...e-cigarettes could serve as "training wheels' for youngsters who want to share in the mystique and sexy allure of appearing to smoke. So sayeth the infamous bansturbater John Banzhaf: (sorry for the lengthy post)
[FONT=Georgia, Times New Roman, Times, serif]E-Cigarette Critics Accused of "Libel" and "Slander" // But FDA is Already Asserting Jurisdiction Over Product[/FONT]
E-Cigarette Critics Accused of "Libel" and "Slander" // But FDA is Already Asserting Jurisdiction Over Product
A major distributor of e-cigarettes has accused critics of the new product of "libel" and "slander," possibly in a effort to discourage efforts to regulate them, but the FDA is now taking action to protect the public, says public interest law professor John Banzhaf of Action on Health(ASH), who has petitioned the FDA to regulate the products.
Indeed, the federal agency is moving to regulate e-cigarettes - devices which resemble cigarettes but which, instead of burning tobacco, emit a cloud of nicotineand then exhaled) by the user. Just as an earlier ASH legal petition helped prompt the FDA to regulate cigarettes containing nicotine, and also an earlier nicotine-emitting cigarette-like device known as "Favor," a new ASH legal petition may be playing a significant role, and does help explain the FDA's action.
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.
Critics such as Professor Banzhaf have pointed to a wide variety of potential dangers from e-cigarettes - and presumably also from e-pipes and e-cigars which have now appeared on the market - and has asked the FDA to determine the safety of the products, as the agency has with all earlier nicotine-delivery products like nicotine gum, nicotine patches, nicotine lozenges, nicotine sprays, and nicotine inhalers.
All of these products are allowed to be sold only with FDA-required warnings. Indeed, an advisory committee recommended that nicotine spray should only be sold with prescriptions, strong warnings about its danger, and a limit on refills.
Proponents of e-cigarettes point to two studies supposedly demonstrating the safety of their product, or at least that it is safer than smoking cigarettes. But the two studies were paid for by e-cigarette manufacturers, so the safety of the devices has not been independently and impartially verified.
Moreover, says Banzhaf, "being somewhat safer than the most dangerous product ever marketed is hardly a glowing recommendation, and certainly not the criteria which new medical products must meet. The same can be said about gum, patches, lozenges, sprays, and inhalers which administer nicotine, but all can be marketed only with FDA-mandated warnings, and some require a prescription - protections the public does not receive regarding e-cigarettes."
E-cigarettes may have risks not associated with other nicotine replacement products, suggests Banzhaf. These could arise from the fact that the nicotine is inhaled directly into the lungs where it is delivered to the brain almost immediately, thereby substantially increasing its addictive potential.
E-cigarettes also deliver significant amounts of propylene glycol, the same substance used to make antifreeze, so their direct and very frequent inhalation into the lungs could do damages beyond that caused by the nicotine. Since the products are being made without FDA oversight, there is no guarantee as to the purity and quality of the various ingredients they may contain.
Some e-cigarettes reportedly contain flavorings and other additives, and the effect of inhaling these chemicals (especially once heated) could be additional dangers. Banzhaf notes that clove extract, while apparently safe when ingested (e.g., with cooked hams), was found to cause death, comas, and other severe medical problems in some users when added to cigarettes and heated as the cigarettes burned.
There are also potential dangers beyond those to the of the user. Purchasers - especially those at elevated risk for cardiovascular problems like heart attacks and strokes - may not make a serious effort to simply quit if they believe that e-cigarettes substantially reduce their. Apparently they does not, with most of the alleged risk reduction coming from the absence of cancer-causing substances found in cigarette smoke.
Purchasers are also being encouraged to use the products in close proximity to other people - including in no sections - so that those nearby will be exposed to nicotine (a deadly poison and a addictive drug) as well as propylene glycol. The possible health effects - especially upon infants, young children, the elderly, and those with existing conditions like which may make them especially susceptible - have not been impartially evaluated.
Finally, warns Banzhaf, e-cigarettes could serve as "training wheels' for youngsters who want to share in the mystique and sexy allure of appearing to smoke, but who either cannot buy cigarettes or don't want to inhale the cancer causing substances. Since they will be inhaling nicotine directly into their lungs, it is reasonable to assume that it could cause some to become addicted. Thus, says Banzhaf, at least the FDA should ban the sale of this product to children.
"In summary, it is illegal and wrong for manufacturers to foist on the public a new product containing a deadly and addictive substance without any independent and impartial determinations as to its safety," says Banzhaf, noting that very safe products like require FDA approval, that many other very safe drugs like also require prescriptions, and that all other nicotine replacement products likewise required FDA approval.
"Smokers desperate to quit should not serve as guinea pigs to test a new product which may be neither safe nor effective. It is the FDA - and not the Chinese manufactures not American importers - which should evaluate safety and adopt whatever restrictions might be appropriate," argues Banzhaf.
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 // (703) 527-8418 // ash.org/
[FONT=Georgia, Times New Roman, Times, serif]E-Cigarette Critics Accused of "Libel" and "Slander" // But FDA is Already Asserting Jurisdiction Over Product[/FONT]
E-Cigarette Critics Accused of "Libel" and "Slander" // But FDA is Already Asserting Jurisdiction Over Product
A major distributor of e-cigarettes has accused critics of the new product of "libel" and "slander," possibly in a effort to discourage efforts to regulate them, but the FDA is now taking action to protect the public, says public interest law professor John Banzhaf of Action on Health(ASH), who has petitioned the FDA to regulate the products.
Indeed, the federal agency is moving to regulate e-cigarettes - devices which resemble cigarettes but which, instead of burning tobacco, emit a cloud of nicotineand then exhaled) by the user. Just as an earlier ASH legal petition helped prompt the FDA to regulate cigarettes containing nicotine, and also an earlier nicotine-emitting cigarette-like device known as "Favor," a new ASH legal petition may be playing a significant role, and does help explain the FDA's action.
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.
Critics such as Professor Banzhaf have pointed to a wide variety of potential dangers from e-cigarettes - and presumably also from e-pipes and e-cigars which have now appeared on the market - and has asked the FDA to determine the safety of the products, as the agency has with all earlier nicotine-delivery products like nicotine gum, nicotine patches, nicotine lozenges, nicotine sprays, and nicotine inhalers.
All of these products are allowed to be sold only with FDA-required warnings. Indeed, an advisory committee recommended that nicotine spray should only be sold with prescriptions, strong warnings about its danger, and a limit on refills.
Proponents of e-cigarettes point to two studies supposedly demonstrating the safety of their product, or at least that it is safer than smoking cigarettes. But the two studies were paid for by e-cigarette manufacturers, so the safety of the devices has not been independently and impartially verified.
Moreover, says Banzhaf, "being somewhat safer than the most dangerous product ever marketed is hardly a glowing recommendation, and certainly not the criteria which new medical products must meet. The same can be said about gum, patches, lozenges, sprays, and inhalers which administer nicotine, but all can be marketed only with FDA-mandated warnings, and some require a prescription - protections the public does not receive regarding e-cigarettes."
E-cigarettes may have risks not associated with other nicotine replacement products, suggests Banzhaf. These could arise from the fact that the nicotine is inhaled directly into the lungs where it is delivered to the brain almost immediately, thereby substantially increasing its addictive potential.
E-cigarettes also deliver significant amounts of propylene glycol, the same substance used to make antifreeze, so their direct and very frequent inhalation into the lungs could do damages beyond that caused by the nicotine. Since the products are being made without FDA oversight, there is no guarantee as to the purity and quality of the various ingredients they may contain.
Some e-cigarettes reportedly contain flavorings and other additives, and the effect of inhaling these chemicals (especially once heated) could be additional dangers. Banzhaf notes that clove extract, while apparently safe when ingested (e.g., with cooked hams), was found to cause death, comas, and other severe medical problems in some users when added to cigarettes and heated as the cigarettes burned.
There are also potential dangers beyond those to the of the user. Purchasers - especially those at elevated risk for cardiovascular problems like heart attacks and strokes - may not make a serious effort to simply quit if they believe that e-cigarettes substantially reduce their. Apparently they does not, with most of the alleged risk reduction coming from the absence of cancer-causing substances found in cigarette smoke.
Purchasers are also being encouraged to use the products in close proximity to other people - including in no sections - so that those nearby will be exposed to nicotine (a deadly poison and a addictive drug) as well as propylene glycol. The possible health effects - especially upon infants, young children, the elderly, and those with existing conditions like which may make them especially susceptible - have not been impartially evaluated.
Finally, warns Banzhaf, e-cigarettes could serve as "training wheels' for youngsters who want to share in the mystique and sexy allure of appearing to smoke, but who either cannot buy cigarettes or don't want to inhale the cancer causing substances. Since they will be inhaling nicotine directly into their lungs, it is reasonable to assume that it could cause some to become addicted. Thus, says Banzhaf, at least the FDA should ban the sale of this product to children.
"In summary, it is illegal and wrong for manufacturers to foist on the public a new product containing a deadly and addictive substance without any independent and impartial determinations as to its safety," says Banzhaf, noting that very safe products like require FDA approval, that many other very safe drugs like also require prescriptions, and that all other nicotine replacement products likewise required FDA approval.
"Smokers desperate to quit should not serve as guinea pigs to test a new product which may be neither safe nor effective. It is the FDA - and not the Chinese manufactures not American importers - which should evaluate safety and adopt whatever restrictions might be appropriate," argues Banzhaf.
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 // (703) 527-8418 // ash.org/
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