What the FDA’s New Regulations for E-Cigarettes Mean for Clinical Research
May 16,2016 Sarah Stapleton

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

In their press release, the FDA says this move allows them “to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide.”

The Path Study, a joint study by the FDA and NIH shows that in 2013-2014, nearly 80% of youth who used tobacco had, in the last 30 days, used a flavored tobacco product. This means, that most of the youth who are using tobacco products are using products like e-cigarettes and hookah, which have a multitude of flavor options. Since not all states regulate the sale to minors in the same way, this ruling allows the FDA to standardize the age limit and prevent children and teens from purchasing these nicotine products and hopefully stop them from developing a nicotine addiction.

ecigarette wide

The FDA’s rule also adds the stipulation that manufacturers of e-cigarette products put on the market after February 2007 (meaning nearly all e-cigarette products) must meet “the applicable public health standard set forth in the law and receive marketing authorization from the FDA.” This means that the FDA will now be able to regulate ingredients, design, and health risks to the general public, including youths and non-users.

“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” said FDA Commissioner Robert M. Califf, M.D. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

As a clinical pharmacology research unit, we are committed to supporting the FDA in their mission to improve public health. This is why Altasciences’ Vince & Associates Clinical Research has added a new, dedicated smoking research facility to its campus. Our purpose-built unit has been designed for the evaluation of all types of smoking products, including e-cigarettes and vaping products. We are equipped for research in smoking cessation, smoking, vaping, tobacco risk assessment and nicotine delivery.

Smoking room

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

As more research is conducted into e-cigarettes, we will know more about their true risks and benefits. It will be a very interesting time in research as this new data is collected, evaluated, and the products become regulated.

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