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Friday . Nov 21

Updated: 6.26.02

Press Release
Public Health Groups File Petitions Urging FDA to Regulate New "Reduced Risk" Products Being Marketed to Smokers as Healthier Alternative
December 18, 2001

The Low-Tar Lie
Is history repeating itself? Read about the recent government study detailing the way the tobacco industry marketed the last generation of "reduced risk" products and how "light" and "low-tar" cigarettes have been proven over time to be of no public health benefit.

Eclipse Cigarettes
A Campaign special report

FDA Authority Over Tobacco
A Campaign special report


There has been a rash of new products containing nicotine being rushed to the marketplace in recent months without the approval of the U.S. Food and Drug Administration (FDA). While the FDA is required to approve new nicotine products sold to help smokers quit like the nicotine patch, these products have circumvented FDA regulation.

On December 18, 2001 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 to users of traditional tobacco products 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.

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 (click to read petitions):

  • 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. Ariva is being test-marketed in Richmond, VA, and Dallas, TX. 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.” 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.” 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.
    Amendment to Ariva (June 24, 2002)

  • Eclipse (R.J. Reynolds Tobacco Holdings, Inc.) – Eclipse bears no relationship to a traditional cigarette. 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.”

  • 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. 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.
    Amendment on Nicotine Water (May 23, 2002)


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    Press Releases and Statements

    July 2, 2002
    FDA Action Against Nicotine Water Underscores Need For Regulation of all Nicotine-Containing Products, Including Tobacco

    May 24, 2002
    Sales of Bottled Water Containing Addictive Nicotine Underscore Need for FDA Regulation of All Nicotine Products

    April 22, 2002
    Public Health Groups Urge FDA to Follow Up on Nicotine Lollipop Ban By Taking Action Against Other New Nicotine Products

    April 10, 2002
    FDA Action to Stop Sales of Nicotine Lollipops Is Important First Step in Regulation of All Nicotine Products

    April 3, 2002
    Proliferation of Nicotine Lollipops Underscores Need for FDA Regulation of all Nicotine Products

    December 11, 2001
    Vector's Data about Omni Cigarettes is Misleading and Underscores Need for FDA Regulation of Tobacco

     

    Campaign for Tobacco-Free Kids

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