For the better part of a decade, the Food and Drug Administration (FDA) has been on the warpath against the most effective quit-smoking tool in history—nicotine vaping. The agency granted itself the authority to regulate nicotine vapor products in 2016, then proceeded to arbitrarily ban millions of the most popular devices and liquids, leaving only 34 options on the market, all sold by major tobacco companies.
FDA justifies this shameless behavior by claiming that these vaping products pose a threat to youth, even though its own survey data shows that underage use of all nicotine and tobacco products is at record lows.
In a bid to check the FDA’s abuse of power, 30 vapor manufacturers have sued the agency on various occasions and one of those cases, originally brought by Triton Distribution, has finally made its way to the US Supreme Court. My organization, the American Vapor Manufacturers (AVM), filed an Amicus brief in the case urging the Court to affirm an earlier ruling that FDA acted “arbitrarily and capriciously” in prohibiting Triton from marketing its vapor products.
The case is poised to upend the FDA’s iron-fisted regulation and expand adult access to vapor products that could save millions of lives. Let’s take a brief look at the arguments the Court will consider.
Changing the Rules Mid-Game
Triton’s argument in the case, which our brief builds on, is simple: the FDA changed its position on the authorization requirements for flavored vaping products after manufacturers had submitted their applications. Initially the agency said that applicants would not have to submit expensive, time consuming studies to have their products authorized. The FDA then refused to authorize millions of products precisely because the manufacturers did not submit those studies with their applications.
‘Fatal Flaw’
That sort of chicanery is unacceptable on its own, but FDA’s excuse for this about-face was even more absurd. The agency implemented this abrupt change in the authorization process because it received 26 million product applications after anticipating that it would receive less than 6,800. To avoid reviewing those millions of products, FDA instituted a “fatal flaw” review approach. As we noted in our brief:
“Importantly, the stated goal of the fatal flaw memo placed expediency over substance by allowing FDA to … quickly deny marketing authorization for as many non-tobacco flavored [vaping products] as possible.”
In short, the FDA rigged its authorization process to lighten its workload, what Triton called “quintessential arbitrary agency action.” The Fifth Circuit Court, which previously ruled in Triton’s favor, was less polite—labeling FDA’s policy change a “regulatory switcheroo.”
Not only was the FDA’s behavior unethical, it was blatantly illegal. The agency is required by law to thoroughly review each product application, as we explained in our brief. A separate statute mandates that federal agencies notify the public of a proposed rule and allow Americans to comment before the proposal takes effect. FDA did neither, apparently expecting us to ignore its Machiavellian scheming.
The agency must be held accountable for so flagrantly disregarding the rule of law and public health. We intend to do just that. As we told the FDA after filing our brief, “See you in court.”
