Feldman: FDA flavoring crackdown will save lives

In 2009, the Food and Drug Administration received authority from Congress to regulate tobacco products. While the legislation statutorily contains some tobacco-product restrictions, it also gives the FDA regulatory powers specifically over cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco. For other tobacco products, the law requires the agency to conduct evidenced-based determinations for actions necessary to protect the public health. As a result, the FDA promulgated a 2014 rule extending its authority to e-cigarettes, cigars, hookah and pipe tobacco. The FDA now regulates the manufacturing, import, packaging, labeling, advertising, promotion, sale and distribution of essentially all tobacco products.

The FDA has been slow to progressively exercise its authority over tobacco, resulting in regulatory gaps. However, recently the FDA began a process of restricting vaping products; and now the FDA proposes to ban menthol flavorings in cigarettes and all flavorings in cigar products, including cigarillos.

Flavorings in cigarettes were statutorily banned in the original legislation but menthol was excluded pending further FDA evaluation. Flavored cigars also represent one of those regulatory gaps. So delinquent were its actions on menthol, multiple public health groups filed a petition requesting the FDA to prohibit menthol. In a related 2020 lawsuit, a federal judge ordered a deadline for the FDA to issue a final menthol rule, which the FDA is now undertaking. The new proposed rules only apply to cigarettes and cigars and will not apply to some vaping products, smokeless tobacco and pipe tobacco. The industry will unfortunately increase marketing of these remaining products.

The tobacco industry has aggressively marketed menthol cigarettes, like Newport and Kool, to minority groups, especially African Americans, but also Hispanics and Asians. About 85% of Black, 46% of Hispanic, and 39% of Asian smokers use menthol cigarettes as compared to about 30% of white smokers. Menthol cigarette use is also higher among LGBTQIA+ individuals. Menthol cigarettes account for about 37% of the cigarette market.

Menthol increases the health risks of smoking. It intensifies the addictive qualities of nicotine, promotes use and makes cessation much more difficult. Because it blunts the harshness of tobacco smoke, menthol smokers tend to smoke more and inhale more deeply, increasing the cumulative dose of toxins. African Americans have higher rates of smoking-related diseases, certainly due in part to menthol use.

Similarly, youth smokers are also enticed by menthol’s flavor and masking effects of tobacco’s unpleasant taste and harshness. About half of teenage smokers use menthol cigarettes, increasing the risks for a lifetime of addiction.

The proposed rule will also address menthol and other flavored cigars and cigarillos. Menthol and other sweet flavorings especially make smoking more appealing to youth. After the 2009 ban on flavored cigarettes there was a shift to flavored cigars among both kids and adults, especially among Black and Hispanic youth who are twice as likely to smoke flavored products as compared to whites. One study found that 74% of teens said they smoked cigars because of the flavorings.

One objection to banning menthol and flavorings is that it would place individuals at risk for criminal prosecution for possession of menthol-tobacco products. The FDA is clear that enforcement would only be applied to manufacturers, distributors, and retailers, not individuals.

The bans are an important step to further promote cessation and to reduce smoking-related premature deaths, especially among minorities.

Next up? FDA limitations on the amount of nicotine in tobacco products.

Dr. Richard Feldman is an Indianapolis family physician and the former state health commissioner. Send comments to [email protected]