Though the U.S. Food and Drug Administration (FDA) is responsible for regulating tobacco products, the agency is floundering when it comes to building a larger market of smoke-free alternatives. As a former smoker, I believe it’s time for Congress to step in and ensure the FDA is fulfilling its mission to support the “development of innovative tobacco products that may be less dangerous than cigarettes.”
Despite a federal law that mandates the FDA’s Center for Tobacco Products (CTP) to review and decide on pre-market tobacco product applications (PMTAs) within 180 days, this process can take years. Since 2009, the CTP has authorized fewer than 50 applications out of the 26 million it has received. In the meantime, thousands of lives are being lost as innovative, smoke-free products continue to get stuck in this regulatory quagmire.
The FDA and CTP both need to establish a more predictable and transparent regulatory process to support the advancement of less harmful tobacco alternatives. Many companies are investing millions of dollars into their products and the FDA’s regulatory process, only to be left in the dark about if or when any of these innovative products will get authorized. All this does is hamper innovation and slow the introduction of smoke-free alternatives that promote public health.
Congress should work with the FDA to update the agency’s internal processes to expedite the introduction of new, smoke-free alternatives—and Senator Cassidy and Rep. Letlow should help lead the charge.
Don Willard
Concordia Parish
