Very Different UK and US Positions on Vaping

If you care about the impact of e-cigarettes on people's health, then this is the worst of times and the best of times, depending on which side of the Atlantic you live on.

In late April, the Royal College of Physicians in the UK released a report titled "Nicotine Without Smoke - Tobacco Harm Reduction." The document presents a strong and scientifically sound case for e-cigarettes:

Providing nicotine that is addictive but free from the harmful components of tobacco smoke can prevent most of the harms of smoking.

The UK is doing the best. In contrast, the stance in the United States is very different.

In May, Sylvia Burwell, the Secretary of Health and Human Services, stated at the FDA headquarters:

"We have more work to do to help Americans, especially our youth, avoid the harms of tobacco and nicotine. While the smoking rate among youth under 18 has declined, the use of other nicotine products, including e-cigarettes, has surged. All of this puts a new generation of Americans at risk of addiction."

Burwell announced new FDA regulations in May, stating that e-cigarettes are considered tobacco products and will be regulated accordingly.

The new regulations advocated by Burwell will almost certainly harm small e-cigarette companies, as they impose excessive regulatory burdens. These requirements are unrealistic from both scientific and management perspectives.

Below is a summary of the details of the new regulations formulated by Professor Michael Siegel of Boston University. Please note that it is not intended for individuals with heart failure.

Clinically, companies must provide evidence of the vapor content of each product and its impact on human health. Specifically, manufacturers need to provide data on "physiological measurements such as heart rate and blood pressure, lung, heart, and metabolic function; adverse reactions such as throat irritation and coughing; and changes in laboratory values such as inflammatory mediators and blood routine indices."

This data will take a long time to collect and is arguably unnecessary for market entry. It is known that e-cigarettes are less harmful than cigarettes. Moreover, based on the known toxicology of e-cigarette aerosol particles, the absence of smoke means that the levels of toxins are negligible, and the harm from e-cigarettes has been significantly reduced. (However, the long-term effects of propylene glycol inhalation remain unknown.)