Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[yvilla]

I have to agree with him, even though I don't want to.

Then, Jacob, you too are apparently blind to the FDA's repeated use of the terms "marketed as containing both products" and "identified as containing ..." in explaining the meaning of the rule.

Draft Guidance: The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act

[PhiHalcyon]

Cool. Now Pepsico can secretly add nicotine to all of its soft drink products.

[LoneRanger]

Happy thanksgiving!! Sun,Legal One, and Judge Richard Leon

From: The Chimp :-)

[PhiHalcyon]

PG has long been used as a tobacco humectant. Guidance has suggested that the combo of tobacco and PG is grandfathered.

I'm not sure what guidance you are referring to, but the law provides for no tobacco product additive to be grandfathered in. All tobacco product additives are subject to regulation, limitation, and banning.

Nonetheless, I have previously stated that an argument can be made for an exclusion of tobacco product additives from the combination prohibition; but when pg/glycerin constitute 75%+ of the e-liquid product, it/they is/are no longer additives. They are excipients containing the drug additive of nicotine.

[tvujec]

This is why the ecig is being reinvented as something other than what it is today. And even though I cannot really comment any further on the matter at this time, I will say that the tax issue has been factored into its design. I want the freedom to vape AND not pay outrageous taxes.

Your inability to comment any further puts you in a tough spot here, as it can mean that you stand to either benefit from a certain categorization of electronic cigarette, or lose if a different choice is made.

[PhiHalcyon]

Your inability to comment any further puts you in a tough spot here, as it can mean that you stand to either benefit from a certain categorization of electronic cigarette, or lose if a different choice is made.

This would appear to be a possibility, but I would rather have the ecig remain on the market than to have a need to fill if it doesn't. My ecig reinvention is merely my personal contingency plan for now.

[JustMeAgain]

Phi: We all should want to know that the e-liquid we buy is what it claims to be, is produced using strict quality control procedures, and is regularly tested for potentially harmful contaminants.

Why? We certainly had no trouble smoking analogs without requiring this information.

[yvilla]

Cool. Now Pepsico can secretly add nicotine to all of its soft drink products.

No. That would be covered by rules as to allowable additives in food products.

We are talking about a rule as to the marketing of tobacco products.

[mirinuh]

I'm not sure what guidance you are referring to, but the law provides for no tobacco product additive to be grandfathered in. All tobacco product additives are subject to regulation, limitation, and banning.

Nonetheless, I have previously stated that an argument can be made for an exclusion of tobacco product additives from the combination prohibition; but when pg/glycerin constitute 75%+ of the e-liquid product, it/they is/are no longer additives. They are excipients containing the drug additive of nicotine.

You are seriously and sadly misinformed. But, at least you are consistent.

[PhiHalcyon]

No. That would be covered by rules as to allowable additives in food products.

We are talking about a rule as to the marketing of tobacco products.

Nonetheless, you are still trying to say there is a distinction to be made in how a product is represented. And this is simply not supported by the language of the law.

More importantly, I do not believe that the decision will ultimately rest on the combination prohibition, but rather, on objective intended use. And, in this respect, I say that based on my own use that the ecig is an indefinite-term nicotine replacement product that simulates the act of smoking.