Does CBD Need To Be FDA Approved?
There's lots of confusion in the general public all things CBD.
If fact, most people are unaware of what exactly CBD is!
Then there's the legal status.
We can't go there without fully understanding the FDA's take on CBD in the marketplace.
Is there even FDA approval of various brands?
Let's get into all of that as well as look future direction.
We'll have to make some distinctions along the way.
Here are the main topics we'll cover:
- Officially what type of CBD are we talking about with FDA status
- What is the FDA's official stance on CBD
- Does CBD need to be FDA approved
- Are there FDA approved CBD brands or products
- Is there any CBD product that has FDA approval
- How to choose the best CBD based on FDA status
Let's get started.
Officially what type of CBD are we talking about with FDA status
First, we have to make a distinction as to the type of CBD we're discussing.
The Farm Bill of 2018 specified CBD that's derived from industrial hemp as being legal in the US at the federal level.
This has FDA's (as of the time of this writing) blessing.
Industrial hemp is cannabis with less than .3% THC content in the raw material.
Above the .3% content and it's still a schedule 1 drug at the Federal level.
Various States (like Colorado and California) have made cannabis with higher levels of THC legal.
There are CBD products with zero THC (such as here) but legally, some other others can have up to the .3% limit.
So, we're talking about CBD derived from industrial hemp in terms of FDA approval.
You can check CBD's legal status by State here since there are some wrinkles at the State level.
So, how does the FDA deal with CBD?
What is the FDA's official stance on CBD
Officially, the FDA treats CBD as a food supplement.
This is similar to vitamins, protein powders, and most of what you find at a GNC.
The net effect of this is that it's not regulated by the FDA.
That's correct...they have (for now) decided not to manage this market if derived from industrial hemp.
There are a few other caveats but the .3% THC is really the important piece.
This is good and bad.
It's great because it allows people to take advantage of CBD (see CBD list of benefits) which are mirrored in many studies.
CBD for anxiety is just one example (list to CBD and anxiety research here).
On the other hand, it's the Wild West out there.
Probably 80-90% of the market is junk.
- Low levels of CBD
- Very expensive per mg of CBD
- Potential contaminants
- Other suspects additives
Again, all the things that go along with an unregulated market.
We'll go through the basic requirements to look at with any CBD below.
Another way people ask the question is below.
Does CBD need to be FDA approved
As of the time of this writing and that may change.
CBD does not need to be approved by the FDA because it's technically a food supplement.
Are there FDA approved CBD brands or products
There are no FDA approved CBD brands or products.
There are, however, FDA approved farms!
This is important because CBD is only as good as the raw biomass it comes from.
The farm we source from is FDA approved which governs process, materials, and handling.
It's also GMP (Good Manufacturing Process) certified.
Another question that comes up…
Is there any CBD product that has FDA approval
The only FDA approved CBD-like product is Epeliodex.
It's a medication for seizures and you need a prescription for it.
One note...Epeliodex is a synthetic version of CBD.
The side effect profile is very different (worse) for Epeliodex than for CBD isolate.
We see this quite a bit with synthetic versions of various naturally occurring compounds.
Progestin versus Progesterone is a perfect example.
Among many issues:
Progesterone was associated with lower breast cancer risk compared to synthetic progestins when each is given in combination with estrogen, relative risk 0.67; 95 % confidence interval 0.55-0.81.
That's a 33% reduction in risk between the two of them and millions of women are being told that synthetics are the same thing!
Don't get us started on synthetic estrogens, hydrogenated oils, artificial sugars, etc.
You would think we would have learned by now.
Anyway...as for CBD, there is no FDA approved CBD on the market outside of Epeliodex, a synthetic version of it.
So...since there's no FDA oversight, how do we choose a good product?
How to choose the best CBD based on FDA status
Here's the baseline list of requirements:
- Must be from organically grown hemp at an FDA approved farm
- CO2 cold processed (cleanest option)
- 3rd party tested free of:
- NO THC (see CBD versus THC here)
- No Heavy metals
- No Solvents
- No Pesticides
- No Bacteria
- No Mold
We actually test IndigoNaturals twice; once at the biomass level and one for the finished product.
Our whole family uses it so we don't mess around.
Learn why you can't buy CBD on Amazon here.
They literally don't allow it so any product that comes up under search is suspect.
Then there's the Full Spectrum versus CBD Isolate question.
Most of the market is Full Spectrum (learn about CBD isolate versus full spectrum here).
The reason we focus on CBD isolate aside from the fact that all the research is on CBD by itself is that 40-60% of the population has allergy or histamine issues.
There can be lots of side effects from full spectrum for those people.
We learned that the hard way when we first tried 3-4 of the biggest brands.
If you have experience GI issues, allergy responses, headaches, anxiety, etc….that's likely either bad product or full spectrum effects.
You can read about it right in the reviews.
Just two ingredients...CBD Isolate and MCT oil (derived from organic coconut oil).
Now, the FDA is constantly threatening to regulate CBD so this may all change.
For now, we need to rely on 3rd party testing to find the best product.
We post ours at the top of each page so you don't have to chase for it.
Always work with a doctor or naturopath with any supplement!
The information provided here is not intended to treat an illness or substitute for professional medical advice, diagnosis, or treatment from a qualified healthcare provider.