Substantial Moves

Are Zeller’s announcements on substantial equivalence and menthol historic—or more of the same from the FDA?

By  Melissa Vonder Haar, Tobacco Editor

Article Preview: 

Besides scientific evidence, Zeller and the CTP will also have to consider any “unintended consequences” menthol regulations might have on public health. For many, these unintended consequences refer to one major issue.

“Zeller and the FDA stated over and over again that it needs to be a science-based recommendation and there cannot be any unintended consequences,” Herzog says. “If they were to ban menthol, you would very likely have a black market.”

For a real-life example of how those unintended consequences could play out, Zeller and his counterparts need look no further than Canada, where menthol cigarettes have already been banned. Combined with high tax rates on legal cigarettes, the ban has led to a rampant black-market state in our neighbor to the North: It’s estimated that as much as 50% of all cigarettes consumed in Canada come from illicit trade.

Not only does this hurt legitimate retailers, but it also hurts public health by making it easier for minors to access tobacco products through the black market. And it also hurts local governments, which lose necessary tax revenue for their coffers.

“If menthol is banned or severely restricted, retailers will be competing with a greatly expanded black market for cigarettes,” reads NACS’ letter to the FDA in response to the menthol ANPRM. “Cigarette sales won’t occur across the counter in our stores. Instead, they will take place down the street, outside our stores, and you can be sure that these street-corner vendors won’t be checking IDs for birthdates.”

Assuming that the FDA makes its menthol decision based on the science and the potential unintended consequences, Herzog finds it difficult to believe that the agency will propose an outright ban.

“Zeller keeps repeating that the decision needs to be very much science-based, rigorous in their testing, and certainly needs to consider the unintended consequences,” she says. “That’s [how] I’m basing my prediction that menthol will not be banned.”

That’s not to say that a complete ban on menthol is the FDA’s only option, especially with the CTP and earlier-released Tobacco Products Scientific Advisory Committee (TPSAC) reports providing a number of ways in which menthol cigarettes pose a threat to public health.

“If the FDA believes the science supports doing something on menthol, there are things they could consider,” says Wilson, pointing to additional labeling requirements for menthol products or distributing public health messages constructed by the agency as possible alternatives to a ban. “I think they’ve got some other tools available that would allow them to raise awareness on issues that they’re concerned about and take some action as long as the science and evidence supports it.”

For her part, Herzog believes an outright ban on menthol is unlikely but anticipates that the agency could instead regulate the amount of menthol allowed in cigarettes.

Click here to download full article