Electronic cigarettes will face new restrictions in the US, the US Food and Drug Administration announced yesterday. These will include curbs on sales to minors and distribution of free samples, as well as provisions forcing manufacturers to place health warnings on packaging.

The long awaited proposals which also stipulate that manufacturers disclose ingredients and make claims of reduced risk only if scientifically validated are less stringent than the Europe legislations voted on in February. Despite the proposed restrictions doing nothing to control advertising or curbing the sale of flavoured products with names such as “Very Berrylicious”, proponents of e cigarettes claim that they are more pragmatic and scientific than the EU rules.

“This is much less onerous than the European Tobacco Products directive,” says Gerry Stimson, a UK consultant who supports “least harm” solutions to health problems. “It is clear that the FDA process, unlike the EU, follows the science, but this is just a first step and the regulatory process could take years, during which the products and the market will develop.”

The proposals will likely provoke further debate for and against e cigarettes, which can resemble real cigarettes but contain no tobacco, only a vapourised form of pure nicotine that users breathe in and out, or “vape”.

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Quitting aid?

Backers of e cigarettes say they have great potential to help hardened smokers quit or cut down, because unlike other nicotine replacement products, they closely resemble cigarettes, both in appearance and use.

A study of online questionnaire responses from 19,000 vapers in Europe, the US and Australia, released this week, for example, found that 81 per cent of people who described themselves as former smokers said they had completely given up real cigarettes in favour of the electronic version. People who said they were current smokers reported reducing the number of real cigarettes they smoked a day from 20 to 4, on average.

But many health bodies and advisors, such as the British Medical Association and the UK government’s chief medical officer, Sally Davies, have expressed concerns that vaping will re normalise smoking and turn back years of progress demonising the practice.

Science first

“The FDA has avoided the stupid pitfalls the European legislation fell into,” says Clive Bates, a campaigner for e cigarettes as a quitting aid. “Unlike Europe, they’ve not banned flavours, they’ve not introduced a total ban on advertising, or imposed totally arbitrary limits on the strength of e cigarettes,” says Bates, who is the former head of the UK anti smoking lobby group, Action on Smoking for Health (ASH).

Bates says that the FDA’s approach to regulation has been much more science based than that in Europe, which he claims was largely driven by politics. “Whatever else the FDA is, it puts the science first,” he says. The EU legislation was criticised by some scientists who claim their own scientific results were mis used as a rationale for the strict rules.

However, the FDA admits that it has too little data yet to resolves some of the dilemmas over e cigarettes. These include whether addiction to nicotine alone is hazardous to health, and whether e cigarettes will become “gateway products” to real cigarettes.

Ram Moorthy of the British Medical Association agrees that more research is needed. “We believe that larger, longer trials are needed to learn more about the long term effects of e cigarettes and uncover whether they can be effective and popular smoking cessation aids,” he says. “However, better regulation of e cigarettes is essential, as studies have shown that they are unreliable in the levels of nicotine they provide, and there’s a lack of evidence regarding their safety.”

The public has 75 days to comment on the FDA’s proposals, which also cover other non cigarette tobacco products including cigars, pipe tobacco, nicotine gels and hookah tobacco. The regulator will then amend the proposals but it could be years before they become law, as the current move is step five of a nine step process.

Journal reference International Journal of Environmental Research in Public Health, DOI 10.3390/ijerph110404356

American teens are less likely than european teens to use cigarettes and alcohol, but more likely to use illicit drugs

Cigarettes online Blog Archive Electronic cigarettes (e-cigarettes)

ANN ARBOR, Mich. The U.S. had the second lowest proportion of students who used tobacco and alcohol compared to their counterparts in 36 European countries, a new report indicates.

The results originate from coordinated school surveys about substance use from more than 100,000 students in some of the largest countries in Europe like Germany, France and Italy, as well as many smaller ones from both Eastern and Western Europe.

Because the methods and measures are largely modeled after the University of Michigan’s Monitoring the Future surveys in this country, comparisons are possible between the U.S. and European results. The 15 and 16 year old students, who were drawn in nationally representative samples in almost all of the 36 countries, were surveyed last spring. American 10th graders in the 2011 Monitoring the Future studies are of the same age, so comparisons are possible.

The differences found between adolescent behaviors in the U.S. and Europe are dramatic, according to Lloyd Johnston, the principal investigator of the American surveys.

About 27 percent of American students drank alcohol during the 30 days prior to the survey. Only Iceland was lower at 17 percent, and the average rate in the 36 European countries was 57 percent, more than twice the rate in the U.S.

The proportion of American students smoking cigarettes in the month prior to the survey was 12 percent again the second lowest in the rankings and again only Iceland had a lower rate at 10 percent. For all European countries the average proportion smoking was 28 percent, more than twice the rate in the U.S.

“One of the reasons that smoking and drinking rates among adolescents are so much lower here than in Europe is that both behaviors have been declining and have reached historically low levels in the U.S. over the 37 year life of the Monitoring the Future study,” Johnston said. “But even in the earlier years of the European surveys, drinking and smoking by American adolescents was quite low by comparison.

“Use of illicit drugs is quite a different matter.”

The U.S. students tend to have among the highest rates of use of all of the countries. At 18 percent, the U.S. ranks third of 37 countries on the proportion of students using marijuana or hashish in the prior 30 days. Only France and Monaco had higher rates at 24 percent and 21 percent, respectively. The average across all the European countries was 7 percent, or less than half the rate in the U.S.

American students reported the highest level of marijuana availability of all the countries and the lowest proportion of students associating great risk with its use factors that may help to explain their relatively high rates of use here, according to Johnston.

The U.S. ranks first in the proportion of students using any illicit drug other than marijuana in their lifetime (16 percent compared to an average of 6 percent in Europe) and using hallucinogens like LSD in their lifetime (6 percent vs. 2 percent in Europe). It also ranks first in the proportion reporting ecstasy use in their lifetime (7 percent vs. 3 percent in Europe), despite a sharp drop in their ecstasy use over the previous decade. American students have the highest the proportion reporting lifetime use of amphetamines (9 percent), a rate that is three times the average in Europe (3 percent). Ecstasy was seen as more available in the U.S. than in any other country.

For some drugs, however, the lifetime prevalence rate in the U.S. was just about the average for the European countries, including inhalants (10 percent), cocaine (3 percent), crack (2 percent), heroin (1 percent) and anabolic steroids (1 percent).

“Clearly the U.S. has attained relatively low rates of use for cigarettes and alcohol, though not as low as we would like,” Johnston said. “But the level of illicit drug use by adolescents is still exceptional here.”

Related Links

• Full European report
• Monitoring the Future

This was the fifth coordinated data collection in Europe as part of the European School Survey Project on Alcohol and Other Drugs, the first being held in 1995 with 26 countries participating. The research plan this time was for each country to generate a representative national sample of 15 and 16 year olds with at least 2,400 students being surveyed. All samples were nationally representative, except those in Germany, Russia, Flanders (the Dutch part of Belgium) and Bosnia Herzegovina. In each of these cases a sub national representative sample was surveyed, such as Moscow in the case of Russia.

The European survey group was led by Swedish sociologist Bjorn Hibbell, who has worked in the substance abuse field for many years. The American survey is led by social psychologist Lloyd Johnston, who has served as principal investigator of Monitoring the Future since its inception 37 years ago. MTF, which is conducted by the University of Michigan’s Institute for Social Research and is funded by the National Institute on Drug Abuse, had a sample of 15,400 10th grade students in 126 high schools in the 2011 survey. Students completed confidential, self administered questionnaires right in their classrooms in both the American and European surveys.