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Comment · Wed, August 12, 2020 · Natrium Health & Nootropics Depot

FDA's rules on supplement manufacturing -- anyone knowledgeable on them?

Original post in this thread

NaturalPermission · 58 points

For months I have been off and on working toward making an herbal supplement company, calling the health departments and FDA offices to ask what regulations I need to follow. I've read up on the DS CGMP and others, but for the life of me can't understand, either from the documents or from conversations with the departments themselves, what rules I actually need to follow. Beyond accurately labeling and describing the products, what is there? The guidance documents are filled with "rules," yet it clearly says they are just recommendations. There's also this contradictory section, first saying:

-"The DS CGMP rule is binding and has the full force and effect of law."

Then immediately after saying:

-"FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. "

I just don't want to sink money and time into the wrong areas and have to reorganize after getting hit with citations.

What they were answering

NaturalPermission · 3 points

Radical, thanks for the direction! What a world to dive into hah

u/MisterYouAreSoDumb · Natrium Health & Nootropics Depot

My pleasure! Good luck! Be prepared to get smacked in the face a few times without warning.

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