Unfortunately, if you're in the US, the rules will apply. So any manufacturer not registered with the FDA and having a PMTA approval on file will not be able to manufacture or sell. The only way around it is to go off shore, or, as you mentioned, subcontract to a foreign manufacturer. And even then it's a gray area if they're maintaining a presence in the US.
Bummed About Future Lack of Innovation
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Unfortunately, if you're in the US, the rules will apply. So any manufacturer not registered with the FDA and having a PMTA approval on file will not be able to manufacture or sell. The only way around it is to go off shore, or, as you mentioned, subcontract to a foreign manufacturer. And even then it's a gray area if they're maintaining a presence in the US.
They said it came up when they added it to the cart. So it sounds like yours will be processed. Let us know.
There is nothing stopping them, except the exclusion of their native market. That is a a significant obstacle. The US market is a rather important one.
California Smog Emmissions Standards drive Japanese motorcycle manufacturing. Why? Because they must sell in the US market to get maximum return on their R&D investment. They don't want to lose out on even a single state of the coveted US market.
Your subcontracting/manufacturing assertion is possible, but I submit that there are some real problems with doing that.
I like my ProVari v2.5. I paid a premium for it in 2013. I did so because I believed their QC process was exceptional. I would not value a ProVari manufactured in China the same way, not even close. It is probable that many others feel the same.
I don't count on a great deal of future US innovations. I hope I am wrong.
I do not agree completely with this assertion, but I can accept it as your perspective. I would submit that the industry had already regulated itself to some degree. I suspect your view of the self-regulation was that it was inadequate.
I will not label either of these positions as unreasonable.
Agreed.
What we got from the FDA was certainly egregious and arguably harmful to public health, and as such, some will be inclined to speculate why. It is natural to question motivations when these things happen. Perhaps there was no ill will and/or collusion, only carelessness/laziness.
Unfortunately when you step back and examine all the relationships involved, one should consider the possibility that it may have been cronyism...particularly when you consider that it would have been pretty simple to minimize these concerns and permit domestic innovation to thrive.
Quite accurate. But at least with CA emissions standards they are clearly defined standards that can be met by manufacturers, even at considerable added expense to the vehicle which of course is passed on to the consumer. I wish such clear standards existed in these regulations so manufacturers could meet requirements and continue to offer new and improved products.
I don't even give them arguably harmful, it flat out is harmful to public health. Every vaper who returns to cigarettes, and every smoke who fails to stop smoking because these regulations restrict an effective method is harmed by these steps.
It flies in the face of common sense and the scientific data available to date. I'm not saying leave a product on the market without any attention until folks start dropping dead from it. Observing for safety in the marketplace is an important function someone should be doing. But when the regulatory agency itself states it doesn't have enough data to establish safety one way or another, I'd expect them to gather the data before taking such drastic restrictions.
Look at how many products that get passed that do have known detrimental side effects.
The truth is: They don't know what's going on with drugs. They don't monitor drugs they fast track approval on, they don't do enough research before approving products, they play favorites with what they approve, and yeah, they approve unsafe products all the time.
The whole sordid mess that is our FDA is easy to research. I encourage all readers to do so.
"It is said that if you know your enemies and know yourself, you will not be imperiled in a hundred battles; if you do not know your enemies but do know yourself, you will win one and lose one; if you do not know your enemies nor yourself, you will be imperiled in every single battle."
--Sun Tzu
Would just like to chime in and say that this is a great read, not just information wise, but how you guys are carrying yourselves. Class.
That's all. Thanks.
That's all. Thanks.
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