Reasons why nicotine should be put under category of drugs

The New Straits Times, July 4, 1997

Q: I recently read of a proposal in the US to regulate cigarettes as drugs. What does this mean? What about in Malaysia?

A: Two years ago, in 1995, the US Food and Drug Administration asserted that nicotine, the main addictive components of tobacco smoke, is a drug. This gives the agency jurisdiction over it. The agency would therefore be in a position to impose stricter rules and regulations governing the sue of nicotine in tobacco.

In other words, cigarettes are regarded as nothing more than a drug-delivery system (just like inhalers are used to deliver drugs by mouth) and an unhygienic one at that because of the thousands of other chemicals and poisons in them (just like contaminated inhalers).

Despite industry protests, of late the FDA's case has been much strengthened by a series of revelations in cigarette industry documents.

These documents seem to suggest the manufacturers have sometimes manipulated the nicotine level in cigarettes to the extent of genetically manipulating it as early as the 1980s (NST May 2).

In fact, as late as February, a US TV network still reported about one major tobacco company which took nicotine extracted from tobacco used to make a low-nicotine brand and added it to tobacco in a different batch of cigarettes. In other words, they were "spiking" cigarettes with nicotine. This is now well documented despite earlier denials by the tobacco company which said that the extracted nicotine had been thrown away.

The extra-strength cigarettes were allegedly sent out to smokers as free samples and at times dumped into the Third World where nicotine levels are said to be considerably higher than in similar brands in the West. Such manipulation implies that a cigarette is actually a nicotine-delivery device, no different from other forms of drug-delivery devices.

Cigarettes are indeed made to deliver a set "dose" of nicotine very much like other devices, for example an injection syringe. Given this analogy, all the rules and regulations governing the control of drugs should apply to nicotine too.

Drugs controls and regulations (ironically not for tobacco) are often more stringent. The analogy therefore implies that cigarette packaging must be accompanied by extensive "information inserts" such as those used in drug packing. Tobacco manufacturers can be forced to follow advertisement codes like that for drugs, namely, no more billboards, no more flashy displays or packaging and no more superfluous claims.

In fact, it is expected that by Aug 28, one of the FDA's new rules is to insist that cigarette advertisements have no picture or colour (leaving them only the aptly naked "tombstone" format of black words on white paper).

Countries such as Canada are already reported to be moving towards making this a requirement, with warnings in bigger lettering such as "Smoking Kills:" or "Smoking is addictive". Among other rules expected to be enforced in the US later:

  • banning free samples, packs with fewer than 20 cigarettes and sales of single cigarettes;

  • banning all sorts of branded free gifts such as T-shirts; and

  • banning cigarette billboards within 300 metres of schools.

The Clinton Administration had previously urged stronger curbs on cigarette advertising as part of a concerted campaign to discourage young people from smoking. In late April, the US Supreme Court upheld and ordinance banning outdoor advertising in Baltimore city in order to reduce underage smoking. This came just a few days after a days after a federal judge in North Carolina ruled that the FDA had no power to regulate tobacco advertising. The Baltimore ordinance is expected to encourage other cities and countries to legislate the same. Hopefully the ripple effect will touch our shores as well.

In addition, by 1998, the FDA will ban cigarette manufacturers from sponsoring sports in the name of their brands. This is again an exemplary move for us because 1998 will see the nation hosting the 16th Commonwealth Game n Kuala Lumpur. Not doing so will only make a mockery of the games in the eyes of the world.

In essence, the control of nicotine as a drug would mean it has to comply with a number of well-established criteria covering aspects of safety, quality and efficacy. In some cases, there is a "need" criterion that must be fulfilled. In other words if all these criteria are not met, the sales could be severely restricted if not banned, especially now that nicotine is classified as a substance with "addiction liability".

A classic example of a drug of similar class to nicotine that is severely restricted in use is morphine, while that totally banned is heroin. In the case of nicotine it should be banned because it is totally useless medically or other-wise.

Moreover, based on WHO documents, since experts in substance abuse consider tobacco dependence to be as strong or stronger than dependence on such substances as heroin, arguably nicotine should be eventually phased out as a "banned" substance in cigarettes. More interestingly, there are also indications that WHO is considering whether to list tobacco under internationally controlled substances like narcotics.

Apart from that, the FDA too will have the power to decide, from to time, what other substances should be permissible in a cigarette. Ammonia, for instance, which is being used by the industry as a so-called "impact booster" for nicotine delivery, can likewise be regulated.

The relevance of all these issues to a country like ours is indeed greater. Recently the Ministry of Health banned the sale, use and possession of tobacco products for those under 18 years of age.

This lead is taken from that recommended by the FDA to the US government. In the same vein, other measures enforceable by the FDA could easily be adopted by our Government as well, especially through our own drug regulatory authority, the Drug Control Authority under the Ministry of Health.

Armed with such rules and regulations, control over tobacco use in our society can be drastically improved. We should urge our Government to emulate the resolve shown by FDA and be more proactive in implementing similar controls after allegations abound that nicotine levels in cigarettes in developing countries are substantially higher, including those in imported brands.


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