Will Europe’s Diacetyl ban affect the FDA e-cig regulations is the U.S.?

Will Europe’s Diacetyl ban affect the FDA e-cig regulations is the U.S.?

The American vaping industry is currently under siege by the newly released FDA e-cig regulations, but the European Union is adding even more governmental pressure of a different sort.  Just days ago, the EU’s Medicines and Healthcare products Regulatory Agency released its long awaited “draft guidance” report for all e-juice manufacturing, and Diacetyl tops the list of officially banned substances.

Diacetyl is a flavoring agent that some, not all, e-juice manufacturers sometimes use.  Even within the circles of the global vaping industry, opinions on its possible negative health effects are widely varied.  Diacetyl is often blamed as a direct cause of “Popcorn Lung,” among other possible medical disorders, and both European and American e-juice suppliers largely avoid this substance in their products. 

Some vapers don’t believe the stories of Popcorn Lung, but a wide majority of the vaping industry tends to agree that Diacetyl-infused e-juices should be avoided whenever possible.  So when several American companies came under fire in 2015 for releasing products riddled with Diacetyl, the vaping industry was quick to react.

Five Pawns e-juice accused of Diacetyl use

In 2015, a company named Cloud9Vaping decided to test the e-juices of some of its competitors for the presence of Diacetyl.  When they published their findings on the company website, one of the worst offenders accused was the California-based Five Pawn, Inc.  At first, spokespeople for the Five Pawn company claimed that the findings were fraudulent.  But after continued pressure, they eventually conducted their own testing and released the results, which weren’t much better than the first group.


Five Pawns and Cloud9Vaping went back and forth for several months, demanding retractions and threatening lawsuits, but the debate forced the American vaping industry to take a deep, hard look at the flavorings choices in their e-juices.  Today, Diacetyl flavorings are much harder to come by, thanks to the self-regulatory efforts of the American vaping industry.

What is the connection to the FDA e-cig regulations?

The FDA considers Diacetyl to be a "Generally Recognized as Safe" (GRAS) food product. Companies are not required to report to the FDA if their flavorings contain less than 1% of diacetyl or diacetyl substitutes, which is why the Five Star vs. Cloud9Vaping controversy is so important. After the topic of Diacetyl use in e-juices became such a hot-button issue in 2015, the vaping industry took matters into its own hands and essentially regulated itself.


But the recent release of the UK’s draft guidance seems to ban Diacetyl completely, which means that even FDA compliant products containing less than 1% of the substance will still be considered as illegal contraband in the UK after May 20 of next year.  For the vast majority of American e-juice manufacturers, this will not be an issue because they stopped using Diacetyl completely a long time ago. 

But the European Diacetyl ban isn’t the real issue.  American e-juice manufacturers are feeling the heat, not only from the home-grown FDA e-cig regulations, but also from our European counterparts across the pond.

If Europe can ban a certain type of flavoring today, what’s stopping them from banning another ingredient next week, next month, or next year? Are the events in Europe a sign of things to come in the U.S.?  Are even more severe FDA e-cig regulations on the horizon?  These are the questions that are currently keeping many American retailers up at night.


The opinions expressed in this article are those of the author's and do not necessarily represent the viewpoints, policy or company position of Vapes.com, the rest of our staff, and/or any/all contributors to this site.

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Matt Rowland - June 2, 2016

Good Point! We need to research that and see what it’s all about. :)

Dimitar - May 27, 2016

And what about the Diacetyl levels in tobacco cigarettes? If they completely ban the Diacetyl no matter the levels in e-liquids then they have ban all tobacco products too because the Diacetyl levels are hundred times higher than the levels in the e-liquids!

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