FDA Urged to Extend Enforcement Deadline

    Photo: Oleksandr Moroz

    A coalition of 23 organizations has asked the U.S. Food and Drug Administration to follow the recommendations of the Small Business Administration (SBA). Earlier this year, the SBA urged the FDA to allow nicotine products to remain on the market for another year after the current Sept. 9, 2021, deadline while their premarket reviews are in progress.

    Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications—the FDA will unlikely be able to process all submissions before manufacturers are required to pull their products off the market, according to the SBA.

    In a letter to the FDA prepared by the Americans for Tax Reform (ATR), the 23 organizations say that the FDA’s promise to exercise discretion in its enforcement provides insufficient certainty for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by the FDA.

    If an extension is not granted, the letter cautions, there could be devastating consequences for businesses, particularly small businesses. Furthermore, any potential reduction in the supply of safe alternatives to tobacco could have a negative impact on public health across the United States and lead to an increase in tobacco-related mortality, according to the authors.

    The letter also argues that “millions of consumers who depend on ENDS products for their health and thousands of businesses who depend on these products for their livelihood are threatened by this needless bureaucratic uncertainty.” The only way to avert such an adverse outcome for businesses and consumers is for the FDA to obtain a court order allowing it to extend the existing moratorium on enforcement by another year, according to the letter writers.

    “The vaping industry, unlike many others, was created by small businesses, and these same small businesses continue to drive innovation in the market,” the coalition letter states. “Without these entrepreneurs, the vape industry will be consolidated into a few large corporations, causing prices to rise and consumer choice to decrease.”