ZONNIC

Zonnic gum, a stop-smoking product from a Reynolds American subsidiary, is the first stop-smoking aid sold by a tobacco manufacturer with FDA approval.

Most adults recognize that nicotine is the ingredient in tobacco that makes them want to smoke.

Nicotine is present in combustible cigarettes, electronic cigarettes and Food and Drug Administration-approved nicotine replacement therapies (NRT) used to help smokers stop smoking.

However, a majority of people erroneously believe nicotine is the ingredient that causes cancer from smoking traditional cigarettes, according to a recent study by a prominent research group, PinneyAssociates.

Instead, it is the burning of tobacco leaves that releases most of the carcinogens related to traditional cigarettes.

That misconception is playing a role in smokers not believing there is a significant reduced-risk harm difference between traditional cigarettes and e-cigs, PinneyAssociates researchers said. Their findings were presented Feb. 24 at the Society for Research on Nicotine and Tobacco’s 24th annual meeting.

Researchers analyzed data from 1,736 adults in the government-run 2017 health information national trends survey.

About 85 percent said nicotine is what causes people to want to keep smoking, while 53 percent said they believe nicotine causes most of the cancer related to smoking.

Smokers are three times as likely — 52.5 percent to 14.6 percent — to believe nicotine causes cancer than e-cig users, the study found.

Only 31.6 percent of smokers agreed that e-cigs are less harmful than cigarettes.

Several prominent studies, including from the Royal College of Physicians, have found that e-cigs are up to 95 percent less harmful to use than traditional cigarettes.

“It’s troubling that adults’ misperceptions about the health effects of nicotine persist despite the long-term availability of FDA-approved over-the-counter NRT products,” said Karen Gerlach, lead author on the study.

PinneyAssociates is a pharmaceutical development company. Among its services are “managing issues and the scientific and policy environments to gain regulatory approval for new products,” and “enhancing the scientific and policy environments to maximize product acceptance.”

In February 2015, Reynolds American Inc. formed a partnership with PinneyAssociates and affiliate JSR LLC to expand Reynolds’ product portfolio for consumers who want to eliminate or reduce nicotine consumption. That work includes Reynolds subsidiaries Niconovum USA Inc. and R.J. Reynolds Vapor Co.

Gerlach and PinneyAssociates indicated the results of the study show federal regulators need to be upfront and clearer “to the public, especially smokers, that nicotine is not what is causing smoking-related disease.”

On July 28, FDA Commissioner Scott Gottlieb announced plans for a sweeping regulatory “road map” on tobacco and nicotine products.

The road map includes: recognizing a continuum of risk involving nicotine and tobacco products; lowering the nicotine level in traditional cigarettes to nonaddictive levels; limiting or eliminating flavorings, such as menthol in traditional cigarettes and candy and fruits in e-cigs and vaporizers, which the agency says appeal to youths; and establishing rules to make the product-review process more efficient, predictable and transparent for manufacturers, while upholding the FDA’s public-health mission.

Since Gottlieb’s statement, analysts and industry observers have pointed to the committee’s votes as a potential watershed moment in public health, as well as offering the best indication to date of how the FDA is responding to the Trump administration’s push for relaxed and/or rolled-back regulations.

Gerlach said that having federal regulators, as well as public-health advocacy group, provide more clarity on how nicotine is consumed can help smokers “understand that there is a continuum of risk across nicotine-containing products, and use that understanding to help them reduce risks to their health.”

Challenge for doctors

Dr. John Spangler, professor of family and community medicine at Wake Forest Baptist Me dical Center, said he faces “this misconception about nicotine virtually every day in clinic.”

He said that notion affects his ability to get some patients to view NRT products as a viable option to quit smoking.

Spangler said nicotine “is pretty safe for the vast majority of patients — except for pregnant women, adolescents and ill patients with unstable heart disease.”

Spangler said he tells patients that using NRT products doubles their chances of successfully quitting, and they can be weaned off nicotine.

“I ask many of my patients facetiously, ‘if you get addicted to nicotine gum or patch, so what?’” Spangler said. “Continued nicotine replacement use is much safer than smoking.”

Spangler said one challenge is getting patients to use enough nicotine to replace the nicotine they get from smoking.

He said a general rule is that a cigarette gives a smoker about 1 milligrams of nicotine, so a pack-a-day smoker should strive to get 20 milligrams of nicotine each day.

“The first-level patch gives 21 milligrams of nicotine for 24 hours. But this is just baseline nicotine,” Spangler said.

“Smokers should also carry short-acting nicotine with them, such as gum or the lozenge, for use when they confront triggers, which often happen after a meal, while on the computer or while they’re under stress.”

In September 2014, Reynolds began national distribution of Zonnic, Niconovum’s NRT product that is the first stop-smoking aid sold by a tobacco manufacturer with FDA approval. It is sold at retail stores nationwide, mostly in convenience store chains.

“We’ve got a lot of people who I believe probably need nicotine for the rest of their lives and the goal here would be — if that’s the case— let’s get them a product that’s not going to kill them,” said John Pinney, chief executive of PinneyAssociates.

Some anti-smoking advocates say offering Zonnic in a smaller volume may encourage smokers who are trying to quit, but don’t want to buy a larger package.

Brad Rodu, a professor of medicine at Louisville and an anti-smoking advocate, said the misconception about nicotine has come from “the demonization of the drug and its conflation with smoking by governmental authorities and major health organizations.”

“The FDA, since 2009, has had regulatory authority over both tobacco and pharmaceutical nicotine. It could have served as an educational resource for correcting misperceptions about the health effects of nicotine.

“It has done nothing.”

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