FDA FDA deeming regulation proposals

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pamdis

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KODIAK™;13002527 said:
This is something else to point out to the FDA. God only knows what side effects nefarious "bathtub gin" brewers will have on the black market.

By the way... can tobacco grow here in AK? :D

If it can't, there are places on the internet where you can buy whole tobacco leaf.

If I have to return to smoking, this is my plan for how to do it without returning to BT.

But you could probably use it for nic extraction too. Especially the organic ones.
 

mkbilbo

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Speaking of issues that have to do with regs harming business:

Office of Advocacy - Regulatory Flexibility Act - The Regulatory Flexibility Act | SBA.gov

"The following text of the Regulatory Flexibility Act of 1980, as amended, is taken from Title 5 of the United States Code, sections 601–612. The Regulatory Flexibility Act was originally passed in 1980 (P.L. 96-354). The act was amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (P.L. 104-121), the Dodd-Frank Wall Street Reform and Consumer Protection Act (P.L. 111-203), and the Small Business Jobs Act of 2010 (P.L. 111-240)."

This bit is interesting...

"(6) the practice of treating all regulated businesses, organizations, and governmental jurisdictions as equivalent may lead to inefficient use of regulatory agency resources, enforcement problems and, in some cases, to actions inconsistent with the legislative intent of health, safety, environmental and economic welfare legislation;"
 
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Sirius

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Speaking of issues that have to do with regs harming business:

Office of Advocacy - Regulatory Flexibility Act - The Regulatory Flexibility Act | SBA.gov

"The following text of the Regulatory Flexibility Act of 1980, as amended, is taken from Title 5 of the United States Code, sections 601–612. The Regulatory Flexibility Act was originally passed in 1980 (P.L. 96-354). The act was amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (P.L. 104-121), the Dodd-Frank Wall Street Reform and Consumer Protection Act (P.L. 111-203), and the Small Business Jobs Act of 2010 (P.L. 111-240)."
Holy mother of bureaucratic double talk..I see your point though.
 

Danoman

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I'm just not a gambling man... (especially where government is concerned) Besides, i'm all set for a VERY long time on PG, VG, Nicotine and more flavors than i'll prolly ever use. When I learned how to make my juice, I got pretty serious about it. I did this because I absolutely hated the e-juice I got when I started vaping. I stuck with it but, decided to make my own so I could actually enjoy what I was vaping. :D
 

mkbilbo

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Holy mother of bureaucratic double talk..I see your point though.

Oh yeah, total bureaucratese. But the law in question deals with applying to small business regs that fit big business. Which the FDA is aiming to do. Like in the preamble:

"(a) The Congress finds and declares that —

(1) when adopting regulations to protect the health, safety and economic welfare of the Nation, Federal agencies should seek to achieve statutory goals as effectively and efficiently as possible without imposing unnecessary burdens on the public;

(2) laws and regulations designed for application to large scale entities have been applied uniformly to small businesses, small organizations, and small governmental jurisdictions even though the problems that gave rise to government action may not have been caused by those smaller entities;"
 
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Kent C

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Speaking of issues that have to do with regs harming business:

Office of Advocacy - Regulatory Flexibility Act - The Regulatory Flexibility Act | SBA.gov

"The following text of the Regulatory Flexibility Act of 1980, as amended, is taken from Title 5 of the United States Code, sections 601–612. The Regulatory Flexibility Act was originally passed in 1980 (P.L. 96-354). The act was amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (P.L. 104-121), the Dodd-Frank Wall Street Reform and Consumer Protection Act (P.L. 111-203), and the Small Business Jobs Act of 2010 (P.L. 111-240)."

This bit is interesting...

"(6) the practice of treating all regulated businesses, organizations, and governmental jurisdictions as equivalent may lead to inefficient use of regulatory agency resources, enforcement problems and, in some cases, to actions inconsistent with the legislative intent of health, safety, environmental and economic welfare legislation;"

Does the deeming doc violate any of the 8 points?

1.√
2.√
3.√
4.√
5.√
6.√
7.√
8.√

100%
 

pamdis

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Does the deeming doc violate any of the 8 points?

1.√
2.√
3.√
4.√
5.√
6.√
7.√
8.√

100%

Yes, but those are just the findings. Read the rest of the law. It doesn't say they are not allowed to make rules that are burdensome to small businesses. It just says the agencies have to submit analysis reports about it, which FDA has done.
 

mkbilbo

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Yes, but those are just the findings. Read the rest of the law. It doesn't say they are not allowed to make rules that are burdensome to small businesses. It just says the agencies have to submit analysis reports about it, which FDA has done.

Ah but 611 discusses judicial review.

Anyway, it's something actual lawyer types may want to look over. Sometimes, a way to fight a bureaucracy is be bureaucratic about the rules. If there's an opening to force them to acknowledge the existence of small vape shops instead of a tobacco like "vape industry"... might throw a monkey wrench in their rush to regulate...
 

pamdis

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Ah but 611 discusses judicial review.

Anyway, it's something actual lawyer types may want to look over. Sometimes, a way to fight a bureaucracy is be bureaucratic about the rules. If there's an opening to force them to acknowledge the existence of small vape shops instead of a tobacco like "vape industry"... might throw a monkey wrench in their rush to regulate...

I stopped reading at the end of section 610, LOL. Too much reading legalese lately and my eyes are starting to glaze.

But 611 does look promising. Sounds like a small business has one year after the final rule to request judicial review and that the remedy could be "deferring the enforcement of the rule against small entities unless the court finds that continued enforcement of the rule is in the public interest."

This may be what CASAA is referring to when they say they might sue after the final rule? If not, we should make them aware of this avenue when/if it comes to that.
 
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Kent C

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Yes, but those are just the findings. Read the rest of the law. It doesn't say they are not allowed to make rules that are burdensome to small businesses. It just says the agencies have to submit analysis reports about it, which FDA has done.

Standard format - BS Idealistic purpose followed by the Cold reality near incomprehensible details for control.
 

salemgold

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