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
Direct reply to the original post — see the thread post above.
u/MisterYouAreSoDumb · Natrium Health & Nootropics Depot
Don't listen to anyone on Reddit for legal advice. Get a regulatory attorney. It's VERY complex. There are literally thousands of regulations to follow. The FDA's posted guidance is just that: a guidance. It is their interpretation of the rules, and how they are going to apply them. It's a framework to guide you into compliance. However, their authority is derived from Congress. So 21 CRF Part 111 is the main set of laws that dictate their mandate and rules. The FDA guidance that they post are their current interpretation of those rules, and how they are going to enforce them. There are other federal statues you need to follow as well. Also, the FDA is not the only one you need to worry about. The FTC has an even broader mandate than the FDA. If I can give you one piece of advice it would be to never fuck with the IRS or FTC. Those are two government agencies with extremely broad mandates, and can completely destroy you legally. The FTC monitors all commercial trade in the US. Doesn't matter if it is a dietary supplement or a washing machine. If you are selling something to a consumer in the US, the FTC has authority to regulate that. The FDA's mandate is a lot more narrow. The FDA regularly works with the FTC and DOJ to do cross-agency enforcement. If the FDA has roped in the FTC and DOJ, that's a sign you are dealing with a serious situation. You'll see that on a few FDA enforcement letters, where they bring in other agencies into the mix. You are jumping into an extremely complex and difficult industry to be in. Make sure you are prepared for that, and get proper legal counsel before doing so.