What I want from the FDA

[Thulium]

Well, besides giving us the TRUTH instead of lies like their most recent "study"...

The FDA was started to protect Americans from hazardous chemicals entering our food supply and ensure that our pharmaceuticals undergo appropriate testing before being released to the public. Do we need this protection from e-cigarettes? Not exactly. Do we need to know what chemicals might be included in consumable products from other countries? The lead found in baby toys made in China says yes. Do we need to know that domestic manufacturers are minimizing or eliminating the risks of exposure to known toxins? Sure. Do we need to know the long term effects of Nicotine? Yes, but that is not really the FDA's job. Do we need to know that the quality of our nicotine-laced vapor is consistent? Absolutely.

Do we need the FDA acting as Big Brother and banning the import of a product that has not been shown to be harmful* until they can figure out a way to make money on it? HELL NO.

I suspect that the key to getting what we need from the FDA without all the bureaucracy and gestapo border tactics is to do what we can to separate the device from the drug. e-liquid SHOULD be monitored and regulated by the FDA as it is consumed like a food and may contain a drug. PV's SHOULD be UL tested to make sure they aren't going to explode. But that doesn't mean "e-cigarettes" should be banned or regulated themselves, it means manufacturers should be required to conform to the same standards we hold for analog products--that is, electronic components should be tested for safety and the food and/or drug components should have FDA determined maximum levels of contaminants just like any other products that contain addictive substances like caffeine, nicotine, and alcohol.

What does that mean for those of us here at ECF? To some extent, I think we need to re-establish our credibility and calm down a bit with the FDA. Allegedly the FDA is only trying to protect us, and as far as that goes, we should encourage it. However, in spite of our protestations, the FDA is exceeding its mandate and MUST be reigned in. It is not the FDA's job to seize safe and legal products or making unsubstantiated claims like "as dangerous as cigarettes" in order to scare people into submission. The FDA can and should regulate the levels of toxins in nicotine vapor and the FDA should study the effectiveness of e-cigarettes as an NRT. Placing an embargo on our health and spreading fear, uncertainty, doubt, and downright LIES needs to stop immediately.

I really wanted to believe that there was no vast conspiracy from the FDA. I wanted to believe that these kinds of theories were the sole domain of paranoids and Tom Cruise. Unfortunately, I learned two things from the FDA's report:
1. Chinese manufacturers are inconsistant (as if I didn't know that already)
2. Maybe there is some credibility to the conspiracy theories regarding the FDA.

*Yes, the FDA did detect some known carcinogens, but they were detected at below the threshold of toxicity. Even when they found Diethylene Glycol in one cartridge, DEG does not vaporize at the temperatures used by personal vaporizers and was not detected in the vapor itself. There was absolutely no evidence of impurities that exceeded the standards set by the FDA. The closest thing was the SmokingEverywhere 555 cartridge that had 1% DEG--but since nobody consumes the e-liquid in its raw form, it is not subject to the FDA's 1% maximum in foods. Its not illegal in antifreeze because you're not supposed to drink antifreeze, so it shouldn't be illegal in e-liquid that you don't drink either. That said, I'm glad to see that the product that contained DEG has been taken out of the market.

Minimum risk (e-cigs) is better than the known killer of cigarette smoke, but no risk (FDA regulated e-liquid) would be better. But the FDA is not making things safer by disallowing the substantially safer alternative to tobacco until they can determine if it is "completely" safe or not.

 

[deewal]

The problem is that it's not "What you want from the FDA" it's "What the forces that Control the FDA want from the FDA"

It is not the FDA's job to seize safe and legal products or making unsubstantiated claims like "as dangerous as cigarettes" in order to scare people into submission.

If it was'nt their job why has no official body objected to it ?

 

[Thulium]

Here's how the FDA defines their own mandate:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

I don't see anything in there about banning the import of goods of undetermined safety or efficacy. On the contrary, I was under the impression that the Bill of Rights specifically forbade search and seizure without the due process of law. The fact that the FDA is seizing anything means they are either acting outside the law or they were somehow granted legislative power.

 

[Thulium]

The problem is that it's not "What you want from the FDA" it's "What the forces that Control the FDA want from the FDA"



If it was'nt their job why has no official body objected to it ?

Well, SmokingEverywhere and others are currently fighting this in court. I just found a resource stating where the FDA has jurisdiction. Apparently they are allowed to seize "before the fact" counterfeit drugs (which the e-cigarette is NOT) and they are allowed to place medical devices on "Administrative Detention". I'm not sure how it is that the FDA determined that e-cigarettes are a "medical device" when nobody else is claiming that. Does the FDA get to start detaining whatever they decide might have a medical use?

 

[aditas]

... The FDA can and should regulate the levels of toxins in nicotine vapor and the FDA should study the effectiveness of e-cigarettes as an NRT...

Why? Don't you trust your own body? I don't want the FDA telling me how much nicotine I should consume. I want the freedom to consume as much as I want.

 

[Thulium]

Why? Don't you trust your own body? I don't want the FDA telling me how much nicotine I should consume. I want the freedom to consume as much as I want.

I didn't say the FDA should tell you how much nicotine should consume, I said the FDA should regulate the amount of the various chemicals in the e-liquid. Really, I don't want anything but PG or Glycerine, flavoring, and maybe some nicotine (or possibly other legal substances, especially when used for medical purposes such as smoking cessation or medication delivery). There's probably some other contaminants that are inevitable, and the FDA should apply the same regulations as in similar products. For example, the FDA has strict standards for the amount of "non food proteins" in packaged food products--personally, I'd rather have NO such additives, but I consider the fact that it is monitored and regulated to keep me relatively safe a good thing.

 

[deewal]

As i wrote in my first post.
The problem is that it's not "What you want from the FDA" it's "What the forces that Control the FDA want from the FDA"

Their is a History of illegal,corrupt collusion between Big Pharma and "their" regulatory Watchdogs the FDA. It has now become a mass abandonment of medical ethics, forcing millions of people onto pharmaceutical drugs for Commercial rather than Scientific reasons. IMHO.

BTW. You can forget The Bill of Rights. It's just a piece of paper.