Tobacco Product Risk Reduction

This is a comment that I’ve just submitted to the FDA asking them to enforce their own regulations and conduct appropriate testing, which has not been done to date, to determine whether all current IQOS applications are in compliance with regard to pesticide residues as required by this rule, and then to determine the impact of any discovered pesticide residues on the manufacturer’s many and deceptive “Modified Risk” claims.

You can support a moveon petition to Congress demanding that FDA investigate by clicking on the cute little hummingbird choking on clouds of vaporized pesticides.

To: US FDA December 4, 2018 via Comment Portal

In reference to: 907(a)(1)(B) of Section 907 of the Federal Food, Drug, and Cosmetic Act:

(B) ADDITIONAL SPECIAL RULE.—Beginning 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.

FDA Comment Submission

I am concerned that

1. The presence of pesticide residues in the Tobacco component of IQOS has not been discussed or referenced in any of Philip Morris’s FDA multiple IQOS applications.

2. While the IQOS applications offer extensively documented comparisons between toxic substances in the IQOS vapor stream and toxic substances in the smoke stream of combusted Tobacco (reference Cigarettes only, not commercial cigarettes), after performing a keyword search through the submitted IQOS documentation I can find no mention of any comparison of pesticide residues in the IQOS vapor stream with those in a reference cigarette smoke stream in support of the IQOS claim of “modified risk”.

3. The public record does not show that FDA has yet requested that Philip Morris demonstrate compliance with Special Rule 907(a)(1)(B) with regard to any of its IQOS applications.

4. To grant any application related to IQOS without first establishing that IQOS can and will comply with Special Rule 907(a)(1)(B) would seriously jeopardize public health in that without demonstrated compliance and published results, the public will not have an opportunity to make a fair and complete comparison of the relative risks the pesticide residue contaminants of the IQOS product vs combustible Tobacco products.

5. To grant any application related to IQOS that claims “harm reduction” without first comparing the relative harm of inhaling the intact pesticide burden in the IQOS vapor stream to the harm of inhaling the partially combusted, altered and degraded pesticides in a conventional Tobacco smoke stream, would not serve the public’s interest in having full and fair disclosure of all relevant risks associated with the use of IQOS.

Discussion

Because the Tobacco materials, along with any pesticide residues, in the Tobacco component of IQOS will be vaporized well below the point of pyrolytic degradation, and none of any pesticide residues contained in the Tobacco component will be destroyed by combustion, therefore it is reasonable to project that a greater proportion of the original pesticide residue burden on the Tobacco component of IQOS will survive and retain bioactivity in the vapor stream compared with the proportion of surviving and bioactive pesticide residues in a smoke stream that would be generated by combusting that same Tobacco component; and

Because in making its case for “modified risk” Philip Morris, by comparing the toxicant properties of an IQOS vapor stream with the toxicant properties of a Reference Cigarette smoke stream, either by oversight or by design fails to address the differences in potential for harm between (1) delivery of the full original pesticide residue burden in the IQOS vapor stream compared with (2) delivery of a reduced portion of the original pesticide residue burden, of which a portion has been destroyed by combustion, and some or all of the remainder of which has been dry-distilled into altered compounds and/or partially degraded by pyrolytic processes; and,

Because Special Rule 907(a)(1)(B) requires that manufacturers “shall not use” tobacco of any origin containing pesticide residues “at a greater level” than “any tolerance” specified under Federal law; and

Because in addition to pesticides registered for use on Tobacco with established tolerance levels, Federal law also specifies certain pesticides that are banned for use on Tobacco; in the context of US Special Rule 907(a)(1)(B) this requires that manufacturers shall not use any Tobacco containing those banned pesticides “at a greater level” than zero; and

Because current Tobacco industry documentation shows that certain pesticides not registered for use on Tobacco in the United States are present in the world Tobacco supply, and certain pesticides banned in the US are also present in the world Tobacco supply (https://www.coresta.org/agrochemical-guidance-residue-levels-grls-29205.html ); and

Because Philip Morris is a large importer of Tobacco stem and waste materials from Brazil, a Tobacco exporter with documented heavy use of pesticides on Tobacco crops; (https://www.zauba.com/Buyers-of-tobacco-stems) and

Because imported Brazilian Tobacco stems and waste that are likely to be contaminated with pesticides residues, some of which may violate the “greater level” condition of  Special Rule 907(a)(1)(B), are used in large quantities (millions of kilograms/year) by Philip Morris in its Tobacco product manufacturing in the US and are therefore, in the absence of any statement by the manufacturer to the contrary, likely used in its IQOS manufacturing processes; however, without testing for the presence and concentration of pesticide residues in the IQOS Tobacco component there can be no demonstration of IQOS compliance with Special Rule 907(a)(1)(B) regarding any such “imported tobacco”; and

Because Brazilian Tobacco pesticide use includes the documented use of pesticides for which US EPA and USDA have established that there are no safe levels, and that are either not registered or banned for use on Tobacco in the US ( https://www.hindawi.com/journals/omcl/2018/7017423/ ); therefore,

I am requesting that FDA suspend further consideration of the Philip Morris MRTP application, and any other Philip Morris application that can result in approval by the FDA for sale of IQOS in the US, until the issues I raise here are addressed under the FDA’s 907(a)(1)(B) authority and any other applicable enabling authorities.