Health Commissioner Petitions FDA to Make Over-the-Counter Nicotine Therapies as Easy to Buy as Cigarettes

Availability Could Help Smokers Decide to Quit

ALBANY, NY (Jan. 28, 2008) – New York State Health Commissioner Richard F. Daines, M.D. filed a petition last week with the federal Food and Drug Administration (FDA) to challenge the misguided federal policy that limits smokers' access to safe nicotine replacement therapy (NRT).

New York is the first state to petition the FDA to relax restrictions on the sale of nicotine patches, gum and lozenges. Right now, these are the safest forms of nicotine and are tightly regulated, while the most dangerous and deadly nicotine delivery system – cigarettes – is comparatively unregulated. A change in federal policy is essential to increase smokers' use of safe nicotine products, like patches, gum, and lozenges, in order to quit successfully.

"We challenge the FDA to rethink its policies regarding nicotine replacement therapy," Commissioner Daines said. "Under the current system, a smoker generally cannot buy safe nicotine in the same store where cigarettes are sold, and, even though most smokers buy cigarettes one day at a time, those who purchase safe nicotine must buy a one- or two-week supply costing $20 to $40. New York's petition sets in motion a process requiring the FDA to critically examine how these products are now sold to smokers and how we can make them more readily available."

"Smokers smoke because they are addicted to nicotine in cigarettes," said Dr. Daines. "But it is the smoke, not the nicotine, which causes a long list of diseases, including lung cancer, heart disease, stroke and emphysema."

"Nicotine is the addictive ingredient in cigarettes that keeps smokers hooked, but it's not the ingredient that harms smokers' health," emphasized Ursula Bauer, Ph.D., M.P.H, director of the state's Tobacco Control Program. "With safe nicotine products, smokers can give up the smoke without giving up the nicotine."

"As smokers become more familiar using other nicotine products, like patches, gum and lozenges, they will find themselves less interested in smoking cigarettes. Over time, more smokers will quit. Right now, the FDA is standing in the way of smokers' easy access to safe nicotine products," said Jonathan Foulds, Ph.D., Associate Professor and Director of the Tobacco Dependence Program and the University of Medicine and Dentistry of New Jersey.

"Many smokers are confused about the safety of nicotine patches, gum and lozenges, mistakenly believing that nicotine causes cancer or that patches are more likely than cigarettes to cause a heart attack. By educating consumers and making these products more widely available, smokers will begin to see them as real alternatives to cigarettes and a product they can use to quit smoking altogether,"said Gary Giovino, Ph.D., Professor of Health Behavior and the University at Buffalo.

New York is petitioning the FDA to:

  1. Allow the sale of over the counter (OTC) nicotine replacement therapy (NRT) in all retail locations where cigarettes are sold, including convenience stores, gas stations, tobacco specialty stores, grocery stores, and other retail businesses that sell tobacco;
  2. Allow OTC NRT to be sold in "daily" units (containing an amount of NRT that would typically be consumed in a 24-hour period) at prices competitive with one 20-count pack of cigarettes and allow OTC NRT to be advantageously positioned near cigarettes and other tobacco products to promote the sale of OTC NRT products; and
  3. Modify labeling requirements to fully disclose to smokers the benefits of OTC NRT use relative to continued cigarette use, with risks associated with OTC NRT compared to risks associated with continued cigarette use.

Under federal regulations, the FDA must respond to the petition within 180 days.

"By offering safe nicotine products wherever cigarettes are sold, at prices and package sizes similar to cigarettes, smokers will have a real choice about whether to purchase the toxic, deadly nicotine or safe, clean nicotine," explained Commissioner Daines. "The more that smokers have access to safe nicotine products and the more comfortable they are using them, the less attractive cigarettes will be."

Nicotine replacement products are a safe alternative to cigarettes and have been approved by the FDA for smokers who want to quit. Smokers could benefit greatly by having these products more readily available in smaller package sizes with package inserts that clearly explain how safe and effective these products are – including that they are always safer than cigarettes.

Smokers can also contact the New York State Smoker's Quitline at 1-866-NY-QUITS or 1-866-697-8487 or visit the Quitline website at www.nysmokefree.com, where trained specialists can answer questions about nicotine replacement products. A free two-week starter kit of nicotine patches, gum or lozenges is available to eligible smokers.

To read the FDA's regulations on submitting a citizen's petition, go to www.fda.gov/ohrms/dockets and click on "How to Submit Petitions."

To read Commissioner Daines' petition to the FDA, go to www.nyhealth.gov.