IndigoNaturals Response to FDA Review
When people search for IndigoNaturals, one of the first things they can see is an FDA warning.
Not exactly the warm welcome they might expect or we might hope for.
We have to go back to early 2020…at the very beginning of the pandemic.
Hopefully, it's obvious from the million+ words of research referencing dozens of NIH studies (search the blog here) that data is what drives us.
Most of the market is pushing full spectrum CBD despite the issues with histamine (see full spectrum versus Isolate)
Small amounts of THC, CBG, CBN, etc which can build tolerance which is the wrong direction.
Lots of bad info out there but we rely on NIH studies. So…
The pandemic hit and our first concerns were simple…
Does CBD affect or impair our immune response?
You could call this self-interest because we take it daily (it doesn't build tolerance over time -see and tolerance).
We went to work and investigated everything we could find. The results were encouraging..very encouraging.
There were probably 6-7 big reviews (2000+ words) looking at a range of topics such as cytokine storm (the immune overreaction after falling behind with infection), effects on the immune, etc.
We even looked at fisetin, quercetin, and other options.
Here's the issue…it was early days and everyone was trying to wrap their heads around an evolving situation under intense fear and uncertainty.
Of course, people came out of the woodwork pitching their wares to "cure" that which shall not be said. Literally…don't want to put it in this article.
The FDA proceeded to crack down on any and all (most) info that even smelled of this.
We were caught in that maelstrom.
They sent a warning letter directly to us with the required edits on the pages.
We made the edits (within 1-2 days).
There was more request for edits. We made those as well.
We then had a conference call with both FDA and CDC representatives to address any requirements needed.
It became pretty apparent that no amount of editing was going to suffice so we offered to just take down the pages.
That's what we did…within 24 hours of the call.
We get it…there were some really bad actors out there promoting all sorts of nonsense and the FDA has full authority (and cause really) to go after this type of information.
We even understand that there's little subtlety in such an endeavor in a "war" like setting which we were indeed in with the initial pandemic.
The pages came down…never to go back up. Keep in mind, that each one had maybe a dozen NIH studies with their excerpts and links but this is secondary in a global panic.
So…the warning that pops up on Google.
About 6 months after all this and complete compliance, we asked if they can take down the warning.
They replied no…once the warning is issued, it stays there (we're guessing forever). A record of the warning per se.
Alright…we can't do much about that and in the end, we just keep trying to dig into NIH studies and understand how CBD and other tools can help people feel better.
An explanation was definitely in order though and this is that.
Feel free to reach out to us with any questions on this or CBD generally.
A few notes though…
- We have 1 million+ words of detailed research on CBD across multiple pathways (see blog here)
- We have multiple reviews on topics we don't SELL…such as Vitamin D, Berberine, Estrogen and mental health, and on and on.
- IndigoNaturals provides CBD isolate at levels that actually match research
- IndigoNaturals sources CBD from US grown hemp at FDA registered farms
- IndigoNaturals offers discounts up to 50% for the best pricing we can find with a quality product
Our basic guarantee:
- No THC (see CBD without THC to learn why)
- No Heavy metals
- No Solvents
- No Pesticides
- No Mold
- No Bacteria
Again, we base our product on research.
As for the nature of our company, read the origin story here.
Then…look at our IndigoNatural product reviews available on any product page here.
These reviews really speak to the kind of people we are and the kind of product IndigoNaturals is. Verified customers through a third-party app in Shopify (called STAMP).
These reviews are why we do what we do. Point.
We take this whole endeavor very seriously for the simple reason that we were once on the other side (founder story here). Our CBD use/research was born out of trauma and this is our way of giving back.
Hopefully, the FDA sees this with time and removes the warning. We appreciate what they do to safeguard our nation's health and wellbeing regardless.
Be well. Take care of each other. Take care of yourself.