Although the FDA has promoted its proposed deeming rule as a reasonable regulation to protect children, the agency’s proposal would ban the sale of most nicotine vapor products on the market because the Tobacco Control Act established February 15, 2007 as the “grandfather date,” which is the date for any tobacco product regulated by Chapter IX (including newly deemed products) to be sold on the U.S. market, and avoids having companies submit (and FDA approve) a PreMarket Tobacco Application (PMTA). Virtually no vapor products were on the market at that time, so the time-consuming and expensive PMTA is the only legal pathway for all other vapor products”. This is why moving the “grandfather date” is so important. Complicating the issue, the FDA has also claimed, “We do not believe that we have the authority to alter or amend this grandfather date.”
In the originally introduced Tobacco Control Act legislation in 2004 (negotiated and agreed to by Phillip Morris, the Center for Tobacco Free Kids’ Matt Myers and then Glaxo Smith Klein lobbyist Mitch Zeller), the grandfather date was set at June 30, 2003. When the legislation was reintroduced in 2005, the grandfather date was then changed to February 15, 2005, and later to February 15, 2007 when it was reintroduced in 2007, which remained when the legislation was reintroduced, again, in 2009; probably in an attempt to ban several recently introduced smokeless tobacco products by Reynolds.
Just one e-cigarette product has been found that was on the market prior to the Tobacco Control Act’s 2007 grandfather date — a first generation e-cigar manufactured by NJOY.
But the manufacturers of an estimated 100,000+ different nicotine vapor products now on the market (including all nicotine containing e-liquids) would be required to submit a PMTA for each SKU (stock keeping unit). The FDA would have to approve the PMTA in order for the product to remain legal to market 24 months after issuance of its final rule. The FDA’s deeming regulation basically redefines all nicotine vapor products introduced since 2007 as new tobacco products, thus requiring FDA approval of a PMTA to keep these so-called “new” tobacco products legal to market to adults.
To date, the FDA issued a Refused to File (RTF) for the four PMTAs that were submitted (for cigarettes, RYO and/or smokeless tobacco products) to the agency, and in 2014, it issued a brief summary of RTF determinations.
The FDA’s proposed deeming regulation states: “We are clarifying here that a PMTA may require one or more types of studies including chemical analysis, nonclinical studies and clinical studies. FDA expects that chemical and design parameter analysis would include the testing of applicable HPHCs and nonclinical analysis would include literature synthesis and, as appropriate, some combination of in vitro or in vivo studies, and computational analyses. For the clinical study component, one or more types of studies may be included to address, as needed, perception, use pattern, or health impact.“ Amazingly, the FDA’s deeming regulation estimated it would cost an average applicant just 5,000 staff hours (i.e., 2.5 full time employees working for one year) and just $333,554 to submit a PMTA.
In sharp contrast, a recent Wall Street Journal article cited the regulatory consulting company Sci-Lucent LLC estimating it would cost $2-$10 million to submit a PMTA, while my 2014 comment to FDA estimated it would cost $3-$20 million to submit a PMTA that FDA would actually evaluate.
Please note that Philip Morris International has already spent $2 billion in research and development for its new low-risk tobacco and nicotine products.
One estimate in FDA’s proposed deeming regulation probably closest to reality is the agency’s estimate that 25 PMTAs would be submitted annually for different e-cigarette products. Those PMTAs would likely to be submitted for cig-alike products by Altria, Reynolds, Imperial, BAT, PMI, JTI and perhaps NJOY. But even if FDA approved all PMTAs submitted for e-cigarettes prior to the FDA’s e-cigarette ban 24 months following final rule issuance, the agency has estimated the deeming regulation would ban >98.5% of the agency’s grossly underestimated 1,675 different e-cigarette products on the U.S. market. So the FDA has essentially acknowledged that the deeming regulation would ban nearly all e-cigarette products now on the market, and creates a new e-cigarette cartel controlled by several large manufacturers.
Even worse for vapor product industry is that FDA’s proposed deeming regulation would effectively ban the sale of all bottles of nicotine containing e-liquid because FDA would require manufacturers to submit studies and lab tests of each e-liquid product when used with each of the hundreds (or thousands) of different premium vaporizers, or open tank systems on the market.
Thankfully, US Representative Tom Cole (R-OK) has introduced a bill (HR 2058) which would change the Tobacco Control Act’s February 15, 2007 grandfather date for e-cigarettes (and other newly deemed tobacco products) to the date of the FDA’s final rule issuance The bill currently has 24 cosponsors.
Concurrently, the US House Appropriations Committee recently approved a bill that would prohibit the FDA from spending federal funds to enforce the deeming regulation’s 2007 grandfather date (Section 747, page 86), but still would allow the agency regulatory oversight if the grandfather date is changed.
Although these legislative options would keep all e-cigarettes currently on the market legal to make and sell in the future, both still require FDA approval of PMTA’s for all new e-cigarette products following issuance of the Deeming regulation’s final rule.
All nicotine vapor companies (including all vape shops) are urged to contact their members of Congress, explain how the FDA’s proposed deeming regulation would impact their ability to manufacture and market vapor products, and urge them to support measures to not only move the grandfather date and continue to sell these product to adults, but not stifle an industry that is creating jobs and has the potential to reduce the public harm caused by smoking.