What has the FDA been up to? Quite a bit. In recent months the FDA has engaged both the public and industry in several matters related to monitoring and regulating the sale and advertisement of tobacco products. Check out the news wrap up below to learn more.

10,000th Tobacco Retailer Warning Letter

Since 2009, the FDA has worked in concert with states and territories by conducting tobacco product retailer inspections to ensure that retailers and the industry are in compliance with laws concerning the sale and advertisement of tobacco products. As of July 31, 2013, over 189,000 tobacco product retail inspections have been completed. First time violators receive a warning letter outlining the law violation and action required to become compliant. Recently, the FDA reached a milestone and has issued its 10,000th tobacco retailer warning letter. In addition, the FDA issued warning letters to three tobacco manufacturers and one tobacco product retailer that sold roll-your-own (RYO) products labeled as “pipe tobacco.” Due to the way the products were packaged and advertised, the FDA deemed them to be cigarette products and as a result they became subject to FDA regulation. Violations included selling modified-risk tobacco products without an order in effect and selling prohibited flavored cigarette tobacco products.
To read the warning letters in their entirety, visit the FDA’s website.

A FDA First: Substantial Equivalents Approval

In June 2013, the FDA approved the first new tobacco products since the enactment of the Family Smoking Prevention & Tobacco Control Act of 2009: Lorillard Tobacco Company’s “Newport Non-Menthol Gold Box 100s” and “Newport Non-Menthol Gold Box.” Four other products were deemed, “not substantially equivalent” and were ineligible for a marketing order. Through the “Substantial Equivalents” approval process, the FDA determines whether or not a new tobacco product causes more harm to public health than products already existing on the market.  If health effects are equivalent to products that are already on retail shelves, the product under review is approved and receives a marketing order. To learn more about the approval process pathways, read the FDA’s article on tobacco product marketing orders.

Under Investigation: Menthol in Cigarettes

On July 23, 2013, the FDA released an Advance Notice of Proposed Rule-making (ANPRM) in order to gather public input, data and research to help determine if regulatory action for menthol cigarettes is necessary. The comment period is open for 60 days and feedback can be submitted here. If the FDA concludes that regulatory action is appropriate, a Notice of Proposed Rule-making will be issued in which additional input from the public will be collected and used to help shape the specifics of a proposed menthol rule.

To date, the FDA has compiled a document of existing scientific literature titled, “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Non-Menthol Cigarettes.” The 153 page report focuses on the effects of menthol cigarettes vs. non menthol cigarettes on public health in nine key areas: smoke chemistry and non-clinical toxicology, physiology, bio-markers, patterns of use, marketing and consumer perception of risk, initiation and progression to regular use, dependence, cessation and disease risk.

The FDA also intends on funding additional research focused on:

• Differences in smoking cessation and quit attempts between menthol smokers and non-menthol smokers
• Analysis of menthol levels by cigarette brands and sub brands
• Comparing exposure of smoke related toxins and carcinogens between menthol smokers and non-menthol smokers
• Examining the role that genetic differences in taste perceptions has on racial disparities in menthol cigarette use
• Investigating the effect of menthol and non-menthol compounds on tobacco addiction and toxicants of tobacco smoke

Other Tobacco Products Regulation on the Horizon

The FDA intends on releasing a Notice of Proposed Rule-making regarding other tobacco products by October 2013. According to the provisions of the Family Smoking Prevention and Tobacco Control Act, other tobacco products include cigars, pipe tobacco and electronic products such e-cigars and e-cigarettes. As of now, it is unclear which products will be the focus and how stringent the proposed FDA regulations will be. After the Notice of Proposed Rulemaking is issued, the public (retailers, trade associations, wholesalers, manufacturers and NATO) will have the opportunity to submit comments. Once the comment period closes, the FDA will review submissions and consider incorporating suggested changes into the finalized regulation.

Stay tuned for updates regarding the release of this rule.

Last updated October 11, 2023