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FDA approves first new tobacco products under ‘substantial equivalence’ rules

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration is allowing the marketing of two new cigarette brands under regulations that allow tobacco companies to market new products if they can prove they are similar enough to products already on the market.

The FDA announced Tuesday that it had authorized Newport Non-Menthol Gold Box and Newport Non-Menthol Gold Box 100s, made by Lorillard Tobacco Co., calling them the first products authorized under "substantial equivalence" rules since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the power to regulate tobacco products. Four other products were denied marketing authorization.

"Today’s historic announcement marks an important step toward the FDA’s goal of reducing preventable disease and death caused by tobacco," FDA commissioner Margaret Hamburg said. "The FDA has unprecedented responsibility to protect public health by not allowing new tobacco products under FDA’s authority to come to market without FDA review."

Under the rules, a new tobacco product can be approved if it has different characteristics from a preexisting product, as long as it does not raise new public health issues. Any product that does raise different questions of public health will be declared not substantially equivalent, and thus not approved. The FDA said its decision not to approve the other four products was because of lack of information about their design and lack of evidence showing that adding new ingredients didn’t raise different questions about public health. 

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Safeway 1-of-15 employers receiving the 2013 Secretary of Defense Employer Support Freedom Award

BY Michael Johnsen

PLEASANTON, Calif. — Safeway was selected to receive the 2013 Secretary of Defense Employer Support Freedom Award, the nation’s highest honor given to employers for exceptional support of National Guard and Reserve employees. Employer Support of the Guard and Reserve, an office of the Department of Defense, announced the award recipients on Tuesday.

Safeway is one of six large companies and the only retailer to be honored with the prestigious Freedom Award. Nine other award recipients are small- to mid-sized businesses or public-sector employers. The recipients, who were chosen from a pool of nearly 3,000 nominated private and public sector employers, were selected for their demonstrated programs, policies and achievements in support and hiring members of the National Guard and Reserve.

"I commend and thank the 15 recipients of the 2013 Secretary of Defense Employer Support Freedom Award for providing exceptional support to our Citizen Warriors," stated Defense Secretary Chuck Hagel. "So many of our nation’s employers are finding ways to contribute to our nation’s security, but these employers stand out for their commitment to our Guardsmen and Reservists. They have the gratitude and thanks of the entire Department of Defense."

"Providing employment opportunities and training to our men and women in uniform and veterans are among the most important public services we perform," stated Safeway’s president and CEO, Robert Edwards. "We are honored to be among a select group of private and public sector organizations who can now call themselves Freedom Award recipients."

Safeway was among the first employers to commit more than 10 years ago to cover the pay differential and extend full benefits to employees in the Reserve and National Guard called to active duty. In 2012, Safeway hired nearly 1,500 veterans, with more than 1,300 of them hired into the company’s retail stores. Safeway also has committed to hiring at least another 1,500 veterans by the end of 2013.  

"We saw an opportunity to recruit new kinds of leaders who will become an important and critical part of our future," stated Larree Renda, Safeway EVP. "Our JMO and NCO recruiting program officially launched in 2010. We accept applicants who have been officers or non-\commissioned officers in the military and place them in an accelerated leadership program."

The 2013 Freedom Award recipients will be honored at the 18th annual Secretary of Defense Employer Support Freedom Award ceremony in Washington Sept. 26.

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Feosol: 23% of women experience unexplained fatigue

BY Michael Johnsen

MARIETTA, Ga. — A recent survey of U.S. women conducted by Harris Interactive for Feosol Iron Supplements found that over the past 12 months, nearly a quarter of women in the United States experienced unexplained fatigue, and many of those have indicated that it negatively affected their lives in a variety of ways. 

What’s more, as many as 69% of these women have not spoken to a doctor about their fatigue.  

"In most cases, unusual and prolonged fatigue in women can be attributed to an illness, pregnancy, excessive exercise or menstruation," stated Erin Palinski-Wade, a registered dietitian. "However, if one experiences fatigue but does not have any of these conditions, it might be a symptom of an underlying condition, such as iron-related anemia. In these cases, which must be identified through a blood work-up, I typically recommend iron supplementation, as well as some dietary changes."

According to the survey, nearly 6-out-of-10 women reported they are less motivated to be physically active. Almost half (47%) believed they had gained weight. 

"Unexplained fatigue that impacts your life should never be self-diagnosed," Palinski-Wade said. "Don’t be afraid to find out what’s causing it. The fix might be as easy as taking a daily supplement or making changes to your diet, so women should not be afraid to investigate what is causing their fatigue."

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