Sen. Johnson Seeks Answers From FDA On Final Rule Over Vaping

On Wednesday May 18, Senator Ron Johnson (R-Wis.), who is chairman of the Senate Homeland Security and Governmental Affairs Committee, sent a letter to Commissioner Robert Califf of the Food and Drug Administration (FDA), regarding their Final Regulations over the vapor industry, reports the HSGAC Majority Media.

In this letter Sen. Johnson addressed several important points and real concerns he has over the recently released Final Regulations. Read: FDA Releases Regulations For Vapor Industry

“Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences,” Johnson wrote.

“The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking. It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes,”

The Final Rule gives the FDA control over all vapor products, essentially marking them “tobacco products”, it also bans the sale of e-cigs to anyone under 18 nationwide. But the most disconcerting portion of the rule that has the vapor industry worried is the Pre-Market Tobacco Application (PMTA) process. Read: SFATA’s Analysis of the FDA’s Final Rule

The notorious PMTA places a heavy burden on all vapor retailers and manufacturers due to the February 15, 2007 predicate date. As any product made after this date must go through the extremely expensive and time-consuming PMTA process, which will cost each manufacturer millions per product. Industry experts believe that 99% of vapor products will disappear due to the PMTA. FDA’s own report from 2014 states that they expect the PMTA’s cost to “be high enough to expect additional product exit, consolidation, and reduction in variety compared with the baseline.” Stated here: Page 35 >> last paragraph of the FDA’s 2014 Analysis

Sen. Johnson asked the FDA if it will revise its Final Rule if sufficient evidence comes to light which proves that e-cigs are a safer alternative to tobacco cigarettes, given that two of the United Kingdom’s leading medical institutions, Public Health England and the Royal College of Physicians have publicly stated their belief that vaping is 95% less harmful than smoking tobacco cigarettes. Read: England Announces Support For Vaping, Finds E-Cigs Are 95% Less Harmful Than Smoking Tobacco Cigarettes

“How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have ‘sufficient data’ about e-cigarettes to determine the effects on the public’s health?,” Sen. Johnson pointed out in his letter. Read: Senator Johnson’s Letter to the FDA in its entirety

Sen. Johnson also states that the FDA’s rule has been predicted to extinguish many small businesses that create and sell vapor products due to the onerous PMTA process. He calls out the FDA for an answer on whether they determined how many e-cigarette businesses would be affected by the rule. He also asked what action they will take if their Final Rule, which would decrease access to vapor products, leads to the increase of users turning back to tobacco cigarettes.

Like Senator Johnson, the vaping industry is eagerly awaiting the FDA’s response to his letter, which he has requested to be sent to his office by May 31, 2016.