FDA’s New Regulations For E-Cigarettes Has A New Message For Clinical Research

Owing to the many critical and fatal aspects of tobacco and cigarette, came the existence of E-cigarettes. But are they safer than tobacco? Or a high-tech way to hook a new generation on a bad nicotine habit?

Truth is uncertain!

Research into the side effects of e-cigarettes is far behind their popularity. But want it or not, the era of e-cigarettes is here. It’s a booming, billion-dollar industry…..on route to outsell tobacco products within a decade. The number of teens and twins using these products doubled between 2011 and 2012.

In a historic move, the FDA extended its authority to all tobacco products. This implies they will now be putting regulations on for e-cigarettes, cigars, hookah and pipe tobacco, as well as others.

In a press release, the FDA said that this initiative allows them to improve public health and protect future generations from the dangers of tobacco using through a variety of steps, including restricting the sale of these tobacco products to minors nationwide.

The Path Study initiative shows that in 2013-2014, nearly 80% of youth who used tobacco had, in a month’s time, used a flavored tobacco product. This means, that most of the youth who are using tobacco products are using products like hookah and e-cigarettes , which have a multitude of flavor options. Now all states do not regulate the sale to minors, this allows the FDA to confirm the age limit and prevent children and teens from purchasing these nicotine products and make an attempt to stop them from developing a nicotine addiction.

The FDA’s rule also adds the condition that manufacturers of e-cigarette products put on the market after February 2007 must meet the mentioned applicable public health standard set forth in the law and receive marketing authorization from the FDA. This says that the FDA will now regulate the ingredients, design, and health risks to the general public, including youths and non-users.

He FDA Commissioner Robert M. Califf, M.D. said that as a physician, he has seen the devastating health effects of tobacco use and added that at the FDA, they should do their

job under the Tobacco Control Act to lessen the harms due to tobacco. That includes ensuring consumers about the information they need to be aware of before taking decisions about tobacco use and making sure that new tobacco products would come under comprehensive FDA review.

Any a clinical research unit, are committed to support the FDA in their mission to improve public health. Hence, Altasciences’ Vince & Associates Clinical Research has introduced a new, devoted smoking research facility to its campus. That research unit has been created for the evaluation of all types of smoking products, including e-cigarettes. In a report they said that they are equipped for research in smoke cessation, tobacco risk assessment, smoking and nicotine delivery.

Though it might take some time probably in years for the FDA to finalize all of the laws and regulations regarding the testing and sale of e-cigarette products. A clinical study funded by the Health Research Council of New Zealand said that e-cigarettes are as effective as other smoking cessation products;but the research is limited, so organizations like the FDA don’t recommend them yet for that purpose. An exception to this is National Health Service in the UK, which made e-cigarettes a part of their smoking cessation program in January 2016.

Many researches are being conducted into e-cigarettes, and eventually all knows more about their actual risks and benefits. It’s high time to conduct clinical research on e-cigarette such that next generation does not fall in the clutches of a probable fatal trap.

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