A subsidiary of Altria, The US Smokeless Tobacco Company, has filed a lawsuit against the FDA over a recent ruling on one of their products
All eyes are on a new lawsuit filed by a branch of the Altria company over a recent FDA ruling on one of their products. The suit is currently in the Washington D.C. District Courts and will be ruled on over the next several months. It was filed by the US Smokeless Tobacco Company and claims that the FDA rejected a recent product application on false grounds. According to US Smokeless Tobacco (UST), their application was denied due to supposedly not meeting a Substantially Equivalent requirement. But they allege that this is unlawful since the only change made was who one of their suppliers is.
As part of the FDA deeming rules, any new tobacco products, which currently includes e-cigarettes, must apply for approval before being legally sold in the US. Though there are several different ways to secure this approval, such as Pre-Market Tobacco Applications, the approval method sought by Altria and UST falls under the umbrella of Substantial Equivalence, where the manufacturer must convince the FDA that a new version of their product uses materials that are essentially the same. But their application being denied has set up a showdown that could have a significant impact on the vaping industry moving forward.
The rejected application in question was over a Flavor Pack offered by UST called Copenhagen Bold Wintergreen. According to the lawyers representing UST and Altria, the FDA ruling denying their Substantial Equivalence application violates the Tobacco Control Act, which is a major foundation for the Deeming Rules at large. In fact, the deeming rules themselves say the only relevant changes that should constitute a “new” product, and therefore require a new full application, are “content, delivery, or form of nicotine, or any other additive or ingredient.”
The lawsuit claims that their Substantial Equivalence application shouldn’t have been rejected since they used the same ingredients, packaging, and format as previous, approved versions, and therefore should have been grandfathered in. But according to the FDA, the changing of tobacco leaf vendors is substantial enough to constitute an entirely new product. UST is arguing that because they haven’t modified any portion of their product, or ingredients, all they should need to do to satisfy their Substantial Equivalence requirement is prove the new vendors mint flavor tobacco leaves have the same essential characteristics of the previous vendor.
Impact On Vaping Industry
This lawsuit could have a significant effect on vaping moving forward. Not only will it set a precedent for challenging the FDA’s deeming rules over ingredient vendors, but it is a test of the limitations of the FDA’s power. Should they be able to decide that opting for a cheaper supplier constitutes needing a whole new application? If the answer is yes, then it could cripple the independent vaping industry, unable to cope with the increased cost of doing business. The result would likely be mass closures of small e-liquid manufacturers and vendors.
A secondary result of these closures would be the excellent opportunity offered Big Tobacco to move in and steal a large portion of the vaping market share. While Altria itself is a fairly large tobacco company, it doesn’t change the fact that if they lose their lawsuit it’ll be harmful to independent vaping. It’s already clear that Big Tobacco companies see the writing on the wall when it comes to traditional cigarettes. Philip Morris International has already gone on the record several times saying that they plan on stopping sales of all combustible cigarettes at some point in the relatively near future. With that being the case, we need to support independent vaping companies and not hand the vaping industry to the very businesses that vaping was invented to stop.
Vaping still suffers from an extremely poor public perception. One poll found that only 13% of adults believe vaping is safer than smoking, while 26% thought it is just as, if not more dangerous. That’s why it’s become so easy for vaping to be equated with smoking in policymaking. But the evidence is clear, vaping is much safer than smoking, and it can help smokers who have had trouble quitting, get off the habit for good. Therefore we must fight against regulations that negatively impact the independent vaping industry and give distinct advantages to the Big Tobacco companies who have already proven they value money over the wellbeing of their customers. Whatever the result of this latest lawsuit, it will surely play a role in the fight for vaping rights.
Do you think it’s fair to require a new application when the only difference was their tobacco vendor? Do you think lawsuits like this can have a significant impact on the direction of the vaping industry? How can we improve public perception of vaping to prevent it becoming a scapegoat? Let us know in the comments.