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FDA Strikes Again: “Not all CBD Products are Beneficial”

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FDA Policy CBD

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.

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US Navy Warns Their Sailors Not to Take CBD

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US Navy warns against CBD

Marines and sailors were told by the US Navy to stop and avoid using CBD and other hemp-derived products.

The US Navy legislation includes a clause that forbids servicepeople from using, ingesting, consuming and applying any cannabinoid preparation that is derived from marijuana or hemp.

Despite the legislation signed by President Donald Trump that removes industrial hemp from the controlled substances list of the federal government, Navy officials still affirm that their members should avoid hemp extracts and CBD products.

There is still a lot of controversy regarding CBD and its legality in the US. The Farm Bill signed last December has made most cannabidiol-containing products legal, although the FDA or Food and Drug Administration has reiterated that CBD-infused food is still illegal in the US.

Navy CBD Ban

A spokesperson for the US Navy stated that the Agriculture Improvement Act of 2018 has not affected in any way the policies of their agency. Despite the law, every product that is derived or made from marijuana or hemp are still very much prohibited.

The Navy stated that hemp-derived products that are commercially available like the CBD oil are not FDA-approved and therefore have no valid claims regarding the diagnosis, treatment, prevention or cure of any illness. They concluded that since the products do not properly list all their ingredients, it is impossible to determine the cannabidiol, THC or other synthetic cannabinoid levels such products may contain.

The agency defines Use as taking any cannabis preparation whether orally ingested, injected intravenously, vaporized/smoked or any other form by which such hemp-derived items may be introduced to the body, which potentially exposes the individual to high psychoactive THC levels.

Risk for Discharge

Navy servicepeople who show positive results for THC tests and other substances that are not prescribed by their doctor could be subject for discharge known as OTH or Other Than Honorable. This label can affect their employment opportunities and benefits as future veterans.

The Navy spokesperson added that every Sailor is responsible for ensuring their diligence in evading accidental or intentional contact with THC or any other controlled substance.

Just last month, police watchdogs from Arizona Peace Officer Standards and Training Board or AZPOST ruled that Arizona cops are allowed to use CBD and hemp-related products.

AZPOST stated on their ruling that the possession or use of over-the-counter CBD-containing products is not related to the illegal possession or use of marijuana, which is a dangerous narcotic drug.

In a report by the Pheonix New Times, it is in AZPOST’s history that OTC CBD use is regarded with the same treatment as in cannabis from a medical dispensary.

In Arizona, cannabis is lawful if used medically, but illegal for recreational purposes.

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Lawmakers Pen Letter to Federal Agencies in Light of Growing CBD Industry

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Lawmakers Pens Letter Federal Agencies

A group of US lawmakers addressed a letter to the Department of Health and Human Services or HHS and the Food and Drug Administration heads earlier this week to push for the establishment of regulations for CBD. This is in light of the cannabidiol industry showing great economic potential.

The group led by NY Democrat Rep. Antonio Delgado stated that the potential for a bigger market can affect the pharmaceuticals, paper, textiles, dietary supplements, and other products. Now that hemp and hemp-derived products like cannabidiol are now federally legal following the 2018 Farm Bill.

Delgado, also a member of the House Committee on Small Business, reiterated that the CBD industry also paves way for more employment opportunities and better local economies as more small firms lead the movement.

A hearing was heard by the panel last month to answer the challenges and opportunities for hemp enterprises regarding the federal prohibition framework.

Alongside Delgado are Committee Chairman Nydia Velasquez (Democrat, NY), Rep. Jared Golden (Democrat, ME), Rep. Adriano Espaillat (Democrat, NY) and Rep. Dwight Evans (Democrat, PA) who have all signed the message as well. Velasquez introduced another legislation earlier this week that provides insurance coverage for marijuana businesses.

What Lawmakers Wrote

The group collectively signed a letter that said the country’s farmers are looking forward to growing hemp and are awaiting the federal regulatory framework from the US Department of Agriculture. They also stated that businesses are gearing up on responding to consumer demands for hemp and its derivatives like CBD. However, the failure to clarify rules by the FDA confused businesses, consumers and farmers alike.

Ever since the passage of Farm Bill, the FDA and USDA have encountered pressure by different sectors to establish clear regulations. Last month, FDA said a status update will be released after the rulemaking process is fully expedited.

USDA, on the other hand, released a statement that said legal hemp regulations for cultivation will be given out before the planting season for 2020.

Lawmakers further added that the confusion regarding hemp regulation is hindering the growth and development of CBD businesses.

Scott Gottlieb, the former FDA commissioner, said that it may take years for CBD to be allowed in food or dietary supplements without congressional intervention. However, the group has declared that these products are already openly sold in commercial stores, pharmacies, restaurants and other places.

Pushing for More Clarity

The group of lawmakers also said that proper regulations will address the confusion on production, quality, labeling, testing, sale and marketing of hemp derivatives like CBD.

While the letter indicates that the group is appreciative of FDA’s efforts to ensure the public’s safety and guard them against unproven claims of other CBD companies, the hemp industry can’t take years of waiting for the agencies to create policies.

They further requested the FDA to develop benchmark quality standards for hemp and hemp derivatives production to harbor trust and satisfaction from consumers so that the industry can mature into a lawful market.

The FDA is expected by the group to release enforcement guidance and interim final ruling on CBD-infused food and dietary supplements by September 30. This is to pave way for a final and legal rule for such products, especially since the Federal government has recognized the hemp industry, and medical marijuana for some states as legal substances.

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CBD Oil Brand Recalled for High THC Level by Irish Government

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Dutch CBD Brand Ordered to Recall

Dutch cannabinoid oil (CBD) brand EUPHORIA was found to have illegal levels of Tetrahydrocannabinol (THC) in the formulation, causing the Food Safety Authority of Ireland (FSAI) to recall their 10ml preparation labeled “Full Spectrum Oil extra strong 20%”.

Hemp and CBD products are legal as per the regulation of the Irish government; however, the formula should not contain THC of more than 0.2% to be viable for sale.

Said oil brand came from the Netherlands and has a best-before date of 31 August in 2020. Distributors and retailers alike are forced to submit to authority and remove the brand from their displays immediately.

CBD is gaining popularity all over the world and is a steadily growing industry due to respective laws being legislated in a number of countries. However, controversy still can’t escape it since it is closely linked to marijuana and THC, which have potent psychoactive elements that can induce drug dependency.

Cannabis Reception in Ireland

In Ireland, cannabis is still a huge topic for debate for supporters and critics. Some people still doubt its efficacy and the presence of side effects that may prove dangerous for a person’s health. The question mark that follows cannabis is heightened because of this recent turn of events.

The country authorized the sale and use of medical cannabis last 2016, but it was met with opposition from a group of medical practitioners. It’s also a hard feat for patients to acquire such since the government failed to retain a central supplier.

To reconcile their lack in implementation, the Ministry of Health headed by Simon Harris recently signed into legislation the 5-year Medical Cannabis Access Program. It aims to push for cannabis treatment when traditional methods fail, according to Harris.

This initiative is designed to legalize medical cannabis prescription made by doctors for various conditions like chemotherapy-sickness, epilepsy, and multiple sclerosis. Like any pharmaceutical product, patients can now present their Rx to drug stores and be given said medicine.

The program also involves the inventory-building of cannabis products, with Tilray being one of the international cannabis companies to successfully export their medical cannabis products to Ireland.

In relation to their first shipment, Tilray has pledged its commitment to providing for the subsequent demands of cannabis products once approved by the government. Their goal is to be the main supplier of the access program, enabling safe and reasonable access to medical cannabis

The company is currently at dialogue with the Irish authorities to shed some insight on the implementation of the newly penned program.

Unfortunately, Tilray failed to secure a spot in Italian cannabis export.

Cannabis in Neighboring Italy

Italy snubbed Tilray and two other international cannabis companies in favor of Aurora Cannabis (Canada) to fulfill the surprising shortage in production at the Florence facility. Italian Ministry of Defense further revealed that Tilray (Portugal) filed incorrect paper works and missed the set deadline, disqualifying them from the roster.

Albeit Italy’s willingness to pay for medical cannabis (the 400-kg cannabis deal cost them €569,000 (US$638,000), debates are also going over the country on whether low-THC “cannabis light” should be sold legally. The court ruled to ban the sale of such products, but enterprise owners fought back.

While it might be a phenomenal story to follow, Italians still appreciate cannabis products such as the CBD oil as an adjunct to medical treatments. Italy, including the Netherlands and Germany, are still the top three European countries with the strong medicinal cannabis industry.

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