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1. I am the CEO and co-founder of Nicopure Labs, LLC (“Nicopure”). I began working for Nicopure on October 22, 2009. I have personal knowledge of, and am competent to testify regarding, the following.
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13. In total, Nicopure produces over 2,400 types of stock keeping units (“SKUs”), with approximately 40% of those consisting of e-liquid. The remaining 60% of Nicopure’s SKUs are for vaporizers and related parts such as batteries, replacement tanks, empty cartridges, heating coils, wall chargers and adapters, mouthpieces, and USB chargers, none of which contains or is derived from tobacco, and none of which is intended for human consumption. For example, SKU #XG6XPASS- MANU-BLCK is a rechargeable battery, which is not made or derived from tobacco, and which is not intended for human consumption.
14. Of Nicopure’s approximately 950 e-liquid SKUs, 83% contain nicotine.
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21. In contrast to the uncertainty of approval, the immense cost of filing a PMTA for a single product (let alone a product portfolio) is definite. FDA itself estimates that the average cost per e-liquid PMTA will be $131,643, and that the average cost of a vaporizer PMTA will be $440,725.
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32. In other words, as of August 8, 2016, Nicopure cannot continue to bring innovative new products to market without (i) investing the substantial time and money required to prepare a PMTA, and (ii) waiting for FDA to adjudicate the PMTA. That process is likely to take years to complete
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33. But for the Deeming Rule, Nicopure would continue to work to improve the variety, quality, and performance of its e-liquids and vaping devices by researching, developing, and introducing new products.
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44. The Deeming Rule will also restrict Nicopure’s ability to make truthful, nonmisleading statements to consumers. Beginning on the Rule’s effective date, Nicopure will not be able to inform consumers that its products are free of, or contain reduced levels of, any substance, without an order of approval from FDA. These restrictions cover, among other things, truthful, nonmisleading statements that Nicopure’s products are free of smoke, ash, tar, and certain chemicals.