Starfleet Innotech Inc (SFIO)

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Until the FDA starts regulating nicotine as a drug the "Nicotine Delivery Devise" should not need FDA approval unless they claim it as a smoking cessation device. IMO
From a competitors website:
Can I use the product to stop smoking and is it FDA approved?
No! Our products are not FDA approved to be used as cessation devices. They have never been tested or proven to be cessation devices and we are not marketing them or selling them for that purpose. We are marketing and selling them to our customers as an alternative to smoking traditional tobacco products. They offer the freedom to be used in most places that currently prohibit the use of tobacco products. They produce no first or second hand smoke. They are virtually odor free and represent an overall lower cost to the user than traditional cigarettes. They help to restore freedom to smoke almost anywhere, anytime and do not lend themselves to creating "social isolation" as one might expect with traditional tobacco products.