The Food and Drug Administration is no longer putting limits on how long someone trying to quit smoking can use a nicotine-replacement therapy product, such as gum or a patch.
The FDA began regulating tobacco products and marketing in June 2009, but it does not have the authority to ban nicotine or tobacco.
The agency said Monday it is removing warnings, as well as limitations in directions, to allow flexibility in how the products are used and for how long. It is recommending that users get a physician’s approval to go beyond the typical 8- to 12-week use period. Makers of the NRT products must seek approval to change their labels.
The changes “reflect the fact that although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold over the counter do not appear to have significant potential for abuse or dependence,” the agency said.
“There are no significant safety concerns associated with using more than one over-the-counter NRT at the same time, or using an over-the-counter NRT at the same time as another nicotine-containing product — including a cigarette.”
Several types of FDA-approved smoking cessation products are available, with and without a prescription. Those sold over the counter include nicotine gum, transdermal nicotine patch and nicotine lozenge products.
“FDA hopes the recommended changes will allow more people to use these products effectively for smoking cessation, and that tobacco dependence will decline in this country,” said Dr. Margaret Hamburg, the FDA’s commissioner.
The decision could serve as a boost for Zonnic gum, an NRT product being test-marketed in Des Moines, Iowa, by the Niconovum pharmaceutical subsidiary of Reynolds American Inc.
“This is a very beneficial step by the FDA,” said Tommy Payne, president of Niconovum USA. He said the FDA already has approved of Zonnic. “Their recommendations have the potential to significantly benefit public health.”
GlaxoSmithKline, one of the leading NRT manufacturers, said it believews the FDA's action "is a positive step to help more smokers quit." The company said it would work with the FDA to make the labeling changes as soon as possible for its products, such as Nicorette and NicoDerm CQ,
John Spangler, a professor of family and community medicine at Wake Forest School of Medicine, said he has known for more than a decade that some patients need to be on NRT products for a long period of time.
“Those of us who help lots of smokers have been doing this already for years,” Spangler said. “No medication is without side effects, but most patients tolerate two NRT products extremely well, and I have not seen any harm.
“It should be noted that pregnant women, adolescents and patients with recent heart disease within the last two months should not use NRT ... even a single product.”
Brad Rodu, a professor of medicine at the University of Louisville and a smokeless-tobacco advocate, said the FDA is “taking a step in the right direction” with its latest recommendations. “The time length listed on these products is more for weaning people off nicotine,” he said.
The FDA said separately it missed Monday’s deadline to submit three tobacco-related reports to Congress. The reports will be made once the agency “is confident that the information is accurate, understandable and not misleading to the public.”
The industry and advocates are waiting for clarity from the FDA over how it will regulate new and existing smokeless products, including those that could serve as a smoking-cessation aid.
The FDA also missed a deadline to provide a list of the levels of dangerous chemicals found in cigarettes and other tobacco products, as well as tobacco company testing and reporting requirements for ingredients and additives. There are no penalties for missing the deadlines.
Some health advocates have questioned the use of NRTs as a smoking-cessation option since they emerged in 1996. Other anti-smoking groups have touted the products as their main, if not only, recommended option for quitting.
In January 2012, the long-term effectiveness of NRTs was called into doubt in a study by researchers at the Harvard School of Public Health and the University of Massachusetts-Boston.
The study of 787 adult smokers in Massachusetts found that the products, specifically nicotine patches and gum, "are no more effective in helping people stop smoking cigarettes in the long term than trying to quit on one's own," said Hillel Alpert, a research scientist with the Harvard group and the study's lead author.
The Harvard study determined “that while the NRT products can help with quitting and withdrawal over two weeks to six months, they are not really designed to help with relapsing,” said Gregory Connolly, director of the Center for Global Tobacco Control at Harvard.
“We also need to raise the bar on how these products are marketed to help smokers understand better how long they should expect the products to be effective for withdrawal and quitting.”
A company that wants to market a lower-risk tobacco product in the U.S. must offer scientific proof to the FDA that the marketing of the product not only will reduce harm to individual users, but also benefit the health of the population as a whole.
The launch of Zonnic represents just the latest innovation for Reynolds, following up on Camel Snus and three Camel dissolvable products. Also on tap is Reynolds' version of an electronic cigarette (Vuse), smokeless pouches and pellets (Viceroy) and such nicotine extract products as lozenges. Vuse and Viceroy are being test-marketed in the Triad at select Tarheel Tobacco outlets.