US Small Business Administration Urges 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 remain on the market for another year while premarket review continues. In a June 7 letter to the FDA, the SBA’s Office of Advocacy asked
The U.S. Small Business Administration (SBA) has urged the Food and Drug Administration to allow nicotine products to remain on the market for another year while premarket review is underway.
In a June 7 letter to the FDA, the SBA Office of Advocacy asked the agency to seek a court order extending by one year the current freeze on enforcement actions against small e-cigarette manufacturers that submitted premarket tobacco applications (PMTA) before last year’s Sept. 9 deadline.
Under the current rules, manufacturers that submitted PMTAs on time may keep these products on the market until Sept. 9, 2021. The SBA Office of Advocacy asked the FDA to request that U.S. District Judge Paul Grimm allow the agency to extend the deadline to September 2022.
Given the large number of PMTAs submitted — the FDA said it received more than 6 million applications — it is unlikely the agency will process all submissions before manufacturers are required to remove their products from the market.
SBA wrote: “As the FDA continues reviewing the millions of timely submitted PMTAs for ENDS products, small ENDS manufacturers cannot afford the consequences of having their products pulled from store shelves.” “Most small ENDS manufacturers do not have the resources to absorb the losses caused by their products being removed from the market for months or longer. Once the FDA orders the products of small ENDS manufacturers to be removed from the market, these small businesses will close permanently.”
The letter also urged the FDA to end its current practice of processing PMTAs in order of manufacturers’ market share. According to the SBA, doing so would nearly guarantee that small vaping companies would be unable to complete review in time to remain on the market.
The SBA is a federal agency that represents the views of small businesses across different branches of government.
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