Friday, August 8 marked the end of the comment period for a proposed rulemaking by the Food and Drug Administration to classify electronic cigarettes as the equivalent of combustible tobacco cigarettes. The proposed rule would ban the sale of e-cigarettes to minors, require FDA approval of the products, and require manufacturers to disclose the chemicals used in the nicotine delivery devices – which replace cigarette smoke with vapor – and note on product labels that nicotine can be addictive.
The following statements from tobacco and e-cigarette policy experts at The Heartland Institute – a free-market think tank – may be used for attribution.
“The FDA’s proposed regulation would decimate the small businesses that make up America’s independent e-cigarette industry and remove a powerful tool smokers are using to kick the habit. Congress never intended for the regulations it crafted for cigarettes and smokeless tobacco to apply to innovative tobacco-free products. The FDA has the authority to propose alternate regulation for e-cigarettes that wouldn’t ban 99 percent of the products. They should do so for the betterment of public health.”
“In my submission, I explain why the FDA should use its statutorily granted discretion in setting a grandfather date for e-cigarettes to the effective date of the proposed rule, or, at earliest, as the date the proposed rule was published.
“The agency’s attempt to incorrectly set the grandfather date for newly deemed e-cigarettes to February 15, 2007 is a failure to exercise its statutorily granted flexible enforcement authority, as well as a failure to implement the statute’s call for appropriate regulatory controls. As a result of the agency’s misapplication of the statute, the FDA’s proposed rule would have the unintended consequence of harming public health by failing to provide effective oversight of industry’s effort to develop, introduce, and promote less harmful tobacco products.
“Ironically, in claiming to implement the statute by adhering to the wrong grandfather date, the agency would be failing to enforce the statute and would harm public health in the process.”