Qualified support for FDA

A US senator has decried the electronic-cigarette provisions of the Food and Drug Administration’s Comprehensive Plan for Tobacco and Nicotine Regulation, which was announced on Friday.

“The tobacco industry produces products that kill thousands of Americans each year, and sustains itself by recruiting ‘replacement smokers’ by marketing to young adults,” Oregon’s Senator Jeff Merkley, the top Democrat on the Senate Appropriations Subcommittee overseeing the FDA, said in a statement posted on his website. “That’s why we were hoping to hear a strong plan from the FDA today [Friday].

“Unfortunately, the FDA instead announced that it will allow e-cigarette products, largely aimed at children, to remain on the market for five more years with very little regulation.

“According to the CDC’s [Center for Disease Control and Prevention] latest data, 20 percent of high school students, and seven percent of middle school students – 12 and 13 year old kids – use e-cigarettes. And they use it [sic] because they have names like ‘cotton candy’, ‘froot loops’ and ‘gummy bear’. These are not products targeted towards adults. “While the FDA’s goal of reducing the level of nicotine in traditional cigarettes is an important and admirable goal, it does nothing to address the growing threat of e-cigarette usage. Thousands more children will become addicted during this time, and everyone who cares about America’s youth should be deeply concerned by this decision.”

Meanwhile, the American Heart Association (AHA) has said that while the FDA’s move to lower nicotine and examine flavoring comprise a promising step, the Deeming Rule delay is disappointing. It is concerned, also, that the FDA has raised the possibility of exempting premium cigars in the future.

“FDA’s move today to lower nicotine levels and take a harder look at how flavored tobacco products attract the young is to be commended,” said AHA CEO Nancy Brown.

“However, the Association is disappointed with the agency’s decision to delay certain e-cigarette and cigar compliance deadlines. Altering the deadline for FDA review of e-cigarettes and cigars is a troubling step and one that we will closely monitor.

“We are also concerned that the FDA has raised the possibility of exempting premium cigars in the future. Tobacco in any form presents risk. That’s why we have advocated for – and will continue to insist – that FDA oversight of all tobacco products is absolutely essential. Premium cigars are no different. Cigars are a concern because high school-aged males now smoke them at a higher rate than [they smoke] cigarettes. As we have seen in recent Senate legislation, often the definition for ‘premium cigars’ creates a loophole that allows the flavored and cheap cigars that attract youth to qualify as ‘premium’. Weakening the deeming rule in any way could lead to an increasing number of Americans at risk for heart disease, stroke or even an early death due to tobacco use.

“As the FDA carries out its new nicotine and tobacco plan, we urge the agency to remember that protecting public health, particularly the health of young people in this country, should be at the very top of its priority list. While we look forward to agency actions that can lower the number of Americans exposed to the harms of combustible tobacco, the FDA must advance all tobacco regulation. We must not take two steps forward and then one step back.”

The 22nd Century Group welcomed the FDA’s announcement. The group said that it was ‘uniquely positioned to deliver on the new product standards’ given that its proprietary “Very Low Nicotine” cigarettes contained less than 0.6 mg nicotine per piece and yielded less than 0.05 mg nicotine per piece. These levels represented a nicotine reduction of at least 95 percent relative to the levels of other cigarette brands.

The group said its tobacco was grown on ‘independently-owned farms in US, and was not subjected to any ‘artificial extraction or chemical processes’.

It was the only company globally that was capable of growing tobacco with non-addictive levels of nicotine.

The cigarettes produced from this tobacco, it added, had the ‘taste and sensory characteristics of conventional cigarettes’.