FDA'S DECISION TO REGULATE NICOTINE IN INHALER SHOWS ABSURDITY OF TOBACCO INDUSTRY'S OPPOSITION TO REGULATION [05/05]


The FDA's decision today to license and regulate what looks like a "fat white cigarette," and which allows the user to inhale nicotine like smokers do, shows the absurdity of the tobacco industry's position that nicotine in cigarette should not be regulated.

The so-called Nicotrol Inhaler þ deliberately designed to let the user experience the sensation in the back of the throat similar to the feeling of inhaling a cigarette, and the ritual of bringing hand-to-mouth that many smokers report they miss when trying to quit þ will be regulated as a medical device.

Thus, users who crave nicotine and desire to inhale it through a tube without also breathing in cancer-causing compounds and poisonous gases must obtain a prescription, and can purchase it only at a licensed pharmacy. Ingredients must be disclosed, and the advertising is strictly limited þ with no billboards, sponsorship of sporting events, etc. permitted, and with a requirement that all ads contain a page-long description of all risks of using the product.

On the other hand, users who crave nicotine and desire to inhale it through a tube, while also breathing and exhaling into the air cancer-causing compounds and poisonous gases, are free to buy their cigarettes virtually everywhere þ and, as a result, they are readily available to children. These far more dangerous products are freely advertised on billboards, at sporting events, and in magazines enjoyed by children, with no disclosure of ingredients or most of the health risks associated with their use.

Of the major nicotine delivery systems þ patches, chewing gum, inhalers, nasal spray, and cigarettes þ the first four have always been regulated by the FDA, and their authority to regulate their sale, advertising, and promotion has never been questioned.

However, notes law professor John Banzhaf, tobacco companies contend that it would unconstitutional to apply exactly the same restrictions on the advertising and sale of their type of nicotine delivery system, even though it looks and behaves very much like the newly regulated inhaler.


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