Submission to FDA docket on Scientific Evaluation of Modified Risk Tobacco Product Applications

In considering any applications for modified risk tobacco products, the FDA should give serious consideration to the fact that the major tobacco companies are currently subject to an on-going federal court orderunder the Racketeer Influenced Corrupt Organization Act for creating an illegal racketeering enterprise for the purpose of defrauding the public. The court also found that the pattern of past activities that led to this decision is continuing and likely to continue in the future.

Creation and promotion of products that were presented to and perceived by the public as “safer” than conventional cigarettes when, in fact, they were not, has been and remains a central element of this fraud. Modified risk” products have a strong potential for simply being the latest chapter in this fraud.

Manipulation of science and the presentation of scientific results has also been a central element of the fraud. For these reasons, the FDA should be extremely sceptical of any scientific results or claims advanced by any tobacco company or any organization with funding or other connections to the tobacco industry.  Searching the Legacy Tobacco Documents Library (legacy.library.ucsf.edu) for industry documents related to “harm reduction” yields many documents that were withheld on the grounds of attorney-client privilege. 

The involvement of attorneys in the selection and presentation of scientific results was and likely remains a key element of the racketeering enterprise, which raises even greater concerns over any scientific assertions offered by the industry or affiliated organizations and individuals.

Results should only be accepted when presented by sources truly independent of the industry. In considering modified risk products, the FDA should pay particular attention to the effects of any such products on overall population-level tobacco use patterns and the attendant health effects. 

As we showed in our recent paper, Mejia et al., “Quantifying the effects of promoting smokeless tobacco as a harm reduction strategy in the USA” (Tobacco Control 2010 Aug;19(4):297-305. Epub 2010 Jun 27), even if a product such as smokeless tobacco was less dangerous than cigarettes for individuals who switched from cigarettes to smokeless, there are likely to be overall shifts in use patterns, including changes in tobacco initiation and cessation, as well as dual use that would make it highly unlikely that there would be any population-level benefits to promoting smokeless tobacco as a harm reduction strategy.

As described in the Mejia et al paper, the tobacco companies are actively promoting a form of smokeless tobacco, snus, as a partial alternative to cigarettes (for use where one cannot smoke) by using common branding with cigarettes, which is designed to promote dual use of both products.  Any such dual use will substantially blunt (and may worsen) both individual and population-level health risks. Any consideration of a proposed modified risk product should include a thorough analysis of the effects of the new product on the overall market and population-level impacts. 

Given the industry’s history and continuing constitution as a racketeering enterprise, the FDA would need compelling evidence of a high likelihood of substantial population-level health benefits before approving any modified risk product for marketing.

In the event that the FDA is somehow convinced that a proposed modified risk product should be allowed to go to market, the agency should ensure that all aspects of the marketing (including branding, packaging, colors and marketing and promotion) are completely independent of any cigarette or other tobacco product brand.   The agency should also monitor actual use patterns and promptly withdraw approval if there is any evidence that the new product is discouraging cessation, encouraging initiation, or promoting dual use.

Thank you for considering this comment.

Submitted to Food and Drug Administration Docket No. FDA-2011-N-0443