With a new Trump Administration now in power there is going to be another push to undo all of the Obama administrations efforts to oversight on innovative tobacco products like vaporizers and e-cigarettes.
This could not be more evident than with WI Senator Ron Johnson a true yes man to the Republican party who recently sent a letter to the FDA commissioner Robert Califf stating that his party would look to target all of the regulations that went into effect last Aug 8, 2016.
Johnson noted to Califf that there is a substantial likelihood that this burdensome rule will be undone by the 115th Congress if the FDA does not stop it from being implemented further.
When asked for a response to Johnson’s letter, a FDA spokesman said the agency would respond directly to the senator.
A clear majority of nicotine and tobacco products introduced after Feb. 15, 2017 need to have FDA authorization covering ingredients and health documentation. The FDA allows for up to a three-year retail exception for products whose manufacturer enters the regulatory gauntlet.
The U.S. House Agriculture appropriations bill for fiscal 2016-17 contained language that would only permit funding for FDA substantial equivalent restrictions on e-cigs, vaporizers and hookahs with a start date of Aug. 8, 2016.
Analysts have projected that the cost of a regulatory review would be several million dollars for each application. An application is expected to be required for each flavoring and nicotine content level.
By comparison, the FDA estimates the average cost of an application at $466,563 each.
Either way, vaping advocates are concerned that expanded FDA regulations will lead to the Big Three tobacco manufacturers capturing most of the vaping market share, and also lead 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.
In its June 16 response to Johnsons inquiry, the FDA estimated that between 5,200 and 10,200 businesses in the United States make and/or sell electronic nicotine-delivery systems.
The FDA said that number could drop between 30 percent and 70 percent with the new regulations, or to a range of 1,500 to 7,000 still in the marketplace.
I hope the FDA will acknowledge the reality of the situation and ensure that small businesses and consumers do not continue to incur avoidable financial costs due to this regulation, Johnson said.
E-cigs and vaporizers have become big business for tobacco manufacturers, chains and mom-and-pop stores since they hit the mainstream marketplace in recent years.
E-cigs sales are expected to reach $1.6 billion in 2016, according to Wells Fargo Securities analyst Bonnie Herzog. They are mostly sold in convenience stores, with R.J. Reynolds Vapor Co.s Vuse being the top-selling brand. Vuse is made exclusively in Reynolds Tobaccoville plant.
Vaporizers and similar products are projected by Herzog to hit $2.5 billion in sales this year. They are sold mostly in vape shops and online.
Johnson has credited vaping supporters for his re-election win, pointing to them the importance of voting for him as a means of fighting the FDA regulations.
Gregory Conley, the president of the American Vaping Association, an advocacy group for the industry, said that with Johnsons re-election and a Donald Trump presidency, we are hopeful that the new Congress will act to stop the FDAs vaping rules from putting tens of thousands of Americans out of work.
It is likely that 60 votes will be required to reverse some of the FDA regulations, but now that the Republicans have evoked the Nuclear Option for the Supreme Court pick we may never need 60 votes again for anything.
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