In need of FDA registered CBD lab

Have a local guy being strong armed over price as the producer he sources from is FDA registered or approved, not quite sure on the process of that.

Looking to find more labs for him, the CBD is isolate used in topical mostly

Thanks for any leads

1 Like

When did the FDA start giving out establishment licenses for CBD producers??? They have a pretty hard stance against all cannabis derived materials going into any food, drug (except epidilex) and cosmetics…

You are looking for a testing facility? You are looking for a manufacturer that has an FDA establishment license?

5 Likes

Looking for it to be produced in a facility that is fda approved. Thinking a place that does gummies as well as isolate may be able to fit the bill.

Honestly this was just what I was asked to source and what they were able to tell me. I’m hesitant to believe what they are saying is needed, just know some of the businesses they are selling to are large corporations that had turned down previous products because of stipulations like this. They are currently sourcing from someone in Philadelphia.

Okay. So you are looking for probably a contract manufacturing Nutraceutical company. That company would have been approved for things unrelated to cannabis derived materials and maybe is open to having cannabis derived materials in their facility. I’m not personally aware of any companies that are doing that. But keyword search contract manufacturing nutraceutical and you should at least get some companies you can ask around about.

None of the nutra companies I worked with in the past are doing this work yet. There are a couple people making these claims out of Oregon and Colorado - I haven’t been or seen any real documentation to confirm that this is the case though. They are 100% on this forum though, so they hopefully will reach out.

1 Like

I don’t get the request.
The only FDA approved manufacturing of CBD would
Be a pharmaceutical company producing Epidiolex.
that is for HUMAN CONSUMPTION.

I believe you can apply for alternative use Licensing , for instance
“Plywood glue”. Or…Sunscreen….and get FDA approval.

The request seems odd at best….The someone who is “requesting” should know all about it, and what is odd is to ask
A third party with out knowledge to apply here?

Of course an interstate shipment request…would be a triple red flag. Please advise if anyone knows otherwise.
Please show us. COPY of a FDA license allowing CBD production for human consumption and interstate commerce.

Other wise the request is total nonsense at the very best.

2 Likes

100% agree. The FDA isn’t sanctioning any of those activities.

2 Likes

Are you asking for a GMP certified facility?

5 Likes

It sounds like something similar to this.

So, the company making it makes tropicals and says they are FDA registered, not usually a CBD lab from my understanding but they do product it for this white label product for this account.

I know it is out of Philadelphia, I do not know the name of rhe manufacturer but plan on looking into them more as well.

The company itself is supposed FDA registered and that is written on their packaging.

I dont not know any of this. I have worked traditional market for over 25 years and grow/make rosin and do some R&D in that field.

The product is called magsoothium and is a magnesium based topical they add CBD isolate to. If Googled it should be found easily.

The accounts they sell to are demanding the FDA thing as some of them are big chains and I think it’s a liability thing.

They had to previously shut down production until they found this singular business who was able to allegedly(as this is just what I’m being told albeit by people I trust in any business situation). This is another business for the owner, he has many other things going on but none are canna or CBD.

So I’m wondering if it is possible to find another company matching the requirements that could manufacturer this for a brand.
Also I’m wondering how legit what is going on is. I plan on asking a ton of questions next week to the business manager about their current supplier to make sure its even what they say it is.

Not my part of the game so trying to rely on people on here who know more about it than I do

That’s the closest thing I’ve seen to what he’s asking for. A nutraceutical company with USDA organic certification and cGMP certification.

Edit: this is what I remember seeing on the wall of a nutraceutical company that was exploiting his certification statuses to market “organic” and “FDA/USDA” CBD products in a deceitful manner. He was not licensed to deal in CBD products intended for human consumption.

1 Like

OK…topical…”sunscreen” not for human consumption…class application…when I researched this a few years back…yes I do think you can apply for such a license with the FDA.

Now the “That’s the closest thing I’ve seen to what he’s asking for. A nutraceutical company with USDA organic certification and cGMP certification.” aspects that @ThePhilosopherStoned mentioned are two separate and distinct hoops to jump through.
If you end up needing a USDA organic process DM me.

1 Like

Yes, those certificates do NOT mean they have a specific license for CBD production for human consumption…
Nor does it mean their production facility produces USDA certified “Organic” CBD isolate, unless the exact process for the CBD is what is “certified”. As I understand the caveats. Which is not the same as “made with USDA certified Organic” materials…which is another variation of label.

I will have to research “FDA registered food facility”
Sounds interesting. Yes we have bananas today?

1 Like

Oh ya I’m aware the certs had absolutely nothing to do with hemp or CBD lol

They were not licensed for any hemp activity but were marketing hemp products with these deceptive labels.

I’m merely trying to warn the OP to be diligent in seeking hemp manufacturers who say they have achieved this level of certification.

2 Likes

Yes, I was just confirming Exactly Your Point.
Correct…100%

1 Like

Its really easy to register your cosmetic business with the FDA. Just follow the instructions on this link: Voluntary Cosmetic Registration Program | FDA

Cheap or free (can’t remember so if it’s not free its cheap enough to forget about) simple, and fast. Literally anyone making topicals should be able to do it.

The last reply looks what the company who is manufacturing for him did. Appreciate the help and should be enough to help moving forward.

If anyone knows of topical manufacturers already doing this(registering tropicals with CBD) and manufacturers for outside companies as well please message me or reply here.

Thanks

1 Like

Why don’t you fill out the form…
And when you describe the Cosmetic…
Be sure to write CBD in capitals…and we will see how far you get.

CBD is a registered drug product.

Cheap, simple fast, anyone can fill out the form…it is another thing to be FDA approved for interstate shipment and non consumption use…give them a call…and ask…I wouldn’t make such a presumption.

Think fentanyl you think just because you are making a cosmetic
You are going to fill the same form out using FENTANYL and get approved?

Think…

Lots of people market their CBD cannabinoid product…
And just do it until they get a cease and desist order from the FDA
Or DEA…and then they just move on. And then there is product liability issues…people sue the drug companies all the time…’

This is not the recreational drug use market….it is food products, neutraceuticals and pharmaceutical drugs…

1 Like

This :100:

“the company making it makes tropicals and says they are FDA registered, not usually a CBD lab from my understanding but they do product it for this white label product for this account.”

I was referring to this statement from the op. If you wanted a setup like this the best thing to do would be to find an existing non cbd topical company that is registered with the FDA and convince them to contact manufacturer your cbd topical. You will probably find someone eventually.

"A. A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”

Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)])."

I think you are good with topicals in regards to the FDA but make sure you run a disclaimer and don’t make medical claims. I still wouldn’t put CBD in my company name or any fed paperwork for many reasons. Not legal advice consult an attorney.

Or please correct me if I am wrong.

1 Like