FDA’s deeming regulations face many grounds for challenge

The proposed e-cigarette regulations of the U.S. Food and Drug Administration (FDA) could face legal challenges on at least five separate grounds if they are enacted without change, a new analysis from ECigIntelligence reveals.

An in-depth report just published by the ECigIntelligence legal team assesses challenges to the scientific foundation of the FDA’s rules as having the best chances of success in court, partly thanks to the agency’s own admission of its ignorance on many key questions.

The report also suggests that specific elements of the so-called “deeming regulations”, such as health warning labels and the cut-off date for the simpler “substantial equivalence” route to product approval, could be open to dispute.

It cites earlier major victories by the tobacco industry against the FDA as demonstrations that the agency can be taken on and defeated.

“FDA regulations are not impervious to challenge, and it is possible that parts of the regulations could be overturned – health warnings for e-cigs could be set aside, for example,” the report says.

“Indeed, courts could prevent the application of the regulations to e-cigs altogether – for example, if e-cig companies are successful with a claim that the regulations are not based on sound scientific evidence.”

At the very least, it adds, “the regulations or a significant part of them may well be put on hold while litigation is pending”.

What This Means: With the regulations themselves quite likely to be altered before coming into force, and the FDA recently having extended the comment period on them precisely in order to hear proposals for changes, it is far too early to say exactly what next legal steps e-cigarette companies might take. But for those who feel the deeming regs impose unacceptable burdens on the new industry, the battle is clearly far from over, as this report shows.

– Barnaby Page ECigIntelligence staff

Barnaby Page

Editorial director

Before joining ECigIntelligence in early 2014 as one of its first employees, Barnaby had a 30-year career as a reporter and editor for newspapers, magazines and online services, working in Canada, the US and the Middle East as well as his current British location. He has edited publications covering fields including technology and the advertising industry, and was launch editor of the first large daily online news service in the British regional media. Barnaby also writes on classical music and film for a number of publications. Barnaby manages the editorial and reporting teams and works closely with the analyst teams, to ensure that all content meets high standards of quality and relevance. He also writes for the site occasionally, mostly on science-related issues, and is a member of the Association of British Science Writers.