Update: Nicopure v. FDA Lawsuit

The Week the Vaping Space Stood Still

From the announcement of the FDA Deeming Regulations on May 5th 2016 the U.S. vaping community was stunned by the illogical and severe restrictions placed on the vape industry. These harsh regulations installed by the FDA have been referred to as a federal overreach as well as a Prohibition fueled by an authoritarian government intrusion. Not to mention, the United States Food and Drug Administration has been accused of applying an unconstitutional decision making process. To add insult to injury, 5 days later on May 10th, these harsh regulations were published with the Office of the Federal Register, which provides access to the official text of federal regulatory material, Federal laws, Presidential Documents, etc.

The FDA Attorneys Go On Record

In the US District Court for the District of Columbia case, with Nicopure Labs as the plaintiff and the FDA as the defendants, there may have been one of the most groundbreaking scenarios to officially take place, which may very well be providing some hope and relief for much of the vape community, especially the eLiquid sector of the vapor product industry. Recently released court documents in the Nicopure v. FDA court case include statements submitted by the FDA legal team, responding to simple questions with layered and slightly vague answers.

Coincidentally, vague communication has become something the FDA is turning into a tradition. However, most of what the FDA recently stated seemed to suggest they have no intention on regulating nicotine-free liquids (NFLs) as tobacco products.

According to official court documents in the Civil Action Case No. 16 – 878 (ABJ). In the defendant’s’ supplemental brief on Ripeness, the FDA submitted a response to the question: “What is it exactly that a manufacturer of a nicotine-free liquid is required to do to comply with the rule?”

The Exact Statements made by the FDA in the Nicopure vs. FDA Case

The FDA legal team responded in a very uncharacteristic fashion when compared to the precise strictness they’ve been known for. The first two words in their response to that question was literally, “Perhaps nothing.” Those two words were most likely unexpected and strange to hear coming from attorneys who represent the FDA. However, following their initial 2 words opening response, the FDA legal team states “Not all nicotine-free liquids are subject to the deeming of rule” (11-1-16). This is not all they had to say of course.

In the Nicopure v. FDA Case, the statements made to the Court by the FDA attorneys continued on, as follows, “Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a ‘component or part’ —that is, if it is ‘intended or reasonably expected’ either…(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory.”

To read everything stated in the Official Court Documents, those statements can be found here (PDF).

Next Generation Labs’ Interpretation of FDA Responses

It’s worth noting that the concept of NFLs not being subjected to tobacco product regulations was not actually a ruling or court decision, this is merely a reactionary interpretation to the FDA’s responses – it’s commendable for Next Generation Labs to be taking the initiative by basically clarifying the blurry vision portrayed in the statements submitted to the courts by the FDA’s legal team in the Nicopure vs. FDA lawsuit.

A representative of Next Generation Labs clarifies what exactly these statements submitted by the FDA lawyers actually mean for their TFN synthetic nicotine product. Next Generation Labs explains, “We believe the wording, reasoning and logic used by the FDA in this statement confirms Next Generation Labs’ position that synthetic nicotine is not a tobacco product and therefore should not be regulated under the deeming rule.”

Additional Comments from Next Generation Labs

All things considered, there are some extremely relevant comments worth highlighting which were Next Generation Lab’s responses to questions submitted on behalf of Vaping Post. Furthermore, Vincent Schuman, CEO of Next Generation Labs, comments: “It’s no secret that many feel the FDA’s Deeming Rule is an onerous and costly regulation that has and will continue to have a detrimental impact on the vape market. However, this statement from the FDA provides hope that synthetic nicotine could provide more opportunities for e-liquid manufacturers to develop new products that won’t be subject to the Deeming Rule, which is only positive for the industry and adult vape consumers.”

Not to mention, continuing to reply to the submitted questions, CEO Vincent Schuman says, “This statement from the FDA is certainly significant for the industry and it’s clear from the chatter online and among industry professionals that it’s a welcomed relief. And while the news offers hope, it’s important to understand what it means for synthetic nicotine – ultimately the responsibility will lie with e-liquid manufacturers to consider how their TFN Nicotine® product is marketed, distributed and positioned to adult consumers to ensure a complete disassociation from tobacco and tobacco devices.”

The FDA’s Unclear Statements Seem to Raise More Questions

If the FDA claims that it will not be regulating “all” nicotine-free liquids as tobacco products, then does that mean 0mg eLiquids will also have the freedom to avoid being regulated as a tobacco product? It would only make since due to the fact that 0mg eLiquids are in fact an NFL. If the FDA legal team truly plans not to regulate NFLs as tobacco products, as their statements to the court have been interpreted, then this is certainly fantastic news and a victory for not only Next Generation Labs and their TFN product, but the vaping industry as a whole.

Nevertheless, according to Next Generation Labs, it seems the FDA could be allowing synthetic nicotine providers to be unregulated products, or at least as the FDA stated “Not all nicotine-free liquids are subject to the deeming of rule.” Which is characteristic of the FDA to communicate so vaguely. So, when they state, “not all” – do they mean probably not TFN or not any synthetic brands of nicotine? Or do they also mean even the 0mg eliquids would not be regulated as tobacco products as well?

Of course, none of this is directly specified. The attorneys for the FDA do in fact state, “if it is ‘intended or reasonably expected’ either…(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory.” This explanation does nt necessarily explain too much regarding precise details, so this causes many to simply assume many are in the clear.

The FDA Attorneys Seem Confused about their Own Agenda

With an increasing amount of questions being raised after the FDA was simply attempting to provide answers to one simple question which they were asked, only further proves how much the FDA loves to dance around and choose to apply unclear descriptions to their unorganized regulation intentions. Painting a fuzzy picture of the future “vape-state” they plan to create only reveals their immense lack of understanding when it comes to the versatility and innovative nature involved with the industry of vapor products.

The FDA may not fully comprehend what it is exactly they’ve become involved with by challenging the vape industry – especially with prohibition-like regulatory overreaching authoritarian practices on a community of vastly independent, rebellious, ambitious, dedicated, passionate and freedom cherishing vapor enthusiasts and advocates.

TFN manufacturer, Next Generation Labs, views these statements as the very beginning to a  promising future business model, especially now that Next Generation Labs sees Big Pharma possibly showing an interest in synthetic nicotine. To quote the introductory article on this topic just recently published by Vaping Post, “Next Generation Labs has also trademarked their synthetic nicotine as a pharmaceutical product as Big Pharma are interested in nicotine, but also in its analogues for the treatment of brain disorders like Parkinson’s, Alzheimer’s, Attention-Deficit Hyperactivity Disorder (ADHD) and Epilepsy.”

FDA finally clarifies about NFLs and Synthetic Nicotine?

Big Pharma Could Once Again Influence the Outcome

After all, Big Pharma has been known to be right in the center of leading the charge against vapor products that use nicotine derived from tobacco, which only legitimizes that perhaps nicotine is not nearly as harmful as many have claimed in the past. Whether derived from tobacco or synthetic, is it still just nicotine regardless? Next Generation Labs holds a firm stance that TFN is devoid from many of the impurities found in nicotine derived from tobacco. Perhaps, this may explain why, in hindsight, Big Pharma could certainly apply the TFN “clean-nicotine” to many of the (NRT) Nicotine Replacement Therapy products they’ve invested billions into.

Therefore, should TFN synthetic nicotine ultimately not be subject to be regulated as a tobacco product, then this scenario would not only be a victory for Next Generation Labs and the vape community as a whole, but also the primary instigator of the deeming regulations – our beloved Big Pharma industry. Seem ideal? Probably not. Seem ironic? Absolutely. Seem acceptable? Sure. At this juncture, the vape industry just needs some form of victory no matter what the cost.

The True Victors Would Still Unequivocally be Next Gen. Labs

Overall, in the near future, Next Generation Labs could be the leading provider for synthetic nicotine in the eliquid sector of the vape industry as they already provide their ensured quality product for 40 eLiquids. With a huge government transition raging through the federal level of the United States, a government team who claims to be in favor of massive deregulation, the vapor industry could very well see some positive changes headed in it’s direction – quite possibly in the form of abolishing the regulations. Then again, when has a U.S. Presidential Administration ever lied, gone back on their word or disappointed the American public?

In all actuality, if TFN is registered as a pharmaceutical product, then how can it be regulated as a tobacco product? However, 18650 lithium ion batteries, sub-ohm coils and any other vaping accessory is basically now regulated as such so who knows what will transpire in the very near future. Questions remain unanswered in full and continue to multiply. What a country! Home of the slave and land of the scheme!

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