Research and clinical evidence confirms that CBD oil relieves pain [1]. This should be good news! 116m Americans suffer chronic pain [2]. Action Alert!
Other approved pain relievers may cause internal bleeding, (e.g. aspirin)[3], cause heart disease (e.g. the now banned Vioxx)[4], kill people (fentanyl, up to 100X more potent than morphine)[5], or lead to both addiction and death (e.g. opioids, killed 33,000 people in the last reported year, as many as from auto accidents [6]). By contrast, CBD oil appears to be effective, safe, and completely non-addictive [7]. It may also help control cancer and other diseases [8].
So why is the FDA trying to shut down information on this lifesaving supplement and, worse, turn it into a highly restricted, expensive prescription drug?
But wait. Is it true that the FDA plans to ban the supplement form? Here is what the Agency itself says in letters sent to CBD producers: “… FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]….” [9]
Please note: CBD oil can only be sold as a dietary supplement or a drug. By denying it supplement status, the FDA is warning us that, once a drug version has been approved, the agency will move to yank the supplement from the market. The drug will require doctor visits and, as a monopoly, cost whatever the drug company chooses to charge.
Here are a few facts about CBD oil you need to know. It can be made from marijuana or from hemp [10]. Hemp does not cause a high [11]. It is in fact a super food, good for you in multiple ways [12].
The US government is totally confused about this. One agency, the DEA, says that hemp and hemp extracts are a schedule 1 drug (this means no possible medicinal use) [13]. Another agency, HHS, owns a medical patent on CBD [14]. The FDA is reviewing it as a prescription drug. Meanwhile the federal government does not allow US farmers to grow hemp, but allows foreign producers to sell it to us [15]. And state attorneys general are threatening to sue opioid producers [16].
It gets worse. A drug company has patented CBD oil for epilepsy [17] and has applied to the FDA for orphan drug approval [18]. It’s questionable that CBD has a significant impact on epilepsy [19] (although it can be treated by diet [20]). So why apply for epilepsy/seizures? Because orphan drug approvals cost less. And once the supplement version is banned, this will be the only legal source. Doctors can still prescribe it “off-label” for anything, including pain [21]. The pain market will be enormous. The FDA understands this. All the insiders are winking at each other. Everyone wins except for the public, who will face restricted access and skyrocketing costs.
This is not an isolated case. There are hundreds of similar stories. Natural treatments are often more effective, safer, and far cheaper than synthetic drugs. But the FDA either bars any discussion of them [22] or kicks them out of the healthcare system [23], thereby creating more drug monopolies.
In prior years, this was mostly done by creating synthetic analogues which, unlike natural products, are patentable, but which, being new to our bodies, often turn out to be toxic. As this has become more problematic, the new trend is for drug companies to claim “novel use” patents (as with CBD) or more commonly the FDA will just seize the natural product and turn it into a protected monopoly free from price competition [24].
Science tells us that food is medicine [25]. But the FDA will put you in jail for mentioning any medical benefit from a particular food. For example, the Agency threatened cherry and walnut producers with jail because they had dared to cite some good science about the health benefits of these common super foods [26].
Healthcare costs so much in general because the government keeps creating medical monopolies. We have them for practitioners as well as for medical treatments. For example, we do not allow nurses to use their full training in treating patients [27].
This is why we need a consumer-run healthcare system which could succeed or just run alongside Obamacare. It is the only way to keep healthcare from bankrupting our country.
What can Congress do right now? Remove hemp from the DEA list. Allow our farmers to grow it. Don’t allow the FDA to ban it as a supplement.
Other articles in this week’s Pulse of Natural Health:
Drug Deception
Lawsuit Revelation
Notes:
1) https://www.ncbi.nlm.nih.gov/pubmed/25635955
2) https://www.ncbi.nlm.nih.gov/books/NBK92510/
3) http://www.webmd.com/drug-medication/news/20001109/even-low-dose-of-aspirin-can-cause-intestinal-bleeding#1
4) http://www.nature.com/news/2006/060501/full/news060501-4.html
5) http://www.newsweek.com/fentanyl-illegal-drugs-591082
6) http://www.economist.com/news/united-states/21721960-deaths-drugs-say-more-about-markets-about-white-despair-inside-opioid
7) https://www.karger.com/Article/FullText/444234
8) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3579246/
9) https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484968.htm
10 http://www.internationalhempassociation.org/jiha/jiha5210.html
11) http://onlinelibrary.wiley.com/doi/10.1111/bph.12944/epdf
12) Hemp seeds as super foods: https://www.ncbi.nlm.nih.gov/pubmed/24292743 and
https://www.ncbi.nlm.nih.gov/pubmed/25493943
13) https://www.gpo.gov/fdsys/pkg/FR-2016-12-14/pdf/2016-29941.pdf?utm_campaign=subscription%20mailing%20list&utm_source=federalregister.gov&utm_medium=email
14) https://www.google.com/patents/US6630507
15) http://www.ncsl.org/research/agriculture-and-rural-development/state-industrial-hemp-statutes.aspx
16) http://dailycaller.com/2017/06/16/attorneys-general-look-to-stick-it-to-drug-companies-over-addiction-crisis/
17) https://www.google.com/patents/US20150359755
18) http://www.reuters.com/article/us-gw-pharma-fda-idUSKCN0XI1HM
19) https://www.ncbi.nlm.nih.gov/pubmed/26724101 and
https://www.ncbi.nlm.nih.gov/pubmed/28617940 and https://www.ncbi.nlm.nih.gov/pubmed/25935511
20) The condition reportedly responds to a ketogenic diet https://www.ncbi.nlm.nih.gov/pubmed/23653425 . Also see Mercola, Joseph, MD. Fat For Fuel. Carlsbad, CA 2016.
21) http://www.webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-need-to-know#1
22) http://www.anh-usa.org/the-science-of-cherries-the-fda-calls-cherries-a-drug/
23) http://www.anh-usa.org/when-is-a-vitamin-not-a-vitamin-when-the-fda-says-so/
24) Ibid.
25) http://www.naturalproductsglobal.com/europe/time-abandon-artificial-contract-food-medicine-anh-founder/
26) http://www.anh-usa.org/the-science-of-cherries-the-fda-calls-cherries-a-drug/
27) https://www.ncsbn.org/ReformingScopesofPractice-WhitePaper.pdf