Latest News! Finally the FDA issues a proposal for the regulation of Electronic Cigarettes
At the same time that electronic cigarettes are soaring in popularity, the US government proposes this Thursday historical rules to prohibit their sale to minors and require warning labels as well as federal approval.
Three years after announcing that it would regulate electronic cigarettes, the Food and Drug Administration is moving to control not only these battery-operated devices, but also cigarettes, pipe tobacco, hookahs (Water pipes) and soluble tobacco products. Currently, the FDA regulates cigarettes, smokeless tobacco and other tobacco products.
The proposed rules do not prohibit advertising unless the products make health claims, nor will they ban the use of flavors such as chocolate or chewing gum, which public health officials say could attract children. .
"This is an important time for consumer protection," said FDA Commissioner Margaret Hamburg, noting that tobacco remains "the leading cause of death and disease in this country." The rules require manufacturers to report their ingredients to the FDA for authorization. They also ban free tobacco samples and most of the sales of vending machines.
"Some of these regulations will be very restrictive," said Ray Story, founder of the industry group TVECA (Tobacco Cigarette Association Electronic Steam), which added that it obtained its own copy prior to the publication of the rules. He said it could be costly for small businesses and slow down the growth of a product that advocates say has helped many smokers quit.
Even so, the story said, consumers could benefit because it "offers them a product that will be consistent." E-cigarettes contain different ingredients and levels of nicotine that are heated in a vapor that users inhale in a practice known as "vaping". Most resemble conventional cigarettes, but some resemble everyday objects such as pens and USB flash drives.
The rules come as e-cigarette sales, fueled by television commercials with Hollywood celebrities, have skyrocketed in recent years and the debate has risen that devices are more likely to attract Children towards tobacco than to help adults quit smoking.
A growing number of states have taken energetic measures by extending indoor smoking restrictions on electronic cigarettes. Last month, US toxicology centers reported an increase in diseases related to liquid nicotine used in the devices.
While they do not contain many of the harmful chemicals of conventional cigarettes, the FDA found traces of toxic and carcinogenic ingredients in various samples at the end of 2008, when the electronic cigarette market was just beginning in the United States. They were tried to regulate them as drug release devices, but in 2010, a federal judge ruled that they could only do so if they make therapeutic claims. So, in April 2011, the agency decided to regulate them as tobacco products, since nicotine is derived from tobacco leaves.
"It has taken more than three years to issue a proposed rule, which we believe is inexcusable," said Vince Willmore of the Tobacco-Free Campaign, an anti-smoking group. Allowed a market like the Far West with irresponsible and uncontrolled marketing on the product. "He says the FDA should quickly finalize the rules, which face a period of 75 days of public comment and a review additional.
The proposed rules go down a narrow path. They will require tobacco products that were not on the market by February 25, 2007 - a date set by a federal law - to request the FDA review within 24 months after the publication of the rules. Products may remain on the market pending the FDA review, says Mitch Zeller, director of the FDA's Center for Tobacco Products, adding that they can get an exemption from additional testing if changes are made Children.
Despite these requirements, the proposal does not contain the marketing restrictions requested by some critics that it was almost certain to trigger litigation. Craig Weiss, CEO of NJoy, a major e-cigarette selling company, said it supports "reasonable regulation" but that "there is a strong response to any attempt to limit my right to freedom of expression to promote my product . "
Several prevailing manufacturers of electronic cigarettes now include three of the country's largest traditional cigarette manufacturers - Philip Morris, RJ Reynolds and Lorillard - have adopted a limited regulation, such as a ban on selling to minors. However, they have argued that their e-products should not be regulated as forcefully as conventional cigarettes - an approach that the FDA is apparently taking.
The FDA said the standard is intended to enhance product safety. It was said that since electronic cigarettes have not been fully studied, consumers have no way of knowing how much nicotine or other chemicals they contain and whether they are safe or beneficial.