Forty-Two AGs Weigh In: Ariva “Cigalett” Falls Under FDA Oversight

The Supreme Court's findings in FDA v. Brown & Williamson Tobacco Corp. allow the agency to regulate Star Scientific's Ariva "cigalett" smokeless tobacco product as either a food or a drug, according to comments from 42 state attorneys general.

Submitted to FDA July 16 by California Attorney General Bill Lockyer on behalf of himself and 41 other state AGs, the comments note the Brown & Williamson decision states that "courts should defer to agencies such as the FDA in the interpretation of statutes that the agencies administer, unless Congress has directly spoken to the precise question at issue."

The case specifically states that courts should defer to federal agencies to resolve "the struggle between competing views of the public interest" because agencies have "greater familiarity with the ever-changing facts and circumstances surrounding the subjects regulated," the AGs note.

With regard to the specifics of Brown & Williamson, the case exempted traditional tobacco products from FDA oversight. However, Ariva, "a new candy-like product that contains tobacco and nicotine, but is intended to be completely ingested by dissolving in the mouth, is precisely the kind of 'ever-changing facts and circumstances' that the Court did not prohibit the FDA from addressing," the comments maintain.

The AGs filing comes in support of two citizen petitions, one submitted by a coalition of public health organizations and the other by NicoDerm CQ and Nicorette smoking cessation product marketer GlaxoSmithKline. Both have asked that FDA regulate Ariva as either a food or a drug (¹ (Also see "Ariva Tobacco Lozenges Outside FDA Purview, Marketer Maintains" - Pink Sheet, 24 Dec, 2001.), p. 5 and ² (Also see "Ariva “Cigalett” Pieces Are Foods, Not Smokeless Tobacco Items, GSK Says" - Pink Sheet, 4 Mar, 2002.), p. 7).

As with the other two parties, the AGs contend Ariva is not a traditional tobacco product because it is neither smoked nor expectorated. Moreover, Ariva's delivery form makes it "more like a nicotine gum or a candy lozenge," placing it squarely within FDA's jurisdiction, the comments state.

However, in its own comments filed May 1, Star maintained expectoration is not required of smokeless tobacco products and noted some dry snuffs and "chewing tobacco bits" dissolve completely in the oral cavity (³ (Also see "Star Scientific Defends Ariva As “Compressed Version” Of Dry Snuff" - Pink Sheet, 13 May, 2002.), p. 8).

Besides focusing on Ariva's composition, the AGs also state the product poses particular dangers to young people. "Because the product is small and does not emit smoke or strong tobacco odors when used, it would be easy for parents and teachers to be unaware of an adolescent's or child's use of this addictive and hazardous substance," the AGs claim.

"Ariva has all the features...of a product that would appeal to youthful new users," such as mint flavoring to cover the taste of tobacco and a relatively low cost, the comments continue.

Moreover, the AGs state that while Star Scientific "touts its blister packs as 'child-resistant,' any child who can use scissors can open a package of Ariva, which looks and tastes like candy." To support their point, the attorneys general note popular products such as William Wrigley Jr. Company's Orbit and Eclipse gums are sold in blister packs.

The comments add that certain labeling also seems aimed at younger consumers, specifically the statement: "As with other oral tobacco products, some users may experience temporary dizziness, heartburn, hiccups or nausea."

This phrase "seems geared to reassure people new to tobacco products" that they should not be alarmed by the effects of nicotine use, as opposed to "cigarette smokers, who have built up a tolerance to nicotine's effects," the AGs maintain.

"Being assured that the symptoms are 'temporary' may persuade a young person experimenting with Ariva not to be alarmed by bodily warning signs...and to keep using the product until addicted," the comments state.

FDA recently took action against other controversial nicotine products for their potential to harm children. In an April 9 warning letter, FDA determined nicotine lollipops were "misbranded" because their labeling did not have "adequate warnings against use by children" (⁴ (Also see "Nicotine Lollipops Active Ingredient Nicotine Salicylate “Illegal” – FDA" - Pink Sheet, 15 Apr, 2002.), p. 7).

In their comments, the AGs "applaud the FDA's recent actions to halt the marketing of...nicotine lollipops...and now urge the agency also to regulate the nicotine lozenge, Ariva."

If FDA fails to regulate Ariva, the product "may well cause preventable disease and death," the comments conclude.