1 reply to this topic

[telizabeth]

Hello, apologies in advance if this topic has been discussed elsewhere but I have yet to find a clear answer...

 

We will be manufacturing and distributing a hemp based edible product (in the USA). To re-state, this is hemp, not cannabis, and while each state has widely varying rules and regulations, technically it is legal on a federal level thanks to the Farm Bill.

 

Besides the state requirements we must adhere to, for example, obtaining a Food Permit, I need to know if there are any other federal requirements. I have found a single article from the FDA that says:

 

"The 2018 Farm Bill...preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act (PHS Act). FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance.."

 

I believe the FD&C Act requirements are found in 21CFR, and because we're producing a food, specifically, Subchapter B "Food for Human Consumption"

 

If I am understanding correctly, would this mean we're bound to the requirements in this section? Most notably would we need GMP certification?

 

THANK YOU for your insight!! 

Edited by telizabeth, 05 February 2025 - 03:40 PM.

[TimG]

I can't see why hemp would be any different than any other food as far as FDA regs go. Not in this order but here are a few I can think of off the top of my head:

1)FDA Bioterrorism Food Facility registration (will need to update this every 2 years)

2)State food manufacturing registration(s)

3)Train or hire a PCQI to have oversight over risk based FSP (FDA has requirements for this position, make sure you meet them all)

4) Create and install a FSP (Can be HACCP based or use risk-based controls as learned in PCQI training)

5) Determine what ID preserved foods you will, if any, sell under (Kosher, Halal, Organic, etc.) and then determine next steps to achieve and maintain certification

6) Determine what food safety scheme if any that you will certify under (generally based on customer requirements)

 

I might add to this as I can think of more. This is just stuff I can think of off the top of my head while I'm stuffin my face with lunch.