The FDA is signaling a change in how supplements are regulated that threatens not just hemp oil, but the entire industry.
The FDA recently rejected two “new supplement” notifications for full spectrum hemp oil products. Previously the agency targeted CBD oil, stating that CBD is not a dietary supplement. These new actions are extremely concerning since they indicate that the FDA will block other hemp products from the market in addition to CBD. Even more concerning is a shift in the agency’s thinking about the safety standard required for “new supplements” that threatens access to thousands of products. We need Congress to support policies that ensure continued access to dietary supplements, including hemp oil and CBD.
The FDA’s actions against CBD, a beneficial compound found in the hemp plant, are an effort to protect drug industry monopolies. Recall that CBD was approved as a drug for a rare form of epilepsy and costs a reported $32,500 a year. CBD and hemp are helpful for a variety of conditions, including pain, anxiety, depression, and even heart disease. The FDA doesn’t want consumers to be able to buy cheap CBD supplements when they can spend thousands on the drug.
Full spectrum hemp oil is an extract of the hemp plant that contains CBD and a host of other beneficial compounds. We reported previously that while the agency was targeting CBD products, the status of hemp oil was unclear. It is discouraging, but not all that surprising, that the FDA is also now blocking the path forward for affordable hemp oil dietary supplements.
How did we get here? Congress legalized hemp at the federal level but preserved the authority of the FDA to regulate products within its jurisdiction that contain hemp, including supplements, cosmetics, and food. The FDA’s current position on the legality of using hemp or CBD in these various products can be found here.
The most concerning aspect of these new actions is the specific language used by the FDA in the rejection of the “new supplement” notifications for hemp oil. By law, any dietary supplement introduced to the market in the US after 1994 is considered “new” and the manufacturer must provide data to the FDA indicating that the “new supplement” can “reasonably expected to be safe.” But in the rejection letters to the marketers of hemp oil, the FDA has applied a different, more stringent safety standard for “new supplements,” requiring that companies now prove there is “reasonable certainty of no harm.” This standard is from an earlier version of the “new supplement” guidance document from 2011—a version which ANH-USA and other stakeholders successfully pushed back against until the FDA withdrew it. The agency then released a new version in 2016 that amended the safety standard called for in the 2011 guidance. Both versions of the guidance are deeply flawed and threaten thousands of supplements—but applying the old safety standard makes it even harder to comply with these requirements.
Safety studies for supplements may sound reasonable, but just remember: requiring these studies is part of the FDA approval process for drugs. Drugs can afford them because they are patentable. Supplements are natural and are not strongly patentable, so if they are also required to conduct pre-market studies, they don’t have the same ability to recoup those costs. This will either force companies to go out of business or it will make supplements so expensive that they are priced out of the market. Supplements also have a consistently sterling record of safety.
It is deeply troubling that after years of inaction, the FDA is reverting back to a standard that will make it more difficult for hemp oil and tens of thousands of other beneficial supplements to reach consumers.
support policies that ensure continued access to dietary supplements, including hemp oil and CBD.
We, the people, DO NOT want any of your restrictions on hemp or cbd oil. I personally have had great results for anxiety depression and muscle aches. I have done my research and use a well known company that is safe and 3rd party tested. Enough of forcing us to use pharmaceutical drugs that are addicting !
This bill is a direct assault on the freedom of millions of Americans, and it must be stopped. The decision to vaccinate must remain a free choice as all medical procedures. Some people have health conditions that preclude them from taking certain medicines or vaccines. There is no medicine/treatment that everyone can take.
Our constitution gives us freedom to choose. It is not legal to make up laws!!!
Congress is a major part of the problem. Congress are agents of the corporations – full stop! It is disheartening that ALH does not grasp this to be true. How can you ask corporate agents to ban these CBD related products? These agents called congress persons, are against medical for all as their sponsors (the corporations they work for) will not make there stockholders profitable. Will I call or petition my congress person on this matter – absolutely NO.
Help hemp!
Natural supplements are safer than pharma. Numerous proof of pharma dangers and side affects, in comparison to rare dangers and side affects from natural medicines, especially when prescribed by certified/licensed herbal practitioners. This is all because of fear of loss of profit at the expense of patients/the public.
I guess my question is: why are they attacking these which hdo little good and approve all the prescriptions on the commercials that openly admit that can cause side effects. They do not want us to have access to nutrition. Drs are not trained in nutrition and the big pharm is trying to limit our access to it. I have had more success with nutritional supplements then I have prescriptions. I have Celiac and they have no understanding of it and how it causes malabsorption of critical vitamins and minerals. Everything is backwards.
Congress must step in and ensure that Americans can continue to access safe supplements like hemp, CBD, and a host of other products! Thank you.
I am unable to take medicinal’s due to severe side effects. The only way I maintain any sense of a normal life is through supplements to enhance my immune system. The FDA has no right to take away what many of us need to survive just to put more money in the pockets of Big Pharma.
Why can’t the makers say these products are G.R.A.S. and tell the FDA to take a hike?
It is high time that the United States stopped living in the stone age as far as supplements such as CBD are concerned. Stop protecting big pharma profits and start working for the people who actually elected you.
For most of my 73 yrs I’ve gravitated toward alternative healing. I’ve researched & purchased supplements to help my health & to heal health problems often times instead of using drugs & or even a surgical procedure. I also many years ago worked for a health store helping customers with their problems at times or just with their choices to help theirs or their family’s own health. I’m very sensitive to drugs & what has almost always worked well for my health are natural vitamins, herbs, herbal tinctures, & teas that had NO SIDE EFFECTS when I took them compared with drugs.
Looking to Ayurvedic medicine. – all natural medicine derives from natural plants and compounds that are derived from then. — which have been used by people for millennia, before there was ever a Big Pharma… you can try to ban natural supplements, but millions of people will still use the homeopathic remedies that have been passed down through centuries. It will end up sort of like the War on Drugs, … or Prohibition. We all know how both of those have turned out.
I am writing to urge you to support policies that ensure continued access to dietary supplements, including hemp oil and CBD.
This will impact people that can least afford it Plus if is a ridiculous standard for natural ingredients
Hemp Supplements are safe and effective
I take multiple supplements as I have several illnesses that include other symptoms which would otherwise be life limiting.
These are plants and their express parts which have been used since early humans roamed the earth, as evidenced by multiple scientific studies into early humans history.
Not only is this ludicrous, this shows there are alot of dirty hands, full pockets, and locked skeleton doors.
You are going to tell everyone in the Free, United States of America, that I’m not allowed to use what Mother Nature, God, Goddess, the Divine, whatever your flavor, I will not go quietly! If I know and herb, aka maybe weed is going to make me feel better and take of my ills without nasty effects, I will do so!
No one has the right to take away my food, my nourishment, my vitamins, minerals, things that make my health the best it can be. You can all take a flying leap. Think about someone in your family that makes, uses, takes, depends on what they get in supplements that, without it’s complementary assistance to their body, they would not be able to do anything more than exist. Don’t be assholes, man. How far do you think we’re gonna be pushed! I’m 63 and I’ve see too much corruption everywhere, especially in our, “keep them unhealthy medical scam” health system. Keep your hands off my food in whatever form I use it!!!! Please.
The FDA is for profit not people and needs to be eliminated.
We must stop this assault on supplements, including hemp oil and cbd. They are trying to take away freedom of choice pretending they care about
The consimer. They must be stopped. This is an obvious attempt to keep big pharma in their position of control where they do nor belong.
Please take note of this serious attempt to wipe out the more natural and effective non-pharma alternative.
I do not need to take any prescribed medications, but I do take some supplements recommended to me by professionals. I would miss some of them if I could not take ! Linda RN MN
My comment was abolish the FDA and force all corporations to operate under full financial liability.
Don’t take away the supplements, and replace it with Big Pharma bullshit.
If I am to take a pill that I can trust…. It would not be a pharmaceutical one…
Anything that needs to be patented is not health-promoting.
Health is not enhanced by a pharmaceutical…
Real organic, nutrient-dense foods, pure water, clean air, and critical supplements are needed…..
Thank you so much for bringing this to my attention! I have been using CBD for over 2 years now daily. It works better than anything I have ever been prescribed or any OTC remedies. I would consider it a crime if any so called protective agency took this away from me. They would be guilty of what they expect these natural substances to proven by. They would be doing me harm!!!
I am very trusting of all the literature I have read on CBD and the success doctors are having with their treatments.
We must do all we can to stop this assault on our ability to self improvement and better health.
They don’t want people to get healthy, unless they can make a profit off of it. Horrible
Please do not take our CBD and Hemp’s natural medication away! So many of us cannot afford big pharma meds, and also so many of us don’t want to take them, let alone pay the ridiculous prices, along with all of the negative side effects! CBD and Hemp cover so many ailments AND mental and physical issues. If you are all smart, you should start investing in all areas of cannabis.
Without CBD oil my epilepsy would be even WORSE & I do NOT take any THC, what gets people “high”. However for SOME epileptics (like one child had up to a THOUSAND seizures/day, I think?, definitely hundreds) & only CBD+THC controlled those seizures, meaning to STOP Hemp is to DESTROY LIVES, meaning to stop Hemp makes YOU into MURDERERS, LITERALLY!
Outrageous!
Congress, please support policies that ensure continued access to dietary supplements, including hemp oil and CBD.
Big pharm cannot make a huge profit on hemp products. If they could, they would embrace hemp and CBD. FDA would then support these products. FDA should concentrate of fixing the opioid mess and leave non-addicting pain relief alone.
Ridicoulus!
Keep hemp oil and other CBD products safe and legal!
You guys need to take a serious look at the science.
Thist assault on natural products is nothing short of criminal. YOU Should be thinking of the world you are responsible for your children.
I believe this is driven by evil…. is this you legacy.
Money, power, control?
Please don’t be this stupid.
Congress must step in and ensure that Americans can continue to access safe supplements like hemp, CBD, and a host of other products.I urge you to support policies that ensure continued access to dietary supplements, including hemp oil and CBD.
Here we go again. What is a person to do? I am 67 years old and suffer from insomnia caused by having a 3 hour paper route in the middle of the night for 9-1/2 years. CBD oil is MY only option. Doctors will not prescribe medicine to help as the government agencies have them terrified. Apparently they are seeing drug addicts behind every bush – forget the people who are not, and have never been drug addicted, that suffer from chronic insomnia and/or pain. Try getting anything for agonizing back spasms. My remedy for that is 5 ibuprofen and that is practically useless. Fortunately, these are rare instances. Insomnia, however, is more frequent and CBD oil is the only thing I have found that helps keep me asleep. As usual, the government in league with big Pharma strikes again. Apparently, they only believe in “my body, my rights” only applies when killing babies. This country needs a major overhaul, from the top on down – especially the health care system.
Hemp is a plant, an herbal plant. Herbs are nutritious, thus contribute to our health and resist diseases. Herbs flavor foods. Herbs in various forms such as fresh, dried, oils are good for people to consume and use on the body. At a very active 90YO, I have only two prescriptions: thyroid and eye drops. I take herbs in many forms every day.
This supplement is not toxic and hemp is a crucial medicine for many. Please do not eradicate something as useful as the hemp plant.
Leave hemp alone. People are in pain
Please keep the options available to be able to buy supplements ie: hemp oil, cbd, etc. We need to have choices in how we want to take care of ourselves. I am a voting American citizen.
Thank you.
Please give us the opportunity to also edit the subject line in your automated emails. As it stands right now, we can’t change the subject line and Government representatives can simply see hundreds of emails with the same subject line and read one (maybe) and ignore the rest of the emails missing any edits we add to the message. I think we all will have much more impact if all our emails with similar content have different subject lines so they aren’t lumped together at the receiving end and treated as one!
I signed the petition but now I’m not so sure I should have. I just came across this research pointing to an increase in DNA/chromosome damage with low level CBD exposure. Also FDA correctly points out in its warning about CBD that it can cause liver damage, though this is typically seen at higher dosages used by people with seizures, however increasingly, people are using these similar higher dosages for anxiety: “Cannabidiol (CBD) and cannabidivarin (CBDV) are natural cannabinoids which are consumed in increasing amounts worldwide in cannabis extracts, as they prevent epilepsy, anxiety, and seizures. It was claimed that they may be useful in cancer therapy and have anti-inflammatory properties. Adverse long-term effects of these drugs (induction of cancer and infertility) which are related to damage of the genetic material have not been investigated. Therefore, we studied their DNA-damaging properties in human-derived cell lines under conditions which reflect the exposure of consumers. Both compounds induced DNA damage in single cell gel electrophoresis (SCGE) experiments in a human liver cell line (HepG2) and in buccal-derived cells (TR146) at low levels (≥ 0.2 µM). Results of micronucleus (MN) cytome assays showed that the damage leads to formation of MNi which reflect chromosomal aberrations and leads to nuclear buds and bridges which are a consequence of gene amplifications and dicentric chromosomes. Additional experiments indicate that these effects are caused by oxidative base damage and that liver enzymes (S9) increase the genotoxic activity of both compounds. Our findings show that low concentrations of CBD and CBDV cause damage of the genetic material in human-derived cells. Furthermore, earlier studies showed that they cause chromosomal aberrations and MN in bone marrow of mice. Fixation of damage of the DNA in the form of chromosomal damage is generally considered to be essential in the multistep process of malignancy, therefore the currently available data are indicative for potential carcinogenic properties of the cannabinoids.Arch Toxicol
. 2019 Jan;93(1):179-188. doi: 10.1007/s00204-018-2322-9. Epub 2018 Oct 19.
Low doses of widely consumed cannabinoids (cannabidiol and cannabidivarin) cause DNA damage and chromosomal aberrations in human-derived cells
Chiara Russo 1, Franziska Ferk 2, Miroslav Mišík 2, Nathalie Ropek 2, Armen Nersesyan 2, Doris Mejri 2, Klaus Holzmann 2, Margherita Lavorgna 1, Marina Isidori 1, Siegfried Knasmüller 3