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FDA Sued By Public Health Groups

FDA Sued By Public Health Groups


FDA Sued By Public Health Groups

The Food and Drug Administration (FDA) is the target of a new lawsuit brought by seven public health groups and various pediatricians for delaying regulations concerning e-cigarettes and some combustible tobacco products like hookah tobacco and cigars, according to a report from CNBC. They're joined in the class action lawsuit by Campaign for Tobacco-Free Kids. This adds to a growing list of people and companies that are suing the FDA, many of which include vaping companies.

At the heart of all the commotion are the so-called “deeming rules” which impose regulations on vapor products mirroring those of tobacco products. Both sides - the vapor industry and anti-tobacco activists - have filed lawsuits against the FDA. On one side vapor advocates are viewing the regulations as unfair with regard to implementation date, while anti-tobacco groups view any potential steps that harm tobacco and/or vapor products as immediately pressing.

In this article, we'll start by going over what the deeming rule is, who it affects, and then we'll dive into the various lawsuits.   

What Is the Deeming Rule?

The deeming rule is a provision that adds vapor products to the Family Smoking Prevention and Tobacco Control Act, which was first passed in 2009. The provision allows the FDA to regulate and approve any vapor products brought to market after February 15, 2007.

There are some aspects of the rule that the vapor industry isn't arguing. For one, it’s made some common-sense regulatory decisions, such as prohibiting the sale of vape products to anyone under the age of 18 and requiring sensible health warnings to consumers.

Problems arise, however, with language that fails to recognize that vapor products, which could even include the glass used to make a clearomizer tank or the 18650 batteries that are also an essential component in laptop computers, power tools, and even hybrid cars, are not always "tobacco" products. Further, by retroactively stating in 2016 that all products introduced after 2007 (when virtually no vapor hardware or liquids existed at all) would need to undergo a costly review, the rules would effectively wipe the vapor industry off the map, handing it over to Big Tobacco backed brands that could afford to spend millions on product review.

Both Sides Are Suing

On the one hand, Campaign for Tobacco-Free Kids is suing the FDA for delaying the regulations put in place.The alleged reason for the lawsuit is that these regulations are immediately needed to keep underage kids safe amid public concern over a rise in vaporizer and hookah use amongst underaged high schoolers.

This is the second time the Campaign for Tobacco-Free Kids has sued the FDA, the first was in 2016 when it joined other organizations to try and force the agency to require graphic health warnings on cigarette packs and advertising, a fight that's still ongoing. Like the recent lawsuit, this lawsuit was over the delay of enacting the existing packaging laws and filed by eight public health and medical groups. As far as I can tell, this lawsuit is ongoing and tangled up in the courts.

On the other side, vapor companies including Halo E-Liquids and Nicopure Labs have filed their own lawsuit challenging the rule, arguing that vapor companies shouldn’t have to follow these regulations due to the fact that e-cigarettes don’t contain tobacco in them and are targeting independent businesses.

Lawsuits like the ones filed by the Campaign are unfortunate, but given the current stigmatization of vaping in America, not surprising.The vapor industry finds itself in a rather precarious position: while sensible regulation of e-cigarettes is welcomed, but it’s hard for the community to get behind something like the deeming rules that could ultimately cripple the industry and mischaracterize what vapor products are all about. Going forward, expect the battle to continue - we’ll be sure to keep you up to date as new developments present themselves. Happy Vaping!