Will FDA Regulations Take Down CBD Oil Supplement Industry?
High scrutiny leads to trouble for CBD oil supplement companies.
Breaking news from the FDA has put the marijuana and CBD supplement industry in the spotlight.
To better understand the FDA's actions and what this means, let's take a step back and start from the top...
What is CBD Oil?
Let's start with the cannabis plant and it's 2 most well-known varieties: hemp and marijuana.
All cannabis plant varieties contain compounds called cannabinoids - in fact, over 60 types of cannabinoids have been identified to date. [1]
Of those, THC and CBD (cannabadiol) are the cannaboids that 2 most people are aware of. THC is the psychoactive compound that is responsible for the "high" associated with marijuana and it's presence in marijuana plants is the unique characteristic that distinguishes them from hemp.
Hemp by contrast contains very low levels (if any) of THC.
Cannabadiol, or CBD for short, is a non-psychoactive component in hemp plants that has demonstrated numerous health-promoting effects and has recently come into popularity as as supplement.
The FDA Crackdown
8 US Companies - including Healthy Hemp Oil whom we interviewed on Episode 21 of the OPP - were singled out by the FDA and informed that 22 of their CBD-containing products are not in compliance with federal laws. [2]
Strike 1:
The companies first mistake came from their aggressive labeling and marketing tactics.
The FDA only allows supplements to make "Structure/function claims."
For example, "this product contains CBD oil which has been show to decrease self-reported feelings of stress" or "improve carbohydrate metabolism."
The companies targeted were busted for making stronger claims about drugs and or disease states.
Here's an example of the claims that got them in trouble: Healthy Hemp Oil touted that its CBD oil could “alleviate anxiety, help heart disease and diabetes, and has anti-cancer properties".
Claims like these are not allowed for any dietary supplement, regardless of ingredient ever since the 1994 Dietary Supplements Health and Education Act (DSHEA) that declared supplements cannot claim to “diagnose, treat, cure or prevent any disease”. [3]
Strike 2
The second strike came when the FDA decided to test the products for potency.
Upon testing many of the CBD oil products on the market, the FDA discovered that most products DID NOT contain the amounts listed on the label. (See some of the test results here).
One possible explanation for these industry-wide shortcomings is that CBD is VERY EXPENSIVE - creating issues from the start with having products contain such high levels of CBD yet trying to meet consumer demands of affordable prices.
It's worth noting that most of these CDB companies are re-sellers, that is, they are not harvesting and manufacturing their own product.
Nonetheless, at Natural Stacks we feel like a company's word should mean something.
We strive to be honest in our marketing and labeling claims and to be transparent with our ingredients - that way you always know exactly what your getting - with every dose and every order.
**We want to point out that Healthy Hemp Oil's 25% CBD Hemp Oil Gold Label was one of the few to meet label claims during the FDA's tests.**
Strike 3
Ironically, the third and final strike for these CBD-sellers comes from the medicinal classification of marijuana and it's components - both THC and CBD.
Under FDA regulation, a supplement can become a drug and remain a supplement (omega-3 fish oils are one such example), but if a substance is a drug first it can never become a supplement. (As Puff Daddy told us back in the 1990's, it's all about the Benjamins.)
In the case of CBD Oil, medical marijuana and other THC treatments date back to 2007 and therefore preclude CBD Oil from ever being able to become a supplement.
What this means...
This appears to be the end of CBD as a supplement.
The labeling claims and potency issues can take down a company, but not an industry.
Ultimately, the FDA ruling that CBD was a drug first will prevent it from ever being sold as a supplement. if this ruling stands, say goodbye to CBD as a legal, over-the-counter, supplement.
Resources:
- http://www.leafscience.com/2014/09/16/5-differences-hemp-marijuana/
- http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm435591.htm
- http://newhope360.com/supplements/did-fda-just-kill-cbd-market?page=1