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Diacetyl – Concern Now for What Kids May Buy… Fake Cigarrettes”!

This article, discusses, in part, some of the issues associated with e-cigs (“fake cigarettes”) in terms of Diacetyl / Flavorings. Some specific partions below are relevant on the topic of having diacetyl (or other flavorings) in “fake cigarettes”.

E-Cigs: Popular With Kids, but What’s in Them? (AOL News)

(Sept. 16) — Two eighth-grade girls carrying their pink cell phones and a tan envelope with cash stopped at a stand in a far corner of the sprawling Union Station in Washington, D.C.

The one-table kiosk offered individual electronic cigarettes for $20 and “complete starter packs” with multiple flavors for $140. The girls, who had ridden Amtrak from Philadelphia, bought an assortment for themselves and some friends.

“They’re very grown-up, you know,” one girl said.

There is a nationwide prohibition on selling tobacco products to anyone under 18, but AOL News was unable to find any federal laws that ban the sale of these nicotine-dispersing faux cigarettes to children, despite growing concerns about the safety of the products byhealth experts and the public.

A woman sells a variety of electronic smoking devices at a kiosk in Union Station in Washington, D.C. She offered a rechargeable electronic cigar for $250; a $20 disposable, advertised to last as long as 20 actual cigarettes; or the standard package of multiple batteries, cartridges, atomizers, a charging unit, and nicotine and assorted flavor liquids, for $140.

Only a handful of states, like New Hampshire, Arizona, Oregon, Minnesota and New Jersey, restrict the sale by age. Others are considering restrictions or outright bans. The devices are being advertised and sold to kids and grown-ups throughout the country, yet little is known about what the estimated million or more people using them are sucking into their lungs. “The sale of these electronic devices is absolutely a health issue, especially to children,” Marie Cocco, a spokeswoman for the Campaign for Tobacco-Free Kids, told AOL News this week.

Her fear is that these devices have been and are being sold in hundreds of malls across the U.S. Estimates from the e-cigarettes industry say the number of outlets is probably higher than 500 and growing rapidly.

With e-cigs flavors like bubblegum, buttered popcorn, fudge and cookie dough, and the fact that there is apparently no age restriction on their sale to minors, the devices are becoming enormously popular among teens and even those younger, says the Campaign for Tobacco-Free Kids and other health advocacy groups.

See chart above showing public support for electronic cigarette laws.

The Food and Drug Administration did go after five e-cigarette companies last week for, among other things, claiming that the devices are a smoking deterrent and can cure erectile dysfunction and lead to weight loss. But critics say the agency has done nothing to halt the sale of the products in the U.S., despite concerns about health effects that led Canada and several other countries to ban them.

Survey: Public Wants Regulation

Almost all of the electronic smoking devices — cigarettes, pipes or cigars — contain a metal tube; a rechargeable, battery-operated heating element; a replaceable cartridge that may contain nicotine or other liquids; and an atomizer that, when heated, converts the contents of the cartridge into a smoke-like vapor.

All are designed to deliver vapors of nicotine, flavoring agents or other substances, including vitamins, herbal remedies, “calming ingredients” and medication guaranteed to cure or help almost any ailment.

That may sound innocent enough, but a new study shows that many people are already worried about these untested products.

According to a survey of 2,061 people released this week by the University of Michigan’s National Poll on Children’s Health [pdf], 91 percent think manufacturers should be required to test e-cigarettes for safety, 85 percent favor prohibiting the sale of e-cigarettes to minors and 82 percent think the FDA should regulate e-cigarettes like other nicotine-containing products.

“There is not yet much scientific evidence about e-cigarettes and kids yet, because these new devices have not been tested extensively,” Dr. Matthew Davis, director of the University of Michigan C.S. Mott Children’s Hospital National Poll on Children’s Health, told AOL News.

“But our poll results strongly indicate that many adults are worried about e-cigarettes leading kids to smoke tobacco. Most adults feel that e-cigarettes should be regulated by the FDA like other nicotine-containing products.”

Do No Harm? Toxicologists, risk assessors and cancer specialists from the National Institutes of Health, the Centers for Disease Control and Prevention and the FDA have long worried about the hazards that could be caused by using these devices. So why has it taken so long for the FDA to get involved?

The agency says it hasn’t tested the toxicity of the liquids or “e-juice” used in the devices or received any useful information from the distributors. Nevertheless, the FDA acknowledges there are signs of health problems.

“FDA is aware of reports of short-term side effects from the use of electronic cigarettes, including racing pulse, dizziness, slurred speech, mouth ulcers, heartburn, coughing, diarrhea and sore throat,” FDA spokeswoman Siobhan DeLancey told AOL News. She added that the agency doesn’t know how common or potentially serious these effects may be.

The composition and toxicity of the flavoring agents worry some with expertise in the field. One physician who for years has studied the damaging effects of the butter flavoring diacetyl in microwave popcorn factory workers and consumers told AOL News he is concerned about the use of the substance in e-cigarette flavorings.

“It’s criminal to allow diacetyl and other untested flavoring agents to be used in these devices,” said Dr. David Egilman, clinical associate professor at Brown University’s Department of Family Medicine. “At the very least, it’s not smart to intentionally inhale substances which have been proven to cause irreversible lung disease that has and can kill you.”

For about 10 years, Egilman has served as an expert witness in scores of cases of people allegedly harmed by diacetyl.

“Americans need to understand that contrary to political rhetoric, there is no real federal regulation of food or food additives,” he said. “There is overwhelming evidence that smoke from cigarettes which contains diacetyl causes disease in the terminal bronchioles — the furthest and smallest tubes that carry air to the lungs.”

Canadians Ban E-cigs; Why Not U.S.? Health Canada had no more information than the FDA does on these products, but last year the Canadian agency ordered that “persons importing, advertising or selling electronic cigarette products in Canada must stop doing so immediately” because they “may pose health risks and have not been fully evaluated for safety, quality and efficacy” by the agency.

“The prohibition on these electronic cigarettes still stands,” Health Canada spokesman Gary Scott Holub told AOL News this week.

If the Canadians could do it, why not U.S. regulators?

The answer from the FDA’s spokeswoman was lacking in specifics and offered no clue as to why the agency didn’t take a firmer stand.

“The agency has not made a decision to remove all e-cigarettes from the market,” but “will regulate electronic cigarettes and related products in a manner consistent with its mission of protecting the public health,” DeLancey said.

What little analysis FDA has conducted shows potentially serious problems.

Agency scientists examined 19 different e-cig brands from two major distributors and found disturbing results, including:

  • Significant quality problems that indicate that quality-control processes used to manufacture these products are substandard or nonexistent.

  • Cartridges labeled as containing no nicotine contained low levels of nicotine in all tested but one; three different electronic cigarette cartridges with the same label emitted a markedly different amount of nicotine with each puff.

  • Certain tobacco-specific nitrosamines, which are human carcinogens, were detected in half of the samples tested.

  • Tobacco-specific impurities suspected of being harmful to humans — anabasine, myosmine and β-nicotyrine — were detected in a majority of the samples tested.

As a result of these findings, the FDA greatly angered the industry when it thwarted the importation of more than 800 shipments of electronic cigarettes into the U.S. on the grounds that they were unapproved drug devices. At least two importers roared that the FDA had no right to meddle with their products and quickly filed suit in federal court.

Perhaps the lingering lawsuits by two e-cig importers and intense lobbying on Capitol Hill thwarted earlier efforts by U.S. agencies to regulate the products, let alone halt their sale. But last week’s FDA action against five large distributors offered some hope that the unfettered marketing of these products may be slowed a bit.

A Secretive Industry

It’s difficult for potential regulators, health investigators and even consumers to get direct answers to questions about the industry.

But in May, a man who offered only a first name, which changed from Fedir to Teddy and back, said he was responding to AOL News’ request from information from the Electronic Cigarette Association.

Here’s what came from scattered discussions with him:

  • More than 1.25 million people are using the cigarette products, and between 2,000 and 18,000 new users begin sucking on the metal and plastic devices each month.

  • Between 300 and 500 companies are selling the products in the U.S., some running 30 or more separate outlets, but, Fedir added, “only a handful of people own them all.”

  • The devices were manufactured in five Chinese factories, three owned by the same people, but are sometimes transshipped through European ports.

Photographs of attractive young people and beautiful women gazing into the distance are used by most of the online sales sites to convey the message that e-cigs are cool, Fedir explained.

By far, he said, the greatest sales come from websites and online stores. Importers sell the same e-cigs under various names.

When asked about health studies, Fedir said he would get the information. He never did.

AOL News attempted repeatedly to contact Matt Salmon, who, according to the FDA, is the current president of the industry association to verify and update the information offered four months ago by Fedir. Salmon did not respond to several e-mails, and the phone numbers on the association’s website were for a public relations agency that said it was no longer handling “that account.”

Concerns Remain, but Who’s Paying Attention?

Some of the e-cig websites insist they have corrected problems in their products that FDA scientists reported last year.

“FDA is still concerned about electronic cigarettes because there is little scientific information on their safety, efficacy or quality,” DeLancey said.

But the two eighth-grade girls from Philadelphia were oblivious to all that jargon when they made their purchases that day at Union Station in Washington. Why did they travel more than 130 miles each way to buy e-cigarettes?

“They’re a lot cheaper here,” one of the girls said before they both rushed off to get the train home.

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