Exploding Batteries? Why FDA is Concerned About E-Cigs and Vaporizers
However you smoke it, your e-cigarette, vape pen, or other device of choice (like the vaporizer in the image) is going to be in front of your face with every puff you take. Due to what FDA has dubbed as the “intimacy” with which this product is used, alarm has been raised about safety issues and batteries in “electronic nicotine devices” (ENDS), i.e., vape pens, e-cigarettes, vaporizers, etc. Of particular concern, are rechargeable batteries due to the way in which consumers have been known to charge their devices, which has included using chargers not intended for use with the ENDS, as well as other reasons which have resulted in physical injury to consumers due to the overheating of the battery and at times, an explosion, some of which have been widely televised. For this reason, not only has FDA held a public meeting on the subject, but they have also collaborated with the highly knowledgeable and respected Underwriters Laboratories (UL) and its Regulatory Affairs group to come up with a set of standards for sellers of ENDS to certify their products to. Generally speaking, certification with a standard, is reflective of a product meeting the minimum safety levels required under the standard where it has been used as intended.
In terms of being able to obtain certification by UL for an ENDS product, it actually has yet to become available. This is because the draft standard, known as UL 8139, and entitled, an Outline of Investigation for Electrical Systems of Electronic Cigarettes, is still in the process of being developed. It is however, anticipated that the draft standard will be completed by year’s end. When it is finalized, the analysis UL intends to provide will be limited to that of the mechanical portions of the device, and therefore, UL would not be assessing the e-liquid (the consumable part) nor its toxicology or the physiological science of how these chemicals impact a consumer when using the ENDS product. It further will not examine how the chemicals found in the air emissions, i.e., the vapor, impacts a user and those around them.
Toxicity in relation to the ingredients and air emissions are however, part of what needs to be addressed in any premarket tobacco application submitted to the FDA. As many of you reading this already know, products which had not been in the US market prior to February 2007 - which would include all e-liquid and e-cigarette products - require the filing of a “Pre-Market Tobacco Application” (PMTA), the approval of which results in what is known as a “marketing order.” It is only with such approval that currently sold products may remain on the market after the relevant due date in 2018, and any new products must obtain a marketing order well in advance of the commencement of any marketing or sales of the product itself.
You should note that the PMTA is separate from the other FDA regulatory obligations sellers of e-liquids, ENDS and other tobacco products must abide by, such as the requirement to report harmful and potentially harmful constituents in a tobacco product, and the ingredients of the products themselves to the FDA. You should further note that several months are needed for the completion of preparing a PMTA itself. For additional guidance on the PMTA and other FDA requirements, head over to their web page on tobacco products at https://www.fda.gov/TobaccoProducts.
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pre-market tobacco application