Will the FDA ban over-the-counter CBD Isolate?

The website CBD.how created a stir on Reddit this month with their prediction that the United States Food and Drug Administration will ban CBD (cannabidiol) isolate products in 2020.  I will embed their video in this post below. When I first saw this video I was skeptical. CBD is everywhere.  How can the FDA put the genie back in the bottle?

The FDA does have a history of banning substances that are being sold as supplements if the same substance is being used (or studied) as a drug.  Pyridoxamine is a form of Vitamin B6 that has been shown to reduce “age-related glycation end products” (AGEs). In this way it may protect the cells of diabetics from damage caused by high blood sugar levels.  In 2009 the FDA retroactively banned pyridoxamine from sale as a dietary supplement because a company was studying it as a potential new drug.  Several companies were selling it as a supplement and had to stop. In this case the FDA banned a vitamin. It almost seems like the FDA only bans the really effective supplements.

Like pyridoxamine, CBD is being sold as a dietary supplement by multiple companies. CBD is also available by prescription as Epidiolex^®.  Doses recommended for children with epilepsy are much higher than the products you see in stores and online.  For example, a U.S. dosage calculator recommends  227 to 554mgs per day for a 50 pound child.  At these higher doses elevated liver enzymes were found in some research subjects.

The FDA can ban chemicals but not whole plants.  (Only Congress can ban plants federally and it’s the DEA – not the FDA – that enforces these bans.) Full spectrum and broad spectrum hemp oils contain multiple ingredients and are quite different from CBD isolate. These oils usually contain many cannabinoids, sometimes including trace levels (below .3%) of THC.  The FDA may have more trouble banning these products, thanks to the 2018 Farm Bill that legalized hemp and hemp derivatives.  The FDA arguably does not have the power to make hemp derivatives illegal again.

I don’t have a crystal ball (and neither does the guy from CBD.how.)  If the FDA does step in and ban some CBD products I agree that the CBD (cannabidiol) isolate products are the most vulnerable.

New Virginia Field Test Distinguishes CBD-dominant Hemp from THC-dominant Marijuana

Virginia is one of the first states that is able to tell hemp from marijuana in the field. The Virginia Department of Forensic Science purchased 16,150 kits that accomplish this and is distributing them to law enforcement agencies in the state.  The officer in the field will first use the existing test, the “Duquenois-Levine field test”, to determine if suspect plant material is actually cannabis. (Hemp and marijuana are two different forms of cannabis.) The new test will then be used to determine whether the cannabis is hemp or marijuana.  The video below was produced to instruct local law enforcement agencies in the process.

Interestingly, North Carolina has taken a totally different approach to the problem of distinguishing hemp from marijuana.  They simply outlawed “smokable hemp.”  The new North Carolina law could go into effect in December of 2020.  Hemp was made federally legal with the passage of the 2018 Farm Bill.  Virginia and North Carolina have diverged politically in recent years, and this different approach to a Federally legal plant highlights these differences.

These new test kits are not perfect.  There is no way to tell what will happen if they test the new CBG hemp flower (which contains no CBD and a tiny amount of THC). There is no test for CBG “plant material.”  Hemp may be a moving target as new cannabinoids are targeted by seed companies, but the Virginia test kits are a step forward – especially compared to North Carolina’s approach. If prohibition is overturned this may be a moot point in the future.

Is it Safe to Travel with CBD?

Two grandmothers were arrested recently for carrying CBD oil in their luggage.  Drug possession charges were dropped in both cases, but only after the women were charged and taken to jail.  The 2018 Farm Bill was supposed to make hemp-derived products legal throughout the United States, but some states and localities are still treating CBD as a
controlled substance.  What should you do if you are traveling?  Here are some things to try:

Photo by bruce mars on Pexels.com

• Take pills instead of CBD oil if you are flying.  Many CBD “liqui-gels” look just like vitamin E supplements.  Divide doses of medications and supplements into small bags or those AM/PM containers. It is unlikely that anyone will test everything in your luggage.  If you don’t take vitamins consider taking some just for the trip so that the CBD doesn’t stand out.
• Consider gummies.  These also blend in nicely with vitamin gummies or they can be tucked into a small plastic bag in your luggage.   Since they are not liquid they don’t attract attention like a bottle of oil. Suck on the gummy before chewing it in order to get some sublingual absorption.
• Look for small containers labeled “hemp oil” if you have some confidence that they contain CBD,   CBDistillery oils, for example, are labeled “Hemp Supplement” and “full spectrum hemp extract” even though “CBD” is in the brand. Avoid traveling with homemade oils and handwritten labels.
• Consider taking a break from CBD.  Sometimes this is a good way to discover whether it is really helping as much as you think.  There are no withdrawal symptoms. CBD is not addictive.

Do you have tips to share?  Do you disagree with me?  Please comment below to share your ideas.

The U.S. Government’s Patent on Cannabis for Health

At the same time that the U.S. government maintained that cannabis was an illegal drug with no medical value the U.S. Department of Health and Human services took out a patent on “Cannabinoids as antioxidants and neuroprotectants.” This apparent hypocrisy is the result of scientists and politicians having very different agendas. The patent was awarded to the Department of Health and Human Services (HHS) in October 2003.  It was filed four years earlier by scientists who worked at the National Institute of Mental Health (NIMH).

In the U.S. a new use for an existing product that is “new, useful, and non-obvious” may be patented. In theory the patent holder can claim exclusive use of the product for that “use” and charge people money to license it. When government employees apply for a patent for work that they did during their work hours the government gets the patent. In some cases they are allowed to share in some of the profits from the patient in a limited way. Aidan Hampson, Julius Axelrod, and Maurizio Grimaldi saw promise in CBD and THC 20 years ago.  In their patent filing they wrote that:

“Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism. This new-found property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, Such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, Such as stroke and trauma, or in the treatment of neurodegenerative diseases, Such as Alzheimer’s disease, Parkinsons disease and HIV dementia. Nonpsychoactive cannabinoids, Such as cannabidoil, are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention.”

Since that time cannabidiol (CBD) has been shown to be a neuroprotectant and to have powerful anti-seizure properties.  THC has been found to dissolve beta amyloid plaques in the brain, one theorized cause for Alzheimer’s Disease.

Will the government try to collect their money?  I guess that’s theoretically possible, but it’s hard to square this obvious acknowledgement that cannabis has value with the continued prohibition at the Federal level.  Some people in the government knew about the medical value of cannabis 20 years ago.  How come they didn’t tell the rest of us?

[edited 3/17/19 to add links to the authors’ biographies]

The Police can’t tell that your Hemp Flowers aren’t Marijuana – so Be Careful Out There.

Law enforcement has field tests for marijuana that can’t distinguish CBD hemp flower from marijuana.  If you live in a place where marijuana is illegal and CBD flower is legal you should take care with your hemp flower.  Avoid driving with it in your car and vape (don’t smoke) it in the privacy of your home.  Ok – maybe smoke it if you want.  Details are in this video from your friendly neighborhood Indiana police officer.  I love the caption “Working for You.”  I don’t think he’s working for me.

Drug Testing and CBD

Some people medicating with CBD are subject to workplace drug testing.  The intent of such testing is to assure that people don’t work while under the influence of intoxicating drugs.  This works well for drugs that are water soluble.  Drugs like cocaine and heroin wash out of your system within 2-4 days.  LabCorp reports that THC is detectable for 2-7 days after a single use and 1-2 months after chronic use. ^1.  This puts people who use medical cannabis (hemp or marijuana) at a disadvantage.

A negative initial test for THC. Note the faint pink band.

Urine drug testing is usually a two step process. The first step is an inexpensive immunoassay test. Immunoassays measure the formation of antibody-antigen complexes.  They can produce false positives.  If you test positive for THC you will usually then be given a more-expensive gas chromatography test that can tell more precisely what is in your urine.

People taking CBD isolate should not test positive on any urine drug screen.  If your job has a strict policy and tests frequently then you should probably only take CBD isolate. Multiple studies have found that CBD isolate works, but that the dose needs to be very precise.  CBD that is accompanied by other substances naturally found in cannabis works over a much wider dose range.

The image to the right shows the results of a $1.00 home urine drug test (Easy@home brand from Amazon) that uses the same technology as the initial tests used in many workplaces.  If no bar at all shows up next to the “T” then it is considered a positive test.  Any bar at all is supposed to represent a negative test. The example shown is the result when I was using CBD isolate supplemented by a small amount of CBD hemp flower twice a week. It’s technically negative, but the lower band is awfully weak. That’s probably because hemp flower contains THC-A that converts to THC when smoked or vaped. This is in addition to the small amount of THC that is usually in flower.If it is essential that you pass urine drug tests then you should probably avoid hemp flower.

homehealthtesting.com

It’s comforting to know that I currently test “negative” for THC, but I’m not confident that every lab technician would read this as a negative result (even though they should). To the left is an example of the instructions for a different brand of test that uses the same technology.

Should you test at home?  You shouldn’t need to if your job doesn’t test, or if you only use CBD isolate products.  If your job tests, and you use full spectrum hemp products, (even hemp oil from places like Amazon that don’t explicitly list CBD as an ingredient) you should consider testing yourself from time-to-time.

1. https://www.labcorpsolutions.com/images/Drugs_of_Abuse_Reference_Guide_Flyer_3166.pdf

Farm Bill Confusion

Hemp farmers and hemp smokers cheered when president Trump signed the 2018 Farm Bill in December 2018. Industrial hemp is now legal in all 50 states, and interstate commerce in hemp is also legal. The new law also appeared to legalize derivatives of hemp including CBD. The DEA could no longer treat CBD as an illegal drug like THC.

At some point people read the fine print. Industrial hemp remained defined in the following manner:

The term `hemp’ means the plant Cannabis sativa L. 
 and any part of that plant, including the seeds thereof and all 
 derivatives, extracts, cannabinoids, isomers, acids, salts, and 
 salts of isomers, whether growing or not, with a delta-9 
 tetrahydrocannabinol concentration of not more than 0.3 percent on 
 a dry weight basis.

This means that hemp-derived products, such as CBD oil, still had to contain less than 0.3% delta 9 THC. All such products on the U.S. market already contain such low amounts.

States and Indian Tribes are allowed to manage hemp growing in their states. Section 297 of the new law outlines the guidelines for these state programs. The section that concerned some hemp flower enthusiasts on Reddit is below:

“SEC. 297B. STATE AND TRIBAL PLANS.
 [must develop]a procedure for testing, using post-
 decarboxylation or other similarly reliable methods, delta-
 9 tetrahydrocannabinol concentration levels of hemp 
 produced in the State or territory of the Indian tribe.

Essentially the states and tribes are required to have a “reliable method” to assure that the industrial hemp being grown is really legal hemp, not illegal marijuana. They list “post-decarboxylation” as one example of a reliable method. Presumably it is not the only reliable method.

Currently available industrial hemp flowers sometimes contain both very low levels of delta 9 THC and very low levels of THCA. When hemp flower is smoked or vaped some of the THCA is converted to THC. If all hemp plants were tested post-decarboxylation the effective THC levels might be higher than the legal limit. Some of today’s legal hemp might not pass the new test.

The new law does not actually require post-decarb testing. It says nothing about THCA. It’s too soon to know exactly how the .3% figure will be applied this time next year.

U.S. Hemp is currently grown in demonstration programs authorized by the 2014 Farm Bill. These programs are expected to continue and states will be able to expand them this year. Hemp is being grown for seed, for fiber, and for CBD. The strains of cannabis (hemp) grown for these different purposes are quite different from each other. As states continue to develop these programs we should see more hemp on the market in 2019.  We just don’t know exactly how potent it will be.