FDA Warns CBD Companies for 2nd Time

By Sweet D | Uncategorized

Feb 11
FDA warns CBD companies Dose of Nature

FDA Warns CBD Companies for Second Time: Examining the latest batch of FDA warnings recently sent out to U.S. CBD distributors on health claims.

2/10/16: In a move similar to one made around this time last year, the FDA has recently sent out a second batch of warning letters (as reported by NewCannabisVentures here) to several companies producing CBD rich hemp oils for sale online. Whereas the first batch of warnings issued by the FDA last year contained admonishments for both medical claims and questionable cannabinoid levels, this latest batch of warning letters seems to primarily focus upon medical claims being made about CBD on many of these merchants websites, social media accounts and other websites that may link back to their store websites.

FDA warns CBD companies Dose of Nature logo

Even one of our recommended merchants, Dose of Nature, has found themselves on this latest list, primarily for medical claim related content posted to sites we don't link to or were previously unaware of, it would appear.  This is an unfortunate mistake on Dose's part, who are an otherwise great supplier of quality hemp oil products.


It can be challenging to market a product, when you cannot tell your customers what it does, or share testimonials or reviews and CBD companies, and the webmasters these companies often have to hire out and rely on, find themselves afoul of this line from time to time. Everyone in the industry wants to share how great this stuff is but are starting to become afraid to even print "CBD" on the product bottle anymore, let alone tell anyone what they believe or have seen cannabidiol do. It is fostering a read between the lines environment with merchants like Amazon now selling "hemp extract"  that was termed "CBD Oil" a year ago.

Medical Claims and Health Supplements


Now medical claims as they pertain to unregulated health supplements are nothing new,... and the FDA says you cannot make them. If a company were to infer that a substance was for the treatment of X, they would need to provide data that would back this up such as proprietary studies the company may have funded. When you are marketing a nutritional supplement and you indicate it may be effective with such and such, you begin to blur the line on what is a supplement and unregulated, and what is a drug, and heavily regulated by our FDA.


And this is where CBD companies are getting themselves in hot water.  Many are linking to 3rd party studies—often done with marijuana, not hemp— that indicate the efficacy of CBD or linking to research articles on CBD illustrating its usefulness.  Many times this can be misleading as much of this study and research is done either with marijuana that also contains THC, or using synthetic laboratory knock offs that mimic substances such as THC and CBD, due to the difficulty of working with whole plant marijuana, which is a Schedule one substance.

There are additionally, in many cases, a very specific type of health claim the FDA is concerned about:


Not just any health claims


The FDA in this case, is looking at the CBD issue from the interests of a particular British based pharmaceutical company by the name of GW Pharma, that is currently testing their own marijuana based CBD product. This product, Epidiolex, is currently in clinical trials in the U.S. pending FDA approval for Rx use. 


GW Pharma, as many developers of pharmaceuticals do, have filed what is known as an IND, or "Investigational New Drug" status for their marijuana based cannabidiol product. This IND attempts to lock up, if you will, specific interests in an otherwise unpatentable plant for this particular company. So they have filed an IND that states their product may be effective for "this, that and the other" and they have publicly published data to support their claims.


This IND now prevents, anyone else, from jumping in and also stating that their similar product does "this, that and the other as well" and marketing it as a nutritional supplement.  So in many cases, these current FDA warnings to companies marketing hemp based CBD, are regarding specific claims that transgress the rights of GW Pharma under their current marijuana based IND.


Now you will noticed that we have highlighted both the words marijuana and hemp in the paragraphs above. This is because GW Pharma is marketing and developing marijuana based CBD. The CBD companies cited are marketing and developing hemp based CBD. And there is a distinct difference when examining the two.


Marijuana vs. Hemp


Now here is where things can get sticky if you will forgive the pun, as they often do when examining the current differences between marijuana and hemp..... and let's just make it absolutely clear, that marijuana and hemp at the end of the day, produce the exact same cannabinoids.  THC is THC and CBD is CBD, regardless of the type of cannabis that produces it.


Now, in order for GW Pharma's IND to stick, they must be able to say that their substance or product was not marketed as a nutritional supplement or food prior to the filing of their IND. In the case of marijuana... this may be accurate, as it has been since the early 1900s since pharmaceutical companies have been able to legally market marijuana based products.


However....


Hemp oil has been legal for import into the United States for quite some time, and cannabidiol is but one of the hundreds of natural constituents found within any given hemp extract. Many hemp oils and hemp seed oils will have natural traces of cannabinoids such as THC and CBD in them. In the case of HIA v. DEA 2004, these trace cannabinoids were deemed outside of the regulation of the DEA and cleared for import into the United States.


So there is compelling evidence, that hemp based CBD has been circulated in the form of "food" for easily a decade in the United States, and likely much longer as it pertains to hemp oils, and that hemp based CBD itself has been being marketed as a nutritional supplement prior to the filing of GW Pharma's IND, as hemp based cannabidiol has been being sold online for years now.


This is where this distinction between the terms marijuana and hemp begins to really matter, despite the fact, that at the end of the day, they are ALL cannabis plants.


Hemp is imported freely into the U.S.,who now stands as the number one consumer of hemp on planet earth....because we have not allowed our farmers to grow it since circa WW2. Marijuana, has been banned outright since 1937. Under the current definition of "hemp" in the Controlled Substances Act, hemp refers to only the stalks and sterilized seeds of the cannabis plant.


In much of the rest of the world, and now in the United States for the first time by way of the 2014 Farm Bill, industrial hemp is recognized as all species of cannabis with a THC content of below .3% dry weight, and any part of that plant is included in that definition, be it a leaf, bud or seed. But the outdated definition remains in the CSA, with current legislation pending to do away with this language once and for all, seeking to amend the CSA with the language contained in the 2014 Farm Bill and many state legal hemp growing programs.


The FDA is currently not acknowledging that there is a difference between hemp and marijuana oils in their commentary thus far on these important issues. The basis for the FDA stating that CBD could not be marketed as a nutritional supplement was taken from an informal marijuana Q&A page on the FDA website.


So this is likely to be a controversy that rages on, with the hemp oil industry contending that they beat GW to the punch by a mile, and FDA stating that marijuana based CBD is covered by the GW Pharma IND filing.


Hemp oil industry leader CannaVest immediately posted a response to the latest FDA warnings to CBD companies, which can be found here.


Warnings like these are not uncommon at all in the supplement industry and you can find a huge volume of letters posted on the FDA website for all sorts of products that make unsubstantiated health claims in their marketing materials. Other than stating in a post that was specific again to marijuana, that CBD did not meet the definition of a nutritional supplement last year due to the GW IND, the FDA has taken no action against the hemp based CBD industry which continues to thrive and experience rapid growth.


The FDA has also not made public what details they examined in making their determination with cannabidiol and nutritional supplements, and in each warning letter, invites the offenders to offer evidence to the contrary that they are apparently willing to look at. It is this authors opinion that the hemp oil industry has very strong footing to stand on in terms of the GW IND. There are companies that are marketing 99.9% "pure" powdered CBD concentrate and in those cases,  it may be likely these products transgress on the GW IND.  We however agree strongly with the sentiment echoed by CannaVest in the above statement with regard to hemp extracts and naturally and incidentally occurring levels of CBD.  


For the FDA to lock up CBD from all sources for the exclusive use of GW Pharma, would be an affront to all of us.


Hemp oil,hemp seed oil,... they are super foods, and granola type folks have been eating these parts of the hemp plant and reaping the benefits for eons. It is going to be very difficult for a pharmaceutical company to completely lock up substances that belong to ALL OF US by way of grandfather rights as human being residents of plant earth.


But it wouldn't be the first time now would it?  Let us hope that future FDA warnings to CBD companies are the result of other typcial supplement/food manufacturing and marketing issues, and not this overlap with GW Pharma's IND on Cannabidiol as a marijuana isolate.