Monday, December 20, 2010

Fed Delays on Alcohol Labeling Stymieing National Policies on Alcohol and Obesity

/PRNewswire/ -- The National Consumers League (NCL) has once again called on the Alcohol and Tobacco Tax and Trade Bureau (TTB) to issue a final rule to improve alcohol beverage labeling.

"The drinking public needs certain basic information on beer, wine, and spirits labels," said NCL Executive Director Sally Greenberg. "With a severe nationwide obesity epidemic, there is no excuse for not having calories listed on all alcohol beverage labels. Consumers also need clear information about alcohol content in order to drink responsibly."

Seven years ago, the National Consumers League petitioned TTB to require an "Alcohol Facts" panel on labels of beer, wine, and distilled spirits. More than 3 years ago, TTB proposed a watered-down version of "Alcohol Facts," which it called "Serving Facts," but has still not issued a final rule.

"The Alcohol Facts panel was intended to provide all the information consumers need in one location, clearly and concisely," said Greenberg. "It would be like the Nutrition Facts panel on food labels, except that it would provide the information relevant to alcoholic beverages." NCL asked that the "Alcohol Facts" panel include serving size, the number of calories per serving, alcohol content information (including the amount of alcohol per serving, the definition of a "standard drink," and the number of standard drinks per container), and ingredient information.

"The nine college students who went to an emergency room for alcohol poisoning after drinking too much of a caffeinated alcoholic beverage earlier this year may not have realized just how much alcohol they were consuming," added Greenberg. "Maybe if the standard drinks per container had been required to appear on the labels, they wouldn't have made that mistake."

TTB's inaction on Alcohol Facts labeling is also interfering with other important public health objectives. A new law requires nutrition labeling of foods and beverages served in chain restaurants and bars, including alcoholic beverages, but there is no approved method for measuring certain nutrients in alcohol and TTB has provided the industry with no guidance. If the Alcohol Facts panel were required, restaurants and bars could simply use the information on the product label.

The lack of calorie and alcohol information on beer, wine, and spirits labels is also an obstacle to application of the Dietary Guidelines for Americans. The Departments of Agriculture and Health and Human Services will soon issue the 2010 Dietary Guidelines, but, without calorie and alcohol information on product labels, consumers still will not be able to follow its recommendations on weight control and alcohol consumption.

"Label reform for alcoholic beverages is a no brainer," according to Greenberg. "What is TTB waiting for?"

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Wednesday, December 15, 2010

FDA says Tessalon liquid cough capsules pose risk for young children

The U.S. Food and Drug Administration is warning that accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death.

Tessalon, approved by the FDA to treat symptomatic relief of cough in patients older than 10, may attract younger children because of the drug’s candy-like appearance – a round, liquid-filled gelatin capsule. The safety and effectiveness of benzonatate in children younger than 10 years has not been established.

“Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, R.Ph., director of FDA’s Division of Medication Error Prevention and Analysis. “The FDA encourages health care professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose.”

A review of the FDA’s Adverse Event Reporting System database from 1982 through May 2010 identified seven cases of accidental ingestion associated with benzonatate in children younger than 10. Five of the cases resulted in death in children ages 2 years and younger. Overdose with benzonatate in children younger than 2 years has been reported following accidental ingestion of only one or two benzonatate capsules.

Common adverse events reported in the overdose cases included cardiac arrest, coma, and convulsion. Signs and symptoms of overdose can occur within 15-20 minutes of ingestion. Some of the deaths reported in children have been within hours of the accidental ingestion.

The FDA is also adding a new Warning and Precaution section to the benzonatate drug label to warn health care professionals about accidental ingestion resulting in overdose and death in children younger than 10.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of benzonatate to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

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Thursday, December 09, 2010

Surgeon General's Report Dramatically Demonstrates Immediate Harm From Smoking and Secondhand Smoke

/PRNewswire-/ -- The following is a statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids:

The U.S. Surgeon General's report released today provides dramatic new evidence that smoking and exposure to secondhand smoke cause immediate harm to the human body, triggering physical changes that lead to cancer, heart attacks, lung disease and many other serious illnesses, including damage to the reproductive systems of both men and women.

The report also concludes that design changes to cigarettes, such as filter ventilation, flavoring agents and added chemical ingredients, have over time made them more addictive. Today's cigarettes deliver nicotine more efficiently to the brain, addicting kids more quickly and making it harder for smokers to quit. The tobacco industry's decades-long effort to finely engineer cigarettes, along with its use of deceptive (and now-banned) cigarette descriptions such as "light" and "low-tar," have undermined smoking prevention and cessation efforts, the report says.

Nearly 50 years after the first Surgeon General's report on tobacco was released in 1964, this latest report is a stark reminder of how lethal and addictive smoking truly is, with every cigarette doing you damage. It sends an unmistakable message to elected officials at all levels that reducing smoking is one of the most effective actions we can take to improve the nation's health and prevent some of the most deadly and costly diseases in our society.

The report also sends important messages to America's kids and smokers. If you do not smoke, don't start. If you do smoke, try to quit immediately and get the help you need to succeed. This is true not only for regular smokers, but also for the 22 percent of smokers who do not smoke every day and to those who consider themselves only "social" smokers and may think they are not at risk. This report's message is clear: You are at risk. There is no risk-free level of exposure to tobacco smoke, and you don't have to be a heavy or long-time smoker to develop a smoking-related disease.

The report underscores the importance of actions that we know work to prevent kids from starting to smoke, help smokers quit and protect everyone's right to breathe clean air, free of the hundreds of toxic chemicals in secondhand smoke. Despite progress in making workplaces and public spaces smoke-free, four in ten non-smokers – and more than half of children between 3 and 11 – are still exposed to secondhand smoke, according to the Centers for Disease Control and Prevention. No one should have to breathe secondhand smoke at work or in public places, and parents should ensure that homes, cars and other places frequented by children are smoke-free.

Federal, state and local policymakers must redouble their efforts to implement proven measures that reduce tobacco use and exposure to secondhand smoke.

The federal government must fund and aggressively implement the new tobacco prevention plan that Health and Human Services Secretary Kathleen Sebelius announced last month. The plan includes a national media campaign to prevent kids from smoking and encourage smokers to quit; expanded assistance and health insurance coverage for smokers trying to quit; effective regulation of tobacco products and marketing; and accelerated research to enhance strategies to reduce tobacco use.

The Food and Drug Administration must continue to vigorously exercise its new authority to regulate the manufacture, marketing and sale of tobacco products to keep these harmful products away from our children and reduce their devastating effects on public health.

The states must step up their efforts to reduce tobacco use by increasing tobacco taxes, enacting smoke-free workplace laws and fully funding tobacco prevention and cessation programs at levels recommended by the CDC. Unfortunately, states have slashed funding for tobacco prevention programs by 28 percent in the past three years and now fund such programs at the lowest level since 1999, when they first received funds from the settlement of state lawsuits against the tobacco industry. The states this year (Fiscal Year 2011) will collect $25.3 billion in revenue from the tobacco settlement and tobacco taxes, but will spend only two percent of it — $517.9 million — on programs to prevent kids from smoking and help smokers quit.

The Surgeon General's report details the serious health effects of even brief exposure to tobacco smoke. It concludes that:

* Tobacco smoke contains more than 7,000 chemicals and compounds, including hundreds that are toxic and at least 70 that cause cancer.
* Every exposure to the cancer-causing chemicals in tobacco smoke can damage DNA in a way that leads to cancer.
* Exposure to secondhand smoke has an immediate adverse impact on the cardiovascular system, damaging blood vessels, making blood more likely to clot and increasing risks for heart attack and stroke.
* Smoking makes it harder for women to get pregnant and can cause miscarriage, premature birth and low birth weight. It also harms male fertility.


The Surgeon General's report provides the grim details of how tobacco use kills more than 400,000 Americans each year and costs almost $100 billion in health care expenditures. It underscores the need for political will and urgent action to win the fight against tobacco.

The report, titled "How Tobacco Smoke Causes Disease," can be found at: www.surgeongeneral.gov.

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