Public Health Groups File Petitions Urging FDA to Regulate New "Reduced Risk" Products Being Marketed to Smokers as Healthier Alternative

Petitions Target Ariva Tobacco Lozenges, Omni and Advance Cigarettes, Eclipse Product and "Nicotine Water"

Dec. 18 2001

Washington, DC — The nation's major public health organizations today jointly submitted petitions to the U.S. Food and Drug Administration (FDA) urging it to regulate five products currently being marketed as a safer, healthier way to consume tobacco or nicotine or both. Among the groups submitting the petitions are the American Cancer Society, American Heart Association, American Legacy Foundation, American Lung Association, American Medical Association and the Campaign for Tobacco-Free Kids.

Each of the petitions state, "although the Supreme Court held last year that the FDA does not have jurisdiction over traditional tobacco products as customarily marketed, the Court left undisturbed the agency's jurisdiction over products containing nicotine other than traditional tobacco products and tobacco products that make health claims." Together these petitions demonstrate just how vulnerable the American public is to a whole new generation of tobacco and nicotine containing products if the FDA doesn't act.

The petitions argue that the FDA already has authority under the Federal Food, Drug and Cosmetic Act (FFDCA) to regulate the so-called "reduced risk" products that are the subjects of the petitions as drugs, drug delivery devices or food products. The petitions ask the FDA to prohibit sales of these products until the manufacturers comply with the law and submit each product for FDA approval.

The petitions concern these five products:

  • Ariva tobacco lozenges (Star Scientific, Inc.) – Ariva is a mint-flavored lozenge the size of a Tic-Tac mint, 60 percent of which is a compressed tobacco powder, but which comes in the shape of a candy like product and is packaged like a smoking cessation product. Star claims it is designed for situations when people cannot smoke or do not want the "unpleasant aesthetics" of smokeless tobacco products. Ariva is being test-marketed in Richmond, VA, and Dallas, TX. The Ariva petition states, "When companies have previously attempted to market nicotine-containing tobacco products in any form other than conventional cigarettes, pipe tobacco, cigars, or traditional forms of snuff and chewing tobacco, FDA has consistently determined that these products must be regulated under the FFDCA. Yet the manufacturers of these mint flavored nicotine lozenges that will be used like a candy product or as a method to sustain a smoker's nicotine dependence are marketing this product without first submitting it to FDA for approval or without going through any government review. Instead, the manufacturer claims the product is exempt from government oversight just because it contains tobacco." The petition urges the FDA to classify and regulate tobacco lozenges such as Ariva as "drugs" or "foods" containing a food additive.

  • Omni (Vector Tobacco Ltd.) and Advance (Star Scientific, Inc. and Brown & Williamson Tobacco Corp.) "low carcinogen" cigarettes – Vector recently launched national advertising for its Omni cigarette with the slogan, "Reduced carcinogens. Premium taste." Their ads also claim Omni is "the first premium cigarette created to significantly reduce carcinogenic PAH's, nitrosamines and catechols, which are the major causes of lung cancer in smokers." Brown & Williamson is test-marketing its Advance cigarette in Indianapolis, IN, Richmond, VA, and Lexington, KY with the slogan "All of the taste … less of the toxin." Despite making these blatant health claims that will lead consumers to believe that these new products are safer, Brown & Williamson and Vector admit that they have no evidence that these products actually reduce smokers' health risks. The single petition on Omni and Advance argues that the health claims made with respect to these products and the companies' use of these claims in marketing bring Omni and Advance within the FFDCA's definition of a drug and subject these products to regulation by the FDA.

  • Eclipse (R.J. Reynolds Tobacco Holdings, Inc.) – Eclipse bears no relationship to a traditional cigarette. For example, Eclipse primarily heats tobacco rather than burning it. According to the Eclipse petition, "Eclipse outwardly looks like a cigarette, but is in fact a sophisticated, technologically-advanced nicotine delivery system that is completely unlike traditional cigarettes." RJR currently sells Eclipse in stores in four states and via direct mail through telephone and Internet sales in 38 states. RJR claims in its marketing that Eclipse "may present smokers with less risk of cancer" and other smoking-caused diseases. The Eclipse petition argues that Eclipse is not a traditional cigarette covered by the Supreme Court's decision and that RJR's health claims with respect to Eclipse bring that product within the FFDCA's definition of a drug and subject it to regulation by the FDA. It also argues that Eclipse can be regulated as medical device or combination drug/device under the FFDCA.

  • Nicotine Water (S.F. Garret) – Sold over the Internet, Nicotine Water is regular bottled water with the addition of nicotine equal to what the manufacturer claims is contained in two cigarettes. Garret claims Nicotine Water is designed to provide a source of nicotine to individuals that is safer than conventional tobacco products and can be used in places where smoking is prohibited or by smokers who want to quit. Nicotine is used as a pesticide and has been shown to be hazardous. Nicotine is not approved as a food additive, nor is it on the GRAS list of additives that are authorized for use in food products. The addition of nicotine has only been approved for use in OTC and prescription drug smoking cessation aids. The Nicotine Water petition calls for the FDA to classify and regulate the product as a "drug" or as a "food" containing a hazardous, unapproved food additive under the FFDCA.

"The products that are the subjects of our petitions today are not conventional tobacco products," said Matthew L. Myers, President of the Campaign for Tobacco-Free Kids. "We believe that the FDA has full authority under existing law to regulate these products to protect public health and safety. Forty years ago the tobacco industry responded to the original health scare about tobacco with a new generation of products, like filter cigarettes and low tar cigarettes, that they promoted as less hazardous to keep another generation smoking. Today we know that those claims were not true. A failure by the FDA to exercise its authority over the new generation of products and claims that are the subject of these petitions would provide the tobacco industry with the freedom to keep Americans smoking through the use of blatant, unproven and misleading health claims about these products."

"FDA currently requires manufacturers of non-tobacco nicotine cessation products to go to great lengths to prove that they are safe and will help smokers quit, said William V. Corr, Executive Vice President of the Campaign. "Unless FDA grants these petitions, consumers face a situation where the safest nicotine replacement products are subject to justifiably rigorous regulation, while the most dangerous nicotine substitution products contain tobacco and are subject to no oversight whatsoever."

Corr also noted that the petitions were filed because the FDA has failed to act based on the limited authority it currently has. This failure once again demonstrates the need for Congress to pass legislation mandating that the FDA regulate so-called "reduced risk" products and grant the agency clear, full and effective authority over all tobacco products, including conventional tobacco products and new products that are marketed now and in the future, similar to those mentioned it today's petitions. Legislation to do so has been introduced in the U.S. House of Representatives by Reps. Ganske (R-IA), Dingell (D-MI) and Waxman (D-CA) and in the Senate by Sens. Harkin (D-IA), Chafee (R-RI) and Graham (D-FL).

"Tobacco companies should be encouraged to reduce known carcinogens and other toxins in their products, but it is irresponsible for them to make statements implying that these new products are safer until an independent government agency, the FDA, has the authority to verify and regulate these claims," Myers said.

Tobacco use is the leading preventable cause of death in the United States, killing more than 400,000 Americans each year. Approximately 90 percent of regular smokers start at or before age 18. Every day, 5,000 kids try their first cigarette. Another 2,000 kids become regular, daily smokers, one-third of whom will die prematurely as a result.

Special Report: New Products, Old Tricks.

 

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