FDA Plans to Regulate Electronic -Cigarette
WASHINGTON (CN) - The Food and Drug Administration plans to regulate electronic cigarettes as it does tobacco cigarettes, according to a proposed regulation.
In recent years, electronic cigarettes have gained popularity as an alternative to tobacco cigarettes. One study of 100,000 adults found the number of people who had ever used e-cigarettes quadrupled between 2009 and 2010.
Critics say there is scant information about the devices' harmful effects and have voiced concern that they are marketed toward minors.
Last week, the FDA took the first steps towards regulating e-cigarettes, which generally contain a nicotine-based glycerin solution derived from tobacco.
The agency regulates tobacco products, including cigarettes and smokeless tobacco, and is considering putting e-cigarettes and other newer nicotine products in that category.
"Young adults often mistakenly think non-cigarette tobacco products are safe alternatives to cigarettes," the agency wrote. "Research has shown that youth are also particularly vulnerable to the appeal of novel tobacco products.
"Because of their addictiveness and the marketing and sale of these products (and their subsequent use by youth), some non-cigarette tobacco products can introduce youth into a lifetime of addicted tobacco product use and related harms, including premature death." (References omitted.)
In addition to e-cigarettes, the proposed rule would regulate dissolvable tobacco, hookah and pipe tobacco, cigars and nicotine gels.
Makers of the newly-regulated products would be required to register with the FDA and would only be allowed to sell them after the agency has reviewed them.
E-cigarette companies would not be allowed to distribute free samples, and could not make claims that the products reduce certain medical risks unless the FDA confirms it through scientific evidence, the proposed rule states.
The rule also would restrict minors from buying the newly classified tobacco products, and require health warnings.
"Tobacco remains the leading cause of death and disease in this country," FDA Commissioner Margaret A. Hamburg said in a statement. "This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products."
The agency conceded that e-cigarettes "could help reduce the overall death and disease toll from tobacco product use," but that more information is needed. The "FDA asks for comments, data, and research to determine whether the agency's evaluation of the relative risk or potential for harm reduction of such a product should be different in the presence of flavors in these products, especially if there is evidence that these flavors make the products more attractive to children."
The agency said regulating the new products would provide it with the tools needed to better combat illnesses and deaths associated with tobacco use and "monitor product development and changes." "We do not currently have sufficient data about e-cigarettes and similar products to determine what effects they have on the public health." "Nevertheless, several recent studies of limited numbers of users suggest that e-cigarettes may have the potential to help smokers, particularly those who have had limited success with currently approved cessation programs," the agency wrote. "There is no evidence to date that e-cigarettes are effective cessation devices. For example, one trial examining cessation success between e-cigarettes, nicotine replacement patches, and placebos found that `achievement of abstinence was substantially lower than we anticipated.'"
Comments on the proposed rule are due by July 9.