Our capacity as humans to "think positive" in the face of impending disaster was perhaps a critical component of our ability to survive in a world of paleolithic predators.
It seems that here on ECF, there are myriad posters who reflect this capability, and who continue to hold a number of questionable views about the likely results of the FDA's proposed rules for vaping regulation.
Based on my admittedly unscientific perusal of posts on other vaping forums, various sites devoted to vaping, and Youtube videos, I'm ready to conclude that there are a plethora of false hopes out there. No one wants to be accused of thinking that "the sky is falling."
Yet most who have looked closely at the FDA's proposed rules, carefully considered the history of FDA regulation in the tobacco products context, as well as FDA actions and pronouncements concerning vaping (not to mention their attitude towards the science), have come to a rather different conclusion.
Namely, we genuinely do believe that the "sky" will "fall" if the FDA's proposed multi-faceted rule becomes final, and ends up being implemented with the same goal of discouraging the use of "tobacco products" that Congress clearly intended to pursue when passing the Family Smoking Prevention and Tobacco Control Act (FSPTCA).
Our view is that there will be nothing left on the market other than a few types of "cigAlikes."
Of course this will lead to numerous consequences, such as the end of vaping as we know it (or at least it will effectively stop the growth in the number of existing vapers who use advanced products), and dramatically reduce the potential for smokers to quit smoking tobacco cigarettes in favor of vaping. Eventually, the prevalence of "dual use" in the cigAlike context may provide the very type of (legitimate) scientific evidence to support the thesis that vaping leads to "more (tobacco cigarette) smoking, not less."
That's why the scope and effect of the FDA's proposed rule on the availability of e-liquid and hardware need to be clarified. In particular, it's critical to identify and debunk questionable if not downright false ideas about the options available to the non-cigAlike vaping industry and users of advanced vaping (non-cigAlike) products.
***
DUBIOUS OR INCORRECT NOTIONS ABOUT THE FDA'S PROPOSED RULE AND THEIR LIKELY IMPACT
I intend this to be only an example of the sort of definitive statement that I'd prefer to see CASAA release at some point, in order to disabuse those who think otherwise.
---
I. BELIEFS ABOUT WHAT CAN BE DONE IN THE NEAR FUTURE
Belief 1: The FDA's proposed rule may be challenged in court, prior to any action undertaken against a specific manufacturer, just as it was in Soterra. So this proposed rule can be stopped long before the two year "window" closes.
False
Federal Courts demand a "case or controversy" before hearing the merits of a claim, and this is often interpreted as requiring that a federal agency act or threaten to act against a particular party before the court will entertain a request to issue an order to the agency in the form of an injunction. In the Soterra case, the FDA had already acted. It seems extremely unlikely that the FDA regulations could be stopped by any entity that had not at least submitted a rejected application for market approval, or received a "cease and desist" letter from the FDA, or been on the receiving end of a product siezure.
Belief 2: The FDA is simply putting foward a framework for negotiation and discussion. If we vapers get together, then organizations that represent us and/or the vaping industry can sit down with the FDA and offer them a series of "compromises," that may result in the FDA drafting a different proposed rule.
False
The FDA's "listening sessions" are over. The only thing that vapers can do right now to participate in the formal process is to submit comments during the period that will end in early July (although CASAA intends to request an extension, the FDA has the sole authority to decline this request). Once the comment period ends, the FDA will draft a final proposed rule that will go to the OMB. If OMB permits the final proposed rule to move forward, it will then be presented to the US Congress. While Congress has the authority to block the proposed rule, it must act affirmatively to do so. Without any such vote, the rule will become final. Furthermore, any such vote would be subject to a Presidential veto.
---
II. BELIEFS ABOUT PRODUCTS SOLD WITHIN DIFFERENT TIME PERIODS
Belief 3: There are products available prior to Feb '07 which are "substantially equivalent" to products available now, such as unflavored nicotine base.
Almost certainly false
Anything available prior to Feb '07 would have to be tested and proven to be chemically identical to whatever is sold now. Furthermore it would need to be offered in identical quantity and packaging. No hardware solution available at that time (if one could be found) is in any way comparable to something that could likely be offered today.
Belief 4: Products introduced prior to the end of the 2-year window after the rule become final will be "grandparented," and not require approval.
False
The FDA has no authority under the law to do so.
Belief 5: As long as an application is submitted within the two-year window after the rule becomes final, the FDA will allow the product to remain on the market until the application is reviewed, which might take many years, given the history of tobacco cigarette applications and the number of applications submitted prior to that application.
Probably false
There are no enforceable rules regarding the order in which applications are reviewed. The FDA could choose to reject every single vaping product on the first day after the two-year window closes. At that point, the products could be immediately pulled from the market, meaning that the FDA has the right to sieze and destroy them at the manufacturer's expense.
---
III. BELIEFS ABOUT COSTS OF THE APPLICATION PROCESS AND THE REGULATORY FRAMEWORK
Belief 6: The costs of an application might be as little as a few thousand dollars, or perhaps a few tens of thousands of dollars.
False
No credible person who has looked at this process has suggested that it will cost less than several hundred thousand dollars (at a bare minimum) to do all the necessary studies and analyses of the product's effect on tobacco product usage behavior as well as fulfill the additional standards. Some estimates are as high as $10M. The FSPTCA statutory framework was specifically set up by Congress to deter big tobacco companies from marketing new varieties of tobacco cigarettes, so the barriars placed in their path will be very similar to those facing any e-liquid or vaping equipment manufacturer.
Belief 7: The FDA is going to establish an approval process for small businesses which is less burdensome than that required for larger ones in terms of the required studies and product analysis.
False
It has no authority to "streamline" application processes for businesses of different sizes. See the previous point as well.
Belief 8: The economic costs of closing down thousands of B&M vape stores and online distributors will be a factor in convincing elected representatives to put pressure on the FDA to revise the proposed rules.
Doubtful
Any cost computation must weigh the costs to the vaping industry against the public health benefits associated with a net decrease in use of tobacco cigarettes that junk science analyses attribute to limiting vaping, such as the "gateway to tobacco cigarette smoking" alleged for minors and the alleged decreased cessation rates attributed to adult "dual users." At $1M per user/smoker, it will take very few additional tobacco cigarette smokers to counterbalance this economic loss. Furthermore, there is no evidence to suggest that the largest-selling cigAlikes will be negatively impacted by the prospect of FDA regulation, thus making it difficult to argue that there will be significant economic costs.
---
IV. BELIEFS ABOUT THE REQUIRED NUMBER OF DISTINCT APPLICATIONS
Belief 9: There will be one approval process for each flavor of e-liquid, which can then be used by other manufacturers.
False
If the history of the tobacco cigarette approval process is any guide, even the smallest variation in chemical composition or manufacturing standards between two e-liquids will require an individual application to be submitted for each. That includes, but is not necessarily limited to variations in nicotine content, package size, VG/PG ratios, and almost certainly packaging and even labelling.
Belief 10: Hardware (vaping equipment) is not affected, so long as it doesn't contain nicotine, and/or isn't sold with nicotine as part of a "kit."
False
Any "component or part" of a "regulated tobacco product" is covered under the act, and the FDA has indicated that the standard is "intended or anticipated for use." While this approach would also theoretically cover rubber O-rings or 186xx batteries that are used for many other types of products, no one anticipates that the FDA will declare those items to be regulated "components or parts" of tobacco products. However anything that's unique to vaping and essential to a particular usable configuration of a regulated "tobacco product" (e.g. a drip tip) will likely be covered. This means it will require a separate application if it is sold separately. As with e-liquid and tobacco cigarettes, the smallest variations in manufacturing, composition, size, shape, color, and so forth will each yield the requirment for a separate application.
Belief 11: There will be one approval process for each type of hardware. For example, "clones" of certain APVs, mech mods, RDAs, etc. can come into the market, once the originals are approved.
False
See above analysis concerning variations in e-liquid.
---
V. BELIEFS ABOUT OTHER "WORKAROUNDS"
Belief 12: A group of manufacturers can submit an application for high-strength e-liquid "base," which would then be used by the customer to create various flavorings. By pooling their resources, this consortium would have have the economic ability to satify the application standards and pursue any needed post-rejection litigation.
Probably false
The FDA is free to reject this application on the first day after the 2-year "window" expires, thus making the product illegal. That means the ROI for the investment involved in submitting the application will be zero until a court intervenes. It might be years before any litigation was concluded successfully for the manufacturers, thus making this an extremely risky prospect. It's not clear what the market would look like for e-liquid, particularly if vaping equipment hadn't been sold for many years prior to any eventual positive outcome in the courts. There are also other issues, such as the base composition ratio between PG and VG, and whether nicotine of that strength could be safely handled by consumers and result in an e-liquid that's also strong enough. Last but not least, any sellers of flavorings that were "intended or anticipated for use" with a "covered tobacco product" (i.e. the high-strength e-liquid) might be in exactly the same situation as vaping equipment manufacturers, i.e. they would be selling a "component or part" of a "tobacco product." This entire strategy is fraught with risks that are difficult to assess at best.
Belief 13: Certain high-quality mech mods, RDAs and so forth will last forever with proper care.
Probably false
Threading and rubber parts such as insulation will wear out and/or threads, screws, and other metal interfaces may require machining after many years of use. Some metal drip tips may last forever, but there is no other essential off-the-shelf equipment used by vapers which is likely to have a lifespan measured in decades. However much of this equipment can be made from off-the-shelf components and this is exactly what was done prior to 2010. Anyone will be free to do so for their own use until laws are passed against "nicotine paraphernalia" (c.f. "drug paraphernalia"). The status of clubs and co-operatives is a bit murkier, the FDA has been known to shut down (for ex.) "raw milk" co-operatives.
Belief 14: The FDA can't possibly stop foriegn internet sellers from making e-liquid and/or vaping hardware available to American consumers.
Doubtful
The FDA has done a fairly good job of keeping unauthorized foreign tobacco cigarettes off the US market. While international smuggling definitely persists, and FDA action against foriegn internet sellers of tobacco cigarettes is constrained by international treaties and obligations (i.e. it has no direct authority), siezures by US customs occur often, and purchasers of these products have been placed on notice by both the FDA as well as state taxing authorities. In some instances, customers have been sent significant tax bills for their illegal interstate and/or international purchases of illegal tobacco cigarettes.
Belief 15: There is no way that the FDA can successfully keep vapers from accessing nicotine and/or vaping equipment on the black market. Besides, all federal agencies are prohibited from drafting regulations that create black markets.
Hard to evaluate
Many existing prescription drugs are sold on the black market. As with all black markets, any given person's experience will likely vary from that of others'.
Many lives are at stake.
