Mental health drive needed in France

Consumer attitudes related to mental health and emotional wellbeing are expected to continue to drive the need for innovation to improve mood and reduce stress, according to ingredients and supplement manufacturer Nexira Health. An Innova Market Insights report cited by the company reveals that 53% of global consumers have taken action to improve their physical wellbeing, while 44% have acted to improve their mental and emotional wellbeing.

Nexira also noted that supplement launches over the past five years have increased by 26%; after immune health, the second most launched claim is brain-mood health (+25%). To emphasise wellbeing and mood health in 2023, Nexira is highlighting Serenzo, a supplement ingredient based on sweet orange essential oil formulated with acacia gum designed specifically for mental and emotional wellbeing. In a 12-week consumer study, Serenzo supplementation reduced subjective feelings of stress by 50%, significantly improved mental load and appeared to boost mood and emotional wellbeing. 

^{Nexira’s new targeted branding for its VMS range}

Nicholas Hall Writes: Isn’t it strange how the pandemic has changed public perception of consumer healthcare? Perhaps it was to be expected that consumers would move away from the previously unstoppable prevention trend and spend more of their disposable income on treatments with tangible benefits. But who could have predicted that in the search for immunity, consumers would be more attracted to general products like vitamin C and multivitamins than more specific brands. The relative failure of antiviral products like ColdZyme is a real mystery to me. If these brands cannot succeed during the worst pandemic the world has experienced in the hundred years since the Spanish flu, when can they? On the other hand, consumers have reached out directly to OTCs and supplements that improve the quality of sleep and reduce stress. This will put a massive premium on the price that potential acquirers will have to pay for mega-successful brands like Prevagen and Natrol.

With these growing lifestyle niches, the market seems even more wide open to new entrants. Nestlé Health Science and Unilever have made big inroads into the VMS sector, with particular success in e-Commerce, which accounts for 40-50% of their health & wellbeing businesses. It seems that Big Tobacco is also circling and may look to dig deeper in attractive adjacent categories such as CBD; and I am fascinated by the news story that the packaged fruits marketer, Dole, is keen to reposition itself after 170 years as primarily a purpose-led health & wellness company.

CRN HIGHLIGHTS SAVINGS FROM SUPPLEMENTS USE

The CRN Foundation’s Supplement to Savings report identified up to US$17.7bn in annual net savings between 2022-30 from the use of specific dietary supplements by at-risk target populations most susceptible to coronary artery disease (CAD). Throughout February, American Heart Month, CRN will amplify the potential of dietary supplements to reduce the health impacts and healthcare costs of CAD. The chapters on CAD focus on four supplement regimens: 

• Average annual cost savings from the widespread daily use of preventative amounts of omega-3 fatty acids EPA+DHA could be US$4.47bn 
• Regular use of magnesium by specific at-risk populations amounts to average healthcare cost savings of US$2.32bn per year 
• Regular use of vitamin K2 by specific populations could generate estimated annual cost savings of US$9.48bn 
• The average cost savings from increased utilisation of soluble fibre for heart-health effects is US$1.47bn per year 

^{Source: CRN Foundation}

Nicholas Hall Writes: We talk a lot about the ability of the CHC industry to reduce the overall cost of public health as well as improving access, but it’s always good to see hard figures with which we can agree or disagree. Even if these estimates are too high – which I’m not saying is the case – a saving of up to US$18bn from coronary artery disease alone, and an even more important saving of lives, are to be greatly desired. To quote Steve Mister, the CRN’s President & CEO: “Today, most of our healthcare resources are spent after people are already afflicted with an ailment. We hope the broader medical community will take notice and evaluate how supplements can enhance nutrition and improve the overall health of their patients.”

I like Steve Mister’s terrier-like defence of dietary supplements, which we witnessed a second time this week when he (rightly) criticised the FDA for its unwillingness to take responsibility for regulating CBD. It is one thing to say that existing regulations cannot provide a pathway for CBD, although one wonders why it took four years to reach this conclusion, but where then is the pathway? Unless the FDA takes hold of this emerging category, it will continue to display all the characteristics of the Wild West, when we are seeking to avoid a “Gunflight at the CBD Corral”. And until firm but fair regulations are put in place, we are unlikely to attract major consumer players to this sector.

Monitor the latest launches across VMS with our dedicated innovation benchmarking tool, CHC New Products Tracker, which features almost 40,000 launches, all graded with a star rating. Subcategories such as CBD, eye health, omega-3 and various herbal supplements are tracked, plus many others. To find out more, or to set up a demo, please contact david.redford@NicholasHall.com.

CHC regulation: News from EFSA and FDA

The European Food Safety Authority has stated that its scientists “cannot currently establish the safety of cannabidiol as a novel food owing to data gaps and uncertainties about potential hazards related to CBD intake”. Following the submission of numerous applications under novel food regulations, the European Commission asked ESFA to give its opinion on whether CBD consumption was safe for humans. EFSA’s expert Panel on Nutrition, Novel Foods & Food Allergens (NDA) believes there is insufficient data on the effect of CBD on the liver, GI tract, endocrine and nervous systems and psychological wellbeing. While studies in animals show significant adverse effects especially in relation to reproduction, it is important to determine if these effects are also seen in humans.

In other notable CHC regulatory news, the FDA has placed Sanofi’s Actual Use Trial to support the Rx-to-OTC switch of ED treatment Cialis (tadalafil) on hold, owing to concerns about the protocol design. Cialis is the only PDE-5 inhibitor that offers men a choice when it comes to treatment for ED – for use as needed and for once daily use. The AUT has not yet recruited any patients, but Sanofi noted that it “continues to work with the FDA to move the programme forward and will engage the agency in upcoming meetings as it determines the next steps”.

^{Source: EFSA}

Nicholas Hall’s Touchpoints: Why am I not surprised at the latest EFSA ruling on CBD? Even though the Chair of the NDA Panel, Professor Dominique Turck, has let a crumb of comfort drop from his high table when he said, “It is important to stress at this point that we have not concluded that CBD is unsafe as food”, the announcement will have disappointed an industry and the many manufacturers who have sunk millions into proving the unique benefits of this new class of consumer healthcare products. This is, after all, the organisation that won’t allow probiotics to be named as probiotics on packaging, although it seems to me highly significant that the authorities in Spain and Netherlands are leading the way to override this ridiculous ruling by the Dr.No’s at EFSA. 

In much the same way, California is pioneering the move for hemp-derived CBD to be treated as supplements and eventually brought under the DSHEA umbrella. This is another crumb of much-needed comfort at a time when the FDA seems in a state of paralysis regarding the regulation of medicinal cannabis. And I’m extremely concerned with the recent news that the FDA has stopped Sanofi’s Actual Use Trial for the switch of Cialis, which my good friend Mary Alice Lawless believes could be a threat to the whole switch process in USA.

Explore the best CBD and lifestyle launches from 2021 in the Innovation Showcase featured in our recent Innovation in CHC report. Drawn from CHC New Products Tracker, you can also explore innovation by marketer, region and country. To order your copy, or for further information, please contact melissa.lee@NicholasHall.com.

GSK eyes CBD market with Cann partnership

Cann Group has entered into an exclusive evaluation & option agreement with GSK Consumer Healthcare in relation to the potential commercialisation of Satipharm CBD capsules for OTC (S3, Pharmacist-only) distribution in Australia. GSK also has potential interest in first rights to negotiate exclusivity periods to assess its interest in taking up commercialisation rights in other markets globally. Cann has granted GSK the exclusive right to evaluate Satipharm (excluding Cann’s Rx CBD products) for 60 days after the delivery of Cann’s final clinical study report.

In consideration of this, GSK will pay Cann £100,000 (US$130,437) as a non-refundable payment. Key terms of any definitive sales & marketing agreement will be contingent on factors including the results of the 4-week Phase 3 clinical trial and path to regulatory approval, as well as GSK’s marketing evaluation. Recruitment for the trial, which will examine the efficacy of Satipharm for the short-term treatment of sleep disturbances and quality of life outcomes, is in progress and the results are expected in H2 2022.

As highlighted in our recently published Innovation in CHC report, global launch activity for CBD products has dropped off substantially over the past two years since the pandemic. Regulatory uncertainty also still hovers over the status of CBD in the key US market, another factor in NPD dropping sharply there. In the near future, we expect there to be a greater emphasis on quality over quantity. Further clinical backing for CBD and other cannabinoids – in the way GSK is pursuing with this Cann partnership – will be crucial to this next phase in the maturity of the category.

^{Source: Nicholas Hall’s CHC New Products Tracker}

Nicholas Hall Writes: “This is a very important story. As Peter Crock, the Cann CEO, says: “Cann’s ability to produce a CBD capsule that presents as a regular pharmaceutical and has proven benefits in terms of stability and bioavailability has attracted interest from a number of potential distribution partners. We are delighted to have this opportunity to work with GSK Consumer Healthcare, which would bring industry-leading expertise and market access to our CBD product platform if we enter into a definitive exclusive agreement.”

Alright, it’s not a done deal yet, but there is an expectation that it will be concluded for Australia, and possibly other markets. It is highly significant in many ways:

1. It’s the first major move since Australia approved CBD for certain OTC indications in February 2021 
2. With all due deference to Nestlé, it’s the first instance of a major CHC company taking a direct interest in the CBD market
3. There is some real science involved
4. The sleep indication will be a sure-fire winner in a category that grew 13.2% in 2021 and still has massive unmet consumer demand

And finally, is it a sign of the greater freedom that the independent Haleon will have to enter “difficult” categories, which might not be possible for an affiliate of Big Pharma? All in all, this is a bold move, and one I hope will succeed.

We are pleased to announce that the latest edition of Innovation in CHC from CHC New Products Tracker is now published! This report showcases 100 major innovations from 2021, profiles best-in-class brands and highlights key ingredient and delivery format trends. To order your copy now, or for more information, please contact melissa.lee@NicholasHall.com.

Kerry survey highlights growing interest in probiotics

Demand for probiotics is growing as digestive health moves up the consumer agenda, according to a survey conducted by Irish taste and nutrition company Kerry. The company surveyed 13,000+ consumers across 16 countries. Almost half (47%) of those questioned were aware of probiotics or cultures, up from 42% in 2019 when the survey was last conducted. Awareness was particularly high in Latin America (63%) and North America (61%). One in four respondents (25%) had used a product containing probiotics in the past six months, up from 21% in 2019; a further 44% said they would consider doing so vs 40% in 2019. Probiotic use in the past six months was especially high in China (49% of respondents), followed by Mexico (42%). Digestive Health was ranked third on the list of reasons to purchase healthy lifestyle products, up from fourth in 2019.

Writing in CHC.Newsflash, Nicholas Hall said this story is a welcome reminder that probiotics remains one of the most attractive categories in consumer healthcare, despite flat sales during Covid. As Kerry VP John Quilter points out: “Demographic changes, such as population ageing and lifestyle choices, have increased the prevalence of digestive disorders, while the pandemic has accelerated the shift towards more proactive approaches to health. As a result, consumers [are] increasingly well educated about the role of probiotics and their ability to support both digestive health and overall wellness.”

Source: CHC New Products Tracker

Nicholas commented further: “Our industry is receiving this message loud and clear, to judge by the large number of probiotic new products. Indeed, it’s highly instructive to look at the very large number of new CHC products launched in 2020 as measured by our Tracker. There were three standout categories: probiotics, CBD and – no surprises – immune supplements. These categories recorded around 250-300 launches each, substantially ahead of multivitamins, antiseptics & disinfectants and sedatives & sleep aids. The impact of Covid is written all over this data, but despite the disruption in purchasing habits, marketer perception of unmet consumer demand is clear, with probiotics and CBD very much front of mind.

“As I’ve written before, I see probiotics as a three-stage process: entry level, using well-known strains with a gut-health positioning; first stage development, embracing new indications such as immunity and women’s health, but still using existing strains and combinations; and the far stage, with exciting new indications including metabolic reconditioning, and completely new strains. At present we are about a third of the way into the second stage, with lots of new probiotics coming to market. But what we lack is clinical evidence with large sample sizes from research centres with unimpeachable credentials, sufficient to persuade, for example, the Doubting Dr Thomases at the European Food Standards Authority to allow claims or even the use of the word “probiotic” on packaging. With a number of heavy hitters from the supply chain – such as Kerry – being attracted to probiotics, I’m confident that we are only a few years away from the Promised Land.“

Take the opportunity to save up to GB£2,100 when you pre-order our forthcoming Immunity hot topic report before 31 August! This essential report will review a number of categories including antivirals, immune supplements and vitamins C & D, and explores the latest launch activity, plus much more. To pre-order your copy with the pre-publication discount, or to find out more, please contact melissa.lee@NicholasHall.com.

FDA rejects two NDI notifications for CBD products

The US FDA has rejected two New Dietary Ingredient (NDI) notifications for CBD as a dietary supplement. The ingredients submitted by both applicants – Charlotte’s Web and Irwin Naturals – were described as “full-spectrum hemp extracts”. FDA rejected the filings on the basis that CBD is the active ingredient in an approved drug (GW Pharmaceutical’s Epidiolex) and because the companies failed to provide sufficient scientific evidence to substantiate their submissions. In objection letters to Charlotte’s Web and Irwin Naturals, the agency said full-spectrum hemp extracts containing CBD “may not be marketed as or in a dietary supplement”.

According to CRN President & CEO Steve Mister, CBD regulation and mandatory product listing are the most important supplement-related issues pending for the VMS industry on Capitol Hill, as revealed in a recent panel interview organised by Nutrition Industry Executive as part of “Turning Point: Washington and the State of the Natural Products Industry“.

Mister also stated in a recent CRN press release that: “Despite very clear direction from Congress when it removed hemp from the Controlled Substances Act in 2018, FDA seems to have made up its mind not to support CBD in supplements and is now trying to justify it. That’s the only logical conclusion to draw from FDA’s actions – and its continued inaction … CRN has publicly endorsed HR 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 and is actively lobbying Congress to do what FDA has refused to do – create a legal pathway to market CBD as a dietary supplement.”

Source: CHC New Products Tracker

Nicholas Hall commented: It was Lenin who spoke of taking “one step forward, two steps back”. Those of us with a less revolutionary nature aim for a more positive journey, with only the occasional backward glance! But regardless of the number of steps in either direction, the news that the FDA has rejected two important dietary supplement notifications for CBD seems highly retrograde. I fully endorse the view of the Council for Responsible Nutrition, which has denounced the FDA decision and urged Congress to act.

In CRN’s view, the FDA has mischaracterised these products as being the same as prescription CBD drugs and has “ignored, dismissed and downplayed ample evidence” that hemp products can be marketed safely. This seems like a re-run of the FDA’s inability to deal with the whole dietary supplements sector many years ago, which ultimately led to Congress’s stepping in with the all-important DSHEA legislation under which supplements are now regulated with a very light touch.

Review the latest new CBD products with CHC New Products Tracker. This ultimate competitive intelligence tool features 30,000+ launches and innovations, and products graded with a star rating. To set up your free demo, or to find out more, please contact waisan.lee@NicholasHall.com.

CBD industry revving up again in 2021

2020 was a tough year for the CBD industry, with Covid causing disruptions to supply chains as well as lower footfall in bricks & mortar retailers, and these setbacks were reflected in greater hesitancy from CBD marketers in terms of NPD activity – according to our CHC New Products Tracker service – with launch activity in 2020 much lower compared to 2019. However, recent regulatory developments in Australia and Mexico, and the uptick in M&A activity in the CBD industry over recent weeks, suggest 2021 will see a revival in NPD activity and sales.

For example, Curaleaf, a leading US provider of consumer cannabis products, last week signed a definitive agreement to acquire EMMAC, the largest vertically-integrated independent cannabis company in Europe, for around US$286mn. Curaleaf Executive Chairman, Boris Jordan, commented: “[This acquisition] provides an advanced base to reach scale within the nascent European cannabis market and transform Curaleaf into a truly international cannabis consumer packaged goods company. The consumer and political liberalisation trends around cannabis that are sweeping USA are also increasingly taking hold in Europe … The European cannabis market has the potential to exceed the US cannabis market over the long-term and will help fuel our growth for years to come.”

In addition, a wholly-owned subsidiary of British American Tobacco last week subscribed for around 58.3mn common shares – a 19.9% equity interest – of Organigram, a leading licensed cannabis producer, for C$221mn (US$176mn). The companies have also entered into a Product Development Collaboration Agreement, under which a Centre of Excellence will be established to focus on developing the next generation of cannabis products, with an initial focus on CBD. “The cannabis industry is still in the nascent stages of product development. We believe that product innovation backed by core fundamental R&D is necessary to establish a long-term competitive advantage in the cannabis industry,” said Organigram Chief Strategic Officer Paolo De Luca.

Another M&A CBD development from last week was MediPharm, a research-driven global leader in cannabis extraction, entering into a GMP white-label supply and contract manufacturing agreement with Cannim. The company has also commenced registrations for the launch of next-generation OTC products in Australia in 2021. Under the 3-year agreement, with options to extend, MediPharm will supply a full range of specially-formulated CBD and THC cannabis oil products, sold initially under Cannim’s Lumir brand. MediPharm will also provide Cannim with contract manufacturing options.

Finally, a bill that would legalise the recreational use of cannabis was approved in Mexico’s lower house of Congress last week and will move to the Senate for final approval. The legislation would enable users aged 18+ years with a permit to carry up to 28g of cannabis and grow up to eight plants at home for personal use. President Andres Manuel Lopez has argued that the bill could help to curb Mexico’s violent and powerful drug cartels. John Walsh, Director of Drug Policy for the Washington Office on Latin America, a US advocacy group, said: “Mexico, given its size and its worldwide reputation for being damaged by the drug war, to take this step is enormously significant. North America is heading towards legalisation.” Canada and Uruguay are the only countries in the world to have legalised cannabis for recreational use. With its liberal switch environment, Mexico could be an early adopter of OTC cannabis, possibly the second or third market after Australia.

Discover who the main CBD players are, and how big the market could get in our recent report, CBD 2020: The 20 Most Important Questions about CBD in the Future of CHC. To find out more, or to order your copy, please contact melissa.lee@NicholasHall.com.

CBD: European market boosted by ECJ ruling

An important recent ruling by the European Court of Justice – that an EU member state may not prohibit the marketing of cannabidiol (CBD) lawfully produced in another member state – could mark a turning point for CBD in Europe. So far, sales and innovation in this high-potential category have been driven by the fast-growing US market, where CBD is available in an ever-growing array of delivery formats and formulations.

Innovation in Europe has, until now, been more cautious. According to our CHC New Products Tracker tool, NPD activity in the region has largely been driven by the UK, along with Germany and more recently Spain. While innovation in Europe has been mainly powered by CBD specialists such as Ignite and Vitality CBD, established CHC marketers are also playing an increasing role, with Nature’s Aid (Stada) launching a range of CBD sprays and gels in the UK in 2019, while Vemedia launched new cream and capsule CBD formats in Spain in mid-2020 under its Valdispro brand umbrella.

Nicholas Hall Writes: “CBD is one of my top picks for a new CHC mega-category. Consumer demand is strong, retailers are eager to stock, there is an abundant supply chain, and very importantly CBD is highly efficacious and seems to have few if any side-effects once “bad boy” THC is suppressed within the cannabis plant. So what is holding back the creation of what we estimate as a potential US$20bn market at retail prices? The answer is clear: regulation. Usually marketers want fewer regulations, not more; but in this instance it is vital that the health authorities determine the scope of the market, indications, dosage strengths, permitted claims and production standards, which will drive away the carpetbaggers.“

“In many countries, CBD is marketed in the form of hemp. To quote the President of the European Industrial Hemp Association, Daniel Kruse: ‘This ruling is the beginning of the end of the arbitrary stigmatisation of CBD. In future, both European and national courts, politicians and authorities will have to orient themselves on the Court’s reasoning. If the hemp industry keeps being proactive and comes up with safety assessments and standards, achieved by the EIHA Novel Food Joint Application, then the products will be legally marketable all over Europe, latest in three years. The market growth will be extremely significant.‘”

CBD 2020 is one of several Nicholas Hall reports that are being heavily discounted as part of our final Q4 promotional event, which runs from tomorrow until end-December. There are also discounts to be had on our Innovation in CHC, Coronavirus 2020 and New Paradigms reports, as well as several more. For more information please contact Melissa.Lee@NicholasHall.com

US Herb Market Report shows dynamism of immunity supplements

In this week’s blog, we look in more detail at the American Botanical Council’s 2019 Herb Market Report, which is based on US retail sales data provided by SPINS and the Nutrition Business Journal. According to the report, US consumers spent an estimated US$9.6bn on herbal dietary supplements in 2019, an 8.6% increase vs 2018.

For the first time, CBD made the list of 40 top-selling ingredients in the mainstream channel, where it ranked 9th at just under US$36mn, up 872% vs 2018. For the second year, CBD was the top-selling botanical sold as a dietary supplement in natural retail outlets.

Sales of immune health-related ingredients also rose sharply. In H1 2020, elderberry had the second-highest increase in the mainstream channel (+241%), making it the third top-selling ingredient; it was up 126% in the natural channel. Echinacea grew by 50%+ in both channels.

Other herbal & natural ingredients that have performed well include oregano (up 75% in the natural channel and 91% in the mainstream channel in H1 2020), which is positioned for respiratory symptoms such as cough, as well as astragalus root and mushrooms / fungi-derived ingredients with an immunity positioning. According to SPINS, sales of mushrooms (other) advanced by 84% in the natural channel and an exceptional 495% in the mainstream channel.

The report indicates that while dietary supplements with immunity positioning were the primary growth driver in the US market in the first half of 2020, other VMS ingredients also performed well, particularly those with a stress or sleep positioning. As of mid-June 2020, supplement sales appear to have levelled off; but if H1 2020 is any indication, the US VMS industry is on track for another record-breaking year.

For the full report, go the American Botanical Council’s website and download the PDF link.

Also, ensure that you have registered to join Nicholas online on 30 September for an all-new hot topics webinar! You will hear about key trends, including the impact of Covid-19, Distribution, e-Detailing and Sustainability. To find out more or register to join, please contact elizabeth.bernos@NicholasHall.com.

Does CBG offer hope against antimicrobial resistance?

According to a recent WHO press release, a lack of innovation in the development of new antibiotics, allied with declining private investment, is undermining efforts to combat drug-resistant infections. The breaking news from China of a sharp rise in diagnoses of an emergent strain of coronavirus, and new reported cases in Japan and Thailand, has raised fears of another outbreak similar to SARS in 2003, which infected more than 8,000 people and killed more than 700.

WHO has raised concerns about a weak pipeline for antibiotic agents, with 60 products in development (50 antibiotics and 10 biologics) that it deems bring little benefit over existing treatments and very few that target the most critical resistant bacteria (Gram-negative bacteria). However, some positive news came from an unlikely quarter over the weekend – an as yet unpublished study that found that CBG (cannabigerol) cured mice of MRSA infections as effectively as vancomycin, a drug widely considered to be the last line of defence against drug-resistant microbes.

One of our recent blogs looked at the potential of a new emerging class of cannabinoids beyond CBD – including CBG, CBN (cannabinol) and CBC (cannabichromene) – and this new study boosts the attractiveness of the cannabinoid industry even further. Eric Brown, the microbiologist who led the research at McMaster University said cannabinoids were “clearly great drug-like compounds”, but noted it was early days in assessing the compounds for use in the clinic.

Brown found that CBG and other cannabinoids did not work well against gram negative multi-drug resistant bugs. However, the study shows that when CBG is used along with small quantities of polymyxin B, an existing antibiotic that targets “the cytoplasmic membrane of Gram-positive bacteria”, the cannabis compound wiped out the drug-resistant pathogens. “We are now pursuing the required paperwork to work with a wide variety of cannabinoids,” Brown said.

What is the current regulatory status of CBD in global markets? Find out in Nicholas Hall’s upcoming report, CBD 2020: The 20 Most Important Questions about CBD in the Future of CHC! You can also read about the main challenges faced by CBD players, the current and forecast size of the market, and much more! Pre-order your copy before 30 January to save with the pre-publication discounted rate! To find out more, or purchase your copy, please contact melissa.lee@NicholasHall.com.