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Tag: FDA PMTA

  • Trump Administration’s Cuts Reach FDA Tobacco Product Employees

    Trump Administration’s Cuts Reach FDA Tobacco Product Employees

    The Trump administration’s attempts to reduce the size of the federal workforce have reportedly extended to the Food and Drug Administration (FDA) this weekend, as recently hired employees who review the safety of food ingredients, medical devices, and other products were fired.

    On Friday, the U.S. Department of Health and Human Services announced plans to fire 5,200 probationary employees across its agencies, which include the FDA, National Institutes of Health, and the Centers for Disease Control and Prevention. Probationary employees across the FDA received notices Saturday evening that their jobs were being eliminated, according to three FDA staffers who spoke to The Associated Press on condition of anonymity.

    The total number of positions eliminated is still not clear, but the firings appeared to focus on employees in the agency’s centers for food, medical devices, and tobacco products — which includes oversight of electronic cigarettes.

    The FDA employs nearly 20,000 people but has been strained since a wave of departures during the COVID-19 pandemic, with a reported 2,000 uninspected drug facilities that haven’t been visited since before the pandemic. It has also been criticized for not moving faster to catch recent problems involving infant formula, baby food, and eyedrops. A former FDA official said cutting recent hires could backfire by eliminating staffers who tend to be younger and have more up-to-date technical skills, whereas the FDA’s current workforce skews toward older workers who have spent one or two decades at the agency.

    “You want to bring in new blood,” said Peter Pitts, a former FDA associate commissioner under President George W. Bush. “You want people with new ideas, greater enthusiasm, and the latest thinking in terms of technology.”

  • PMTA Deadline Approaching

    PMTA Deadline Approaching

    Courtesy: US FDA

    Manufacturers of nontobacco nicotine (NTN) products on the market as of April 14, 2022, that wish to continue to market their products are required to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration by May 14, 2022.

    The May 14 deadline is only for applicants submitting electronically, as required by the FDA. Applicants can, however, request a waiver from the FDA to submit a PMTA in a different format. An application submitted in hard copy must be received by the FDA no later than 4 p.m. Eastern Daylight Time on Friday, May 13.

    The FDA received from the U.S. District Court of Maryland a 14-day extension to file the first PMTA status reports required by the court’s revised remedial order on April 29.

    “The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and defendants have been working with plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states.

    The new law additionally provides that an NTN product with a tobacco-derived “previous version” that received a negative action on a PMTA from the FDA, such as a refuse-to-file or marketing denial order, may not continue to be marketed after May 14, 2022, without receiving a marketing granted order from the FDA.

    Such products must be removed from the market, even if a new PMTA is submitted, until the marketing granted order is received, according to the agency. Products on the market after July 13, 2022, without an FDA marketing granted order are in violation of section 910 of the Food, Drug and Cosmetic Act and may be subject to FDA enforcement.

    For products not on the market on April 14, 2022, a PMTA must be submitted to the FDA and marketing authorization must be received before the product can be sold in the United States.