Right Honorable Dudes and Dudettes of the Legal Eagles Society, … wuhzup with this abstruse verbiage ?
(“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.
(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.
(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. ”
(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).
(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.”
(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.
(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.