Remarks for Reagan-Udall Foundation
My name is Amanda Wheeler and I’m the president of American Vapor Manufacturers, a trade association I co-founded because independent vape businesses are so absurdly overmatched in trying to navigate FDA’s labyrinth on their own. So when I speak here about the catastrophe of FDA’s approach to vaping regulations, I do so as a small business owner, an entrepreneur and working mom, a cancer survivor and former smoker who quit thanks entirely to nicotine vaping. I am also the representative of thousands of small businesses just like mine that are helping millions of Americans to take charge of their own health destiny.
This is a civil dialogue, which is all we have ever asked from the federal government, and I am here asking for your help. But the truth is that I am outraged, many of my members are bankrupt and in despair, and their customers are bereft of any choice but returning to the cigarettes they fought so mightily to overcome.
It is incredible to realize that in the many recent years that the vaping industry has been steadily crushed in the gears of FDA’s process, they have never once heeded any suggestion of ours and have consistently ignored our every warning about both the flaws in the application process and the looming black market that is now exploding. I am speaking from long experience and you have my earnest hope that our pleas will finally be heard.
The long catalogue of malfeasance in FDA’s regulatory process staggers the conscience. Here are just a few of the major aspects which we will detail further in our written submission.
FDA memoranda obtained by Freedom of Information request this year revealed that the agency arbitrarily altered its internal standards for the review of market applications. No explanation, no notice, no rationale. That means some companies were given opportunity for review while others were simply cast to the wind.
In many instances we have documented, companies received letters from FDA acknowledging filed applications and then later got contradictory letters refusing to accept those applications. Others received market denial orders and then later got letters saying the exact opposite, that their applications were under review.
Bear in mind that FDA accepts no fault or responsibility for any of this – and all of those companies must operate under a Sword of Damocles that the agency will abruptly declare them outlaws. Instead, we have received countless phone calls from national news media, citing the FDA’s guidance, accusing our members of breaking the law.
That is typical and the agency routinely communicated its decisions on application reviews not by contacting the companies themselves but instead by self-aggrandizing press releases or exclusive articles arranged with favored journalists.
Notice too that the very largest companies – global tobacco conglomerates – received favored treatment from the agency in the form of a special review pathway that got focused attention, extra duration, and active interaction. Many of those applications got careful attention for a year or more, while smaller firms were dismissed before they even got in door.
That means that thousands of smaller businesses entirely dedicated to vaping, many of which are owned by women and minorities, were summarily excluded. The agency set up unseen trap doors to reject wide swaths of applicants in an automated fashion, using boilerplate language in the decisions with no regard for the actual merits of the application.
FDA changed the required paperwork just days prior to the filing deadline, making an already immense burden for small companies totally impossible – and then rejected them on that rigged basis alone. The federal courts have lambasted FDA other maneuvers like that, calling FDA’s underhanded methods “a surprise switcheroo.” Even then, the agency scoffed at the courts also.
In another egregious example, the agency published a form that applicants were required to complete and then – with zero public notice – changed the form just days before the filing deadline. Companies that used the earlier form as FDA had insisted were then automatically rejected.
They even used supposed deficiencies in one product to reject ALL the products submitted by a particular company.
Many small companies spent enormous sums to produce the scientific data that FDA demanded – sometimes having to spend life savings or the entire investment capital of those businesses. But FDA did zero scientific review of that data. I repeat, those applications were tossed in the garbage before FDA even examined the detailed research it had obliged those companies to produce.
Even the most fundamental yardstick in FDA’s assessment of whether vaping products help people quit smoking is rigged. It requires not a comparison of efficacy versus cigarettes – but rather a comparison with tobacco flavored vaping. The agency’s intent there is both obvious and cynical – they wish to exclude all flavored vaping from the market except tobacco, even as they know full well that nearly all adult Americans rely on flavored vape products. That process flaw alone cost FDA a defeat in the 11th Circuit federal court and has the agency careening toward a reckoning at the US Supreme Court.
The tragic result of all this blinkered incompetence is that 99.99 percent of the applications for vaping products have been rejected and FDA is now actively enlisting the Department of Justice to execute its crackdown. That means thousands of businesses shuttered, investments and dreams down the drain, jobs lost, and worst of all it means countless Americans nationwide are being corralled back to smoking cigarettes because FDA has stripped away the vaping products they rely on to quit smoking.
And what do all these symptoms of bureaucratic dysfunction have in common? They speak to a larger ideological rigidity that seems to regard any solution to smoking cessation that arises outside of the agency’s own creation with total hostility. Here we have by far the single most effective method to quit cigarettes ever devised and as we speak, the FDA is paying Madison Avenue advertising firms to create campaigns that compare vaping to explicitly being possessed by demons.
Dr. Califf declares publicly that “dialogue with industry consortia” is essential – but we have never heard from him, except when he insults us in his speeches as “the twitterati who bring more heat than light.” Brian King said publicly just days ago that vaping is “markedly less risky than smoking” and that the public has been misinformed about that crucial fact. But Mr. King’s office legally forbids me saying the exact same thing in my vape shop and he’d no doubt send the DOJ after me if I did. His predecessor Mitch Zeller repeated at a conference just last week that vaping helps adults quit smoking, calling that “an inconvenient truth.” Yet these are the architects of this broken system that has systematically stripped away the fundamental right that Americans have to switch to vaping.
There are millions of ordinary Americans across every state, city, and town in this country that have finally been able to stop smoking with the help of nicotine vaping. I want to say that again – millions of our fellow Americans who are counting on us and on your recommendations that the FDA should start doing its job properly once and for all.
Simply handing the FDA more money is not going to solve these challenges – just the opposite, it will accelerate them and invigorate the black market that FDA has already unleashed. Instead what’s needed is a reliable regulatory process that is objective, transparent, empirical, and especially that can be realistically achieved by any good faith American that wants to take an upstanding part in the marketplace.
What we have now is an outright calamity, riddled with political interference and corrupt processes. It is costing lives and economic disaster and is succeeding only in worsening the number one health problem in this country, cigarette smoking, that we are all trying to solve.