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FDA DEVELOPING POLICIES FOR E-CIGARETTES & NICOTINE PRODUCTS

By Vanessa Blanchard, Daily Digest News

Wednesday, June 11, 2014

Policies are expected to be developed over the next few years and will incorporate scientific data gathered on the risks and benefits of e-cigarettes independent of traditional cigarettes.

The FDA announced on Wednesday that it is currently working to develop a strong and thorough set of standards meant to regulate the e-cigarette industry. The goals of the policies will be to regulate non-combustible nicotine delivery devices in ways that address public health, and that protect companies and the agency itself from litigation.

The standards are expected to be developed over the next several years. There is still a great amount of data left to collect regarding whether or not the potential health risks of electronic cigarettes are similar to that of smoking.

Director of the FDA’s Center for Tobacco products, Mitchell Zeller, says that the development of standards will incorporate scientific findings on this topic but notes that nicotine itself is not the greatest danger presented in traditional cigarettes. “It’s not the nicotine that kills half of all long-term smokers, its the delivery mechanism,” he said. “We have to recognize some of these realities and figure out how they can impact regulatory policy.”

So far, the FDA has enforced its first regulations on the e-cigarette industry by restricting sales to those 18 years or older. Their restrictions do not include internet advertising or sales, nor does it restrict flavor productions. Some criticism was garnered in the wake of these omissions. Zeller insists that nicotine consumption is not to be encouraged in minors, but reminds the public that restrictions need to be based on scientific evidence that has not yet been fully gathered. Determinations of health and safety need to be based on empirical data unique to the product in order to avoid limiting potentially beneficial technologies for cigarette smokers.

Plans for future regulations include standards for production and for monitoring the effects of products once they are released. They also want to ensure that law enforcement establishes a strong network meant to ensure compliance with the standards developed by the FDA. Additionally, accurate educational efforts will be made to ensure that distinctions between nicotine products are publicly known. Each product will be treated individually of the others, meaning e-cigarettes will not be classed with traditional cigarettes in policy development.