FDA Relaxes On Vape Regulations… For Now

vape regulations postponed by FDA

A rule originally set to become effective beginning May 10, and enacted during the Obama administration, will now be postponed… at least temporarily. Attorneys for the Justice Department have asked for time extensions for the viewing of two cases at a civil level. This will give Health And Human Services appointees more time to take a closer look at the rule in question and the cases’ issues and relax vape regulations.

What Is This ‘Rule’?

The FDA under the 2009 Tobacco Control Act, was given jurisdiction over loose tobacco and cigarettes. Certain language contained within The Act could be construed as giving the FDA jurisdiction in a similar manner over vaping products and e-cigarettes. The clause (quote) “any other tobacco products that the Secretary by regulation deems to be subject to this chapter” is the language in question.

Also required by the rule would be that manufacturers having brought e-cigarettes to market post-2007’s February 15 cut-off date would need to do research on a health-based, psychological, and behavioral level. They would need to determine the impact of not only their product but the impact of product combinations as well.

What Was the Reaction to This Rule?

The rule’s possible implementation spurred tobacco trade associations and e-cigarette companies to file law suits against the federal government. Their complaint –  the misapplication of the rule. They did not agree that antiquated regulations could be applied to a category that was nonexistent when the regulations were originally passed. They were, however, in support of framework that was regulatory and based on a risk level of sorts. They do believe in responsible product innovation that offers fewer risks than those of cigarettes.

The new White House administration, with its pro-business focus, is not nearly as enthused about the rule. There is every possibility that, because from a business standpoint the rule is a ‘bad’ move, the regulation will be curbed. On the other hand, it is not expected that e-cigarettes will simply go completely and totally unregulated and the manufacturers of them allowed to do as they please.

So What’s in the Future?

For lack of a crystal ball, the future is uncertain at best. And while the implementation of the all-powerful rule has been temporarily postponed, in no way, shape, or form has it been totally overridden or nullified. Equally unclear is the outcome of the two civil lawsuits that are currently pending. Part of the uncertainty of the civil cases may have to do with the involvement of certain individuals who have previously served on or worked with boards of tobacco or e-cigarette companies.

If one sets aside the complications provided by a conflict of interests, efforts at a congressional level to include exemptions for vaping products and such into bills for funding has failed, thus far. Just recently, a bill was introduced that would alter e-cigarettes’ classification. And though they would still be regulated by the jurisdiction of the FDA, they would no longer be classified as a tobacco product, but something else entirely. What exactly… remains to be seen.