While the U.S. Food and Drug Administration’s proposed deeming regulations on cigars, pipe tobacco, e-cigarettes and hookah tobacco that were released in August have garnered most of the industry’s attention, there are other important issues and actions that the FDA is working on that may affect tobacco retailers in the future.
Menthol in Cigarettes
Although the FDA is not under any mandate from Congress to adopt more regulations on the use of menthol in cigarettes, in July 2013 the agency asked for public comment on whether the agency should propose additional restrictions on its sale, distribution, advertising and promotion.
The public submitted more than 225,000 comments to the FDA on the question of more regulations on menthol cigarettes. Since the public-comment period closed in November 2013, the FDA staff has spent more than a year reviewing the comments.
The FDA has also conducted an extensive review of existing studies on menthol cigarettes. Moreover, the FDA has funded three ongoing studies as a way of obtaining more scientific data on the subcategory. These studies focus on the topics of taste perception and tobacco use, measurement of the uptake of carcinogens by menthol-cigarette smokers, and the role of menthol in airway health consequences.
While there is no specific timeline for the FDA to consider proposing new regulations on menthol cigarettes, a federal judge issued a ruling on a lawsuit brought by Lorillard Tobacco Co. and R.J. Reynolds Tobacco Co. against the FDA that requires the agency to appoint new members to the FDA’s Tobacco Product Scientific Advisory Committee (TPSAC).
This court ruling is important because it also prohibited the FDA from using or relying on the report prepared by the TPSAC, which in part concluded that the “removal of menthol cigarettes from the marketplace would benefit the public health in the United States.” However, in July 2014, the FDA appealed this ruling to the U.S. Circuit Court of Appeals. The lawsuit remains on appeal.
In short, the ongoing review of public comments, the commissioning of three major studies on menthol and the appeal of the federal court decision mean that the FDA may not make any formal decisions on whether to pursue additional regulations on menthol cigarettes for the foreseeable future.
Minimum-Age Study
While states and cities consider law changes to raise the legal age, the FDA has funded a study through the Institute of Medicine to determine if raising the legal age to purchase tobacco products to 21 or 25 would have an effect on the public health. The study is a requirement of the Family Smoking Prevention and Tobacco Control Act, the law that Congress passed that authorized the FDA to regulate tobacco products. The legal-age study is scheduled to be completed and presented to the FDA by April or May. The FDA then must report to Congress on the study conclusions.
On the federal level, it would be up to Congress to consider legislation to increase the legal age to purchase tobacco products. The FDA does not have the authority on its own to raise the legal age.
The ‘Real Cost’ Ads
The FDA has produced a second set of four TV commercials under the agency’s “The Real Cost” campaign, which is targeted at youth ages 12 to 17 to educate them about the health consequences of tobacco use. The new commercials can be viewed at www.fda.gov/tobaccoproducts.
The important characteristic of the new commercials is that they do not depict a young person buying cigarettes or tobacco products in a convenience store. The first set of TV commercials produced and aired by the FDA earlier this year showed a young male and a young female purchasing cigarettes with money and body parts in a c-store. The new commercials are being aired on TV and are also on YouTube.
FDA Retail Compliance Checks
Over the past four years, the FDA has contracted with state agencies to conduct compliance checks on retailers that sell tobacco products. According to an FDA report titled “Compliance and Enforcement Report” covering the period from June 2009 through September 2013, there have been 221,774 compliance inspections for such retailers.
As a result of these 221,774 inspections, there have been only 9,786 instances of retailers selling tobacco products to a minor. This translates into a 95.6% success rate. Moreover, only 6,533 instances occurred in which a retailer failed to verify the age of a person purchasing tobacco products by means of photographic ID, which is a 97.1% success rate. This means that the vast majority of retailers are diligent about doing their part to comply with the law and keep tobacco out of the hands of underage youth.
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