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Ariva Tobacco Lozenges Outside FDA Purview, Marketer Maintains

This article was originally published in The Tan Sheet

Executive Summary

Allegations Ariva tobacco lozenges make implicit drug claims are without legal merit, Star Scientific maintains in response to a Dec. 18 1petition jointly filed by 18 public health organizations. The petition urges FDA to regulate the lozenges as either a food or a drug

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Ariva debate

FDA denies 2001 petition by Campaign for Tobacco-Free Kids and 18 other public health organizations to regulate Star Scientific's Ariva "cigaletts" as either an unapproved new drug or adulterated food, the campaign reports in Aug. 29 1release. Ariva - a compressed tobacco lozenge - is currently regulated as a tobacco product under the Comprehensive Smokeless Tobacco Health Education Act (1986) (2"The Tan Sheet" December 24, 2001, p. 5). According to CTFK, FDA claims it lacks authority to regulate Ariva based on a U.S. Supreme Court decision in 2000 that the agency does not have authority over traditional tobacco products as customarily marketed. Ariva is "clearly neither a traditional tobacco product nor is it marketed like one," CTFK contends. "It is used and consumed like a food and has been marketed as a drug. We believe FDA's decision is wrong and places consumers in unnecessary jeopardy"...

Ariva debate

FDA denies 2001 petition by Campaign for Tobacco-Free Kids and 18 other public health organizations to regulate Star Scientific's Ariva "cigaletts" as either an unapproved new drug or adulterated food, the campaign reports in Aug. 29 1release. Ariva - a compressed tobacco lozenge - is currently regulated as a tobacco product under the Comprehensive Smokeless Tobacco Health Education Act (1986) (2"The Tan Sheet" December 24, 2001, p. 5). According to CTFK, FDA claims it lacks authority to regulate Ariva based on a U.S. Supreme Court decision in 2000 that the agency does not have authority over traditional tobacco products as customarily marketed. Ariva is "clearly neither a traditional tobacco product nor is it marketed like one," CTFK contends. "It is used and consumed like a food and has been marketed as a drug. We believe FDA's decision is wrong and places consumers in unnecessary jeopardy"...

Ariva debate

FDA denies 2001 petition by Campaign for Tobacco-Free Kids and 18 other public health organizations to regulate Star Scientific's Ariva "cigaletts" as either an unapproved new drug or adulterated food, the campaign reports in Aug. 29 1release. Ariva - a compressed tobacco lozenge - is currently regulated as a tobacco product under the Comprehensive Smokeless Tobacco Health Education Act (1986) (2"The Tan Sheet" December 24, 2001, p. 5). According to CTFK, FDA claims it lacks authority to regulate Ariva based on a U.S. Supreme Court decision in 2000 that the agency does not have authority over traditional tobacco products as customarily marketed. Ariva is "clearly neither a traditional tobacco product nor is it marketed like one," CTFK contends. "It is used and consumed like a food and has been marketed as a drug. We believe FDA's decision is wrong and places consumers in unnecessary jeopardy"...

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