Friday, March 16, 2018

Smokers Deserve Improved FDA E-Cigarette Regulation: Pass Cole-Bishop

It’s no secret: E-cigarettes are vastly safer, increasingly popular and successful substitutes for traditional tobacco cigarettes.  More and more smokers are replacing combustible tobacco with vapor technology to reduce their health risks (here), or even to ultimately eliminate their nicotine consumption.  This is a particularly important development for my home state Kentucky, where smoking and lung cancer rates are among the highest in the country.

Unfortunately, government bureaucrats, dreaming of a tobacco-free society (read: prohibition), are trying to condemn the emerging e-cigarette industry to regulatory purgatory. The FDA’s plan to retroactively enforce cigarette-style regulations on vapor could decimate e-cigarettes, which are cigarettes’ greatest potential adversary. 

Cigarettes burn tobacco, creating smoke that contains thousands of harmful toxins. Vaping products, on the other hand, heat e-liquid into an aerosol.  They eliminate combustion, which significantly reduces toxic byproducts.  Many e-cigarettes don’t even contain nicotine.  

E-cigarettes barely existed in 2009 when Congress passed the tobacco legislation that the FDA is trying to retro-fit to vapor.  Furthermore, the agency interpreted the law to require that any e-cigarette or vapor product not on the market in February 2007 – in other words, every product on the market today – pass an onerous, expensive and time-consuming review.  Similar regulatory hurdles would apply even when a manufacturer only wants to upgrade a battery, develop a new e-liquid or make even minor improvements. 

E-cigarettes are among Americans’ most commonly used quit-smoking aids. In fact, they are the only aid more likely to make one a former smoker (that is, a successful quitter) than quitting cold-turkey, according to an analysis I recently published using FDA survey data (here and here).  Without these products, smokers face a difficult choice: try FDA-approved smoking cessation products that have a documented 93% failure rate, go cold turkey, or remain a smoker.  FDA regulation should not subject smokers to such a quit-or-die predicament when alternatives like e-cigarettes are available.

Congress must intervene in the interest of public health, by passing the Cole-Bishop Amendment, which contains provisions to ensure that smokers across the U.S. continue to have access to safer cigarette substitutes.   

The Cole-Bishop Amendment would grandfather products that are already on the market.  It supports consumer safeguards such as manufacturing standards and accurate product labeling. Bottom line: Cole-Bishop provisions recognize the scientific and technological differences between vapor and smoke and the significant differences in their risk profiles.  It has broad consumer support, including a coalition of sixteen center-right public policy organizations and think tanks (here) and all major vaping groups.

Vapor products represent a vital “fire escape” for millions of inveterate smokers. FDA regulations should not make it more difficult for people to stop smoking, and stay smoke-free. 

Thursday, March 8, 2018

Beyond the Headlines: Trace Toxins, Present in All Teens, Improperly Blamed on E-Cigarettes

The University of California San Francisco publicized a study on March 5, asserting that “Adolescents who smoke e-cigarettes are exposed to significant levels of potentially cancer-causing chemicals.” (here)  The study’s lead author, Mark Rubinstein, M.D., said, “Teenagers need to be warned that the vapor produced by e-cigarettes…actually contains some of the same toxic chemicals found in smoke from traditional cigarettes.”

This led to messaging that vaping is just as dangerous as smoking -- “Teens Using E-Cigarette Have the Same Toxic Chemicals Found in Smokers” (here), “E-Cigarette Users Ingest High Levels of Cancer-Causing Chemicals” (here).

In fact, the research, published in Pediatrics, analyzed urine, not vapor.  The study reports the presence of minute amounts of volatile organic compounds (VOCs) in the urine of teens who didn’t smoke or vape (i.e., controls), e-cigarette users, and dual users of e-cigarettes and cigarettes.

Here are the study results:

Median VOC Levels (ng/mg*) in the Urine of Controls, E-Cig Users and Dual Users

Parent CompoundControlsE-Cig UsersDual Users

Ethylene Oxide1.30.51.0
Propylene Oxide152940
*ng/mg = parts per MILLION (creatinine)

Significantly, there were no cigarette smokers in the study.  Existing research tells us that their VOC levels would have been far higher, undercutting the UCSF anti-e-cigarette narrative.

Note that there are no alarming elevations in benzene or butadiene, and levels of ethylene oxide were actually lower among users than controls.  This data indicates that teens virtually no exposure to these chemicals.

While levels of other agents are higher in e-cigarette users and especially in dual users, levels in controls are not zero. 

The authors are on shaky ground in their attribution of higher toxin levels among e-cigarette users to the vapor.  A previous study (co-authored by one of the current authors, here) that they cite failed to find any acrolein and crotonaldehyde in vapor from 12 e-cigarettes.  A Centers for Disease Control and Prevention study (here) found that nonsmokers’ urine had up to 245 ng/g of acrolein and up to 158 ng/g of propylene oxide (smokers had far higher levels of both).  Thus, toxin levels seen in e-cigarette users in the new UCSF report are not necessarily due to vapor.

The UCSF research ignores a possible alternative source of these contaminants: recent marijuana smoking, as shown in a CDC study that identified elevated VOC levels among tokers (here).  As I recently noted (here), marijuana use is more prevalent among teens than vaping or cigarette smoking; data from one federal survey shows that about 40% of teen vapers are current marijuana users.  These findings increase the odds that toking impacted results in the new study.

The UCSF research was supported by four grants totaling some $32 million from the National Institutes of Health to authors Rubenstein, Neal Benowitz and Stanton Glantz. 

Friday, March 2, 2018

Beyond the Headlines, E-Cigarette Vapor Has Only Trace Amounts of Metals

The American media have been obsessed with a new study (here) claiming that “e-cigarettes are a potential source of exposure to toxic metals (chromium, nickel, and lead), and to metals that are toxic when inhaled (manganese and zinc).”

The headlines misrepresent or overdramatize the facts:      

“E-Cig Vapors May Contain Brain-Damaging Toxic Metals, Says New Study” Tech Times

“E-Cigarette Vapor Filled With Dangerous Toxins Like Lead, Study Finds” Newsweek

“E-cigarettes leak toxic metals, study finds” Medical News Today

“Are E-Cigarettes Safe? Alarming Levels Of Metal Found In Its Heating Coils” International Business Times

The research, published in the journal Environmental Health Perspectives, was authored by faculty at Johns Hopkins University, Columbia University, and the Universities of Granada (Spain) and Graz (Austria). 

They reported the metals’ median levels and range (from the 25th to the 75th percentile) in 56 e-cigarette devices’ aerosols.  All values are in micrograms (ug, one-millionth of a gram) of metal per kilogram (kg, one thousand grams) of vape aerosol.  For reference, there are 454 grams in a pound. 

The following table shows how much liquid an e-cigarette user must vape per day to exceed either the FDA’s daily exposure limit for inhaled medicines (here), or the CDC’s minimal risk levels (MRLs) for workplace inhalation (here).  I used the upper level (75th percentile) of the range, so the results below are not underestimates. 

Maximum Levels of Metals in E-Cigarette Vapors, and Amount of Liquid Used Daily to Exceed FDA Maximum Levels for Inhaled Medicines And/Or CDC Minimal Risk Levels (MRLs)
MetalMaximum Vapor Level (ug/kg)Daily FDA Maximum or CDC MRL* (ug)Volume of Vaping Liquid Exceeding FDA Max or CDC MRL*
Cadmium0.13215.4 LITERS
0.136*1.1 LITER*
Chromium43.9368 milliliters
Copper51.030588 milliliters
Manganese9.564.08*427 milliliters*
Nickel289517.3 milliliters
Lead37.15135 milliliters
30*808 milliliters*
Antimony1.932010.4 LITERS
Tin19.4603.1 LITERS
NA, not available

One thing is crystal clear: an e-cig user could be exposed to excessive metal levels only by consuming high volumes of vape liquids.  For example, vapers would have to use 15.4 liters (nearly four gallons) of liquid per day to achieve exposure to 2 micrograms of cadmium. 

Nickel is an outlier because at a high 75th percentile value (289 ug/kg), the exposure limit is 17 milliliters (the typical vaper uses 10 milliliters or less daily).  However, the median value for nickel in all samples was much lower (6 ug/kg), meaning that users could consume 800 milliliters before reaching the recommended exposure limit.

The authors emphasize that some of these metals, notably cadmium, chromium, nickel and lead, are toxic.  However, they fail to mention that toxicity is proportional to dose and duration.  The metal doses delivered by e-cigarette liquids in this study are trivial.

Note: Thanks to Dr. Konstantinos Farsalinos, a researcher at the Onassis Cardiac Surgery Center,
the University of Patras and the National School of Public Health in Greece, for his expert assistance with this entry.