2009-05-19 07:03:17 - The Food and Drug Administration [FDA] is moving to regulate e-cigarettes - devices which resemble cigarettes but which, instead of burning tobacco, emit a cloud of nicotine which is inhaled (and exhaled) by the user. Just as an earlier ASH legal petition helped prompt the FDA to regulate cigarettes containing nicotine, and an earlier nicotine-emitting cigarette-like device known as "Favor," a new ASH petition may be playing a significant role, and does help explain the FDA's action.

Filed without publicity in April, the legal petition by Action on Smoking and Health (ASH), America's first antismoking organization, argues that the FDA must begin regulatory proceedings over the new product, as it did with prior nicotine products (like gums and patches) as well as cigarette-like devices like "Favor," because it contains a known dangerous and addictive drug, and falls within the statutory jurisdiction of the agency. ash.org/ecigpetition

Preliminary regulatory steps are already being taken. For example, the FDA has begun listing the product on its "Import Alert" as "misbranding" and as an "unapproved new drug" - "Product appears to be a combination drug-device product that requires pre-approval, registration and listing with FDA." This has prevented shipments from being imported into

the U.S., and triggered a new legal action.

ASH's legal petition also argues that such regulation is not barred by a Supreme Court decision which banned the agency from regulating conventional tobacco-burning cigarettes which had long been subject to legislation by Congress, that regulation is necessary to protect both users (and nonsmokers in their vicinity) from unnecessary exposure to dangers which may exist, and because failure to act could preclude action later under legal doctrines such as "latches."

"Manufacturers are not free to foist on the U.S. market - and to use purchasers as guinea pigs for - a product that emits a dangerous and addictive drug which has always been regulated by the FDA, and to make totally unsubstantiated claims about the safety of the product and its efficacy in helping users to quit smoking, all without any independent review of the claims or any restrictions on the ads, its marketing, etc.," argues public interest law professor John Banzhaf of ASH.

ASH notes that nicotine in a wide variety of non-cigarette products has always been regulated by the FDA. Nicotine gum and nicotine patches, for example, initially required a doctor's prescription, and were only permitted to be sold without one (but still subject to FDA jurisdiction) when the makers produced medical evidence showing to the FDA's satisfaction that the products were safe and effective.

Similarly, other cigarette-like devices which permitted the user to inhale nicotine have been regulated by the FDA. A prime example was called "Favor," which the agency described as “a plug impregnated with a nicotine solution inserted within a small tube corresponding in appearance to a conventional cigarette" with each pack having "a nicotine delivery capacity intended to satisfy the average smoker of conventional cigarettes for an entire day.” The FDA held that this made it a "nicotine delivery system intended to satisfy a nicotine dependence," and therefore subject to the FDA's jurisdiction and requirements.

While some, including U.S. Senator Frank Lautenberg, have called for a ban on the product because of dangers it may present, and others have argued that it should continue to be sold because it appears to be less dangerous than smoking tobacco cigarettes, ASH has taken an intermediate position because no one can be sure just have dangerous - or beneficial - science may find the product to be.

ASH's legal petition argues that the FDA must assert jurisdiction because the law clearly requires it, but that the FDA should then decide based upon competent and impartial medical evidence whether it should be permitted to be sold, whether a prescription should be required, what if any other restrictions on sales - e.g., age limits - should be imposed, what warnings if any should be required, and which claims meet the tests of scientific validity and can therefore be made.

ASH, unlike others who have argued the issue, has also raised concerns about other potential dangers, including those to nonsmokers when the products are used - as they are advertised to be used - in crowded indoor areas where the smoking of conventional tobacco products is prohibited:

* "First, many smokers who might otherwise quit (and eliminate all the risks of smoking) if there were no readily available alternative might be tempted to take a shortcut by switching to e-cigarettes, and thereby continue to be exposed to the cardiovascular and other risks from nicotine."

* "Second, some people (especially children) might be tempted to use an e-cigarette to get a nicotine “high” (“lift,” “buzz,” etc.) or in the hopes of relieving tension. Once begun, they could become addicted to nicotine, and possibly even go on to smoking tobacco."

* "Nicotine is also known to be a toxic drug which can trigger, and/or at least contribute to, a variety of very serious cardiovascular problems including heart attacks, strokes, etc. While these concerns may be small when nicotine is very slowly released from gum and patches, the risks may be far greater when the drug is inhaled and instantly absorbed into the bloodstream of the user."

* "In this connection it must be noted that the vapor containing nicotine is reportedly exhaled into the air by the user, apparently even in areas where smoking (i.e., the use of lit tobacco products) is prohibited. That means that many people - including the elderly, those with a variety of serious pre-existing conditions, etc. - will be exposed to some concentrations of this drug."

* "Since so many people smoke cigarettes and other tobacco products in close proximity to children, often even when they are holding the child or even breast feeding an infant, it is virtually certain that a significant percentage of e-cigarette users will likewise use this new product in close proximity to children - especially if they become convinced from the advertising or otherwise that the exposure does not present any significant risks. Thus very young children, whose bodies and bodily defenses are still developing, and including many with pre-existing medical conditions, will also be exposed to this toxic drug. These are all major concerns which cannot be ignored any longer."

Some of these concerns have been echoed by the FDA. For example, "We're concerned about the potential for addiction to and abuse of these products," says FDA spokeswoman Rita Chappelle. "Some people may mistakenly perceive these products to be safer alternatives to conventional tobacco use." www.prurgent.com/2009-04-13/pressrelease35790.htm

ASH's legal petition concludes by noting how the FDA's action regarding e-cigarettes could impact a bill now pending to give the agency jurisdiction to regulate tobacco products: 'Some may argue that an agency which is unwilling to assert a jurisdiction which already clearly exists - and to confront a tiny company - is not to be trusted to regulate not only all novel nicotine drug-delivery products, but also tobacco products, as a bill now before Congress would require. To prove itself worthy of this proposed dramatic expansion of its power to protect the public from the most dangerous product ever made (tobacco cigarettes), as well as to regain its public credibility, the FDA should unambiguously assert jurisdiction over e-cigarettes."

PROFESSOR JOHN F. BANZHAF III
Professor of Public Interest Law, and Executive Director
Action on Smoking and Health (ASH)
2013 H Street, NW, Washington, DC 20006, USA
(202) 659-4310 // ash.org/