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Curaleaf Gets a Warning Letter From The FDA For Selling CBD Products With Unsubstantiated Claims

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A warning letter has been issued to Curaleaf Inc. of Wakefield in Massachusetts for illegally selling and marketing CBD based products online with unsubstantiated medical claims that the products carry high medical potency in dealing with opioid withdrawal, Alzheimer’s disease, pain, cancer and even pet anxiety, among other ailments, announced the U.S. Food and Drug Administration. 

 

Ned Sharpless, the acting FDA Commissioner said the top priority for the agency remains protecting and promoting public health. They are examining potential pathways for creating a lawful framework for marketing of products that contain cannabis or compounds like CBD which are derived from cannabis plants such as hemp. 

 

But selling and using unapproved products with unsubstantiated medical benefit claims – that CBD is highly effective in mental health disorders and can treat serious diseases and conditions – can put consumers and patients at risk by making them inclined towards such products, leaving tested, prescription based medicines. 

 

Moreover, there are plenty of unanswered questions about the safety, quality and effectiveness of these unapproved products infused with CBD. 

 

The warning has clarified one thing – the agency stands firm at its stand and is committed to continue tracking and monitoring the CBD marketplace for ensuring the safety of the public. FDA will take requisite actions against companies that deceive consumers, making high claims and putting them at risk by selling products illegally, marketing them as a medical treatment for which they are not approved such as severe ailments like cancer and Alzheimer’s. 

 

Given the buzz around cannabis and its derivative compound, CBD, the agency continues to make an integrated and collaborative approach to develop a regulatory framework that ensures public health safety while rendering positive effects, if any. The agency has created a  high-level internal working group which will explore potential pathways for different types of CBD products to be marketed lawfully. 

 

One of the major components of this job is obtaining and evaluating relevant information to address the long standing questions related to CBD products’ safety. These considerations will be taken in by the agency and will help in building the regulatory framework for CBD products while maintaining high public health standards as per the FDA’s rules. 

 

In an attempt to understand CBD better and explore its potential arenas, the agency held a public meeting with stakeholders, retailers, business leaders, consumers and other officials on May 31. It has also opened a docket inviting written comments from people to gather scientific data and information about the safety, production, processing, marketing, labeling, sales and product quality of cannabis or cannabis derived compounds.

 

The agency has been committed to evaluate various aspects of CBD products, including several factors such as the existing drug approvals policies of the FDA, public health safety, scientific data backing up information claimed by companies and many other things. 

 

They said they plan to report their progress by early this fall to address many questions surrounding CBD. They are using a stepwise, science-based approach which will ensure the safety of patients and public health, while fostering innovation for safe and effective products. 

 

Curaleaf used its social media platforms, webpages and online store to unlawfully market its products to consumers, making high claims. Here is a list of unapproved and unsupported claims made by the company: 

 

  • CBD has proven to have characteristics that counteract cancer development.
  • CBD had been efficacious in killing cancer cells of breasts.
  • The use of CBD in Parkinson’s disease is also proved efficient.
  • CBD is associated with efficient Alzheimer’s illness therapy.
  • CBD is increasingly being embraced as a natural treatment for depression and anxiety in place of pharmaceutical therapy.
  • CBD can also be used with opioid drugs, and several studies have shown that CBD actually reduces the severity of opioid withdrawal and reduces the growth of tolerance.
  • CBD oil is gaining popularity as it serves as an all-natural source of relief for addressing the symptoms of many medical conditions such as chronic pain, anxiety, acute aches, etc. 
  • Many researches have found that CBD oil helps in combating mental health issues such as anxiety, depression, schizophrenia and even post traumatic stress disorder. 
  • CBD cures chronic pain caused from fibromyalgia, slipped spinal discs and can also help with eating disorders and addiction. 
  • Vets prescribe puppy Xanax to pet owners that helps in particular instances, however Xanax is not an ideal or a desirable medication to give to your dog regularly. Whereas cannabidiol is natural and offers similar soothing and healing results without the use of any chemicals. 
  • CBD can help reduce pain, spasms, nausea, inflammation and anxiety which are often related to cancer in dogs.

 

The FDA has requested for responses from Curaleaf within a span of 15 working days stating how these violations will be corrected. Failure to implement new regulatory method may lead to legal action against the firm that might include seizure of products and injunction.

Ivan writes about Cannabis at The Cannabis Radar. He has a degree in Nutrition Sciences from University of Oklahoma Health Sciences Centre. He likes to spend his spare time reading to his daughter or spending time with his wife.

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FTC has decided to go after the offenders of regulation of CBD

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After the legalization of the hemp plant and its derivatives by an act of law on 2018, CBD and hemp have flooded the market like never before. But, Food and Drug administration which the focal body of approval believes that a lot is still left to be understood not just about CBD but also the regulations concerning it. Under the Federal Food, Drug and Cosmetic act, CBD cannot under legal circumstances be added in any food product as a dietary supplement.

Cannabidiol or CBD is a popular remedy for many ailments. It is one of the few of the 100 chemical compounds that are found in the cannabis plant. Tetrahydrocannabinol or THC is one of the main psychoactive compounds that is found in the plant although its quality of getting high is often associated with marijuana. However, unlike THC, CBD is not psychoactive and also has anti-inflammatory compounds. This makes CBD as a great option who are looking to get relief from various symptoms because it does not come with the mind-altering package that marijuana has to offer.

The federal trade commission or FTC has folded its sleeve and has got stricter with its policies on CBD. Recently it had sent notices to three unnamed companies that are in the business of selling oil, tinctures, capsules and creams that contain CBD. These letters were warning letters for their over advertising their products containing CBD. In their promotional ad, they also compared CBD to a miracle drug which releases and relieves pain in a jiffy as compared to any over-the-counter drug for pain relief. The advertisement upgraded the wonders CBD to relieve the patient of the worst pains. The letters were issued to these companies by FTC in a move to warn them against advertising anything about CBD that is not proportional to the scientific evidence.

Most of the states out of the 50 states are beginning to believe that legalization is the best option, but they are doing so with wavering restrictions. Federal authorities treat it at par with marijuana but do not have enforced against its usage the way it does for marijuana. In December 2015 it did ease some regulations by allowing for CBD trials to take place. The stand of government concerning CBD is confusing but more clarity is required because CBD trend is fast catching on.

Many studies on rodents have been done to strengthen the argument of CBD, but anything major coming out of it does not imply that it will work on humans too. New research studies have been undertaken to establish the benefits of CBD on humans, but there is a long way to go.

CBD is gaining momentum in the health care and wellness industry. These scientific studies conducted have partly established how CBD can help recover and ease chronic pains and anxieties. It reduces chronic pain thereby reducing inflammation and improves interaction with neurotransmitters. CBD also has been found effective in treating disorders like stress, anxiety, cancer, Alzheimer’s, injury pain and bruise and much more.

The warning letters so sent were done on the premise that it is not right to mislead people into buying their products without proof. Earlier this year also, FTC & FDA had sent them notices concerning the same issue. These advertisements showed that the product was effective in treating pains as compared to other products.

FTC and FDA have decided to step up their vigilance on products that have CBD because coming from the same plant which produces marijuana, it is important to have clarity on what CBD stands for in reality. It only expects the companies to be truthful about their products and to advertise truthfully about the products. By advertising them without scientific evidence meant that they were misleading the users to use it for their pain.

The bottom line is that CBD is now studied for its role in easing symptoms of many issues that have been discussed. Research on its potential benefits is still ongoing and much is yet to be learnt about the efficiency and the safety of CBD. Marijuana driver CBD products are illegal under the federal law but many states have deemed it legal.

Hemp-Derived CBD products have CBD below 0.3% but before any action can be taken it will be better to research well and check your relevant state laws to start using the product.

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Kim Kardashian keeps aside Xanax to give way to CBD for her condition

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Kim Kardashian

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Kim Kardashian is one of the most celebrities in America. Her fame to popularity came with her tryst with reality shows. Apart from being a huge star, she is also a doting mother of 4 kids. Life is a continuous run for this huge star that along with her stardom also has to raise her kids. For anyone her place some supplements are taken on prescription will do her good to tackle the regular pressures.

Kim Kardashian has an effective way to deal it like a super mom and celebrity. She uses cannabidiol or CBD which is found in the cannabis Sativa plant. In her recent interview to one of the famed magazines, she told about the secret which helps her relax and deal with the entire day. She gracefully answered the questions posed to her and gave all credit to CBD that has taken her through every challenge in the best frame of mind. She also clarified that she is not a weed smoker and neither intends to do. CBD being the genetic brother of marijuana is completely different in characteristics. She believes CBD is the key to her enduring a life that she is leading now. Although she has been taking it for a few months CBD has transformed her life a great deal.

CBD or cannabidiol is a hemp-derived chemical compound that is anti-inflammatory. It is completely different from marijuana because of the THC level in it. The psychoactive compound is found in marijuana which is found in high levels, enough to give one a high on addictive consumption. On the other hand, CBD does not have any such effects which it was believed to have back then when people did not have precise information. As is believed in the case of marijuana which presents mind-altering effects on the taker, CBD is just the opposite because, upon consumption, CBD enables you to feel better about yourself rather than feeling high.

Kim’s reliance on CBD has increased manifold over the months she has taken it. She also uses it a bit when she wants to sleep by consuming gummies. She also now is aware that she is free from prescription drugs for her condition. She had been taking Xanax and Ambien and she is delighted that she does not have to take them again. CBD has entered the medical and wellness sector with a bang. Although still under study, the benefits of CBD are already known and people have become reliant on CBD now for their pains and sufferings.

On the front of the medical world, CBD has been found effective in treating various problems like seizures, cancer, injury pains, joint pains, mental trauma’s, depression, stress and anxiety. Many studies so conducted of the effectiveness of CBD have proven to be successful in rats. Most of the states in America have also made it legal to use CBD yet the federal government is taking one step at a time.

Ever since the passing of the farm bill in 2018 has indicated towards the legality of CBD, it has caught on the popularity charts of people throughout the country. Big personalities like Kim Kardashian are now switching to CBD to relieve themselves of their conditions that comes with the stress of being a part of the entertainment line. In her reality show, Kim broke down when she mentioned that she suffered from an auto-immune condition called lupus.

People are now desperate to know more about what CBD has to offer. The government stand on CBD is a bit confusing because of the lack of scientific evidence. Till the evidence is strong enough to pin it for good or bad, the government is doing its best to keep CBD under wraps and use it to the minimum. Despite the laws being in place, there is still enough to be done to get straight and precise the regulations.

Many people like Kim Kardashian have felt immense relief in their conditions after taking CBD. Her sleep has improved immensely and she has been able to handle all the pressures with a fresh start after CBD. Till then she was suffering and now she has asserted that she will never leave the side of the wonder CBD.

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CBD makes Audra fail her employment drug test

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Audra Dieffenbach

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Audra Dieffenbach is a woman in great pain. She has been suffering from pain due to her condition of endometriosis. This is an ailment which refers to the abnormal growth of tissues on the pelvic organs cause excruciating pain. But, little did Audra know that she will be asked to leave her current organizational opportunity because of the supplements she has been taking for the cause.

Audra was hitherto working in a temporary job at Maine Health, but when she planned to go for a permanent one, she had to undergo medical tests for it. She was taken aback when the tests for drug came positive with traces of THC found in her bloodstream. Her decision to go permanent was based on the recommendations of her direct manager. She loved her job and loved interacting with her patients which is what strengthened her decision. Maine Health is a federal owned medical centre and any test done has to confirm under the standards set by the federal laws. Her shock and disbelief are understandable.

Audra consumes a supplement called Amethyst Elixir manufactured and distributed by Freeport Company. The supplement taken by Audra is to ease her from pain and contains the legal and acceptable limit of THC under the federal law. She started taking the supplement about two years ago that helped her battle the pain. She did her research and found that the acceptable levels of THC will see no trouble in future. The supplement containing CBD oil has been a blessing for her because she can lead a life without enduring the pain.

CBD is known to be an extract of the cannabis plant from which hemp is also derived. CBD characteristically has very little traces of THC which is an active ingredient in Marijuana. CBD, unlike Marijuana, is touted to be heredity brother yet does not active THC level to the extent that marijuana has. The anti-inflammatory properties of CBD make it a friendly ingredient in many applications all used well within the federal boundaries. CBD industry has taken the entire world by storm and the US in particular especially after the hemp plant was regarded legal. People also have been seeing a transformation in the world of medicine with CBD being used to treat many a disease. The boom has to be regulated yet, many are taking opportunities in the right direction to take full advantage.

Audra’s supplement only contains traces of THC but the continual intakes might have clogged in her body to render the result. Maine Health is very firm in its policies of drug intake and is funded by the federal government. It then becomes mandatory for them to get all their potential employees tested for hard drugs like marijuana.

The President of Maine Health Mr Jon Porter issued a statement on behalf of Maine Health explaining their cause of action. He was quoted saying that Maine health is an extremely dedicated health care centre that only wants all their patients to get the best of health. The mission to keep patients happy is achievable only when the staff is fit to do the job. Hence the requirement to undergo tests becomes mandatory, especially for controlled substances. The protocols of the Maine Health applicant drug-testing system are following federal drug-free workplace act. These tests comply with the rules and regulations of both state and federal laws.

The initial enzyme for marijuana and its metabolites is tested with a doorsill limit of 50ng/ml. When there are backing gas chromatography tests done then the standard figure is 15ng/ml. Audrey is shocked but holds no grudges against Maine Health because she has the utmost respect for them. She mentioned in her quotes that she loves working there as Maine health is dedicated to patient care. Her tiff is with the employment laws that are not upgraded according to current trends.

Her appeals were rejected even though CBD is now an accepted ingredient. It has become very popular even in medical circles with the miracle portion working wonders for patients suffering from seizures, joint pains, injury pain, cancer and Alzheimer’s. Apart from being effective for physical ailments, it is considered equally effective for psychological issues like depression, stress and anxiety.

What Audrey suffered was unfortunate but laws are strict. There is both a good and bad side of looking at these laws. Audrey is now actively pursuing other opportunities.

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