Origins in the USA in the 1980s of the warning that smokeless tobacco is not a safe alternative to cigarettes: a historical, documents-based assessment with implications for comparative warnings on less harmful tobacco/nicotine products.

BACKGROUND: Before the 1980s in the USA, smokeless tobacco carried no health warnings, was not judged to cause disease, and was a declining practice. In 1986, the federal government passed legislation requiring rotating warnings on "mouth cancer," "gum disease and tooth loss," and "This product is not a safe alternative to cigarettes." This paper explores the history of the establishment of these warnings with emphasis on the 'not a safe alternative' warning and the bases for claiming that smokeless was 'not safe' (absolute harm) versus 'not safer than cigarettes' (relative harm).

METHODS: Results of searches of Truth Tobacco Industry Document archives and transcripts of legislative hearings were analyzed. Critical assessments were made of the evidence-base.

RESULTS: New evidence of oral cancer causation emerged along with a much-publicized case of a teenager dying of oral cancer. Public health concerns also arose over a widespread, successful marketing campaign implying smokeless was a safe alternative to cigarettes. Industry wanted pre-emptive federal warnings, to prevent a diversity of pending state warnings. To avoid an addiction warning, the industry accepted a compromise 'not a safe alternative' warning, which had not been initially proposed and which the cigarette industry may have sought in order to constrain the smokeless tobacco industry. The evidence presented supported smokeless only as 'not safe' and not 'as harmful as cigarette smoking.'

CONCLUSIONS: The comparative warning was a compromise to prevent an addiction warning and consistent with the preferences of cigarette companies. Prior surveys indicated that the public generally did not view smokeless tobacco as harmless, but they did generally report smokeless as less harmful than cigarettes despite expert interpretations to the contrary. As would not have been appreciated by public health supporters at the outset, subsequent research has shown that the 'not a safe alternative' message is misinterpreted by consumers to indicate that smokeless is 'not safer' than cigarettes-which was not established and has been disconfirmed by subsequent assessments of that question. Though many countries have banned smokeless tobacco (but not cigarettes), where smokeless is legally available accurate information on the nature of harms and differential harms needs to be developed.