In a turnabout that could only happen in the ever-surprising realm of vaping, the e-cig industry is outpacing the regulators in creating sensible standards for the product. The flock is truly leading the shepherd.
The UK trade group ECITA (The Electronic Cigarette Industry Trade Association) is presenting a “best-practices” document to the British Standards Institution that is certain to be a game-changer. “The Draft Publicly Available Specification“, published this week on the ECITA blog, amounts to “a very significant move,” according to ECF founder and head Oliver Kershaw, while Peter Beckett, who heads the Public Affairs division at ECITA, calls it “a pivotal moment in the regulatory history of this category.”
PAS 54115 (for “Publicly Available Specification”) will be “a guide for the importation and sale of electronic cigarettes and directly related products, with product-safety testing methods.” Although revisions are to be expected as the guidelines move toward adoption, the summary published yesterday will serve as a base document. The guide is aimed both at manufacturers and distributors of vaping products and also at laboratories responsible for testing them, although it does not address issues relating to products seeking medical licensing.
After a helpful glossary, the document addresses a comprehensive list of issues important for the production of e-cigs, including the ability to trace all ingredients and components throughout the supply chain, batch control, methods for verifying nicotine concentrations, food grade standards for flavourings and other chemicals including Toxicity Risk Assessment (TRA), appropriate guidelines for product Technical Dossiers, hardware manufacturing recommendations, and more.
Packaging and labeling issues addressed include warning labels, age limits, child-resistant packaging, safety information regarding storage and operation, appropriate and inappropriate product claims, among other issues.
Testing guidelines indicate what substances should be measured, what ubiquitous chemicals should be kept below trace levels, what percentages are recommended, and so forth. Suggestions are made for battery testing procedures at a variety of output levels, and controls are presented for minimising environmental effects on test outcomes, among other recommendations, and a blacklist of unacceptable chemicals is included. A final section includes diagrams relating to computer animated design for a test bed atomiser, and detailed instructions for wick coiling, with supporting diagrams.
One of the foremost assets of the document is the assistance it will doubtless provide to small firms producing vaporisers and mods, firms which comprise a significant segment of ECITA's membership, in fact. It has been feared that one downside of strict regulation may be a burden of expensive paperwork and certification procedures that small companies cannot afford, while wealthy Big Tobacco corporations will take the burden in stride. Many have decried the possibility that regulation will effectively hand the industry to cigarette companies. This ECITA document, especially once it is adopted by the BSI, will certainly smoothe the certification path for the little guy.
ECITA is already known for setting a high bar of industry accountability. This document will go even further in that direction. This will be both a public relations coup for the non-Big-Tobacco vaping products industry, and also a triumph for public health.
Another key factor relates to the timing of the document. Regulatory measures are at this very moment being formulated in the US, the EU, and other countries around the world. The path to regulation has been pursued ham-handedly, with political considerations outweighing sensible public health concerns, and without much well-informed attention to scientific issues. This document will provide a beacon of good sense that is likely to have positive impact on both sides of the Channel, and on both sides of the Atlantic.
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