I’ve just submitted the following Citizen’s Petition to FDA asking them to halt their authorization of IQOS products pending investigation of possible pesticide residue contamination that would make these products more dangerous, not less dangerous than smoking the same tobacco that is being heated in the IOS device. The petition has been accepted and it is on the Docket under consideration and available for public comment. Here’s the link:
https://www.fda.gov/tobacco-products/products-guidance-regulations/tobacco-products-related-citizen-petitions
Citizen’s Petition
Date: 11/26/2023
ACTION REQUESTED
The undersigned submits this petition under 907(a)(1)(B) of Section 907 of the Federal Food, Drug, and Cosmetic Act and related authorities cited below to request the Commissioner of Food and Drugs to act immediately to test the tobacco components of all IQOS products, whether currently authorized by FDA or in process with FDA, for the presence of pesticide residues and, if pesticide residues are detected, to immediately release these results to the public in full and transparent fashion and to immediately initiate further testing to determine:
(1) the identities and concentrations of pesticide residues present in IQOS tobacco component vapor that is generated in normal “heat not burn” operation of the IQOS device, compared with
(2) the identities and concentrations of pesticide residues present in the smoke generated by combusting, or ‘smoking’ a representative IQOS tobacco component, experimentally, using the appropriate laboratory procedures and equipment at the appropriate puff frequency, ventilation, strength of draw, temperature and other standard parameters to replicate cigarette smoking conditions.
Petitioner further requests that, for comparison with the results of the IQOS tobacco component testing requested above, the Secretary also test for and document the identities and concentrations of pesticide residues that may be present in the smoke of: (1) a sample of Kentucky Reference Cigarettes; (2) a sample of one or more “organic tobacco” cigarette brands; and (3) a sample of one or more conventional cigarette brands.
Section B: STATEMENT OF GROUNDS
Part 1. Relative Hazards of Heated Not Burned Pesticides
Petitioner asserts that the potential or known presence of detectable concentrations of pesticide residues in the Tobacco component of the IQOS product has not been referenced in any of Philip Morris’s multiple IQOS FDA applications that Petitioner has examined, nor has Petitioner found any documentation that the potential or actual presence of pesticide residues in IQOS products has been referenced or addressed by FDA in publicly disseminating the following conclusions apparently summarizing the “available evidence” in support of the IQOS claims of reduced harm:
“AVAILABLE EVIDENCE TO DATE:
- The IQOS system heats tobacco but does not burn it.
- This significantly reduces the production of harmful and potentially harmful chemicals.
- Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”
The undersigned has submitted this petition under 907(a)(1)(B) of Section 907 of the Federal Food, Drug, and Cosmetic Act and related authorities cited below to request the Commissioner of Food and Drugs tomove immediately to investigate through laboratory analysis the possible presence of pesticides in the IQOS product tobacco component, and if any are found, to immediately suspend and move to re-evaluate all prior MRTP evaluations and authorizations of the IQOS product in light of the potential harm that could arise from inhaling non-combusted pesticides that have been vaporized, volatilized intact, or dry-distilled in the “heat not burn” device IQOS.
Petitioner asserts that while the “heat not burn” process may in fact eliminate exposure to harmful combustion byproducts, the “heat not burn” process of pyrolytic oxidation may also simultaneously increase exposure to intact, non-combusted pesticide residues, when compared with the pesticide residues present in the combusted tobacco product smoke stream.
Petitioner asserts that without a transparent basis available to the public for comparing the relative risk levels, FDA’s authorization of IQOS products should be suspended pending testing and reconsideration and if initial findings are positive for pesticide residues in the IQOS tobacco component, FDA should consider a product recall.
Petitioner can find no research, FDA or otherwise, that establishes the relative risk profiles of inhaled pesticide-free tobacco smoke and combustion byproducts with the risk profiles of inhaled “heat not burn” conventional tobacco vapor and oxidative pyrolysis byproducts.
Petitioner cites the following as additional supporting authority for the requested action:
https://www.fda.gov/tobacco-products/tobacco-science-research/tobacco-productproblem-reports
“FDA may conduct focused product sample testing as part of a coordinated probe of a national public health threat.”
Realizing that no pesticide chemical is currently designated by FDA as an HPHC in tobacco product smoke, nevertheless, in support of the requested action, Petitioner cites FDA’s actions in classifying 93 substances as identified Harmful and Potentially Harmful Constituents, with this classification resting on the principle that exposure to the identified HPHC would “cause or could cause harm”.
“The Food, Drug and Cosmetic Act (FD&C Act) requires tobacco manufacturers and importers to report the levels of harmful and potentially harmful constituents (HPHCs) found in their tobacco products and tobacco smoke. HPHCs are chemicals or chemical compounds in tobacco products or tobacco smoke that cause or could cause harm to smokers or nonsmokers. FDA must publish HPHC quantities in each brand and sub brand of tobacco product, in a way that people find understandable and not misleading.”
The requested action is further supported by the Precautionary Principle, as expressed in the precautionary ” cause or could cause ” language of the FDA/HPHC quote above, and which FDA has rightly and fairly applied in other regulatory decisions and actions not involving pesticides.
“The Precautionary Principle”
https://pubmed.ncbi.nlm.nih.gov/15968832/
“The Precautionary Principle in its simplest form states: “When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause-and-effect relationships are not fully established scientifically“.
“The Precautionary Principle has been used in the environmental decision-making process and in regulating drugs and other consumer products in the United States.”
The Requested Action falls squarely under the Precautionary Principle in light of increasing scientific evidence that chronic pesticide exposure harms or could harm people exposed by regular smoking or vaporization and inhalation of pesticide-contaminated tobacco products.
Pesticides and human chronic diseases: Evidence, mechanisms, and perspectives
https://www.sciencedirect.com/science/article/abs/pii/S0041008X13000549
“In this review, we present the highlighted evidence on the association of pesticide exposure with the incidence of chronic diseases and introduce genetic damages, epigenetic modifications, endocrine disruption, mitochondrial dysfunction, oxidative stress, endoplasmic reticulum stress and unfolded protein response (UPR), impairment of ubiquitin proteasome system, and defective autophagy as the effective mechanisms of action.”
Petitioner asserts that if pesticide residues are present on the IQOS tobacco component, then inhaling them completely or partially intact after vaporization or volatilization without combustion, may not in fact be less hazardous than inhaling smoke from tobacco initially containing the same quantities and concentrations of pesticide residues on conventional tobacco products after they have been subjected to combustion and heat degradation through conventional smoking of that tobacco product.
Without direct experimental data, this must remain an open question, pending further investigation, but it is one that deserves full application of the Precautionary Principle in the Secretary’s response to Petitioner’s requested action, given the potential for inaccurate or misleading misinformation on the presence or absence of harmful or potentially harmful tobacco product constituents in the form of pesticide residues to impact the health and safety of many people who are using or are considering the use of the IQOS product in the highly promoted and FDA-supported belief that it is a less harmful alternative to smoking conventional tobacco products.
Part 2. Indirect Evidence Of “Heat Not Burn” Pesticide Survival
While there is not yet any direct experimental data on the survival of pesticides after the IQOS “heat not burn” process, there are reasonable indications from research on pesticide survival during fires, including forest, field, and warehouse fires, that while pesticides are sensitive to degradation by heat and even more so by direct flame, many survive “smoldering” (350oC) temperatures and fires intact and biologically active, creating serious inhalation hazards.
Such research, which is fairly robust, supports the possibility that pesticides in the IQOS tobacco component may survive the “heat not burn” process with less degradation than they would during combustion in a conventional cigarette and therefore represent not reduced, but greater potential for harm in the context of the IQOS product.
Fire And Pesticides: A Review Of Air Quality Considerations
“The most extensive studies of pesticide fate during the combustion of wildland fuels have been conducted by Bush et al. (1986, 1987~2, 19876), McMahon and Bush (1986,1992), and McMahon et al. (1985). Although these studies mainly deal with herbicides, they do include insecticides.”
“More variable amounts of pesticide residues (0 to >lOO%) were recovered from the smoke stream in the case of smoldering combustion. Relatively stable compounds such as lindane and dicamba, as well as compounds with significant vapor pressures, can be expected to be released under smoldering or slow-heating conditions. For example, lindane and dicamba and the herbicide 2,4-D were extensively recovered intact in the smoke stream (43%, 92%, and 92%, respectively), while the insecticide chlorpyrifos and the herbicides hexazinone and picloram were extensively decomposed (<28% residue recovery).”
The following citation offers support for the Petitioner’s assertion that the byproducts of oxidative pyrolysis of the IQOS tobacco component, if contaminated with pesticides, could yield more hazardous pesticide-derived vapors than if that same tobacco component were smoked, due to the incomplete degradation of pesticides in the “heat not burn” process – making the IQOS claim of reduced harm and FDA’s acceptance of that claim open to question.
A Toxicological Review of the Products of Combustion
“Oxidative pyrolysis, also known as smoldering, can be described as the thermal breakdown and chemical conversion of materials in a normal oxygen environment, but in the absence of flaming. Smoldering combustion progresses at a much slower rate than flaming combustion, most commonly involves a porous fuel material, and is sustained by the heat given off during oxidation at the fuel surface. Oxidative Pyrolysis occurs at a much lower rate temperature than flaming combustion and is commonly defined as the thermal degradation of material at a temperature below the auto ignition temperature.”
“During pyrolysis, oxidation occurs at the surface of the solid material, in contrast to within the gas phase around the material such as occurs during flaming combustion. Smoldering combustion may occur in the initial stage of a fire, and can provide a pathway to flaming combustion from a heat source which is insufficient to directly produce a flame. Smoldering is a form of incomplete combustion due to the lower temperatures involved, and therefore may yield a much greater quantity of toxic products than flaming combustion.”
Part 3. Misleading Language
The following is cited as an example of what Petitioner believes illustrates the FDA using language that, perhaps unintentionally, misleads the public with regard to the harm or potential harm caused by pesticide contaminants of non-organic tobacco products compared with literally pesticide-free organic tobacco products.
NOTE (Please see “Challenge to Misleading Statements” below this citation and discussion)
“Chemicals in Every Tobacco Plant”
1. “Natural,” “organic,” or “additive-free” cigarettes are safe alternatives to traditional cigarettes.
True or false?
FALSE. All cigarettes—even those advertised as “natural,” “organic,” or “additive-free”—have chemicals that could cause serious harm to your health.4 Whether it’s organic or not—there is no such thing as safe tobacco.3
Review of citations given in support of the above “FALSE” statement:
Citation 3 (“…-there is no such thing as safe tobacco3“) is the NIH publication: “How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease“
Petitioner has searched Citation 3 for the word “pesticide” and finds three pesticide mentions:
p. 52 “For example, nicotine is toxic to many insects and, for many years, has been extracted from tobacco for use as a commercial pesticide (Domino 1999).”
p. 61 “Although metals can be deposited on tobacco leaves from particles in the air and some fungicides and pesticides containing toxic metals have been sprayed on tobacco leaves or soils in the past (Frank et al. 1977).”
p. 62 Aromatic amines and their derivatives are used in the preparation of dyes, pharmaceuticals, pesticides, and plastics. (Brougham et al. 1986; Bryant et al. 1994″.
Citation #4 (“…chemicals that could cause serious harm to your health4“) is the NIH publication: The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General.
https://www.ncbi.nlm.nih.gov/books/NBK179276/
Petitioner has searched Citation 4 for the word “pesticide” and finds four pesticide mentions:
p. 141 “Numerous poisonings have been documented in the literature since the use of nicotine as a pesticide became widespread in the early part of the twentieth century.”
p. 142 “Nicotine is a highly bioactive compound with effects ranging from being a natural pesticide in tobacco leaves to causing addiction in tobacco users.”
p. 183 ” Many factors can influence the chemistry of tobacco smoke: … (2) agricultural practices (which can influence levels of nitrates and pesticides, but also polonium and heavy metal content as well) (Hoffmann and Hoffmann 1997; Rodgman and Perfetti 2009)”….
p. 1066 – Index reference
CHALLENGE TO MISLEADING STATEMENTS
It is misleading to state: “Whether it’s organic or not—there is no such thing as safe tobacco” because that statement implies that all tobacco is equally unsafe, which is counter-factual with regard to pesticide-free organic tobacco.
Also, in the above-referenced “Chemicals in Every Tobacco Plant” language, the term ‘organic’, which has a clear legal definition, is lumped together with ‘natural’ and ‘additive-free’ claims and then all the terms are discounted as a group of illegitimate claims.
As FDA knows, when the term “organic’ is used legally in the context of agricultural products it is specifically intended to inform the public about the absence of the pesticide class of harmful or potentially harmful chemicals in the product that is labeled organic.
The widespread harmful impact of FDA’s confounding the terms “organic”, “natural”, and “additive-free” can be illustrated by the widely consulted and trusted WebMD’s counter-factual but authoritative assertion on their website on Smoking Cessation:
“Regardless of whether you purchase a regular cigarette or an organic one, every type of tobacco product has the same chemicals.”
https://www.webmd.com/smoking-cessation/what-is-organic-tobacco
It’s notable that WebMD makes this counter-factual and misleading assertion a few paragraphs on its “Smoking Cessation” website after informing readers that:
“Organic tobacco is grown without using any sort of fertilizers, chemicals, or pesticides.”
FDA knows that the term ‘natural’ has no legal definition and that ‘natural’ can be and is used in multiple misleading ways in consumer products. Because of this clear distinction it is misleading to equate the legal, technical term “organic” with the amorphous, potentially misleading terms “natural” and “additive-free” when referring to the relative hazards of smoking or vaping tobacco products.
This language avoids informing the public that organic tobacco products are legally required to be uncontaminated with pesticide residues, in contrast to ‘natural’ and ‘additive-free’ tobacco products which are under no such legal requirement and fails to give tobacco product users the full information they need to make fully informed choices when consuming an agricultural product. In support Petitioner cites:
7 USC 1518: “”Agricultural commodity” defined”
https://uscode.house.gov/view.xhtml?req=(title:7%20section:1518%20edition:prelim)#
Organic: A labeling term that refers to an agricultural product produced in accordance with the Act and the regulations in this part.
“Agricultural commodity”, as used in this subchapter, means wheat, cotton, flax, corn, dry beans, oats, barley, rye, tobacco,….”
Title 7 Subtitle B Chapter I Subchapter M Part 205 Subpart A
https://www.ecfr.gov/current/title-7/subtitle-B/chapter-I/subchapter-M/part-205/subpart-A
Organic. A labeling term that refers to an agricultural product produced in accordance with the Act and the regulations in this part.
Part 4. Pesticides Absent In IQOS Documentation
Petitioner has reviewed publicly available previously submitted IQOS FDA applications that offer documented comparisons between toxic substances, including HPHCs, in the IQOS vapor stream, and toxic substances, including HPHCs, in the smoke stream of combusted Tobacco products (obtained using reference cigarettes only, not commercial cigarettes). However, after performing a keyword search through the submitted IQOS FDA documentation, Petitioner 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”.
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.
To grant any application related to IQOS without first establishing that IQOS is in compliance with Special Rule 907(a)(1)(B) seriously jeopardizes 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 compared with combustible Tobacco products.
To grant any application related to IQOS that claims “harm reduction” without comparing the degree of harm or risk of harm from inhaling the intact pesticide burden, possibly dry-distilled in some instances, in the IQOS vapor stream compared to the degree of harm or risk of harm in inhaling the partially combusted, pyrolytically altered and degraded pesticides in a conventional combusted Tobacco smoke stream, would not serve the public’s interest in having full and fair disclosure of all relevant and potentially increased or decreased risks associated with the use of IQOS.
https://www.researchgate.net/publication/228820426_The_pyrolysis_of_tobacco_ingredients
Part 5. Further Discussion of The Need For Testing and Verification
Because the Tobacco materials along with any pesticide residues in the Tobacco component of IQOS will undergo oxidative pyrolysis below the temperature of combustion of either the tobacco or any pesticide residues on the tobacco,
(https://www.sciencedirect.com/science/article/abs/pii/S016523700700006X)
AND
Because none of any pesticide residues contained in the IQOS Tobacco component will be destroyed by combustion, it is reasonable to project that a greater proportion of the original pesticide residue burden, if any, on the Tobacco component of IQOS will survive and retain bioactivity in the vapor stream WHEN COMPARED WITH the proportion of surviving and bioactive pesticide residues, if any, 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 Kentucky Reference Cigarette smoke stream, fails to address the differences in potential for harm between (1) delivery of the full original pesticide residue burden, if any, in the IQOS vapor stream compared with (2) delivery of a reduced portion of the original pesticide residue burden in the Kentucky Reference Cigarette, if any, a portion of which 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 statutes also specify 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 below the limits of detection;
AND
Because current Tobacco industry documentation shows that certain pesticides not registered for use on Tobacco in the United States are widely present in the world Tobacco supply, and certain pesticides banned in the US are also widely 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 foreign countries including Brazil, Nicaragua, and Dominican Republic, that are Tobacco exporters with documented heavy use of pesticides on Tobacco crops produced for export; (https://www.zauba.com/Buyers-of-tobacco-stems);
AND
Because imported Tobacco stems and waste from exporting countries of origin like Brazil are likely, according, for example, to published research on the use of pesticides in Brazilian tobacco, to be contaminated with multiple pesticides residues, some of which may violate the “greater level” condition of Special Rule 907(a)(1)(B), and because these stems and waste are used in large quantities (millions of kilograms/year) by Philip Morris in its US Tobacco product manufacturing and are therefore, in the absence of any statement by the manufacturer to the contrary, potentially being 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” that may be present in the IQOS tobacco component;
AND
Because Brazilian Tobacco pesticide use includes the documented use of pesticides including DDT that are either not registered or are banned for use on Tobacco in the US ( https://www.hindawi.com/journals/omcl/2018/7017423/ );
THEREFORE
Because there is a reasonable possibility that IQOS products may be contaminated with undisclosed or unknown and potentially hazardous pesticide residues that may also be in violation of Special Rule 907(a)(1)(B), potentially creating an increased level of exposure risk when compared to conventional combusted tobacco products, I am requesting that FDA temporarily withdraw authorization of all Philip Morris MRTP applications until final determination of the presence or absence of pesticide residues, and their toxicity, and the accompanying level of hazard to smokers and their families in IQOS products, and a ruling by FDA on whether this presence, if verified, constitutes sufficient reason to grant or deny Philip Morris’s MRTP application(s), acting under the final guidance as given in:
Section 911 of the Federal Food, Drug, and Cosmetic Act – Modified Risk Tobacco Products
“j. Withdrawal of Authorization. The Secretary, after an opportunity for an informal hearing, shall withdraw an order under subsection (g) if the Secretary determines that:
- the applicant, based on new information, can no longer make the demonstrations required under subsection (g), or the Secretary can no longer make the determinations required under subsection (g);
- and that FDA temporarily withdraw authorization for any Philip Morris application that has resulted or can result in approval by the FDA for sale of IQOS in the US, until the issues raised in this Citizen’s Petition are addressed under the FDA’s 907(a)(1)(B) authority and any other applicable enabling authorities.
Section C. Environmental Impact
Petitioner asserts that the use of organic tobacco in tobacco products reduces the environmental impact of pesticides that are used extensively in conventional tobacco production, as well as reducing public and private exposure to pesticides in tobacco smoke or vapor and in second-hand smoke or vapor.
Section D. Economic Impact
Petitioner asserts that organic tobacco production and use has been proven to be both profitable for tobacco growers and tobacco product companies and has been shown to be accepted by consumers; therefore, the economic impact of Philip Morris using organic tobacco for the tobacco component of their “heat not burn” devices would have substantial positive economic impact with no negative downside.
panaceachronicles 