FDA deeming regs ‘embarrassment to public health’
A US public health expert has issued a robust and detailed criticism of the information publicly available about the Food and Drug Administration’s proposed deeming regulations, as they apply to electronic cigarettes.
In his Rest of the Story blog, Dr. Michael Siegel, who is a professor in the Department of Community Health Sciences, Boston University School of Public Health, described the FDA as being out of its mind. ‘These deeming regulations should really be called “The Cigarette Protection Act of 2015”,’ he said. ‘The regulations are an embarrassment to public health.
‘They create stringent requirements for electronic cigarettes, while allowing the much more toxic real cigarettes to remain on the market, unencumbered and unchallenged by competing products that are much safer and that could have otherwise transformed the nicotine market away from combustible tobacco products, thus saving thousands of lives.
‘The regulations will decimate the e-cigarette industry, forcing thousands of small vapor shops and e-cigarette sellers out of business. This will no doubt result in many vapers returning to cigarette smokers and many potential quitters from trying to quit using these products.’
In making his comments, Siegel made the point that they were based solely on his review of the PMTA (pre-market tobacco product applications) draft guidance that the FDA intended to release in conjunction with the deeming regulations.
The Tobacco Vapor Electronic Cigarette Association (TVECA) had obtained a copy of the FDA electronic cigarette deeming regulations that were sent to the Office of Management and Budget (OMB) for final approval before promulgation, as well as a draft of the guidance that the agency intended to release in conjunction with the deeming regulations, Siegel said. The guidance related to the recommended procedure for filing PMTAs. The TVECA had made the PMTA guidance publicly available on its website, but did not make the deeming regulations available upon the request of the FDA.
Siegel said it was possible, though unlikely, that the actual deeming regulations included exemptions or modified provisions for certain small businesses.
‘I had originally made a decision to postpone my commentary on the draft guidance document until the deeming regulations were released in their entirety, in order to avoid any error in case there are exemptions in the deeming regulations,’ Siegel said. ‘However, I have made the decision to publish the commentary now because by the time the deeming regulations are released, it will be too late to change them.
‘I believe that the risks associated with the possibility that the fine details of the deeming regulations render invalid my commentary below are far outweighed by the benefits of making this information available to the public so that interested parties can provide meaningful feedback to the OMB to inform a properly informed review of the regulations.’
Siegel’s blog is at: http://tobaccoanalysis.blogspot.co.uk/2015_11_01_archive.html.
