U.K. Regulators Launch Crackdown On CBD And Issue Health Warning

U.K. Regulators have warned the country’s CBD industry to comply with Novel Food rules or face having their products taken off their shelves.

The Food Standards Agency has also issued a health warning to mums-to- be and those taking medication not to use CBD. In a press release today the FSA has given the industry a little over a year to comply with its new novel food guidelines. 

The press release reads as follows: “The FSA has set a deadline for CBD businesses to provide more information about CBD products and their contents. It also advises vulnerable groups not to take CBD, and healthy adults to take no more than 70mg a day.

The Food Standards Agency (FSA) is giving the CBD industry a deadline of 31 March 2021 to submit valid novel food authorisation applications. After 31 March next year, only products which have submitted a valid application will be allowed to remain on the market. The authorisation process ensures novel foods meet legal standards, including on safety and content.

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Local authorities enforce the novel food legislation. They have been advised that businesses should be able to sell their existing CBD products during this time provided they are not incorrectly labelled, are not unsafe to eat and do not contain substances that fall under drugs legislation.

In addition, the FSA is today advising those who are pregnant, breastfeeding or taking any medication not to consume CBD products. Healthy adults are also advised to think carefully before taking CBD, and the FSA recommends no more than 70mg a day (about 28 drops of 5% CBD) unless under medical direction. This new precautionary advice is based on recent findings by the government’s Committee on Toxicity (COT).

Emily Miles, Chief Executive of the Food Standards Agency, said:

“CBD products are widely available on the high street but are not properly authorised. The CBD industry must provide more information about the safety and contents of these products to the regulator before 31 March 2021, or the products will be taken off the shelves. 

The Thorny Issue Of U.K. CBD Regulation In A Post-Brexit World

Also today, we are advising that CBD could be risky for vulnerable groups, and suggesting an upper limit of 70mg a day for everyone else taking the product.

The actions that we’re taking today are a pragmatic and proportionate step in balancing the protection of public health with consumer choice. It’s now up to industry to supply this information so that the public can be reassured that CBD is safe and what it says it is.”

Professor Alan Boobis, Chair of the Committee on Toxicity, said: 

“My committee has reviewed the evidence on CBD food products and found evidence there are potential adverse health effects from the consumption of these products. We are particularly concerned about pregnant or breast-feeding women and people on medication.

“We don’t know enough to be sure about such a risk but I am pleased with the sensible and pragmatic approach the FSA is taking. The committee will continue to keep these products under review in the months ahead.”

CBD Testers will be proving reaction from the industry as we receive it. For more updates and articles like this one, subscribe to the CBD Business Weekly Newsletter.  

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CBD Warnings From FDA Spook Major Consumer Brands

The United States Food & Drug Administration has started 2020 as it ended 2019 – with a shot across the bows of the booming CBD industry.

And, the FDA’s on-going irritation with the unregulated, low-THC cannabis market is spooking the blue-chip brands once poised to enter it. Reports have surfaced, since the turn of the year, of many major brands recoiling from CBD as a result of the FDA’s position.

Late last year the FDA set out its stall saying CBD posed ‘real risks’ to health, and earlier this month it said it expects CBD-infused product developers to pursue a drug-trials’ validation route.

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Enforcement Cash Boost

At the end of last year the Federal Spending Bill provided the FDA with $2 million of firepower to undertake enforcement. This money will allow it to pursue rogue CBD companies making contentious medical claims, as well as an in-depth analysis of CBD product content – both, to be completed by the summer.

However, the FDA’s proclamations have not gone down well in the commercial CBD world. The Wall Street Journal reports on the uncertainty it has caused, saying the likes of PepsiCo, Starbucks, Kellogg and Red Bull have all put CBD plans on hold.

It quotes Mike Luce, co-founder of consultancy High Yield Insights, as saying it has gone from ‘all gas on, one foot from the consumers’ to ‘now there’s a very strong foot on the brakes from the FDA’.

FDA Says CBD ’Not Safe’

The WSJ says it approached Kellogg and was told that it doesn’t have any plans to use CBD in its food ‘because the FDA doesn’t recognize it as safe’.While it also quoted a spokeswoman for Ben & Jerry’s saying the company would work on a CBD ice cream, ‘only if the FDA approved the compound’.

This uncertainty is spreading north of the border, too. In its most recent earnings call in on January 14, Irwin Simon, CEO of Canadian cannabis firm Aphria, said its plans to expand into the the U.S., for now, ‘would not include CBD’.

Fellow Canadian firms Tilray and Canopy Growth have said retailers have been reluctant to sell CBD in the U.S. as they await firmer guidelines from the FDA.

Former Head Of The FDA Says CBD Is ‘Not Safe’

Fightback Underway

However, a fightback, of sorts, against the FDA’s tin-eared stance is underway . Just last week a cross-party bill was brought before Congress by Republican  Collin Peterson, chairman of the House Agriculture Committee. This calls for the Federal Food, Drug and Cosmetic Act to include CBD in its definition of dietary supplements.

In a letter to Congress last month some major trade bodies, including the American Herbal Products Association, Consumer Healthcare Products Association, and United Natural Products Alliance all pressed for intervention.

They called on Senators ‘to pass legislation to clarify that CBD derived from the hemp plant is a lawful dietary ingredient if the dietary supplement containing the CBD meets established product safety and quality criteria’. 

2018 Farm Bill

The Farm Bill has set many things in motion for the hemp and cannabis industries

This whole furore over the sale of CBD products follows the passing of the Farm Bill in late 2018. This removed cannabis, with less than 0.3% THC, from Schedule 1 of the 1970 Controlled Substances Act, effectively turbo-charging the U.S. CBD market.

The law change is acknowledged in this month’s FDA announcement, which also goes on to suggest it is exploring alternative routes to market approval for CBD food supplements. This FDA statement says it is committed to encouraging the development of cannabis-related drug products, including CBD. 

‘Streamlined ‘Approval

Then a few paragraphs later – referring to the Farm Bill – it states: “This change in the law may result in a more streamlined process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, a result which could speed the development of new drugs containing hemp.”  

In a Congress hearing earlier this month Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation of Research, said it was currently evaluating research to determine CBD’s safety and efficacy.

And he went on to say it was considering ‘non-drug pathways for compounds derived from federally legal hemp, and creating avenues for new drug development involving cannabis compounds’, reports CNN.

This three-and-half-hour hearing is, in itself is noteworthy, as it is the first time the Health Subcommittee of the US House Committee on Energy and Commerce has delved into cannabis and highlights its growing acceptance in the political sphere.

It is important to mention at this point that the FDA’s deliberations are generally concerned with the addition of CBD to food and drinks, it should have little impact on other CBD-containing products such as oils and  topicals.

And, it’s also correct to say consumer-facing businesses want CBD to be treated as a food supplement, and not as a drug.

It’s Time The FDA Regulated CBD As A Food – Not As A Drug

Massive Growth

Over the last year the CBD industry has recorded phenomenal growth in the U.S. as the Farm Bill provided some legal clarity for investors and businesses – something the federally-illegal THC cannabis business lacks.

The CBD industry had an estimated worth of $ 1 billion in 2019, and prior to the FDA warning, some analysts saw CBD market as set to grow to $20 billion in five years. However, analysts are now are now saying the FDA’s warnings could curtail activity.

Nic Balzer, co-founder of Cincinnati-based Queen City Hemp beverages, sees ‘big brands’ hesitation with CBD consumer products as an opening for his start-up to capture more of the nascent market’, reports the Wall Street Journal.

Corporate Coyness

The market in North America is mainly one for the independent start-ups, such as Queen City Hemp, and small and medium-sized companies in the process of building their reputations and profits.

That is certainly not the case for the major brands concerned with reputational longevity and shareholder value. And, it is this corporate caution that is deterring the major brands and Big Box retailers from engaging with the massive opportunities in the U.S. CBD sector.

At least for now, this corporate coyness is a welcome boon for the industry’s  ‘little guys’.

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‘CBD Is The Same As Cannabis’ Say 8 Out Of 10 Brits.

Over 85% of 2,000 British people questioned in a survey believe that CBD is the same as cannabis.

The research, initiated by Manchester-based CBD company Dr. Ed, also finds that around the same percentage describe CBD as ‘dodgy’. Whilst, yet again, over eight in 10 people believe that you cannot buy CBD online or from High Street stores.

So, despite all of the hype around CBD and the million-plus users in the U.K. this research suggests there is still a long way to go before the benefits of cannabidiol – or CBD – are more widely recognised.

‘CBD Is Just A ‘Fad’

In a press release, passed on the CBD Testers by Alex McMillan, the co- founder of Dr. Ed, the company elaborates on its findings. Alex’s business partner Neuroscientist Dr Edward Jones, says in the release:

“Although cannabidiol was isolated as a compound decades ago, knowledge of its potentially potent therapeutic value is only now becoming mainstream. As with most emerging industries, regulation is loose, which has led to a great deal of misinformation and misunderstanding surrounding CBD and an awful lot of mis-selling.”

Other findings from the survey show that only 8% of those questioned had never heard of CBD, and over three-quarters classified CBD as nor more than a ‘fad’.

Middle-Aged Women And CBD

And, there is also a great deal of misunderstanding around the regulation of the industry with just 4% believing the industry is unregulated, when to all intents and purposes, it is currently self-regulated

The study also found CBD is most widely used by women, aged 45 to 60, with two-thirds claiming to have taken or considered taking the oil. At the other end of the scale, those aged 25 to 30 were least likely to use CBD, with just 21% open to trying it.

Dr Jones added: “There is increasing evidence that CBD can be used to successfully treat a number of complaints including anxiety and pain, and can also help with concentration, sleep, and muscle recovery after sports.”

“Far from being ‘dodgy’ or illegal, CBD is still actually a bit of an untapped resource,” he continued. “And with further research and clinical trials there will no doubt be many more health benefits to emerge.”

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Boris Johnson Appoints Cannabis Backers to His Team

Hopes for a more liberal approach to cannabis regulations from the Boris Johnson Government have risen with the appointment of two cannabis supporters to his team.

Blair Gibbs, former Policy Lead at the Centre for Medicinal Cannabis, who worked with the new Prime Minister when he was Mayor of London, has joined the No 10 Downing Street policy team. Where he will be working with fellow cannabis supporter Danny Kruger, the Prime Minister’s new Political Secretary, who has also called for an end to the prohibition of cannabis.

Tough Stance on Drugs

While the new PM says he enjoyed cannabis in his younger days he has since gone on to take a firm stance against decriminalization of most drugs.One of Mr Gibbs initial tasks may be to focus on establishing clearer regulations for the U.K. CBD industry which currently operates in a regulatory lacuna.

And, secondly, the frustrating situation where raw ingredient CBD – for use in all British retail CBD products – has to to be imported into the U.K.

CBD Regulations On The ‘To Do’ List?

In a recent interview with CBD Testers he expressed his irritation: “We have the perverse situation where farmers must pay the Home Office – the national security department of the British state – for a licence to grow hemp from a list of approved hemp seeds all of which have guarantees to certify they will produce no more than 0.2% THC.

“Once licensed, however, they are mandated to remove and destroy the most valuable part of the plant. That isn’t sustainable, and explains why the U.K. hemp sector is so small in stark contrast to the boom on the Continent. In practical terms there is nothing more radical that needs to happen than DEFRA and the Home Office jointly agreeing changes to the licensing conditions for hemp. A small change at a stroke would give the U.K. the ability to have a domestic hemp industry supplying CBD in to the U.K.

At the CMC, Blair Gibbs worked with Government on devising clearer guidelines for the CBD industry telling CBD Testers we need to encourage the ‘the adoption of a credible and robust system of voluntarily self-regulation’ for the sector. He said: “I’m, not sue we quite have that yet.”

The Victorians Did Not Ban Everything

Having lived in Canada he is said to favor the Canadian Government’s legalization route recently posting the following on twitter. “When the UK gets round to legislating to regulate a legal market for recreational cannabis it will need to learn from other models but also devise one that fits its own culture and institutions best.”

Mr Kruger is a former speech wirier for ex-Prime Minister David Cameron, and in 2017 said: “We do not need to ban everything bad. After all the Victorians never prohibited alcohol.” Earlier this year CBD Testers reported how the British public is now in favor of cannabis legalization and some politicians believe it could happen within five years.

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Congress Exerting Pressure On FDA For Clarification On CBD Regulations

Many are accusing the FDA of dragging their feet when it comes to approving and regulating CBD products. Following a dedicated public meeting recently, many expected some long-awaited guidance by now.

Lawmakers are now putting pressure on the Food and Drug Administration to get moving and draft their rules on the regulation of CBD products. However, to their defense, the whole issue is so complex, it’s taking the FDA longer than expected to get their heads around the matter and issue some guidance.

One has to have some sympathy for the FDA after they were forced to scramble to get a hold on hemp-derived CBD (cannabidiol) products following the Farm Bill 2018. The bill allowed for the industrial cultivation of hemp and sent many people into a tailspin; not least, the good people over at the FDA.

CBD is both considered to be a health supplement and a drug, and that’s the main reason why the FDA has such a difficult battle on their hands. Some lawmakers have even gone as far as to threaten that they won’t wait for FDA guidance and will proceed as they see fit at the legal level. Like Jonathan Miller, general counsel for the industry advocacy group U.S. Hemp Roundtable said according to a report from The Hill, “In Congress, some are itchy [for action]. If their patience ends [and FDA doesn’t act], there will be an effort for legislation,” Miller said.

The FDA’s public hearing on May 31st was supposed to resolve the matter, as expert after expert stood and spoke about CBD and its numerous benefits. Despite 10 hours back and forth at that meeting, the FDA Commissioner, Ned Sharpless did not indicate timeframes.

fda cbd

CBD has been around for many years but the FDA tried to ignore it

“While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know,” Sharpless said. One sticking point is dosing levels; another is the long-term effects of CBD (if any) that are not known about due to decades of cannabis prohibition. CBD from hemp is legal, but a separate issue arises when it comes to CBD in food, beverages or as a dietary supplement due to consumption and other issues.

As Miller pointed out, those inside the cannabis industry are willing to wait for the FDA to get their act together, but only because they believe it’s good for business. “We want to give FDA the appropriate space to come up with their conclusions,” Miller said. “They are under a lot of pressure from Congress, and Congress is under pressure from the public. I think they realize they need to move quickly.”

At the same time, Senators on a bipartisan level are pushing the FDA to get moving and offer some clarification. More than $100,000 was earmarked and set aside as part of a House appropriations package to study CBD. Senate Majority Leader Mitch McConnell even met last week with Sharpless and told him to get a move on. 

“Congress’s intent was clear with the passage of the Farm Bill that these products should be legal, and our farmers, producers, and manufacturers need clarity as well as a workable pathway forward regarding the agency’s enforcement,” McConnell said to reporters.

While the process for approving new products with the FDA traditionally takes at least a couple of years, it’s taking much longer than that to get a hold on CBD. While everyone is mainly on the same team here; all wanting a better understanding of CBD, it’s effects and level of safety, lawmakers don’t want the FDA to use that as an excuse to drag their feet on this occasion.

As attorney Jessica Wasserman noted, “FDA needs to create a pathway without taking years worth of safety data,” she said. “[CBD] has been on the market for a long time, and they [FDA] haven’t been using their enforcement powers on it.” And while that may be true, the buck stops with the FDA, and that’s one of the reasons why they need to proceed with extreme caution when it comes to hemp-derived CBD and CBD products.

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