FDA walking an e-cigarette tightrope
E-cigarettes might be closer to smoking cessation devices than to regular cigarettes, and regulators are keeping “an open mind” on their potential health benefit, according to a story by Edney Anna for Business Week (Bloomberg), quoting Mitch Zeller, head of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP).
Zeller said the agency was exploring expedited reviews for tobacco products based on risk and toxicity levels as it prepared its e-cigarette rules.
He said he wanted advocates and foes to view nicotine-containing products as a continuum—from cigarettes to their electronic counterparts to cessation gums and patches.
“Cigarettes are designed to create addiction,” Zeller said on Wednesday at a Washington conference. “Ultimately it’s not the nicotine that kills. It’s all about the delivery mechanism.”
But, according to a National Association of Convenience Stores story, Zeller said the CTP did not yet know the extent to which e-cigarettes were harmful.
And, he added, it did not know if e-cigarettes were more likely to help current smokers transition away from tobacco use, or if they are more likely to encourage nonsmokers to begin using tobacco.
The FDA is responsible for implementing the Family Smoking Prevention and Tobacco Control Act, which was enacted in June 2009. The law, which gives the FDA broad authority to regulate the manufacture, marketing and retail sale of tobacco products, initially granted the FDA jurisdiction over cigarettes, roll-your-own tobacco and smokeless tobacco products. But, in April, the FDA proposed extending its authority to cover additional products such as e-cigarettes, cigars and hookah tobacco.
Meanwhile, a story by Toni Clarke for Reuters said the FDA was working to develop strong product standards for e-cigarettes and other nicotine delivery devices that would protect public health and enable the agency to withstand legal challenges.
Zeller had said the CTP was exploring potential product standards in the areas of addiction, toxicity and product appeal as it prepared to gain regulatory authority over e-cigarettes and other nicotine-delivery devices.
The establishment of product standards was one of five priorities for the division over the next few years, Zeller said. The priorities included putting in place regulations for approving new products and monitoring them after they reached the market, ensuring that the agency had in place a strong compliance and law enforcement presence in every state, public education and the formulation of an FDA-wide nicotine policy that recognized some products were less risky than others.
