FDA E-CIG REGULATIONS HAVE NEGATIVE EFFECTS ON PUBLIC HEALTH
FDA E-CIG REGULATIONS HAVE NEGATIVE EFFECTS ON PUBLIC HEALTH
Vaping products are providing an alternative for those seeking to stop smoking cigarettes. While more research on vaping may be warranted, there is evidence that these products are helping many people quit using traditional tobacco.
Nonetheless, the FDA has issued its new regulations of e-cigarettes, e-liquids and related products, which treat vaping products as traditional tobacco products. The FDA’s new rule would require companies to show that their vaping products are “substantially equivalent” to a tobacco product that was on the market as of February 15, 2007 (the “grandfather date”). As most of these products were not on the market at that time, the companies will be required to submit for pre-market authorization using the extremely costly and time-consuming Pre-Market Tobacco Application process. The pre-market approval process must be completed by August 2018. For many companies, the process will be impracticable. As a result, numerous products currently on the market may not be available.
FDA officials and tobacco control advocates have relied on the precautionary approach (i.e. prove something isn’t harmful before allowing it) to support their position. However, in doing so they have ignored millions of past, current and future smokers who are addicted to a product already known to be deadly and who may be able to make the switch to a lower-risk nicotine product if presented with desirable alternatives. It is possible that people now using e-cigarettes could move back to smoking if this FDA’s rule is not addressed.
There are many pending lawsuits challenging the FDA’s treatment of vaping products as “tobacco products.”
But, while the lawsuits are proceeding, Congress could take the step of changing the “grandfather date” to the effective date of the FDA’s regulations (i.e. August 8, 2016). Currently, there is an amendment pending (the Cole Bishop Amendment) that would move the grandfather date to August 8, 2016. This would ensure that the potentially life-saving products would not be subject to regulatory obstacles that may keep them off the market. This one simple correction could play a pivotal role in helping to save many lives.