Synthetically Derived Nicotine: Holy Grail of Libertines?

Right Honorable Dudes and Dudettes of the Legal Eagles Society, … wuhzup with this abstruse verbiage ?

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(“Hands Off the Fruity E-Cigs”; National Review, September 13, 2019):

The law applies to “tobacco products,” including those derived from tobacco, and the nicotine in vaping liquids indeed generally comes from tobacco - so I do not dispute that the FDA does have this authority. Well, at least until the industry manages to make wider use of synthetic nicotine and prove, in court if necessary, that products made this way don’t fall under the FDA’s purview.

But the FDA shouldn’t have this authority. Congress should write laws, especially laws that ban entire product categories, not turn that power over to unelected busybodies who will opt for regulation over personal freedom every single time they encounter a choice between the two. The law is a mistake and should be changed, especially if the FDA is determined to abuse it in this way.

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(June 27, 2016):

The downside of synthetic nicotine is cost. SQN uses Next Generation Labs’ synthetic nicotine in three lines - NKTR, NKTR Sour, and Melt - and Uy says it costs 13 times as much as the readily available natural version.

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(December 15, 2016):

Next Generation Labs, the makers of proprietary TFN Nicotine ® - a non-tobacco derived synthetic nicotine liquid and crystals - is pleased to note statements made to the court by FDA in the Nicopure® vs. FDA lawsuit that confirms products not made or derived from tobacco are not regulated tobacco products under the recent Deeming Rule.

Vincent Schuman, CEO of Next Generation Labs, comments: “ The FDA’s statements to the Court seem to confirm our long-held position: TFN Nicotine ® products cannot be regulated under the Deeming Rule as they simply are not tobacco products. In order to comply with the FDA, the onus is on 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.

Source: https://www.globenewswire.com/news-release/2016/12/15/898116/0/en/Statements-From-FDA-in-NICOPURE-vs-FDA-Lawsuit-Confirm-Next-Generation-Labs-TFN-NICOTINE-Is-Not-A-Tobacco-Product.html

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(Foodstuff Dictatorial Agitators: January 9, 2017):

A. Definition of “Tobacco Product”

The Tobacco Control Act was enacted on June 22, 2009 (Pub. L. 111-31), amending the FD&C Act and providing FDA with the authority to regulate tobacco products. Section 101(a) of the Tobacco Control Act amends section 201 of the FD&C Act by adding paragraph (rr), which defines the term “tobacco product.” In general, a “tobacco product” is defined as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). Section 201(rr)(2) of the FD&C Act excludes from the definition of a tobacco product any article that is defined as a drug under section 201(g)(1), a device under section 201(h), or a combination product described in section 503(g) of the FD&C Act (21 U.S.C. 353(g)). Section 201(rr)(3) of the FD&C Act explains that any article that is a drug, device, or combination product shall be subject to chapter V of the FD&C Act (the authorities for drugs and devices) rather than chapter IX (the authorities for tobacco products).

B. Drug/Device/Combination Product Definitions

1. MEDICAL PRODUCT DEFINITIONS

As noted in section I.A, the definition of “tobacco product” excludes anything that is a “drug,” “device,” or “combination product” under the FD&C Act.

The FD&C Act defines “drug” (in relevant part) as an article intended either: (1) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease (referred to as the “disease prong” of the definition) or (2) to affect the structure or any function of the body (the “structure/function prong”) (section 201(g)(1) of the FD&C Act). The FD&C Act defines a “device” (in relevant part) as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, intended either: (1) For use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or (2) to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent on being metabolized for the achievement of its primary intended purposes (section 201(h) of the FD&C Act).

Source: https://www.federalregister.gov/documents/2017/01/09/2016-31950/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or

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(Next Generation Labs, January 29, 2017):

“The FDA is slowly revealing its stance on regulating synthetic nicotine and while this latest update is a welcome one, we fully anticipate further clarification from the FDA as the August PMTA deadline approaches. All indications from the FDA confirm our long-held position: TFN Nicotine products cannot be regulated under the Deeming Rule as they are not tobacco products, and we continue to believe that an open or closed system device for use with a choice of synthetic nicotine products will qualify as a non-tobacco product.”

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(FDA, March 30, 2018 - Web-page removed by the agency at a time not determined):

… it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.

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(August 26, 2019):

Next Generation Labs, the world’s first and sole producer of bulk R-S and S non-tobacco derived nicotine, is pleased to announce the doubling of annual production capacity to meet increasing demand from nicotine vape manufacturers and device cartridge fillers in the USA and internationally.

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NOTE: THIS IS NOT INTENDED AS AN ADVERTISEMENT
Content sourced from: https://www.nextgenerationlabs.com/

Next Generation Labs

For more information please contact us at:

info@nextgenerationlabs.com

For adult recreational use only. Must be legal age.

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Info regarding Nicopure Labs’ litigation challenging FDA “deeming” of their synthetically derived Nicotine:

NICOPURE LABS, LLC V. FOOD AND DRUG ADMINISTRATION, ET AL. / RIGHT TO BE SMOKE-FREE COALITION, ET AL. V. FOOD AND DRUG ADMINISTRATION, ET AL.

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For those with Flashplayer and/or (some) recent internet browsers:
Nicopure Labs v. FDA, et al - Oral Arguments (September 11, 2018)

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Just a little aside from the synthetic nic.
A few years back there was (and probably still is) Non tobacco nicotine derived from eggplant it was very expensive at about $400 per litre shortly after Hiliq came out with an NTN which was later shown to not be NTN but normal nicotine derived from tobacco and sold with a massive inflated price.

Just a tidbit and not really relevant but if NTN is still around I imagine they would also be an option for non tobacco derived Nic - if they are still around

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The only known industry challenge (based upon “synthetic, non-tobacco” origins), by Nicopure Labs, LLC, was completely abandoned by the plaintiff:

The Industry has not pursued on appeal its broadside challenge to the FDA’s decision to deem e-cigarettes “tobacco products” under the Act, including its challenges to relevant deadlines for e-cigarette compliance.

Source: Page 22 in the December 10, 2019 US Court document entitled:

"United States Court of Appeals
For the District of Columbia Circuit
Argued September 11, 2018
Decided December 10, 2019
No. 17-5196

NICOPURE LABS, LLC AND RIGHT TO BE SMOKE-FREE
COALITION, APPELLANTS AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION, ET AL.,
APPELLEES

v.

FOOD & DRUG ADMINISTRATION, ET AL.,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 1:16-cv-00878)

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(Feb 28, 2020): Congress legislated that FDA has jurisdiction over “synthetic” Nic:

H.R. 2339 bans advertising and sales to those under 21 years old, bans online sales of tobacco products, and bans tobacco flavors, including menthol.

… provisions in the bill include:

… Instructing FDA to regulate products containing synthetic nicotine or nicotine that is not made or derived from tobacco; …

Source:
https://www.acc.org/latest-in-cardiology/articles/2020/02/28/14/56/house-passes-reversing-the-youth-tobacco-epidemic-act-of-2019

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Ugh, eggplant. Looks like Nicotine fiends in Trumptown will soon need to either pony-up for Trump Crystal Clean Coffin Nails, or satisfy themselves binging on eggplant :eggplant::nauseated_face: Glad that I planned ahead for this day.

Interestingly, however, I see my staple tomatoes, bell peppers, and potatoes are all (similar to eggplant) Solanaceae (nightshades), and contain small amounts of groovy “organic” Nicotine. Now expecting for the Thought Police to break down my door with a no-knock warrant using snarling canines trained to sniff-out Nicotine in nanoGram quantities, bearing numerous sealed indictments from the Ministry of Moral Rectitude.

:grimacing:

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I’m no expert in US law, let alone in my own country, but isn’t the FDA the food and drug administration? Nicotine, whatever the source is, is listed as a drug, no?

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BTW - I do agree, however: “But the FDA shouldn’t have this authority”, is from the quoted article above. The phrase “Foodstuff Dictatorial Agitators” - as found in post above - is my own personal editorializing.

Yes to the former question. The Food and Drug Administration (FDA), under Health and Human Services Division (HHS) (which is also over the CDC) - all part of the Executive Branch of the US Government.

Nicotine (in large part due to so-called “Big Tobak” interests) has long evaded jurisdiction of the FDA (as a drug, except for if claimed as a medicinal treatment). The former FDA Administrator, David Kessler, lusted to accomplish just that for all of the years of his tenure. The 2009 “deeming” act is where Congress gave the FDA jusrisdiction over “Tobacco products” - and the litigation noted in this thread was an (obvious, but it appears for whatever reasons abandoned) attempt to limit the FDA to Nicotine derived from Tobacco plants (as language of the FDA regulation above rather clearly states specifically constitutes a “Tobacco product”). These rules/regulations are (with a semi-public process under the federal Administrative Procedures Act) written by the public agencies themselves - under the “statutory authority” of Congressional legislation enacted into law. Such rules/regulations can be and are often challenged in the US Federal Court System.

Nicotine never has been included in the Federal (or any of the individual US States’) “scheduled”/“controlled” substances - as is the case for virtually all other “psychotropic” (mood-altering) substances. This is due to Tobacco interests - just as the very harmful drug Ethanol has been spared from being “scheduled” by Liquor interests. In these cases, two of the most harmful substances have avoided “drug status”. Abject hypocrisy (if one desires for the government to supervise their existence) - or the right approach (if one desires for government to leave them alone, and to let them make informed decisions regarding their own bodies/minds) As we well understand, profiteering trolls thrive all along the way, extracting monies from consuming users.

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You left out caffeine and sugar.

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Have you tried this ??? Im not.opoosed to switching… I just went down to 1mgml and there is no difference to me …

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No, just read about the company and product. (I read) that they only sell it to wholesale customers. If it (still, these days) costs ~13x as much money to produce, we can imagine that the only claim that they (once could have) made was that they would win in their ongoing litigation against FDA, et al - and as a result, their fully synthetic Nicotine would (reasonably, after all, as the rule exists) evade the FDA’s own definition of a regulate-able “tobacco product”. Nicopure LLC’s 2018 court brief(s) filed specifically abandoned that important fight. Then Congress intervened.

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River Supply to the rescue

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LNW has had it for a month already. It was always out there if you looked for it. They are just finally ready to mainstream the product. Have read the FDA stated from the start they will still include it as a tobacco product.

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Have you ordered any to try?

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Woh! I didn’t notice the price :-1:

I totally got excited and jumped the gun. I thought this was a way around the FDA “tobacco” classification. Stupid me. The fact that vapor products were ever classified as “tobacco” products should have been my clue that they will do whatever the hell they want to do.

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No @Letitia, I had assumed it was going to slide by the regs, but apparently not. :frowning:

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Lot of info on ecf if you dig around on the deeming and Nicotine big threads.

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