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Senators Send Letter Urging Obama to Quickly Review E-Cigarette regulation Rule


October 21, 2015 -11:10 PM


WASHINGTON, D.C. – U.S. Sen. Sherrod Brown (D-OH) – along with U.S. Sens. Jeff Merkley (D-OR), Richard Blumenthal (D-CT), Charles E. Schumer (D-NY), Patty Murray (D-WA), Barbara Boxer (D-CA), Edward J. Markey (D-MA), Dick Durbin (D-IL), Jack Reed (D-RI), Dianne Feinstein (D-CA), and Elizabeth Warren (D-MA) – today pressed the White House Office of Management and Budget (OMB) to complete its review of a long-overdue rule to regulate e-cigarettes and other forms of tobacco as quickly as possible. Due to the federal government’s failure to finalize regulations, in just one year, e-cigarette use among both high school and middle school students has tripled. After years of inaction, the Food and Drug Administration (FDA) finally released its proposed rule on April 25, 2014. However, more than one year later, this rule has still not been finalized. The FDA finally sent the rule to OMB for OMB’s Office of Information and Regulatory Affairs’ (OIRA) review earlier this week. A Centers for Disease Control and Prevention (CDC) study released in April found that e-cigarette use had tripled among high school students in just one year, from 4.5 percent in 2013 to 13.4 percent in 2014.

In today’s letter to OMB Director Shaun Donovan, the Senators wrote, “In the six years since the passage of the Tobacco Control Act, tobacco and e-cigarette companies have had time to develop new, innovative products, many with candy and fruit flavors, to attract and ultimately addict America’s youth…. It is critical that the Administration take swift and immediate action to finalize the tobacco deeming rule in order to reduce tobacco’s harmful effects on public health, and especially the health of America’s youth.”

Congress gave the Food and Drug Administration (FDA) the power to oversee various forms of tobacco products more than six years ago, when Congress passed the Family Smoking Prevention and Tobacco Control Act in June 2009. However, it took until April 2014 for FDA to issue draft “deeming” rules that would bring e-cigarettes, cigars, and other forms of tobacco products under the FDA’s jurisdiction, and in the 18 months since as youth e-cigarette use has skyrocketed, the rules still have not been finalized. The Senators have repeatedly pressed the administration to finalize the rules in a timely fashion.

In their letter, the Senators also urged OMB to ensure that the final rule includes strong regulations to help prevent youth tobacco use and other harmful effects, including a minimum age standard, limits on advertising, health warnings on the products, bans on the use of flavorings and marketing that appeals to children, and mandatory child-proof packaging of e-liquids to protect young children from accidental nicotine poisoning. Additionally, they urged the Administration not to grandfather products such as e-cigarettes from reviews to determine whether they constitute threats to public health.

The full text of the letter follows below.

Dear Director Donovan:

We are writing, more than six years after Congress passed the Family Smoking Prevention and Tobacco Control Act giving the Food and Drug Administration direct authority to begin regulating all tobacco products, to urge the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) to complete its review of the FDA’s final tobacco deeming rule as soon as possible. We also strongly urge that the final rule gives FDA authority over all tobacco products, including e-cigarettes, and does not move the “grandfather date” for new products.

As you know, Executive Order 12866 limits to 90 days the period for OIRA review. Yesterday, an FDA spokesman stated that “[w]hile the office has 90 calendar days to review rules, the window could be extended to allow for further interagency discussions.” Finalizing this rule cannot wait until 2016. The proposed deeming rule was issued over eighteen months ago on April 25, 2014 and FDA, HHS, and OMB have had ample time to confer.

Every day of further delay is compromising the health of America’s youth. According to the Centers for Disease Control and Prevention (CDC) 2014 National Youth Tobacco Survey released in May, e-cigarette use among high school students tripled in the last year, from 4.5 percent in 2013 to 13.4 percent in 2014. In the six years since the passage of the Tobacco Control Act, tobacco and e-cigarette companies have had time to develop new, innovative products, many with candy and fruit flavors, to attract and ultimately addict America’s youth.

Due to the impact this rule will have on protecting public health, we urge OIRA to complete its review expeditiously so that FDA can issue the final rule as soon as possible. In Executive Order 13563, President Obama confirmed the need for a transparent and timely review process. Once the deeming rule is final, FDA will be able to regulate new tobacco products in important ways. These include imposing minimum age standards, limits on advertising, and health warnings on the products; requiring the registration of tobacco product manufacturers with FDA; and mandating FDA approval of some novel products.

We urge OMB to work quickly to finalize review of the final deeming rule, ensuring that the rule gives FDA authority over all tobacco products including e-cigarettes and cigars, explicitly bans the use of flavorings and marketing that appeals to children, and mandates child-proof packaging of e-liquids (liquid nicotine). We also implore that the final rule 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 the Administration take swift and immediate action to finalize the tobacco deeming rule in order to reduce tobacco’s harmful effects on public health, and especially the health of America’s youth.

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