April 1 is most commonly known as April Fool’s Day, but it’s also a day of recognition for an important healthcare cause: Take Down Tobacco National Day of Action.
As the culmination of a year-long process by the Campaign for Tobacco-Free Kids, Take Down Tobacco National Day of Action encourages people to stand up against Big Tobacco companies.
Formerly known as Kick Butts Day, the effort fits in with the larger push to establish a tobacco-free future, which has been a mostly successful movement thus far.
Since the late 1990s, tobacco usage among Americans has dropped precipitously, with less than one-in-five adults reporting use of any tobacco product, according to research conducted by the National Institutes of Health.
However, there are still millions of Americans either smoking cigarettes or seeking to consume nicotine in a smokeless way. This has contributed — in part — to the rise of e-cigarettes and vapes, along with Zyn nicotine pouches, with some pointing out abuse of the products or risk of harmful side effects.
This has also led to a series of regulatory battles between e-cig manufacturer Juul and the Food and Drug Administration as well as Swedish Match, the parent company of Zyn, and Senate Majority Leader Chuck Schumer, (D-N.Y.).
Beyond the smokeless tobacco debates, the Biden administration has been eyeing action on menthol cigarettes for years now.
While the White House delayed a ban on the products in December after months of pushback from civil rights groups that said regulatory action would unfairly target African Americans, FDA Commissioner Robert Califf reportedly pressed senior members of the administration to recommit to the ban in recent weeks.
With so much in flux, there is an opportunity for new smoking cessation therapies to enter the market and aid consumers seeking to wean off cigarettes, according to Qnovia CEO Brian Quigley.
A longtime head of Altria’s smokeless division, Quigley told MM+M that the lack of development around smoking cessation therapies and limited effectiveness of existing products leaves consumers with only a few options at their disposal.
He cautioned against a full-scale menthol cigarette ban, arguing that such a move could lead to unintended consequences like an illicit market. Instead, Quigley said the Biden administration should be pushing not only for additional regulations against smoking products but also supporting new medicines to help smokers quit.
“What we’re dealing with in 2024, if a regulation like this were to pass, are smokers left with the number one way to quit: cold turkey,” he said. “I think that is a real problem and there’s an obligation for regulations to happen in conjunction with a renewed focus on medicines to help people quit.”
That’s why Qnovia, a private equity-based pharma company, has been concentrating its resources behind its lead asset, QN-01, a nicotine replacement therapy.
In the fall, the company released positive results from its first-in-human pharmacokinetic and safety study of the drug and announced plans to file an investigational new drug application with the FDA and advance the clinical development program into Phase 1/2 clinical trials this year.
Additionally, Qnovia raised $17 million in a Series A financing effort in late 2022 to support development of its RespiRx nicotine-replacement product.
Quigley noted that for the next phase of tobacco use in America, health brands must learn from the sins of the past to avoid mistakes with marketing their products and inviting regulators to act.
By recognizing the unethical practices of marketing products to young consumers and ignoring the risks associated with tobacco products, he said companies can now go forward and market their nicotine products in a more appropriate, effective way.
He said operating in a more restrictive environment isn’t inherently a bad thing for tobacco companies or healthcare organizations looking to get into the nicotine space to help smokers successfully quit cigarettes.
There is a long-term opportunity to help people in need improve their health but Quigley cautioned that if the product that is intended to curb one evil contributes to the rise of another, that could create a whole host of problems from a marketing perspective.
“In this world of reduced-risk products, it’s been easy for some people to say, ‘Well, maybe [brands] are not being as disciplined as they were with cigarettes in the past.’ They could say, ‘But this is a safe product that will help this person, it will reduce their risk,’” he said. “This may be true, but it still doesn’t offset the fact that if a bad trend starts to occur, then you’re going to lose that opportunity.”
He added that a company entering the nicotine space should not only have their actions line up to the letter of the law, but also be guided by the spirit of the law as well.
