Op-ed: FDA’s Center for Tobacco Products Needs Serious Reforms
by Matt Adams
Congress and the Trump Administration have a rare opportunity achieve government reforms that would eliminate waste, promote public health, and give adults who smoke in North Carolina and across the country new avenues to leave cigarettes behind for good: Establish an efficient, workable pathway for less harmful alternatives to cigarettes to be legally sold in the U.S.
That starts with reform at the FDA’s Center for Tobacco Products (CTP), which was created in 2009 to help regulate cigarettes and other tobacco products, as well as to help regulate a market of novel, innovative smoke-free products. Unfortunately, the CTP has been dropping the ball and failing to meet its most basic requirements set by Congress in authorizing smoke-free products.
According to its federal mandate, the CTP is supposed to review and decide on new nicotine and tobacco product applications within 180 days. However, this process often drags on for years, leaving a backlog of tens of millions of unreviewed applications – many of which are for smoke-free options that could help the 30 million American adults who still smoke traditional cigarettes find a satisfying alternative that’s a better decision for their health. Unfortunately, CTP has authorized hundreds of cigarette products over this same time frame – a clear contradiction of the Center’s mission (https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp) to “protect the public health of the U.S. population from tobacco-related death and disease.”
The United States has come a long way in reducing the national smoking rate, but there is more progress to make. Policymakers in Washington should be doing everything in their power to help more adults who smoke quit. Instead of enabling a robust and legal market of smoke-free products to meet consumer demand and could help save lives, bureaucratic roadblocks at the CTP stand in the way.
In fact, according to a report (https://tobaccoreporter.com/2022/10/31/comments-in-fda-assessment-suggest-agency-in-disarray/) by the independent Reagan-Udall Foundation, the CTP under the previous administration suffered from ineffective leadership, a lack of direction and a culture that stifles scientific integrity. The CTP’s own staff have described (https://tobaccoreporter.com/2022/10/31/comments-in-fda-assessment-suggest-agency-in-disarray/) an environment where “scientific disagreement is frowned upon, if not entirely suppressed,” political agendas overrode sound science, and the mission to reduce adult smoking-related harm is lost in a sea of government dysfunction.
The time to reform the CTP is now and the Tar Heel State is fortunate to have leaders who understand what’s at stake. Our congressional delegation, Democrats and Republicans alike, have stepped up to demand accountability and reform at the CTP, and deserve to be commended for their efforts. They recognize that helping adults who smoke transition to smoke-free products is not a partisan issue – it’s a public health imperative.
Our leaders in Washington should keep up the good work and push for much-needed reforms that would ensure the CTP is doing what it needs to do to prioritize the authorization of new, innovative smoke-free products. With Dr. Marty Makary recently taking the helm at the U.S. Food and Drug Administration (FDA) and Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., now is the time for bold, decisive action that will truly help make America healthy again.
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