On the surface, the ruling, which was finalized today, bans the sale of e-cigarettes, cigars, pipe tobacco, and hookah tobacco to people under the age of 18 in line with current cigarette regulations.
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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. Producers will be subject to FDA inspections and will not be able to market their products as “light” or “mild”, unless the FDA allowed them to.
E-cigarette makers will be required to submit for regulatory review any products that were not on the market as of 15th February 2007 – in other words, effectively all e-cigarettes.
But the regulations also require that e-cigarette manufactures register with the agency and put any new devices through a pre-market regulatory approval process. These regulations include some relatively uncontroversial rules such as a ban on selling e-cigs to minors (which some states have already done), requiring a photo ID to buy e-cigs, not selling e-cigs out of vending machines, and a ban on free e-cig samples.
Manufacturers can continue to sell their e-cig products during the two years in which FDA tobacco product applications are being submitted.
“Today’s rule is a milestone in consumer protection that marks a new chapter in our efforts to do everything we can under the law to protect Americans from the dangers of tobacco products”, Califf said.
“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap”, said Health and Human Services Secretary Sylvia Burwell.
FDA approval can cost anywhere from $2 million to $10 million per item, said SciLucent LLC, a regulatory consulting company.
“E-cigarettes are clearly tobacco products, and they should be strictly regulated as such”, March of Dimes President Dr. Jennifer L. Howse said in a statement. While nicotine can still be addictive in vapor form, e-cigarettes lack the chemicals of tars and burning tobacco.
The new rule also has several provisions meant to restrict youth access to such products. “We can not let the enormous progress we’ve made toward a tobacco-free generation be undermined by products that impact our health and economy in this way”.
For now, e-cigarette users may not see big changes.
The FDA announced the new rules Thursday.
Manufacturers will have to report to the FDA the contents of e-cigarette fluid, which is heated into a mist that can be inhaled.
Not only will sales now be banned to anyone under 18, e-cigarettes will have to carry health warnings on their packaging.
“Today’s action by the FDA will do nothing to improve our nations’ public health objectives”.
And it’s been argued that using e-cigarettes to slowly decrease the amount of nicotine has allowed long time smokers to quit entirely.
About one in five Americans smokes, and the habit kills 480,000 people in the United States each year, according to health authorities.
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That could force e-cigarette smokers back to regular cigarettes, he says.
