I don’t normally write these blogs in the first person, but I want to make clear this is only my opinion, and in that regard, I may as well begin with our United States Food and Drug Administration (FDA) required disclaimer:
None of the statements made herein have been evaluated by the United States Food and Drug Administration. PharmaXtracts cannabidiol (CBD) products are not intended to diagnose, treat, cure, or prevent any disease.
The FDA takes the position CBD cannot be marketed as a drug or as a nutritional supplement. Doctors cannot prescribe CBD unless in an FDA approved drug. So far, the FDA has only approved Epidiolex (cannabidiol) oral solution “for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.” The FDA has taken the position that CBD cannot be introduced into a food, like at a restaurant. A number of restaurants have advertised their food is fortified with CBD and have drawn FDA sanction.
GW Pharmaceuticals, the maker of Epidiolex, got the jump on American drug companies by manufacturing and performing clinical trials on Epidiolex in the United Kingdom where the company was not put off by the Drug Enforcement Administration’s successful effort to severely limit cannabis research in the United States. Ironically, a lot of that restriction was due to influence from large American pharmaceutical companies to limit cannabis research as a means to insure them a better market for their opioid-based drugs.
According to The Wall Street Journal a year’s supply of Epidiolex would cost $32,500. See https://www.wsj.com/articles/new-marijuana-based-epilepsy-treatment-to-cost-32-500-a- year-1533761758. It is hard to evaluate this dollar figure. The recommended beginning dosage of Epidiolex is 2.5 milligrams of CBD per kilogram of body weight which would equate to 113 milligrams of CBD for a 100 pound child. If the child was given that much CBD twice a day, the total daily CBD dosage would be 223 milligrams per day. PharmaXtracts sells 7500 milligrams of CBD for a retail price of $275 which would be a 30 day supply at 250 milligrams a day.
If those figures hold, the total cost of PharmaXtracts' CBD would be $3,300 per year, or roughly one tenth the cost of the Epidiolex treatment if we figure 250 milligrams of CBD a day for a child weighing slightly over 100 pounds. However, with Epidiolex being FDA approved, doctors can now prescribe it for treating Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age and older, and some of its prescribed cost can be billed to one's private insurance, medicaid, or medicare.
According to GW Pharmaceuticals, prescribed CBD levels can be raised to 20 milligrams of CBD per kilogram, which would equate to 1,814 milligrams of CBD a day if a 100 pound child was given 907 milligrams of CBD twice a day. At my weight of 250 pounds, that would be equate to 4,535 milligrams of CBD a day which to me seems quite absurd and would inevitably result in diarrhea from the MCT oil from ingesting 18 milliliters of MCT oil a day, or almost two-thirds of one of our 7500 mg of CBD in 30 ml MCT bottles every day.
GW Pharmaceuticals is also performing clinical tests on Epidiolex for treating autism spectrum disorders, glioma, neonatal hypoxic-ischemic encephalopathy (NHIE), schizophrenia, and cerebral palsy in children.
The difference between GW Pharmaceuticals’ CBD and PharmaXtractss’ CBD should be nonexistent if GW Pharmaceuticals starts out by extracting and refining pure CBD from hemp flower the same as PharmaXtracts, which it says it does. GW Pharmaceuticals places its CBD in a different solvent, but that should make little difference if the Epidiolex customer does not mind ingesting sucralose, an artificial sweetener, and 99.5 percent pure ethyl alcohol that GW Pharmaceuticals uses in its Epidiolex formulation along with sesame seed oil, and a strawberry flavoring. PharmaXtracts’ tinctures are made by dissolving pure CBD in medium chain triglyceride (MCT) oil refined from coconut and palm kernel oils, and PharmaXtracts’ tinctures contain no flavoring or artificial sweeteners. Personally, I do not find the taste of our PharmaXtracts’ tinctures objectionable, and I take a dropper full holding 250 milligrams of CBD every morning. So in my opinion, our tinctures can and should remain unflavored.
There are those who argue the CBD industry is like the Wild West with few controls, and a lot of people really don't know what they are getting. At PharmaXtracts, we pride ourselves in informing our customers about exactly what they are getting, and our nutritional information for each tincture, like that seen below, is displayed on our website under the product descriptions and appears on all our tincture labels.
PharmaXtracts has a Nevada Hemp Handler’s License issued pursuant to an industrial hemp pilot program under the direction of the Nevada Department of Agriculture, and we at PharmaXtracts can legally sell and ship our CBD products to customers in all states and territories without a doctor’s prescription pursuant to the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014, 7 U.S.C. §5940, as applied to the states and territories by the Supremacy Clause and the Commerce Clause of the United States Constitution.
The law doesn't say we at PharmaXtracts cannot sell CBD, just the opposite. The law encourages us and other CBD manufactures working with state industrial hemp pilot programs to study the marketing of CBD which would be greatly hindered if we could not sell and ship our CBD products to customers in all states and territories. We just cannot sell CBD for the advertised purpose of diagnosing, treating, curing, or preventing any disease.
I was not surprised to see that according to GW Pharmaceuticals’ clinical research CBD is neither contraindicated for any other drug nor considered a serious problem encouraging the selection of an alternative drug. However, I was surprised to see a listing of 198 drugs, the use and effect of which should be watched carefully if one is taking CBD. See https://reference.medscape.com/drug/epidiolex-cannabidiol-1000225#3. Our disclaimer seen below already states that one should check with their doctor before taking CBD if one is taking prescription medications. Most of the problems mentioned by CW Pharmaceuticals seems to be the possible effect taking CBD may have on the hepatic enzyme CYP2C19 metabolism.
The long and short of it is that because the United States Government suppressed research into cannabis based remedies for 80 years, scientific research into the benefits (and potential dangers) of CBD is 80 years behind the times.
There is also a caution to look for elevated liver transaminases which may be an indicator of liver damage which surprised me because many people take CBD to fight pain and inflammation rather than take common nonsteroidal anti-inflammatiory drugs like aspirin and ibuprofen specifically for the purpose of protecting their liver. There are also studies showing CBD is good for the liver. See Avraham, Y., Grigoriadis, N., Poutahidis, T., Vorobiev, L., Magen, I., Ilan, Y., et al. (2011, April). Cannabidiol improves brain and liver function in a fulminant hepatic failure-induced model of hepatic encephalopathy in mice. British Journal of Pharmacology, Vol. 162(7), pp. 1650–1658. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3057300/; Caraceni, P., Domenicali, M., Bernardi, M. (2008, May). The endocannabinoid system and liver diseases. Journal of Neuroendocrinolog, 20 Suppl 1, pp. 47-52. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/18426499 (“Thus, molecules targeting the CB(1) and CB(2) receptors may represent potential therapeutic agents for the treatment of liver diseases.”); Lowe, H., Toyang, N., McLaughlin, W. (2017, Jan.-Mar.) Potential of Cannabidiol for the Treatment of Viral Hepatitis”; Pharmacognosy Research, Vol 9(1), pp.116-118. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/28250664 (“CBD could be further developed and used therapeutically against HCV (hepatitis C).”); Lim, M.P., Devi, L., Rozenfeld, R. (2011, June 9). Cannabidiol causes activated hepatic stellate cell death through a mechanism of endoplasmic reticulum stress-induced apoptosis. Cell Death and Disease, Vol. 2:e, p. 170. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/21654828 (“the induction of activated HSC death has been proposed as a means to achieve resolution of liver fibrosis . . . cannabidiol (CBD), a major non-psychoactive component of the plant Cannabis sativa, induces apoptosis in activated HSCs through a cannabinoid receptor-independent mechanism. . . . We propose that CBD, by selectively inducing death of activated HSCs, represents a potential therapeutic agent for the treatment of liver fibrosis.”).
To read all the warnings and recommendations based on GW Pharmaceuticals’ clinical research, click here: https://reference.medscape.com/drug/epidiolex-cannabidiol-1000225.
One thing the FDA is going to have difficulty with is approving a full-spectrum CBD product. We are presently working on one at PharmaXtracts that will be superior to all others offered, and we will be releasing it as our Gold Line. I cannot wait to give it a review. The problem is each batch of our Gold Line product, although much more consistent than that of any of our competitors because of its extreme purity, will be very slightly different because each batch of hemp flower from which it is made is going to be very slightly different (this includes flower from the same crop). The lack of perfect consistency, possible only in a synthetic product or in a product like CBD that has been completely isolated, is something the FDA hates. In a full spectrum CBD product, the FDA should have no worry because cannabis products are so safe, but the people at the FDA are stuck in their ways which is why industrial hemp and CBD is something taken completely out of the FDA’s ability to control so long as it is not advertised to diagnose, treat, cure, or prevent any disease. (Tobacco and alcohol, two products infinitely more dangerous than anything cannabis, have also been removed from the FDA's control, so it should come as no surprise that industrial hemp and the products made from it have also been taken out of the FDA's ability to control.)
The “dangers” of cannabis or any cannabis product, including CBD, have not proven great enough for anyone to ever die from ingesting it in any quantity. In a 1988 ruling, DEA Administrative Law Judge Francis L. Young found as a matter of fact,
“Nearly all medicines have toxic, potentially lethal effects. But marijuana is not such a substance. There is no record in the extensive medical literature describing a proven, documented cannabis-induced fatality.
“This is a remarkable statement. First, the record on marijuana encompasses 5,000 years of human experience. Second, marijuana is now used daily by enormous numbers of people throughout the world. Estimates suggest that from twenty million to fifty million Americans routinely, albeit illegally, smoke marijuana without the benefit of direct medical supervision. Yet, despite this long history of use and the extraordinarily high numbers of social smokers, there are simply no credible medical reports to suggest that consuming marijuana has caused a single death.
“By contrast aspirin, a commonly used, over-the-counter medicine, causes hundreds of deaths each year.
“Drugs used in medicine are routinely given what is called an LD-50. The LD-50 rating indicates at what dosage fifty percent of test animals receiving a drug will die as a result of drug induced toxicity. A number of researchers have attempted to determine marijuana's LD-50 rating in test animals, without success. Simply stated, researchers have been unable to give animals enough marijuana to induce death.
“At present it is estimated that marijuana's LD-50 is around 1:20,000 or 1:40,000. In layman terms this means that in order to induce death a marijuana smoker would have to consume 20,000 to 40,000 times as much marijuana as is contained in one marijuana cigarette. NIDA-supplied marijuana cigarettes weigh approximately .9 grams. A smoker would theoretically have to consume nearly 1,500 pounds of marijuana within about fifteen minutes to induce a lethal response.
“In practical terms, marijuana cannot induce a lethal response as a result of drug-related toxicity.
See J. Young, In the Matter of Marijuana Rescheduling Petition, Docket No. 86-22, Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of Administrative Law Judge, Sept. 6, 1988, http://www.ccguide.org/young88.php.
There is no standard therapeutic dosage for CBD and no daily value has been set. We at PharmaXtracts sell the strongest tincture at 250 milligrams of CBD per milliliter of MCT Oil. CBD is extremely safe. In one study, human test subjects were given 1500 milligrams of CBD per day without ill effect. See Bergamaschi MM, Queiroz RH, Zuardi AW, et al., “Safety and side effects of cannabidiol, a Cannabis sativa constituent.” Curr Drug Saf. 2011; 6:237–249, https://www.ncbi.nlm.nih.gov/pubmed/22129319.
I find some people need more CBD than other people, and it also depends on their complaint. In general, I find less CBD is needed to treat anxiety, sleep disorders, suppress bad memories, or to simply provide relaxation. Higher doses are needed to treat pain and inflammation and the physical “non mental” stuff. That’s my opinion based on what I have read and discussions with out customers as I handle the more complicated customer service requests here at PharmaXtracts.
Scientific research into cannabis-based medical remedies is in its infancy. CBD is already outside the control of the FDA unless advertised to cure a specific disease, and I believe the law will evolve to completely free cannabis-based medical remedies so they can be marketed and sold to customers over 21 years of age in all states and territories whether or not they have Delta-9 THC in them in amounts greater than 0.3 percent.
This is what the American public overwhelming wants. A Quinnipiac University poll of 1,062 American voters from across the country conducted from April 12 to April 18, 2017, showed 94 percent of voting Americans believe a person should be able to use medical marijuana if prescribed by their physician. The FDA presently forbids doctors from prescribing medical marijuana .
One of the joys of working for PharmaXtracts is bearing witness to our success stories, even if they ultimately have unhappy endings. We started out one young man weighing no more than 120 pounds and ready to enter a hospice with a rare form of leukemia with 250 milligrams of CBD a day, and it had an excellent effect. Originally given less than one month to live, the young man was quickly becoming bed ridden. Taking CBD, he was able to live a fairly active life for another seven months. CBD is not a cure all, but in this case, I sincerely believe taking CBD extended this young man’s life by six months and greatly extended his quality of life.
I’m convinced cannabis-based medical remedies will define the advancement of medicine for the next thirty years.
Our CBD Crystalline Tinctures in the 30 milliliter size come with a graduated pipette. It is graduated by the quarter milliliter, but the gradations are about a quarter inch apart, so one can easily extrapolate to the eighth milliliter. The graduated pipette increases our expense, but we believe it greatly aids more accurate dosing.
For anxiety, I recommend starting by once or twice a day taking a milliliter (a full dropper) from one of our 500 mg of CBD in 30 ml of MCT bottles in which each milliliter only contains 16.66 milligrams of CBD. Often times, for anxiety, for sleep, for bad memory suppression, and for relaxation, the amount of CBD ingested smoking from one of our disposable vape pens or from one of our vape cartridges using one of our cartridge mods should be sufficient.
At an average of 125 puffs per pen or cartridge, each puff would contain 1 milligram of CBD. Some of the CBD is exhaled, but the remaining CBD reaches the brain quicker, and all the low CBD conditions mentioned, anxiety, sleep, memory, and relaxation, are brain centered.
For pain and inflammation or if you are trying out CBD to treat cancer or some other serious condition, I believe most people buying CBD products from our competitors are taking insufficient dosages if they are truly serious about battling inflammation or achieving pain relieve as an alternative to anti-inflammatory and pain medications, especially opioid-based pain medications. I believe the wide marking of CBD and cannabis-based medical remedies is very important in addressing the opioid epidemic.
For customers suffering from pain, inflammation, or serious physical conditions, I believe it best to start out by taking a milliliter from one of our 1000 mg of CBD in 10 ml of MCT bottles for a dosage of 100 milligrams of CBD. This can be taken once or twice a day depending on effect, and the customer may soon want to increase their dosage to 250 milligrams a day or more by buying our 2500 milligrams of CBD in 10 milliliters of MCT bottle or our 7500 milligrams of CBD in 30 milliliters of MCT bottle for greater savings if they experience good results from taking our CBD tincture.
The Federal government has still not entirely warmed up to industrial hemp. When industrial hemp was legalized in 2014, the FDA in retaliation classified CBD and all other marijuana extracts Schedule I drugs. The Deputy Attorney General representing the Department of Justice Drug Enforcement Administration admitted during oral argument before the Ninth Circuit that if the product came from industrial hemp grown in conformance with the 2014 Farm Bill, then the manufacturer would have a valid defense, but the DEA has attempted to place the burden of proof with the manufacturer instead of with the state, and the DEA has intentionally misadvised other federal agencies, such as the United States Patent and Trademark Office and the Department of the Treasury, that CBD is a product that cannot legally be placed into commerce. It is as if the minions at these federal agencies have never heard of the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014. I suspect this is being done to slow down the growth of the CBD industry as a favor to Big Pharma. There is no reason CBD companies should have difficulty registering their logos as trademarks or engaging in usual banking activities.
At any rate, we cannot expect the FDA to classify CBD as a food generally recognized as safe when they keep acting as it is a Schedule I drug as dangerous as heroin.
PharmaXtracts Legal Department