As a vape store owner and operator, I was glad to see the U.S. Senate Committee on the Judiciary press top officials at the U.S. Food and Drug Administration (FDA) and Department of Justice for answers about the massive increase in illicit, unauthorized vaping sales in the United States. The federal government’s inaction and ineffectiveness has created an untenable environment, forcing states like Florida to fill the void. Unfortunately, states don’t have the authority, resources, or expertise to holistically address this issue. Congress needs to reform the appropriate federal agencies to meet their legislative mandates.
The Senate Judiciary Committee’s latest hearing, which follows similar hearings in the U.S. House, illustrated precisely why the FDA’s Center for Tobacco Products (CTP) is in desperate need of immediate reform. The review and approval process for premarket tobacco product applications (PMTAs) overseen by the CTP must be streamlined so the agency can do its job and approve legitimate smoke-free tobacco alternatives, while cracking down on dangerous e-cigarettes and vaping products, many of which are coming in from other countries.
Legal e-cigarettes and vaping products have an important place in the U.S. market, providing the roughly 28 million Americans – including more than two million Floridians – who still smoke cigarettes with more options for less harmful forms of nicotine. However, the review and approval process for these products is currently paralyzed, which has opened the doors for illegal products that haven’t received FDA authorization, or even filed an application in some cases, to flood the U.S. marketplace.
During the hearing, CTP Director Brian King cited a backlog of PMTAs seeking FDA approval that has slowed the agency down, delaying the approval of new smoke-free tobacco products. However, there’s no excuse for approving fewer than 50 out of more than 26 million PMTAs that have been submitted since 2009, especially when the CTP’s staff has more than doubled in recent years – growing from 426 employees in 2013 to more than 1,100 today.Between a staff that size and the hundreds of millions of dollars the FDA collects in user fees from tobacco manufacturers and importers annually, there should be plenty of resources for the FDA and CTP to expedite the approval of smoke-free alternatives. Unfortunately, the broken, unclear PMTA process and a general lack of transparency at the CTP is preventing that from happening, which has undermined public health and led to the rise of the illegal e-cigarette market.
The FDA’s failed approval process leaves so many responsible entities in the dark as to how or why the CTP reaches its decisions. According to findings by the Reagan Udall Foundation, that is exactly what is happening as stakeholders navigating the process “expressed concerns about a lack of clarity, transparency, and communication” regarding the CTP’s priorities and decision-making processes.
This is more than just a matter of government dysfunction. With more than 32,000 Floridians – and thousands of Americans – dying from diseases related to smoking cigarettes every year, this is also a matter of protecting and promoting public health.
By failing to properly regulate e-cigarettes, including reviewing and approving new PMTAs in a timely manner, the FDA is failing to build a larger marketplace of legal tobacco alternatives that could help millions of adult smokers make better decisions. Hopefully, Congress will keep holding the FDA accountable and push for reforms that can help reverse the tide of illegal e-cigarette sales and build a legal market of smoke-free tobacco alternatives that can reduce smoking and cancer rates in the Sunshine State and across the country.
Nick Orlando is a vape shop owner and the President of the Florida Smoke Free Association.
