Smoking-cessation products contain the addictive substance nicotine but do not carry many of the other harmful chemicals found in cigarettes, chewing tobacco and snuff. The products, once available only by prescription, are now available over the counter.
Several anti-smoking groups lobbied for the changes and lauded the FDA's decision as a step that will help more people kick the habit.
"These labeling changes recognize that cigarette smoking is extremely addictive, and most smokers make multiple attempts to quit before they succeed," Matthew Myers, president of the Campaign for Tobacco-Free Kids, one of the groups involved, said in a statement.
Typically, the FDA approves such changes at the request of product manufacturers. But these actions came at the urging of health professionals and activists, who said that research no longer supports such strict rules and that they present a barrier for people trying to quit.
Many smokers have a difficult time quitting in the eight, 10 or 12 weeks often listed as the limit for the safe use of over-the-counter smoking-cessation products, proponents said. And some stop using the products if they break down and have a smoke, fearing that it is not safe to double up.
Years ago, "there were some concerns [about] getting too much nicotine and getting sick from that," said Grail Sipes, senior regulatory counsel for the Office of Regulatory Policy at the FDA's Center for Drug Evaluation and Research.
Recent studies, however, show that this is not as risky as once feared. In one study the FDA cited Monday, more than 1,000 participants reported only minor, passing symptoms after using nicotine gum for a year or longer. Another study found that the long-term use of nicotine gum did not increase or decrease the likelihood of developing cancer. Other studies suggest a low likelihood of abuse or dependence.
"What we're saying is if people want to use [the products] a bit longer, that's fine," Sipes said. "In the same vein, if you want to use more than one [product] at once a patch and also do gum if you feel that that's helping you, there's not going to be a problem with that."