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

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Kent C

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True, but Johnson is also very specifically querying the FDA regarding how many small business in the USA would be... out of business should the regulations remained unchanged. Remember - if you put a coil in a thing you are considered a "manufacturer" - which according to the FDA is a bad thing.

Perhaps the only thing worse than our lack of manufacturing jobs would be the FDA killing off small businesses on a grand scale that "manufacture" to sell what we do not actually manufacture. (Sorry - brain went into FDA doublespeak mode...)

The EPA and other regulations and taxes (and unions) are more responsible for business moving offshore - but the FDA doesn't help either.
 

ZeroedIn

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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.

YESSS!
 

MacTechVpr

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The EPA and other regulations and taxes (and unions) are more responsible for business moving offshore - but the FDA doesn't help either.

Agreed it's far more than the tobacco act or deeming that has chilled prospects for technological development and capital formation. And we are certainly not the only community or industry affected. But as individuals partaking in a very social and overtly visible activity we are squarely in the bullseye.

Our opponents in gov have definitely miscalculated that vaping could be so easily draped over with the lies of addictiveness and harm of nicotine. We're definitely a burdensome thorn in their side as is. But just imagine if we had a million or two more vapers devoted to the effective use and advancement of open systems. Dedicated to the principle of preserving that freedom. If even 10% of them joined our ranks.

We need them to help us to tell gov to extract vaping from tobacco legislation.

Good luck all. :)
 
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sofarsogood

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Senator Johnson, however, is running an ad bemoaning how much merchandise is imported into this country, and how little we are producing ourselves. That is a massive problem for the e-cig industry.
I work for a company that makes custom machines and lines of machines for automotive suppliers and the car companies. Most of what we make is exported including to China. I'd much rather be selling sophisticated production machines to China and buying their ecigs than the other way around. We have to buy something from them or they don't have money to buy from us. I'm a free trader at heart. Let everybody do what they are good at.
 

Katya

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Interesting read:

- U.S. Supreme Court rejects GlaxoSmithKline; FDA e-cig regulations under further scrutiny
- The FDA and GlaxoSmithKline: A pattern of deceptive and devious behavior
- Margaret Hamburg: Long history of ‘conflict of interest’
- Sen. Ron Johnson: An unlikely ally of the vaping industry

U.S. Supreme Court rejects GlaxoSmithKline; FDA e-cig regulations under further scrutiny

girl_yes3.gif
Very interesting read.

v1.bTsxMTE3ODAyODtqOzE3MDc3OzIwNDg7ODAwOzEyMDA
 

MacTechVpr

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I work for a company that makes custom machines and lines of machines for automotive suppliers and the car companies. Most of what we make is exported including to China. I'd much rather be selling sophisticated production machines to China and buying their ecigs than the other way around. We have to buy something from them or they don't have money to buy from us. I'm a free trader at heart. Let everybody do what they are good at.

Like you said sofa, down with all that…if it were true in fact.

Worked in int'l trade for most of my career. Our individual right of free association, of contract, of property ownership and trade or commerce are some of the most cherished principles of human civilized existence.

The fact is if these rights are not reciprocal in our exchange are we really practicing those rights? If the rights of government and if artificial entity are superior or qualifying of such individual autonomy and authority are we in fact trading freely? Do we then actually control the value of our labor and production?

One thing is to administer (regulate, as to abide by established consensus) trade; another, to control it.

This is fundamental to the problem before us.

If we rely on the transfer of technology you describe and our profit centers and capital follow it offshore encouraged or compelled by legislation and regulation then…who creates, who produces who really owns any mods here? In the absence of a level playing field all we're left to own is debt.

As I said, if it were true in fact.

Good luck all. :)
 

sofarsogood

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Like you said sofa, down with all that…if it were true in fact.

Worked in int'l trade for most of my career. Our individual right of free association, of contract, of property ownership and trade or commerce are some of the most cherished principles of human civilized existence.

The fact is if these rights are not reciprocal in our exchange are we really practicing those rights? If the rights of government and if artificial entity are superior or qualifying of such individual autonomy and authority are we in fact trading freely? Do we then actually control the value of our labor and production?

One thing is to administer (regulate, as to abide by established consensus) trade; another, to control it.

This is fundamental to the problem before us.

If we rely on the transfer of technology you describe and our profit centers and capital follow it offshore encouraged or compelled by legislation and regulation then…who creates, who produces who really owns any mods here? In the absence of a level playing field all we're left to own is debt.

As I said, if it were true in fact.

Good luck all. :)
There are trading rules and there are national security lines in the sand. I don't oppose those in principle. I developed a product with a stiched fabric componant. The kind of work necessry to produce that part is not done in the US. The only way to get it was from Pakistan, China, etc. When it was feasible to manufacture parts in my own shop I did. There are always important advantages like revisions on the fly, inventory control, quality control, the list goes on. Once upon a time Americans were shifting from agrarian to factory work for the sake of a better life. Now people in other parts of the world are doing that and it's hard to justify impeding that and erecting barriers to keep low tech, low wage jobs in the US. Empires are gone because they are inefficient. It makes more sense to trade than conquer.
 
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MacTechVpr

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…it makes more sense to trade than conquer.

Agreed…or to be conquered and assimilated.

Like I said, I'm all for the free exercise of commerce or real human technological progress. But we don't have that. And we won't as long as artificial constructs, e.g. FDA deeming authority, have equal or greater rights than the individual. Witness this emerging industry and technology which makes us principal witnesses to the effects of such. At some point I would hope we may not be so hopelessly at odds with each other as Americans that we may start to view the importance that the individual represents in terms of truly accomplishing anything of greatness. For us that means the larger community responding to the blatant unfairness of gov's coercive decimation of this industry domestically. That is not what I would call free trade.

Good luck. :)
 

sofarsogood

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Agreed…or to be conquered and assimilated.

Like I said, I'm all for the free exercise of commerce or real human technological progress. But we don't have that. And we won't as long as artificial constructs, e.g. FDA deeming authority, have equal or greater rights than the individual. Witness this emerging industry and technology which makes us principal witnesses to the effects of such. At some point I would hope we may not be so hopelessly at odds with each other as Americans that we may start to view the importance that the individual represents in terms of truly accomplishing anything of greatness. For us that means the larger community responding to the blatant unfairness of gov's coercive decimation of this industry domestically. That is not what I would call free trade.

Good luck. :)
You're getting kind of broad. I want trade to be as free as possible. We've all agreed that laissez faire is too broad. The ecig problem boils down to corruption which is a controlling issue for most big problems. My definition of corruption is broad.
 
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retired1

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The huge issue of losing manufacturing to overseas companies can be boiled down to a company's inability to make changes on the fly. The reasons for this are numerous (unions, etc. etc. etc.). Where a spec change can be sent to a Chinese facility and the change is made within 12 hours, it's hard to justify keeping that work in the US. Could you imagine the uproar if the engineers sent a spec change for a Chevy, and wanted it completed within 12 hours?

Some interesting reading.

http://www.nytimes.com/2012/01/22/business/apple-america-and-a-squeezed-middle-class.html

For a good chunk of what's imported (including e-cigarettes), bemoaning about the amount of product that's brought in is a red herring. We have only ourselves (collective, not individually) to blame as we became more rigid about how the job was done. Most manufacturing facilities in the US would laugh you out of the room if you asked if they could do a design change and get it to production in less than 24 hours.
 

Rickajho

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Wow - I'm really amazed at the smokescreen being pointed at the American workers and unions. I'm sure the little guys on the ground were the ones who pushed for NAFTA. Of course if you feel good about people working for $2.00 an hour (if they should be so lucky) then by all means - keep blaming the American workers for the loss of manufacturing jobs to offshore locations while corporate profits reach all time highs.
 

Kent C

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Of course if you feel good about people working for $2.00 an hour

The thing about that line of reasoning, it almost never includes cost of living. And people invariably compare it to making $2.00 an hour here. $2.00 a hour (or less) is sometimes the difference of working at a respectable job vs. not so respectable job, or no job at all, in some countries. And if it weren't a 'living wage' they'd all die.
 

retired1

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I despise NAFTA as much as anyone. It still doesn't erase the fact that foreign companies are more nimble and give more bang for the buck than US manufacturers. If US manufacturers were as quick to please as foreign manufacturers are, there'd be a lot more business kept inside the US. When you can send your e-cigarette design to China, and have a working product within days that's ready for manufacturing, there's a lot to be said for how things could be done here in the US.
 
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zoiDman

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... When you can send your e-cigarette design to China, and have a working product within days that's ready for manufacturing, there's a lot to be said for how things could be done here in the US.

That's Cool. And Rapid turnaround is Great.

But when the Cost of Goods Sold for a Manufacturer is so Disproportional between China and the USA, I don't see that it is the Deciding Factor as to being Profitable.
 

zoiDman

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It was for Apple. The cost difference between manufacturing the iPhone in China and the US was around 65 dollars if I recall. it was China's ability to rapidly make design changes and ramp up production within hours that tipped the scale.

It may well have been for Apple. But can the same be Said for the Manufacturing Market in General?

Much/Most of Manufacturing is Static without Design Changes. Just Pumping out Parts to make a Delivery Schedule. And this is where Most Foreign Manufactures with Lower Operating Costs clean up on US Manufactures.
 
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