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FDA issues first warning letters for products containing delta-8-THC

Five US companies have been issued warning letters.

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FDA delta-8-THC

Today, the US Food and Drug Administration issued warning letters to five companies for selling products labelled as containing delta-8-THC in ways that violate the Federal Food, Drug, and Cosmetic Act.

This is the first time the FDA has issued warning letters for products containing delta-8-THC, a psychoactive compound similar to the more widely-known Delta-9-THC. The FDA said it has received reports of adverse events experienced by patients who have consumed products containing delta-8-THC.

Delta-8-THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects. As of yet, there are no FDA-approved drugs containing delta-8 THC.

The warning letters address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses. The letters also cite violations related to drug misbranding and the addition of delta-8 THC in foods such as gummies, chocolate, caramels, chewing gum, and peanut brittle.

The FDA revealed that it issued warning letters to ATLRx Inc, BioMD Plus LLC, Delta 8 Hemp, Kingdom Harvest LLC and M Six Labs Inc.

“The FDA is very concerned about the growing popularity of delta-8-THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D. in a statement. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”

The FDA recently published a consumer update expressing concerns about the potential health effects of delta-8 THC products following  adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners, and law enforcement, some of which resulted in the need for hospitalization or emergency room treatment. The agency is also aware of an increasing number of exposure cases involving products containing delta-8-THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8-THC.

In addition to the violations related to FDA-regulated products containing delta-8-THC, several of the warning letters outline additional violations of the FD&C Act, including marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods.

The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases, in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food products. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.

The FDA said it has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence.

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Charlotte’s Web full spectrum CBD passes novel foods validation

Charlotte’s Web is now the only vertically integrated US company with a full-spectrum hemp extract to have passed the UK novel foods validation phase.

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Charlotte's Web Novel Foods

Charlotte’s Web has passed validation in its FSA Novel Food applications for its original formula full-spectrum hemp extract product.

This marks a milestone for Charlotte’s Web, as it becomes the only vertically integrated US company with a full-spectrum hemp extract to have passed the UK novel foods validation phase. The product will now advance to the safety assessment phase. Charlotte’s Web said the approval uniquely positions the company in the growing UK CBD market.

Charlotte’s Web products are distributed in the UK by Savage Cabbage Ltd. Under the new Novel Foods regulatory framework, Savage Cabbage said it will leverage its extensive distribution network in the UK to expand the presence of Charlotte’s Web in retail distribution channels and on the high street. The company said that it is now preparing to expand distribution in the UK, EU and countries worldwide.

Charlotte’s Web understands that product quality, safety, and brand values matter to global health seekers who are demanding premium full-spectrum products,” said Jacques Tortoroli, CEO of Charlotte’s Web, “It’s critical to scaffold these emerging markets with the high bar set by our proprietary hemp genetics, scientific rigour and innovation practices.

“International audiences are only now learning the difference between full-spectrum and isolate CBD products, which provides a great opportunity for education, product differentiation and consumer adoption as they begin to understand the health advantages inherent in full-spectrum products.”

Novel Foods are ingredients which have not been widely consumed by people in the UK or EU before May 1997. This includes cannabidiol (CBD) and other consumable derivatives of the hemp plant, including whole-plant hemp extract. Novel Foods needs to be authorised by the FSA before they can be included on the list of novel foods and marketed for sale.

In addition to its Novel Foods application, Charlotte’s Web is collaborating with The European Industrial Hemp Association (EIHA) which is part of the Secretariat Advisory Board (SAB), a European consortium of the UK’s and Europe’s leading CBD and hemp trade bodies and groups. The SAB is focused on encouraging the development of clear UK regulation for CBD that reflects evidence-based policy to safely serve the public and wider national interests engaged in public wellness.

According to the Brightfield Group, the UK CBD market has grown rapidly in recent years. The number of CBD consumers virtually doubling in 2019 to reach over 7 per cent of the adult population in 2020, representing sales of more than US$250m in 2020, growing to an estimated US $1.3b by 2025.

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JM Wholesale sees 750 products included on FSA CBD list

The CBD stockist has described the development as a milestone for the company.

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JM Wholesale sees 750 products included on FSA CBD list
Home » News » Politics & policy » FDA issues first warning letters for products containing delta-8-THC

Following a partnership with the European Industrial Hemp Association (EIHA) and active participation with the Food Standards Agency (FSA), JM Wholesale has had more than 750 items included on the public CBD list.

Earlier this year the FSA published its list of CBD products linked to what it deems as credible Novel Food applications. Products included on the list will be advancing through the final stages towards authorisation, expected by 2023. 

More than 900 applications for thousands of UK products have been submitted for approval, with the majority being rejected for lacking basic information such as toxicity levels.

JM Wholesale has announced that it has now had 750 of its products included on the public list.

Read more: FSA CBD list now closed for applications

Thomas Lowe, operations director at the Leicester-based company, said that, after 200 per cent business growth in the past 18 months and a resulting move to major new premises, JM Wholesale is now perfectly placed to consolidate its position as the UK’s premier CBD wholesaler.

Lowe commented: “We have a larger range of approved CBD products than any other distributor and this moment is another milestone for our company.

“We’ve worked hard to ensure that our customers and our business are protected, by getting rid of any products not published on the FSA’s website, regardless of how big those brands are.

“In fact we’ve always loved finding unique products, including those where the CBD can be absorbed in different ways. That way, more people from different walks of life can enjoy CBD no matter how they prefer to access it.

“From our distribution centre we now provide the largest range of isolate and full spectrum CBD products in the UK, all of which are 100 per cent accepted by the FSA.

“We are the first distributor to add the relevant Novel Food classification numbers to all of our relevant listed products.

“The past few months have been extremely challenging for our industry but we have made efforts to take an active role in the novel food submission process. We anticipated regulation of this industry, we were determined not to let it stand in the way of the growth of our business, and we’ve participated accordingly.

“All in all, this is excellent news for our customers and partners.”

The company has stated that it has experienced rapid growth off the back of increased awareness of the health benefits of CBD products in the UK, and that, alongside its consumer business, it also exports to suppliers in the UK and in 170 countries worldwide.

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Halo Collective announces new chief executive officer

Current CEO Kiran Sidhu has resigned as the result of a mutual agreement between Mr Sidhu and the board of Halo.

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Halo collective Kathryn Field

Halo Collective Inc has promoted its president Katharyn Field to the position of chief executive officer.

Kathryn Field has been appointed chief executive officer of Halo replacing current CEO Kiran Sidhu. Ms Field takes the helm at Halo with nearly a decade of direct cannabis experience, including strategy, retail, corporate development, legal & regulatory and investor relations.

She first entered the cannabis industry in 2014 at Costa Farms, where she led the procurement, build-out and sale of one of five original vertically integrated companies in Florida.

She subsequently operated a strategy consulting practise focused on cannabis and also worked at MariMed as EVP of Corporate Development. She joined the Halo executive team in April 2019, serving initially as chief strategy officer, before moving onto the role of president in February 2020. She became a board member in July 2021.

“Halo is very well-positioned in the US West Coast cannabis space with a strong consumer brand portfolio and a loyal customer base. In particular, we have developed a valuable portfolio of California assets including wholesale and white label manufacturing as well as retail assets in Los Angeles,” said Ms Field.

“My initial focus will be on streamlining the organisation to establish a rationalised, focused business comprised of assets that create the most value and hold the most promise. While sales are down in California year over year, our business is up. Furthermore, our manufacturing business is profitable and the Budega stores are trending well.

“I’m confident that by prioritising near-term profitability and bolstering our growing retail presence, Halo will be able to scale from a position of strength, which is the best path to generate shareholder value.”

Mr. Sidhu’s departure was the result of a mutual agreement between the board of Halo and Mr Sidhu, and “reflected the board’s view that the company and Akanda – of which Halo owns approximately 40 percent – need to prioritise near-term profitability”. Mr Sidhu will provide consulting services to the company for six months to facilitate a smooth leadership transition.

“The Board believes the time is right for not only a change in leadership, but a change in strategy, and Katie has the right experience and capabilities to leverage the company’s valuable assets to create tangible and sustainable shareholder value,” commented Ryan Kunkel, Chair of the Board.

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