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Pure, Natural Coca Leaf – A Healing Gift Of The Divine Plant


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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.


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Stop IQOS From Vaporizing The Lives Of Millions

This MoveOn.org petition urges Congress to intervene and order the FDA to suspend all IQOS applications while conducting an investigation of a previously-unrecognized public health threat represented by the IQOS system.

Please click on the happy little hummingbird hovering in all that harmless IQOS vapor, sign the petition, and help stop this sinister fraud.

The Petition Is Simple

“We ask that Congress act with urgency to direct and enable FDA to immediately conduct testing for residues of toxic and banned pesticides on the Tobacco component of IQOS before any further consideration of any of the pending IQOS applications.

And It’s Important

The pesticides in IQOS Tobacco won’t be burned – they’ll be vaporized with full bioactivity intact. There will be much higher concentrations of these toxic substances in Tobacco vapor than in Tobacco smoke.

Teens and younger children whose neurological and reproductive development is still highly vulnerable to the xenobiotic activity of these chemicals will be inhaling a concentrated pesticide vapor, including vapors of pesticides banned for use anywhere in the world.

In its applications for IQOS Philip Morris never mentions pesticides. Accidental oversight or deliberate omission? Philip Morris is well aware of the presence of these toxic substances in the world Tobacco supply yet they appear nowhere in the list of substances being avoided by IQOS users in comparison to smokers.

       FDA has the authority 

       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.

Congress has to act now, before IQOS can begin vaporizing millions of American lives. And not incidentally, that’s why the 24 countries where IQOS is already vaporizing lives need to investigate and act with even more urgency than the US Congress.

PLEASE CLICK HERE TO SIGN THE MOVEON.ORG PETITION

This is a list of pesticide residues from an internal industry document that reveals the 100+ pesticide residues in the world Tobacco supply. That means any or all of these could be in any given Tobacco product in any country. IQOS uses Tobacco to produce its vapor. There is enough authoritative published evidence that these pesticide residues will be present in IQOS Tobacco vapor for Congress to order the FDA to investigate and if necessary act to prevent the chronic exposure of potentially millions of Americans to these 100% avoidable toxic substances.

Why avoidable? Because the industry knows how to produce organic Tobacco products. But they choose not to. That’s an purely financial decision, disregarding the health consequences, that could only be made safely if they believed that the fix was firmly in and working smoothly.

Is it? Please sign and share the petition.

2,4,5-T, 2,4-D, Acephate, Acetamiprid, Acibenzolar-S-methyl, Alachlor, Aldicarb, Aldrin + Dieldrin, Azinphos-ethyl,Azinphos-methyl, Benalaxyl, Benfluralin, Benomyl, Bifenthrin, Bromophos, Butralin, Camphechlor (Toxaphene), Captan, Carbaryl, Carbendazim, Carbofuran, Chinomethionat, Chlorantraniliprole, Chlordane , Chlorfenvinphos CPA, Chlorothalonil, Chlorpyrifos, Chlorpyrifos-methyl, Chlorthal-dimethyl, Clomazone, Cyfluthrin ,Cyhalothrin, Cymoxanil, Cypermethrin, DDT, Deltamethrin, Demeton-S-methyl , Diazinon, Dicamba, Dichlorvos  Dicloran, Diflubenzuron, Dimethoat, Dimethomorph, Disulfoton, Dithiocarbamates (as CS2), CPA, Endosulfans, Endrin, Ethoprophos,  Famoxadone, Fenamiphos, Fenitrothion, Fenthion, Fenvalerate, Fluazifop-butyl, Flumetralin,  Fluopyram , Folpet, HCH, HCH (Lindane), Heptachlor, Hexachlorobenzene, Imidacloprid, Indoxacarb, Iprodione, Malathion, Maleic hydrazide, Metalaxyl, Methamidophos, Methidathion, Methiocarb, CPA, Methomyl, Methoxychlor, Mevinphos, Mirex, Monocrotophos, Naled, Nitrofen, Omethoate, Oxadixyl, Oxamyl, Parathion-ethyl, Parathion-methyl, Pebulate, Penconazole, Pendimethalin, Permethrin, Phorate, Phosalone, Phosphamidon, Phoxim, Piperonyl butoxide, Pirimicarb, Pirimiphos-methyl, Profenofos, Propoxur, Pymetrozine, Pyrethrins, Tefluthrin, Terbufos, Thiamethoxam, Thiodicarb, Thionazin, Thiophanate-methyl CPA, Tralomethrin,Trichlorfon, Trifluralin.

What a Tobacco connoisseur’s delight! Mmmmm – a nose reminiscent of Chlordane with hint of fresh Parathion. Sweet!