This week, we learned that the U.S. Food and Drug and Administration (FDA) delivered its proposed regulations to the White House Office of Management and Budget (OMB). Now eleven U.S. Senators have sent a letter to OMB Director Shaun Donovan to complete its review process as quick as possible.
The eleven U.S. Senators include: Dick Durbin (D-Ilinois), Jeff Merkley (D-Oregon), Richard Blumenthal (D-Connecticut), Charles E. Schumer (D-New York), Patty Murray (D-WA), Barbara Boxer (D-California), Edward J. Markey (D-Massachusetts), Sherrod Brown (D-Ohio), Jack Reed (D-Rhode Island), Dianne Feinstein (D-California) and Elizabeth Warren (D-Massachusetts).
In a press release, the Senators reference Executive Order 12866 that limits a review period to 90 days, but also notes that the window could be extended to allow for further interagency discussions. The Senators also note that the proposed regulations were issued back on April 25, 2014 and that the various agencies have had “ample time to confer”. The delivery of the proposed regulations to the OMB is a necessary step as this organization administers the budget necessary to implement such regulations.
The letter cites “youth tobacco use” as a driving force and calls for such regulations as a minimum age standard, health warnings on the products, bans on the use of flavorings and advertising / marketing limitations.
One issue that has been a major question impacting the cigar industry is the proposed grandfather date for new products effected by the regulations. The eleven Senators urged the OMB not to move the proposed grandfather date from February 15, 2007. Last year, three members of Congress (which included Speaker John Boehner, House Majority Leader Kevin McCarthy, and Fred Upton) wrote to the Department of Health and Human Services requesting the date be moved to either April 25th, 2014 or a date the final rule was published. There is a proposed Bill, H.R. 2058 in the U.S. House of Representatives that supports this.
While E-Cigarettes are prominently mentioned in the letter, it is also worth noting the eleven Senators urge that the final rule be implemented for “all tobacco products”.
The contents of the propsed ruling are not known at this time. When the FDA released its Deeming Document containing a set of proposed regulations. In that document, two Options were presented, one of those options known as “Option 2” defines what a premium cigar is and provides for an exemption.
Simultaneously, there are members of the Senate opposed to such regulations. Currently, 18 Senators have signed on to S. 441 which calls an exemption from FDA regulations for premium cigars.
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.