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 it. And he mentioned a section about 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 cannot 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 expressed sympathy for the issues that have driven the agency to confront the vaping market.
He also owns shares and is a board member of a vaping 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 vape industry to a screeching halt in November 2018, when all products not launched since February 2007 will be removed from the market 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, HR 1136, or Senator Duncan Hunter's HR 2194.
Or he could instruct the Center for Tobacco Products to improve the regulatory rule by changing the certification date from 2007, which CTP has argued cannot be done because the 2009 Tobacco Control and Family Smoking Prevention Act already covers other certification years. Many experts believe the agency's insistence on using the TCA certification date is dishonest, and FDA has the ability to change this.
Another way is for the FDA and the Justice Department to not defend this regulation in court. There are currently six laws that have been passed by 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.
