When the FDA e-cig regulations were first announced on May 5, 2016, Sen. Ron Johnson from the Committee on Homeland Security and Governmental Affairs sent a rather detailed letter demanding further information and raising several concerns. The FDA had until May 31 to respond, but missed the deadline. After sending a second letter in early June, Johnson finally heard back from the FDA, but the agency’s response was deemed “insufficient” by the Wisconsin Senator.
In the original letter, Johnson listed several points of interest surrounding the FDA e-cig regulations, specifically in regards to possibly negative and perhaps unintended consequences that the new restrictions would place on small businesses. He also asked if the rules could be revised in the future if adequate data was later discovered identifying electronic cigarettes as a safer alternative to conventional tobacco products. Johnson ended the first letter by stating,
“The Committee on Homeland Security and Governmental Affairs is authorized by Rule XXV of the Standing Rules of the Senate to investigate ‘the efficient and economy of operations of all branches of Government’...Thank you for your prompt attention to this matter.”
(Related Article: WISCONSIN SENATOR RON JOHNSON FORCES FDA TO EXPLAIN DEADLY E-CIG REGULATIONS)
FDA response provides no new information and false statistics
After sending two letters, the original and a more aggressively worded second reminder letter, Sen. Johnson finally heard back from the FDA on July 15, 2016. However, the only information that the FDA provided in its response was data and statistics that could already be easily found online. No new insights were offered, and several of Johnson’s demands were still left largely ignored.
Furthermore, much of the information cited in the FDA’s 8-page response is simply false or intentionally misleading, such as the agency’s claim that there are three available pathways for e-cig and vaping manufacturers to bring their products to market. But thanks to the highly controversial predicate date of April 15, 2007 included deep within the FDA e-cig regulations themselves, two of these pathways are essentially obsolete.
This only leaves the uber-expensive Pre-Market Tobacco Application (PMTA) process, which the majority small business owners cannot afford. Even more alarming, the FDA has only approved one PMTA application in the past six years, even after the million-dollar price tag has already been paid.
The FDA response letter also makes claims that teenage use of e-cigs is on the rise, and even cites the Centers for Disease Control (CDC) as a supporting source of this information. But the agency falls short of providing the precise scientific documentation, as Sen. Johnson originally requested.
“Tobacco is a significant public health threat that is particularly affecting youth. While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb. A recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has increased from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) and hookah use has risen significantly. In 2015, three million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes.”
(Related Article: SEN. RON JOHNSON & FDA E-CIG REGULATIONS: WHAT HAPPENED WITH ‘THE LETTERS?’)
In another section of the FDA’s response, the agency claims that it will only allow e-cigs and vaping products onto the market after the retailer has shown them to be appropriate for the protection of public health. Meanwhile, tobacco cigarettes continue to get a free pass. In short, the FDA’s response letter is essentially 8-pages of nonsense regurgitated from undocumented sources.
FDA stalls as Sen. Ron Johnson faces re-election
For many political activists inside the vaping community, this “insufficient response” by the FDA is exactly what was expected. After all, Washington D.C. is well known for its bureaucratic red tape, and Sen. Ron Johnson is up for re-election in November. And unfortunately, his chances of winning do not look very good at the moment.
Johnson is a Republican, and he may be one of the down-ticket victims of a possible Trump backlash. By drawing out the information-gathering process, perhaps the FDA hopes that Johnson will be defeated in the Fall, and the entire issue over the legality of the FDA e-cig regulations will simply go away.
But Sen Ron Johnson keeps pushing forward. His third letter is even longer and more detailed than the previous two, and his tone is noticeably tougher and more severe. In one section, Johnson even states, “The American public deserves complete answers from the FDA about its rulemaking.” This time, Johnson is demanding full and complete answers to the FDA e-cig regulations by July 29, 2016. The saga continues.
(Related Article: THE TRUMP EFFECT: ‘E-CIG’ SENATOR RON JOHNSON FACES RE-ELECTION TURMOIL)