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FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)
https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
On this page:
Consumer Information
FDA Communications
Regulatory Resources
Questions and Answers
There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.
Consumer Information
What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding
Some Medicines and Driving Don’t Mix
FDA Communications
FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity
Congressional Testimony: Cannabis Policies for the New Decade
Archived VideoExternal Link Disclaimer
FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
Remarks at the Council for Responsible Nutrition Conference
Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit
FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease
Congressional Testimony: Hemp Production and the 2018 Farm Bill
Archived Video
FDA is Committed to Sound, Science-based Policy on CBD
Remarks at the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds
Statement on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
Statement on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds
Statement on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
Regulatory Resources
Information on CBD Data Collection and Submission
FDA and Cannabis: Research and Drug Approval Process
FDA Regulation of Dietary Supplement & Conventional Food Products Containing Cannabis and Cannabis-Derived Compounds
Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing
Federal Register Notice
Public Hearing Page
Public Docket
Warning Letters and Test Results for Cannabidiol-Related Products
State, Local, Tribal, Territorial (SLTT) Regulatory Officials: FDA is committed to working with our SLTT public health regulatory partners as developments occur in the regulatory landscape. Please contact the Intergovernmental Affairs team with any questions at IGA@fda.hhs.gov.
Questions and Answers
Below are a number of frequently asked questions and answers on this topic.
What are cannabis and marijuana?
How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?
Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?
Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?
What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?
Has the agency received any adverse event reports associated with cannabis use for medical conditions?
Is it legal for me to sell CBD products?
Can THC or CBD products be sold as dietary supplements?
Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?
In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?
Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?
What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
Can I import or export cannabis-containing or cannabis-derived products?
What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?
Does the FDA object to the clinical investigation of cannabis for medical use?
How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?
Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?
Does the FDA have concerns about administering a cannabis product to children?
Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?
What does the FDA think about making CBD available to children with epilepsy?
What should I do if my child eats something containing cannabis?
I’ve seen cannabis products being marketed for pets. Are they safe?
Can hemp be added to animal food?
Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?
“ We look forward to taking our next steps towards commercialization of CVSI-007, including discussions with potential strategic partners.”
My favorite line as well, now seeing that this was already posted!
Arthritic dog testing was to be completed in mid March. Maybe they want that data and plan on releasing the pet line next week, like on Tuesday.
IMO
News rescheduled for a Monday is a heck of a lot better then news rescheduled for a Friday!
IMO
Nice!
US HEMP ROUNDTABLE
Action Alert
https://hempsupporter.com/state-action/nationwide/prod-fda-to-act-on-cbd
FDA Issues CBD Report to Congress
More than a week after a Congressional deadline, FDA finally released its long-awaited report to Congress on the potential regulatory pathways for the sale of hemp-derived CBD products. Click here for the full report.
There’s not much cause for celebration — FDA continues to kick the can down the road, claiming that more study is needed before it takes action. The agency’s delay results in the worst of both worlds — U.S. hemp farmers are denied profitable markets for their crops, while unregulated products continue to proliferate, with no safeguards for public health and safety.
The report, however, does provide valuable insight into the Agency’s thinking and next steps including the following:
FDA is actively evaluating a potential rulemaking to allow CBD in dietary supplements. In the meantime, the agency is considering the issuance of a risk-based enforcement discretion policy to provide more transparency regarding its enforcement priorities.
With regard to adding CBD to food and beverages, FDA maintains that the data currently available raises safety concerns and encourages parties to share relevant information with FDA.
FDA argues that those marketing cosmetics should ensure the safety of their products, noting that there is limited data on topical use of CBD, and that topical products – including those with CBD – should not make structure/function or therapeutic (drug) claims.
FDA is re-opening the docket to obtain information on “full spectrum” and “broad spectrum” hemp extracts, and how they compare to CBD isolate products. The agency is also actively working to develop a sampling study of the CBD marketplace to determine the extent to which products are adulterated or misbranded.
FDA’s baby steps, combined with Commissioner Hahn’s recent statements that it would be a “fools game” to shut down the CBD business, offer some hope about the inevitably of FDA action on CBD regulation. But in order to protect hemp farmers — and provide U.S. consumers access to safe and legal products that they demand — FDA’s go-slow approach is not tenable.
We call on Congress to force FDA’s hand, declare CBD and other hemp constituents as lawful ingredients, and require the agency to implement a regulatory plan to protect consumers and unleash U.S. hemp farming.
Hemp’s friends in Congress are developing plans to spur FDA action. In the meantime, Hemp Supporters are encouraged to contact their U.S. Congresspersons, and urge them to co-sponsor H.R. 5587 which would allow FDA-regulated, hemp-derived CBD to be marketed in dietary supplements and as food and beverage additives. Please use our online portal to email your Representative to have your voice heard today.
CONTACT YOUR CONGRESSPERSON!
Very good IR, spoke with him twice!
""Boccardi said her CBD comes from a local manufacturer, and she's working to label her own product for her customers.
"They would buy it from me because they know if I do it, it's what it says it is,” she said."
And this is why we need the F....king DA to do something and soon!
IMO
PFIZER.CEO ENLISTS SCOTT GOTTLIEB TO SQUASH CBD MOVEMENT
This is how it went down!
IMO
This is how it went down..............IMO
Pfizer Ceo: Hey Scott, we have a seat on the board over here at Pfizer for you.
Gottlieb: Wow, to what do I owe this honor?
Pfizer Ceo: Great credentials Scott and by the way, this CBD movement is getting a little out of hand, don't you think?
Gottlieb: Not a problem, I'm on it!
God forbid the American public should have a substance that relieves pain and makes them feel better naturally.That's the last thing BP wants! BP just wants to make drugs that treat things, not cure anything. The F___king DA is tied to BP and as far as they are concerned the American public can just go to hell.......!
All bureaucratic assholes looking to fill their pockets with with BP $$$$$$$$$$$$$!
IMO
"And if the phase 1 smokeless tobacco study goes well"
It won't mean crap to BP without a patent and they would rather steal it than pay for it or just kill it entirely. The pharmaceutical business is a dirty business and the FDA is right in there with them.
Maybe you should read Deetew's post again?
Desperately Seeking Harm: The FDA on CBD
By Martin A. Lee On January 13, 2020
Diagnosing the FDA's CBD problem
Illustration of a man in a suit and tie standing at a podium. His shadow, in read, appears to have devil horns.
Is there a doctor in the house? The Food and Drug Administration (FDA) is ailing and needs some serious attention.
The FDA has got a bad case of CBD – as in Chronic Bureaucratic Dysfunction. This affliction has been evident for some time, but the symptoms are getting worse.
The FDA can’t figure out how to regulate CBD, short for cannabidiol, the all-star cannabis compound with formidable therapeutic properties that won’t make a person feel high. Although it doesn’t cause intoxication or impairment, cannabidiol has completely befuddled FDA officials, who aren’t able to scale with the magnitude of CBD’s meteoric rise in popularity.
CBD has scrambled the prohibitionist narrative. It has disordered the FDA’s cosmos. Over 64 million (one in seven) Americans have thumbed their nose at the FDA by choosing to use a CBD product. Many are taking CBD for medical conditions that don’t respond well to FDA-approved pharmaceuticals.
The FDA is responsible for ensuring that everything we eat or drink, every drug we take to feel better, is safe (and supposedly effective). But there’s no precedent for regulating a substance so versatile that it works as a single-molecule pharmaceutical, a wellness nutraceutical, an essential oil extract, and an artisanal herbal preparation that can be ingested as food or beverage, inhaled as vapor or smoke, or absorbed sublingually and applied topically in various ways. Such is the case with CBD.
So, the FDA does what it always does. It reverts reflexively to old bureaucratic habits. The FDA only recognizes the medical utility of isolated components of cannabis. Single-molecule CBD is an FDA-approved prescription pharmaceutical. So is single molecule tetrahydrocannabinol (THC). But herbal cannabis, the natural source of CBD and THC, isn’t an FDA-approved therapy. Full spectrum, CBD-rich essential oils extracted from resinous cannabis flower tops are frowned upon by the FDA, which routinely privileges pharma over farmer.
Bad Advice
The FDA recently reiterated its official disapproval of nonpharmaceutical uses of cannabidiol in an updated Consumer Advisory that generated alarmist headlines about the perils of CBD. The FDA also dispatched blunt warning letters to 15 CBD companies, taking them to task for making unproven medical claims and mislabeling the amount of cannabidiol in their products.
There’s no precedent for regulating a substance as versatile - both in forms and consumption methods - as CBD.
It wasn’t the first time that the FDA slapped the wrist of CBD businesses or wagged a finger at self-medicating consumers. But the latest FDA missives were less nuanced and more strident than before – with stark language about liver injury and other dangers allegedly attributable to CBD, including male reproductive toxicity, stomach upset, and interactions with different drugs.
In the world according to the FDA, CBD is not a safe substance and it is not a legitimate dietary ingredient or supplement for people or pets. “CBD has the potential to harm you,” the FDA declared, noting that is it “has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.”
Investors moaned, vendors vented, and consumers scratched their heads.
Is More Research Needed?
The FDA claims that it lacks sufficient scientific data on CBD’s effects to move forward with CBD regulation. What’s more, according to the Foot Dragging Administration, it could take years to sort out the pros and cons of CBD.
How often have we heard the same refrain – “more research is needed” – from recalcitrant officials who prefer to see no change in policies that should be guided by science? “From climate denial to cannabis prohibition, the demand for absolute scientific certainty is a call for inaction,” says Adrian-Devitt Lee, Project CBD’s chief science writer. “It begs the question: When is there ‘enough’ research? How about not enough to eliminate all uncertainties, but enough to recommend a medical treatment or a change in policy?”
Actually, CBD has been the focus of extensive scientific inquiry. Medical researchers already know a great deal about this remarkable botanical compound. In 2017, a Mayo Clinic investigator noted that CBD, a potent antioxidant, acts through 65 different molecular channels in the human brain and body, and since then at least a dozen more CBD pathways have been identified. Preclinical studies underscore CBD’s therapeutic potential for numerous conditions.
To date, there has been no evidence of public health-related problems directly attributable to the widespread use of cannabidiol. A 2018 report by the World Health Organization concluded that CBD “is generally well-tolerated with a good safety profile [and] exhibits no effects indicative of any abuse or dependence potential.” But the FDA stubbornly insists that it is not aware of any basis to conclude that CBD is GRAS [Generally Recognized as Safe] among qualified experts.
The FDA Sees What It Wants to See
The FDA is desperately – and disingenuously – seeking harm, inflating the dangers of CBD and minimizing benefits. Why? The problem is political, not pharmacological. Since June 2018, CBD has been approved in the United States as a prescription pharmaceutical, known as Epidiolex, for two severe pediatric seizure disorders. Therefore, according to standard pro-pharma FDA policy, CBD can’t also be marketed as a food supplement or an over-the-counter remedy.
Safety data pertaining to Epidiolex, produced by GW Pharmaceuticals, has figured prominently in the FDA’s evaluation of CBD. Cannabidiol comprises 98% of the cannabinoid content in Epidiolex, an artificially sweetened, ethanol-based, CBD-infused tincture.
There is little, if any, evidence that shows CBD, at any dose, is harmful to human beings who are not also taking another drug.
Whereas Epidiolex can cause adverse side effects when administered in large doses, there is little, if any, evidence that shows CBD, at any dose, is harmful to human beings who are not also taking another drug. This does not mean that a CBD isolate is perfectly safe or a smart medical choice; it only means that the current scientific literature does not validate the FDA’s contention that CBD is dangerous.
In its recent Consumer Advisory, the FDA rattled off several undesirable side effects of CBD, including diarrhea, drowsiness, changes in mood (irritability, agitation), and liver damage. While it’s true that ten percent of epileptic children, when administered Epidiolex in clinical trials, experienced adverse events, the FDA fails to make the case that these side effects were actually caused by CBD:
Gastrointestinal distress. Diarrhea, loose stool, and other symptoms of GI distress are the most common side effects of Epidiolex, which is laced with sucralose, the ubiquitous artificial sweetener marketed under the brand name Splenda. According to several reports, incuding a 2017 study by Japanese scientists in Nutrients, sucralose alters gut microflora in ways that foster dysbiosis, blood sugar imbalances, and an overall, unhealthy metabolism. Other studies indicate that sucralose causes leukemia and liver damage in lab animals, prompting the Center for Science in the Public Interest to warn people not to consume sucralose. Why is this toxic, gut-disturbing compound allowed in our food supply? And why is sucralose an FDA-approved ingredient in a pharmaceutical preparation for children with seizures?
Irritability and agitation. It’s not surprising that an ill child on several medications would become moody or agitated if given repeated doses of drug that causes gut dysbiosis. CBD, an anti-inflammatory painkiller, does not foster unhealthy bacterial growth in the microbiome.
Somnolence. A small dose of CBD can induce wakefulness and insomnia, while a large dose, like the amount utilized in the Epidiolex trials, can have a sedating effect. CBD combined with alcohol or other central nervous system depressants “increases the risk of sedation and drowsiness,” according to the FDA. Of course, most drugs shouldn’t be mixed with alcohol. How, then, did the FDA determine the allowable limit of ethanol exposure for a neurologically compromised child on a high-dose regimen of Epidiolex, which includes ethanol as a carrier ingredient?
What About the Liver?
Drug-induced injury is a major cause of liver failure in the United States. Alcohol, high fructose corn syrup, NSAIDs and other widely consumed over-the-counter products are major culprits. That hasn’t stopped the FDA from green-lighting these products. But in the world according to the FDA, CBD is just too risky for Americans, who’ve been putting their livers at risk a long time thanks to unhealthy FDA regulatory policies.
Based on the Epidiolex data, the FDA asserts: “CBD can cause liver injury.” Indeed, there were problems in some cases when very high doses of Epidiolex were given to severely ill patients who were also taking other anti-epileptic medications that have toxic profiles of their own. All the Epidiolex test subjects suffered from refractory seizures, which means they had already tried several anti-epileptic medications that failed to quell their seizures.
Liver stress has been observed in some cases when very high doses of Epidiolex were given to severely ill patients who were also taking other anti-epileptic medications that have toxic profiles of their own.
Sometimes combining different meds can have positive results, but drug interactions must be carefully managed by a health professional. At high doses, CBD may interact with numerous pharmaceuticals, including harsh anti-epileptic drugs such as clobazam. That’s what the Epidiolex data showed: CBD can increase blood levels of clobazam by inhibiting its metabolism – and clobazam is a potent benzodiazepine that can cause a lethal overdose by depressing respiratory function. Thus, it was necessary for doctors to adjust the amount of clobazam given to Epidiolex patients, who were on a high-dose CBD regimen.
Long-term use of valproate, another anti-epileptic drug, is known to cause symptoms of liver toxicity. Although valproate and CBD don’t appear to interact metabolically, it’s conceivable (but not proven) that in combination they might put additional stress on the liver. Despite such concerns, researchers have found that the combination of CBD and valproate can be a very effective anti-convulsant treatment for some patients when nothing else helps.
The FDA’s recent Consumer Advisory neglected to mention animal studies that indicate CBD has a positive impact on liver function by inhibiting fibrosis and protecting against alcohol toxicity. According to a 2019 report by Israeli scientists in Frontiers in Pharmacology, CBD enhances the effects of doxorubicin, a chemotherapy drug used to treat liver cancer and other malignancies. And a 2019 longitudinal study by Spanish researchers found that people with a history of cannabis use are less likely to develop fatty liver disease than cannabis abstainers.
The Fully Discredited Administration
“We treat substances derived from cannabis just like we do any other substances,” says the FDA, which purports to favor a “rigorous science-based approach [to] products containing cannabis or cannabis-derived compounds, including cannabidiol.”
The sheer mendacity of such pronouncements is striking even for “the Fully Discredited Administration.” That’s how medical marijuana pioneer Tod Mikuriya, MD, referred to the FDA, which has long since forfeited any claim to credibility with respect to cannabis.
The fact that CBD is officially both a Schedule I substance and Schedule V substance is symptomatic of a deeply flawed drug policy mired in contradiction.
In the world according to the FDA, any cannabis cultivar with more than 0.3 percent THC is a dangerous drug with no medical value and any CBD-rich oil extracted from such a plant is an illegal Schedule One substance. But the hemp-derived CBD present in Epidiolex is a legal Schedule Five substance, the safest (non-OTC) designation possible. The fact that CBD is officially both a Schedule One substance and Schedule Five substance is symptomatic of a deeply flawed drug policy mired in contradiction, rather than a policy informed by a “rigorous science-based approach” to public health.
The FDA’s Double Standard
As for treating CBD like any other substance – a brazen double standard is evident. Compare the FDA’s assessment of animal experiments with CBD to how the FDA responds when preclinical (and clinical) research questions the safety of widely available FDA-approved food ingredients. A plethora of toxic food additives (corn syrup, emulsifiers, nitrates and nitrites, artificial sweeteners and colors, phony flavors and textures …) gets a free pass from the FDA, which turns a blind eye to scientific data showing harm from processed food. But when a single study, in which a mega-dose of cannabidiol is injected into mice, hints at possible harm, that’s flagged by the FDA as proof you can’t trust your health with CBD.
Extrapolating from animal studies to humans – or choosing not to – is a tricky business, given that mice and people metabolize CBD differently and inconsistent findings result from different experimental designs. The FDA likes to have it both ways, ignoring animal data that shows sucralose is harmful, to cite but one example, while emphasizing animal data that casts the slightest aspersion on CBD’s safety.
Although there’s little evidence that CBD is a factor in the declining sperm counts of American men, the FDA’s recent Consumer Advisory raised the specter of CBD-induced “male reproductive toxicity” by referencing a 1986 study, which examined whether plant cannabinoids had a negative impact on the fertility of male mice. Curiously, this study seemed to exonerate THC: “Males exposed to … THC appeared to have spermatozoa in number comparable to controls.” But a large dose of CBD, unlike THC, “reduced the percentage of successful impregnations by cannabinoid-exposed males.”
Dosing High & Low
The FDA also likes to have it both ways when interpreting clinical data from the Epidiolex trials, in which patients were given huge doses – up to 20 mg per kg of body weight – of CBD in addition to various anti-epileptic meds. When problems arose, the FDA blamed CBD, even though Epidiolex also contains noxious ingredients (ethanol, sucralose) and adverse reactions may stem from interactions with other drugs.
So, when there’s harm the FDA views Epidiolex as equivalent to CBD. But when there are benefits, such as less frequent and less intense seizures, that’s not because of generic CBD. It’s because of Epidiolex, a unique, FDA-approved pharmaceutical – unlike nonpharmaceutical CBD products, which, by definition, lack therapeutic value because they don’t have the FDA’s seal of approval.
The FDA cites potential adverse effects from CBD but does not distinguish between the huge doses administered to Epidiolex patients and the small amount of CBD typically present in unregulated supplements.
The FDA cites potential adverse effects from CBD but does not distinguish between the huge doses administered to Epidiolex patients and the small amount of CBD – 5 to 25 mg – typically present in unregulated supplements. By comparison, the recommended dose of Epidiolex would be equivalent to a 150-pound adult taking as much as 1400 mgs of CBD daily, which is way more than the real-world experience of the vast majority of CBD consumers. And that makes a big difference. Drug interactions are much more likely if one consumes large doses of a CBD isolate. But that’s not what most people are taking. The unregulated CBD market and licensed medical cannabis markets are awash in oil extracts that contain a full spectrum of cannabis components, including a tiny amount of THC, in addition to CBD.
A 2018 meta-analysis evaluated the efficacy of CBD isolates and CBD-rich oil concentrates for treating epilepsy. (Epidiolex and some unregulated, hemp-derived CBD products are considered isolates, as they lack the full range of cannabinoids and terpenes that are present in whole-plant extracts.) Conducted by Brazilian scientists, this meta-analysis found that single-molecule CBD and artisanal CBD-rich oil extracts were both effective for certain kinds of epilepsy, but the full spectrum extracts had a wider therapeutic window and generally produced better results than the CBD isolates. Perhaps the most salient finding was the dramatic difference in requisite doses for isolates compared to full spectrum CBD-rich extracts. As the main ingredient in a full spectrum extract, cannabidiol was four times more potent than an equal amount of CBD in an isolate. And that means one would need much less CBD from a whole plant oil extract to achieve a desired result.
The FDA Consumer Advisory rang alarm bells about cumulative exposure to unregulated CBD products: “How much is safe to consume in a day?” “What happens if you eat food with CBD in it, use CBD-infused skin cream and take other CBD-based products on the same day?” “What if you use these products daily for a week or a month?” Of particular concern: How will long-term exposure to CBD impact “special populations,” such as children, pregnant women, and seniors?
Mislabeled CBD Products
In the world according to the FDA, too much CBD is a major looming problem. But in the real world, where millions of people are actually using CBD, too little may be more of an issue than too much. More often than not, according to several surveys, the amount of cannabidiol present in a hemp-derived CBD product does not match the amount of CBD indicated on the label – and among mislabeled products, most contained less CBD than promised. Some products had no CBD in them at all.
While fears of overexposure are overblown, the FDA has raised valid concerns about quality control within the unregulated CBD market. “Some CBD products are being marketed with unproven medical claims and are of unknown quality,” the FDA cautioned.
Pesticide and solvent residues, along with toxic additives and other contaminants, plague the fledgling CBD industry. But these problems persist largely because the FDA has abdicated its responsibility to regulate a popular wellness supplement. The FDA’s inaction with respect to CBD, the big regulatory stall, has facilitated the rapid growth of the unregulated marketplace that the FDA abhors.
Conjuring Harm
As 2019 drew to a close, the FDA ratcheted-up the fear mongering. Although CBD doesn’t damage DNA and is neither mutagenic or tetargenic, the FDA warned women not to use CBD while pregnant or breastfeeding. (“What is the effect of CBD on the developing brain?” the FDA asked forebodingly.) Pet-owners were urged to steer clear of CBD-infused pet food.
And then came clincher: The FDA issued a bulletin on Dec. 18, 2019, warning people not to drive a motor vehicle under the influence of CBD! It bears repeating that CBD is not intoxicating, does not cause a high, does not impair coordination or perception, and has never been linked to hazardous driving. But in the world according to the FDA, “Taking Cannabidiol (CBD) Products and Driving Can Be Dangerous.” Why? Because epileptic children heavily medicated on benzos became drowsy after they were given a big dose of CBD. We kid you not.
The FDA’s disproportionate fears with respect to CBD, the cherry-picked scientific data and the blatant double standard that drives FDA policy – these are all clues of a profound institutional pathology.
The FDA’s disproportionate fears with respect to CBD, the cherry-picked scientific data and the blatant double standard that drives FDA policy – these are all clues of a profound institutional pathology. What diagnosis would a medical detective render if the FDA was the patient? Excessive bureaucratic plaque? A hardening of the administrative arteries? Or could it be more serious?
The FDA’s behavior toward CBD has much in common with a bizarre mental illness known as Munchausen syndrome by proxy (MSBP). This is an unusual mental condition in which an abusive caregiver makes up and projects symptoms of a malady or injury on to a vulnerable person under their care, typically a child or elderly adult. A parent with MSBP will lie about their child’s symptoms, change test results to make a child seem sick, and, in some cases, inflict physical abuse on a child to make symptoms appear. That’s how the FDA relates to nonpharmaceutical CBD. Like a depraved parent with Munchausen syndrome, the FDA concocts harm and projects problems while refusing to implement regulatory standards for safe CBD products.
In the world according to the FDA, it’s legal to put carcinogens in food and beverages without even so much as a warning label, but a CBD edible is too dangerous to consume. Thanks to the FDA, our heavily processed food supply is rife with endocrine disrupters, GMOs, transfats, artificial sweeteners, and other hazardous substances. Our cosmetic and personal care products reek with toxins. And big pharmaceutical firms get away with falsifying data to win FDA approval for dubious drugs that work no better than a placebo. All of this amounts to business as usual for the FDA, which, unlike CBD, is a clear and present danger to public health.
“Of the hundreds of CBD companies operating in the U.K., only a handful have the means for it. We expect this FSA announcement to drive consolidation.”
Hopefully we are next!
"so.... " LMAO!
LOL!
Market in high gear while the FDA siphoned all the gas out of the CVSI tank!
FDA SUCKS! GET RID OF ALL THOSE LEECHES!
US HEMP ROUNDTABLE
State legislative sessions are underway and there are several important hemp and CBD bills currently being considered and debated. Over the past few weeks, we have highlighted some key legislation (in states like Hawaii, Kentucky, and Washington). We will continue this effort in the weeks ahead.
Today, we are highlighting important legislation in five states, including in two states that do not have hemp programs. We encourage all Hemp Supporters to use our State Action Center to contact their legislators and urge them to pass these bills into law.
State Alert:
California
The end of 2019 left many California Hemp Supporters disappointed because AB 228, which would have legalized the retail sale of hemp-derived CBD, was declared dead. However, we are excited to share that AB 228 is being taken up again in the California Assembly. We are actively lobbying for AB 228’s enactment. California Hemp Supporters are encouraged to use our State Action Center to urge state legislators to support AB 228.
State Alert:
Massachusetts
As we shared last, lawmakers from the Bay State have introduced a bill that provides some of the strongest protections for CBD in the country. The bill—HB 4001—addresses unfavorable guidance from the Massachusetts Department of Agricultural Resources. HB 4001 is tremendously important for the hemp industry in Massachusetts and across the country, as it makes clear that CBD may be added to cosmetic and food products and that such products are not adulterated simply due to inclusion of CBD. The USHRT has an active lobbying campaign to help HB 4001 become law. Massachusetts Hemp Supporters are encouraged to use our State Action Center to encourage state legislators to support HB 4001.
State Alert:
Maine
We recently reported that the Maine Department of Agriculture, Conservation and Forestry issued rules that prohibit retailers from selling consumable hemp products unless those products are produced in Maine. There is a bill before the Maine legislature—LD 1747—that would change that for the better. The bill makes clear that CBD may be added to food and that the addition of CBD does not cause a food to become adulterated. It also strengthen Maine’s hemp program. LD 1747 has been postponed, so we need your help in getting it back on the legislative agenda! Maine Hemp Supporters are encouraged to use our State Action Center to urge state legislators to support LD 1747 (or any other bill that provides protections for hemp-derived CBD).
State Alert:
Mississippi
Mississippi is one of only three states that have not established a hemp program. In fact, there are real concerns that Mississippi officials will treat hemp as marijuana. Fortunately, positive change is happening. HB 320 was recently introduced in the Mississippi House. The bill removes hemp-derived CBD from Mississippi’s Schedule I controlled substances list. This is an important first step. If enacted, HB 320 will remove all doubt that hemp is legal in the Magnolia State and possibly open the doors to a full hemp program. Mississippi Hemp Supporters are encouraged to use our State Action Center to urge state legislators to support HB 320.
State Alert:
South Dakota
Like Mississippi, South Dakota is one of only three states without a hemp program. You probably heard that, in 2019, Governor Kristi Noem vetoed a bill that would have established a hemp program in South Dakota. Her veto was just a few votes away from being overridden. There is yet again a bill before the South Dakota legislature—HB 1008—that would create a hemp program. The bill also allows for the purchase and sale of CBD. Governor Noem has stated that as long as the bill meets her “guardrails,” she will sign it. South Dakota Hemp Supporters are encouraged to use our State Action Center to urge state legislators to support HB 1008.
Even if you do not hail from or live in any of these states, please share this email with people who do, as well as your friends, colleagues, customers, and social media contacts. When we raise our voices for hemp, we win!
CVSI is providing free waders with every share purchased to get through the BS posted here!
IMO
"How do we get them on our side (i.e., helping to drive the price up or maintain it?)."
WOW! That was joke right?
LMAO
"How the hell does a penny stock trade at thousands of a cent? (.9604 vs .9644?)."
High speed algorithm machines can trade this back and forth all day without any profit or loss to the Market Manipulators doing it and it doesn't matter if the volume is big or small. They are in total control. They can run it up or take it down. With the absents of online retail traders who jump in and out on news driven days you wind up with low volume days like today.
No FDA guidance = No share price movement = DEAD MONEY
IMO
Everything you said is true except one thing,
“Just remember: this is Investors Hub not Traders Hub.”
"Annual report won't be out till around April 1st"
April Fools Day!
"Q4 EOY Reports come out in 2-3 weeks?"
It's already been posted Q4 EOY comes out end of March.
What the heck are you talking about?
Farmers Insurance Open Selects +PlusCBD™ Oil as Their First-Ever CBD Sponsor
GlobeNewswire GlobeNewswire•January 21, 2020
SAN DIEGO, Jan. 21, 2020 (GLOBE NEWSWIRE) -- CV Sciences, Inc (CVSI) (the “Company”, “we” or “our”), a preeminent supplier and manufacturer of hemp cannabidiol (CBD) products through its brand PlusCBD Oil™, is the first-ever CBD sponsor of the Farmers Insurance Open. The Farmers Insurance Open is a PGA Golf tournament taking place Thursday, Jan. 23, through Sunday, Jan. 26, at Torrey Pines Golf Course in San Diego, California.
CV Sciences is the official CBD Partner of the Farmers Insurance Open as well as the Presenting Sponsor at the tournament. CV Sciences will be hosting a booth at The Grove, adjacent to the 18th Hole of the South Course at Torrey Pines. Tournament attendees will be able to sample PlusCBD™ Oil products, learn more about the potential benefits of hemp-derived CBD, and have the chance to win PlusCBD™ Oil products and exclusive CV Sciences gear.
Why CBD & Golf
Emerging scientific evidence suggests that hemp-derived CBD may promote relaxation and assist in muscle recovery. For these reasons, golf athletes turn to hemp CBD products to help with body aches and soreness that hinder them on the course, as well as the “first tee jitters.” CBD works with the body to aide in muscle recovery after a long golf game by regulating inflammatory response. Since 2018, when the World Anti-Doping Agency removed CBD from its banned substance list, the PGA Tour Anti-Doping organization does not list CBD as a prohibited substance for players.
“We are proud to be the official CBD Partner of the Farmers Insurance Open as this serves as another proof point of our commitment to safe, high-quality products,” said Joseph Dowling, Chief Executive Officer, CV Sciences. “We believe both professional and amateur golfers can benefit from PlusCBD™ Oil products and we look forward to increasing our visibility among the golf community through this sponsorship.”
https://www.benzinga.com/pressreleases/20/01/g15153886/farmers-insurance-open-selects-pluscbd-oil-as-their-first-ever-cbd-sponsor
$2 by Friday?????
"Monday 1.50-2.00"
Probably right, but not till Tuesday.
I'm glad I'm not the only one paying attention. lol
NEWS TUESDAY?????
and thanks!
NEWS MONDAY?????
Help Secure Co-Sponsors on HR 5587 that Would Prod FDA to Act on CBD
US HEMP ROUNDTABLE
As we’ve shared with you often, FDA’s past promises to lay out a regulatory path for the retail sale of hemp-derived CBD products have so far gone unfulfilled.
Inaction by the agency has led to a worst of all worlds: While a legal cloud hovers over commerce in safe, quality-assured, popular CBD products, unregulated bad actors continue to sell inferior products that give misleading information to consumers and potentially endanger public health and safety.
Congress has begun to lose its patience. And an effort led by U.S. Rep. Collin Peterson (D-MN) could force the FDA’s hand.
Yesterday, Rep. Peterson introduced HR 5587 that would allow FDA-regulated, hemp-derived CBD to be marketed in dietary supplements and as food and beverage additives. The bill would also require a study and report from the USDA on the regulatory and market barriers for farmers engaged in hemp production. HR 5587 is co-sponsored by some of hemp’s most resolute friends in Congress: Rep. Chilliest Pingre (D-ME), James Comer (R-KY) and Thomas Massie (R-KY). Read the entire bill here.
We need your help to send a powerful message to the FDA.
Please click here to encourage your U.S. Representative to co-sponsor the HR 5587. Even if you don’t know who your Congressman or Congresswoman is, once you type in your name and zip code, our online portal will populate an email that will be sent directly to your Representative.
Please help us today. When Hemp Supporters share our voices, we win!
CONTACT YOUR REPRESENTATIVE!
Interesting BID and ASK at close today with .65 BID and $2.50 ASK.
Does this portend to news tomorrow?
Is "sleuth" correct with his sleuthing?
Your article actually comes from this Canadian company trying to drum up readership in any way possible.
http://www.postmedia.com
Actually IMO it's in the 3rd paragraph..........
"But it has also become profoundly vulnerable to political interference and other special interests. And a revolving door — F.D.A. staffers frequently go on to lucrative jobs at the very companies they were tasked with policing — has hurt the agency’s credibility."
Thailand launches full-time clinics dispensing cannabis oil
https://abcnews.go.com/Health/wireStory/thailand-launches-full-time-clinics-dispensing-cannabis-oil-68091282
Thailand has opened its first two full-time clinics dispensing cannabis oil for medical treatment
By JERRY HARMER and BUSABA SIVASOMBOON ASSOCIATED PRESS
January 6, 2020, 5:22 AM
NONTHABURI, Thailand -- Thailand on Monday opened its first two full-time clinics dispensing cannabis oil for medical treatment, a step forward in the government's policy of promoting the licensed use of marijuana products to relieve the symptoms of a range of ailments.
About 400 patients, many of them with cancer, were given the oil for free at a flagship clinic at the Public Health Ministry in a suburb of Bangkok.
The initial four formulations handed out are used for treating conditions such as migraines, insomnia, nausea, numbness and pain. The medicines are touted as being based on traditional remedies.
Thailand was previously known for harsh anti-drug laws, but is now eyeing the economic potential of cannabis. A report last year by Prohibition Partners, which claims to be the leading authority on the subject, said Asia's medical cannabis market would be worth around $5.8 billion by 2024.
Around 25 similar clinics have been operating part-time since the legislature agreed in 2018 to amend the country's drug laws to allow the use and production of medical cannabis.
The Health Ministry clinic and another in Bangkok are forerunners of a planned nationwide network, if they show positive results.
"Marijuana could be an answer. At least the patients' quality of life is improved," said Dr. Prasert Mongkolsiri, the director of a public hospital, who helped advise patients on Monday.
"At least it can lessen the side effects of the modern chemical-based medicines that they've been taking for 10 or 20 years," he said, referring to chemotherapy for cancer patients.
Chamroen Nakurai, 57, was diagnosed with lymph node cancer two years ago. She said cannabis oil helps lessen the side effects of her chemotherapy, but until now she had been able to get it only through illegal underground suppliers.
"The treatment isn't widely available and the cost is quite high if you visit underground clinics, but this service is free and anyone can access it," she said.
Nuthjutha Ulpathorn, 29, was born with cerebral palsy that makes her unable to walk and garbles her speech. She began to use cannabis oil two months ago after her mother brought her to a government hospital that started to give out cannabis oil.
"I sleep better, and (am) less cranky," Nuthjutha said with a smile.
Health Minister Anutin Charnvirakul, the chief architect of the new policy drive, toured the suburban clinic on Monday. He expressed hope that the remedies might be soon added into the National List of Essential Medicine, which allows them to be covered by Thailand's 30-baht ($1) universal health care scheme. Officials say the policy of free cannabis is likely to be changed.
Anutin is the leader of the Bhumjai Thai Party, a partner in the country's coalition government. The party won 50 seats in March's general election after Anutin campaigned for legalization of the production of marijuana to aid farmers. Moves to allow small-scale private production are moving ahead.
The Public Health Ministry, meanwhile, supervises cannabis production at six locations around the country.
"even if the FDA has its way and demands every brand produce a New Dietary Ingredient dossier. An NDI dossier could cost upwards of $1 million to produce, and would lead to there being only a small handful of brands left on the market."
Good article, this part reads like CVSI............