WASHINGTON — The Food and Drug Administration issued a sweeping set of tobacco rules Thursday that would regulate electronic cigarettes, cigars and other products for the first time, despite resistance from industry groups that say the new rules would be costly and unnecessary.
The 499-page final rule would require regulatory reviews for electronic cigarettes, cigars, and other products that went on sale after Feb. 15, 2007, unless the manufacturers can prove to the FDA that they’re “substantially equivalent” to products already being sold or that there is some other reason they should be exempt.
The rule also would ban the sale of e-cigarettes to anyone under age 18. Some states already have banned sales to minors, but others have not.
Under the new rules, manufacturers will have two to three years to come into compliance. That time frame includes a year, 18 months, or two years to prepare their applications — depending on whether the manufacturers are submitting to the reviews or arguing they should be exempt — and another year to win approval from the FDA. The process, known as “premarket review,” is used by the FDA uses to determine whether potentially risky products are safe.
“Today’s announcement is an important step in the fight for a tobacco-free generation — it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions,” Health and Human Services Secretary Sylvia Mathews Burwell said in a statement.
The new policy was a long time coming. In 2009, Congress authorized the FDA to regulate additional tobacco products, besides cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
The safety of e-cigarettes has been a topic of heated debate. Manufacturers insist they’re safer than tobacco cigarettes and are an effective way to help people stop smoking, but public health groups insist they’re still dangerous and need to be regulated.
In April 2014, the agency proposed what is usually referred to as “the deeming rule.” That proposal called for extending FDA authority to electronic cigarettes, cigars, pipe tobacco and other tobacco products.
The agency sent the final version of the tobacco rule to the White House Office of Management and Budget for review in October. That set off a round of lobbying by consumer advocates and the cigar industry as well as the nascent e-cigarette or “vaping” companies.
At the same time, uncertain about which way the rule would go, lobbyists for the cigar and e-cigarette industries pushed Congress to create bills that would exempt them from the new rules, or at least “grandfather” in products that are already on the market.
The rule also brings all kinds of cigars under the FDA’s authority, a step that the cigar lobby had been fighting. There had been a push to exclude so-called “premium” cigars — usually hand-rolled and with more expensive flavorings — but the agency concluded there was no public health justification for excluding any subset of cigars.
One big concern for cigar manufacturers was that cigar boxes, which enthusiasts often regard as works of art, would be subjected to warning labeling requirements. The agency has decided to mandate warning labels on all cigar packages, covering at least 30 percent of the main sections of the package and displayed in at least 12-point font.
The agency did say, however, that it would not require manufacturers to submit their products for approval before reaching the market when some, but not all, blending changes are made, another point of contention from manufacturers.
The rule, which is effective in 90 days, will ban the sale of e-cigarettes and other products to anyone under age 18, either in person or online. They also will have to carry warning labels declaring that the products contain nicotine and that nicotine is addictive.
The rule also will ban the sale of these and other tobacco products in vending machines, and customers will have to show photo identification to be able to buy them.