Howard Sklamberg Discusses FDA Authorization Standards for Nicotine Pouches in CBS News
Howard Sklamberg, Arnold & Porter Life Sciences & Healthcare Regulatory partner and former Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), was recently quoted in the CBS News article, “Bureau of Prisons Faces Scrutiny Over Startup’s Exclusive Deal to Sell Non-FDA-Authorized Nicotine Pouches to Prisoners,” which examines a Bureau of Prisons arrangement allowing a newly formed Florida company to serve as the exclusive supplier of flavored nicotine pouches to federal prison commissaries, despite the product lacking FDA authorization for sale in the U.S.
The article notes that only two companies currently hold FDA authorization to sell nicotine pouches, underscoring how narrow a path the agency has cleared for products to reach the market legally. Drawing on his time overseeing FDA enforcement, Howard explained why that bar is so difficult for a company to clear. “It is a very big deal to file one of these applications. You spend a lot of money on consultants. You have to have a lot of science. It’s not a box-checking exercise,” he said.
