“If a company does not submit a PMTA by the end of today, it must remove its products from the market. If the product was “verifiably” on the market prior to Aug. 8, 2016 (the FDA’s cutoff for new products) and submitted a PMTA application before Sept. 9, the product can stay on the market for up to a year or until the FDA approves or denies the PMTA. For any PMTA submitted after today’s deadline, a product may not be marketed until the FDA grants a marketing order, according to the FDA. Because the cost of complying with the regulations is staggeringly high, experts expect that many manufacturers will fail to clear the hurdle, and the e-cigarette market will be left largely to the tobacco giants. Although the FDA estimates a single PMTA costs anywhere from $117,000 to $466,000, those figures are considered low by the industry. As of Aug. 31, the FDA had received applications for around 2,000 deemed products, of which around 40 percent have been resolved, according to Mitch Zeller, director of the agency’s Center for Tobacco Products.”
NOTE: By “resolved” he means accepted for consideration, not “Approved” for market
ARTICLE LINK:
The Final Countdown: PMTA Submissions Due Today
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