By Todd Seavey
Neither ACSH's assistant director of public health Ashlee Dunston nor our medical director Dr. Gilbert Ross think the new nicotine-laced (or "nico") water is a particularly useful or desirable product, but they disagree on whether the FDA followed its own regulatory logic in deciding to ban the product. Whether the FDA should be in the business of regulating at all is a debate that will have to be left for another time.
|FDA Gets It Right
By Ashlee Dunston
The FDA is right on target in its recent ban of nicotine-laced water, or so-called "Nico Water." Following standard protocol, this governmental agency is authorized, and hence required to, regulate or approve any new food or drug placed on the consumer market. There are two main reasons for the ban: FDA considers the water an unapproved drug and the product has been illegally marketed as a dietary supplement.
According to the web site www.nicowater.com, Nico Water "is a convenient beverage for when you can't or don't want to smoke..." and "provides a refreshing break to the smoking habit and craving for nicotine when not smoking for an hour, a day, a week, or a lifetime." This is clearly an advertisement for a nicotine replacement therapy (NRT), or a smoking cessation product intended to treat nicotine addiction. Nicotine addiction is a classified disease, and any product or drug intended to treat a disease must be FDA-approved. Current smoking cessation products on the market, like the patch, gum, inhaler, and nasal spray, all contain forms of nicotine and are regulated for safety and efficacy. There is no reason that this product should be excluded. FDA recently did the same with nicotine lollipops and lip balm, citing a similar violation.
In a creative attempt to avoid FDA regulation, the manufacturer of Nico Water, QT5 Inc., was marketing the product as a dietary supplement because FDA does not have dietary supplements under its wing of regulation. However, just because a product is marketed as a dietary supplement does not necessarily mean that it is one, and marketing a product as a supplement cannot be merely a way to bypass regulation. According to FDA, Nico Water cannot be marketed as a dietary supplement because a "dietary supplement does not include a product that contains an active ingredient that FDA has already approved for use in a drug." That would be the nicotine, or the nicotine polarcrilex, which is the active ingredient in the water. (FDA does not have the authorization to regulate tobacco products, but it can otherwise regulate products due to nicotine content.) FDA has approved both nicotine and nicotine polacrilex for use in various smoking cessation aids (drugs). A product containing an FDA-regulated drug cannot be sold legally until the product is approved, not even if sellers planned to require consumers to be over the age of 18.
Nicotine is a highly addictive substance, and stopping smoking is not an easy feat. The greater the number of cessation products available on the market, the better for people who are trying to quit. However, you cannot simply put a drug into a food or drink especially one that is as ubiquitous as water and make it available to everyone. We must assure that those products are safe and effective and that they do not merely increase the number of nicotine addicts.
Ashlee Dunston is ACSH's assistant director of public health.
Dr. Gilbert Ross
The recent decision by the FDA to ban "nicotine water" is another example of needless regulatory overkill by the federal health body.
Don't get me wrong: I really can't defend this product as a meaningful addition to the smoking cessation armamentarium. The amount of nicotine in a whole bottle would only amount to a temporary respite from the tortures of a cigarette smoker's nicotine addiction if it were absorbed completely. However, only a small amount of the ingested nicotine would ever make it to the brain's pleasure/addiction receptors to do its anti-withdrawal work. Thus, in medical terms, the nicotine water supplement would be little more than a placebo.
But why ban it, given our general laissez-faire attitude toward supplements? There are many, many supplements on the market hundreds, thousands with no efficacy whatsoever. Indeed, there are only perhaps a handful of so-called "dietary/nutritional supplements" that have demonstrated any health benefit for anyone, anytime, anywhere. Why pick on "Nico Water"? It can't be just lack of efficacy, given the free ride that other ineffectual supplements get. The nicotine water manufacturers never claimed any specific benefit anyway; they are proscribed from any such claim by strict FDA rules against non-approved health claims. Instead, they left any potential benefits left to the imaginations of prospective buyers, a group that most likely composed of smokers who would use it to aid them in avoiding resorting to a smoke.
The whole supplement category has been in a regulatory "never-never land" ever since control of this group of substances was removed from FDA oversight in 1994 by Congress. Supplement marketers can now imply any health benefit they want to, as long as they (a) avoid making specific health claims and (b) note that their product has not been evaluated by the FDA. Nicotine water would seem to fit right in here.
But the government has an oddly inconsistent attitude toward the substance. The government leaps on nicotine water and regulates it but does not allow FDA to regulate cigarettes though most people would agree that, functionally speaking, cigarettes are merely devices for delivering a drug, nicotine, to addicted smokers (the tobacco industry admitted this in recently revealed documents). This is just another example of how cigarettes are exempted from rules of marketing to which all other industries must accede. Nicotine, relatively harmless in itself, gets hammered by regulations, while tobacco smoke which kills gets a pass (and the tobacco industry effectively gets away with murder).
So in its wisdom, the FDA has decided that nicotine water must go, perhaps because they fear it might hook innocents into nicotine abuse, thus making the product a "gateway" drug to cigarettes. That's hardly likely, though, given the tiny exposure to nicotine a user would get.
I say, let those who wish to believe that using nicotine water might help them cut down on cigarettes use it. There is really no valid reason why it should be banned when so many other useless products and even some that are actually dangerous (such as ephedra and androgenic substances) are allowed to thrive. There's something odd about a regulatory system that permits useless supplements on the one hand and permits deadly cigarettes on the other but shows no mercy toward nicotine water.
Gilbert Ross, M.D. is Medical/Executive Director of the American Council on Science and Health.
July 7, 2002
I'm shocked! Both Ms. Dunston and Dr. Ross extol the "efficacy" of nicotine labeled as "therapy." Alcohol is alcohol, cocaine cocaine, and nicotine regardless of delivery device is still nicotine, a substance capable of permanently enslaving the dopamine circuits of over 70% of regular users.
My concern is that the FDA and science are being manipulated by brilliant marketing minds in order to make billions in profits by selling nicotine to those chemically dependent upon nicotine. The ignorant, uneducated, uncounseled, and unsupported abrupt-nicotine-cessation quitter has historically had a 10% to 12% chance of quitting for six months, and a 5% to 6% chance of quitting for a year. In light of the dismal results from the last three OTC patch studies, how can either of you use the word "efficacy" with a straight face when speaking of NRT?
The 1998 Davidson OTC patch study, in which only 8.2% of patch users were not smoking at twenty-four weeks, could have been considered an aberration. The 1999 Hays OTC patch study with its 8.7% rate should have caused all of us to pause and take note. The May 2002 release of the Shiffman OTC "real-world" patch and gum study, with 5,348 OTC patch and gum users, should have been a serious wake-up call for every cessation health official and dependency scientist.
Yes, three times in a row OTC studies have come back with efficacy ratings substantially lower than historic "on your own" rates. The OTC portion of Shiffman's study generated an 8.4% six month gum rate and a 9.2% patch rate. Smokers are not quitting with NRT; they're quitting in spite of it!
I'm sure that Ms. Dunston and Dr. Ross are both aware that placebos used in most NRT studies are being doctored by pharmaceutical companies with differing levels of nicotine, and that most studies fail to disclose either the doctoring or the amount used. We're not talking about the amount needed to establish dependency but the amount needed to slightly extend the most intense period of physiological withdrawal: the first three days.
I'm sure that Ms. Dunston and Dr. Ross also know that if a patch quitter participating in a study grew weary and discontinued his use of the patch after only one day and quit on his own, these NRT studies took full credit for that hard-fought victory. What kind of science is this? If someone doesn't follow through with "therapy," how can therapy take credit for his healing?
I submit that OTC nicotine gum is probably no more effective as a cessation tool than having smokers attempt gradual nicotine withdrawal while chewing cheaper nicotine contained in chewing tobacco. I submit that heavy reliance on NRT is costing tens of thousands of lives each year.
The problem isn't the FDA. The problem is that the FDA, Ms. Dunston, and Dr. Ross are being duped by the newest nicotine pushers to hit the street, and in the name of "science" they refuse to open their eyes.
John R. Polito
July 12, 2002
An update from Polito:
I'm writing to thank you for bringing attention to the efficacy evidence on nicotine replacement threapy. I've just completed a review of the newest NRT study, released in May, 2002, which presents what the author (Shiffman) calls "real-word" NRT efficacy rates. The results are shocking! This is the link:
I'd also greatly appreciate ACSH looking a bit deeper into NRT study placebo doctoring issues. Just like on Wall Street, the books are being cooked, and I fear that millions of meaningful cessation opportunities, and lives, are being lost.
John R. Polito