Proposed new rule ‘disastrous’

A leading US community health specialist has described as potentially disastrous a proposed rule that would prohibit electronic-cigarette companies from suggesting that their products might be useful for smoking cessation.

Dr. Michael Siegel, a Professor in the Department of Community Health Sciences, Boston University School of Public Health, said it appeared that the Food and Drug Administration was preparing to issue such a rule.

The proposed rule, as reported by The Hill, would classify as a drug/device any electronic cigarette or vaping product that made any claims related to quitting smoking. ‘The White House is reviewing a final rule from the Food and Drug Administration (FDA) on tobacco products,’ The Hill story said. ‘The rule aims to clarify when the FDA can regulate a product like nicotine gum as a drug or device versus a tobacco product like electronic cigarettes. For the agency it all comes down to the product’s intended use. The FDA sent the rule, first proposed in September 2015, to the White House Office of Management and Budget (OMB) on Monday. The proposed rule states that tobacco products intended for human consumption are regulated as a drug, device or combination product if intended for diagnosing or treating a disease. … Given the availability of FDA approved drugs for smoking cessation, FDA believes that consumers are particularly susceptible to confusion where products made or derived from tobacco that otherwise appear to be products intended for recreational use make claims related to quitting smoking.’ Siegel said the rule would be disastrous for the protection of the public’s health because it would mean that vaping companies could not inform consumers that the primary purpose of electronic cigarettes was to help smokers get off of cigarettes – to quit smoking.

‘They could not share testimonials about smokers who have quit using e-cigarettes because doing so would likely be interpreted by the FDA as making a cessation claim, which would subject the product to the regulations related to drugs, which would require clinical trials before the product could be marketed,’ Siegel wrote on his blog. ‘This rule will essentially force e-cigarette companies to market their products as cool, digital devices – a message that resonates with youth and will increase the appeal of these products to youth. The alternative – that the FDA allow cessation claims – would enable companies to tell the truth to consumers and to market these products based on their actual intended use. In other words, this rule would essentially force e-cigarette companies to lie to consumers and to withhold from them critical information.’

Siegel’s arguments are laid out at: http://tobaccoanalysis.blogspot.co.uk/2016/10/fda-poised-to-issue-rule-that-will-be.html