The date April 19, 2016, marked a giant leap forward for vaping advocates and the industry alike as a bi-partisan amendment was adopted by the U.S house appropriations committee to move the FDA’s predicate date for vapor products with a vote of 31-19.
While some are dancing in the streets at this first step in the process, others remain cautious as to the amendments true impact on the future of the industry.
The amendment to the Agriculture and Rural Development Appropriations Committee’s bill by Rep. Tom Cole (R, OK) and Rep. Sanford Bishop (D, GA) is different from Rep. Cole’s HR 2058. The latter was literally the addition of 4 lines of language to an existing bill to move the FDA’s grandfather date of regulatory control from 2007 to the date their regulations are put in place.
The 2009 Tobacco Control Act allows a new tobacco product to be authorized for sale if it can be shown to be “substantially equivalent” to a product already on the market before February 15, 2007. If no such product exists, the new product must undergo a more extensive review under the agency’s “premarket tobacco application” (PMTA) process.
Without this language, 99% of vapor products currently on the market would have to be removed for the simple fact that they were not invented 9 years ago, and to be considered for sale they would have to go through a lengthy and costly testing process that has no guarantee of success.
The amendment that moved forward from the committee does indeed move the FDA’s goal posts to a date in the future when their regulations are put in place, and will allow vapor products currently on the market to remain so.
“Today is a good day for the vapor industry in the effort to help reduce the public harm caused by smoking, specifically because it helps protect the consumer-driven innovations made in the vapor industry over the past several years,” said Cynthia Cabrera, president and executive director of SFATA. “While the work is not yet done, we will continue to work with Congress to protect the rights of businesses and consumers in the manufacturing and use of vapor products, ensuring that these products stay on the market as effective replacement tools against smoking.”
Whatever vapers believe, we are not looking at “if” the FDA regulates, but “when”. Regardless of our feelings on the matter, they are hell bent on classifying this industry as a Tobacco industry and the federal government will get its way, turning low-risk products into the very things they were invented to help get rid of.
Some of the language in this amendment has set off alarm bells in the minds of some of the industries most outspoken advocates, but we will be doing in-depth interviews with some of them over the coming days to allow them to get their points across in full, giving those of us that may misread or misunderstand certain aspects, the chance to fully comprehend what is going on.