Framework to Estimate Total Particulate Mass and Nicotine Delivered to E-cig Users from Natural Environment Monitoring Data


We define the cumulative yield, YAC, of individual Aerosol Constituents (AC) of emissions delivered from an ENDS to the mouth of a user as the integral of the product of the time dependent mass ratio of the aerosol constituent, the Total Particulate Matter (TPM) concentration of the whole aerosol, and the user’s volumetric flow rate:

$${Y}_{{rm{AC}}}equiv {int }_{{t}_{{rm{initial}}}}^{{t}_{{rm{final}}}}{f}_{{rm{AC}}}(t){C}_{{rm{TPM}}}(t)dot{v}(t)dt$$

(1)

where the mass ratio of the constituent fAC(t) = mAC/mTPM [mg/mg] and TPM Concentration CTPM(t) = mTPM/v [mg/mL] (mass per volume) vary with time as a user changes puffing patterns, tobacco product choices, and user-selectable device settings. The constituents in the ENDS aerosol may be present in the un-puffed e-liquid, or generated as decomposition products. We normalize all aerosol constituents (including vapor phase constituents, compounds originating in the e-liquid, and thermal decomposition products) by the mass of TPM emissions to facilitate separation of variables between the fAC and CTPM terms. We posit the TPM concentration and mass ratio of constituents may be expressed as linearly independent functions of Product Characteristics (PC) and User Behavior Characteristics (UBC). Numerous ENDS PC may affect the CTPM including but not limited to the device operating power (reflected in coil wattage, amperage, or temperature), flow path geometry, coil design, and aspiration features. Additionally, the solvent composition of the e-liquid consumable (such as the PG/VG ratio which directly impacts the saturation temperature of the e-liquid) may impact CTPM. Additional consumable PC impacting fAC may include nicotine concentration, flavor additives, viscosity, and pH. Furthermore, a variety of UBC may affect the CTPM and/or fAC including puff duration, d, flow rate, q, volume, v, and interval, i:

$${C}_{{rm{TPM}}}={ {mathcal F} }_{{rm{TPM}}}(PC,UBC)$$

(2)

$${f}_{{rm{AC}}}={ {mathcal F} }_{{rm{AC}}}(PC,UBC)$$

(3)

For the current study we limit variability in PC by selecting a single ENDS with no user-adjustable settings and a single e-liquid. We thus focus on the interaction between UBC and the flow path PC, reflected by the topography parameters q and d, and consider a single AC, nicotine, to illustrate the approach. Prior work4 demonstrated a power law relationship between CTPM [mg/mL] and puff flow rate, q [mL/s]. Therefore, we propose the form of Eq. 4 to account for puff flow rate, q [mL/s], puff duration, d [s], and the product of those terms, which has physical significance as the puff volume v = q d [mL]. A transformation of variables enables a linear systems model describing the model-predicted TPM concentration, ({hat{{rm{C}}}}_{{rm{TPM}}}), of a single puff in terms of a set of empirical coefficients, b:

$$mathrm{ln}({hat{C}}_{{rm{TPM}}})={b}_{1}+{b}_{2},mathrm{ln}(q)+{b}_{3}(d)+{b}_{4}(mathrm{ln},{(q)}^{2})+{b}_{5},mathrm{ln}(d/1000)+{b}_{6}(qcdot d)$$

(4)

The experimental observations of CTPM can be computed as the ratio of the mass emissions captured on a filter pad per measured volume of aerosol passing through the pad. The coefficients in Eq. 4 may be estimated using ordinary least squares (OLS), weighted least squares (WLS), or other regression techniques. OLS regression is employed in the current work. Since the ENDS device chosen for the study does not have a user-selectable power setting, and the nicotine concentration of the e-liquid is held constant across all trials, we hypothesize a first order linear model, Eq. 5, for the model-predicted nicotine mass ratio, ({hat{{rm{f}}}}_{{rm{NIC}}}), as a function of puff flow rate, q.

$$widehat{{f}_{{rm{NIC}}}}={beta }_{1}+{beta }_{2}(q)$$

(5)

The regression coefficients, β, are also determined using OLS.



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EU E-Cig Study Criticized For Being Selective in Its Reported Findings


Despite all the scientific evidence to the contrary, the SCHEER said that e-cigarettes act as a Gateway to smoking.

The EC commissioned SCHEER review concluded that e-cigarettes pose health risks to the respiratory tract and cardiovascular system, while risks from the cumulative exposure to nitrosamines and aldehydes was found to be weak to moderate. Moreover, the researchers also reported weak to moderate risks from second hand vapour exposure.

Sadly, despite all the scientific evidence to the contrary, the SCHEER report also said that e-cigarettes act as a Gateway to smoking. “Regarding the role of electronic cigarettes as a gateway to smoking/the initiation of smoking, particularly for young people, the SCHEER concludes that there is strong evidence that electronic cigarettes are a gateway to smoking for young people. There is also strong evidence that nicotine in e-liquids is implicated in the development of addiction and that flavours have a relevant contribution for attractiveness of use of electronic cigarettes and initiation.”

Research indicating the effectiveness of e-cigs for smoking cessation refuted

Finally, the paper refutes all the research indicating the effectiveness of vaping products as smoking cessation devices and says that the evidence indicating this is weak. “Regarding the role of electronic cigarettes in cessation of traditional tobacco smoking, the SCHEER concludes that there is weak evidence for the support of electronic cigarettes’ effectiveness in helping smokers to quit while the evidence on smoking reduction is assessed as weak to moderate.”

For all these allegations, the paper was criticized for being selective in the findings it reported. However, the EC maintains that the study was based on the latest and up-to-date evidence. “The SCHEER committee takes into consideration the most recent and up-to-date scientific evidence and technical developments and, as appropriate, the existing provisions concerning e-cigarettes under the TPD (in particular Article 20(3)), and the evolution of new products on the market,” said an EU spokesperson.

“The scientific opinion addresses considerations relevant both at individual level and at population level, from a public health perspective and reply to specific questions from mandating DG only (cf. mandate),” added the spokesperson.

Naturally, renowned for its anti-vaping stance, the World Health Organisation (WHO) concurred. “However, it is too early to provide a clear answer on the long-term impact of using them or being exposed to them,” said the UN agency.

Ignoring scientific data

Meanwhile, multiple reliable public health entities such as Public Health England (PHE) insist on the relative benefits of the products. “Current vaping is mainly concentrated in young people who have experience of smoking. Less than 1% of young people who have never smoked are current vapers.”

Communicating with renowned and award winning researcher and professor Riccardo Polosa, who is also the director of the Center of Excellence for the acceleration of Harm Reduction (CoEHAR), European independent media network EURACTIV was informed that the “Opinion did not take much time to evaluate cessation – less than two pages in the report”.

Anyway a person can stop smoking is good

Soon after the paper was published, added Polosa, the “well-respected Cochrane review” came out with an update that suggested moderate evidence of effectiveness. “Science has a high bar for proof, which is right. At the same time, any way a person can stop smoking is good – chewing gum, sucking lollipops. It is well known in harm reduction that substitution is easier to achieve than abstinence, so that is why e-cigarettes have worked for many people to stop smoking,” he concluded.

New Study Links Nicotine Exposure to Breast Cancer Metastasis



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The debate over e-cigarettes demands stronger evidence of their value


A young man exhales a cloud of vapour from an e-cigarette

Over the past few years, e-cigarettes containing increased concentrations of nicotine have attracted users.Credit: Volodymyr Melnyk/Alamy

For more than half a century, the world has known that tobacco kills — yet it is still killing more than 8 million people a year. Tobacco use remains the world’s worst entirely preventable public-health emergency, and there is a desperate need for fresh ways to tackle it.

So it is little wonder that e-cigarettes have attracted attention as a potential solution. More than half of US adult smokers try to quit each year: in theory, e-cigarettes might boost their chances of success. It is generally agreed that vaping is safer than smoking conventional cigarettes.

But even as e-cigarette sales have boomed — the global market was worth US$11.3 billion in 2018 — concerns have mushroomed, and research has failed to keep up. Urgent questions about vaping remain: whether it really does help people to quit smoking, whether it serves as a gateway to cigarettes, and whether the liquid formulations have short- and long-term health effects. Until such questions are answered, it seems premature to advocate strongly for e-cigarette use, and imperative that regulators develop guidelines to limit vaping by adolescents.

A UK study published this year highlights the evidence gap. In a large randomized, controlled trial, researchers found that smokers who used e-cigarettes to help them quit were less likely to start smoking again for at least a year, compared with those who used other aids such as nicotine gum or patches1. The study was one of the most rigorous so far — yet the benefit was slight, and 75% of study participants had already tried and failed to quit using the other cessation aids, so it was less surprising that they failed again. Overall, studies have not found strong evidence for a benefit of e-cigarettes over other quitting strategies — including nicotine-replacement therapy combined with antidepressants.

It’s also hard to say whether recent results will translate to the real world, where e-cigarettes are changing fast. Over the past few years, US vapers have flocked to devices that contain nearly three times the European Union’s legal limit on nicotine concentration. The most concentrated pods of the popular devices, made by Juul of San Francisco, California, for example, contain as much nicotine as a pack of 20 cigarettes.

There is huge concern about the surge of vaping among young people, and the potentially addictive nature of such products, which have been backed by aggressive marketing campaigns. Vaping among high-school students in the United States (14–18 years old) rose 78% from 2017 to 2018. One out of every 5 high-school students — and nearly one out of every 20 middle-school students, typically 11–13 years old — has vaped at least once in the past month.

This could be a major health concern. Many studies have shown that adolescents who vape are more likely to take up smoking, but none has established a causal link. And the long-term effects of e-cigarettes — particularly ones with a high nicotine concentration — on young brains remain unknown.

With so few data, researchers’ debate over e-cigarettes has been divisive and sometimes emotional. Proponents of e-cigarettes see a way to help the millions who are trying to quit smoking and stem the grave harm caused by tobacco. Vaping critics — some of whom have received death threats after giving public talks critical of the devices — fear they could lose ground in the decades-long battle against tobacco and create a generation of e-cigarette addicts. They see the spectre of Big Tobacco — the five largest global tobacco companies — rising again. That fear was further fanned when tobacco giant and Marlboro-maker Altria of Richmond, Virginia, purchased 35% of Juul last year.

Studies showing that cigarettes cause lung cancer turned tobacco into an enemy of public health. Now researchers, research funders, public-health agencies and policymakers must unite to provide answers about e-cigarettes by designing better studies, repeating those that have been done already and simultaneously addressing the next generation of nicotine products.

There are reports that manufacturers are looking at ways to increase the voltage of their devices, and so deliver more nicotine without raising the nicotine concentration of their juice — a way of sidestepping EU limits on nicotine content. And other devices are coming online: in Japan, cigarette smokers are increasingly using electronic products that heat tobacco without burning it, and the US Food and Drug Administration approved its first such product in April.

The right policies on e-cigarettes — ones that minimize risks — will be built on evidence and collaboration, not on opinion and vitriol. It might be too early to say whether e-cigarettes will make a major difference in helping adult smokers to quit. It’s the right time for regulators to protect the next generations from having to.



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First Big Tobacco cannabis player backs out after bankruptcy


The first Big Tobacco company to join the hemp and marijuana industries is getting back out.

Pyxus International, one of the world’s largest tobacco suppliers, said Thursday that it will focus on its more profitable tobacco and liquid nicotine products after filing for bankruptcy in June.

Based in Morrisville, North Carolina, Pyxus was growing hemp in the U.S. and marijuana in Canada. But the company was hard hit by declining tobacco consumption and coronavirus-sparked supply disruptions.

Pyxus’ Canadian subsidiaries, Figr Brands, were not part of the initial bankruptcy filing but have since filed for and received creditor protection. Pyxus is looking for a buyer for its Figr companies.

“We maintain our belief that there is value in FIGR, and its growth can be accelerated with the right capital structure and partner,” Pyxus CEO Pieter Sikkel said in a statement.

Pyxus, formerly Alliance One International, was part of the influx of Big Tobacco and Alcohol into the cannabis industry.

Pyxus trades on over-the-counter markets as PYXX.



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France: Vaporesso Works With Local Vape Shops to Support The Needy


With COVID-19 still raging throughout the country and most of the world, many people have been struggling financially and unable to cope, let alone celebrate any holidays with their families. Launched on Christmas Eve 2020, the Vaporesso initiative involved distributing relief supplies to local communities in collaboration with 17 vape shops around France, with the intention of helping people who have been negatively affected by the pandemic.

“At Vaporesso, we take being a positive corporate citizen very seriously. Doing what we can to give back to the community is part of our global mission to make the world a better place,” said Vaporesso Global Marketing Director, Niki Zhang.

Throughout the pandemic France has had a comprehensive policy on tobacco. The Ministry of Health had issued a legal decree explicitly allowing tobacco and e-cigarette shops to remain open, adding them to a detailed list of essential businesses allowed to operate.

The UK faces the 3rd lockdown

Meanwhile, across the English Channel, British Prime Minister Boris Johnson has recently announced the third lockdown in England, which started earlier this month and will last until around mid-February. Once again, this sadly includes vape shops

The UK fully endorses the use of vapes as smoking cessation and/or harm reduction tools, and it is a well known fact that the pressures brought about by the pandemic are leading to a lot of smoking relapses. To this effect, public health experts have been pointing out that closing vape shops at this time is particularly nonsensical. Only last October, the government-funded campaign – Stoptober, was urging smokers to quit cigarettes by switching to vaping.

“Only last month the Government-backed Stoptober campaign was encouraging smokers to quit, including through taking up vaping. Those who took up the challenge during the month now do not have access to the same level of support and products from their local vape stores. We will be making these points strongly to the government on behalf of the industry and asking them to reconsider their stance on vape stores and reclassify them as essential in future,” argued John Dunne, Director General of the UKVIA last November, ahead of the 2nd lockdown.

Vaporesso Launches “Together We Can!” Campaign



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The Effect of Electronic Cigarette User Modifications and E-liquid Adulteration on the Particle Size Profile of an Aerosolized Product


This study seeks to understand the relationship between various electronic cigarette modifications and the particle size profile of the aerosols generated by the device using a cascade impactor. The coil resistance, battery voltage, and the composition of the glycols in the e-liquid were varied to determine the impact on particle size formation. E-liquids using 12 mg/mL nicotine were evaluated as well as two e-liquids containing DOTNs, 60 mg/mL methamphetamine and methadone. Methamphetamine is a schedule II CNS stimulant with a history of smoking as a mode of administration. In recent years, arrests have been made with individuals having been found with methamphetamine inside their e-cigarette devices20. Methadone, a schedule II synthetic opioid in the same class of compounds as heroin, is primarily taken orally for opioid addiction maintenance. The liquid concentrate formulation of methadone is composed of propylene glycol, which is also a constituent in e-cigarette e-liquids21.

Reagents and supplies

Nicotine, methamphetamine hydrochloride, and methadone hydrochloride were purchased from Sigma Aldrich (St. Louis, MO). The vegetable glycerin and propylene glycol were purchased from Wizard Labs (Altamonte Springs, FL). The Kangertech replaceable atomizers were purchased from Discount Vapers (Oakville, CT), the AeroTank Clearomizer from My Vapor Store (Panama City, FL), and the e-go V v2 variable voltage battery from Vivid Smoke (Irvine, CA). Nicotine, methamphetamine, methadone, nicotine-d4, methamphetamine-d11, and methadone-d9 reference standards were all purchased from Cerilliant Corporations (Round Rock, TX). The methanol and 20 mL scintillation vials were purchased from Fisher Scientific (Pittsburgh, PA). The Micro-Orifice Uniform Deposit Impactor (MOUDI) was purchased by MSP Corporation (Shoreview, MN). The flow meter was purchased from Dwyer (Michigan City, IN).

Particle size experiments

An AeroTank Clearomizer with a KangerTech pre-assembled atomizer was used in conjunction with an eGo-V2 variable voltage battery to develop a model for research, to easily control variables, and generate the condensation aerosol. This specific device was used due to its popularity in the United States at the time of purchase, and the atomizer was easy to adapt with typical user modifications, such as coil configurations.

Nicotine e-liquid formulations were prepared at 12 mg/mL in 50:50 PG:VG 100% PG, or 100% VG solution in order to measure the impact of PG and VG formulation on particle size. Coil resistance was set at 1.5, 1.8, or 2.2 Ω at 4.3 V. Common battery output voltages were set at 3.9, 4.3, or 4.7 V at 1.8 Ω, the most common resistance for this device. Methamphetamine and methadone e-liquid formulations were prepared at 60 mg/mL in 50:50 PG:VG solution to evaluate the impact of different drugs on particle size and generated with a device operated at the most common battery and resistance settings of 3.9, 4.3, or 4.7 V at 1.8 Ω. E-liquids were stored in a cabinet at room temperature until the experiments were started. The AeroTank clearomizers were filled at half capacity with e-liquid formulation at the day of the experiment and were vortexed prior to aerosol generation. The battery was charged the night prior to the experiments.

A 10-stage micro-orifice uniform deposit impactor (MOUDI), draws the sample through a cascading sequence of nozzles that deposit the aerosol onto plates, was used for particle size analysis8,9,10. Aluminum disks were placed on the plates for stages 1–9 of the MOUDI with filter paper placed on the final stage (stage 10). The mass of the AeroTank Clearomizer containing the e-liquid, each aluminum disk, and the filter were recorded pre- and post aerosolization. The 10-stage MOUDI was operated at a flow rate of 30 L/min. The e-cigarette mouthpiece was positioned flush with the USP induction port (simulated throat) which was connected to the inlet of the impactor to allow sampling of the e-cigarette aerosol. The e-liquids were undiluted. An aerosol was generated 6 times, 10 seconds each, for a single MOUDI collection and performed in triplicate. The particle size distribution data generated by the MOUDI was time-averaged data. Following each experiment, the aluminum disks and the filter were weighed and then were each placed into 20 mL scintillation vials and washed with 1 mL methanol. The USP induction port was washed with 1 mL methanol.

Particle size distributions of the glycols was determined gravimetrically. The change in weight of each aluminum disk and filter was used to determine the total mass of e-liquid collected in the MOUDI. The percent mass recovered on each MOUDI stage was determined for each trial (n = 3) and averaged.

Analysis of nicotine particle size samples by LC-MS/MS

A previously validated method was used to analyze nicotine concentrations on each stage of the MOUDI using a Quattro micro MS with a Shimadzu LC system (Shimadzu, Kyoto, Japan). Chromatographic separation was achieved on an Agilent Polaris 5-Si A 50 × 3 mm, 5 μm column (Agilent Technologies, Santa Clara, CA). The injection volume was 10 μL with a flow rate of 0.4 mL/min. The total run time for this method was 4.5 minutes and the instrument was operated in multiple reaction monitoring mode (MRM) for the following m/z transitions: Nicotine, 163 > 130 and 163 > 117; and nicotine-d4, 167 > 134. A seven-point calibration curve ranging 10–1000 ng/mL of nicotine, along with a blank, double blank control, and nicotine controls were analyzed. Controls were prepared as a limit of quantitation quality control (10 ng/mL), low quality control (30 ng/mL), mid quality control (300 ng/mL), and high quality control (900 ng/mL). The internal standard (100 ng/mL nicotine-d4) was added to each calibrator, blank, control, and samples. Dilutions of the samples were prepared to assure that all samples were bracketed within the calibration range.

Analysis of methamphetamine and methadone particle size samples by GC/MS

An Agilent 6890 N Gas Chromatograph with a 5973 Mass Selective Detector (MSD) was used for chromatographic separation and detection using a HP-5MS 30 m × 0.25 mm id × 0.25 μm column (Agilent Technologies, Santa Clara, CA) and helium carrier gas.

For methamphetamine, the GC/MS was operated in split mode at 6:1 ratio and a 1 μL injection volume. The helium carrier gas had a flow rate of 35 cm/s and the inlet temperature was set to 275 °C. The GC oven had an initial temperature of 120 °C with a ramp rate of 10 °C/min until 200 °C before undergoing a second temperature ramp of 30 °C/min until 280 °C. The total run time was 10.67 minutes. The MSD was operated in select ion monitoring (SIM) mode with 58, 64, 91, 96, and 134 m/z as the selected ions and the quantitation was performed using 58 and 64 m/z as the quantitative ions for methamphetamine and methamphetamine-d11 respectively. A six-point calibration curve ranging from 100–2000 ng/mL of methamphetamine, along with a blank, double blank control, and methamphetamine controls were analyzed. Controls were prepared with a limit of quantitation quality control (100 ng/mL), low quality control (150 ng/mL), mid quality control (600 ng/mL), and high quality control (1500 ng/mL). The internal standard (500 ng/mL methamphetamine-d11) was added to each calibrator, blank, control, and samples. Dilutions of the samples were prepared to ensure all samples were bracketed within the calibration range.

For methadone, the GC/MS was operated in split mode at 20:1 ratio and a 1 μL injection volume. The helium carrier gas had a flow rate of 39 cm/s and the inlet temperature was set to 275 °C. The GC oven had an initial temperature of 225 °C with a temperature ramp of 15 °C/min until 285 °C for a total run time of 4 minutes. The MSD was run in SIM mode with the following ions monitored: 72, 223, 294, and 309 m/z for methadone and 78, 226, 303, and 318 m/z for methadone-d9 and quantitation was performed using 72 and 78 m/z as the quantitative ions for methadone and methadone-d9, respectively. A seven-point calibration curve ranging from 100–5000 ng/mL of methadone, along with a blank, double blank control, and methadone controls were analyzed. Controls were prepared with a limit of quantitation quality control (100 ng/mL), a low quality control (150 ng/L), a mid quality control (1000 ng/mL) and a high quality control (4500 ng/mL). The internal standard (500 ng/mL methadone-d9) was added to each calibrator, blank, control, and samples. Dilutions of the samples were prepared to ensure all samples were bracketed within the calibration range.

The geometric mean diameter (GMD), geometric standard deviation (GSD), and mass median diameter (MMAD) were calculated using the methods detailed by Ramachandran and Cooper22. Precision was evaluated by calculating each relative standard deviation for each replicate measurement. The threshold for statistical difference was set at a P-value of 0.05 (n = 3).



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USDA: Final hemp rules aren’t on hold — but new administration will review


Nationwide hemp rules released in the closing days of the Trump Administration aren’t on hold, according to the U.S. Department of Agriculture.

But the agency will be reviewing all programs implemented by the previous administration, as is common when there is a new president.

USDA spokesman Matt Herrick told Hemp Industry Daily in an emailed statement that “we have no specific programs or rules to point to at this time that are on hold, but it’s proper for a new administration to have adequate time to review existing programs as well as those implemented by the previous administration in the final days of their tenure.”

He didn’t say whether hemp producers finalizing planting plans for 2021 should expect USDA to again open the rules for public comments.

The agency already re-opened them once, but some hemp activists are hoping USDA will take another round of feedback.

That’s because the White House issued a memo late Wednesday instructing federal agencies to consider additional 30-day comment periods for rules that have been finalized but not yet taken effect. Hemp falls into that category; the rules were published Tuesday but don’t take effect until March.



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UPS Will End Home Delivery of Vaping Products


Following congressional passage of the “vape mail” ban that will end U.S. Postal Service shipping of vaping products to consumers, UPS has joined Fedex in announcing it too will end shipping of vapes. The ban covers shipping to both consumers and businesses.

“Effective April 5, 2021, UPS will not transport vaping products to, from, or within the United States due to the increased complexity to ship those products,” a company spokesperson told Vaping360 by email. The policy, which will soon leave no major shipping service willing to deliver vaping products to homes, has left online vaping retailers scrambling to find a solution.

The announcement followed days of uncertainty, with some vaping businesses being told that their accounts would be closed, and others being reassured that the company’s tobacco and vapor product policy would not change. (The UPS website has still not amended the policy.)

Fedex had already confirmed that it will end vapor product shipping as of March 1. DHL, the other major shipping service, previously banned domestic retail shipments of e-cigarettes and all nicotine-containing products.

The new law, which was inserted into the federal Omnibus Spending Bill, mandates that the U.S. Postal Service create regulations within 120 days banning U.S. Mail delivery of vaping products—whether they contain nicotine or not. The bill was so broad that the wording includes all vaping products, including all cannabis, CBD, and flavor-only liquids and devices.

The Postal Service has not issued its new rules yet. Existing USPS regulations allow manufacturers, distributors and retailers to ship cigarettes and smokeless tobacco to each other, but not directly to customers. If those rules carry over to vaping products, vape shops will still be able to receive products, but individual customers will be unable to receive deliveries at home.

In addition to banning USPS deliveries of vaping products, the “Preventing Online Sales of E-Cigarettes to Children Act” forces vape product sellers into the Prevent All Cigarette Trafficking (PACT) Act, which is part of the larger federal Jenkins Act. The PACT Act imposes a series of stringent requirements on shippers of included products:

  • Register with the U.S. Attorney General/ATF
  • Verify age of customers using a commercially available database
  • Use private shipping services that collect an adult signature at the point of delivery
  • If selling in states that tax vaping products, sellers must register with the federal government and with the tobacco tax administrators of the states
  • Collect all applicable local and state taxes, and affix any required tax stamps to the products sold
  • Send each taxing state’s tax administrator a list of all transactions with customers in their state, including the names and addresses of each customer sold to, and the quantities and type of each product sold
  • Maintain records for five years of any “delivery interrupted because the carrier or service determines or has reason to believe that the person ordering the delivery is in violation of the [PACT Act]”

Sellers who do not register or don’t comply with the requirements of the PACT Act are subject to severe penalties, including prison. The PACT Act provisions of the law take effect in late March, and apply to all online sales, no matter which carrier ships them.

You can read our previous coverage of the “Preventing Online Sales of E-Cigarettes to Children Act” here:



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Effects of Model, Method of Collection, and Topography on Chemical Elements and Metals in the Aerosol of Tank-Style Electronic Cigarettes


Over view

This is the first study using controlled laboratory conditions that compares: (1) the contribution of collection vessels to elements/metals in the analyte, (2) the elements/metals in aerosols produced by different tank-style EC, (3) the efficiencies of two methods of aerosol collection, and (4) different topographies for aerosol production. Acid presoaking of the glassware used for aerosol collection was necessary to remove elements that leach from glass and could add to the concentrations of elements measured in aerosols. Of 19 elements/metals screened, three (cobalt, silver, titanium) were not detected in any samples. It is likely that some of the elements in tank aerosols, such as aluminum, calcium, chromium, copper, iron, lead, magnesium, nickel, silicon, tin, and zinc, were from components in the atomizing units. The total concentrations of elements/metals in aerosols collected with the cold trap method (1,226 to 6,767 µg/L) was higher than that for the impinger method (43 to 3,138 µg/L). The impinger method had the advantages of being faster to perform, collecting some elements not found with the cold trap method, and avoiding surfaces, such as tubing, that could contribute elements to the aerosols leading to an overestimation of total concentrations. For total concentrations of individual elements averaged for all brands, occasional differences were observed with different topographies, but in general concentrations were similar across topographies, as well as with the two methods of collection. The concentrations of some elements, such as lead, were significantly higher in aerosols produced at high voltages. When comparing individual elements across brands, results were again remarkably similar. For example, with the exception of one brand, zinc appeared in all aerosols irrespective of topography. Lead appeared in all aerosols, except those made with Clone, which had a simple atomizer and overall fewer elements in its aerosols. These data provide a useful benchmark for element/metal concentrations in aerosols made from a range of tank-style EC used with different topography parameters.

Leaching of elements from glassware

Other EC reports have not addressed leaching from glassware as a possible source of contaminants that affect concentrations of elements in EC aerosols, but leaching from filters used in cigarette smoke analysis has been reported41. Our data demonstrate the importance of establishing that elements do not leach into the aerosol solution from surfaces used in collection and taking this into account when computing final concentrations of elements. Acid corrosion can occur in glass by creating pores in the silica scaffold thereby leaching the alkali components of the glass and bringing them into solutions42, which could explain why there was some potassium in the impinger acid solutions even after 5 days of soaking. In addition to pretreating glassware, all plasticware should be pretreated with acid to seal it43. It is also important to minimize the amount of time a sample is stored before analysis, as elements could leach during storage and contribute contaminants to the aerosol solutions.

Methods of aerosol collection

There is currently no standard method for EC aerosol collection for metal analysis4. Therefore, labs have used various methods, such as glass washing bottles with methanol in dry ice, quartz filters, and condensation using pipette tips and narrow tubing31,44,45; however, these have been used without examining how the method affects the element concentration in aerosols. As our study shows, element concentrations can vary with the method of collection. The total concentration of elements in the cold trap high voltage low air flow rate group was about 3.5 times higher than the continuous impinger method. This could be due to: (1) leaching of elements in the cold trap method from the peristaltic pump tubing or plastic storage tubes, which were not pretreated in acid, (2) more efficient collection of all aerosol with the cold trap method, (3) the longer time (6 minutes) between puffs with the cold trap may have enabled more complete collection of the aerosol, and (4) the cold trap was a better method of collection for silicon and calcium, which contributed to the higher total concentration. It is also important to note that the cold trap method was better at collecting the alkali (sodium and potassium) and alkaline earth metals (magnesium and calcium) and metalloids (silicon, boron), but not as efficient as the impinger method at collecting the transition (heavy) metals (chromium, iron, nickel, zinc, and copper). Although we do not know the reason for these different efficiencies, these data clearly show that the method of collection can affect concentrations and that not all elements were affected in the same way. The use of two different methods provides insight into ranges of elements in EC aerosols and may help understand differences in values reported in prior literature.

Aluminum, boron, iron and nickel were present in higher concentrations in aerosols collected with the impinger method than with the cold trap. This may be due to better mixing of the aerosols with the larger volume of solvent in the impinger or loss of some elements in plastic storage tubes that were not acid sealed in the cold trap method. We recommend the use of the impinger method in conjunction with presoaking the impingers in nitric acid until leaching stops and storing aerosols in acid pre-sealed tubes with analysis as soon as possible after collection.

Effects of topography

Some elements were only present in samples prepared using specific topographic parameters. With the cold trap method, aluminum, copper, and lead were generally detected in samples prepared using high voltage, suggesting that the EC must heat high enough to drive these elements/metals into the aerosol. These same three elements were detected in all impinger samples, which were all prepared using high voltages. In cases in which an element was present only in aerosols created at low voltage (e.g., low air flow rate for aluminum with impinger method – Fig. 5B) or only in aerosols created with continues puffing (e.g., aluminum and sodium Fig. 3B), it is possible that the element was part of a coating that was released during the initial use of the EC and no additional aluminum was available for aerosolization with the subsequent topographies.

The impinger method results are generally similar for each element within a brand. Aerosols created with the continuous puffing protocol usually contained more elements than aerosols made with the interval method, while the interval puffing protocol produced aerosols that generally had somewhat higher concentrations of individual elements (e.g., lead) than those produced by the continuous protocol (Fig. 3B). Although the reason for the higher concentration with interval puffing is not known, the cycling of the filament through hot and cold temperatures could make it more friable and prone to release more elements. The interval puffing protocol is more similar to the way a consumer would use the product and probably better represents actual user exposure.

Dominant elements

Those elements/metals that were dominant in the aerosols, i.e. appeared in all or almost all samples (aluminum, calcium, chromium, copper, iron, lead, magnesium, nickel, silicon, sodium, tin and zinc) have been reported previously in the atomizing units of cartomizer and disposable EC products28,29,30,46, and it is likely that they originated in the atomizers. The Clone had the fewest metal parts and the fewest types of metal in the atomizer, and also had the fewest number of elements in its aerosol. The elements that are present in aerosols from the Clone are in similar concentrations to those in other products. These data suggest that reducing metal components in atomizers will decrease metals in aerosols, in support of our prior study29. It is also possible that some elements/metals in aerosols originated in the e-fluid, as one prior study reported26. Although not included in the current study, we have unpublished data on elements in a spectrum of EC fluids. Only sodium was high enough in some fluids we used to affect the data in this study. In fact, the difference seen in sodium in Fig. 3B is likely due, at least in part, to a high level of sodium in the refill fluid used for the continuous but not the interval puffing.

Source of elements/metals in aerosols: The concentration of elements/metals in e-fluids is higher after an EC has been used26, supporting the idea that metals in aerosols come from heated components in the atomizers. Some elements, such as lead, potassium, sodium, and zinc, have relatively low melting points (321 °C, 64 °C, 98 °C, 420 °C respectively) that would facilitate their transfer into aerosols when ECs heat up to 320 °C (Supplemental Table 1)25. Zinc was commonly found in aerosols, suggesting these devices heat up to over 320 °C. The atomizing units of the ECs used in this study did not contain lead46 nor did the refill fluids. Thus the source of the lead has not yet been determined for these products, but could be the glass or metals components of the tank/reservoir.

Number and concentration of elements are affected by model and method

The number of elements in the aerosols varied with method of collection and also with the model of the EC. The interval method produced a significantly higher concentration of copper and zinc in the aerosols from Aspire and Smok products than the continuous method. This is important since it more closely resembles how an EC would actually be used. The higher concentrations of chromium, copper, and iron in the impinger aerosols of Smok and Tsunami suggest that the sub-ohm batteries and newer tanks deliver more metals into the aerosols than the older models of tank-style EC.

Comparison to prior data

The range of total concentration of elements/metals in the aerosols of tank-style EC in the current study (374 to 3,028 µg/L) was similar to that found previously in disposable EC (973 to 2,296 µg/L)30. A group recently screened 15 elements in the aerosols from different brands of tank-style EC using a condensation method of collection26. For the subset of eight elements (aluminum, chromium, copper, iron, lead, nickel, tin, zinc) that were present in the current and preceding studies, the total median concentrations were 670.04 µg/L (tanks – condensation collection)26 101.172 µg/L (disposable -cold trap collection)30, 161.44 µg/L (tanks – cold trap collection- current study), and 441.30 µg/L (tanks – impinger collection- current study). For this subset of elements, the median concentrations of the impinger (current study) and the Olmedo et al. 2018 study are in reasonable agreement. However, the subset medians for both cold trap methods are lower than that for the tank condensation and impinger collection methods. These differences could be due to less efficient collection of certain elements using the cold trap method, lower concentrations of elements in the aerosols produced by the lower voltage disposable models, the use of different EC models/brands in each study, or a combination of these factors. The importance of voltage/power is shown by the observation that some elements (aluminum, boron, copper, iron, lead, sodium) were only produced at the higher voltage.

Comparison to cigarette smoke

The total concentration of elements/metals in the aerosol of tank-style EC (226–6,767 µg/L) was higher than that found in cigarette smoke prepared using the International Organization for Standardization (ISO) (2,690 µg/L), Health Canadian Standard (HCS) protocols (1,103 µg/L)30. Of the 19 elements screened in this study, four (boron, iron, silver, titanium) were present in cigarette smoke and not in EC aerosol prepared using the cold trap method. However, some elements (aluminum, cadmium) were present in EC aerosol and not in cigarette smoke. Four elements (copper, lead, nickel, zinc) were present in both EC aerosol and cigarettes smoke, and both lead (407 µg/L) and zinc (36 µg/L) were found in higher concentrations in EC aerosol than in cigarette smoke (ISO – 0.126 µg/L, HCS – 1.252 µg/L)30. The concentration of copper and nickel in cigarette smoke was within the range in EC aerosol (nickel: ISO – 0.655 µg/L, HCS – 2.769 µg/L, EC – 0.074–2.3 µg/L, copper: ISO – 80 µg/L, HCS – 170 µg/L, EC – 19–200 µg/L)30. Other studies have reported that individual metals in cigarette smoke prepared using the HCS usually had a higher concentration of metals than samples prepared using the ISO protocol41,47,48,49. For example, the concentrations in Marlboro Red cigarette aerosols were two to three times higher in samples prepared using the HCS47.

Potential health effects of EC elements/metals

The potential health effects of elements and metals in EC aerosols have recently been reviewed34,50,51. Chromium, lead, and nickel are of particular concern as they are known carcinogens32. Prolonged exposure to chromium from EC aerosol could cause gastrointestinal effects, nasal and lung cancer, respiratory irritation, and lung function impairment34,52,53,54. Tank-style EC deliver higher concentrations of nickel than previous EC models28,29,30. Nickel inhalation can cause lung disease, damage to the nasal cavity, lung irritation, lung inflammation, hyperplasia in pulmonary cells, and fibrosis53,55,56. Prolonged exposure to lead, which has been found in varying concentrations in all styles of EC, could produce vomiting, diarrhea, cardiovascular effects, and lung cancer34. Olmedo et al. 2018 also reported that concentrations of chromium, lead, and nickel are high enough in EC aerosols to be a health risk26. Likewise the concentrations of some elements (chromium, copper, lead, nickel, zinc) reported in our study exceed the proposed Occupational Safety and Health Administration, permissible exposure limit (OSHA PEL)34. For example, the OSHA PEL for chromium is 5 × 103 ng/m3 34, and the concentration of chromium found in one brand of tank-style EC (Tsunami 2.4) was 3.3 × 107 ng/m3, which is much higher than the OSHA PEL. Because, OSHA values are for occupational not recreational exposure, our values may underestimate potential harm to EC users.

Speciation

Since most methods of measuring metals in aerosol samples only report concentration and not speciation, it is not yet known if the species of chromium, nickel and lead would be harmful. For example, chromium (III) is an essential nutrient in the human diet and not readily absorbed by cells, but its reduction to Cr(VI) could cause oxidative stress, DNA adducts, DNA-protein crosslinks, and damage to lipid bilayers in cells57,58. In addition, exposure to Cr(VI) is a respiratory irritant and could lead to nasal, sinus, and lung cancer54.



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FDA withdraws pending CBD enforcement proposal


(Updates throughout with FDA response.)

U.S. drug regulators have withdrawn their proposal to regulate over-the-counter CBD, handing the industry another setback after years of delay from the Food and Drug Administration.

The proposal in question was withdrawn because of the changing administration. The delay was widely anticipated but still frustrating for CBD operators awaiting the rules.

The FDA sent the proposal to the White House Office of Management and Budget last July, a final stop before new regulations go public.

But the FDA withdrew its CBD proposal last Thursday, a day after President Joe Biden was inaugurated. The withdrawal came hours after the Biden administration issued a memo to all federal agencies telling them to withdraw pending rules, such as the FDA’s CBD guidance.

Details of the proposal were never released. They were sent more than a year after the FDA started a fresh review of CBD and other cannabinoids.

There is no legal deadline for the FDA to clear a path for legal over-the-counter CBD. But the agency has repeatedly confirmed that they know the product is commonly sold and that regulatory safety standards are overdue.

The Trump White House OMB reportedly met to discuss new CBD rules with CBD makers and retailers including GW Pharmaceuticals and chain retailer General Nutrition Centers (GNC).

An FDA spokeswoman told Hemp Industry Daily Monday that the agency “will work closely with the new administration to advance appropriate regulations and policies that are in line with the agency’s public health mission.”

She gave no timeline for resubmitting a CBD proposal.



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