FDA Facing More Lawsuits Over The Controversial Deeming Rule


Group of vape businesses represented by the Pacific Legal Foundation filed suit aiming to block deeming rules permanently

Anyone who is familiar with the vaping community is aware of the FDA’s dreaded deeming rules originally made in 2016. This policy essentially equates vaping with smoking, giving the FDA broad powers to regulate and approve products before they can be legally sold. Members of the vaping community, both users, and business owners believe that since vaping is much safer and used as a smoking cessation tool, it doesn’t make sense to treat them the same. These critics also argue that by treating vaping as merely an alternative form of tobacco consumption, the FDA is reinforcing the abysmal public understanding of the relative risks of vaping compared with smoking.

Fast forward to now, and in spite of the decision to delay their implementation until 2022, many in the vaping business are still fighting to make sure these rules never see the light of day at all. That is precisely why vape shops from five states have come together and hired the Pacific Legal Foundation to file lawsuits over the constitutionality of the ruling. While this specific instance may ultimately prove to be minor, it’s certainly indicative of the more significant issue facing vaping rights. That is the inclination for the FDA and similar agencies to treat vaping and smoking as essentially the same.

Another Legal Battle

This round of legal action claims that the proposed deeming rule is unconstitutional because it violates the first amendment by attempting to restrict a non-tobacco derived product under the Tobacco Control Act. If the rule were allowed to take full effect, it would require the FDA approves products before they can be advertised as being less dangerous than combustible cigarettes. Filed in Minnesota, Texas, and the District of Columbia, the lawsuits filed take particular issue with precisely who issued the original ruling. They claim the rule was made legitimate without complying with the proper chain of command. They allege that because Leslie Kux, who has worked for the FDA since 1988, was the person who first issued the decision, it shouldn’t be enforceable.

Another part of their case is claiming the deeming rules are unconstitutional because they require the vaping companies to prove their devices aren’t as harmful as cigarettes, as opposed to the FDA having to prove that vaping is just as dangerous as smoking. Given that vaping and smoking are factually different forms of drug intake, it would seem that they may have a case here. If they can prove that it’s unjust to assume vaping and smoking are analogous merely because they’re similar looking, then it would make a strong case that the mountains of evidence condemning smoking shouldn’t be the default for vaping. Regardless of this outcome, most of the peer-reviewed studies on vaping have already concluded that vaping is dramatically safer than smoking.

Evidence Of Harm Reduction Value

While the question is far from answered, the vast majority of peer-reviewed studies looking into differences between vaping and smoking have concluded that even though they’re not 100% harmless, e-cigarettes present drastically less harm to everyday users than cigarettes do. A now famous 2015 study conducted by Public Health England found that vaping is at least 95% than smoking. But it hasn’t stopped there, just last October research published in the Journal of Aerosol Sciences concluded that the excess lifetime cancer risk of vaping is around 57,000 times lower than with traditional smoking.

Improving the case for vaping further is the evidence that shows e-cigarettes may be the best tool we have for getting people off of cigarettes for good. Vapers have noted this effect for years, and now scientific evidence is supporting those claims. Last November a study conducted by researchers at the University of Louisville showed that vaping was the most successful method tested for helping smokers off cigarettes. Their test group even included prescription smoking cessation drugs, but nothing could match the success rate of vaporizers. But this development wasn’t even breaking news, as earlier in the year a joint study conducted by Columbia and Rutgers Universities reached the same conclusions, noting that over half of daily vapers eventually quit smoking for good. All of this evidence points to the fact that vaping is an extremely valuable tool in the fight against tobacco.


This is not the first time that the FDA has faced legal action over the deeming rules. Back in July of last year, the US District Court for D.C. ruled that the FDA had the right to place vaping under the regulations of tobacco. So it’s unlikely that anything will come from these particular lawsuits, but they do signal a growing unified front against the unfair discrimination of vaping in America. The delay of the deeming rules already gave us more time to convince the public that vaping is worth utilizing to help smokers off cigarettes, but unless more reputable doctors and agencies get on board, it will all be for nothing.

The first step is to keep getting the word out about how vaping is the best choice for smokers looking to quit. If you can start a dialogue with the cigarette smokers in your life, then maybe they will pay it forward, and even more people will understand how much safer vaping is than smoking. Unfortunately, poll numbers indicate that only a tiny percentage of the general population understands how much safer vaping is than smoking. Action on Smoking and Health found only 13% of respondents believed vaping was much safer than smoking, while over 25% said they thought vaping was just as, if not more dangerous. These rates simply have to improve if anything is ever going to significantly change for the better.

What do you think about the FDA’s deeming rules? Do you think these lawsuits have a chance to be successful? How can we improve the public understanding of vaping? Let us know what you think in the comments.

Dustin has been vaping for almost a decade. He found e-cigarettes in 2008 and quickly became drawn to them as an early adopter. He's been writing reviews ever since and has established himself as a well-versed authority on the subject.

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2 Responses

  1. Jeremy Salter says:

    Hopefully by 2022 we won’t need lawsuits like this to protect the vaping industry. By that time we should have mountains of additional evidence to support vaping and prove that it’s significantly less harmful than smoking and poses very little risk to users or bystanders. England is ahead of the game in this regard, and hopefully as more long-term evidence surfaces, US officials will eventually see it the same way. We have almost 5 more years to go… guess we’ll see!

  2. roger pihl says:

    I think that’s great that us vape shops are fighting back because the FDA is completely worthless.

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