- Apr 2, 2009
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A major problem with Chapter IX regulations is that they were negotiated and agreed to by CTFK and Philip Morris in 2005 to regulate the existing oligopoly of several very large and wealthy US based tobacco manufacturers.
But the e-cigarette industry (at least for the starter products) is a grassroots US consumer and vendor driven industry with several hundred US based importers that contract with several (or perhaps several dozen) manufacturers in China.
Regarding e-liquid, I don't even know the various source "manufacturers" of e-liquid (but I've heard that some are in China and others are in the US), and it is uncertain how the FDA would attempt (if they apply Chapter IX to e-liquid) to regulate manufacturers and/or importers of e-liquid. While companies that manufacture pure liquid nicotine probably would be considered e-cigarette product manufacturers, it is probable that the FDA would also insist that any company that dilutes the concentration of nicotine in e-liquid (or that adds flavorings to e-liquid containing nicotine) is also a "tobacco manufacturer".
Also, anyone who imports any e-cigarette product from abroad would also have to register with FDA and comply with Chapter IX regulations.
Bottom line is that since Chapter IX was/is a regulatory scheme to regulate an oligopoly of several very large US tobacco manufacturers, the entire e-cigarette industry could be turned upside down very quickly (if FDA proposes/approves of a regulation applying Chapter IX to e-cigarette products containing nicotine), resulting in a few very large corporations (that employ lots of lawyers but that only sell several different prefilled/disposable cartridge products).
But the e-cigarette industry (at least for the starter products) is a grassroots US consumer and vendor driven industry with several hundred US based importers that contract with several (or perhaps several dozen) manufacturers in China.
Regarding e-liquid, I don't even know the various source "manufacturers" of e-liquid (but I've heard that some are in China and others are in the US), and it is uncertain how the FDA would attempt (if they apply Chapter IX to e-liquid) to regulate manufacturers and/or importers of e-liquid. While companies that manufacture pure liquid nicotine probably would be considered e-cigarette product manufacturers, it is probable that the FDA would also insist that any company that dilutes the concentration of nicotine in e-liquid (or that adds flavorings to e-liquid containing nicotine) is also a "tobacco manufacturer".
Also, anyone who imports any e-cigarette product from abroad would also have to register with FDA and comply with Chapter IX regulations.
Bottom line is that since Chapter IX was/is a regulatory scheme to regulate an oligopoly of several very large US tobacco manufacturers, the entire e-cigarette industry could be turned upside down very quickly (if FDA proposes/approves of a regulation applying Chapter IX to e-cigarette products containing nicotine), resulting in a few very large corporations (that employ lots of lawyers but that only sell several different prefilled/disposable cartridge products).