FDA Senator Ron Johnson sends letter to FDA Cmsnr Califf asking important questions about deeming ban

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KY_Rob

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The FDA's response about Senator Johnson's letter.

"FDA spokesman Michael Felberbaum said Thursday the agency is reviewing the letter and “will respond directly to the senator.” "

Senator asks FDA for clarity on consequences of new e-cig rules

My gut tells me, we'll hear nothing more of this. In fact, the media hasn't even covered this that I have seen. At the risk of sounding insensitive, if this issue involved transgender bathrooms, or sectarian conflict, it's all we would hear about.
FDA is bought and paid for boys and girls. BP/BT/BG have already made sure the outcome they desire takes place. I think the only hope we have, is outright incontestable proof of the suspected bribery and corruption that's made it happen.
Its brazenly apparent to me, that the good ole US of A is broken, and badly. The only thing we can do, is make an informed vote. I think that very few local and national politicians deserve to remain in office. Unless every single eligible citizen takes the time to reach out to their candidates, and develop a solid opinion of those candidates specific positions on the issues, then nothing will change.
 

Katya

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My gut tells me, we'll hear nothing more of this. In fact, the media hasn't even covered this that I have seen. At the risk of sounding insensitive, if this issue involved transgender bathrooms, or sectarian conflict, it's all we would hear about.
FDA is bought and paid for boys and girls. BP/BT/BG have already made sure the outcome they desire takes place. I think the only hope we have, is outright incontestable proof of the suspected bribery and corruption that's made it happen.
Its brazenly apparent to me, that the good ole US of A is broken, and badly. The only thing we can do, is make an informed vote. I think that very few local and national politicians deserve to remain in office. Unless every single eligible citizen takes the time to reach out to their candidates, and develop a solid opinion of those candidates specific positions on the issues, then nothing will change.

Did you contact Sen. Johnson and the Committee? Please do so--thank him for his efforts, courage and wish him luck. Show your support. :D
 

Katya

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nicnik

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zoiDman

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nicnik

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I could be Wrong.

But I believe that the Senate Government Affairs Oversight Committee Chairman is the Only Committee member who has Subpoena Powers that do Not Require a Committee Vote.
Thanks. You could be right.
I'll wait and see if anyone else chimes in with further info, before I try to look it up.
 

LaraC

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United States Senate Committee on Homeland Security and Governmental Affairs - Wikipedia, the free encyclopedia

The United States Senate Committee on Homeland Security and Governmental Affairs is the chief oversight committee of the United States Senate. It has jurisdiction over matters related to the Department of Homeland Security and other homeland security concerns, as well as the functioning of the government itself, including the National Archives, budget and accounting measures other than appropriations, the Census, the federal civil service, the affairs of the District of Columbia, and the United States Postal Service. The committee had been called the United States Senate Committee on Governmental Affairs before homeland security was added to its responsibilities in 2004.[1]The committee serves as the Senate's chief investigative and oversight committee. The chair of the committee is the only committee chair in the Senate with the power to issue subpoenas without a committee vote, though in practice, such unilateral subpoenas have rarely been issued in recent years.
 

nicnik

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United States Senate Committee on Homeland Security and Governmental Affairs - Wikipedia, the free encyclopedia

The United States Senate Committee on Homeland Security and Governmental Affairs is the chief oversight committee of the United States Senate. It has jurisdiction over matters related to the Department of Homeland Security and other homeland security concerns, as well as the functioning of the government itself, including the National Archives, budget and accounting measures other than appropriations, the Census, the federal civil service, the affairs of the District of Columbia, and the United States Postal Service. The committee had been called the United States Senate Committee on Governmental Affairs before homeland security was added to its responsibilities in 2004.[1]The committee serves as the Senate's chief investigative and oversight committee. The chair of the committee is the only committee chair in the Senate with the power to issue subpoenas without a committee vote, though in practice, such unilateral subpoenas have rarely been issued in recent years.
Nice intervention. Thanks!

So Senator Johnson has some unique power, and it's great to see he's puting it to very good use.
 

Richriv

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Just came across the following on one of the other sites. The good news is that Sen Johnson expects a response from the FDA:

WASHINGTON — On Monday, Sen. Ron Johnson, chairman of the Senate Homeland Security and Governmental Affairs Committee, sent a second letter to the Food and Drug Administration (FDA) inquiring about new e-cigarette regulations, a follow-up to his previous letter to FDA Commissioner Robert M. Califf on May 17, 2016.


Johnson is raising concerns about the agency’s recent e-cigarette regulation, which could create undue burdens on small businesses and possibly lead to negative unintended health consequences.


“Since I sent my initial letter to you, I have heard from many small-business owners who manufacture or sell e-cigarette products,” Johnson wrote in the letter. These job creators have contacted my office expressing their grave concerns about the FDA’s regulatory overreach. They fear that the FDA’s e-cigarette rule will force them out of business by requiring them to complete costly and time-consuming premarket applications for each e-cigarette product. In addition, a large number of individuals have contacted my office to tell their stories about how they use or have used e-cigarettes to quit smoking. They do not want the FDA to make access to e-cigarettes more difficult for them—or others like them—as they fight to kick an addiction to smoking.”


The letter can be found here and below:


June 6, 2016





The Honorable Robert M. Califf, MD Commissioner


U.S. Food and Drug Administration


10903 New Hampshire Avenue


Silver Spring, MD 20993


Dear Dr. Califf:


The Senate Committee on Homeland Security and Governmental Affairs is continuing to examine the U.S. Food and Drug Administration’s (FDA) recent regulation that expands its authority over e-cigarettes. On May 17, 2016, I wrote to request your assistance in understanding the consequences that this new regulation may have on small businesses and the public’s health. To date, you have not responded to my letter. Therefore, I write again to reiterate my request for information about FDA’s regulation and its potential consequences.


I requested that the FDA provide data on the number of e-cigarette businesses that will be affected by the rule. I also asked the FDA whether it would issue a revised rule if sufficient data demonstrate that e-cigarettes are a safer alternative to traditional cigarettes. Further, I questioned the FDA about the potential unintended consequences of its rule that may result in decreased access to e-cigarettes and increased consumption of traditional cigarettes.


Since I sent my initial letter to you, I have heard from many small-business owners who manufacture or sell e-cigarette products. These job creators have contacted my office expressing their grave concerns about the FDA’s regulatory overreach. They fear that the FDA’s e-cigarette rule will force them out of business by requiring them to complete costly and time-consuming premarket applications for each e-cigarette product. In addition, a large number of individuals have contacted my office to tell their stories about how they use or have used e-cigarettes to quit smoking. They do not want the FDA to make access to e-cigarettes more difficult for them—or others like them—as they fight to kick an addiction to smoking.


As chairman of the primary oversight Committee of the United States Senate, I urge the FDA to be transparent and accountable in its regulatory actions. I ask that you please respond to my requests for information so that the Committee and the American public may fully understand the FDA’s rulemaking and its consequences for small businesses and the public’s health. With this in mind, please respond to each of the questions in the letter I sent on May 17, 2016. In addition, because of the significant public interest in this matter, I ask that you please provide all documents and communications referring or relating to the FDA’s regulation of the e-cigarette industry.


Please provide this information and material as soon as possible but no later than 5:00 p.m. on June 20, 2016. If the FDA does not provide an adequate response to these inquiries, the Committee may be forced to resort to other means to compel the production of this information. Thank you for your attention to this matter.
 

Kent C

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Just came across the following on one of the other sites. The good news is that Sen Johnson expects a response from the FDA:

Thanks for posting!

They're getting some of their own medicine lol...

"If the FDA does not provide an adequate response to these inquiries, the Committee may be forced to resort to other means to compel the production of this information. Thank you for your attention to this matter."
 

Kent C

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Right On Ron.

It's time to put some "Checks" back into this Government that is supposed to be based on Checks and Balances.

I know this isn't the 'Congressional Review' that you spoke about earlier but it's close. I would prefer that both the House and Senate take up their responsibility, but if THIS leads to that, then something has been accomplished.
 

Bob Chill

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Hard to say how much authority the committee really has on this and I'm sure some of Johnson's motivation is chest thumping to a degree. What would be really good to see is additional pressure from other members join the party.

I'm not knocking or dismissing the effort in any way of course. Just saying that I doubt a whole lot can come out of it for the time being.

Is the FDA even required to reply at all?
 

Kent C

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Hard to say how much authority the committee really has on this and I'm sure some of Johnson's motivation is chest thumping to a degree. What would be really good to see is additional pressure from other members join the party.

I'm not knocking or dismissing the effort in any way of course. Just saying that I doubt a whole lot can come out of it for the time being.

Is the FDA even required to reply at all?

I disagree with the 'chest thumping' idea - said earlier by someone else as well, but he has subpoena power unlike any other chairman in the Senate in that he needs no vote to issue - at least that's how I understand it - see Lara's post or mine much earlier in another thread where it is written out what his powers are.

edit: from wiki:

"The committee serves as the Senate's chief investigative and oversight committee. The chair of the committee is the only committee chair in the Senate with the power to issue subpoenas without a committee vote, though in practice, such unilateral subpoenas have rarely been issued in recent years."


The FDA might not be 'required' to reply to his letters, but they would be required to respond to a subpoena. Again, as he has said elsewhere, he was going to make requests by letter first before going to the subpoena.
 
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