Details Created on Wednesday, 19 March 2014 18:08

Is e-cigarette industry the biggest enemy of the e-cigarette today? A reply.

By Dr John Lauterbach

Dr. Farsalinos is correct. The e-cigarette industry is the biggest enemy of the e-cigarette today. However, the answer is not in the development of test methods. They are important, but there is much work and time between developing test methods that are meaningful to product safety and performance, and taking them through all the steps needed to become international standards (e.g., test methods that are published by standards-setting organizations such as International Organization for Standardization and ASTM International) that are recognized by governmental regulators. In other industries, the process has often taken years, not months, and has often been driven by the major companies in a given industry as they provide the scientific expertise and laboratory time for the collaborative studies that are needed to bring a test method to the level of an international standard.

What is needed now is good product stewardship. For good product stewardship, you need to know everything that is in your products and how those materials and ingredients are likely to perform under normal and excessive conditions of use. Based on that information, you modify or remove the materials that are likely to be problematic. However, most in the e-cigarette industry purchase components of e-cigs and/or components of flavors, so the first step in product stewardship is to get full ingredient disclosures (not just material safety data sheets and/or certificates of analysis) from your suppliers for everything you are purchasing. However, don’t expect your suppliers to hand over their trade-secret information without legal protection and the suppliers’ confidence that you or someone in your organization is trained to review it. Also, don’t be surprised if they suggest that you use a third-party consulting firm that specializes in ingredient review to receive the trade-secret information and review it for you.

If you do the review yourself, you will need to review the ingredient disclosures you receive and look for materials that may be problematic. For example, Goniewicz et al.(Tob Control 2014;23:133–139) recently reported finding toluene in the aerosols from several brand-styles of e-cigarettes. Should toluene be in the aerosol from an e-cig? No, it is a known toxicant (also it is a component of gasoline) and is on the California Proposition 65 list. Did the toluene come from the e-liquid? Probably not (although you would need a detailed disclosures from the suppliers of e-liquids and/or components to make sure). So where did the toluene come from? It likely came from various subassemblies used to fabricate the e-cigarette. If you had full ingredient disclosures from all your suppliers of the components you are buying, you would be closer to finding the source of the toluene. You might find it as part of an adhesive or coating formulation. Residual toluene is even found in certain plastics including those approved for use in food packaging. So, review of ingredient disclosure sometimes requires more expertise than just looking a list of chemicals and seeing what you can find on the Internet. It is important to remember that volatile materials such as toluene will migrate through the device over time and collect on surfaces exposed to the e-liquid. Another example is formaldehyde. Does the formaldehyde found in the aerosol of most e-cigs come from the e-liquid, or from pyrolysis of nonvolatile components (e.g., sugars from fruit flavors), or from the e-cigarette itself (some adhesives and coatings contain latent formaldehyde that would be released on heating)?

So, if getting started in product stewardship is easy, why do most e-cig and e-liquid firms refuse to do it? My understanding is that it is a matter of cost and convenience. Some of these companies are spending tens of thousands of dollars on advertising, but they are not willing to spend a much smaller amount on product stewardship. It has been said that product stewardship can wait until there is governmental regulation. Can it?

Are you sure that your overseas suppliers will give you the needed information when you are required to disclose it to regulators? Will you be able to put supplier information in the format regulators want? Do you know the basic physical parameters of the products you are selling and the tolerances on each of those parameters? Getting such information takes time. Once you have all the information, who is going to review it for consistency and completeness? Will you be able to spot components that you should have removed or have modified to eliminate potential adverse health effects? Remember, some components of e-cigs and e-liquids have already been identified as having potential regulatory issues. Will you act now or wait until it is too late?

Dr John Lauterbach is a chemist and toxicologist, owner of Lauterbach & Associates, LLC (L&ALLC)



