FDA Responding to FDA deeming proposal - Please wait!!

[DrMA]

@SmokeyJoe - Last week I would've agreed with you completely. But the shift in ANTZ tactics referenced in post #12 is very disconcerting. Remember, they have insider info on this whole process. There must be a reason why they decided to go for quantity vs quality.

OTOH, it's clear to me, both from the deeming doc itself (give a brief read to Section IV.B), and also from Zeller's statements, that facts or science won't stand in the way of FDA on this matter. IMO, this is a move motivated by politics and money and has nothing to do with public health. I also know for a fact, from participating in a few of these regulatory decision-making processes, that unsupported opinion does actually count. As part of this process, FDA will have to prepare a summary of the comments and the ones in the "generic pile" will be summarized as the "public sentiment" with respect to the regs. I'd rather this "pile" weigh in our favor.

I do agree with you, however, that substantive, factual contributions should theoretically carry more weight than "generic" pro or con comments. That's why in each of my own micro-comments I highlight one particular topic and try to contribute sound science and interpretation in addition to strong opposition to the deeming.

Finally, I also agree that lobbying congress on the appropriateness of PACT remains a priority, as well as the FSPTCA, in particular the issue of the grandfather date.

 

[DC2]

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[DC2]

My understanding is that the PACT Act would have to be specifically amended by Congress to include electronic cigarettes.
And that the Pact Act is not in any way directly related or affected by the deeming regulations.

Am I missing something?

 

[NorthOfAtlanta]

My understanding is that the PACT Act would have to be specifically amended by Congress to include electronic cigarettes.
And that the Pact Act is not in any way directly related or affected by the deeming regulations.

Am I missing something?

Yes, the FDA has the power to deem them a tobacco product do to the nicotine source and that is what they are attempting to do with the deeming regulation. Congress gave them that authority under the tobacco act.

 

[Oliver]

DC2 - my understanding is that it's PACT which gives the FDA the authority to deem e-cigarettes as tobacco products.

Doc, thank you very much for your insight, very useful. It sounds, therefore, that you are recommending we encourage vapers to submit en mass as a matter of urgency?

 

[DC2]

Yes, the FDA has the power to deem them a tobacco product do to the nicotine source and that is what they are attempting to do with the deeming regulation. Congress gave them that authority under the tobacco act.

Doc, thank you very much for your insight, very useful. It sounds, therefore, that you are recommending we encourage vapers to submit en mass as a matter of urgency?

I'm pretty sure it is the FSPTCA that gives the FDA authority to deem electronic cigarettes as tobacco products.

And I'm also pretty sure that the PACT act does not include "tobacco products" as a group, but specifically identifies those tobacco products to which the PACT Act applies.
And further, that Congress would have to pass an amendment to the Pact Act to include any other specific tobacco products.

The one thing I will concede is that if the FDA deems electronic cigarettes to be tobacco products, it may be more likely that the PACT Act would be amended at some point.

 

[DrMA]

I'm pretty sure it is the FSPTCA that gives the FDA authority to deem electronic cigarettes as tobacco products.

And I'm also pretty sure that the PACT act does not include "tobacco products" as a group, but specifically identifies those tobacco products to which the PACT Act applies.
And further, that Congress would have to pass an amendment to the Pact Act to include any other specific tobacco products.

The one thing I will concede is that if the FDA deems electronic cigarettes to be tobacco products, it may be more likely that the PACT Act would be amended at some point.

To the best of my knowledge, this is exactly correct.

 

[DrMA]

<snip>
Doc, thank you very much for your insight, very useful. It sounds, therefore, that you are recommending we encourage vapers to submit en mass as a matter of urgency?

In a word, yes.

So far, I have not heard dissenting opinion that was able to convince me this is not the best course of action at the moment. I do remain open to hearing others' arguments for alternative courses of action. However, I propose that out of all possible alternatives, doing nothing is not an option.

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In separate news, having visited the Regulations.gov site daily in the past week, I've noticed what appears to be a significant uptick in the rate of comments being received. As of right now, there were 54,233 submitted, with a little over 40K posted. Most of the newly posted comments appear to be about cigars.

A search for "electronic cigarette" sorted by "Date posted" reveals that many of the newest (posted) comments are from antis (I scanned the first 100). There are also some positive and fact-based comments from Siegel, Godshall, a few vape shops, and some individual consumers.

 

[aikanae1]

I felt the SBA comment was a good source too.