E-cigarettes 'should not be marketed as smoking cessation aids'

[pnwmom]

93. Tobacco products are exempt from the normal FDA requirement that

drugs that are marketed must be proven to be safe and effective. Cigarettes contain a highly addictive drug, nicotine, and cigarettes are not safe EVEN WHEN USED PRECISELY AS DIRECTED -- unlike alcohol, for example, which is safe when used the way most people use it, in low or moderate amounts.

Under normal circumstances, a dangerous addictive drug product -- like cigarettes -- would be illegal. But the tobacco industry is powerful and that is why cigarettes contain to remain on the market, despite the risks.

If e-cigs want to make the claim that their pure nicotine is LESS addictive than combusted nicotine, as ridiculous as that seems, they are welcome to do so -- with research submitted to the FDA.

E-cigs are currently classified as tobacco products, because of the lawsuit brought by an e-cig maker. And the FDA has been working on drafting new regulations for years -- but as of today, those regulations are only in DRAFT form. They have not been approved and they are subject to change.

Here is more information about the current law. Note that it places new regulations on tobacco products, but it does not require the manufacturers to provide safety and efficacy data, as the FDA does with other addictive drugs. That exemption is the only reason the cigarette industry still exists, since they will never be able to prove that their product is safe, even when used as directed.

http://publichealthlawcenter.org/sites/default/files/fda-1.pdf

On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and
Tobacco Control Act, giving the U.S. Food and Drug Administration (FDA) comprehensive authority
to regulate the manufacturing, marketing, and sale of tobacco products.The new law represents
the most sweeping action taken to date to reduce what remains the leading preventable cause of
death in the United States. Before enactment of the new law, tobacco products were largely exempt from regulation under the nation’s federal health and safety laws, including the Food, Drug, and Cosmetic Act. The FDA has
regulated food, drugs and cosmetics for many decades, but not tobacco products, except in those rare circumstances when manufacturers made explicit health claims.

In addition to the FDA’s new powers to regulate the structure of tobacco products, the agency has
wide-ranging authority to regulate tobacco products and tobacco product marketing. The new law:

Restricts tobacco advertising and promotion in order to promote overall public health (the
judicial system will almost certainly be asked to determine whether any of the legislated
advertising restrictions unconstitutionally interferes with free speech under the First
Amendment)

Stops illegal sales of tobacco products to minors

Bans all cigarettes that have a characterizing flavor, including all fruit and candy flavors,
other than tobacco or menthol

Prohibits health claims about purported reduced-risk products, where such claims are not
scientifically proven or would cause net public health harms (for example, by discouraging
current tobacco users from quitting or encouraging new users to start)

Requires tobacco companies to disclose the contents of tobacco products, changes to their
products and research about the health effects of their products

Requires much larger, more visible, and more informative health warning labels, including
color and graphics, on cigarette and smokeless tobacco product packages

Similarly requires much larger, more visible, and more informative health warning labels on
advertisements for cigarettes and smokeless tobacco

Prohibits terms such as “light,” “mild” and “low-tar” on tobacco product packages and
advertisements, while authorizing the FDA to restrict additional terms in the future
The law also imposes certain limits on FDA authority. The agency cannot ban conventional tobacco
products, such as cigarettes and smokeless tobacco, or require the total elimination of nicotine in
tobacco products. However, the FDA may order the reduction of nicotine to non-addictive levels in
some or all tobacco products. The agency could also order an increase in nicotine levels in some
or all tobacco products if it determined that doing so would promote overall public health. For
their part, states retain the authority to ban all or some tobacco products or the sale of tobacco
products containing nicotine

The law also prohibits the FDA from using its new authority to increase the new federal minimum
age of 18 to a higher level, require prescriptions for the purchase of tobacco products, ban tobacco
product sales in any particular type of sales outlet, or regulate tobacco farming directly. In all of
these areas, the FDA could ask Congress either to take these actions or to provide the agency
with new authority to do them. Moreover, states have the authority to take such actions without
congressional approval