A bipartisan bill introduced in the U.S. House could serve as the legislative path for peeling back tightened regulations on electronic cigarettes and other innovative tobacco products.
The U.S. House bill is named the “FDA Deeming Authority Clarification Act of 2017.”
A co-sponsor, Rep. Tom Cole, R-Okla., has pursued for several years a new grandfather date for marketplace introduction of those products. The other co-sponsor is Rep. Sanford Bishop, D-Ga.
The need for Food and Drug Administration authorization of ingredients and health document submission covers any nicotine or tobacco product introduced after Feb. 15, 2007 — the clear majority in the marketplace.
The FDA began on Aug. 8 enforcing tighter regulations on e-cigs, vaporizers, cigars, pipe tobacco and other products.
Although the FDA allows for up to a three-year retail exception for products whose manufacturer enters the regulatory gantlet, the high regulatory costs has driven many small e-cig and vape shops out of business or to begin selling off their inventory. Critics of the Feb. 15, 2007, grandfather date said the FDA is creating a marketplace where only the major tobacco manufacturers will be able to compete.
Bishop and Cole included similar legislation in the U.S. House Agriculture appropriations bill for fiscal 2016-17.
The bill contained language that would only permit funding for FDA “substantial equivalent” restrictions on e-cigs, vaporizers and hookahs with a start date of Aug. 8.
“While there is disagreement about whether certain tobacco products should be regulated or not, there should be agreement that new regulations should apply to products moving forward, and not retroactively,” Cole said.
“This legislation preserves the FDA’s ability to regulate these products on part with cigarettes, grandfathers currently available products, and then requires the FDA’s approval before any new product is introduced.”
The bill also would “impose common-sense licensing and advertising guidelines for vapor products and direct the FDA to establish product standards for vapor product batteries.”
Cole and Bishop said they believe e-cigs and vaporizers have a significantly reduced-risk usage compared with traditional cigarettes.
Some studies, including one by the Royal College of Physicians, have claimed e-cigs and vaporizers are up to 95 percent less harmful than traditional cigarettes. The Royal College’s study on traditional cigarettes played a key role in the landmark 1964 surgeon general’s determination.
“This legislation would ensure the FDA’s regulatory process does not limit the availability of safer tobacco options for those seeking to make use of them,” Bishop said.
On Dec. 8, U.S. surgeon general Dr. Vivek Murthy sounded an alarm about e-cigs, saying there’s no safe use of the products for people younger than 25.
“We know enough right now to say that youth and young adults should not be using e-cigarettes or any other tobacco product, for that matter,” Murthy said. “Electronic cigarettes place a whole new generation at risk for nicotine addiction.”
Murthy has been quoted as saying e-cig technology should be embraced if evidence shows it can help smokers who otherwise have trouble quitting their habit.
After President Donald Trump’s victory in November, U.S. Sen. Ron Johnson, R-Wis., sent a letter to the FDA commissioner warning him that a Republican-controlled Congress and White House will take aim at the new regulations.
In July, the two main takeaways from a report by the U.S. Centers for Disease Control and Prevention were claims that e-cigs are the most commonly used tobacco product among youths, and e-cigs may serve as a gateway to cigarette use.
Yet, the CDC report found high school students’ use of traditional and electronic cigarettes continued to go in opposite directions during 2015.
Anti-smoking advocates have explained the increase in young adults consuming e-cigs as experimentation typical of the young, and e-cigs as a better alternative to traditional cigarettes.
Anti-tobacco advocates are prodding Congress and the FDA to target flavorings in e-cigs and vaporizers because of their attractiveness to youths, to limit e-cig marketing, particularly on televisions, and raise the minimum age for all tobacco products to 21.
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