Unpacking the Questions from the FDA Hearing and What Happens Next
We have been monitoring the news across industries from investments to tech to the medical field in the wake of the FDA Hearing on May 31, 2019. At Elder Farms, you, our clients are our top priority so as we read the articles, watched the hearing (again) along with other broadcast pieces following the hearing, we feel the crux of the issue at this stage is whether too much CBD is harmful (the short answer is no) and the importance of ensuring your CBD products are tested. Let’s go ahead and unpack the issues.
Legality and Effectiveness
CBD is legal in Missouri. We are reaching some key deadlines in our state as well as on July 1, 2019, the Missouri Industrial Hemp Pilot Program receives any spending authorized by the approved FY2020 budget.
Then, on July 30, 2019 Industrial Hemp Pilot Program rules become effective and you can read all about Missouri’s Industrial Hemp Pilot Program and find a link to the department’s proposed rules Webpage by clicking here.
A Quick Look Back
The State of Missouri began gathering feedback a year ago and held a listening session to inform them as they developed the proposed regulations for implementing the hemp cultivation pilot program.
Back in November of 2018, FOX4 Kansas City ran a story that provided the perspective of doctors as well as patients on the effectiveness of CBD. Not surprisingly, the feedback from CBD users was extremely positive as were the comments of Dr. Steven Thornton, the Director of Poison Control at the University of Kansas Health System. Dr. Thornton indicates that if anything, CBD seems to be too good to be true.
Of importance here is the fact that to date, medical and governmental research has been limited and there is not enough data to determine exactly how effective CBD is for conditions such as anxiety, chronic pain, inflammation, and sleeplessness.
The strongest scientific evidence for the effectiveness of CBD is in treating childhood epilepsy syndromes, such as Dravet syndrome and Lennox-Gastaut syndrome (LGS) that don’t typically respond to anti-seizure medications.
“In numerous studies, CBD was able to reduce the number of seizures, and in some cases, it was able to stop them altogether.”
The FDA approved the first ever cannabis-derived medicine Epidiolex, which contains CBD in June of 2018.
FDA Extends Deadline on Public Comments
The hearing on May 31, 2019, was the first step in hashing out what should be done with CBD as it pertains to food and beverages in the United States, with comments expected to continue to be taken by the FDA into July.
In fact, just this morning, the FDA announced that they will extend the amount of time they are allowing comments from July 2, 2019, to July 16, 2019, and you can read that official announcement here. The FDA also provided a little more detail (and clarity) about what they are examining with regard to CBD.
“FDA officials leading the CBD review said earlier this week the agency is “committed to evaluating the regulatory frameworks for nondrug uses, including products marketed as foods and dietary supplements.”
CBD: Not an Rx but a Supplement
The best way we can advise you, our clients is to conceive of CBD not as a prescription drug medication. That’s where the stock and investment information comes in as traders try to predict whether big pharmaceutical companies will be immersed in research and development of CBD medications (like Epidiolex).
If you would like to take a deep dive into the investment side of CBD and CBD infused products we recommend you read this analysis of the market and do thorough research into the food and beverage products and how the FDA is likely to view them, long term.
As of now, based on the information we have to date, we recommend conceiving of CBD as a supplement and implementing your dosage based on your own, personal needs. In fact, those needs may change on a day to day or week to week basis and we understand that. What you are getting with Elder Farms HempBerry is not just CBD. HempBerry is a combination of hemp extract, organic MCT oil, and our farm fresh elderberry syrup. HempBerry contains 12ml (20%) of concentrated elderberry syrup. 1mL/Full dropper contains 12.5mg CBD (25mg CBD in 1500mg option) and broad-spectrum hemp extract (THC-Free).
Why the elderberry you ask? Because just like we know Vitamin C and Zinc are helpful in boosting the immune system, we know that elderberry likewise aids your immune system. Many doctors say it’s safe to take elderberry as part of a healthy diet plan that includes foods with Vitamin B, Vitamin B6, and Vitamin E. Our clients report taking it before and during travel as a preventative while others take HempBerry and eat Elderflower Honey every day because it just makes them feel good.
Even the “doubting Thomases” on the subject do not have a concern that CBD will harm you if you take too much. Dr. Steven Thorton shared his perspective in the FOX4 Kansas City story we referenced earlier by stating, “It doesn’t have the psychoactive effects of THC, which is the main sort of drug in marijuana,”… “but probably has some effects that don’t seem to be too harmful.”
No more than you would take a handful (i.e. 10 or more) Vitamin B12 supplements, you should never “over-use” any supplement because in addition to possibly upsetting your stomach, the body simply cannot process exorbitant levels of any supplement, regardless of whether the delivery system is tincture, gummies, food or beverage.
However, taking a measured dose at the start of each day (as many of our clients do) just like your morning (or evening) Vitamins is a good way to effectively track your body’s response to CBD. We even recommend keeping a journal as you work your way through your first bottle of HempBerry so you can look back and evaluate the effectiveness of HempBerry for yourself.
The Things We Know About CBD
We know that our clients report positive effects from Elder Farms HempBerry and they tell us that they experience reduced inflammation and pain along with an enhanced feeling of well-being (possibly the reduced anxiety) as well as improved sleep.
“A study from the European Journal of Pain using an animal model showed CBD applied on the skin could help lower pain and inflammation due to arthritis. Another study demonstrated the mechanism by which CBD inhibits inflammatory and neuropathic pain, two of the most difficult types of chronic pain to treat. More study in humans is needed in this area to substantiate the claims of CBD proponents about pain control.”
We also know that:
“CBD appears to be a safe ingredient at the levels sold in dietary supplements and food products. In 2018, the World Health Organization issued a report concluding that CBD is safe, and the FDA made similar findings regarding CBD in its scheduling recommendation to DEA regarding Epidiolex.”
The Things We Don’t Know About CBD
CBD is not regulated by the FDA. That means that there actually isn’t a “correct” dose, only recommended doses based on the product—so you’ll have to figure out what’s right for you as you. We did some really deep dives into not only the feedback of our own clients but the research and client feedback across the 17 states in which CBD is legal (and selling like hotcakes) and we found that those who report negative side effects reported the following:
- Changes in appetite
- Changes in mood
- Dry mouth
Based on our research, the reports of any negative side effects were the exception, not the norm and should you experience any of these side effects, we recommend you scale back your dosage (and of course, rule out other possible culprits for the side effects) to see if CBD is indeed the cause.
We also know that just like grapefruit, CBD oil may interact with several medications, including some types of anti-epileptic drugs and coumadin (a common blood thinner) so do inform your doctor of the fact that you are taking HempBerry.
And of course, we know that expectant mothers should avoid CBD (just like they avoid other types of cannabis, alcohol, and caffeine). “A report from the American Academy of Pediatrics (AAP) published in the journal Pediatrics cautions pregnant women and nursing mothers to avoid marijuana use due to possible adverse developmental effects on the baby. In a study reviewed for the report, short-term exposure to CBD was found to increase the permeability of the placental barrier, potentially placing the fetus at risk from certain substances.”
Ask any pregnant woman how she keeps track of all of the things she should avoid and all the things she should be doing and she will likely laugh because there is a plethora of recommendations and opinions on what expectant mothers should and should not do.
So we know to take care, just as we take care of everything we put in our bodies. Everything in moderation (as our mothers say). We feel not only confident but highly optimistic about the future of CBD as a supplement for wellness and well-being.
We encourage you to submit your comments to the FDA before July 16, 2019, and watch for new product offerings from Elder Farms in the coming year as the FDA decides how to classify and regulate CBD infused foods and beverages.
Last but certainly not least, we strongly advise you to examine the testing procedures for any CBD product you purchase. You know exactly what you are getting with Elder Farms HempBerry because we have conducted thorough, third-party testing to ensure everything we provide you is safe.
Yours in Wellness,
The Elder Farms Team