I've been researching most of the day today to find out what the connection with nicotine and the FDA is. I wasn't quite sure why the FDA has to control NRTs. Then I find out that nicotine addiction is considered a disease and I assume the reason the FDA is stepping in is that NRTs claiming to "cure" such a disease would be considered a drug. Thus forcing any company claiming to assist in quitting smoking to file a NDA (New Drug Application)
I also looked up the sections cited in the letter people were receiving from customs when their shipments were held.
This is what was written:
Please be aware that electronic cigarettes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action. In this regard, these products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body. The "electronic cigarettes" that we have reviewed are designed with a re-chargeable battery-operated heating element that volatilizes the chemical constituents contained within replaceable cartridges. These cartridges may or may not include nicotine. Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic cigarettes" is covered by an approved NDA. Thus, the marketing of them in the United States would be subject to enforcement action, which is why your products have been detained.
Furthermore, the "electronic cigarettes" that we have reviewed are not subject to the Federal Cigarette Labeling and Advertising Act (FCLAA), Pub. L. No. 89-92, (15 U.S.C. §§ 1331 et seq), nor are they subject to the Comprehensive Smokeless tobacco Health Education Act (CSTHEA), Pub. L. No. 98-474 (1986), (15 U.S.C. §§ 4401 et seq). Thus, they do not fit within the regulatory scheme that Congress has established for tobacco products.
Section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act reads:
g)(1) The Secretary shall in accordance with this subsection assign an agency center to regulate products that constitute a combination of a drug, device, or biological product. The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of—
(A) a drug (other than a biological product), the agency center charged with premarket review of drugs shall have primary jurisdiction,
(B) a device, the agency center charged with premarket review of devices shall have primary jurisdiction, or
(C) a biological product, the agency center charged with premarket review of biological products shall have primary jurisdiction.
FD&C Act Chapter V, Sections 501-510
Section 21 321(p) of the US Code reads:
(p) The term ``new drug'' means--
(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a ``new drug'' if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
WAIS Document Retrieval
I've also looked up the nicotine lollipop case and the FDA warning letters sent. Here's the links to that.
http://www.fda.gov/cder/warn/2002/nico2.pdf
CNN.com - FDA stops nicotine lollipop, lip balm sales - April 10, 2002
And this one is to NicoWorldwide.
http://www.fda.gov/OHRMS/DOCKETS/dailys/04/oct04/100504/04p-0281-c00001-vol1.pdf
They are currently selling nicotine water. Note the marketing techniques:
http://www.nicoworldwide.com/index.html
From what I can tell, harm reduction approaches are not very common. It's all about quitting smoking. It's been said before, but it definitely looks as if smoking is slowly being phased out. I have found a few that are supporting the harm reduction approach as they realize that not everyone wishes to quit (or can quit even if they want to).
Harm reduction - a tobacco-free approach
Nicotine and addiction. (tobaccoharmreduction.org)
Tobacco Harm Reduction- International Harm Reduction Association
Sorry for being redundant as I know some of this has been discussed elsewhere. I believe that Quit Smoking claims and wording are the #1 enemy in the case of the FDA. It really does appear to all be linked to marketing. Don't write a check you're ... can't catch!
I do wonder if only the few companies making these claims will be effected by this or if it will result in a ban for all of them.
Do any of you know if there are any regulations on nicotine? If there were ever a ban across the board I'd think it would be for this substance and not the devices.
I also looked up the sections cited in the letter people were receiving from customs when their shipments were held.
This is what was written:
Please be aware that electronic cigarettes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action. In this regard, these products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body. The "electronic cigarettes" that we have reviewed are designed with a re-chargeable battery-operated heating element that volatilizes the chemical constituents contained within replaceable cartridges. These cartridges may or may not include nicotine. Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic cigarettes" is covered by an approved NDA. Thus, the marketing of them in the United States would be subject to enforcement action, which is why your products have been detained.
Furthermore, the "electronic cigarettes" that we have reviewed are not subject to the Federal Cigarette Labeling and Advertising Act (FCLAA), Pub. L. No. 89-92, (15 U.S.C. §§ 1331 et seq), nor are they subject to the Comprehensive Smokeless tobacco Health Education Act (CSTHEA), Pub. L. No. 98-474 (1986), (15 U.S.C. §§ 4401 et seq). Thus, they do not fit within the regulatory scheme that Congress has established for tobacco products.
Section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act reads:
g)(1) The Secretary shall in accordance with this subsection assign an agency center to regulate products that constitute a combination of a drug, device, or biological product. The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of—
(A) a drug (other than a biological product), the agency center charged with premarket review of drugs shall have primary jurisdiction,
(B) a device, the agency center charged with premarket review of devices shall have primary jurisdiction, or
(C) a biological product, the agency center charged with premarket review of biological products shall have primary jurisdiction.
FD&C Act Chapter V, Sections 501-510
Section 21 321(p) of the US Code reads:
(p) The term ``new drug'' means--
(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a ``new drug'' if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
WAIS Document Retrieval
I've also looked up the nicotine lollipop case and the FDA warning letters sent. Here's the links to that.
http://www.fda.gov/cder/warn/2002/nico2.pdf
CNN.com - FDA stops nicotine lollipop, lip balm sales - April 10, 2002
And this one is to NicoWorldwide.
http://www.fda.gov/OHRMS/DOCKETS/dailys/04/oct04/100504/04p-0281-c00001-vol1.pdf
They are currently selling nicotine water. Note the marketing techniques:
http://www.nicoworldwide.com/index.html
From what I can tell, harm reduction approaches are not very common. It's all about quitting smoking. It's been said before, but it definitely looks as if smoking is slowly being phased out. I have found a few that are supporting the harm reduction approach as they realize that not everyone wishes to quit (or can quit even if they want to).
Harm reduction - a tobacco-free approach
Nicotine and addiction. (tobaccoharmreduction.org)
Tobacco Harm Reduction- International Harm Reduction Association
Sorry for being redundant as I know some of this has been discussed elsewhere. I believe that Quit Smoking claims and wording are the #1 enemy in the case of the FDA. It really does appear to all be linked to marketing. Don't write a check you're ... can't catch!
I do wonder if only the few companies making these claims will be effected by this or if it will result in a ban for all of them.
Do any of you know if there are any regulations on nicotine? If there were ever a ban across the board I'd think it would be for this substance and not the devices.
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