E-Cigarette Sellers Could Face Prison // Misbranded Drug Sales Felonies, Even Absent Claims
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2009-08-31 14:12:05 - E-cigarette sellers have been banned in one state, threatened with civil actions in another, sued by an attorney general, had their imports blocked, and abandoned by PayPal and Facebook, but many may not realize that they might also face prison for the unlawful sale of a misbranded drug, suggests the public interest law professor who has been leading the so-far successful legal assault against this novel new product which dispenses nicotine to users.
Unlike other nicotine-administration products such as patches, gums, inhalers, throat sprays, lollipops, and water -- all of which are classified as drugs and/or drug-device combinations by the Food and Drug Administration [FDA], and require the agency's approval to be marketed -- e-cigarette marketers have maintained that their product is outside the jurisdiction of the FDA and can lawfully be sold
without agency authorization.
But the FDA "has already declared that electronic cigarettes are subject to FDA approval as a drug or medical device, much like nicotine patches, gum and inhalers -- and therefore they are illegal until they are cleared," and has stated that electronic cigarettes are "unapproved new drugs and/or misbranded drugs or devices," and appear "to be a combination drug-device product that requires pre-approval, registration and listing with FDA."
Federal law, particularly 21 U.S.C. 331, prohibits the "introduction or delivery for introduction into interstate commerce" of any misbranded drug, and 21 U.S.C. 333 provides for imprisonment for one year for each individual violation; e.g., for each individual sale.
Despite the FDA's clear statement, e-cigarette sellers argue that their product is not a "drug" (or "drug-device") subject to FDA jurisdiction because, they maintain, they do not make the drug-type claims which they assert are necessary to demonstrate their intent as sellers that the product be used as a "drug."
The FDA disagrees, arguing that the sellers do make drug-type claims clearly establishing their intent, and citing numerous statements about using the device to help people quit smoking, to satisfy a nicotine addiction, etc. which the agency asserts are drug-type claims which clearly establish its jurisdiction over the product.
But, as law professor John Banzhaf has pointed out, there are many judicial decisions -- including one in a case which he himself brought -- holding that the FDA can assert jurisdiction over a product as a drug even if the sellers make no drug-type claims at all.
Banzhaf, of Action on Smoking and Health (ASH), filed a legal petition to prompt the FDA to assert jurisdiction over e-cigarettes, provided information and encouragement to attorneys general to crack down on e-cigarettes in their states, warned PayPal about their potential legal liability for facilitating the sale of e-cigarettes, and filed a court brief in support to the FDA's authority to stop the importation of e-cigarettes.
E-Cigarette Sellers Could Face Prison // Misbranded Drug Sales Felonies, Even Absent Claims
PROFESSOR JOHN F. BANZHAF III
Professor of Public Interest Law and Executive Director
Action on Smoking and Health (ASH)
America's First Antismoking Organization
2013 H Street, NW, Washington, DC 20006, USA
(202) 659-4310 // (703) 527-8418 // ash.org
Contact Information:
Action on Smoking and Health (ASH)
America's First Antismoking Organization
2013 H Street, NW,
Washington, DC 20006, USA
Contact Person:
Law Professor John Banzhaf
Chief Counsel
Phone: (202) 659-4310 // (703) 527-8418
email: email
Web: ash.org
Print article
Refer to a friend
2009-08-31 14:12:05 - E-cigarette sellers have been banned in one state, threatened with civil actions in another, sued by an attorney general, had their imports blocked, and abandoned by PayPal and Facebook, but many may not realize that they might also face prison for the unlawful sale of a misbranded drug, suggests the public interest law professor who has been leading the so-far successful legal assault against this novel new product which dispenses nicotine to users.
Unlike other nicotine-administration products such as patches, gums, inhalers, throat sprays, lollipops, and water -- all of which are classified as drugs and/or drug-device combinations by the Food and Drug Administration [FDA], and require the agency's approval to be marketed -- e-cigarette marketers have maintained that their product is outside the jurisdiction of the FDA and can lawfully be sold
without agency authorization.
But the FDA "has already declared that electronic cigarettes are subject to FDA approval as a drug or medical device, much like nicotine patches, gum and inhalers -- and therefore they are illegal until they are cleared," and has stated that electronic cigarettes are "unapproved new drugs and/or misbranded drugs or devices," and appear "to be a combination drug-device product that requires pre-approval, registration and listing with FDA."
Federal law, particularly 21 U.S.C. 331, prohibits the "introduction or delivery for introduction into interstate commerce" of any misbranded drug, and 21 U.S.C. 333 provides for imprisonment for one year for each individual violation; e.g., for each individual sale.
Despite the FDA's clear statement, e-cigarette sellers argue that their product is not a "drug" (or "drug-device") subject to FDA jurisdiction because, they maintain, they do not make the drug-type claims which they assert are necessary to demonstrate their intent as sellers that the product be used as a "drug."
The FDA disagrees, arguing that the sellers do make drug-type claims clearly establishing their intent, and citing numerous statements about using the device to help people quit smoking, to satisfy a nicotine addiction, etc. which the agency asserts are drug-type claims which clearly establish its jurisdiction over the product.
But, as law professor John Banzhaf has pointed out, there are many judicial decisions -- including one in a case which he himself brought -- holding that the FDA can assert jurisdiction over a product as a drug even if the sellers make no drug-type claims at all.
Banzhaf, of Action on Smoking and Health (ASH), filed a legal petition to prompt the FDA to assert jurisdiction over e-cigarettes, provided information and encouragement to attorneys general to crack down on e-cigarettes in their states, warned PayPal about their potential legal liability for facilitating the sale of e-cigarettes, and filed a court brief in support to the FDA's authority to stop the importation of e-cigarettes.
E-Cigarette Sellers Could Face Prison // Misbranded Drug Sales Felonies, Even Absent Claims
PROFESSOR JOHN F. BANZHAF III
Professor of Public Interest Law and Executive Director
Action on Smoking and Health (ASH)
America's First Antismoking Organization
2013 H Street, NW, Washington, DC 20006, USA
(202) 659-4310 // (703) 527-8418 // ash.org
Contact Information:
Action on Smoking and Health (ASH)
America's First Antismoking Organization
2013 H Street, NW,
Washington, DC 20006, USA
Contact Person:
Law Professor John Banzhaf
Chief Counsel
Phone: (202) 659-4310 // (703) 527-8418
email: email
Web: ash.org
Makes me sad. (and a little bit ...... off... ok... maybe a lot ...... off)
