The Obama administration on Thursday released the long-awaited final version of a sweeping new rule that, for the first time, allows the agency to regulate all tobacco products, including cigars, electronic cigarettes, hookahs, personal vaporizers and electronic pipes.
The rule prohibits companies from selling any of these newly deemed tobacco products to anyone under the age of 18 and requires sellers to check photo IDs when making a sale.
The rule also prohibits the products from being sold in vending machines, distributed as free samples or marketed as “light,” “low,” or “mild” unless authorized by the Food and Drug Administration (FDA).
Manufactures will also be required to put health warnings on product packaging and on advertisements.
When the rule was first proposed in April 2014, the industry was most concerned about a provision that would have required all products that hit store shelves after February 2007 to apply retroactively for approval — a process that companies claimed would be prohibitively expensive and said would wipe out the e-cigarette industry.
To address these concerns, the FDA said it’s staggering the compliance date for newly deemed products.
For products on the market when the rule takes effect in 90 days that were not on the market on Feb. 15, 2007, manufacturers will have 12 months to submit an exemption request, 18 months to submit an application proving the product has a substantial equivalent already on the market and 24 months to submit an application for pre-market approval.
The American Lung Association welcomes what it called a long-awaited step to protect public health.
“At last, the Food and Drug Administration will have basic authority to make science-based decisions that will protect our nation’s youth and the public health from all tobacco products, including e-cigarettes, cigars and hookah,” ALA President and CEO Harold Wimmer said in a statement.
“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” FDA Commissioner Robert Califf said in a statement. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”
The FDA is expecting cigar manufacturers or importers to spend $278,000 to $397,000 in the first year, $292,000 to $411,000 in the second year, and $235,000 to $257,000 in the third year to comply with the new rule.
E-cigarette manufacturers or importers are expected to spend $827,000 to $1.21 million in the first year, $832,000 to $1.21 million in the second year, and $22,000 to $64,000 in subsequent years.
While the FDA said in its rule-making that it expects the number of vape shops in operation to fall in the first year, it expects many to continue to operate.
The Vapor Technology Association said the FDA’s new rule will kill a decade of innovation that’s helped people stop smoking.
“If enforced, the unreasonable and excessive regulations proposed by the FDA will only serve to put these innovators out of business, their employees out of work and hand deliver a monopoly on vapor products to Big Tobacco,” VTA National Legislative Director Tony Abboud said in a statement.