The Food and Drug Administration has begun developing regulatory guidance on CBD, and commissioners have invited the public to weigh in on how to proceed. A public comment period closed this week, providing the FDA with nearly 3,500 perspectives on the legality, availability and apparent health benefits of CBD products.
See the full list here and read through a sampling of the public comments below.
Because cannabidiol is a chemical compound found in an FDA-approved pharmaceutical drug, Epidiolex, it is classified as an “active ingredient” in the same. Those chemical compounds are subject to greater barriers when used as ingredients in food and beverages—and when sold in the general marketplace of consumer-packaged goods.
While customers can still find cannabis-derived CBD products in state-licensed dispensaries, it’s the CBD oils and various hemp-derived products of unknown sources that has caused the federal government to intervene. The FDA’s crackdown on CBD products that fall outside the regulatory oversight of state-licensed cannabis markets has induced a chilling effect on the product category.
“We recognize that there is significant public interest in these products, for therapeutic purposes and otherwise,” Amy Abernethy, principal deputy commissioner of the FDA, and Lowell Schiller, principal associate commissioner for policy, wrote in a joint letter on the subject. “At the same time, there are many unanswered questions about the science, safety, and quality of many of these products. As we approach these questions, we do so as a science-based regulatory agency committed to our mission of protecting and promoting public health.”
The 2018 Farm Bill didn’t legalize CBD, per se; rather, the descheduling of hemp created a legal gray area for the cannabinoid, one which the FDA is working to clarify this year. A progress report is due sometime this fall.
Here is a sampling of the 3,499 public comments shared with the FDA, (sic) throughout:
– Please keep CBD products legal in all 50 states. CBD oil has helped me to handle my anxiety with no side effects unlike prescribed anti-anxiety medication. CBD is inexpensive, safe and effective.
– I’ve been on countless pharmaceutical medications for fibromyalgia. CBD oil has been the most effective for my chronic pain, anxiety, and general fatigue, as well as improving my ability to concentrate and my memory, which either directly or indirectly improved my chronic episodes of major depression. As a result, I was able to stop taking most of my pharmaceutical medications, which eliminated side effects and other concerns that I had with them. It’s easy and convenient to use and I attribute my reclaimed quality of life to CBD oil. It’s a tragedy that this solution isn’t available to Americans over the counter and frankly, it doesn’t make sense to me.
– Cannabis is part of the wave of the future, whether the United States gets on board or not. Studies on cannabinoids up to this point have yielded unique and significant medicinal effects by mechanisms that otherwise don’t naturally occur outside of the cannabis plant.The two most-studied cannabinoids, THC and CBD, are already indicated medicinally for a plethora of illnesses by a different mechanism from what other medicinal agents exist.
The studies that exist point to lucrative medicinal quality.
If the United States is to stay powerful and influential, it must take advantage of the medicine in the cannabis plant. There is a good chance that, if all natural cannabinoids are studied, we will find more effective treatments for a remarkably large amount of otherwise less-treatable illnesses.
The two studied cannabinoids, which haven’t even been studied much due to red tape, THC and CBD, already are indicated as particularly medicinal for serious maladies.
Additionally, cannabis legalization is an excellent way of stimulating the economy, directly and indirectly. Beyond tax dollars, people will be more able to work with its treatment potential, and the plant provokes peace.
– My family and pets use CBD, please keep it legal and regulated so we know what we are getting when we purchase. If were were in a legal state we would also use cannabis so we could benefit from the THC and CBD together for the entourage effect.
– My husband was diagnosed with Parkinsons Disease approximately eight months ago. Since that time, he has been seen by a top Neurologist and his family practitioner, has had testing and is now presently being medicated with Carbidopa Levodopa, 3.5 pills per day, along with movement, speech and exercise classes to keep him moving and functioning. He has had to discontinue his General Dentistry in our two offices, a career of which he has loved doing for 40+ years. This has been so difficult in so many ways. We live in North Carolina and cannot legally purchase Medicinal Cannabis to our knowledge. However, when we have traveled to legal states and he has used it, he feels so much better and the tremors (full body, but particularly in both hands) completely cease! He sleeps better. He cramps less…and on and on and on.
Please…we dont know what it will take to legalize this, but I can only say WE NEED THIS FOR PEOPLE WHO NEED THIS !!!
– I’ve been using the sublingual 1500MG 0% CBD oil tincture for a month to help me with chronic back pain and inflammation. I can notice the difference in my body and in my mood. I will definitely continue to use this brand of CBD because I like everything they do to help veterans.
– I am a doing one heck of a job getting rid of my opiate addiction from taking upwards of 500 mgs of morphine daily and am down to only around sixty mg and am sure if I stick to my guns, by July I will have completely rid myself of opiates. I was diagnosed with a terminal illness back in 1996 and have been on a rollercoaster ride since, trying so hard to beat my addiction. My doctors and pharmacists are amazed as to what I have accomplished over the past two years. And I dont care what others think, I know for a fact, it has been because of me using edibles made from marijuana , and yes I smoke a little. Not cigarettes either! Thank the Good Lord! No one knows, unless they have been also doing this change from opiates to marijuana! I almost think it is a miracle and cant understand the confusion the DEA and politicians have and are trying to make out of this. Seems we have been lied to for over fifty years. I am a sixty eight year old male, who, had it not been for the changing times, I would still be taking a large dosage of opiates , another by my choosing but by fate .
Please, understand, I would not be writing this if it were nonsense It truly has been a blessing when Ohio finally made medical marijuana legal and I truly believe that everyone should have the same opportunity and chance to do the same.
It makes no sense at all to call marijuana a scheduled substance and only hypocritical thinking keeps it that way. Cigarettes and alcohol are the real dangerous drug, but lo and behold, because many politicians use them both, and some politicians have large investments in both, even though, the whole world knows that they are the real danger to everybody, they, of course are okay to use. Please, we all know how ridiculous that really is. And sad!!!!! Lets do what is right for a change, and take this (marijuana) off the scheduled drug list and do what the majority of Americans are begging you people to do. Do the right thing and make marijuana legal for people that are of adult age, doesnt make any sense at all not to! Thank you for taking time to read my letter.
– I’m 65 and have been taking CBD oil for almost a year. My arthritis inflammation is significantly better. My hands are actually pain free now. I sleep better at night and know the CBD has had a very positive impact on my overall health and well being.
– Please approve CBD on a federal level it would be great to be able to eat or drink this rather than the pain meds I take daily to deal with my chronic back pain.
– I am a former Patrol Deputy Sheriff, diagnosed in 2014 with service related PTSD. I cant even begin to tell you how horrible an affliction PTSD is. It is destructive of almost every part of life people without PTSD take for granted. I am unable to process emotion. I have horrible nightmares. All of this changed dramatically when I discovered CBD oil. To say this substance is a miracle is an understatement for someone like me. It relaxes me without a feeling of high, no loss of faculty, no issues with health or side effects. Not only does it relieve anxiety and suppress the despair and nightmares that come with PTSD, but it also has a pain suppression, soothing effect on aches and pains I have from years of heavy physical activity also related to my LEO service. In addition, it is making the moles and precancerous skin areas on my body go away! I mean completely. That was unexpected and miraculous for me. PLEASE do not make this product harder to get or regulate it in ANY way. In fact, PLEASE allow access to this product and hemp production in personal use amounts for the average person without need of tax, burdensome regulations and the like. We must break the strangle hold of opiates and big pharmaceutical in this nation. This is a natural, benign product with amazing health benefits. Please do not deny this to the citizens of this great nation.
– I urge the FDA not to take steps in favor of the pharmaceutical industry but instead take steps to help the citizens of the United States. Please do not recommend outlawing CBD simply because it is now the ingredient in an FDA-approved prescription medication. Please do not take away the option of using CBD, which is helping many, many people, including myself, with intractable physical symptoms. Finally we have the opportunity to find help without relying on physicians to allow us to try it, and without having to pay thousands of dollars that many do not have available for prescription medications. I am in favor of third-party testing for CBD labeling of milligrams and ingredients, but I beg you not to harm millions of people by siding with the big pharmaceuticals in the quest for more profits from brand-name drugs. Side with us instead. Please.
Published at Thu, 18 Jul 2019 20:18:00 +0000