Nicotine Water, which the Food and Drug Administration removed from the market six years ago, is back. Introduced in 1998, the product was marketed as an alternative to cigarettes in situations where smokers are not allowed to light up. "From a practical standpoint," a company spokesman told A.P. in 2002, "you're on a plane from New York to L.A., this is to keep you from clawing the seat in front of you." The manufacturer called Nicotine Water a "dietary supplement," trying to take advantage of the relatively loose regulatory requirements for products in that category. But in 2002, at the urging of anti-smoking groups, the FDA said Nicotine Water was in fact an "unapproved drug," because "it is intended to treat or mitigate nicotine addiction as a smoking cessation product," and "nicotine addiction is considered a disease." Furthermore, Nicotine Water "contains an active ingredient [nicotine] that FDA has already approved for use in a drug" (i.e., nicotine gum and patches), a characteristic that made the "dietary supplement" label inapplicable.
So how did Nicotine Water get around this obstacle? It now comes in two versions. One provides four milligrams of nicotine and contains a little tobacco, rendering it (according to the manufacturer) a "tobacco product." The other, described as a "homeopathic formulation," contains barely more than half a milligram of nicotine, and I assume it is about as effective as the average homeopathic remedy. This case illustrates both the absurd arbitrariness of U.S. drug regulations and the puritanical zealotry of anti-smoking groups, which actively oppose safer alternatives to cigarettes (including smokeless tobacco), insisting instead on complete abstinence.
I shook my head over the regulatory treatment of various nicotine products, including Nicotine Water, back in 2001. Last year I noted how an energy drink introduced as a "dietary supplement" became an "unapproved drug."
[Thanks to Bill Godshall for the tip.]