Despite decades of efforts to reduce tobacco use, it continues to be the leading cause of preventable disease and death in the United States. To address this public health problem, the U.S. Food and Drug Administration (FDA) announced on April 24, 2014, “sweeping” proposed regulations, including banning the sale of e-cigarettes and cigars to minors.
The proposed rules also call for strict regulation of other tobacco products, including pipe tobacco, nicotine gels, and waterpipe tobacco.
Consistent with currently regulated tobacco products, under the proposed rule, manufacturers of newly- deemed tobacco products would be required to:
- Register with the FDA and report product and ingredient listings
- Only market new tobacco products after FDA review
- Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole
- Not distribute free samples
Under the proposed rule, the following provisions would apply to newly-deemed tobacco products:
- Minimum age and identification restrictions to prevent sales to underage youth
- Requirements to include health warnings
- Prohibition of vending machine sales, unless in a facility that never admits youth
Read more in a statement from the FDA.
Pennsylvania physicians and the Pennsylvania Medical Society (PAMED) are encouraged by this news.
“While there is scant scientific knowledge about e-cigs, we do know a few things,” said PAMED President Bruce MacLeod, MD, in a statement. “The percentage of high school students using e-cigs has more than doubled in one year. And, the number of calls about nicotine toxicity to poison control centers nationwide is increasing. This in combination with the evidence that they can be a gateway to tobacco products raises the alarming concern that a new generation of tobacco abusers is being developed.”
Last October, physicians from Berks County, led by Richard Bell, MD, raised a red flag on these products at PAMED’s annual House of Delegates meeting. Since then, PAMED has dedicated a great amount of energy working to educate the public as we work to keep these away from children. We’ve had help from champions in the Pennsylvania legislature, including Sen. Tim Solobay who drafted Senate Bill 1055 to address this issue.
As the FDA recommendations go through a 75-day public comment period, PAMED applauds the move by the FDA and encourages those with similar concerns to participate in the commenting process.