Harvard’s distortion

Harvard’s distortion

December 1, 2015

A recent Harvard study published in Environmental Health Perspectives pointed out that diacetyl, acetyl propionyl or acetoin were present in 92 percent of the 51 tested electronic cigarette products. This information is misleading and has to be placed back in context.

By Arnaud Dumas de Rauly

Layman’s background

Diacetyl is an aromatic molecule (ketone) commonly found in the food industry. The aromatic notes of diacetyl are buttery and/or caramelized. This is why it is often used in baking, dough products, coffee flavors, chocolate, vanilla and caramel.

This molecule has been singled out because it presents a risk if inhaled and can cause chronic bronchitis otherwise known as popcorn lung. As there is no risk in case of ingestion, its use in the food industry faces no restrictions.

Konstantinos Farsalinos, a cardiologist and researcher at the Onassis Cardiac Surgery Center in Greece, and known expert on e-cigarettes, was the first to launch a global analysis on e-liquids targeting diacetyl. His work concluded that traces of diacetyl may appear if they are less than 22 parts per million (ppm) and not represent a hazard to health. Some recent studies pointing to e-liquids containing diacetyl have reported more than 500 ppm, hence the need for product standards and their implementation (also known as regulation).

Product standards

In the past three years I’ve been all around the world trying to get this industry up to speed on the need for product standards without too much traction. In 2014, during my tenure as the president of FIVAPE (the French Vaping Trade Association) we managed to launch a nationwide call for these standards leveraging AFNOR (the French equivalent to ANSI in the U.S., the national standards body). This built interest as there aren’t that many nascent industries willing to set standards for self-regulation purposes.

The AFNOR standards body voted to launch the specific Vapor Products Steering Committee, which was broken up into 3 working groups:

  1. Electronic Cigarette Hardware (XP D90-300-1)
  2. E-liquids (XP D90-300-2)
  3. Emissions ((XP D90-300-3)

This paved the way for three product standards documents, of which the first two were released to the public in March 2015. The last one on emissions, being the one that requires the most work and input, is due out in April 2016.

You might be thinking at this point, how is any of this relevant to the Harvard study? Stay with me, though; we’re almost there.

These e-liquid standards (XP D90-300-02) prohibit diacetyl from being added as an extra ingredient in flavoring mixtures, but also sets a maximum limit of 22 ppm (or 22 mg/ml) as diacetyl is naturally found in certain fruit extracts, plants & nuts as explained above. It is found for instance in coffee beans and chocolate beans.

If every e-liquid producer had followed these standards, there wouldn’t be any issue. All the major e-liquid producers in France are or are getting certified for these standards. As France was the first country to set these standards and publish them, we are chairing the CEN (European Standards) using the French ones as a building block. These standards have also been presented to ANSI in the U.S. and currently a TAG team to ISO TC 126 Sub-Committee on Vapor Products is being setup. I encourage every e-liquid producer to become an active member and expert in this committee.

Why the Harvard study is irrelevant

As for the study itself, it is worth explaining that there are a couple of inconsistencies, both in terms of form and content:

  • Analysis for quantities of diacetyl, acetyl propionyl or acetoin are made once the e-cigarettes vaporize the whole of the e-liquid, but everyone knows that a vaper doesn’t vape a whole tank in one shot
  • The logic of this study is very “tobacco-like” as we can easily see that they use only cigalikes but most of all, the conclusions aren’t useful as they state “e-liquid A produces Xmg of diacetyl” without ever talking about which quantity of e-liquid was used (Another question that can be asked: was the same quantity used for each e-liquid? Was quantity the same for each cartomizer?)
  • The wording used to present the results is nevertheless very thought through: “the quantity of diacetyl measured up to 239 mg”. Whereas, of the 51 e-liquids tested, only one had 239 mg, the next one was already down to 38 mg and the median measurement is 8 mg: in other words, nothing harmful.

As Farsalinos says, “They failed to mention that these chemicals are present in tobacco cigarette smoke and violated a classical toxicological principle that the amount determines the toxicity and the risk.”

Which brings me to my last comment: please keep in mind that e-cigarettes are an alternative to traditional cigarettes, so any data on e-cigarettes must be compared to their traditional counterparts. In this case, a single cigarette contains between 80 and 120 ppm of diactyl.

Considering what has just been said, I can easily imagine that this same study, if put through a spinning engine (and of course by being more thorough with protocol) could actually show very good information about the vaping industry. I can only encourage every e-liquid producer to be very straightforward and thorough when putting their products on the market.

We at Gaïatrend, the No. 1 e-liquid producer in France since 2008, have a checklist for every single SKU that comes out of our production lines:

  1. MSDS in French and in English,
  2. Toxicology reports on:
    1. Diacetyl
    2. Acetyl propionyl
    3. Acetoin
    4. Formaldehyde
    5. Acetaldehyde
    6. Acrolein
  3. List of any allergens

All of this is done in-house and also by an external independent lab, just to make sure that there aren’t any inconsistencies. This information is available to the consumer at any time on our website.

Arnaud Dumas de Rauly is president of Gaïatrend USA (Alfaliquid Brands) and a board member of the Vapor Technology Association.

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