I know the FDA is already "looking into" e-cigs, and I wanted to find out exactly what they were doing.
I had a nice conversation and learned a bunch about the process they go through.
The first thing I learned is the only way the FDA can approve a product is if someone actually submits one to them to review. This means the vendor who wants to sell the product has to send them one. It is not so simple though, the submission needs to be combined with some pretty detailed studies and details regarding the manufacturing of the drug. He said nicotine is in some foods, and if the chemical is in food and being marketed as such then the procedure is different than if nicotine is in drug form and being marketed as a drug.
The FDA told me that the packaging is the key here. If a product is being sold as a quit smoking device then it is considered a drug. If it is being sold as a Cigarette then the governing body is the ATF. So I asked the ATF if they would consider the E-cig a Cigarette, and they said no, because it has no tobacco. I had asked the ATF prior to speaking with the FDA and told him what the ATF said, and he said he knew that the ATF would say that.
I asked him straight out, if the ecig is marketed as a cigarette and that brings it under the ATF, then the ATF does not see it as a cigarette then who is responsible? He said it would then fall under the "no regulation" category. He said the FDA can only regulate something if it is being marketed as a drug. The bottom line though is the FDA is eventually going to classify the e-liguid as a drug product the same way the patch and gum are classified. He told me that eventually someone will submit the product and the real work will begin.
I asked him what steps if any is the FDA taking to monitor or control the e-liquid side of this product. He said the only area they are concerned about is the importation to the United States from other countries. The China products are of great concern to the FDA in light of recent national headlines regarding lead paint and poisons in the consumer products that have been finding their way into the American market place.
The fact that the products are being imported allows more control for the FDA and the law enforcement community. Products that are manufactured here in the USA are not enforced as much because the consumer has more legal rights against US based manufacturers.
So to finish my questions to the FDA I asked for a realistic time frame when consumers might see a real answer as to the legality of purchase/manufacture and use of e-liquid. The FDA said these things if pushed through clinical trials and heavy finacial backing from the prospective manufacturer can go to market legally in 2 or less years. The back log of cases though in reallity puts it closer to 10 years.
So does this mean the products will not appear in the stores until the FDA approves it? Absolutly not. The FDA can only remove the products from the shelves if there is a complaint against the seller that completes an investigation in to the allegation of the complaint and finds in favor of the complaintant. Due process of law prevails.
My hope is as follows. I feel so strongly that the E-cig is the holy grail of quitting smoking devices, that the population through word of mouth and smart marketing will put the Tobacco companies out of business and save millions of lives. By the time the FDA acts, the possitive results of the e-cig will have made the population hail the e-cig as a "to good to fail"
I had a nice conversation and learned a bunch about the process they go through.
The first thing I learned is the only way the FDA can approve a product is if someone actually submits one to them to review. This means the vendor who wants to sell the product has to send them one. It is not so simple though, the submission needs to be combined with some pretty detailed studies and details regarding the manufacturing of the drug. He said nicotine is in some foods, and if the chemical is in food and being marketed as such then the procedure is different than if nicotine is in drug form and being marketed as a drug.
The FDA told me that the packaging is the key here. If a product is being sold as a quit smoking device then it is considered a drug. If it is being sold as a Cigarette then the governing body is the ATF. So I asked the ATF if they would consider the E-cig a Cigarette, and they said no, because it has no tobacco. I had asked the ATF prior to speaking with the FDA and told him what the ATF said, and he said he knew that the ATF would say that.
I asked him straight out, if the ecig is marketed as a cigarette and that brings it under the ATF, then the ATF does not see it as a cigarette then who is responsible? He said it would then fall under the "no regulation" category. He said the FDA can only regulate something if it is being marketed as a drug. The bottom line though is the FDA is eventually going to classify the e-liguid as a drug product the same way the patch and gum are classified. He told me that eventually someone will submit the product and the real work will begin.
I asked him what steps if any is the FDA taking to monitor or control the e-liquid side of this product. He said the only area they are concerned about is the importation to the United States from other countries. The China products are of great concern to the FDA in light of recent national headlines regarding lead paint and poisons in the consumer products that have been finding their way into the American market place.
The fact that the products are being imported allows more control for the FDA and the law enforcement community. Products that are manufactured here in the USA are not enforced as much because the consumer has more legal rights against US based manufacturers.
So to finish my questions to the FDA I asked for a realistic time frame when consumers might see a real answer as to the legality of purchase/manufacture and use of e-liquid. The FDA said these things if pushed through clinical trials and heavy finacial backing from the prospective manufacturer can go to market legally in 2 or less years. The back log of cases though in reallity puts it closer to 10 years.
So does this mean the products will not appear in the stores until the FDA approves it? Absolutly not. The FDA can only remove the products from the shelves if there is a complaint against the seller that completes an investigation in to the allegation of the complaint and finds in favor of the complaintant. Due process of law prevails.
My hope is as follows. I feel so strongly that the E-cig is the holy grail of quitting smoking devices, that the population through word of mouth and smart marketing will put the Tobacco companies out of business and save millions of lives. By the time the FDA acts, the possitive results of the e-cig will have made the population hail the e-cig as a "to good to fail"
