Synthetic nicotine or nicotine extracted from "other than tobacco" sources just isn't cost effective.
Not even close.
Not even close.
FDA Big news coming out of FDA
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Ding! Ding! Ding!
There's a plant that wants to make it with just sunlight, water and good soil, after all.
I'm not saying it would be cost effective. I'm just saying that if they banned extracted nicotine, synthetic nicotine could fill the void but with a great deal of risk.
I'm not allowed to talk about it here, but another black market industry had their product synthesized. It's much more dangerous now, but it gave them a legal workaround. It's considerably more dangerous then the original product which was illegal to begin with.
Regulations frequently become a cat and mouse game. But, releasing new, untested products can be very dangerous.
The definition of a tobacco product can be anything that the FDA thinks can be defended in court. IMO what they're doing is pretty similar to how drug paraphernalia is treated. It sucks, but it is what it is.
OTOH batteries, resistance wire, PG, tomatoes, etc, will never be controlled.
An outright 'ban' of anything vape-related is not in the best interests of the various governments, or their agencies. Regulatory control is what they seek, and the financial gains that will follow.
They feel left out, and they're doing what they do best to try and get in the game.
They feel left out, and they're doing what they do best to try and get in the game.
A family member of mine used the synthetic "other stuff" about 3-4 years ago. That stuff is dangerous! We had two ER visits because of it. My family member is fine now after going through outpatient treatment and growing up some. I have no doubt that the real 'other stuff" isn't near as dangerous as the fake "other stuff"
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I have a feeling that would only take a small change to the language, or addition of a bit of new language to the regulations to overcome
- Apr 2, 2009
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The FDA proposed banning even more truthful claims about e-cigs, and is further challenging Judge Leon’s 2010 ruling that an e-cig is a “tobacco product” unless the manufacturer makes a “therapeutic claim”: agency proposes redefining and regulating/banning any “tobacco product” as a “drug, device or combination product” if the agency believes it is “intended for use in the . . . prevention of disease” or “intended to affect the structure or any function of the body in any way that is different from effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.”
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-24313.pdf
Note that FDA’s proposal above follows warning letters FDA sent on 9/8/2010 to five e-cig companies and a trade group alleging that dozens of truthful marketing claims made by those companies (urging smokers to use their e-cig product) violated the FDCA despite Judge Leon’s ruling (since smoking isn’t a disease, and since just one of the dozens of marketing claims cited by FDA could be considered a “therapeutic claim”)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225224.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225206.htm (Johnson Creek)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225177.htm (Gamucci)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225178.htm (E-CigaretteDirect)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm225181.htm (Ruyan America)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm225187.htm (E-Cig Technology Inc)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM225263.pdf (Electronic Cigarette Association)
https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 (Judge Leon’s 1/14/2010 ruling striking down FDA’s e-cig ban as unlawful, and stating that FDA could only regulate e-cigs as drugs or devices if a manufacturer made a “therapeutic claim”).
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-24313.pdf
Note that FDA’s proposal above follows warning letters FDA sent on 9/8/2010 to five e-cig companies and a trade group alleging that dozens of truthful marketing claims made by those companies (urging smokers to use their e-cig product) violated the FDCA despite Judge Leon’s ruling (since smoking isn’t a disease, and since just one of the dozens of marketing claims cited by FDA could be considered a “therapeutic claim”)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225224.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225206.htm (Johnson Creek)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225177.htm (Gamucci)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225178.htm (E-CigaretteDirect)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm225181.htm (Ruyan America)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm225187.htm (E-Cig Technology Inc)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM225263.pdf (Electronic Cigarette Association)
https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 (Judge Leon’s 1/14/2010 ruling striking down FDA’s e-cig ban as unlawful, and stating that FDA could only regulate e-cigs as drugs or devices if a manufacturer made a “therapeutic claim”).
I have a feeling that would only take a small change to the language, or addition of a bit of new language to the regulations to overcome
Yes. But you also have a lot of options in the syntheses process. A slight tweak to a formula can get by regulations. It truly becomes a dangerous cat and mouse game quickly.
For better or worse, the government works more slowly then a motivated, unscrupulous entrepreneurial chemist.
So after being told by Judge Leon that a "tobacco" product is only a drug if MARKETED that way...
The FDA has decided to not only ignore that ruling, but to extend it to if they BELIEVE it is intended for such use?
Or am I losing my mind?
Here is an exert from the FDA Clarification...
"2. How Intended Use Is Determined
In determining a product’s intended use, the Agency may look to “any . . . relevant
source,” including but not limited to the product’s labeling, promotional claims, and advertising
(see, e.g., Action on Smoking and Health v. Harris, 655 F.2d 236, 239 (D.C. Cir. 1980); United
States v. Storage Spaces Designated Nos. “8” and “49,” 777 F.2d 1363, 1366 (9th Cir. 1985),
Hanson v. United States, 417 F. Supp. 30, 35 (D. Minn.), aff’d, 540 F.2d 947 (8th Cir. 1976)).
For example, FDA may take into account any claim or statement made by or on behalf of a
manufacturer that explicitly or implicitly promotes a product for a particular use (see, e.g.,
§ 201.128 (drugs), § 801.4 (devices)).
To establish a product’s intended use, FDA is not bound by the manufacturer or
distributor’s subjective claims of intent, but rather can consider objective evidence, which may
include a variety of direct and circumstantial evidence. Thus, FDA may also take into account
any circumstances surrounding the distribution of the product or the context in which it is sold
(see id.; see also U.S. v. Travia, 180 F.Supp.2d 115, 119 (D.D.C. 2001)). In the context of
medical products, generally, circumstantial evidence often ensures that FDA is able to hold
accountable firms that attempt to evade FDA medical product regulation by avoiding making
express claims about their products. As FDA has previously stated, however, the Agency would
not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm’s knowledge that such product was being prescribed or used by
doctors for such use (Ref. 5).
Thus, when a product made or derived from tobacco is marketed or distributed for an
intended use that falls within the drug/device definitions, it would be regulated as a medical
product, subject to the limitations discussed further in this document. Courts have recognized
that products made or derived from tobacco marketed with “disease” claims and certain
“structure/function” claims are drugs (see United States v. 46 Cartons . . . Containing Fairfax
Cigarettes, 113 F.Supp. 336, 337, 338 (D. N.J. 1953) (cigarettes marketed for the prevention of
respiratory diseases); United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes, 178
F.Supp. 847, 851 (D. N.J. 1959) (cigarettes marketed for weight reduction))."
https://s3.amazonaws.com/public-ins...ivery&utm_medium=email&utm_source=govdelivery
Marketing determines the perception and, thus, the definition.
well if they are stupid enough to throw Vaping under the banner of "medical"... then I will just have to use my H.S.A. plain to buy all sorts of goodies... 8) After all... "it's a medical expense...right???"
The horrors. Nurtricigs can no longer sell weight loss e-liquid...
I don't care how they are labeled as long as they're available and not taxed insanely. We have a problem in the country, "bartering with god". I see many people saying "keep them legal I'll pay the tax", but they shouldn't be taxed. The cigarette and booze taxes are wrong, and taxes on ecigs are even more wrong. We already pay sales tax. It gives capitalism a bad name. We have a free market, but we don't. My governor wants to ban them completely.. I think the fear is that if they can find a way to make money from them, like cigarettes, they will keep them around. But that's totally backwards logic. It shouldn't be up to them if ecigs are available or not.
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