Issue link: https://read.dmtmag.com/i/724263
22 tobaccoasia / Issue 4, 2016 September / October tection of public health both of users and non-us- ers, considering both the risks of the product and the likelihood of changes in initiation or cessation rates. To date, there are no vapor products that meet FDA's description of "legally on the market" and a crystal ball will be required to guesstimate an individual product's effects on initiation or cessa- tion rates. Each variation of a product, such as nicotine strength or flavors, requires a separate applica- tion, which FDA refers to as a "PMTA." So, for example, a company that sells only 1 model of e- cigarette with a choice of 4 nicotine strengths and 6 flavors would need to submit 24 PMTAs. FDA has estimated the cost of preparing the applica- tions at $330,000 each, although this estimate is considered extremely conservative by some stake- holders. It should be noted that regardless of how much time or money a company has spent prepar- ing and submitting applications for its products, FDA may, at its discretion, decide to disallow the marketing of those products. 4. Protect consumers from tobacco- related disease and death Left unregulated, vapor products were doing a wonderful job of protecting consumers. After re- maining fairly level for a number of years, smok- ing rates began to drop when e-cigarettes came onto the market. By 2015, the Centers for Disease Control and Prevention (CDC) announced, nearly one in four (22 %) recent former cigarette smokers (quit within the past year) were using e-cigarettes. CDC also mentioned that current cigarette smok- ers who had tried to quit in the past year were more likely to use e-cigarettes than those who had not tried to quit. The deeming regulation of vapor products will have a chilling effect on this trend. The expense of submitting pre-marketing applications for every variation of a product will drive most, if not all, small companies out of business. Small companies cannot afford to risk millions of dollars to find out whether FDA will approve their existing products for sale. Consequently, the number and variety of products available to be used as a substitute for smoking will shrink dramatically. Increased feder- al, state, and local requirements will undoubtedly increase the price of smoking substitutes, thus it is very likely fewer smokers will switch. Some smok- ers that had switched to electronic cigarettes may switch back to smoking conventional cigarettes, because FDA will have made it cheaper to smoke than to vape. 5. Comprehensively regulate products that contain nicotine, based on the "continuum of risk" In 2013, Mitch Zeller, director of FDA's Center for Tobacco Products, wrote: "There is a spectrum or continuum of tobacco and medicinal products that aim to do the same thing—deliver nicotine to the user. But the toxicity associated with those products varies dramatically. At one end of the spectrum is the conventional cigarette…" Smoking causes numerous diseases—includ- ing heart attacks, strokes, lung diseases, and several forms of cancer. These diseases are not caused by the nicotine itself, but by other elements in smoke—in- cluding tar, carbon monoxide, and toxic chemicals. Since smoke creates the risk of disease, any product that can deliver nicotine without smoke may lower the risk of disease and death. These products may include smokeless tobacco, vapor products, and "nicotine replacement" products such as the patch, gum, lozenges, and inhalers. Zeller also wrote, "Anyone who would pon- der the endgame must acknowledge that the con- tinuum of risk exists and pursue strategies that are designed to drive consumers from the most deadly and dangerous to the least harmful forms of nico- tine delivery." The Tobacco Act that went into effect in 2009 regulates the most hazardous source of nicotine— conventional cigarette products—with a very light touch. Any new conventional cigarette must un- dergo the pre-market approval process, but the thousands of products that were already on the market by the predicate date may remain on the market with no pre-approval requirements. No toxicology testing of tobacco or smoke, no clinical trials, no comparison to other products. In contrast, vapor products that have been on the market for up to eight years must stop being sold within the next two to three years if they have not received FDA pre-market approval. Even if the predicate date were moved for- ward to remove the ex post facto effect on cur- rently available products, current products will not be able to be improved without significant invest- ment in attempting to prove scientifically that the change will not harm public health. If a component becomes unavailable, making a substitution would require an entire PMTA. Furthermore, FDA re- searchers at Georgia State University's Tobacco Center of Regulatory Science have found, "ENDS [electronic nicotine delivery systems] need to im- prove as a satisfying alternative or the attractive- ness and appeal of the regular cigarette must be degraded to increase the potential of ENDS re- placing regular cigarettes." The bottom line? When it comes to reduc- ing disease and death by regulating based on the continuum of risk, the federal government has it exactly backwards. This article was sourced from The Daily Signal, http:// dailysignal.com/2016/07/05/5-myths-about-fdas-regu- lation-of-vapor-products/.