A White House office deleted language in a recently introduced tobacco regulation that would have removed flavored e-cigarettes from the market until they had been authorized by the Food and Drug Administration, an edited version of the document shows.
On May 5, the FDA released a final rule extending its tobacco authority to include e-cigarettes, pipe tobacco, cigars and hookah. The rule becomes effective in early August. Under the rule, companies must seek marketing authorization for any tobacco product introduced after Feb. 15, 2007.
The rule gives manufacturers a grace period of up to two years to submit marketing applications, during which they can continue to sell their products. They can sell them for an additional year while the FDA completes its review.
As submitted by the FDA to the White House Office of Management and Budget (OMB), the rule gave a grace period for flavored products of only 90 days after the rule became effective.
Public health advocates have long called for flavored tobacco products to be banned, saying flavors such as bazooka Joe Bubble Gum and Cotton Candy are designed to appeal to children.
The FDA provided pages of data and scientific studies in support of its plan, noting "a dramatic rise in youth and young adult use of typically flavored tobacco products, like e-cigarettes and waterpipe tobacco, and continued youth and young adult use of cigars."
The OMB deleted both the FDA's planned policy and the rationale for the policy.
A White House spokeswoman, Emily Cain, said the OMB "does not comment on changes made during the interagency review process." The FDA also does not comment, FDA spokesman Michael Felberbaum said.
In its originally submitted rule, the FDA said it recognized that numerous flavored products would come off the market within 180 days of the rule's publication "and that this will significantly impact the availability of flavored tobacco products at least in the short term."
But it said the move was important because tobacco products with characterizing flavors, including menthol but excluding tobacco flavor, were attractive to young people.
"FDA made an overwhelming scientific case to OMB," Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in an interview. "For reasons that are not articulated, those people substituted their own judgment."
"We are deeply troubled that these important safeguards were stripped in this way when FDA repeatedly demonstrated that...Read more..
Many smokers have symptoms of chronic obstructive pulmonary disease (COPD) even before they've been diagnosed with the lung condition, according to a new study.
Symptoms of COPD include shortness of breath, coughing, difficulty exercising and history of asthma. COPD is the third leading cause of death in the United States, researchers said. Smoking is a major cause of the disease.
"We found that a significant number of current and former smokers who don't meet the typical criteria for COPD [based on a breathing test] otherwise look and behave like patients who do carry a diagnosis of COPD," said study co-lead author Dr. Meilan Han, medical director of the University of Michigan Women's Respiratory Health Program.
The study included more than 2,700 people. It included current or former smokers and people who never smoked.
"We found significant respiratory symptoms in half of the current or former smokers with technically 'normal' breathing tests. We also found that these individuals needed to seek medical attention for breathing flare-ups with similar frequency as some patients who actually meet criteria for a diagnosis of COPD," Han said in a university news release.
But Han noted that it isn't clear if all of these people will eventually be diagnosed with COPD. More study is needed, she said.
"Given how common smoking is, everyone likely knows someone who suffers the condition we describe here. As these patients may require medical treatment and in some cases even hospitalization, the impact of this condition is very real. This study is just the first step in trying to better identify these patients so we can develop targeted treatments," Han said.
The study was published recently in the New England Journal of Medicine.
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A new study by a New Zealand doctor is the first to show that vitamin D supplements may prevent allergies and asthma development in babies and young children.
The study, composed by Associate Professor Cameron Grant, notes that there is a vitamin D deficiency in 57 per cent of New Zealand newborns - a statistic which may spawn from "a sun-avoidance public health policy".
Dr. Grant says the high level of prevalence of both asthma and allergies in children could also be sourced to our diets which feature low amounts of the vitamin and supplements containing it aren't often used.
"It's the first study to show that correcting poor vitamin D status during pregnancy and infancy might prevent childhood asthma," he said.
"In our clinical trial of vitamin D supplementation during pregnancy and infancy, we showed that when these supplements were started in the mum at 27 weeks’ gestation and then continued in her child until the child was six months old, they prevented sensitization of the child to house dust mites."
The Associate Professor from the University of Auckland says the implications of the findings could be life-changing.
"Early life events, including those before birth, can influence a baby's later sensitivity to allergens."
"In theory maintaining normal vitamin D status when that sensitivity is developing late in pregnancy and early in infancy, could prevent later allergy sensitivity in the child."Read more..
Big news unfolded yesterday, May 05, 2016! Electronic cigarettes will now be regulated much like tobacco cigarettes and their sale to children banned, according to a new federal rule issued.
Under the rule, the U.S. Food and Drug Administration would have to approve all tobacco products not currently regulated that hit stores after February 2007. The e-cigarette industry was virtually non-existent before then.
Premium, hand-rolled cigars, as well as hookah and pipe tobacco, are also included in the new regulation, which federal officials call "historic." The rule prohibits selling "covered tobacco products" to people younger than 18, and buyers must show photo ID. It also requires health warnings be displayed on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements; and bans free samples and the sale of covered products in vending machines not located in adult-only facilities.
The Tobacco Control Act of 2009 sets Feb. 15, 2007, as the latest date by which all tobacco products would have to have to be grandfathered in. Mitch Zeller, head of the FDA's Center for Tobacco Products, has said publicly that he couldn't choose a later date, although industry officials disagree.
That means nearly every e-cigarette on the market — and every different flavor and nicotine level — would require a separate application for federal approval. Each application could cost $1 million or more, says Jeff Stier, an e-cigarette advocate with the National Center for Public Policy Research and industry officials.
An amendment to appropriations legislation working its way through the House would change the date so more e-cigarettes would be grandfathered in. White House Press Secretary Josh Earnest said Thursday that President Obama "takes a very dim view of attaching ideological riders to appropriations bills," but stopped short of threatening a veto of any legislation.
The proposed rule was released more than two years ago, in April 2014, and the final rule gives the industry two additional years to comply. The industry will have had "plenty of time to submit their applications," says Robin Koval, CEO of the Truth Initiative, an anti-tobacco health group.
However, stores have to comply with the rule in about three months (90 days from its publication May 10), and Zeller says contractors tasked with enforcement will be ready to "hit the ground running" on Day 91.
Koval says "it's perfectly reasonable"...
Diminished lung capacity and development of persistent wheeze in children were associated with prenatal but not postnatal exposure to bisphenol A, according to recent study data.
Adam Spanier, MD, PhD, MPH, FAAP, associate professor of pediatrics and behavioral pediatrics medical director, University of Maryland Midtown Campus, and colleagues studied 398 pregnant women between March 2003 and January 2006 in the Cincinnati area who were aged 18 years or older, were at 16 weeks’ gestation and lived in a home built before 1979. The women were tracked through pregnancy, and children were tracked through age 5 years. Gestational and child bisphenol A (BPA) exposure were assessed through maternal urine samples during pregnancy at 16 and 26 weeks and child urine samples annually.
Main outcomes included parent-reported wheeze every 6 months for 5 years, and child FEV1 measured at ages 4 and 5 years. Associations of BPA exposure with respiratory outcomes (FEV1, child wheeze and wheeze phenotype) were studied.
Data for maternal urinary BPA concentrations and FEV1, assessed for 208 children, showed a mean range of 0.53 to 293.55 mcg/g creatinine (geometric mean, 2.4; 95% CI, 2.1-2.7 mcg/g creatinine). Urinary BPA concentrations and parent-reported wheeze results, available for 360 children, ranged from 15.9% (at 30 months) to 24.1% (at 12 months).
“In multivariable analysis, every 10-fold increase in the mean maternal urinary BPA concentration was associated with a 14.2% (95% CI, –24.5% to –3.9%) decrease in the percentage of predicted FEV1 at 4 years, but no association was found at 5 years,” the researchers wrote. “Every 10-fold increase in the mean maternal urinary BPA concentration was marginally associated with a 54.8% increase in the odds of wheezing (adjusted OR=1.55; 95% CI, 0.91-2.63).”
There was a 10-fold increase in 16-week maternal urinary BPA concentration associated with an increase in persistent wheeze odds (aOR=4.27; 95% CI, 1.37-13.3). No association, however, existed between the mean maternal urinary BPA concentration and wheeze phenotype.
There were no associations between child urinary PBA concentrations and FEV1 or wheeze.
“If future studies confirm that prenatal PBA exposure may be a risk factor for impaired respiratory health, it may offer another avenue to prevent development of asthma,” the researchers concluded.
Independent associations were found between asthma and polycystic ovary syndrome as well as overweight and obesity, according to results presented here.
“The results of this study need to be confirmed with results in other populations, and exploration of these relationships in longitudinal studies is needed,” Anju Elizabeth Joham, MBBS, FRACP, an endocrinologist and postdoctoral research fellow at Monash University in Melbourne, said in a press release.
Joham and colleagues evaluated data from the Australian Longitudinal Study on Women’s Health on the survey responses of 9,145 women aged 28 to 33 years about their PCOS and asthma status. Researchers sought to determine the prevalence of asthma and the impact of obesity on the prevalence of asthma in women with and without PCOS.
Prevalence of PCOS was 5.8%. There was a 15.2% prevalence of asthma in women with reporting PCOS compared with 10.6% of those not reporting PCOS (P = .004).
Mean BMI was significantly higher in women reporting PCOS and asthma (BMI, 29.9 kg/m2) compared with women reporting asthma but not PCOS (27.7 kg/m2; P < .001).
PCOS was associated with increased odds of asthma (OR = 1.34; 95% CI, 1.004) after adjustment for age, BMI, PCOS and smoking status on multivariable regression analysis. Increased odds of asthma were linked with BMI in the overweight (OR = 1.24; 95% CI, 1.02-1.5) and obese range (OR = 1.77; 95% CI, 1.46-2.15).
“A greater proportion of women with PCOS report asthma, and the results of this study suggest that asthma is associated with PCOS and excess weight,” Joham said in a press release. “These findings highlight that PCOS is a complex disorder that includes significant inflammatory underpinnings. These results also raise awareness of the need to consider higher risks in other health areas in this condition.” – by Amber Cox
Joham AE, et al. Poster SAT 186. Presented...
Excessive iron build-up in the lungs could be a major cause of chronic obstructive pulmonary disease (COPD), Weill Cornell Medicine scientists find in a new study. The investigators also believe that they have identified the culprit for the excess: A gene they previously found to increase patients' susceptibility to the progressive lung disease.
For their study, published online on Jan. 11 in Nature Medicine, researchers examined a gene that is tasked with regulating iron uptake in cells, called iron-responsive element-binding protein 2 (IRP2). They discovered that mice that express IRP2 developed the hallmark symptoms of COPD — a condition defined by obstruction to expiratory airflows that makes breathing difficult — when exposed to cigarette smoke, while rodents that lacked the gene remained healthy. A drug given to the symptomatic mice prevented additional lung damage and even reversed COPD's effects.
The investigators say their discovery is significant because they validate the results of a 2009 study that implicated IRP2 in the disease's development and demonstrate how the gene supports COPD. The findings also illustrate that IRP2 may be a powerful therapeutic target.
"At the end of the day, we always like to have an impact on human disease, whether it's improving diagnostics, prevention or therapeutics, and this study actually gets to the therapeutic angle," said senior author Dr. Augustine Choi, the Weill Chairman of the Weill Department of Medicine at Weill Cornell Medicine. "Not only does it validate our previous work, but it also provides us with a really good understanding of how IRP2 functions and facilitates the development of COPD."
COPD, which includes smoking-induced emphysema, chronic bronchitis and non-reversible asthma, is the third-leading cause of death in the United States, affecting more than 20 million people nationwide. It's commonly associated with smoking cigarettes and long-term exposure to air pollution, second-hand smoke, dust fumes and chemicals. But investigators have long wondered if there is a genetic predisposition to the disease.
In 2009, Dr. Choi and colleagues published a study in the American Journal of Human Genetics that analyzed the genes of patients with COPD and their family members to determine if there was a common genetic link. IRP2 was one of the top hits.
To validate that finding and determine the gene's functional role, the researchers exposed two sets of mice to cigarette smoke...Read more..
In analyzing 51 different flavored e-cigarettes, author of the study Joseph Allen and his team found at least one of three top toxins — diacetyl, acetoin and 2,3-pentanedione — in 47 of the e-cigs. Not only that, "the amount of diacetyl in 39 of the e-cigs exceeded the amount that was able to be detected by the laboratory."
"Diacetyl and other related flavoring chemicals are used in many other flavors beyond butter-flavored popcorn, including fruit flavors, alcohol flavors, and candy flavored e-cigarettes," said Allen, assistant professor of exposure assessment science at Harvard.
He found this particularly disturbing because of the appeal fruity e-cigarettes such as "Cotton Candy, Fruit Squirts, and Cupcake" may have to young people.
Since e-cigarettes are a fairly new technology, the study's co-author David Christiani, Elkan Blout Professor of Environmental Genetics, warns that Popcorn Lung may be just the tip of the iceberg when it comes to the dangers e-cigs pose to their users:
“Since most of the health concerns about e-cigarettes have focused on nicotine, there is still much we do not know about e-cigarettes. In addition to containing varying levels of the addictive substance nicotine, they also contain other cancer-causing chemicals, such as formaldehyde, and as our study shows, flavoring chemicals that can cause lung damage.”
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