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EU Moving to Ban E-Cigarettes - Could Affect FDA
On Wednesday, the European Commission will unveil its proposed Tobacco Product Directive, a comprehensive tobacco control document. Among its many provisions is one which would effectively ban e-cigarettes [electronic cigarettes]
Among its many provisions is one which would effectively ban the sale and use of e-cigarettes [electronic cigarettes], says law professor John Banzhaf, a public interest lawyer who helped trigger a number of legal actions aimed at e-cigarettes. A copy of the still-secret text of this provision appears below.
The EU ruling could also affect how the U.S.'s Food and Drug Administration [FDA] finally decides to treat e-cigarettes and similar products, and perhaps also governments in other countries which have been advised to likewise ban e-cigarettes, suggests Banzhaf, who first petitioned the FDA to assert jurisdiction over the new products.
Along the same lines, a strong push to ban e-cigarettes around the world came when delegates to a convention charged with enforcing the world's first antismoking treaty - the Framework Convention on Tobacco Control [FCTC] - met in Seoul, Korea, in November. Banzhaf has had a major role in enforcing the FCTC.
A report issued by the Convention Secretariat to the body, which represents 176 countries containing 88% of the world's population, is very critical of e-cigarettes. Entitled "Electronic Nicotine Delivery Systems, Including Electronic Cigarettes,"
Banzhaf, whose legal actions prompted the FDA as well as several attorneys general to take action concerning e-cigarettes, suggests that what the EU and FCTC countries do could have a profound effect on how the FDA finally decides to regulate e-cigarettes in the U.S.
"After all, if most of the world regards any nicotine delivery device, other than those providing medical benefits, to be a danger to the public health, it would seem incongruous and inconsistent for the U.S. - which has been a leader in many antismoking areas - not to crack down on e-cigarettes, and to provide them with an implied regulatory approval," suggests Banzhaf. Several U.S. jurisdictions have already enacted legislation dealing with e-cigarettes.
Recently, USA Today reported on a variety of dangers presented by e-cigarettes, including damage to the lungs of users, and potential hazards to bystanders forced to inhale the nicotine-laden vapors.
It also reported: "'There's a danger e-cigarettes could lure in kids who might not otherwise smoke,' says anti-smoking activist John Banzhaf, a professor at the George Washington University Law School in Washington, D.C. He pushed for the Food and Drug Administration to regulate them."
BELOW IS THE STILL-SECRET TEXT RELATED TO NICOTINE CONTAINING PRODUCTS
3.7 Nicotine containing products (NCP)
NCP fall outside the scope of Directive 2001/37/EC and Member States have so far taken different regulatory approaches to address these products, including regulating them as medicinal products, applying certain provisions that are used for tobacco products or having no specific legislation.
The proposal stipulates that NCP that either have a nicotine level exceeding 2mg, a nicotine concentration exceeding 4mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 mg per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance. NCP with nicotine levels below this threshold can be sold as consumer products provided they feature an adopted health warning. The nicotine threshold identified in this proposal has been established by considering the nicotine content of medicinal products (Nicotine Replacement Therapies, NRTs) for smoking cessation which have already received market authorisation under the medicinal products' legislation.
The proposal removes current legislation divergence between Member States and the differential treatment between Nicotine Replacement Therapies and Nicotine Containing Products, increases legal certainty and consolidates the on-going development in Member States. It also encourages research and innovation in smoking cessation with the aim of maximising health gains. Given the novelty and rapid increase of the NCP market as well as their addictive and toxic character there is an urgency to act, before more people—unaware of the content and effects of these products—inadvertently develop a nicotine addiction.
Where NCP below the identified threshold are allowed, the labelling requirement set out in this proposal will better inform consumers about the health risks associated with the products.
JOHN F. BANZHAF III, B.S.E.E., J.D., Sc.D.
Professor of Public Interest Law
George Washington University Law School,
FAMRI Dr. William Cahan Distinguished Professor,
Fellow, World Technology Network,
Founder, Action on Smoking and Health (ASH)
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