Last year, our blog “We Don’t Know Enough About Electronic Cigarettes” outlined how the lack of information about these increasingly popular nicotine delivery systems makes it impossible to determine, among other things, if they help people quick smoking tobacco and what are their side effects for users or bystanders.
Now, the FDA wants to scrutinize these products more carefully and is proposing tighter regulations on their use. As described by the New York Times, for the first time, the new rules would extend the agency’s authority from cigarettes to e-cigarettes, which “have grown into a multibillion-dollar business with virtually no federal oversight or protections for American consumers.”
Electronic cigarettes are battery-powered devices that supply nicotine from a chamber containing liquid that’s heated to a vapor.
The proposed regulations would ban the sale of e-cigarettes, cigars and pipe tobacco to anyone younger than 18, and would require consumers to prove they are old enough to purchase the products. Some states already impose those requirements.
Use of pipe tobacco and cigars has increased lately, and they haven’t been regulated, so the proposal has implications for the whole tobacco industry.
If implemented, the regulations would apply to what, according to The Times, “has been a market free-for-all of products, including vials of liquid nicotine of varying quality and unknown provenance. It has taken the agency four years since Congress passed a major tobacco-control law in 2009 to get to this stage, and federal officials and advocates say it will take at least another year for the rules to take effect – and possibly significantly longer if affected companies sue to block them.”
The 2009 law, according to the FDA, empowered it to prohibit sales to minors of all tobacco products over which it has authority, so it would expand to cover more products. The proposal doesn’t comment on their safety, just their need to be regulated.
Manufacturers of cigars and e-cigarettes would have to register with the FDA, supply a detailed accounting of their products’ ingredients and disclose their manufacturing processes and scientific data. They would be subject to agency inspections.
Manufacturers would be prohibited from offering samples, and e-cigarette packaging would include warning labels that they contain nicotine, which is addictive. Companies would not be able to claim that e-cigs are less harmful than tobacco cigarettes unless scientific studies proved it to the FDA.
But, as The Times points out, the proposal is notable for what it doesn’t do. It doesn’t ban the flavoring often used in the liquid that many public health experts claim is meant to attract children (kid-friendly flavors include bubble gum and peanut butter, to name two). Also lacking is any restriction of marketing of e-cigarettes. So, unlike tobacco cigarettes, they could be advertised on TV.
FDA officials said the proposal is the first major step in asserting the agency’s authority, and that in the future it might be able to regulate flavors and marketing. It can’t impose such restrictions until a health risk to young people has been proved. Remember, the FDA’s attempt to dissuade consumers from using cigarettes by displaying graphic warnings on the packaging was met with a First Amendment right to free speech complaint by tobacco companies, which they won.
The proposed regulations cover other tobacco products not named in the 2009 tobacco control law, including certain dissolvable tobacco products, water pipe tobacco and nicotine gels.
The proposal is open to public comment for 75 days, after which the FDA will make final changes. If you want to read and comment on the regulations, link here.