E-Cigarette Regulations Proposed By The FDA
April 24, 2014

FDA Proposes Extending Tobacco Authority To E-Cigarettes

Brett Smith for redOrbit.com - Your Universe Online

As the debate rages on over whether electronic cigarettes are a healthier alternative to traditional cigarettes or a gateway to them, the Food and Drug Administration unveiled new regulations controlling electronic smoking devices and other previously unregulated tobacco products on Thursday.

The new regulations would ban the sale of the smoking devices, as well as the nicotine products they burn, to individuals under the age of 18. The new rules would also ban the sale of cigars, pipe tobacco, waterpipe (or hookah) tobacco, and dissolvables – products that previously went unregulated at the federal level. Some states and large cities already have laws similar to the new FDA rules in place.

“This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” said HHS Secretary Kathleen Sebelius in a statement from the FDA.

The new rules call for the specific products to essentially come under the same regulatory umbrella as cigarettes. Manufacturers would have to register with the FDA and report all product ingredients. Also, new products could only be marketed after FDA approval and companies would be prevented from giving out free samples.

While some have claimed that e-cigarettes are a more benign alternative to conventional cigarettes, manufacturers would not be able to make that claim unless it is backed by FDA-confirmed scientific studies.

“Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products,” said FDA Commissioner Dr. Margaret A. Hamburg. “Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth.”

“Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims.”

Anti-tobacco advocacy groups praised the new regulations, but noted that the rules must first go through a comment period and potential litigation from the e-cigarette industry.

“If it takes more than a year to finalize this rule, the FDA isn’t doing its job,” Matthew Myers, president of the Campaign for Tobacco-Free Kids, told the New York Times.

Critics of the law also said that it didn’t go far enough in not regulating sales over the internet and of flavored tobacco e-cigarette liquids.

“You can’t get to the flavors until you have regulatory authority over them,” Zeller noted, adding that the new regulations are “foundational.”

Anticipating new regulations on their industry, e-cigarette advocacy groups sent lobbyists to pushback against potential regulation in November – holding almost 50 meetings with legislators to educate them “about the negative impact inappropriate regulation could have on this nascent industry,” according to a statement from the Smoke Free Alternatives Trade Association.