Three of the most powerful members of the House of Representatives have requested the grandfather date used for the proposed regulations of tobacco products by the U.S. Food & Drug Administration (FDA) be moved to a date no earlier than April 25, 2014.
Speaker of the House, Rep. John Boehner, R-Ohio, House Majority Leader, Rep. Kevin McCarthy, R-Calif., and Fred Upton, R-Mich., the Chairman of the Committee on Energy and Commerce, co-authored a letter that will be welcome news to cigar smokers.
It was addressed to Sylvia Burwell, secretary of the Department of Health and Human Services (HHS), Margaret Hamburg, commissioner of the FDA, and Mitch Zeller, director for the FDA’s Center for Tobacco Products. In it, they requested the date for the grandfathering of tobacco products be moved from Feb. 15, 2007 to April 25, 2014—the day the proposed regulations were announced—or the date in which is enacted, which will be in 2015 at the earliest.
Regardless of how the FDA regulates premium cigars, any product that was being marketed prior to Feb. 15, 2007 will be grandfathered in. Even if the strictest rules are imposed on premium cigars, the only changes manufacturers will have to make to these products are: new warning labels, refrain from providing free samples and disclose their ingredients to the FDA. Boehner et al. are asking for the date to be moved back, a potentially huge win for cigar smokers.
“IPCPR supports and applauds the Speaker’s letter to HHS and FDA,” said Kip Talley, IPCPR senior director of federal legislative affairs, to halfwheel. “By correcting the date, our industry manufacturing partners will be treated fairly and innovative new products will continue to be developed.”
That 2007 date was created by the Tobacco Control Act. The three House Republicans argue that the 2007 date would “create an inequity between currently regulated products and newly deemed tobacco products.” This is in reference to e-cigarettes, which the FDA did not consider regulating until 2011, two years after the Tobacco Control Act was passed.
Boehner et al. argue that because virtually no e-cigarette products were on the market as of Feb. 15, 2007, the grandfather date will unfairly limit the category’s growth. For products like premium cigars, companies will almost certainly use a “substantial equivalence” standard for approval of any product introduced after the grandfather date. In short, a company looking to gain approval would argue that their new product is substantially equivalent to a product already approved, including those grandfathered. A company might argue that a premium cigar rolled entirely by hand using a mixture of tobaccos from Cameroon and the Dominican Republic is substantially equivalent to a grandfather Arturo Fuente Hemingway, and as such poses no additional risk to public health.
Because no e-cigarette products will be grandfathered under the current date, it’s unlikely e-cigarettes will be able to use that standard for some time. As such, each company will have to go through far costlier new product applications or pull their products from the market. In addition, the FDA’s track record of approving new product applications is abysmal, approving only one new product over the course of a few years.
It should be noted that major tobacco corporations such as Altria, RJR-Lorillard and Imperial Tobacco have all taken interest in the e-cigarette space recently.
For more information about the proposed regulation of premium cigars, visit halfwheel.com/fda.