Before there was even a fancy term like "nicotine replacement therapy," the Swedish were using nicotine gum in the 1960s to help royal navy submariners manage their nicotine cravings while aboard the confines of the vessel. That gum eventually became Nicorette gum, which today is manufactured by Johnson & Johnson's (JNJ 0.42%) McNeil subsidiary and is distributed in the U.S. by GlaxoSmithKline (GSK 0.77%), the industry's largest NRT manufacturer, with 50% market share.
Since then, a whole class of NRTs have been recognized by the FDA that include skin patches, lozenges, nasal sprays, and inhalers, but because their intended use is to have you quit smoking as opposed to merely get a nicotine fix through a different means -- and the fact that, when introduced, there was no data available about the health effects of long-term use -- the FDA requires manufacturers to carry warning labels to cease use after 12 weeks.
Today, however, there is a growing global body of evidence that there are no ill effects from extended usage of NRTs, and after long consideration, the FDA recently signed off on their safety and will allow manufacturers to remove the warning labels from their packaging..
That's not an insignificant development, because there are growing competitive threats to the industry. While Glaxo's dominance has long held generic NRTs largely at bay and has seen only modest competition from Novartis, with its Habitrol lozenges, and Pfizer, with prescription-grade NRTs, some studies suggest that gums, patches, and the rest have little impact on helping smokers actually quit. At the same time, the rise of cigarette alternatives such as electronic cigarettes could eat into the NRT market.
Harvard University found that NRT use was no more effective in helping smoking cessation over the long haul than people trying to quit on their own. Despite the prevalence of NRTs in the market for decades, they point to CDC data showing that previous declines in adult smoking rates and quitting rates have stalled in the past five years.
But electronic cigarettes could be the bigger threat. Featuring no smoke, no ash, and, more importantly, no tar -- it's the tar that kills you -- electronic cigarettes are a small but growing niche for tobacco companies. From 750,000 e-cigs sold in 2010, its estimated some 3.5 million were sold in 2012.
The FDA originally sought to prevent their importation but lost several court cases and now says so long as they're not marketed as therapeutic, they're legal. Lorillard (LO.DL) has become a big e-cig manufacturer, with more than $39 million in sales and enjoying a 30% share of the market. Goldman Sachs estimates it will be a $1 billion in industry sales in a few years, which may prove too lucrative an option for Altria (MO 0.93%), the biggest tobacco company and one still on the e-cig sidelines. Reynolds American (RAI) plans to play all sides, as it will soon introduce both e-cigs and NRT gum.
Although it's doubtful e-cigs will ever get the same establishment support as nicotine gum and patches -- some states are trying to regulate them and ban them out of existence -- it could mark a new period for smokers to choose an option that doesn't require them to be second-class citizens, separate and not even equal.
While warning labels on NRTs were never in the same league as the graphic images on cigarette packages that failed to muster judicial support, the new labeling rules could be an impetus for additional growth while allowing them to maintain their marketplace advantage.