Amidst the rollout of new FDA regulations on e-cigarettes, the U.S. vaping sector faces further challenges from abroad. The European Union’s recent measures have escalated these concerns. Notably, the EU’s Medicines and Healthcare products Regulatory Agency has initiated a comprehensive “draft guidance” for e-juice producers, putting Diacetyl, a controversial substance, on the blacklist.
Used sporadically as a flavor enhancer in e-juices, Diacetyl’s reputation is a contentious subject across the vaping community worldwide. It’s been implicated in causing ‘Popcorn Lung’ and other health concerns, prompting many suppliers, both in the U.S. and Europe, to steer clear of incorporating it in their offerings.
The skepticism surrounding the harmful consequences of Diacetyl, particularly the allegations linking it to Popcorn Lung, has not dissuaded a significant portion of the industry from advocating for a cautious approach. The revelation that numerous U.S. producers had Diacetyl-laced products in 2015 triggered swift self-regulation within the sector.
Controversy Over Diacetyl in Five Pawns E-Juice
The year 2015 saw Cloud9Vaping undertake independent testing of rival e-juices for Diacetyl content. The disclosure of these tests singled out California’s Five Pawn, Inc. as a notable violator. Initial rebuttals from Five Pawn representatives were subsequently overshadowed by the company’s follow-up tests, affirming the unwelcome presence of Diacetyl.
The ensuing months were marked by a volley of recriminations and legal threats between Five Pawns and Cloud9Vaping. Nevertheless, this period catalyzed introspection regarding flavoring components within the U.S. vaping circles. The industry’s proactive stance has made Diacetyl-based flavorings increasingly rare.
The Implications for FDA E-Cigarette Regulations
Despite the FDA’s classification of Diacetyl as a “Generally Recognized as Safe” (GRAS) ingredient for food, its role in e-juices has drawn scrutiny. The absence of mandatory reporting for flavorings with less than 1% Diacetyl or its derivatives underlines the significance of the Five Pawn-Cloud9Vaping saga. The industry’s response to the 2015 controversy effectively set a new standard through self-regulation.
The stringent stance adopted by the UK, eliminating Diacetyl entirely, suggests that even FDA-approved e-juices with minimal Diacetyl content will not pass muster in the UK beyond the specified compliance deadline. This development poses little complication for U.S. manufacturers who have largely forsaken Diacetyl. However, the broader implications of the European ban are causing ripples.
The EU’s capacity to outlaw specific e-juice ingredients raises the specter of further prohibitive measures. This regulatory zeal could very well signal tighter constraints on the horizon. The evolving scenario in Europe casts a shadow of uncertainty over the U.S. market, prompting speculation about impending FDA restrictions. The gravity of these deliberations is not lost on U.S. vendors, who find themselves grappling with these complex regulatory forecasts.
