VTA: FDA CTP's Actions Undermine Public Health

On January 19th, Tony Abboud, the Executive Director of the Vapor Technology Association (VTA), announced that the U.S. Food and Drug Administration (FDA) has issued a Marketing Denial Order (MDO) for Suorin and blu PLUS+ e-cigarettes. This decision by the FDA and the Center for Tobacco Products (CTP) is seen as part of their ongoing efforts to effectively ban e-cigarettes in the United States.

Abdullah states that the FDA continually emphasizes that e-cigarette manufacturers have not provided "sufficient scientific evidence" in their PMTA applications. However, the FDA refuses to address the Reagan-Udall Foundation's fundamental criticism of the entire regulatory process, which is that the FDA has not clearly outlined what needs to be proven for something to be considered "appropriate for the protection of public health (APPH)," nor how it interprets what APPH entails.

Abdul believes that not objectively defining and using standards to refuse marketing authorization for critical smoking cessation and harm reduction products is a serious overreach for any government agency that follows a scientific mission.

The court found that the process had become "arbitrary and capricious" in practice, with CTP leadership determining standards based on specific circumstances. Meanwhile, the company was simply attempting to do the right thing by adhering to the PMTA process established by the FDA.

He continued, "Most notably, CTP claims to have denied Suorin's PMTA because its product promotes 'sustained use and progression' of dependence. If this is the standard, then every nicotine product would fail CTP's bizarre criteria, as nicotine is addictive, furthering CTP's implementation of a ban on less harmful nicotine."

"The actions taken by the FDA and CTP today do not contribute to the protection of public health or to assisting Americans who smoke. VTA once again urges CTP to reverse its malicious behavior and restore the scientific integrity of its regulatory and decision-making processes. Enough is enough," said Abdu.