Deeming Regulations have been released!!!!
- Thread starter Oliver
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I'm confused. (nothing new) Does the following parts of what I read mean businesses don't have to comply at all?
"This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page."
"FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required."
That's just a loophole for the FDA. If they get sued for requiring something that can't be accomplished, they can simply say that was not a requirement.
Concerning this FDA announcement. You can still bring new products to market.
However if they were not on the market and sold before 8-8-16 you need approval
by the FDA to sell them. The FDA did not ban new products.they need pre-market approval.
Mike
However if they were not on the market and sold before 8-8-16 you need approval
by the FDA to sell them. The FDA did not ban new products.they need pre-market approval.
Mike
I'm thinking that moving out the registration date from 12/31 to next June 30 is the simply FDA's attempt to demonstrate they are reasonable while retaining all the extreme elements of the regulation. I don't see it as much of a change at all.
No. I just see it as a Release of Liability by the FDA if you use their Guidance and then things don't turn out the way you would have Liked them To.
True.
But Hopefully between Now and next June there will be some form of Intervention relaxing the Deeming Rule set.
To me it sounds like introducing more ambiguity into the process to allow for selective enforcement. Remember, they threw this one in there:
".........describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited."
They already released 500 pages of regulatory requirements. Which means the use of the word should anywhere in those regulations is not viewed as a recommendation. Besides, they throw this little out for themselves in there:
"This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public"
".........describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited."
They already released 500 pages of regulatory requirements. Which means the use of the word should anywhere in those regulations is not viewed as a recommendation. Besides, they throw this little out for themselves in there:
"This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public"
I personally see it as a positive. More time for things to shake out in the courts and congress.
More products stay on the market for a greater period of time.
The question I have is how many companies might have tried to stay around if they had known they would have an additional 6 months to register. Sort of rhetorical I know.
More products stay on the market for a greater period of time.
The question I have is how many companies might have tried to stay around if they had known they would have an additional 6 months to register. Sort of rhetorical I know.
I wonder if the 'extension' was planned on beforehand so that 'they' could just get rid of some companies right off the bat..
The FDA has known from the start that the majority of companies would bail and close shop rather than go through the expensive and tedious process they require. They admitted this rather blatantly in the deeming regulation itself.
I wonder if it's because the FDA has gotten very few product registrations, yet there are plenty of vendors still open, and the level of non-compliance exceeds their ability to enforce in any meaningful manner? So by issuing an extension, they look less impotent? I know of at least one shop that's taken the civil-disobedience attitude of: I will not comply, and I will stay open until men with guns, court orders, and padlocks close me down by force.
Then there's also the fact that the FDA is about to be under new management, and the new boss promised to reduce excessive regulatory burdens.
Then there's also the fact that the FDA is about to be under new management, and the new boss promised to reduce excessive regulatory burdens.
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