Local vape shop owner sues FDA
From: Clare County Review
By Pat Maurer, Correspondent
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Manor said, “By 2022,” she said, “I will have to pay $500,000 for a PTMA (premarket tobacco product application). When you create a new tobacco product or modify a tobacco product in any way, you must obtain an order from the FDA authorizing the marketing of the before the product may be introduced or delivered introduction into interstate commerce.”
She continued, “I have 40 flavors, each available in seven levels of nicotine. Each of those flavors are available in three different amounts, 30 ml. 60 ml. and 120 ml. Each one is a SKU or “Stock Keeping Unit” and, she continued, “each of the 840 SKUs will cost me at least $500,000 for each application.
