WASHINGTON, D.C. – As the six-year anniversary of the Family Smoking Prevention and Tobacco Control Act passed by this week, in an unsparing new letter nine U.S. Senators blasted the Obama Administration’s failure to finalize anti-tobacco regulations, calling the delays “unacceptable” and noting that youth use of new tobacco products is spiking as the Administration sits on the new rules.
The regulations, known as the “tobacco deeming rule,” would put in place important federal regulations, such as restrictions on sales to minors, for e-cigarettes and other currently-unregulated forms of tobacco and nicotine products.
In a letter to Health and Human Services Secretary Sylvia Burwell and Office of Management and Budget Director Shaun Donovan, Senators Jeff Merkley (D-OR), Patty Murray (D-WA), Sherrod Brown (D-OH), Richard Blumenthal (D-CT), Barbara Boxer (D-CA), Edward J. Markey (D-MA), Dick Durbin (D-IL), Jack Reed (D-RI), and Chuck Schumer (D-NY) pointed out that the rate of e-cigarette use recently tripled among high school students in just one year, yet the Administration has failed to take action to finalize the rule, a draft of which was published more than a year ago.
“The continued delay has put the health of America’s youth at risk, as every day the Administration delays, more and more young Americans start using currently unregulated tobacco products, such as e-cigarettes,” the Senators wrote. “Meanwhile, tobacco and e-cigarette companies continue to develop all kinds of new, innovative products, many with candy and fruit flavors to attract and ultimately addict America’s youth.”
“These unacceptable delays must come to an end,” they wrote.
The Senators also urged the Administration to make the finalized rule as strong as possible by explicitly banning the use of flavorings and marketing to appeal to children, and by ensuring that the “grandfather” date is not moved from February 15, 2007. A provision recently inserted into a U.S. House of Representatives Appropriations bill would move the grandfather date to exempt products currently on the market from FDA safety reviews, which would effectively create a huge loophole in which unregulated products that enter the market before the deeming rule is finalized would be exempted forever from reviews to ensure that the products are safe to use.
The full text of the letter follows below.
Dear Secretary Burwell and Director Donovan:
We are writing to express our deep concern and frustration with what have now been years of delay, and to urge the U.S. Department of Health and Human Services (HHS) and the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) to expedite their review of the Food and Drug Administration’s (FDA) final tobacco deeming rule.
It has been six years since the Family Smoking Prevention and Tobacco Control Act was signed into law. One of its major provisions was authorizing FDA to take authority over the full range of tobacco products, and yet the Administration has not even taken the most basic step – finalizing the tobacco deeming regulations – which would initiate that process. The continued delay has put the health of America’s youth at risk, as every day the Administration delays, more and more young Americans start using currently unregulated tobacco products, such as e-cigarettes.
According to the Centers for Disease Control and Prevention’s (CDC) 2014 National Youth Tobacco Survey released in April, the use of e-cigarettes among high school students tripled in the last year, from 4.5 percent in 2013 to 13.4 percent in 2014. That means in just one year of the Administration’s delay, approximately 1 million high school students started using e-cigarettes. And that was a year ago.
Meanwhile, tobacco and e-cigarette companies continue to develop all kinds of new, innovative products, many with candy and fruit flavors to attract and ultimately addict America’s youth.
It is important to note that this rule is only the deeming rule. If finalized as drafted, FDA will have to engage in further rulemaking in order to institute critical public health protections for new tobacco products, including e-cigarettes, such as placing limits on advertising and requiring health warnings on the products.
For that reason, we urge you to make the final deeming rule itself as protective as possible. The rule must give the FDA authority over all tobacco products including e-cigarettes and cigars, and it must explicitly ban the use of flavorings and marketing that appeal to children and mandate child-proof packaging of e-liquids (liquid nicotine). We also urge that the final rule will not move the “grandfather date” for new products (set at February 15, 2007). Altering this grandfather date would exempt a wide range of e-cigarettes and related products from any premarket review to determine whether they constitute threats to public health.
It is critical that HHS and OMB, in cooperation with FDA and the Administration, take immediate action to finalize the tobacco deeming rule to reduce tobacco’s harmful effects on public health, and especially the health of America’s youth. These unacceptable delays must come to an end.