Am I delusional or does anyone else share my point of view on this new regulation set forth by the FDA under the FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT. If you’re anything like me you’re probably, thoroughly ...... off, at the new regulations set forth by the FDA and the long term ramifications which may, quite possibly, cause ex-smokers to go back to smoking and on top of that stifle creativity across the nation as the small e-juice artists can no longer afford to market their applied creativity. Sure there are upsides to a regulation, but this goes way too far…
Now in my ...... off rage I decided to do a little research, as labeling e-juice a “Tobacco Product” is not only wrong it’s downright insane. So I did a little digging to ascertain just what gives the FDA the right to regulate and control nearly every aspect of the “vaping” industry and I came up with a few interesting facts that seem – at least to me – to raise more question than they answer.
In case you didn’t know by now the FDA was appointed “in charge” per say of Tobacco Products under the FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT of 2007, also known as FSPTCA which gives them the right to regulate and control any Tobacco Related Products that meet the qualifications of this document. So I decided to look into what exactly qualifies a Tobacco Product, a “Tobacco Product”, and came across an interesting statement under (SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT., DEFINITION OF TOBACCO PRODUCTS, (a) subsection 2)) which I’ll share below;
(2) The term ‘tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g).
Now, and to the best of my knowledge as the FDA has yet to get back to me as to why they’re classifying e-juice as a “Tobacco Product”, I’m assuming that the reason why e-juice is classified as a “Tobacco Product” is because it contains nicotine which is found naturally in Tobacco amongst many other things including but not limited to potatoes and eggplants. However if this is the reason why they’re classifying e-juice a “Tobacco Product” that would raise questions, as according to the sentence above, merely because an article that is a drug under (and we’ll swing back around to this) subsection (g)(1) doesn’t make it a ‘tobacco product’… This doesn’t make sense to me, because the FDA is classifying e-juice a “Tobacco Product” which it clearly isn’t “Tobacco” which means that they must be basing this off of one of its ingredients and until I’m proved wrong I’m sticking with nicotine.
Now moving on to the aforementioned subsection (g)(1), which the document we’ve been referring to actually states that they’re only amending this to the end of Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). Back on track here, if we visit this document and search for (g)(1) we’ll find the following;
(g)(1) The term ‘‘drug’’ means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.
There we’ve it, and I quote, “articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them”, in short if the Official United States Pharmacopoeia or any of the other aforementioned branches or encyclopedias, medical encyclopedias if you’ll (forgive me as this is starting to get a little convoluted), consider something to be a drug then it must be ruled as an exemption and can’t be considered the basis behind classifying a product as a “Tobacco Product”. Now as I don’t want to spend upwards of $50.00 on the latest and greatest copy of the United States Pharmacopoeia, I managed to do a little digging and come up with a copy from 2009 (I’m sure nicotine hasn’t changed much in terms of its classification since then) and from what I can tell nicotine is listed in the book labeled supplements and if I’ve learned anything throughout high school, nicotine is a drug…
So to wrap this up, is it just me or did the FDA overstep their authority with their new regulations that they’re implementing under the FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT? Do they have the right to do this given the exemptions listed under the subsections of SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT., DEFINITION OF TOBACCO PRODUCTS? Or am I just delusional, ...... off and seeing and believing what I want to see and or believe even though it may not be there?
What's your input?
Thanks
EDIT:
Well I can't post my sources, PM me if you want them.
Now in my ...... off rage I decided to do a little research, as labeling e-juice a “Tobacco Product” is not only wrong it’s downright insane. So I did a little digging to ascertain just what gives the FDA the right to regulate and control nearly every aspect of the “vaping” industry and I came up with a few interesting facts that seem – at least to me – to raise more question than they answer.
In case you didn’t know by now the FDA was appointed “in charge” per say of Tobacco Products under the FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT of 2007, also known as FSPTCA which gives them the right to regulate and control any Tobacco Related Products that meet the qualifications of this document. So I decided to look into what exactly qualifies a Tobacco Product, a “Tobacco Product”, and came across an interesting statement under (SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT., DEFINITION OF TOBACCO PRODUCTS, (a) subsection 2)) which I’ll share below;
(2) The term ‘tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g).
Now, and to the best of my knowledge as the FDA has yet to get back to me as to why they’re classifying e-juice as a “Tobacco Product”, I’m assuming that the reason why e-juice is classified as a “Tobacco Product” is because it contains nicotine which is found naturally in Tobacco amongst many other things including but not limited to potatoes and eggplants. However if this is the reason why they’re classifying e-juice a “Tobacco Product” that would raise questions, as according to the sentence above, merely because an article that is a drug under (and we’ll swing back around to this) subsection (g)(1) doesn’t make it a ‘tobacco product’… This doesn’t make sense to me, because the FDA is classifying e-juice a “Tobacco Product” which it clearly isn’t “Tobacco” which means that they must be basing this off of one of its ingredients and until I’m proved wrong I’m sticking with nicotine.
Now moving on to the aforementioned subsection (g)(1), which the document we’ve been referring to actually states that they’re only amending this to the end of Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). Back on track here, if we visit this document and search for (g)(1) we’ll find the following;
(g)(1) The term ‘‘drug’’ means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.
There we’ve it, and I quote, “articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them”, in short if the Official United States Pharmacopoeia or any of the other aforementioned branches or encyclopedias, medical encyclopedias if you’ll (forgive me as this is starting to get a little convoluted), consider something to be a drug then it must be ruled as an exemption and can’t be considered the basis behind classifying a product as a “Tobacco Product”. Now as I don’t want to spend upwards of $50.00 on the latest and greatest copy of the United States Pharmacopoeia, I managed to do a little digging and come up with a copy from 2009 (I’m sure nicotine hasn’t changed much in terms of its classification since then) and from what I can tell nicotine is listed in the book labeled supplements and if I’ve learned anything throughout high school, nicotine is a drug…
So to wrap this up, is it just me or did the FDA overstep their authority with their new regulations that they’re implementing under the FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT? Do they have the right to do this given the exemptions listed under the subsections of SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT., DEFINITION OF TOBACCO PRODUCTS? Or am I just delusional, ...... off and seeing and believing what I want to see and or believe even though it may not be there?
What's your input?
Thanks
EDIT:
Well I can't post my sources, PM me if you want them.
