," Matthew Myers, president of the Campaign for Tobacco-Free Kids said in a statement.

The case is R.J. Reynolds Tobacco Co et al v. FDA, U.S. District Court for the District of Columbia, No. 11-1482.

Thursday, February 23, 2012

Qnexa Poses Heart and Birth Risks



United States - The experimental drug known as Qnexa won the approval of the U.S. Food and Drug Administration despite the side-effects which are cause for concern.

Qnexa, a combination of the appetite suppressant phentermine and the anti-seizure drug topiramate, is the first weight-loss drug to be approved by the agency in more than a decade.  The last one, Xenical, was given approval in 1999 shortly after the "fen-phen" scandal.

The health concerns with Qnexa mainly deal with the heart which is the same with "fen-phen" and Meridia, another weight-loss medication that was pulled from the shelves in 2010.

Citing obesity and its associated health risks as a reason, a panel of experts outside of the FDA voted to approve the drug. They will make their final decision on April 17th.

Patients are said to be able to lose at least ten percent of their weight using the drug, patients also complained of memory loss and higher-than-usual heart rates.  There are also worries it may increase the chances of birth defects

Wednesday, February 22, 2012

Obama Shoots for Science Increase

By Ivan Semeniuk, Meredith Wadman, Susan Young, Eric Hand, Eugenie Samuel Reich, and Richard Monastersky

From Nature Magazine

“It’s not every day you have robots running through your house,” Barack Obama quipped last week at the White House science fair, a showcase for student exhibitors that also gave the US president a chance to reiterate a favourite theme. Science and technology, he said, “is what’s going to make a difference in this country, over the long haul”.

Obama would clearly like to see many more robots, as well as researchers and engineers, running around in the future, a wish reflected in his budget request for fiscal year 2013, released on 13 February. The document’s message is one of big ambitions with fewer resources.

A year ago, Obama proposed bold increases for science agencies, but a Congress intent on curbing government spending refused to back many of them. This time, the White House has scaled back in several areas but boosted overall funding for non-defence research and development by 5%, pushing it up to US$64.9 billion.


“Overall, the budget sustains an upward trend,” says John Holdren, director of the White House Office of Science and Technology Policy in Washington DC. “Because of fiscal restraints, it’s not at the rate we preferred.”

With an election coming this November, House Republicans are unlikely to be generous with the president’s request. As in previous years, Congress could delay action on the budget, especially if it decides to wait for voters to weigh in on Obama’s presidency before making its decision. And the spectre of a severe across-the-board cut dangles over the government because of an act introduced last year that aims to chop $1.2 trillion from spending, starting in January 2013.

Here is an overview of what the president’s request would mean in key science domains (see ‘Tough decisions’).

Biomedicine and public health

The National Institutes of Health (NIH) in Bethesda, Maryland, by far the largest US research agency, sees its budget held level at $30.7 billion — a far cry from the $1-billion increase Obama proposed a year ago. Despite the ceiling, Lawrence Tabak, the NIH’s principal deputy director, sees the budget as “continuing our priorities in basic science”, and it allows the agency to boost the number of new and competing grants it funds by 8%.

The newly launched National Center for Advancing Translational Sciences (NCATS) in Bethesda will grow by 11%, to $639 million. Much of the rise goes to the Cures Acceleration Network, an effort to spur development of badly needed medicines through bold, multimillion-dollar grants. The programme’s allocation grows fivefold next year, to $50 million.

Accomplishing all this within a flat budget requires cuts. Losers include the National Children’s Study, a long-term study of early influences on the health of more than a hundred thousand children, which received $194 million in 2012, but has been cut by $29 million; and the Institutional Development Award programme, aimed at developing research infrastructure in rural and undeserved states, which loses nearly $48 million.
To pinch the pennies that will make new grants possible, the NIH plans to eliminate inflationary increases for some existing grants, cut others by 1% and keep grants seeking renewal at current levels. The agency predicts that these measures would boost the success rate for grant applications, currently at a historic low of 18%, but only to 19%.

The flat-lined budget has drawn bleak appraisals from NIH advocates. “We are talking about a budget that is probably close to 20% smaller than it was a decade ago, adjusted for inflation,” says David Moore, senior director for government relations at the Association of American Medical Colleges in Washington DC.
Jennifer Zeitzer, director of legislative relations at the Federation of American Societies for Experimental Biology in Bethesda, says that her organization will work with research champions to persuade Congress to boost the allocation for the NIH. The president’s request, she says, “is not what we need to take advantage of the scientific opportunities that are before us”.

The outlook is even less favorable for the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, which has had its budget cut by 12%, to make a total of 22% in cuts since 2010. Those cuts are, in part, counterbalanced by bringing in funds from a long-standing health-services evaluation fund and from the Prevention and Public Health Fund, which is part of the health reform law that Obama introduced in 2010.
The dependence on the Prevention and Public Health Fund worries public-health advocates. Using the fund to patch holes in the CDC’s budget is “troubling”, says Emily Holubowich, executive director of the Coalition for Health Funding, based in Washington DC. “The future of the fund is tenuous at best.”

Obama has also kept the budget mostly flat for the Food and Drug Administration (FDA) in Silver Spring, Maryland. However, the agency will receive a $583-million bolus from new industries, mainly from food-registration and inspection fees and from makers of generic drugs and biosimilars.

The FDA has already been criticized for becoming too reliant on industry funding, but Margaret Hamburg, the FDA’s commissioner, says that the fees are needed to ensure effective and timely drug and device review. “There is a common good here,” she says.

Physical sciences

The White House continues to support a long-term doubling of budgets for physical-science agencies, including the National Science Foundation (NSF) in Arlington, Virginia; the Department of Energy’s Office of Science in Washington DC; and the National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland. The doubling, relative to 2006, is a goal of the America COMPETES Act, introduced under former President George W. Bush that year, and signed into law in 2007. Congressional appropriators have, however, slowed the pace of these agencies’ growth considerably since then (see ‘A long way to go’).
The budget also shifts funding towards the applied end of the research spectrum, where advances should translate into economic gains more quickly. It continues to fund I-Corps, a programme launched last year that partners entrepreneurs with scientists seeking to test the marketability of their research. And advanced manufacturing, which supports industry by developing measurement capabilities and standards to guide new product development, gets $149 million — money that NSF director Subra Suresh says will help to stem a decline in US manufacturing. “In times of constrained budgets, we need to be crystal clear about why NSF matters,” Suresh says.

The NSF emerges as a clear winner in Obama’s request, with a 5% boost to its bottom line. And one thing is very clear at the agency: researchers pursuing interdisciplinary research will be rewarded, with $63 million allocated to a programme that supports such work.

The NIST also gets a large increase, much of which is aimed at advanced manufacturing, including both a robotics programme and a ‘materials genome’ initiative that aims to speed up the development of new materials.

The Department of Energy’s Office of Science receives a more modest rise, much of which goes to its national laboratories and Energy Innovation Hubs. Several basic-research programmes are trimmed, including nuclear physics and high-energy physics, a shift that is consistent with the administration’s emphasis on applied research that is most relevant to energy technology.

“Basic research is systematically down,” says Milind Diwan, a physicist at Brookhaven National Laboratory in Upton, New York, and co-spokesman for a planned particle physics experiment that received a drop in funding. “Those of us in fundamental-research have to live within those priorities.”

At NASA, the talk is of “tough but sustainable choices” for an agency that would receive $17.7 billion in 2013, $59 million less than in 2012. Its science budget drops by 3.2%, but planetary science bears the brunt of that, with a cut of 21%. For years, NASA has been pursuing plans with the European Space Agency for joint missions to Mars in 2016 and 2018. But on Monday, NASA administrator Charles Bolden pulled the plug. “We just cannot do another flagship right now,” he said. Officials fear that the costs for these missions would spiral out of control, as they have for the $8.8-billion James Webb Space Telescope, a follow-on to the Hubble telescope that is slated for a 2018 launch.

The pinch will perhaps be felt most keenly at the Jet Propulsion Laboratory (JPL) in Pasadena, California, the traditional home of the Mars Exploration Program. Last year, the laboratory had to lay off the equivalent of 246 full-time employees, reducing its staff to 5,047. When the $2.5-billion Mars Science Laboratory lands in August, the JPL will have to quickly find new work for a few hundred employees so the latest Mars cancellations make more lay-offs likely. “Our expectation was that we’d have another mission to move these people on to,” says Richard O’Toole, the JPL’s manager of legislative affairs. “We definitely feel the pressure.”

Energy, Earth and environment

In Obama’s plan, spending on energy efficiency and renewable energy rises by $457 million, to $2.3 billion, with the largest increases targeting advanced manufacturing, and vehicle and building technologies. These programmes, run by the Department of Energy, are aimed at bolstering the competitiveness of industry. “Our motto is ‘Invented in America, made in America, sold worldwide’,” says energy secretary Steven Chu.
Included in the package are increases for research in solar energy, bioenergy and fossil fuels, including $155 million for carbon capture and storage systems. But there are reductions and shifts as well: the budget for wind power remains unchanged but is allocated mainly to offshore technologies. Spending on nuclear energy continues an ongoing move toward small, modular reactors.

The National Oceanic and Atmospheric Administration (NOAA) in Washington DC receives a boost of 3%. That isn’t enough to offset both inflation and rising salaries, but nonetheless protects a core agency priority: a programme of polar-orbiting weather and environment satellites that has been troubled by delays and cost overruns. Last year, NOAA requested a hefty increase of $688 million to get the programme back on track, but received just under two-thirds of that. This year, the satellite programme is boosted by $169 million.

NOAA watchers looking for signs of the president’s proposed reorganization of the Department of Commerce, which would move NOAA from there to the Department of the Interior, found no trace of the plan in the 2013 budget. The budget is also silent on another big initiative, the creation of a climate service within NOAA.

In what could be a third straight year of declining budgets for the US Environmental Protection Agency (EPA) in Washington DC, the agency’s funding has been slashed by 1%, to $8.3 billion, almost $2 billion less than in 2010. Nonetheless, funding for initiatives that target climate change and the environment rises slightly, to $807 million, protecting core science and regulatory efforts. To compensate, the White House has cut $359 million from a pair of clean-water grant programmes. These programmes are popular in Congress, and law-makers have reversed similar cuts in the past.

“They did a pretty good job in making sure we are not hurting our environment and conservation programmes,” says Scott Slesinger, legislative director at the Natural Resources Defense Council in Washington DC. But Slesinger expects Congress to inflict further cuts.

With a 3% rise for its overall budget, the US Geological Survey (USGS) in Reston, Virginia, fares better than most mission-oriented science agencies. The agency’s research and development portfolio expands from $675.5 million to $726.5 million. Part of the increase includes an extra $13 million for research on the effects of hydraulic fracturing, the process used by the oil and gas industry to squeeze hydrocarbons out of non-porous rock. The president has also pumped an extra $10.3 million into natural-hazards work, including $2.4 million for research on quick responses to earthquakes, volcanic eruptions and landslides, and $1.6 million to study the risk of earthquakes in the eastern United States, which was shaken by a magnitude-5.8 tremor last August.

Daniel Sarewitz, a geoscientist and co-director of the Consortium for Science, Policy and Outcomes at Arizona State University in Tempe, supports the increase for the USGS. “The survey doesn’t get a lot of attention, but it does things that are important for the nation and it’s structured in ways that make its science very useful.”

Education

The administration has taken pains to advertise a $3-billion effort to increase and strengthen the future US science and technology workforce. For example, a combined expenditure of $135 million by the Department of Education and the NSF aims to boost the number of science and mathematics teachers by 100,000 over the coming decade. An even more ambitious effort allocates an additional $81 million to increasing the number of science graduates by one million — roughly 30% more than there are today — over the same period. According to Carl Wieman, associate director for science at the Office of Science and Technology Policy, simply reducing the attrition of science majors, which currently runs as high as 60%, could drive much of that increase.

Obama made a point of previewing both initiatives during the White House science fair, telling students there, “You give me confidence that America’s best days are still to come.” Now, as the budget goes to Congress, the battle to support lofty goals with real dollars begins a new round.

Wednesday, February 1, 2012

Feds Argue for Graphic Images on Cigarette Packs

By Nedra Pickler

Washington D.C. - The federal government fought an uphill battle Wednesday to convince a skeptical judge that tobacco companies should be required to put large graphic photos on cigarette packs to show that the habit kills smokers and their babies.

Cigarette makers told U.S. District Judge Richard Leon at a hearing that they can't be forced to spread the government's anti-smoking advocacy with "massive, shocking, gruesome warnings" on products they legally sell. Attorneys for the Obama administration countered that the photos of dead and diseased smokers it wants on all cigarette packs are "factually uncontroverted."

Leon has already ruled that the cigarette makers are likely to succeed in their lawsuit to stop the requirement, which was supposed to go into effect next year. Leon blocked the rule from taking effect until after the lawsuit is resolved.

Leon found in his earlier ruling that the nine graphic images approved by the Food and Drug Administration in June go beyond conveying the facts about the health risks of smoking or go beyond that into advocacy — a critical distinction in a case over free speech.

Leon also ruled the size of the labels suggests they are unconstitutional — the FDA requirement said the labels were to cover the entire top half of cigarette packs, front and back and include a number for a stop-smoking hotline. The labels were to constitute 20 percent of cigarette advertising, and marketers were to rotate use of the images.

The judge showed no sign that he was changing his position in favor of the government after the hour-long hearing Wednesday. "It sounds like they are headed to a place where you have to watch a 10-minute video before you can even buy a pack of cigarettes," he said.

The packaging the government wanted to require included color images of a man exhaling cigarette smoke through a tracheotomy hole in his throat; a plume of cigarette smoke enveloping an infant receiving a mother's kiss; a pair of diseased lungs next to a pair of healthy lungs; a diseased mouth afflicted with what appears to be cancerous lesions; a man breathing into an oxygen mask; a cadaver on a table with post-autopsy chest staples; a woman weeping; a premature baby in an incubator; and a man wearing a T-shirt that features a "No Smoking" symbol and the words "I Quit"

The Obama administration has appealed Leon's preliminary injunction stopping the rule from taking effect. The U.S. Court of Appeals for the District of Columbia is scheduled to hear the case April 10.

Attorney Mark Stern, representing the government, told Leon they don't expect he'll change his mind after siding so strongly with the tobacco companies in his initial ruling. But he said the government disagrees and argued the images factually show what can happen to smokers. "This will kill you," Stern said. "This will kill your baby."

Tobacco lawyer Noel Francisco said the government is free to try to tell Americans how to live their lives, but not to require cigarette manufacturers "to serve as the government's unwilling spokesman in that paternalistic endeavor."

Congress instructed the FDA to require the labels by a wide bipartisan majority, following the lead of the Canadian regulations that require similarly graphic images on cigarette packs. But Leon said Wednesday "there's just nothing — nothing — on the record" to indicate lawmakers consider the First Amendment implications of compelling commercial speech.

The cigarette makers that sued the FDA are R.J. Reynolds Tobacco Co. of Winston-Salem, N.C., Lorillard Tobacco Co. of Greensboro, N.C., Commonwealth Brands Inc. of Bowling Green, Ky., Liggett Group of Mebane, N.C., and Santa Fe Natural Tobacco Co. of Santa Fe, N.M.

Tuesday, January 31, 2012

FDA Urged to Require Sodium Reduction in Food Supply

71 Percent of Americans Believe Industry Should Lower Salt

Washington D.C. - January 30 - Voluntary efforts by industry to reduce sodium levels in the food supply have failed, according to comments filed with the Food and Drug Administration last week by the nonprofit Center for Science in the Public Interest. On Friday CSPI urged the agency to create strong, but realistic, mandatory regulations to reduce sodium levels in restaurant and packaged foods. According to a recent survey commissioned by CSPI, the public sees the need to lower sodium. 71 percent of Americans indicated that the food industry had a responsibility to reduce the sodium content of their foods, and 58 percent support a government requirement to reduce the sodium in processed and restaurant foods.

“Overconsumption of sodium is one of the single greatest causes of hypertension and cardiovascular disease, and restaurant and packaged foods—not salt shakers—are far and away the largest contributors of sodium in the American diet,” said CSPI deputy director of health promotion policy Julie Greenstein. “Unfortunately, the food industry has failed to significantly bring down sodium levels despite 40 years of governmental admonitions. It’s time for the FDA to step in and require reasonable reductions.”

The U.S. government’s 2010 Dietary Guidelines for Americans recommends that people with hypertension, those who are middle-aged or older, and African Americans should consume no more than 1,500 milligrams of sodium per day. According to the Center for Disease Control, about 70 percent of adults fall into those categories, yet current average daily consumption is actually closer to 4,000 mg. Recently, the American Public Health Association passed a resolution that calls on FDA to begin regulating sodium in the food supply within one year and to establish a timetable for gradually reducing sodium in the food supply by 75 percent over 10 years. CSPI’s filing notes that reducing sodium consumption would save billions of dollars in medical costs, and upwards of 150,000 lives annually.

Overwhelming evidence indicates that excess sodium levels pose significant health risks, but consumer education efforts are poorly funded and ineffective, according to CSPI, making efforts to reform dietary habits of Americans difficult. A recent survey indicates that 59 percent of Americans are “not concerned” about their sodium intake. As a result, an Institute of Medicine committee recommended mandatory regulations limiting sodium levels to improve public health and decrease healthcare costs.

Many frozen dinners and canned foods contain high amounts of sodium. Boston Market frozen Meatloaf with Mashed Potatoes and Gravy has 1,460 mg of sodium per serving (about one day’s worth). Marie Callender’s frozen Creamy Chicken and Shrimp Parmesan has 1,200 mg of sodium (almost a day’s worth). One of the worst restaurant offenders is Applebee’s Provolone-Stuffed Meatballs with Fettuccine, which has 3,700 mg of sodium (more than two days’ worth). Denny’s Spicy Buffalo Chicken Melt has 3,760 mg of sodium (two and a half days’ worth).

Wednesday, January 4, 2012

FDA Quietly Ends Attempt to Regulate Antibiotics in Animal Feed By Noel Brinkerhoff


The Food and Drug Administration has decided to withdraw rules limiting the use of human antibiotics in animal feed, much to the dismay of environmental and consumer groups.
 
The FDA used the holiday season to quietly make the policy change by publishing its announcement in the federal register.
 
Health advocates argue that the inclusion of antibiotics such as penicillin, cephalosporin and tetracyclines in agricultural animal feed contributes to the development of drug-resistant superbugs. The FDA itself has repeatedly agreed with this finding, having first acknowledged in 1977 that too much utilization of antibiotics in healthy livestock could prove unsafe.
 
In addition, if an animal doesn’t eat its required daily dose of food, it also doesn’t ingest its required daily dose of antibiotics, and whatever harmful bacteria are being fought are not wiped out.
 
Rather than regulate the medications, the FDA now expects the farming industry to self-regulate itself on the use of antibiotics.

Sunday, November 27, 2011

Odd Stories: Stay Septical people.


West Palm Beach – A three-person toilet paper scheme the perpetrators in jail.

Officials in Florida say the people involved in the con gained more than a million dollars from the plot. More than a dozen people were told they require special toilet paper to prevent their septic tanks from damage due to a federal regulation on toilet paper. They also sold customers what they call a “Septic Remedy treatment”, which would eliminate their customers' need to purge the tanks. Also available was special soap and detergent.

The trio, Christopher Lincoln, Mary Moore and Joseph Nouerand, plead guilty to the crime of wire fraud and say they will help authorities in obtaining information on another three people. The company under which they operated, FBK Products, presented itself as affiliated with the Environmental Protection Agency, the U.S. Food and Drug Administration and the U.S. Department of Agriculture

For the record the EPA does not regulate septic systems despite what the company claims.

They are facing more around 20 years in jail.