WASHINGTON D.C. -- January 4, 2002 -- Major U.S. public health groups recently submitted petitions to the Food and Drug Administration (FDA) urging it to regulate five so-called "reduced risk" products being marketed as a safer way to consume nicotine and tobacco. Among the groups filing the petitions are the American Cancer Society, the American Heart Association, American Legacy Foundation, American Lung Association, American Medical Association and the Campaign for Tobacco-Free Kids ( see press release, Campaign for Tobacco-Free Kids).
Although the U.S. Supreme Court has determined that the FDA does not have jurisdiction over traditional tobacco products, the petitions argue that the FDA may regulate "reduced risk" tobacco products as drugs, drug delivery devices or food. They ask the FDA to halt sales of five such products and require the manufacturers to submit them for approval.
Products May Be Falsely Marketed
The products involved are Ariva Tobacco Lozenges, Omni and Advance "low carcinogen" cigarettes, Eclipse tobacco product, and Nicotine Water.
Ariva Tobacco Lozenges, manufactured by Star Scientific, Inc., are mint-flavored candies that contain 60 percent compressed tobacco powder. The petition seeks to classify these lozenges as drugs or food containing a food additive.
Omni and Advance cigarettes have been promoted through use of the slogans, "Reduced carcinogens, premium taste" and "All of the taste ...less of the toxin." The petition states that there is no evidence that these products are safe and that the cigarette manufacturers' health claims make the cigarettes a drug subject to FDA regulation.
Eclipse, which is manufactured by R.J. Reynolds Tobacco Holdings, Inc. primarily heats tobacco rather than burning it. R.J. Reynolds claims that it "may present smokers with less risk of cancer." The petition argues that Eclipse is not a traditional cigarette and that it falls within the purview of the FDA as a drug or medical device.
The last product mentioned in the petitions is Nicotine Water, a bottled water with added nicotine that is sold over the Internet. It is marketed for use in places where smoking is prohibited and as an aid in quitting smoking. The petition asks the FDA to regulate Nicotine Water as a drug or food. It also points out that nicotine is used as a pesticide and is not approved as a food additive.