Another News Article On FDA Regs

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Nate760

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I was just reading this and thought that I would share here.

E-cig industry awaits looming federal regulation

It would be great if the FDA really does go lightly with the regs as this article suggests.

It would be great, but I have a hard time believing it's actually going to happen. Nothing happens in Washington that isn't at the behest or with the consent of the lobbies and industry groups that are affected by the action in question or stand to benefit from it. The pharmaceutical lobby has spent many years and billions of dollars transforming the FDA into little more than a rubber stamp organization that consistently does its bidding and protects its interests. I have no expectation that this case will be any different.
 

AgentAnia

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Michael Felberbaum's articles on ecigs have generally been balanced and reasonable; this one is no different.

My pessimism stems from my fear that, even if FDA's proposed regulations are on the "light" side and even with the best intentions of everyone involved, any regulation at all is going to mire the industry in a morass of bureaucratic red tape.
 

salemgold

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It is kind of like eating food at a restaurant IMO Unless you go and inspect the cleanliness and environment yourself, there is no real way to know for sure of the conditions that your food is being cooked in.

The same with most processed foods that we buy. The only way to know for absolutely sure is to cook and process food ourselves. Government agencies are not that reliable at making sure that things are safe. History has proven this fact.
 

Bill Godshall

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AgentAnia wrote:

Michael Felberbaum's articles on ecigs have generally been balanced and reasonable; this one is no different.

I disagree, as Felberbaum's articles have been repeating many false and misleading accusations by e-cig prohibitonists since 2009, and his articles have always favored Obama's FDA, CDC and other e-cig opponents. He's also refused to acknowledge (i.e. report) that the deeming regulation (i.e. Chapter IX of the TCA) would ban all e-cigs (after I repeatedly sent him a copy of Chapter IX and delineated how Section 905 and 910 would ban all e-cigs) in any of his many articles on FDA e-cig regulation.

Felberbaum's most inaccurate statement in this article is
There's not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it's unclear how safe they are.
 

twgbonehead

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See I think we should have SOME regulations in this industry at least in the regards of juice. I don't know about y'all but I would feel better knowing all the juice we buy is made in a lab type setting and not in someone's bathroom or something like that.

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If your concern was about "All the juice that I buy" that would be one thing.

But worrying about "All the juice that we buy"? I ask you to keep your hands off of MY vendors and MY e-liquid supply.

If you can't tell whether the e-juice you buy was made in a bathtub or made in a lab then you're just expecting the Government to do your homework for you. And if their other attempts at safeguarding products are any indication, expect to get a C- on it.
 

djwyman

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If your concern was about "All the juice that I buy" that would be one thing.

But worrying about "All the juice that we buy"? I ask you to keep your hands off of MY vendors and MY e-liquid supply.

If you can't tell whether the e-juice you buy was made in a bathtub or made in a lab then you're just expecting the Government to do your homework for you. And if their other attempts at safeguarding products are any indication, expect to get a C- on it.

But see most good juice vendors welcome such things. Just ask for instance mike of roar vapor(he has been asked this). The only ones it would hurt is people who are mixing juice in substandard ways. Now that is only if they do it reasonably. If the fda takes my flavor away they can go screw them selves.

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djwyman

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Besides that it is not a mater of IF its gonna come. It will come it is a matter of how far they go that should be the concern. There are no 2 ways about it we will get regulated by the fda. It is better to hope it is fair regulations instead of crazy out right industry destroying regulations.

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Stosh

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The government would never go overboard in applying regulations, over reacting, "saving the children". This for example is a Class 1 recall which is defined as :
This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

recalling approximately 96,000 pounds of Oscar Mayer Classic Wieners because the products may contain Classic Cheese Dogs in the Classic Wieners’ packages. The product labels are incorrect, as they do not reflect the ingredients associated with the pasteurized cheese in the cheese dogs,

Missouri Firm Recalls Hot Dog Products Due To Misbranding and Undeclared Allergens
 

patkin

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See I think we should have SOME regulations in this industry at least in the regards of juice. I don't know about y'all but I would feel better knowing all the juice we buy is made in a lab type setting and not in someone's bathroom or something like that.

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I don't know how long you've been researching but I've been here long enough to know, via ECF-approved vendor moves and setups at new locations, that the individual states do inspect due to nicotine which all vendors making juices use. Wizard Labs, for instance, was delayed quite a long time filling orders due to the long wait on Florida's state inspectors to pass/inspect their lab when they moved there. If you're concerned about it, look into your local regulations... State, County and City.
 

KODIAK (TM)

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Where the real questions remain is how the agency will treat the thousands of flavors available for e-cigarettes. While some companies are limiting offerings to tobacco and menthol flavors, others are selling candy-like flavors like cherry and strawberry.
I'd love to see how the FDA manages this one.

They can't. Since there's no "tobacco" in e-juice other than a simulated and immeasurable "flavor". Which leads me to believe they'll just throw their arms up and ban as much of the industry as they possible can. (Akin to throwing a bunch of crap against a wall and taking what "sticks"). Perhaps we'll have FDA trained and certified e-juice "sniffers".

I'd also be curious to hear their rationale for banning mods that look nothing like a cigarette yet allow all the cig-a-likes.
 
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The FDA also will decide the grandfather date that would allow electronic cigarette products to remain on the market without getting prior approval from regulators — a ruling that could force some, if not all, e-cigarettes to be pulled from store shelves while they are evaluated by the agency.

Is this true? I thought Congress determined the Feb 16 '07 cutoff. See: Family Smoking Prevention And Tobacco Control Act

***

BTW Bill, hate to quibble, but this statement: "There's not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it's unclear how safe they are." is theoretically defensible as written, albeit grossly misleading because it implicitly rejects the notion of harm reduction by substituting a higher standard, and uses the term "scientific" in a squirrely way.

Try: "There's not much [peer-reviewed] scientific evidence [in prestigious medical journals] showing e-cigarettes help smokers quit or smoke less, and it's unclear how [close to being 100%] safe [,as compared to drinking a minuscule drop of distilled sterilized room-temperature water] they are [,when used extensively over many years, because of the lack of longitudinal controlled studies involving many thousands of users published in prestigious medical journals, as might be preferred for FDA-approved 'safe and effective' therapies.]"

It's not "inaccurate" as written, merely misleading to the point of falsehood. As in the assertion: "There is no scientific evidence to show that two plus two is four." This is also correct. The proposition relies on arithmetic, which can't - by definition - be validated through scientific (i.e. empirical) investigation.

IMO, the original statement by the AP reporter is about the best that one is going to get in today's US media climate. Go back 30 years, and imagine a story written about a school teacher who was fired solely for being gay. Such an article might note that s/he had never been charged with a criminal offense (meaning: child molestation).

***

Anyway I'm not interested in debating the word games that dominate US media coverage, either as a result of design, lack of sophistication, or social conditioning: my Q is how can FDA possibly change the Feb 16 '07 date which is hard-coded in the statute? (As is March 21, '11, I believe).
 
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