In a speech to FDA staff on his first day as head of the agency, Professor Scott Gottlieb spoke in favor of vaping , although he also raised public concerns about the health safety of “the kids.”
Gottlieb told his new staff that protecting patients and consumers is the agency's core mission and that he believes in that mission. And he touched on the challenges facing FDA regulators.
“Between these and other opportunities, there is certainly no product innovation we will create in the near future that will have a dramatic impact on reducing the number of people who smoke,” Gottlieb told the crowd.
“We must redouble our efforts to help more smokers quit. And we must provide more scientific evidence to help smokers switch to safer products if they are unable to quit. And at all times, we must ensure that children are kept away from the harmful effects of tobacco.”
This is exactly what the vaping industry wants to hear. But what does it mean? We know Gottlieb has written about the FDA’s opposition to harm reduction, and has shown sympathy for the issues that have driven the agency to confront the vaping market.
He also owns some shares and is a board member of a vape company, a relationship that has raised questions about potential conflicts from Democratic senators during his inaugural panel.
What can Mr. Gottlieb do?
As most vapers know, FDA regulations could bring the entire vaping industry to a halt in November 2018, when all products not released since February 2007 will be removed unless they are approved for sale by the agency.
The new FDA administrator could delay or suspend changes to the statute's limits, allowing more time to introduce more appropriate legislation like Cole Bishop's HR 1136 or Senator Duncan Hunter's HR 2194.
Or he could instruct the Center for Tobacco Products to improve its regulatory rules by changing the certification date from 2007, which CTP has argued is impossible because the 2009 Tobacco Control and Family Smoking Prevention Act already covers other certification years. Many experts say the agency’s insistence on using the TCA certification date is dishonest, and FDA has the ability to change it.
Another way is for the FDA and the Justice Department to not defend this regulation in court. There are currently six laws in place from a number of federal agencies in the country. The current administration simply refuses to defend this ridiculous tobacco regulation.
Gottlieb’s supporters seem convinced that he will take action to ensure the vaping market works. But vapers have heard enough promises to continue their support until they see real results. What everyone agrees on is that action needs to be taken sooner rather than later.
Source: Jim McDonald - Vaping360.
