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To Trust Is To Be Naive

 Posted by in General Articles, News, Featured Posts on December 10, 2015 .
Should you trust everything you read?

As we're sure you've already seen/read the recently published study about Diacetyl and Acetyl Propionyl used in e-liquid products, we'd like to take a moment to educate rather than simply blaming someone or saying the article is "wrong".

The Compounds Of Concern:

Diacetyl and Acetyl Propionyl (2,3-Pentanedione) are both organic compounds known as diketones. Inhalation of Diacetyl (specifically) at certain levels is known to cause respiratory issues like illness and in some cases, an incurable respiratory disease known as Bronchiolitis Obliterans (or "Popcorn Lung"). These compounds are well known to the flavoring industry as they can both be used for buttery/creamy notes in certain flavors. This is no secret to the e-liquid industry as most responsible manufacturers do everything in their power to avoid using them. What many e-liquid manufacturers don't know, is that even though a flavoring supplier claims that their flavor is "Diacetyl Free" or "Acetyl Propionyl Free" doesn't necessarily mean that they are.

The Reason for This:

...Chemical manufacturers and importers of food flavorings containing one percent or more diacetyl must convey information in the health effects section of an FFCD MSDS regarding the human health effects…
an excerpt from OSHA’s HAZARD COMMUNICATION GUIDANCE FOR DIACETYL AND FOOD FLAVORINGS CONTAINING DIACETYL 

One percent sounds like a very small number, but when we’re looking at things on a trace level, one percent equates to roughly 10,000 ug/mL. When we’re testing on the trace level (down to 1 ppm or 1 ug/mL), suddenly one percent seems like a tremendous amount. That’s because it is. Theoretically, a flavoring could contain as much as 9,999 ug/mL Diacetyl and still claim to be Diacetyl Free by its manufacturer.

The Flavoring Industry At A Glance:

The flavoring industry is more or less comprised of two types of flavoring sources, Flavoring Manufacturers, and Flavor Compounders.

1) The flavoring manufacturer is the source that produces raw flavoring or emulsions that may be used as a finished flavor or may be further compounded to achieve a target “blend”. Typically, a flavor manufacturer does not sell or distribute products to the consumer market, their target customer are commercial food manufacturers and flavor distributors/compounders. In many cases, flavoring manufacturers refuse to work with the e-liquid industry due to potential liability issues. The liability in promoting the sale of a flavoring to be used in an e-liquid product is that most commercial flavors are produced with the intent of being ingested as part of a food product. The health effects of inhaling these flavorings aren’t yet well known and this isn’t something that the flavoring manufacturers care to assume the risk for, understandably.

2) A flavor compounder is a party that purchases from the flavoring manufacturer and either sells the product in its original state or compounds two or more base flavors to achieve a target flavor profile. Flavor compounders are becoming more popular lately with the growth of various industries that rely heavily on these specialized flavor profiles. The majority of these flavor compounders are more than happy to work with the e-liquid industry and some of them may even attribute a lot of their growth to our industry.

As much as it might seem dishonest to say “Diacetyl Free”, please understand that Flavoring Compounders are not federally required to disclose levels under one percent.

So we have an underlying issue that requires reform. If a flavoring compounder is knowingly allowing the sale and distribution of flavorings to individuals or companies that have the intent to use them in an inhalation format, they should disclose whether or not the flavoring contains Diacetyl and/or Acetyl Propionyl (2,3-Pentanedione) at a level that is more appropriate for the method in which these flavorings will be consumed, inhalation.

What level do we ask them to disclose at? 

Perhaps we ask them to test each of their flavorings using the same methods that are becoming the standard for our industry, down to 1 ppm or 1 ug/mL. These flavoring compounders stand to make a substantial gain from the sale of these products to our industry, why shouldn’t we ask them to perform a $150 analysis so we truly know what levels of diketones exist in the products we’re purchasing? Even if the test were to be performed annually, as long as the recipe of the flavoring did not change. This would not solve the problem entirely, however, it would be a HUGE stride forward in eliminating a known inhalation hazard and would be of great service to our industry.

Who’s doing it right?

We cannot say with absolute confidence that any Flavoring Compounder is doing things perfectly, however, some flavoring compounders have always done their part to be upfront and honest with the industry. 

One example of a company that strives for excellence is Flavour Art. Flavour Art recently published testing on all of the flavorings they market to the vaping industry. Flavour Art, while headquartered in Italy, has always worked hard to cater to our industry and it’s North American market(s).

Another example is Linda from The Perfumer’s Apprentice. Linda has always been upfront in disclosing if a flavoring may contain certain molecules like Acetyl Propionyl. While The Perfumer’s Apprentice does not currently supply Diacetyl and Acetyl Propionyl (2,3-Pentanedione) analysis on each of their flavors, we suspect that such testing and reporting is not far off. The Perfumer’s Apprentice has not only recognized that these potentially harmful compounds exist, they’ve recently released several flavorings that (they claim) are free from any of these compounds. These flavorings can be found on Perfumer’s Apprentice with the prefix DX which we can only assume means that they’ve crossed out any “D”iketones from the flavoring.

Another recent example is Capella Flavors who actually DOES provide DA/AP analysis on their flavorings. Capella Flavors has always claimed to be Diacetyl Free, however, they’ve also recently recognized the need to remove Acetyl Propionyl and Acetoin from their flavorings. Many of the new flavorings can be found on their website with the suffix V2.

Is this all of the Flavoring Compounders that are doing things correctly? We’re sure that it’s not, and there are several more that we could mention, but we’ve listed a few mentionable examples.

Why doesn’t this solve the problem?

Diacetyl is a natural byproduct of fermentation and can form after two flavor ingredients (known NOT to contain Diacetyl) are blended and begin to ferment.

As an e-liquid manufacturer, we have a responsibility to consumers

While having test reports from Flavoring Compounders on each flavoring that is being used in an e-liquid product is a great start, the more appropriate method to ensure an accurate representation of detection is to test the final product once all ingredients have been blended. The same thing applies here, if your favorite e-liquid supplier does not already provide you with Diacetyl (DA) and Acetyl Propionyl (2,3-Pentanedione) (AP) analysis on the flavor you’re purchasing, demand the product be tested before you continue to purchase it. This type of finished product testing is what any responsible e-liquid manufacturer should be providing after the widespread discovery that we could not accurately assume whether or not “Diacetyl Free” meant truly Diacetyl free or if it meant that it was below the threshold for reporting (according to reporting requirements of OSHA).

On September 11, 2014, the American E-Liquid Manufacturing Standards Association (AEMSA) published a blog post recommending that all finished products be tested to ensure that Diacetyl and Acetyl Propionyl was not present in finished e-liquid products.

...With these concerns in mind, AEMSA has encouraged and provided guidance to its members to have their e-liquid products tested using third-party accredited labs using appropriate and scientifically verified analytical detection limits and procedures.  The testing process itself is complex.  The testing protocols demand appropriate methodologies, with low detection limits, to establish consistent accuracy.  Flavors are formulated and have a varying number of ingredients, which can cause detection and quantification complications for targeted molecules, depending on detection method used.  AEMSA has worked with its Subject Matter Experts to ensure that appropriate methodologies with low limits of detection are used consistently.

From this testing, we have learned that some flavors are more likely to contain diacetyl- and/or acetyl propionyl than others (often only at trace levels).  Many flavors test negative (no identifiable presence) for these molecules.   For those flavors showing detectable presence of these molecules, results can vary from one batch (of the same flavor and same brand) to another batch.  Additionally, different brands, of any given flavor, can also yield differing test results.  These variations can vary in both presence and/or in detectable quantities (amounts).  But because all of these flavors are formulated products, AEMSA is confident that that the presence of any substances of concern can be eliminated...
- Visit AEMSA to read the entire post (http://www.aemsa.org/aemsa-recommends-flavor-testing/)

What is Texas Select Vapor doing to combat the issue?

We had 100% of our revised e-liquid line (released on 11-6-2015) analyzed for 3 compounds, Diacetyl, Acetyl Propionyl (2,3-Pentanedione), and Acetoin. We’re proud to report that our analysis reports were returned with 100% of our finished e-liquids containing no detectable amount of Diacetyl or Acetyl Propionyl (2,3-Pentanedione). Since we’ve recently revisited several of our original blends and revised some of them for enhanced flavor, we decided to proceed with testing in order to deliver the highest level of transparency and good manufacturing practices. Moving forward, any product that shows the DA/AP FREE badge on the product label has been tested and is nondetectable above the LOQ. In addition, each e-liquid product we offer now lists the DA/AP Analysis directly on the product page on the tab labeled DA/AP Analysis. You can also find a complete list of DA/AP tested products using NicTrace™.

In response to the published study about Diacetyl and Acetyl Propionyl (2,3-Pentanedione)

There are certainly a lot of opinions floating around about this study and we agree with the recent comment made by world renown scientist Dr. Konstantinos Farsalinos, MD in his recent blog post about this study. An excerpt from his blog post:

…Although I agree that we should know if e-liquids contain diacetyl and acetyl propionyl, I must note that the study has missed some very important points. One is the assessment of the levels found in their samples. The levels presented in Figure 2 are quite low, much lower that what we found in our study. In many cases, levels of these compounds are absolutely minimal, and it is NOT expected to raise any concerns about human health effects. Additionaly, the authors FAILED to mention the presence of these compounds in tobacco cigarette smoke. This omission creates the impression that e-cigarettes are exposing users to a new chemical hazard, while in reality their exposure will be much lower compared to smoking. Finally, the try to argue that the use of the NIOSH-defined safety limits should not be used because they refer to working environment and not to the general population. The latter may include vulnerable people or people with disease. However, we have previously argued that such an argument is irrelevant for a simple reason: e-cigarettes are used by smokers. Whether you are healthy or not, smoking will be a much stronger risk factor for health damage compared to any exposure coming from e-cigarettes (at least at the average levels found in our study and the new study). Thus, this argument is invalid and refers ONLY to never-smokers (and everyone agrees that there is no reason for a never-smokers to use e-cigarettes, whether they contain diacetyl or not).

In conclusion, the article is creating false impressions and exaggerates the potential risk from diacetyl and acetyl propionyl exposure through e-cigarettes. 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…
- Dr. Farsalinos, MD - E-Cigarette Research (http://www.ecigarette-research.org/)

As a concerned consumer, you should always request testing reports for your e-liquid to ensure that your manufacturer is doing things as responsibly as possible. Our test results can be found through our DA/AP Tracking on NicTrace™.

 Tags: da, diketones, acetyl propionyl, diacetyl, testing, ap Last update: January 07, 2016

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