U.S. Groups Seek Regulation of Tobacco Alternatives
WASHINGTON (Reuters) - Leading U.S. health organizations and anti-tobacco groups took legal action on Tuesday aimed at helping the Food and Drug Administration regulate so-called cigarette alternatives including lozenges and water containing nicotine.
They said such products are not safer alternatives to cigarettes as they are marketed and should be regulated by the FDA. The FDA has for years sought to regulate tobacco and related products but the Supreme Court ruled last year that the agency has no authority to do so.
But in the past year a number of new products have hit the markets, including ``safer'' cigarettes, and the groups say the FDA should be able to regulate these.
Four petitions to the FDA are signed by the American Cancer Society, American Heart Association, American Legacy Foundation, American Lung Association, American Medical Association and the Campaign for Tobacco-Free Kids.
``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,'' each petition reads.
The products include Ariva tobacco lozenges, a small mint-flavored wafer made by Star Scientific, Inc.
``Ariva is a compressed, powdered tobacco product designed to dissolve in the mouth without expectoration, and to be used during situations when smoking is prohibited or inconvenient,'' Star Scientific said in a statement last month.
``The manufacturer claims the product is exempt from government oversight just because it contains tobacco,'' the petition reads. It asks the FDA to classify and regulate tobacco lozenges as ``drugs'' or ``foods'' containing a food additive.
A bottled water containing nicotine, sold by S.F. Garret over the Internet, should also be regulated, the groups said. ''Nicotine Water is regular bottled water with the addition of nicotine equal to what the manufacturer claims is contained in two cigarettes,'' the groups said in a joint statement.
``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.''
The groups also say the FDA should regulate Omni, marketed by Vector Tobacco Ltd. as a ``reduced carcinogen cigarette that tastes, smokes and burns just like any other premium cigarette,'' and Advance, co-marketed by Star Scientific and Brown & Williamson Tobacco Corp.
``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 groups said in their statement.
``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 Federal Food, Drug and Cosmetic Act's (FFDCA) definition of a drug and subject these products to regulation by the FDA.''
A fourth petition says FDA should regulate Eclipse, which looks like a cigarette but which heats tobacco rather than burning it. It is sold in four states and on the Internet by R.J. Reynolds Tobacco Holdings, Inc.
``RJR claims in its marketing that Eclipse 'may present smokers with less risk of cancer' and other smoking-caused diseases,'' the groups said.
``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.''
``The products that are the subjects of our petitions today are not conventional tobacco products,'' Matthew Myers, President of the Campaign for Tobacco-Free Kids, said. ``We believe that the FDA has full authority under existing law to regulate these products to protect public health and safety.''
David Iauco, R.J. Reynolds' senior vice president for marketing, said he disagreed that the claims about Eclipse qualify the product for FDA regulation.
``We do make some unique claims about Eclipse. Those claims do not make it a drug,'' Iauco said.
But he also said the company had scientific evidence to back up assertions that Eclipse is safer than other cigarettes and said the firm would support some FDA oversight.
``This is an area where we would support regulation. We believe it would be a benefit to consumers,'' Iauco said.
Other companies did not immediately return calls seeking comment.