America's love affair with tobacco dates back centuries, and the nation continues to be a leading producer of tobacco leaves. Tobacco use is the single largest preventable cause of disease, disability and death in the United States, and is responsible for more than 480,000 deaths each year.
Cigarettes, smokeless tobacco, cigars, pipe tobacco, snuff, and chewing tobacco are some of the forms of tobacco. An estimated 42.1 million people, or 18.1% of all adults (aged 18 years or older), in the United States smoke cigarettes, according to the CDC.
Though the need to bring tobacco under the regulatory powers of the FDA was widely debated ever since the 1964 Surgeon General's Report established that tobacco smoke causes cancer and heart disease, it didn't materialize until the summer of 2009.
On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, giving FDA power to regulate the manufacturing, marketing and sale of tobacco products.
Only cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco are currently regulated by the FDA under the Family Smoking Prevention and Tobacco Control Act.
As the latest step in its efforts to make the next generation tobacco-free, the FDA has proposed a new rule that would extend its tobacco authority to cover additional tobacco products, including e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables.
The proposed rule calls for makers of the products meeting the legal definition of a tobacco product to "register with the FDA and report product and ingredient listings; only market new tobacco products after FDA review; only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole and not distribute free samples".
In addition, the proposed rule, seeks to prevent sales of the newly covered tobacco products to underage youth and limit tobacco vending machines to adults-only venues.
The reactions to the FDA's proposed rule to regulate electronic cigarettes, cigars and other tobacco products have been mixed.
Terming the proposed regulations as "long overdue", the Campaign for Tobacco-Free Kids noted that the FDA must now quickly finalize the proposed rule and take further action to ban flavorings in cigars or e-cigarettes that entice kids.
Responding to the proposed FDA regulations, Murray Kessler, Chairman, President and CEO of Lorillard Inc., the third largest tobacco company in the United States and owner of blu eCigs, the leading U.S. electronic cigarette company, said, "It appears that the FDA is taking a science-based approach, and that the proposed rule itself defines a constructive process that recognizes that e-cigarettes are different than combustible cigarettes".
But Greg Conley, President of the American Vaping Association, who has a different view said, "We are greatly concerned that the Food & Drug Administration's proposal to regulate electronic cigarette products as 'tobacco products' will hand the electronic cigarette market over to Big Tobacco and potentially ban the sale of products used today by tens or hundreds of thousands of ex-smokers. While we support banning the sale of electronic cigarettes to minors, we also believe that the FDA's current regulatory scheme is entirely inappropriate for these innovative, technology-driven products."
The proposed rule will be available for public comment for 75 days.
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