Comment · Tue, August 11, 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 · 2 points
Thanks for the response, good info. Looking at 21CRF, it still seems to be vague enough that getting a regulatory attorney would be helpful. In so many words it still seems like it's effectively saying "keep records, be clean, label correctly, don't be an idiot."
u/MisterYouAreSoDumb · Natrium Health & Nootropics Depot
For the most part, yes. Have processes and procedures, have documentation for why you chose to make them that way, always follow those procedures, document the following of those procedures, and be ready to defend yourself if the FDA inspects.