Center for Tobacco Products Director Says Menthol Cigarette Ban Remains Top Priority

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In May, the Food and Drug Administration’s Center for Tobacco Products (CTP) Director Brian King spoke to a joint meeting of the National Association of Tobacco Outlets (NATO) board of directors, the Energy Marketers Association (EMA) board leadership and EMA’s state association executive directors in Washington, D.C.  King’s presentation focused on four areas:  rules and regulations, premarket tobacco product application review, compliance and enforcement and public education.

The following were several key takeaways from King’s presentation and from the engagement with NATO and EMA leadership:

• While the Biden administration has announced a delay in the finalization of the menthol cigarette and flavored cigar ban rules, King said implementing these bans remains a top priority of the agency.  He also said that these rules, while separate, remain tied together in the timing of the rulemaking process.
• Regarding the premarket tobacco product applications (PMTAs) review process, King said the agency has completed its review of 99% of the 26 million applications (mostly for e-cigarettes) submitted and is currently reviewing 9,500 PMTAs for products containing synthetic nicotine (926,000 rejected). 
• While King reiterated that only 23 e-cigarette products have received marketing authorizations, he said that there will be other e-cigarette products authorized and is open to authorizing a flavored product if the science submitted meets the appropriate for the protection of public health standard.  He indicated that applications remaining for review are very substantial, and the agency is working diligently to review them.
• On compliance and enforcement, King touted the agency’s ramped up efforts against e-cigarettes that lack proper authorization including recently issuing more than 550 warning letters, assessing more than 130 civil monetary penalties, and collaborating with U.S. Customs Border Protection on seizures at ports of entry.
• King also encouraged retailers to use the agency’s resources to keep up-to-date on agency developments including utilization of the searchable tobacco products database. The database is expected to be updated monthly and contains information on legally marketed products. When asked if the database could include products that have pending applications, King said there are legal and privacy restrictions that prevent that information from being published. He also reminded the attendees that FDA makes retailer compliance webinars available to keep retailers informed.

NATO will continue to engage with King and FDA leadership in support of its members.

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