U.S. Small Business Administration asks FDA to extend PMTA grace period
The U.S. Small Business Administration (SBA) has urged the Food and Drug Administration to allow nicotine products to be sold on the market for another year, while conducting pre-market review.
In a letter to the FDA on June 7, the SBA Propaganda Office asked the agency to seek a court order to extend the freeze period for current enforcement actions against small e-cigarette manufacturers who submitted pre-market tobacco applications (PMTA) before last year One year. Deadline September 9.
Under the current circumstances, manufacturers who submit PMTA on time may leave these products on the market until September 9, 2021. The SBA Advocacy Office asked the FDA to ask US District Court Judge Paul Grimm to allow the agency to extend the deadline to September 2022.
Considering the large number of PMTAs submitted-the FDA says it has received more than 6 million applications-the agency is unlikely to process all submitted applications before manufacturers are required to withdraw their products from the market.
SBA wrote: “As the FDA continues to review the PMTA of millions of ENDS products submitted in time, small ENDS manufacturers cannot afford the consequences of their products being removed from store shelves.” “Most small ENDS manufacturers do not have the resources to come. Absorb the losses caused by the withdrawal of its products from the market for several months or longer. Once the FDA orders the removal of the products of small ENDS manufacturers from the market, these small businesses will be permanently closed."
The letter also urged the FDA to end its current practice of processing PMTA in the order of manufacturers’ market share. According to SBA, by doing so, the FDA can almost guarantee that small e-cigarette companies will not be able to complete the review in time to stay on the market.
The SBA is a federal agency that represents the opinions of small businesses on various government departments.
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