FDA Answers 5 Questions on Proposed Menthol Cigarette Ban

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) is on track to release two proposed product standards by spring—one prohibiting menthol as a characterizing flavor in cigarettes and another prohibiting all characterizing flavors in cigars.

At a Feb. 10 webinar, leaders at the FDA’s Center for Tobacco Products (CTP) answered questions regarding the proposals; however, they would not answer questions about specific details of the proposed rules, like how the FDA is defining characterizing flavors and what products this would apply to, until they are published.

Here are highlights reflecting the most common questions the FDA answered:

After the FDA publishes the proposed regulations in the Federal Register, there is usually a 60-day period for the public to submit comments. Then the FDA reviews the comments, makes any changes to the proposed regulations that it sees fit, obtains approval of the final regulations from the White House Office of Management and Budget (OMB) and publishes a final version of the regulations with an effective date.

While May Nelson, director of the CTP Office of Regulations, said she could not speculate on the anticipated effective date, she said it is usually at least one year after the date of its publication.

“The tobacco control act specifically states that product standards generally must have an effective date of at least one year after the date of its publication, unless FDA determines that an earlier effective date is necessary for the product of public health,” she said.

Once the proposed rules are published in the Federal Register and posted on regulations.gov, the FDA will begin accepting comments. The Federal Register notice will provide instructions on how to submit comments and will specify the timeline for which comments are allowed.

The product standards being discussed would only address manufacturers, distributors, wholesalers, importers and retailers, Nelson said. And because FDA’s regulation of tobacco products is federal in nature, these product standards would set requirements for those entities throughout the country.

“Though a city, county, or state could theoretically enact sales and distribution laws regarding flavored cigarettes and cigars that may be more stringent, FDA’s regulatory authority is such that it can enforce its product standards throughout the country and does not need additional laws to do so,” Nelson said.

The FDA is aware of concerns that removal of these products could result in increase in illicit or black-market products, Nelson said. The FDA will consider any adverse effects including the possibility of an illicit market, when considering a product standard.

“FDA believes that there are several significant public health benefits to moving forward with the product standards, which are aimed at reducing initiation, reducing progression to regular smoking and increasing cessation,” she said.

The agency also has regulatory tools and enforcement authority to address products marketed without authorization, she said.

Each year, more than 480,000 people die prematurely in the United States for tobacco-related disease, mainly due to smoking, said Kathy Crosby, director of the CTP’s Office of Health Communication and Education. And nearly 41 million adults in the United States use any combusted tobacco products, including cigarettes and cigars, she said.

“The proposed rules FDA will publish this spring are intended to make the largest impact in reducing tobacco-related death and disease by targeting the deadliest tobacco products,” Crosby said. “At the same time our commitment to address youth use of e-cigarettes and other electronic nicotine delivery systems in unwavering.”

The FDA is addressing youth use of e-cigarettes, in part, through the premarket tobacco product application (PMTA) process, which is ongoing.