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Also, there are some provisions in Chapter IX (e.g. the February 15, 2007 grandfathering date) that will be very difficult for the FDA to justify applying to e-cigarettes, as doing so would create a black market.
FDA to regulate e-cig as tobacco
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But KDK, classification as a "drug" under the FDCA (Food, Drug and Cosmetic Act) doesn't imply anything negative - other than that it puts whatever substance that is classified as a drug squarely under the FDA's regulatory authority of course.
Are you perhaps confusing the medicinal term "drug" with those illegal to sell or possess substances that are legally classified as "controlled substances", but commonly called drugs, or street drugs? That's an entirely different issue!
But actually, vitamins are usually classified as "dietary supplements" under the food provisions of the FDCA.
Well, I guess I'm glad they are usually classified as "dietary supplements", but they do, in fact, affect the structure and functioning of the body. That suggests to me that the FDA might, at some time declare them to be drugs. And severely limit our ability to get them OTC. That would be, IMO, a huge factor in public health. And no, I wasn't thinking of street drugs, have no experience with or knowledge about those!
When I read your original post, I saw where you were going...
Vitamins seem to fit the definition of drugs.
Not sure why they aren't classified as drugs, given the definition that the FDA uses.
Can anyone clear this up?
KDK, many pharmaceutical "drugs" regulated by the FDA are available OTC. Think aspirin, certain cough and cold remedies, etc, etc. Other "drugs" are prescription only. So it's not whether a given substance is a "drug" that determines OTC availability, it's the FDA (and all the regulations promulgated by it under Chapter V of the FDCA, that determines that.
But here's an example for you, of a natural vitamin still available relatively cheaply, fortunately, and still classed a "dietary supplement" as with most vitamins, but used by many to "affect the structure and function" of their bodies: Niacin, when used as an alternative to a statin in combating high cholesterol. But, as you may know, in the form of Niaspan®, it was recently turned into a patented pharmaceutical product, regulated as a "drug", and only available by prescription. And of course, the cost of Niaspan is through the roof as compared to the cost of plain old niacin!
But even worse, there are plenty of cheaply available substances that have been scooped up by pharmaceutical companies for patenting and sale as extremely expensive "drug" products - and been competely removed from availability in their original non-patented state. In some cases the FDA is forced to relent due to extreme pressure, but not always. One recent example of this is the substance used to prevent premature birth, turned into an outrageously expensive patented drug named Makena.
http://www.nytimes.com/2011/04/05/health/05FDA.html
A Perfect Preterm Storm! More News on Preventing Early Deliveries - Health Blog - WSJ
But here's an example for you, of a natural vitamin still available relatively cheaply, fortunately, and still classed a "dietary supplement" as with most vitamins, but used by many to "affect the structure and function" of their bodies: Niacin, when used as an alternative to a statin in combating high cholesterol. But, as you may know, in the form of Niaspan®, it was recently turned into a patented pharmaceutical product, regulated as a "drug", and only available by prescription. And of course, the cost of Niaspan is through the roof as compared to the cost of plain old niacin!
But even worse, there are plenty of cheaply available substances that have been scooped up by pharmaceutical companies for patenting and sale as extremely expensive "drug" products - and been competely removed from availability in their original non-patented state. In some cases the FDA is forced to relent due to extreme pressure, but not always. One recent example of this is the substance used to prevent premature birth, turned into an outrageously expensive patented drug named Makena.
http://www.nytimes.com/2011/04/05/health/05FDA.html
A Perfect Preterm Storm! More News on Preventing Early Deliveries - Health Blog - WSJ
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Do you want the simple answer? Because the FDCA says so.
Seriously, congress wrote that distinction into Chapter IV of the FDCA, the food chapter.
This essentially "protects" Big Pharma. Under the Dietary Supplement Health and Education Act (DSHEA) vitamin C is a dietary supplement, and as such, it can only make structure/function claims (i.e. Vitamin C boosts the immune system). DSHEA came about after intense lobbying against the FDA's attempts to control supplements, herbs, etc. and restricts its authority over them PROVIDED manufacturers make no claims about their products treating, preventing or curing diseases, etc.
Making such claims about any product makes it a drug - and since Big Pharma is the drug cartel, only Big Pharma can make those claims. This is why I'm not allowed to tell you that lavender helps insomnia, muscle pain, and acne, or that it helps heal burns, bites and abrasions - even though we all know it does all this.
This is also why we don't claim e-cigs help smokers avoid tobacco cigarettes. To do so would be claiming that they treat a disease, which means they're drug, which means they belong to the FDA and BP.
I can answer this one.
Vitamins and supplements were defined and regulated under the Dietary Supplement Health and Education Act (crafted by Congress and signed by Clinton in 1994) which brought them under the umbrella of foods. In a nutshell, the FDA can require; that they be safe and content labels are correct, that new ingredients be reported to them before marketing and be proven as safe, and that no treatment or cure claims can be made. They cannot however ban them unless they have proven to be unsafe nor can they classify them as drugs unless health claims are made. Sound somewhat familiar? The FDA page on the DSHEA; Overview of Dietary Supplements and the DSHEA itself; Chapter I - Dietary Supplement Health And Education Act of 1994
By the way, if you think we had a tough fight with e-cigs, take a look at the history behind stevia. The only thing that stopped the FDA's witch hunt against the simple sweetener was the DSHEA; Stevia Sweetener History & Government Control, and this is only an abbreviated version of the story, it was actually much worse.
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Who ever said anything thr FDS does makes sense.
They ok hundreds of drug that have caused enough harm that they require a long list of "possible side effects," many of which list "death" or "cancer," and even admit "we don't know exactly why this drug works, but it seems to), yet raids a honey producer's business and takes all of their supplies and equipment because they made "health claims" about a product that has never harmed anyone (beyond rare allergies.)
Think about cranberry juice. No one knows why, but everyone knows cranberry juice somehow seems to help with urinary tract infections. However, should Ocean Spray ever tell it's customers that it could possibly help them with their urinary tract, they'd receive a cease and desist from the FDA and risk being banned from the market if they don't! It's ridiculous. It's one thing to be acting within their purpose of weeding out the snakeoil, but it has become completely power hungry and seems to think it's sole purpose is to protect BP from competition that hasn't had to "pay their dues."
They ok hundreds of drug that have caused enough harm that they require a long list of "possible side effects," many of which list "death" or "cancer," and even admit "we don't know exactly why this drug works, but it seems to), yet raids a honey producer's business and takes all of their supplies and equipment because they made "health claims" about a product that has never harmed anyone (beyond rare allergies.)
Think about cranberry juice. No one knows why, but everyone knows cranberry juice somehow seems to help with urinary tract infections. However, should Ocean Spray ever tell it's customers that it could possibly help them with their urinary tract, they'd receive a cease and desist from the FDA and risk being banned from the market if they don't! It's ridiculous. It's one thing to be acting within their purpose of weeding out the snakeoil, but it has become completely power hungry and seems to think it's sole purpose is to protect BP from competition that hasn't had to "pay their dues."
That's exactly what the FDA wanted and still wants, but the Dietary Supplement Health and Education of 1994 has kept that from happening - so far. Prior to 1994 they were regulated as food.
FDA is still fighting for control of supplements, herbals, etc., with no plans on stopping. In 1994 Pearson and Shaw took the FDA to court for rejecting valid, scientific health claims on supplement labels. Five years later a U.S. Court of Appeals affirmed the lower courts ruling for the plaintiffs on grounds it violates their First Amendment rights.
Believe it out not (easy to believe, really), the FDA actually argued it had the right to "protect consumers by suppressing scientific information it believes is too misleading for consumers to understand..."
Exactly - That's the point I've tried to make a few times. While I haven't been involved in the e-cig movement very long, I have been watching and fighting against the FDA for many years on another front. They constantly step outside the bonds, try to slide things under the radar and ignore science. The only time they are stopped is when public outcry gets seriously loud or they're taken to court. Every 18 months or so they try to run something else through, and it's only the perpetual, combined efforts of many that hampers it. No reason to expect that to change. That's not doom and gloom, that's just a very unfortunate reality.
Yes.
"The FDA has fulfilled the founding fathers' dire prediction of what would become of an agency of the government delegated by Congress legislative power. The FDA has become tyrannical. It is a law unto itself. It is unaccountable to the Congress. It is unaccountable to the courts. It is unaccountable to the American people. It is corrupt. It is the handmaiden of the pharmaceutical industry. Its decisions have sacrificed tens of thousands of Americans lives. It has gotten away with that history of homicide."
Read "FDA Violation of the Rule of Law"
And this is exactly why we need to step up, every one of us.
What more can I say?
My question is - at what point does something "come into existence?" E-cigs certainly existed before 2007, but are they a "new tobacco product" simply because the FDA stated this week they would regulate them as tobacco products?
I know that this was mentioned before- BT cornering the market and selling e-cigs. Exatly this has happened in Japan. JT (Japan Tobacco), Japan's Big Tobacco and only authorized seller of "tobacco products" released its first e-cig last year. This is the only allowed item that actually has nicotine in it in Japan...all other e-cigs, because they aren't sold by JT do not have nicotine because they aren't allowed to sell nicotine unless they are sold by JT. Just thought this was interesting- not sure how relevant unless someone here wants to connect the dots in terms of what's going on here in the States and what could happen in the future. Anyway, here's an article about JT's E-Cig. "Zero Style Mint" Japan Tobacco Revolutionary Cigarette
Edit- they are cheap enough though- cheap enough to compete with real packs of cigarettes over there- just don't think they would be very satisfying, especially for us Vapors who can adjust our nicotine levels. I tried to find out how much nicotine each cartridge has but never found that information.
Edit 2- wait a minute- these don't even vape...they just let you suck through tobacco leaves...you would barely taste some tobacco... no way they would catch on....
Edit- they are cheap enough though- cheap enough to compete with real packs of cigarettes over there- just don't think they would be very satisfying, especially for us Vapors who can adjust our nicotine levels. I tried to find out how much nicotine each cartridge has but never found that information.
Edit 2- wait a minute- these don't even vape...they just let you suck through tobacco leaves...you would barely taste some tobacco... no way they would catch on....
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Your quotes in this article seemed odd to me. Like, you were an anti saying "oh no, now people will have nicotine hand cream!" But then the next quote was ... Non-anti (unanti? Antianti? We're using 'anti' as a noun, so my brain wants to explode).
I believe typically it's when a product is first marketed in the US. It can be proven though various sources, the Better Business Bureau for one, that e-cigs and bottled juices were being sold here as early as late 2006.
I like the sound of that.
I brought that up in another discussion and got shot down, that no, it's a new product. I would hope the concept, application and functional design would be the determining factors, but who knows
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