Most of you know by now that the new regulations have come out and the document is 499 pages long. However, the last 50 or so pages are definitions, a list of laws and references used in the document. In actuality, MAYBE 100 pages pertain to e cigs specifically. But many of these pages are things we already knew were going to happen such as age limits, nicotine warnings, etc. They even talk about vending machines. I can't recall the last time I saw an operational cigarette vending machine; I thought they were outlawed years ago. Of course there is quite a bit of legal speak and a lot of the regs address issues such as keeping tobacco out of the hands of kids, environmental concerns, etc. This document not only addresses ecigs, it covers cigars, hookahs and roll your own cigarettes.
It took a good 3-4 hours to read through the pertinent information on e cigs and another hour to cruise through the rest. The FDA lists comments and responses to certain aspects. Most of it, as I said, we already know. A lot of it is stuff we could care less about. There are even a few sections that made me chuckle, such as some items that are considered tobacco products such as wire, screwdrivers and lanyards because the are used specifically for tobacco product consumption. I knew the FDA was going to do some things we don't want to happen, however, to consider a screwdriver or a lanyard a tobacco product???
This being said, the regulations are not as bad as many are making them out to be. A bit restrictive maybe, but it's not the end of vaping. The FDA even states, "This final deeming rule places some restrictions on the sale and distribution of tobacco products, such as minimum age restrictions, but it does not bar sales to individuals generally." Also, "FDA is not banning any category of tobacco product by issuing this final deeming rule." So for those that believe that vaping will cease to exist, the regulations even say it will.
I went through and highlighted quite a few statements that give us hope that FDA is not going to totally turn our world upside down. There are even quite a few areas where they are open to new information and also helping smaller companies deal with the costs of "registering" their vaping goods so that big companies won't have an advantage. This is not the only place the FDA is offering to help us.
Here are just a few of the more important passages pertaining to e cigs from the final ruling (which isn't written in stone as the FDA says they could change and amend (for the good) as information becomes available):
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(Comment 26) Many comments stated that a requirement to prepare PMTAs for all of the many parts and components that go into some of the newly deemed tobacco products would create an effective ban of these products. (Response) The definition of a tobacco product includes components and parts, and these products are subject to the automatic provisions of the FD&C Act, including premarket authorization requirements. However, at this time, FDA intends to limit enforcement of the premarket authorization provisions to finished tobacco products. In this context, a finished tobacco product refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use (e.g., filters or filter tubes sold separately to consumers or as part of kits). For example, an e-liquid sealed in final packaging that is to be sold or distributed to a consumer for use in a finished tobacco product will be subject to enforcement if it is on the market without authorization. In contrast, an e-liquid that is sold or distributed for further manufacturing into a finished ENDS product is not itself a finished tobacco product. At this time, FDA does not intend to enforce the premarket authorization requirements against such eliquids or other components and parts of newly deemed products that are sold or distributed solely for further manufacturing without a marketing order. (So hardware is not going to be as hard to come by as first believed)
(Comment 161) Many comments expressed concern that Congress did not wish to effectively ban e-cigarettes (as they claimed would occur as a result of deeming these products), because such a ban violates section 907(d)(3) of the FD&C Act. They stated that if Congress wanted to ban them, they would have done so under their drug authority. (Response) FDA is not banning any category of tobacco product by issuing this final deeming rule.
However, we recognize that the availability of alternatives to traditional tobacco flavors in some products (e.g., ENDS) may potentially help some adult users who are attempting to transition away from combusted products. Furthermore, at least some flavored combusted products are likely to be “grandfathered” and therefore would remain on the market regardless of the compliance period provided in the preamble. (The grandfather clause we hoped for. It might not be much, but it's a start)
Further, CTP’s OCE will continue to assist small-scale tobacco product manufacturers in their submission of rotational warning plans for FDA approval and to provide a system to assist such businesses in navigating the regulatory requirements of FDA. FDA considers a "small-scale tobacco product manufacturer" to be a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5,000,000 or less. (The little guys won't bear as much of the expense as many say)
Until the FDA publishes a final guidance for each product category and to provide ENDS manufacturers a lengthier compliance period based on where they purport to fit within the risk continuum for nicotine-delivering products (e.g., Comment No. FDA-2014-N-0189-81859; Comment No. FDA-2014-N-0189-10852). In response to these comments, we note that nicotine use in any form is of particular concern for youth and pregnant women. On the other hand, some evidence suggests that ENDS may potentially promote transition away from combusted tobacco use among some current users and it is possible that there could be a public health benefit. (Did they say possible health benefit???)
FDA intends to seek additional public comment and issue a rule or guidance to provide further clarification on assemblies of materials that are a "component or part" of a tobacco product because they are intended or reasonably expected to alter or affect the tobacco product's performance, composition, constituents, or characteristics or are intended or reasonably expected to be used with or for the human consumption of a tobacco product. (Our time for offering suggestions is NOT over. They still want our input!!!)
(Comment 141) Many comments stated, but did not provide supporting data, that ecigarettes: (1) Are approximately 99 percent less hazardous than cigarettes; (2) are only consumed by smokers and former smokers who quit by switching to e-cigarettes; and (3) have not been found to create nicotine dependence in any nonsmoker. They also stated that there is no evidence that ingesting e-liquid leads to fatalities. (Response) As discussed throughout this document, FDA agrees that use of ENDS is likely less hazardous for an individual user than continued smoking of traditional cigarettes. (SEE, even the FDA recognizes that e cigs are "likely" less hazardous!!)
(Comment 161) Many comments expressed concern that Congress did not wish to effectively ban e-cigarettes (as they claimed would occur as a result of deeming these products), because such a ban violates section 907(d)(3) of the FD&C Act. They stated that if Congress wanted to ban them, they would have done so under their drug authority. (Response) FDA is not banning any category of tobacco product by issuing this final deeming rule.
(Comment 167) Many comments stated that the NPRM would ban virtually all of the eliquid products and premium vaporizers (including mods, tanks, and open systems) and other components or parts because manufacturers of such products would not have adequate resources to comply with the requirements of the law. (Response) FDA disagrees. FDA is not banning any tobacco product under this final rule. Rather, FDA is extending its authority to regulate such products under section 901 of the FD&C Act. Manufacturers of ENDS products were on notice that they could be considered FDA-regulated tobacco products since the enactment of the Tobacco Control Act and the issuance of the Sottera decision shortly thereafter. See section VIII.K for additional discussion regarding the Sottera case. Therefore, FDA disagrees with any comments referring to this rule as banning any categories of tobacco products. (Regulation NOT prohibition as so many have claimed)
(Comment 203) One comment stated that alternative nicotine products, such as nicotine toothpicks, (Wait...what? Never heard of these LOL)
(Comment 216) Many comments suggested that FDA include a ban on flavored tobacco products with this final rule. Other comments suggested that FDA continue to allow the sale of fruit or candy-flavored e-cigarettes, because they aid cigarette smokers in decreasing cigarette use and in smoking cessation. (Response) FDA is not banning flavored tobacco products with this final deeming rule. If additional evidence emerges that flavored ENDS make it more likely that smokers switch completely to ENDS, such evidence submitted as part of a PMTA would help support that application, as part of the analysis of whether the marketing of the product is appropriate for the protection of public health. (So we are not going to be stuck with plain tobacco, menthol and clove...thank goodness!)
Somebody asked me in a previous post if I had "fell asleep at the wheel" when I said that the regulations weren't as bad as we thought. No I didn't, I was too busy actually reading the regs and taking notes!!!
