A few more thoughts on why we should take off the rose-colored glasses. This was a definition of e-smoking I posted last February, I believe it was:
"What we have today is an unregulated drug delivery device being sold at low cost to anyone over the Internet, a device that uses highly poisonous liquid sent by parcel post in leaky glass vials, a device made in China by companies that defraud customs with phony content invoices and value declarations, a device with a single purpose -- sustaining an addiction in the addicted or creating an addiction in the curious."
That definition still holds true.
And I think the ruling of the Food and Drug Administration on nicotine lollipops and lip balm in 2002 could apply to our carts, liquids and devices:
"Today FDA issued warning letters to three pharmacies that are selling "nicotine lollipops" and/or nicotine "lip balm" over the Internet. The letters inform the pharmacies that FDA has found their nicotine lollipops and lip balm to be illegal. Based on statements from the pharmacies' Internet sites, the products are promoted as aids for smoking cessation or to treat nicotine addiction.
"FDA is concerned about the health risk of these products because they appear to be compounded and dispensed without a doctor's prescription, contain a form of nicotine that is not used in FDA-approved smoking cessation products, and because these candy-like products present a risk of accidental use by children."
In further explanation of the ban, the FDA wrote:
"The claims on the websites include that the products help alleviate the "hand to mouth fixation" associated with smoking and are a "convenient, tasty way" to replace the cigarette habit. After investigating and carefully assessing these websites, FDA has determined that the pharmacies' nicotine lollipops and nicotine lip balm are intended for use as "drugs" and appear to be illegal for the following reasons:
"They are compounded and dispensed without a doctor's prescription.
"They are unapproved new drugs which need, but do not have, FDA approval.
"They are made from a drug substance, nicotine salicylate, which is not permitted for use by pharmacists in compounding drugs. The FDA-approved smoking cessation products are made from different forms of nicotine.
"They are misbranded because their labeling does not have adequate directions for the uses for which they are being offered and does not have adequate warnings against use by children.
"FDA is requesting a response from the pharmacies in writing within 15 days of receipt of the warning letters stating the action the firms will take to discontinue marketing of these drug products. Failure to do so may result in further regulatory action, potentially including a seizure or injunction action. FDA will take appropriate action to protect the public health."
And ... bam! ... these items became a footnote to smoking history. 15 days later they were no longer available.
Not one word from the FDA about making smokers healthier with a safer alternative. Not even a consideration. Bam! Banned.
See any sentences here that might be applied to our drug delivery devices and solutions? Sorry to say, I do.
"What we have today is an unregulated drug delivery device being sold at low cost to anyone over the Internet, a device that uses highly poisonous liquid sent by parcel post in leaky glass vials, a device made in China by companies that defraud customs with phony content invoices and value declarations, a device with a single purpose -- sustaining an addiction in the addicted or creating an addiction in the curious."
That definition still holds true.
And I think the ruling of the Food and Drug Administration on nicotine lollipops and lip balm in 2002 could apply to our carts, liquids and devices:
"Today FDA issued warning letters to three pharmacies that are selling "nicotine lollipops" and/or nicotine "lip balm" over the Internet. The letters inform the pharmacies that FDA has found their nicotine lollipops and lip balm to be illegal. Based on statements from the pharmacies' Internet sites, the products are promoted as aids for smoking cessation or to treat nicotine addiction.
"FDA is concerned about the health risk of these products because they appear to be compounded and dispensed without a doctor's prescription, contain a form of nicotine that is not used in FDA-approved smoking cessation products, and because these candy-like products present a risk of accidental use by children."
In further explanation of the ban, the FDA wrote:
"The claims on the websites include that the products help alleviate the "hand to mouth fixation" associated with smoking and are a "convenient, tasty way" to replace the cigarette habit. After investigating and carefully assessing these websites, FDA has determined that the pharmacies' nicotine lollipops and nicotine lip balm are intended for use as "drugs" and appear to be illegal for the following reasons:
"They are compounded and dispensed without a doctor's prescription.
"They are unapproved new drugs which need, but do not have, FDA approval.
"They are made from a drug substance, nicotine salicylate, which is not permitted for use by pharmacists in compounding drugs. The FDA-approved smoking cessation products are made from different forms of nicotine.
"They are misbranded because their labeling does not have adequate directions for the uses for which they are being offered and does not have adequate warnings against use by children.
"FDA is requesting a response from the pharmacies in writing within 15 days of receipt of the warning letters stating the action the firms will take to discontinue marketing of these drug products. Failure to do so may result in further regulatory action, potentially including a seizure or injunction action. FDA will take appropriate action to protect the public health."
And ... bam! ... these items became a footnote to smoking history. 15 days later they were no longer available.
Not one word from the FDA about making smokers healthier with a safer alternative. Not even a consideration. Bam! Banned.
See any sentences here that might be applied to our drug delivery devices and solutions? Sorry to say, I do.