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FDA seeks public input to form regulatory model for cannabidiol infused food and drinks

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Cannabis Infused Food

After the federal government passed the Farm Bill in December 2018 and removed hemp derived cannabinoid from its list of Controlled Substance Act, companies have been flooding in the CBD space with a gamut of products to gain traction from the market.

From CBD infused lotions, creams, oils, tinctures to CBD based edibles including popcorns, beer, mojitos, alcoholic beverages and burgers, the new ingredient has been trending in the market ever since. Despite the U.S. Food and Drug Administration prohibiting use of cannabinoid in any food and drinks, companies continue to produce and cater to the consumers.

Recently, the Food and Drug Administration (FDA) issued warning letters to 3 different companies jointly with the FTC as the companies were marketing their CBD products as a cure to some severe ailments like Cancer and Alzheimer’s. CBD is known to be associated with a number of health benefits, however, there is no recognized study or research which backs up these claims.

Nonetheless, this has not stopped people from consuming the drug as an alternative treatment for their medical prescriptions. Patients have reported a significant improvement in their health after using CBD oil only for a few days, especially in the case of epilepsy and seizures.

The U.S. Food and Drug Administration will hold a public hearing on CBD at the end of this month on May 31. The federal agency will continue to take public comments online and via postal delivery about creating a regulatory framework for safely using cannabidiol.

During the process, the agency will assess the “safety, manufacturing, product quality, built, concentration, marketing, labelling and sale” issues of products containing hemp derived cannabinoid such as CBD. The regulated concentration allowed as per the federal law for THC is 0.3% per individual product, however many states continue to follow their previous – 0% THC – regulation.

The public hearing will provide a platform for people to openly discuss and talk about how cannabis could be safely incorporated in the consumer sector without causing any harm. The FDA Commissioner Scott Gottlieb announced that the public meeting will be held on May 31 at the agency’s White Oak Campus in Silver Spring, MD.

The agency will be accepting public comments on the issue, which may be submitted online through July 2, 2019. Earlier this year, the FDA submitted opinions to the World Health Organization, which is reconsidering the UN’s international cannabis and CBD policies.

Gottlieb has discussed the issue several times and states that it might take “years” for the agency to establish rules and regulations surrounding the cannabis market and products infused with cannabinoid.

Gottlieb further expressed concerns about the bigheads of the retailer industry like Walgreens and CVS selling hemp-derived cannabinoid infused products on the front shelves including lotions, sprays and tincture oils.

After the federal law had cleared cannabinoid off its list of Controlled Substance Act, the FDA stated the following day,“Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.”

The agency further stated that it is unlawful under the FD&C Act to introduce food containing added CBD or THC into the interstate commerce, or to the market with products being sold as dietary supplements, regardless of whether the substances are hemp-derived or not. As of now, the agency is selectively targeting for manufactures who market CBD infused products as a 100% alternative to medical prescriptions or appear appealing to the younger generation.

With the final decision still lying with the FDA, companies and organizations are confused about whether to go forward with CBD plans or not. But, until the air is cleared for consumers and manufactures, no one can be safe in the CBD industry, especially those who are introducing CBD infused food and beverages.

The safest industry in the cannabinoid space is the beauty and lifestyle domain where companies are selling CBD based lotions, creams, tinctures, oils and numbing creams which are specially used by celebrities for red carpets where they have to stand for hours to get photographed!

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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CBD

A new ‘Apple-style’ CBD oil shop is opening in Bristol

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CBD oil shop is opening in Bristol

CBD is quite the sensation all around the world- from the western lands of America to the United Kingdom, everyone is hailing CBD for its medical benefits

A cannabis oil shop labelled as a distinct and one of its kind is opening in Clifton in the UK this weekend. The ‘Apple Style’ store will be the third store by Goodbody Wellness launching in the last two months following successful openings in Cirencester and Bath, right ahead of a countrywide roll-out. 

The Queens Road outlet will be launching on August 24 (Saturday), it will offer a range of about 50 products consisting of muscle rubs, skincare, coffee, vape oils and bath bombs!

The brand Good body Wellness seems to follow the footsteps of Mary Jane’s coffee shop, which garnered a huge popularity and achieved success since its launch on the White ladies Road back in May. 

The Somerset-based brand’s rapid expansion began at the beginning of 2019, when the position of the managing director was filled in by Chris Jones. 

Jones said that their product identity and store resonates flawlessly with those individuals who are inclined towards the world of CBD and want to explore more, but also want to see CBD products displayed logically in a great environment supported by highly professional and trained staff with a welcoming and warm personality. 

He further stated that they are extremely passionate about their customer experience and brand. They not only plan to focus on the brand’s reputation as a company but also want to offer valuable products to their customers. Every product in the store is exclusively branded by Good body Wellness and created with the highest quality of natural products. 

The product’s stock is tested, traceable and provides a perfect balance of the endocannabinoid system, which is something that customers really look forward to. 

Given the stigma around marijuana for years – it causes hallucinations and gets people addicted to it- CBD has come quite gently in the market with a soft corner in customers’ hearts by offering plenty of medical benefits. There are several medical research and studies that support the medical claims of using CBD

It is a hemp-derived substance which has anti-inflammatory properties. Unlike marijuana’s psychoactive compound which causes the ‘high’ when users smoke weed or pot, THC (tetrahydro cannabinoid), CBD does not produce any such mind altering effects. 

Infact, CBD is widely popular for treating stress, anxiety, depression, panic attacks, insomnia, epilepsy and even Alzheimer’s. Many people have used CBD for speedy recovery after injuries and accidents, for acute pain, chronic aches, inflammation, swelling and even cancer

With the boom in the global CBD industry, consumers are becoming more aware of the effects of the chemical and wanting to learn more. 

The Goodbody Wellness will offer an enjoyable experience to customers who enter into their stores to learn more about CBD. The organization is a part of the Stavia Group PLC based in Beckington, Somerset, where intensive testing and research for CBD takes place throughout the 200-acre farm. 

Chris said that Clifton was the perfect place to launch their third store. He added that it was great to be associated with the city of Bristol, and that they could work really well there. The city is amazing and has a blend of different people with different interests. Retail isn’t dead, instead you need to offer value to the customers to make them walk in your store and buy something and the Goodbody Wellness can pull off a task like this, said Chris. 

Cannabinoid is a naturally occurring chemical in hemp plants, a cannabis genus plant, which has seen a boom in the users since last year specifically. CBD is usually extracted with nearly 100 other nutrients from hemp plants that can help treat a wide range of ailments such as anxiety, depression, stress and even arthritis, fibromyalgia, according to many people and research data.

It is estimated that about 300,000 people in the United Kingdom are regular users of CBD supplements, the majority of which are bought online. Goodbody Wellness will open on August 24 at 75 Queens Road. The store will be open from Monday-Saturday 9am-5pm and Sundays 10am-4pm.

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CBD, a game changer from Garnering the Trust of Tour Players to consumers in the public sector

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CBD game changer

Phil Mickelson has created quite the news on the second-round of Masters telecast where he pulled out a small vial from his golf bag, squirted a liquid into his mouth and tucked the vial back in his bag. Many people have already watched the viral YouTube video, which ignited speculation that Mickelson might have been the latest Tour pro to join the CBD bandwagon.

Several pros like Brandt Jobe, Bubba Watson, Charley Hoffman, Morgan Hoffmann and Scott McCarron, have signed up for endorsement deals with CBD manufactures. CBD or cannabinoidal is a rapidly growing category distinct from medical marijuana, which is derived from pure, natural hemp plant, a cannabis genus plant.

CBD has garnered immense popularity because of its gamut of medical benefits. It is known to treat anxiety, depression, panic attacks, seizures in epilepsy, insomnia, acute pain, chronic aches, inflammation, swelling and even severe diseases such as cancer, tourettes and Alzheimer’s. However these are simply medical claims of CBD and while there are many studies and research that support them, law enforcement agencies still remain skeptical about the safety and effectiveness of CBD.

Manufacturers are not allowed to advertise any medical claims with CBD products as it is prohibited by the U.S. Food and Drug Administration. The agency has been issuing warning letters to companies that market their CBD based products as a cure for ailments or alternatives to prescription based medicines.

The stringent regulations by the FDA has deterred many Tour players from giving CBD a try.

Hoffmann was diagnosed with muscular dystrophy in 2016, he then went to Nepal last year for his four months of herbal therapy sessions. Soon after he returned, Medterra CBD contacted Hoffmann and he has been using its products ever since.

Hoffmann explains that after taking CBD, he has not had any injuries, and his body is rejuvenated with a calm mind.

Despite that the World Anti-Doping Agency has removed CBD from its life of controlled substances earlier this year in January, the PGA Tour remains wary. In April, the Tour warned players that some CBD products might contain traces of THC, which could result in a positive drug test.

Hoffmann says that he had alerted the Tour of his future plans with CBD and was advised to be careful about the source of cannabinoid as any traces of THC could land him up in a crucial situation with no one else to take ownership of it, but him.

The FDA held a public meeting on May 31 with stakeholders, business leaders, consumers, marketers, industrialists, manufacturers, and others to discuss the regulatory framework for CBD. The agency is firm in its decision of first evaluating the aftermath of CBD instead of waving off a positive sign to companies to flood the market with CBD products.

A spokesperson from the FDA said the public’s health safety is the utmost priority for the agency as always and it will not promote or allow any marketing of CBD products unless they’re fully researched and checked for their quality.

But, despite the efforts of the FDA to control and regulate CBD products, companies have been exploding the market with CBD products. Worldwide Golf Shops recently announced their partnership with Medterra. Another famous company, Functional Remedies, which sponsors McCarron, has launched its CBD products in pro shops, according to Steve Patterson, who looks after the sales of the company.

Dr. Larry McCleary, an advisor to Boomer Natural Wellness, a CBD manufacturer, said that the medical community is all over CBD to find out its safety and effectiveness, and they’re gradually gaining acceptance.

The event that triggered CBD boom in the U.S. market was the Agricultural Improvement Act in December 2018, which removed hemp-derived cannabinoid from the list of controlled substances. The law has been a game changer for the CBD industry and the product is now flourishing the consumer market with products ranging from skin care and beauty to fitness and wellness.

Jay Hartenbach, the CEO of Medterra CBD said growing hemp is legal on a federal level now and farmers have responded positively by ramping up their hemp production. The higher the cultivation of natural hemp, the more prices could go down for CBD products, that are a bit expensive as compared to conventional over-the-counter medications.

Hartenbach added that it seems that CBD has made space for itself in the mainstream America and consumers are now receptive to CBD.

CBD has been long associated with marijuana, and high causing compounds like THC, tetrahydro cannabinoid which is responsible for causing hallucinations when people smoke weed or pot. However, the federal regulations has cleared off CBD for any psychoactive effects and made it legal. As for THC, the highest limit for THC per product is 0.3%, above which the product becomes illegal and unlawful to produce, process, market, sell or possess.

 

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Inspired by father’s Alzheimer’s treatment using CBD, two girls open CBD oil shop in Hebden Bridge

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CBD oil shop in Hebden Bridge

Hemp-derived CBD is a natural supplement which has been widely popular for treating mental health disorders like depression, stress, anxiety, panic attacks, seizures in epilepsy and even Tourettes. CBD is an anti-inflammatory and non-psychoactive component which has intense healing capabilities if derived from pure hemp plant. 

Two entrepreneurs have been using CBD for their startup and the product is growing immense following. Two Calderdale women were so motivated from the benefits of CBD oil that they set up their own business which offers high quality CBD and is gaining more and more traction. 

Kate Henderson and Michelle Oxley created The Tonic Tribe after observing health improvements from using CBD supplements by Michelle’s father who was suffering from Alzheimer’s.

Michelle said that after researching a natural compound to aid her father’s symptoms of paranoia and anxiety, she stumbled upon CBD but still struggled to find a good quality product. She was then inspired to launch her own line organic, high quality products with her friend Kate. 

The duo started looking for suppliers who were able to meet their stringent criteria for high-quality hemp, after months of research and the lookout for an ideal supplier, they finally found one in Holland. 

They both then set out to build their own shop out of Michelle’s therapy room situated in Bridge Mill, right in the heart of the Hebden Bridge. 

Michelle explained how her father had developed Alzheimer’s and suffered from terrible symptoms that would make him fearful and angry. She was looking for a product to relieve him and improve his condition, and CBD really worked for him. 

Convinced by the benefits of CBD oil, Michelle said she wanted to help other people as well and wanted them to benefit from the miracle product that had helped her father. 

CBD is a natural compound found in cannabis genus plants, but the amount of oil is strictly restricted within legal parameters to ensure a healthy and safe consumption. CBD has garnered widespread popularity and caused a buzz amongst people. From those suffering from severe diseases to those who just want to live a healthy life, all seem to rely on CBD products. 

Both Kate and Michelle said that many of their clients are older people who want a product that can help with their ailments in a subtle manner- just like CBD. The duo has taken the oil themselves to treat different ailments. 

Kate is a mountain biker and fell runner, she said that CBD helped her by speeding up the recovery process and treating her injuries and cramps. She stated that it is amazing to work with a product that is completely natural and can be typically used for a wide variety of diseases. 

She further added that people are always conscious about their well being, and ensure the products they use are ethical, so this is why the duo has set out to explore a product that is completely organic putting safety, purity and quality first. 

Both Kate and Michelle said that one of the best things they loved about creating The Tonic Tribe was the actual interaction they had with their customers in the shop. 

Kate said that people are looking for nurturing values from nature itself, and they love being able to recommend people that product which they themselves believe in and is highly natural. 

CBD market in the United Kingdom has grown multi fold, especially after it was legalized. It is now worth about £5.5m and is expected to rise exponentially over the coming years. 

Cannabis oil is linked with marijuana, however the stigma around marijuana should not affect CBD as it is a completely unique and different chemical. The psychoactive compound which causes the ‘high’ and leads to hallucinations when users smoke weed or pot is known as THC or tetrahydro cannabinoid. 

THC is not a part of pure CBD oil and the law has enforced strict rules that companies have to abide by when dealing with CBD products. 

According to the law in the United Kingdom, CBD products must not contain anymore than 1 mg of CBD per container, irrespective of the size of the container. 

 

Any contaminants tend to reduce the effectiveness of the compound resulting in ill effects. Before buying any CBD product, make sure that it is clinically tested and is approved by the required law enforcement bodies. 

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