While the American public has been pushing for the legalization of using CBD products, the U.S FDA still believe that although CBD is non-intoxicating, it might not be as safe, healthy and effective for wellness as they have been told. Very recently, the FDA published an update on its website to address some of the claims made by people surrounding CBD, in an attempt to disapprove that CBD is risk-free and can cure certain illnesses miraculously.
The FDA is currently gathering enough evidence from health experts, patients, and cannabis industrialists to gain insight into how CBD might be helping them. The update mentioned that there are still many questions about the safety and quality of CBD products. So, before the public push for relaxed use of CBD, the FDA want to clarify some points regarding CBD.
CBD May Cause Liver Damage And Other Serious Side Effects
Although the FDA admitted that there still isn’t enough evidence to outweigh risks against benefits, it did uncover that CBD could cause liver damage in a small study. In the clinical trials of Epidiolex, a CBD-based drug approved for epilepsy treatment, some patients showed liver toxicity. The symptoms displayed potential liver injury. Epidiolex does not entirely contain CBD but has much higher concentrations of it compared to the hemp products flooding in the market. The CBD in the medicine is 98% purified and oil-based extracted directly from the cannabis plant. Thus, it is highly unlikely that other components of the medicine could cause liver damage.
A study at the University of Arkansas also found that high doses of CBD caused liver damage in mice in 24 hours. Many animals died or almost died within four days. Critics mention that the dose was extremely high, however, according to the study, it was equivalent to the maximum recommended dosage for human maintenance mentioned in Epidiolex. Thus, the mice were given amounts comparable to the amount of Epidiolex ingested by epileptic patients. Doctors are advised to monitor liver enzymes in these patients. Doctors in Colorado, where weed is legal for any reason, monitor liver enzymes for patients ingesting CBD or marijuana.
The most common side effects of Epidiolex is sleep disorder, lethargy, low appetite, weakness, suicidal thoughts, agitation, depression, and panic attacks. Although CBD products in the market may not contain as much as CBD as Epidiolex, the risk of these side effects cannot be underestimated.
CBD Is Not A Cure
The FDA has made it clear to the public that none of the CBD products currently sold in shops, stores, and dispensaries have been approved. So far, only Epidiolex was granted approval, which took several years. FDA also mentioned that Epidiolex is useful as a treatment for children with two rare forms of epilepsy– Dravet syndrome and Lennox-Gastaut syndrome, and not any other condition. Epidiolex is not a sure cure anyways. It was found effective in only 32% of patients. The cannabis industry has used this as leverage on the public and convinced some that CBD can provide remedy from anxiety, depression and even cancer. The FDA refutes such claims and urges people to beware of false hope so that they resort to proper diagnosis and treatment, not baseless claims. The agency warned companies from advertising CBD as a cure for serious diseases like anxiety and depression.
However, the FDA also has its own record of flaws. A 2017 study found the third of all drugs approved by FDA were flagged as threats from 2001 to 2010. FDA states that what might be safe today may not be safe in the future. A poll showed that 44% of Americans believe that the FDA is trustworthy regarding the truth about medicine.
More Research On CBD Needed
Very little is known about CBD and its benefits and risks, which is the main reason behind the FDA’s skepticism towards CBD. Further research is definitely required to weigh out options and to really trust cannabinoid. For someone who is considering using CBD to treat a serious condition, it is better to consult with a physician and specialists in medicine to ensure that their well-being is not at risk. It is best not to buy CBD products blindly now despite their grand claims of curing stress, anxiety and sleep problems.
Kamala Harris Jokes About CBD to Make a Serious Point on Cannabis Reform
Senator Kamala Harris (D-CA) joked about how entrepreneurs are promoting cannabidiol or CBD lotion be rubbed on the skin as a cure-all at the same time that people of color struggle to enter the cannabis industry due to being targeted by the nation’s war on drugs.
Harris firmly pointed out social equity as a need in the growing marijuana industry.
Stance on cannabis
When she was still a prosecutor, Harris opposed reform efforts on the cannabis market. As a 2020 presidential candidate for the Democrats, she now recognizes the necessity of legislation that fully legalizes it. She said in her Cosmopolitan interview that those under prohibition enforcement should be allowed participation in the burgeoning market.
Harris stated that America’s mass incarceration system is a source of shame and is the reason for the incarceration, in particular, of brown and black men due to the failure of the war on drugs. She said that this is why she supports the legalization of marijuana and wants an equitable market when it happens.
However, Harris also talked about the cannabis industry, and how CBD is poised as a miracle remedy that can cure every problem by simply rubbing it all over the body. She noted how sellers are making a lot of money selling weed, calling the industry a massive cash cow.
She went on to mention brown and black men who are tagged as felons by selling the same. She called it unfair and wrong and a travesty.
A reform plan for marijuana
Harris further laid out her reform plans for the cannabis market, citing previously incarcerated folks who were convicted of a felony be considered for expungement. She also plans to prioritize them should they want to return to selling cannabis. She added that they should be first in line if marijuana legalization will be realized.
The candidate has sponsored a Senate bill that moves to de-schedule cannabis federally and offers reinvestments and expungements for people and communities affected by the drug war.
However, Harris received criticism for being previously opposed to the marijuana reform. In a skit last September, Saturday Night Live featured the US’ “cool aunt” who gives out weed but later on arrests those who were holding the substance in their possession.
Representative Tulsi Gabbard (D-HI) also slammed Harris during a Democratic debate for being instrumental to the incarceration of low-level cannabis felons during her stint as a prosecutor.
Another presidential candidate, Senator Cory Booker (D-NJ), scrutinized Harris, for taking a swipe at her being a past user of cannabis.
Cannabis sativa L., the source plant species for marijuana and hemp variety, is where cannabidiol or CBD is extracted from. This active component is said to have therapeutic benefits and is marketed as an infusion to many products, including skincare, makeup, pet items, and more. There is a serious lack of studies and clinical trials to support the claims, but users patronize CBD due to its alleged effectiveness.
NYS CBD Regulation in Limbo as People Wait for Governor’s Signature
The United States Department of Agriculture (USDA) finally released its regulations on CBD to give more explicit federal guidelines on hemp cultivation that produces CBD.
In New York, however, lines are still blurry as the bill approved by the State Legislature that aims to regulate CBD across the state is yet to be enacted upon by Gov. Andrew Cuomo.
Wild West in CBD Market
Jen Metzger, the Senate bill sponsor, expressed her hope that the NY Governor will sign the bill soon. She sponsored the proposed legislation to regulate cannabidiol, a compound derived from the hemp plant variety of Cannabis sativa L.
It’s the same source plant as marijuana, which has high amounts of tetrahydrocannabinol or THC, the chemical responsible for the psychoactive effects of the illegal substance.
According to Metzger, who is Hudson Valley Democrat, it’s the Wild West in the CBD market since there is no regulation of the said product.
The bill proposes routine testing for CBD products sold across New York and observance of proper labeling to prevent confusion and misunderstanding about the product’s ingredients and additives. It also includes guidelines for New York farmers regarding hemp cultivation and profit share.
Risks of unregulated CBD
CBD is currently in a legal gray area. The 2018 Farm Bill essentially legalized hemp-derived CBD with less than 0.3% of THC content and is also federally allowed for sale.
However, CBD-containing beverages and food are still illegal for the market. The New York City Health Department stopped restaurants and eateries in the state from selling CBD edibles and drinks since consumables with CBD have not yet been approved as a safe food additive.
Recently, a mysterious THC-related illness affected thousands across the country and claimed dozens of lives due to the use of a particular vape product. Metzger stated that CBD is not a common vaping ingredient. She relayed her concerns about the lack of regulation causing more illnesses since products may bear unfounded claims in the packaging.
Metzger pointed out that worrying about CBD might be necessary due to a lack of quality standards.
CBD is commonly used to relieve stress and help in insomnia and anxiety. It has more claimed therapeutic benefits, and the FDA has approved a CBD-containing drug used to treat seizure disorders in children.
Calls for more CBD studies
Metzger encourages more research on cannabidiol and its alleged effects, whether positive or negative.
Metzger and co-legislator Donna Lupardo presented the measure during a 2019 legislative session as soon as they realized that the comprehensive bill being worked on was not winning an approval. This bill was supposedly for the legalization of adult recreational marijuana use.
Metzger and Lupardo are the chairperson of their respective agricultural committees.
Gov. Cuomo has allied with three neighboring states to work on a comprehensive bill about vaping and cannabis use, which could be up for voting in 2020. However, Metzger said a concrete CBD regulation on or before the year ends still necessary.
Chuck Schumer Calls for FDA to Hasten CBD Rules Issuance
Chuck Schumer (D-NY), Senate minority leader, speaks about his request to the Food and Drug Administration or FDA to expedite the issuance of guidelines regarding hemp-derived CBD and its lawful marketing.
Schumer made a statement during a press call last Wednesday to call for regulatory clarity that is currently hampering the growth of the cannabidiol industry. He also mentioned the federal legalization of hemp and hemp-derived products in the 2018 Farm Bill.
However, the FDA is yet to publish official rules that allow sellers to market their products. In New York, most hemp cultivators also produce cannabidiol, according to Schumer.
Appealing to the FDA
Schumer cited a letter that he and colleagues in the Senate addressed to Ned Sharpless, an FDA acting commissioner. They collectively asked to show the agency’s outline regarding its plans for an official CBD regulatory framework and the timeline of finalization and implementation of enforcement policies concerning the substance. The group asked for an answer within 90 days.
According to Schumer, the CBD industry is a potential billion-dollar market in New York, which could bring in countless jobs and improved the economy along with its rise. However, he also stated that for these to be realized, critical players in the industry, such as the farmers, producers, consumers, and sellers should have a strict set of rules to follow.
He called on the FDA to perform its duty promptly and issue the guidance on CBD and its classification, quality, marketing, labeling, and sales.
Schumer believes that the FDA regulations on CBD are critical in the development of the industry and to protect consumers by setting stringent quality control benchmarks.
FDA stance on CBD
The FDA has expressed its awareness of the Congress’ request for CBD regulation amid the legalization of hemp. However, the agency points out that there are specific regulatory challenges they are still working to overcome.
The Cannabidiol or CBD-containing product that FDA recognizes is the approved Epidiolex medication. It is a prescription drug used to treat intractable epilepsy. CBD edibles, on the other hand, are yet to be FDA-approved and may need alternative pathways for regulation.
Scott Gottlieb, a former FDA commissioner, stated in an interview that the federal government should include themselves in state marijuana program regulation. He suggested that congressional involvement may be needed to make CBD marketing lawful if they want to hasten the process of developing rules.
It’s not only Schumer that reached out to the FDA. Mitch McConnell (R-KY), Senate majority leader, called on the FDA to release guidelines on enforcement discretion so producers, manufacturers, and owners in the CBD industry can do business without worrying about being penalized. McConnel led the inclusion of hemp legalization in the said agriculture legislation.
FDA stated that they are particular about CBD companies that make baseless claims about the therapeutic properties of CBD, which the agency considers to be highly inappropriate. The FDA, along with the Federal Trade Commission, issued a warning notice to a particular CBD business that violated the standard.
Featured9 months ago
Benefits of CBD Oil for Dogs You Might Not Know About
Research10 months ago
Does CBD Oil Have Side Effects? Studies Say Yes, It Does
Featured10 months ago
What is CBD and it’s Health Benefits?
Featured2 months ago
Spiked CBD Are Being Sold in Texas Stores States Authorities
Research8 months ago
CBD Oil Can Help you Sleep [According to the latest Study]
Featured3 months ago
Surprise Discovery: Mother Finds 4x THC Legal Limit in CBD Oil for Anxiety, Other Varieties Don’t Have Cannabidiol
Featured7 months ago
Is Golf Pro Phil Mickelson Resorting To CBD Oil For Fighting Arthritis?
Featured11 months ago
Upcoming Cannabis Trends in 2019