FDA Sen Johnson (R-Wis) demands answers from FDA RE deeming

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Katya

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Bob Chill

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Sorry folks but the Johnson/Vicki piece sounded too much like a self-serving stump speech. Yes, I'm jaded.

If he actually does something about it I'll consider voting for him. Multiple times.

The only benefit to the response is to bring attention (and hopefully litigation) to some of the more serious flaws in the regs. The FDA is sandbagging because they know everything they say is public and will be dissected. I mostly expect the answers to be as vague and incoherent as the regs but we have nothing else immediately on the table to watch for right now.
 

KODIAK (TM)

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I mostly expect the answers to be as vague and incoherent as the regs but we have nothing else immediately on the table to watch for right now.
I actually don't expect them to respond at all. Especially if they're not legally compelled to do so.

But again, I'm jaded. :)
 

Katya

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The only benefit to the response is to bring attention (and hopefully litigation) to some of the more serious flaws in the regs. The FDA is sandbagging because they know everything they say is public and will be dissected. I mostly expect the answers to be as vague and incoherent as the regs but we have nothing else immediately on the table to watch for right now.

And Azim (and other lawyers) are watching and taking notes. ;)
 

Kent C

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from nclobo's link (thanks)

"I asked him what the next steps are for the Committee. He reports there are several steps to take with clear historic examples of how to proceed. The initial steps are simply “louder” requests, but should those requests remained unfulfilled, the eventual endpoint is a subpoena creating the opportunity for FDA management to be formally charged with contempt of Congress."
 

Katya

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from nclobo's link (thanks)

"I asked him what the next steps are for the Committee. He reports there are several steps to take with clear historic examples of how to proceed. The initial steps are simply “louder” requests, but should those requests remained unfulfilled, the eventual endpoint is a subpoena creating the opportunity for FDA management to be formally charged with contempt of Congress."

girl_yes3.gif


Like I said earlier, I'd love to see Zeller and Califf in handcuffs. Hey, a girl can dream.
 

nclobo

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from nclobo's link (thanks)

"I asked him what the next steps are for the Committee. He reports there are several steps to take with clear historic examples of how to proceed. The initial steps are simply “louder” requests, but should those requests remained unfulfilled, the eventual endpoint is a subpoena creating the opportunity for FDA management to be formally charged with contempt of Congress."
I wish they would just skip any more requests and go for the jugular ..
 

Jumpin' In...

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from nclobo's link (thanks)

"I asked him what the next steps are for the Committee. He reports there are several steps to take with clear historic examples of how to proceed. The initial steps are simply “louder” requests, but should those requests remained unfulfilled, the eventual endpoint is a subpoena creating the opportunity for FDA management to be formally charged with contempt of Congress."
The problem with having to go through all the multiple requests is that the clock is ticking.

Anyone have any idea what happened to Halo's (I don't remember the company's name) request for an injunction? Those are usually heard in relatively short order.
 
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MacTechVpr

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from nclobo's link (thanks)

"I asked him what the next steps are for the Committee. He reports there are several steps to take with clear historic examples of how to proceed. The initial steps are simply “louder” requests, but should those requests remained unfulfilled, the eventual endpoint is a subpoena creating the opportunity for FDA management to be formally charged with contempt of Congress."

It's to be expected from a lame duck admin intent on using the stall to get its way on all its executive edicts. As I suggested months ago before things got hot, hope B&M's got ready to sell no nic. And ready too to challenge any fed enforcement…not selling tobacco. Only way to keep their business really after the 8th. Nobody's ready to comply in truth and they're not meant to be. I sure as hell wouldn't have been labeling my [Moderated] a tobacco product these past few weeks. The law is, after all, to coin a word — unsettled.

The FDA doesn't make law. It scrambles it and leaves the egg shells.

Good luck all. :)
 
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Rickajho

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Contrary to convention wisdom of the day, the definition of a lame duck presidency is that short window between when the winner of the next election is known, and said new president elect is sworn into office. It's not a broad time span nor a moving target for the sake or convenience of any given agenda.
 

DaveOno

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Squidward

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At last, a voice of reason! Personally, I wouldn't mind the FDA taking a look at e-cigarettes in order to quantify their impact on health, especially compared to cigarettes, but there's more than enough consistency in the current de-facto standard manufacture of e-liquid for them to evaluate the impact of inhaling PG, VG, food-grade flavorings and liquid nicotine without destroying the entire industry in the process.
 

Rickajho

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At last, a voice of reason! Personally, I wouldn't mind the FDA taking a look at e-cigarettes in order to quantify their impact on health, especially compared to cigarettes, but there's more than enough consistency in the current de-facto standard manufacture of e-liquid for them to evaluate the impact of inhaling PG, VG, food-grade flavorings and liquid nicotine without destroying the entire industry in the process.

That, and I thought the FDA had to take into consideration any "no harm" evidence that already exists. (I tried to research this one but cannot locate what I thought I previously read.) The idea that, if the product has already been in the marketplace, and the longer it has been in the marketplace, with no substantial evidence that the product poses significant health or safety risks, that evidence of "no harm" had to be considered when determining what, if any, regulation of the product is required or relevant.
 
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