FDA Commissioner Scott Gottlieb has announced on Twitter that the September 30 deadline for manufacturers to register each of their vapor products will be delayed. This may have resulted from pressure from members of Congress contacted by desperate constituents, although the FDA probably figured it out themselves. Gottlieb attributed the delay to “connectivity problems,” but many other problems have occurred. The new deadline has not been set and at the time of this writing there has been no official announcement.
Manufacturers have had problems with connectivity. But page after page of other problems can be found in the widely praised Facebook group created by Skip Murray to help small manufacturers navigate the FDA Unified Registration and Listing (FURL) process. These include complete system outages, frustration with ambiguous instructions, people being locked out of their accounts for minor errors in submissions, inexplicable warnings about errors in submissions, enormous delays after initial registration before being able to use the system, and data from other vendors appearing in people’s accounts.
The challenges of registration are illustrated by the experience of Jennifer and David Higginbotham, who run HiggyCigs, LLC, an e-liquid manufacturer located near Atlanta, Georgia. Despite being literally a mom-and-pop shop, the Higgenbothams faced an immensely greater registration burden than the major tobacco companies.
The Higginbothams were not among the small manufacturers who were unprepared and might not even be aware they need to register, of the type previously reported. They planned ahead, understood what they needed to do, and actively engaged with other vendors to navigate the process. But it was still a marathon that has brought them up against the deadline.
HiggyCigs produces bespoke made-to-order liquid, allowing the consumer to choose the flavor, nicotine concentration, and other options. The huge number of possible combinations means they had to register 898,277 different products. Even if the registration process worked smoothly, this would still mean creating almost a million lines of spreadsheet entries with details about each product. Ms. Higginbotham knows of another company with more than four times that many.
The process was far from smooth for the Higginbothams or many others. Most recently, after they uploaded the last of their data with only a few days to spare, the system told them there was an error in the content. Upon checking the spreadsheet in their account, Mr. Higginbotham discovered his submission had been replaced by a file from a different manufacturer, containing that company’s proprietary information.
Critics might argue that this week’s crunch is no different from people who finish preparing their personal income tax returns the night of April 15: They have had months to prepare and knew the deadline. But the situations are quite different. First, the IRS system is designed to accept the predictable deluge of online submissions just before the deadline. There are no registration delays and few errors that cause a tax return to be rejected. While it is unwise to make an error in your tax returns, you can correct it later. But an error in the FURLs submission means that the FDA could choose to shut down the company.
Second, the IRS does not change the rules between January and April. By contrast, the FDA has changed the rules numerous times and so, as Ms. Higginbotham observed, “starting the process before you absolutely had to seemed pointless.”
Initially the system deleted your data if you did not complete your submission within 14 days, a fate suffered twice by the Higginbothams. This was eventually changed. The submission spreadsheet FDA originally used allowed for only 800 entries, illustrating the FDA’s fundamental misunderstanding of this industry. This was later increased to 250,000, so the HiggyCigs product line required submitting four files rather than the 1,100 they would have needed had they filed sooner. Other changes, reflecting FDA’s belated understanding of the problems in what they were demanding, were also made.
It must be remembered that this huge burden is just a registration process. However, if FDA ever acquires the capacity to process this data, it presumably will be used for enforcement.
For example, FDA already bans introducing new products. So if HiggyCigs or another manufacturer had a customer with very particular tastes and, say, wanted to split the difference between two of the offered nicotine concentrations, the manufacturer is not allowed to meet that demand. The registration data could be used to detect any such violation, though this would require the FDA to acquire the capacity to know what is being sold.
More ominously, the registration database could be used to make a list of flavor descriptors for purposes of banning some of them and, perhaps, preventing manufacturers from selling the “new” product that would be the same flavor under a different name. Even if the FDA does not choose to make an issue of flavor descriptors, there is the possibility of third parties who are more anti-vaping than FDA acquiring that list through a massive data breach.
Manufacturers are legitimately concerned about the security of their proprietary registration information. Stable and established government and corporate databases are compromised every week. The demonstrated flaws in the FDA system suggest it may be particularly vulnerable. Indeed, with the cross-posting of some information to competitor’s accounts, there have already been data breaches.
It has long been clear that the FDA does not have the capacity to expand from the traditional tobacco products they regulate, which amount to a few thousand. There’s simply no way they can handle registering – let alone regulating – millions of vapor products. The Consumer Advocates for Smoke-free Alternatives Association noted this when commenting on the proposed deeming regulation in 2014. In 2015 comments about the deeming regulation presented to the Office of Information and Regulatory Affairs (the internal government watchdog), CASAA warned that, “FDA does not even have the capacity to handle the resulting registration paperwork.” This has proven to be the case.
CASAA concluded that it must be the FDA’s intention to not even try to regulate e-cigarettes. Rather, they would simply let the looming stealth ban (the requirement that products go through an extremely expensive and uncertain new product approval process) eliminate all but a handful of mass-produced products. This would shrink the market to a size the FDA could handle. But with the delay of the stealth ban, from 2018 to 2022 (and thus, perhaps, forever) the FDA is faced with actually regulating vapor products. It is not working out well for them so far.