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FDA Issues Deeming Tobacco Regulations

The long-awaited rules have a negative impact on e-cigarettes and will require congressional action to amend.
May 6, 2016

​WASHINGTON – Yesterday, the U.S. Food and Drug Administration issued deeming rules, extending the agency’s authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.

The FDA first released its proposal to regulate e-cigarettes and other tobacco products in April 2014. The final regulations published this week will have a severe impact on the electronic cigarettes industry, thanks to a mandate that requires any nicotine delivery devices that hit stores after Feb. 15, 2007, to apply retroactively for approval, a costly and lengthy Premarket Tobacco Application (PMTA) process. E-cigarettes were not on the market prior to Feb. 15, 2007 (the predicate date).

While e-cigarettes could remain on the market during the PMTA process, it’s an extremely expensive route with an uncertain outcome. The FDA previously indicated that it did not have the authority to change the predicate date, and that it could only be done by congressional action.

This regulation, according to Ray Story, CEO of the Tobacco Vapor Electronic Cigarette Association, would “wipe out” the e-cigarette industry because it would require a change in current law.

“We agree with the commonsense decision to establish a minimum purchase age for electronic cigarettes,” said Jan Verleur, CEO and co-founder of vapor company VMR Products. “V2 was among the first electronic vaporizer companies to advocate for a ban on sales to underage users. Electronic cigarettes and vaporizers are not and have never been intended for anyone under the age of 18.

“We do disagree, however, with the decision to subject electronic vaporizers to an unnecessarily onerous approval process identical to combustible cigarettes,” Verleur added. “Current scientific research does not support this all-or-nothing approach, which threatens to eliminate 99% of the electronic vaporizer industry. And while many electronic vaporizers may look like traditional cigarettes to better simulate the tactile aspect of the smoking experience, there is otherwise no meaningful resemblance between the two product categories.”

Congressional action to change the predicate date took place on April 19. NACS Daily previously reported that the House Appropriations Committee passed an amendment to its Fiscal Year 2017 Agriculture Appropriations Bill that would change the predicate date for newly deemed products to the date of the FDA’s final rule. The amendment also includes additional consumer protections such as requiring safety product standards for e-cigarette batteries, requiring face-to-face sales, requiring “keep out of reach of children” and “underage sale prohibited” displays on vapor products, restricting advertising of the products to children, and labeling of nicotine content. The amendment also requires retailers to register with the FDA if they engage in the retail sale of vapor products, unless a retailer is already subject to an active registration under any state law relating to tobacco products.

Gregory Conley, president of the American Vaping Association, told Roll Call that the FDA’s refusal “to modernize the February 2007 predicate date will cause a modern day prohibition of products that are recognized worldwide as far less hazardous than cigarettes," adding that if the rule is not changed through congressional action or the courts, “thousands of small businesses will close in two to three years. Tens of thousands of jobs will be lost and consumer choice will be annihilated.”

FDA’s new regulations also restrict the sale of e-cigarettes to those under the age of 18. In March 2014, NACS issued a statement of position that encourages stores selling e-cigarettes to adopt as a best practice a policy of treating these products as age-restricted, subjecting them to the same age-verification procedures as those applicable to tobacco products.

The new regulations are effective 90 days from the date of publication of the final rule.