FDA Regulations Draw More Than 70,000 Comments

Tobacco companies and public health officials are debating the health consequences of using electronic cigarettes, as the comment period for the Food and Drug Administration’s new e-cigarette regulations closes today.

A group of public health organizations, including the American Cancer Society, American Heart Association and Campaign for Tobacco-Free Kids, are asking the FDA to strengthen the regulations and speed up implementation.

But e-cigarette companies say such rules would have a “negative” impact on public health, because they would limit the access people to have a product that may actually help them quit smoking.

The FDA will wade through these and more than 72,000 other remarks, as the agency enters the final stages of the rule-making process.

“The serious adverse public health consequences of the current unregulated market for cigars, e-cigarettes, and other products demand that FDA exhibit a sense of urgency in its rulemaking process on deeming,” the group of health organizations wrote in a letter to the agency. “FDA should commit itself to issuing a final deeming rule within one year of publication of the proposed rule, which is on or before April 25, 2015.”

That notion is backed by Lorillard, the largest e-cigarette maker which controls about 40 percent of the market.

“Electronic cigarettes hold the potential to advance the public health dramatically by moving existing users of conventional tobacco products to lower risk options,” Lorillard writes in its comment. “In fact, an international expert panel recently estimated that electronic cigarettes have only four percent of the maximum relative harm of conventional cigarettes, suggesting that substitution of electronic cigarettes for conventional cigarettes is likely to provide a significant public health benefit.”

The FDA proposed the e-cigarette regulations in April and extended the comment period through Friday, so that both sides would have more time to consider the rule.

Once the comment period closes, the FDA will begin reviewing each of the comments, which could take months as more than 72,000 people responded. After this, the agency can move forward with a final rule.