The reality of a Donald Trump administration focused on rolling back regulations has led a US senator to jump-start efforts to curtail the US Food and Drug Administration’s rollout of new rules on innovative vapor products, according to a story by Richard Craver for the Winston-Salem Journal.
Republican senator Ron Johnson, who won re-election on November 8, sent a letter on Tuesday to the FDA Commissioner Robert Califf warning him that a Republican-controlled Congress and White House would target some, if not all, of the regulations that went into effect on August 8 in respect of electronic cigarettes and vaporizers.
Johnson is the chairman of the Senate Homeland Security and Governmental Affairs Committee.
He advised Califf that there was a ‘substantial likelihood that this burdensome rule will be undone’ by Congress if the FDA did not stop it from being implemented further.
The need for FDA authorization of ingredients and health document submission covers any vapor product introduced after February 15, 2007 (the grandfather date) – most of the products on the market.
The FDA allows for up to a three-year retail exception for products whose manufacturer enters the regulatory system.
Craver said that analysts had projected that the cost of a regulatory review would be several million dollars for each application. And an application is expected to be required for each flavoring and nicotine content level.
The FDA estimates the average cost of an application at $466,563.
Either way, vaping advocates are concerned that the expanded FDA regulations will lead to the big three tobacco manufacturers capturing most of the vaping market share, and to black market sales of unregulated products.
Johnson has said for several months that the cost of adhering to the new regulations “are so needlessly high that the very existence of the vapor products industry is being threatened”.
The full story is at: http://www.journalnow.com/business/business_news/local/senator-warns-fda-that-gop-will-target-e-cig-regulations/article_e373e5aa-9fe6-5db3-8f08-be2d117dfc64.html.