By Paul Kemp Posted Monday, March 28, 2016
A recent article in Natural News about CBD (cannabidiol) products worried many happy consumers of CBD and other natural products — such as the herb kratom, already on thin regulatory ice. The initial article by Mike West made it seem that the FDA had overnight “outlawed” legal products the public had come to depend on. Fortunately, this was not the case, as it was explained in the correction linked above.
CBD is not yet “outlawed, though imported herbs not protected under the DSHEA law are still at risk.
Many Americans feel they owe their lives and happiness to being able to freely purchase herbal products like CBD and kratom, which they prefer over the widely-prescribed pharmaceutical alternatives.
While the immediate threat of a shutdown of our ability to purchase these herbal products is not imminent, there is still a lurking danger for all of us, buried in the complexity of the boring FDA regulations.
Let’s see if we can make this murky complexity crystal clear…
CBD oil and related products are legal is all 50 United States. Kratom is currently legal in 45 states. Both products must be imported into the U.S. to support the huge and growing demand.
Here’s the Deal:
If you want to market your products as a Dietary Supplement, you must be aware that any time a pharmaceutical company files — and receives an approval — of an Investigational New Drug (IND) application, you may be told by the FDA you can no longer sell your product as a Dietary Supplement.
This doesn’t mean you can’t sell it! It just means you can’t sell it, implying or stating that it is for human consumption. (It must be approved first.)
If the FDA finds any evidence on your Website or Facebook page that indicates you, the vendor, are marketing your product as a dietary supplement — either CBD or kratom — your ability to import your product into the U.S. may be denied. Kratom vendors are all-too-familiar with this issue.
One more turn in this whole labyrinth of federal regulations is the fact that unless you can prove that your product was marketed in the U.S. as a food or a dietary supplement before October 15, 1994, you cannot even sell it as such without applying for a New Dietary Ingredient permit — which, in the case of CBD oil the FDA is saying, based on the available evidence, CBD doesn’t qualify.
So, the bottom line is that ANY of the helpful herbs, such as CBD and kratom and many others, are walking a highwire at all times. They can be possessed and sold, but vendors shouldn’t say anything related to what they can do for you if you consume them — which restricts considerably a vendor’s ability to sell their product.
This needs to change.
CBD and the herb Kratom have much in common. They are both natural herbal products, with immense medicinal potential, both proven scientifically and seen over years of use in humans. And both are threatened by arcane FDA regulations that may place them both — as well as any other herbal medicine that can’t prove it was marketed in the U.S. prior to October 15, 1994 — off limits to being marketed as a Dietary Supplement, if the pharmaceutical industry decides to use any of the compounds they contain as the basis for a new synthetic drug.
The intention of this blog is not to discuss the biological pathways by which CBD or kratom acts, but simply to remark on the benefits we have seen in the lives of thousands of humans who are using both these substances in their whole or extracted forms — and to point out that our use of these herbs should not be threatened in order to protect the profit margins of any pharmaceutical company’s Investigational New Drug application.
The rights of the American people should not be denied to use any herb we wish. The drug companies should not have a legally-protected monopoly that comes before the right of the people to use herbs.
We who reject the dogma that single-ingredient synthesized pharmaceuticals are superior to complex herbs need to speak up.
If drugs prove to be better, in the judgement of the consumers, then these pharmaceuticals are welcomed to compete fairly in an open market.
To say that all sales of any herbal product should cease, if and when a pharmaceutical investigation has begun, is an absurd expansion of the powers granted to the FDA and should cause us to question whether it might be time to rein in the powers of the FDA.
Is the FDA truly working to protect us — or are they protecting the pharmaceutical industry’s profits, at our expense?
Testimonials for Kratom
Sarah: “I have sleep apnea, I wake up 3-4 times a night. I hate my sleep machine. Since starting kratom I wake up maybe 1 time during the night. I really do sleep better and breathe better since kratom came into my life!”
Toni: “Chronic Pancreatitis. Kratom has saved me in more ways than one by helping with pain better than prescription opioids, and boosted my mood to get me feel good enough mentally to come back from the face of death!”
Ariane: “I was dependent on applying topical steroids for over a decade to help treat my eczema. The withdrawal period can make your skin feel like it’s sustained burns. I used Kratom for pain management and it helped me feel like a person again. Some people are bed bound for months on end. I worked full time going through the withdrawal and I credit Kratom for helping me.”
Terry: “Neck pain related to an unsuccessful cervical fusion, knee pain, low back pain related to DDD and Sheuermann’s Disease, PTSD, and Chronic Fatigue. I am so grateful for kratom. I was on several opiate drugs for about ten years before transitioning to kratom. I now have a fulltime job.”
Tammy: “ My PTSD is sooo much better since using kratom!!!!!!”
William: “Kratom substantially relieves inflamed nerves in my spine and pelvis and it doesn’t kill off flesh like the shots I was receiving.”
Linda: “I was able to cold turkey from very high doses of anti-depressants, that I never thought I could live without, big pharma and the serious side effects scared me from trying to stop. Well I took a leap because my insurance canceled me so it was a matter of $3000.00”
(This illustrates another reason why the public should have natural options like CBD and kratom — so that when new insurance, CDC, or DEA regulations prevent access to prescription drugs, people will still have natural options.)
Beverly: “Chronic pain was my issue. Kratom gives us our life back. Just one of several (benefits), but a vital one for me.”
Dawn: “Helped me with alcoholism…clean for 10 months now after a lifetime of drinking. Also helps with migraines It saved my life.. Literally!”
Michelle: “PTSD. I’m a female vet with PTSD from MST (military sexual trauma). Since starting kratom, my nightmares and anxiety are much better. I’m also less anxious with environmental stimuli…crowds, people being too close, the dark, etc.”
Gayla: “Kratom helped me with my Blood pressure……because of kratom I NO longer take the medications and I was on the strongest meds since the age of 25 years old and I’m now 59 years old and the doctors took me OFF of them 8 months ago.
“My heart doctor asked me what I had been doing because when they put me on them when I was YOUNGER they told me it would be lifelong because my blood pressure was so BAD. Even losing weight didn’t help and then four months after I started using kratom my blood pressure (while still taking meds) was constantly bottoming out to the point at one time I went by ambulance because IT was 80/40. They got it down and told me to see my heart specialist. I went and he asked me what I had been doing differently to lower it so much and I just told him that honestly the only thing I had been doing different was that I started using kratom for PAIN and he wrote it down and said he was going to research it because he thought it was remarkable and took me OFF all blood pressure meds after 34 years…..WOO HOO!”
Liz: “(Kratom helped with) Blood pressure, chronic fatigue, depression, social anxiety, stress eating, alcoholic consumption…..All of these are from personal experience and what kratom has helped me with. I started it for chronic pain, these were just unexpected gifts.”
Comments on the Benefits of CBD Oil
Terri: “I can’t believe this. I take it for everything from nausea, vertigo, anxiety, pain.”
Melinda: “My son who is now 4 had his first seizure at 2 and a half years old. He since then has lived with a seizure disorder. Immediately we knew we wanted to try any natural alternatives and treatments we knew of. We were introduced to CBD oil, and various other CBD products around 7 months ago and for 6 months now he has not had one seizure and takes zero medications. I never thought that something so natural could help him as much as it has. I don’t live in fear anticipating when his next episode will be or feel like I have to plan our lives around the possibility of him having one. CBD has helped improve the quality of his life tremendously, has improved his anxiety, his overall attitude and allows him to focus on things he used to find difficult.”
These folks have a human right to the herbal medicines they choose. This right shouldn’t be taken away by the FDA. Any regulations that are found to contradict this human right need to be removed from the CFR.
Paul Kemp writes frequently on topics of natural health, herbal medicines, a freedom.