CDPHE 2021 changes

https://drive.google.com/file/d/15kEVNcFFdP07OFaalZ8D5OG4KEStUxce/view?usp=drivesdk

I haven’t seen anyone talking about this on here yet.

5% is all good under your manufacturers license, and D9THC in end products that are labeled is good.

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not just that everything will have to be manufactured in a cGMP certified facility. This will go into effect June 1st.

Just in Colorado or…?

Yep these are Colorado’s updates on the hemp program.

Where did you see they are requiring cGMP, have a link by chance? I checked my recent emails from the but did not see that, want to forward it to our manufacturing partners

Its in section 21.7 of the document that he linked for normal food, dietary supplement, and cosmetics handling.

And then there’s specifc section for packaging and labeling under cGMP that points directly to the Code of Federal Regulations depending on the kind of product you are packing and labeling.

For Foods and dietary supplements - Section 21.7, g, 2 - CFR Link 101

For Cosmetics - Section 21.7, g, 6 - CFR Link 701

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Just pulled up the link from @TheLastHashbender again to review that, I see where it says that packaging and labeling requirements need to meet the same standards but I think @steelrollin is saying they are requiring that the actual facilities all be cGMP certified. GMP compliant packaging and labeling is one thing, but full facility retrofits and GMP auditing is a whole separate animal.

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for sure but my understanding is that is also involves the facility not just the labeling.

I’m not sure, I don’t think they would have lumped that big a change under their Packaging and Labeling tag. The subsection they list in the CDPHE Regs is 21 CFR 101 A-G, which is specifically titled ‘Food Labeling Requirements,’ and then is immediately followed up with a list of their own labeling requirements. I feel like they would have stated that a facility must be fully cGMP certified and compliant in a much larger way in this document.

I sent them an email asking for clarification, will let you all know what they say in response.

Here’s the response I received from CDPHE this morning:

“It has always been a requirement for facilities to utilize a commercial kitchen to produce products. A cGMP facility is not required unless the facility decides to get that certification through a 3rd party company.”

Hope this helps

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Agreed. That is actually in section 21.7 - it lists out the specific cGMP things they are going to start auditing for and points you to local regulatory authorities (which in Colorado have historically been the local health departments for these products). Its not everything under the sun for cGMP like you would see in a food processing facility, and nothing close to pharma. But they did start with supplier control for all ingredients, expanded the testing that is needed, the sampling that has to be done, and employee controls.

What @CPC says here:

Has been my experience with them for sure. Commercial Kitchens have their own food handling HAACP driven cGMP requirements. And now there are more requirements for the labeling portion of the quality system in the new sections here as well.

Gotta look to the county or local municipality to see if they have extra provisions for food stuffs, dietary supplements, etc.

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according to our legal team who has been in very close contact with them regarding this, everything is required to be manufactured in a cGMP certified facility. There might be potential for extraction facilities to not be required to have cGMP but any facility formulating finished products and packaging them will be required to be cGMP. This is standard for the supplement industry which is what we are playing in. Not the food industry. All products will need to be labeled with batch and lot tracking and you will have to be able to perform recalls. You can’t just do that out of a CDPHE approved kitchen.

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I’m all ears for more feedback from your legal team regarding clarification, but I have not found any printed rule in the regulations, even for final products, that states they must be manufactured in a cGMP Facility.

If all products within the state are required to be manufactured in a cGMP facility starting June 1st, a certification process that takes months to upgrade existing facilities and even longer to complete the audit process, I hope it would be very explicitly stated since many current businesses would be forced to shut down their operations overnight. The quote I posted above came directly from their office via email stating that a commercial kitchen is required, but if their office may have misunderstood my questions and it actually explicitly states that cGMP is required then I definitely want to know so we can get the certification process starting immediately :pray:

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I do think there is a misunderstanding here. You can’t just have cGMP labels and packaging. GMP stands for good manufacturing practices, which in theory should incorporate the entire process of product formulation, packaging, labeling, and distribution. I think what they mean by labeling and packaging has to be cGMP means it has to be done in a cGMP facility.

Maybe you can make your gummies or something in a commercial kitchen but once that it done it would need to be transferred to a cGMP facility for packaging, labeing, and distribution is kind of my understanding. That is if you are willing to find a cGMP certified facility that is willing to take the product in and quarantine it to ensure it’s safety before packaging.

My understand is also that this will put a lot of people out of business if they do enforce it.

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In the original text that @TheLastHashbender links above they just say labeling should be done in accordance to those CFR rules, which covers health claims, nutritional information being printed, etc etc, but I don’t think they state any certified GMP requirements. I understand what you mean about having GMP labeling and packaging but not actually incorporating an entire GMP process, that wouldn’t make any sense at all, but it doesn’t seem like any GMP certifications at all are required though.

I think I used cGMP and CFR too interchangeably which added to the confusion, that’s my bad. I’ll take some time this afternoon and reread through 21 CFR 101 A-G and see if they explicitly mention requirements for GMP within those reference sections, I did not see anything the first time but I could have easily missed it.

Wouldn’t be a bad thing for them to eventually require facilities be certified GMP, I’d hope for a little more time to prepare though.

There is no necessary certification process for cGMP facilities. There is a regulatory inspection and you maintain continuous improvement. So don’t think that most of the companies already actively producing under the FDA have some kind of certifications - they don’t. They get their establishment license and that’s that.

This seems like the same kind of process that appears from the CDPHE documents. And Denver was already on this track two years ago - so it doesn’t seem terribly new to me at all. And I decided not to have a facility in Denver because of this. It seems like that is expanding to the whole state now - which seems normal since it always felt like things were being rolled out from Denver to me. :frowning:

Following cGMP is just good business practice. Its industry best standard for our sister industries, you know?

My experience with enforcement is that it is risk based. Here’s something from the FDA about how that thought process works. There will be people who are harmed. There will be people who fly under the radar. This will be based on the normal things: customer complaints, failing test results, size, previous audit experience, etc.

I feel like you are really missing these parts. I even gave you the section in the new CDPHE document that lists out the GMP requirements. It does not say GMP what it says are the things you do to maintain GMP. There is very clear statement that points to “Pure Food and Drug
Law”, Section 25-5-401. This points out all the things that make your product adulterated or misbranded in CO. The opposite of those things is GMP. <3 More info about that below.

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Also - it clearly limits the type of stuff that this is now “allowing” - which does not include things that are federally controlled by the FDA. So this new document only applies to food, dietary supplements, and cosmetics (topicals).
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There is also a section that outlines that these rules only govern intra-state commerce - meaning you cannot make stuff under these rules and get around the FDA’s rules that say you cannot put these products into interstate commerce.

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Here’s the 10 principles of GMPs. I’ve noted which ones are included in this new document from CDPHE - which is why I think there are people agreeing that this document clearly says GMP is the rule. That’s 9 out of 10 - seems to me like 90% GMP is GMP. And that last 10% is probably implied but just not explicit.

  1. Writing Step by Step Work Instructions (Covered now in section 21.7 D)
  2. Following the Work Instructions you have written (Covered now in section 21.7 D)
  3. Documenting the work you are doing (Covered now in section 21.7 D and 21.7 G)
  4. Validating the the work you are doing happens consistently (Covered now in Section 21.7 G 2)
  5. Clean facility design and cleanable equipment selection (Covered now in section 21.5 A)
  6. Maintaining your facility and equipment in a clean and operable state (Covered in 21.2 and 21.7 G)
  7. Training your employees and making sure they are competent for their jobs ( I didn’t see this one explicitly, although it is included in the Pure Food and Drugs law)
  8. Protecting against contamination (aka packaging in a clean space) (Covered now in section 21.7 G)
  9. Controlling components and ingredients (Covered now in section 21.4 A1 - and also 21.7 E)
  10. Conducting and planning periodic internal audits of the above (Discussed in section 21.7 G 1 E)
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I have only seen one communication from the cdphe and it says literally. “A cGMP facility is not required unless the facility decides to get that certification through a 3rd party company”. That seems pretty straight forward. Unless someone else shows a communication from them that says “you must use commercial kitchen” I Don’t see why it would be required

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You need to follow the rules set out in the CFR and state specific reqs, but a third party audit isn’t required. I.e. you need to have SOPs for holding and distribution, recalls, record keeping, sanitation procedures, validation stuff, etc. but you don’t need to have SGS or NSF come out and audit. Seems to be what the new guidelines and CDPHE say.

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My main sticking point in this entire conversation is the word “Certified” was used in regards to facilities. This implies an independent audit and accreditation process.

Operating within state guidelines that are designed in accordance with many GMP practices, that’s fine. I believe we are in full agreeance of what the state is asking of facilities within their guidelines, but @steelrollin has said a facility certification is required. That is the point of confusion and discussion here, at least for myself. To my understanding your facility may be GMP compliant as a result of the regulations but there is no required certification that must be independently sought out. That is what the CDPHE has confirmed as well.

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Our understanding is the facility has to be cGMP certified and that is what we are going with. I’m glad we have all of that in place and are ready for whatever. I’d recommend reading into rules a regulations for the supplement industry and get them in place now. Because the FDA will require that soon.

Either way I wish you the best of luck and would recommend getting some sort of legal team in place.