WASHINGTON, D.C. – Following a proposal in the U.S. House of Representatives that would leave many e-cigarette products on the market without a safety review, U.S. Sen. Sherrod Brown (D-OH) criticized the Obama Administration for its failure to finalize tobacco deeming regulations that would give the agency the same regulatory authority it has over cigarettes to other unregulated tobacco products, such as e-cigarettes and hookah. In the year that the Federal Drug Administration (FDA) has failed to finalize regulations, e-cigarette use among both high school and middle school students has tripled. The move by the House comes on the heels of the sixth anniversary of the Family Smoking Prevention and Tobacco Control Act – which gave the FDA full authority to regulate tobacco products.
Brown outlined his concerns in a letter to Health and Human Services (HHS) Secretary Sylvia Burwell and Office of Management and Budget (OMB) Director Shaun Donovan, also signed by eight of his Senate colleagues.
“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.”
This week, the U.S. House of Representatives reported a draft of its Agriculture and FDA appropriations bill, which includes a provision that would exempt most e-cigarettes and flavored cigars that are already on the market from the pending federal regulation. This provision would move the “grandfather” date for products currently on the market to exempt them from FDA safety reviews. This would create a large and dangerous loophole through which unregulated products that enter the market before the deeming rule is finalized would be forever exempted from reviews to ensure that the products are safe to use.
According the Centers for Disease Control and Prevention (CDC), e-cigarette use increased from 4.5 percent in 2013 to 13.4 percent in 2014 among high school students, and from 1.1 percent in 2013 to 3.9 percent in 2014 among middle school students.
The FDA’s proposed rule was released more than one year ago – on April 25, 2014 – but has not yet been finalized. In March, Brown sent a letter to Secretary Burwell urging her to finalize these rules. Brown has also introduced legislation to close loopholes in the tax code that allow the tobacco industry to avoid paying taxes on their products. The Tobacco Tax Equity Act would simplify and equalize taxes on all tobacco products, including existing products that currently fall into loopholes as well as new products like e-cigarettes.
The full text of the letter follows:
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.