By Brady Dennis,
The Food and Drug Administration said Thursday that it intends for the first time regulate the booming market of electronic cigarettes, as well as an array of other products such as cigars, pipe tobacco and hookahs.

The move would begin to place restrictions on e-cigarettes, a nearly $2 billion industry that for years has operated outside the reach of federal regulators. If adopted, the government’s plan would force manufacturers to curb sales to minors, stop handing out free samples, place health warning labels on their products and disclose the ingredients. Makers of e-cigarettes also would be banned from making health-related claims without scientific evidence

The FDA’s proposal stops short of broader restrictions sought by many­ ­tobacco-control advocates. Regulators at this point are not seeking to halt online sales of e-cigarettes, curb television advertising, or ban the use of flavorings such as watermelon, grape soda and piña colada — all tactics that critics say are aimed at attracting young smokers and that have been banned for traditional cigarettes.

Those restrictions might come eventually, FDA officials said, but not before more rigorous research can establish a scientificbasis for tougher rules.

“Right now, for something like e-cigarettes, there are far more questions than answers,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

He said Thursday’s action is about expanding FDA’s authority to products that have been “rapidly evolving with no regulation whatsoever,” in order to create a foundation for broader regulation in the future, adding, “It creates the framework. We’re calling this the first step. . . . For the first time, there will be a science-based, independent regulatory agency playing a vital gate-keeping function.”

E-cigarettes vary from brand to brand, but they generally resemble the size and shape of traditional cigarettes. Instead of burning tobacco, the battery-powered devices heat up flavored, nicotine-laced liquid, turning it into a vapor that the user inhales, or “vapes.” Supporters say that makes e-cigarettes an attractive alternative to their ­cancer-causing tobacco counterparts.

Congress passed a law in 2009 giving the FDA broad power to regulate cigarettes, including requirements for new warning labels, restrictions on ads and explicit approval of new products. The law also gave the FDA the authority to broaden its jurisdiction over other tobacco-related products. While the agency has indicated for years that it planned to do just that, action has been slow in coming.

Reactions to Thursday’s announcement from the e-cigarette industry, public health officials and consumer advocates was swift — and mixed.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the FDA’s action an important step but said that it is “inexcusable” that the agency had taken so long to act. “In the absence of any meaningful regulation, the e-cigarette manufacturers have acted as if it’s the wild, wild West, with no rules and no restraints,” Myers said. “Their advertising is exactly the same type of advertising that made cigarettes so appealing to young people” decades ago.

He said FDA needs to move quickly to finalize Thursday’s proposal and conduct the scientific research it will need to put more stringent rules in place down the road on marketing practices and flavors.

“They can’t move forward at the same pace that they have been moving and do their job protecting public health,” Myers said. “We can’t waste another five years; this cannot take that long. There is a moral and public health imperative for them to treat this with the urgency it deserves.”

Still, whatever changes are coming won’t happen overnight. The public will have 75 days to comment on the proposal. After the FDA sorts through a likely tidal wave of responses and finalizes its regulations, companies will have to begin complying almost immediately with the proposed age and identification restrictions. But they will have two years to submit applications to the FDA to approve their products, which can remain on the market in the meantime.

The FDA’s effort to begin overseeing the sprawling e-cigarette market comes at a critical time. Sales have doubled year after year, with no signs of slowing, according to some industry analysts. That pales in comparison with the estimated $80 billion-a-year U.S. market for conventional tobacco products, but the gap is shrinking steadily. In addition, tobacco giants such as Lorillard, Reynolds and Altria have entered the ­e-cigarette market in recent years, joining hundreds of smaller manufacturers.

Some industry advocates worried Thursday that federal regulation will benefit only a handful of those large companies, who have established distribution channels and the money and manpower needed to file the streams of paperwork that will now be required to seek FDA approval of all e-cigarette products.

“This is worse than I expected,” said Greg Conley, a board member of the American Vaping Association, who said he welcomed the age-restriction rules but had hoped the FDA would grandfather in existing products, rather than force e-cigarette makers to file lengthy applications for any product on the market dating to early 2007. “A lot of these companies, they are supporting several employees, investing any profits back into their buisness … They can’t afford this, and it’s going to lead to a whole lot of consolidation and increased prices for consumers.”

Not everyone in the e-cigarette industry bristled at Thursday’s proposal. Indeed, some of the larger players in the e-cigarette market praised FDA for committing to a science-based regulatory process, which they hope will allow them to make a strong case that e-cigarettes have the potential to reduce tobacco-related harm and be an overall positive for public health.

“What they did today was very encouraging … We’ve already done many things to prepare ourselves and act responsibly,” said Miguel Martin, president of Logic Technology Development o

Mesker Park Zoo & Botanic Garden invites you to celebrate our natural world during Party for the Planet on Saturday, April 26, 2014.
Activities for the day include live music, animal encounters, zookeeper chats, rain barrel auction and more.

Mayor Lloyd Winnecke will attend the party to view all of the completed rain barrels from various community groups.
The mayor will address the crowd at 2:00 pm in the Events Plaza.

The zoo is participating in Party for the Planet along with other AZA accredited organizations from around the world to encourage people to spend more time in the nature and to incorporate conservation practices into their homes.
Attendees can expect family-friendly events and practical tips on conservation from the many vendors participating in the party.

Regular admission rates apply. Zoo members are free. For a complete schedule of Party for the Planet activities, click on the attached or visit www.meskerparkzoo.com

Indiana remains committed to providing the best education possible for Hoosier students. As the Director of Early College High School, I know that a high quality education leads to greater future success and is something we should continually deliver to Hoosier students. This past session, I am pleased that we made great progress to improve the quality of education in our state.

Right now, there is a one-size-fits-all approach to the Core 40 diploma. I authored House Enrolled Act (HEA) 1213 , which calls for a committee to study the diplomas Indiana currently offers, make recommendations on whether those need to be updated and decide if there is a need for a Career and Technical Education diploma. Science, technology, engineering and mathematics (STEM) courses offer training into high wage, high demand fields in Indiana. I want to promote these courses so more Hoosiers can find rewarding employment opportunities.

Another law we passed, HEA 1388 , provides a useful diagnostic to help schools excel and improve. This legislation makes changes to the information a teacher preparation program must submit annually to the Department of Education and requires both school corporations and charter schools to report each teacher in the program who earned an initial license as well as the annual retention rate for certificated employees. I supported this legislation which will increase the analysis of teacher preparation programs in order to improve them.

We also provided more opportunities to help adults acquire a high school diploma. On average, adults with high school diplomas make more than $8,000 a year than adults who do not have their diplomas. HEA 1028 allows for more charter adult high schools to provide a high school education to better serve at-risk populations within our community.

Through Senate Enrolled Act 85 , we were able to provide additional resources for training School Resource Officers (SROs). This law will require that a SRO be employed by a law enforcement agency and authorizes the Indiana Law Enforcement Training Boards to approve training programs. I was pleased to support this new law as it brings clarity and additional guidance to the school safety legislation passed in 2013. The safety and well-being of Hoosier students is always a top priority for me.

Providing the highest quality education is the key to future success and will help Hoosiers better compete in today’s globally dynamic marketplace. I applaud all of the schools in our area that received a four star designation: Farmersville Elementary, Marrs Elementary, North Posey Jr. High, South Terrace Elementary, Corpus Christi, Mater Dei High School, Resurrection and St. Wendel.

All of these schools are leading the charge for a better education system in Indiana and are a testament to what happens when parents, students, teachers, administrators and faculty are all working together. I am proud of the strides we made this session, and by working alongside our top-notch educators and dedicated students, Indiana is on track to having the best education system in the country.

More than half of parents said the drugs are helpful

By Serena Gordon
HealthDay Reporter

More than 7 percent of American schoolchildren are taking at least one medication for emotional or behavioral difficulties, a new government report shows. Apparently, the medications are working: More than half of the parents said the drugs are helping their children, according to the report. “We can’t advise parents on what they should do, but I think it’s positive that over half of parents reported that medications helped ‘a lot,’ ” said report author LaJeana Howie, a statistical research scientist at the U.S. National Center for Health Statistics. Howie and her colleagues weren’t able to identify the specific disorders the children were being treated for, although she said 81 percent of the children with emotional or behavioral difficulties had been diagnosed with attention-deficit/hyperactivity disorder (ADHD) at some point in their lives. The researchers were also unable to identify the specific medications prescribed to the children for their emotional and behavioral difficulties, according to Howie. An expert not involved with the report agreed that ADHD likely would be one of the most common conditions involved. “Although the authors don’t really talk about the diagnoses, ADHD is likely the most overwhelming diagnosis. Oppositional defiant disorder, anxiety and depression are other likely diagnoses,” said Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at Steven and Alexandra Cohen Children’s Medical Center of New York, in New Hyde Park. Data for the study came from the National Health Interview Survey, which continually collects information about health and health care in the United States. All of the information on children is obtained through parental (or other guardian) responses. None of the information comes from medical records. Overall, the researchers found that 7.5 percent of U.S. children between the ages of 6 and 17 were taking medication for an emotional or behavioral problem. Significantly more boys than girls were given medication — 9.7 percent of boys compared with 5.2 percent of girls. Older females were more likely than younger females to be given medication, but the age difference among males wasn’t significant, according to the report. White children were the most likely to be on psychiatric medications (9.2 percent), followed by black children (7.4 percent) and Hispanic children (4.5 percent), according to the report. The study found that significantly more children on Medicaid or the Children’s Health Insurance Program were on medication for emotional and behavioral problems (9.9 percent), versus 6.7 percent with private insurance and just 2.7 percent of children without insurance. Additionally, more families living below 100 percent of the federal poverty level had children taking medications for emotional and behavioral problems than those above the federal poverty level. Fifty-five percent of parents reported that these medications helped their children “a lot,” while another 26 percent said they helped “some.” Just under 19 percent said they didn’t help at all or helped just a little. Parents of younger children (between 6 and 11) were slightly more likely to feel the medications helped a lot compared to parents of older children. Parents of males were also more likely to feel the medications helped a lot — about 58 percent of parents of males reported that they helped a lot compared to about 50 percent of the parents of females. The report found that parents with incomes less than 100 percent of the federal poverty level were the least likely to feel the medications helped a lot. Just 43 percent of those parents said the medications helped a lot, while about 31 percent said they helped some. More than one-quarter of these parents said the medications only helped a little or not at all. Of those findings, Howie said, “We really can’t speculate what factors would account for the difference.” For his part, Adesman said there are many factors that might contribute to more use of medications in people living under the poverty line and for those on government insurance programs. “There may be parenting challenges, such as more single-parent households, medications may be more available than access to behavioral treatments, there may be more logistical issues with nonpharmaceutical interventions, like getting time off from work,” Adesman said. “Many more families have access to prescription medications than to non-pharmaceutical interventions. There’s a lack of mental health treatment parity. “It’s encouraging that children who are identified as taking prescription medications are benefiting from those medications,” Adesman said. However, he added, “There are nonpharmaceutical treatments for virtually all psychiatric diagnoses in children. For households where a child has significant emotional or behavioral difficulties, counseling, behavior management and some forms of psychotherapy can be helpful as well.” More information Learn more about medications for childhood emotional and behavioral problems from the American Academy of Child and Adolescent Psychiatry.