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Deeming authority: Deadly serious and seriously outraged

We had a bit of fun last week on April Fool’s Day, imagining that the deeming regulations that establish the Food and Drug Administration’s authority over “other tobacco products” (e.g., cigars, hookah, and e-cigarettes) were at long last finalized.

Our April Fool's take on the deeming process was good for a laugh. But the fact that the deeming regulations have not been finalized is deadly serious and a serious disappointment.

The Obama administration ushered in the Family Smoking Prevention and Tobacco Control Act seven years ago with a triumphant signing ceremony where the president said all the right things about the law’s promise for ending tobacco-related death and disease. But it took five years to get from a new law to draft regulations which would finally give the FDA authority to regulate all tobacco products. And as of April 25, 2016, two full years will have passed since the draft regulations were published. To be sure, the volume of comments on the rule was considerable. But the final regulation was transmitted to OMB in October for what should have been a 90-day review period. Nearly six months later, we still have no firm fix on when the final regulations will be published.


According to the Surgeon General, 5.6 million U.S. children alive today will experience premature death due to smoking unless we can take the next steps to end the tobacco epidemic.

There may be those who don’t share our sense of urgency, so permit me to highlight what’s at stake:

Tobacco is still the number one preventable cause of death in the U.S. – and by a long shot. Nearly half a million Americans experience premature death caused by tobacco use every year. These are debilitating illnesses and painful deaths due to respiratory and heart failure as well as cancer. According to the U.S. Surgeon General, one-third of cancer deaths are caused by smoking – cancer deaths that are avoidable by dramatically reducing tobacco use. And its not just lung cancer: tobacco has firmly established links to at least a dozen different kinds of cancer – including mouth, larynx (voice box), esophageal, pancreatic and colorectal cancers, as well as acute myeloid leukemia.

There are those who think cigarette use is down so much that regulating those products that are not currently under the FDA’s jurisdiction isn’t a major health factor – but they’re wrong. While cigarette use is down among youth and adults - teen cigarette use was 7.0 percent in 2015 and adult use was 16.8 percent in 2014- current youth tobacco use trends show increasing use of unregulated tobacco products, many of which are combustible tobacco and therefore just as deadly as cigarettes. The percentage of U.S. teens that used combustible tobacco increased to 11.2 percent when taking into account the use of unregulated cigarillos alone. The hookah tobacco, little cigars and cigarillos and e-cigarettes that appeal to young people are the products that would be regulated once the deeming rules are finalized.

According to the Surgeon General, 5.6 million U.S. children alive today will experience premature death due to smoking unless we can take the next steps to end the tobacco epidemic. This is the low hanging fruit of cancer and disease prevention.

Delaying the obvious next steps for tobacco control benefits only big tobacco, whose business model depends upon finding replacement smokers for their addictive and deadly products. And as President Obama noted in his remarks at the signing ceremony for the Tobacco Control Act, the tobacco industry has

generally won the day up on the hill.

Yet seven years later we are up against the very real prospect that even if the deeming regulations are finalized, the process will have taken so long that Congress could act to nullify the regulations as soon as the Obama’s moving van pulls away from the West Portico. The process is linked to the number of days left in the Congressional session, and while we don’t know exactly when, by mid-May we calculate we are at risk of being pushed back to square one when it comes to extending the FDA’s authority beyond cigarettes, smokeless tobacco and roll-your-own tobacco.

We can’t afford to go back to square one because the deeming regulations take us only the first lap - there’s so much more that the FDA and HHS need to do. We need deeming rules so the FDA can move ahead with next steps, like issuing product standards to reduce the toxicity, addictiveness and/or appeal of cigars and e-cigarettes and reducing the nicotine content of cigars and e-cigarettes to eliminate the addictive nature of these products. And specifically to protect kids from tobacco, we need the FDA to get busy extending the ban on flavored cigarettes to include all tobacco products and especially menthol-flavored tobacco products, including cigarettes. Seven of ten youth tobacco users reported that they had used a flavored tobacco product within the past 30 days. And 88 percent of African American smokers, whose smoking-related mortality is higher than among whites, report using menthol products.

There’s an enormous amount to be done with millions of young lives at stake. So while we hope you enjoyed a good laugh with us last week, we’re even more hopeful you will share some of our outrage this week.