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 

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.

Stark 2023 growth warning from IMF head

The Managing Director of the International Monetary Fund has cautioned that 2023 is going to be a “tough year”, with one-third of the world economy expected to be in recession. The three big economies, USA, EU and China, are slowing simultaneously, translating to negative trends globally. Kristalina Georgieva added in an interview with the CBS News programme Face the Nation that, while USA is most resilient and may avoid recession, the strong labour market is a “mixed blessing” as interest rates could remain tight to lower inflation.

Meanwhile, half of the EU – severely hit by the war in Ukraine – will be in recession this year and China, which in 2022 slowed dramatically because of its zero Covid policy, will slow down further (+4.4% growth in 2023 projected) as the relaxation of restrictions leads to soaring coronavirus cases. Overall, IMF forecasts that Advanced Economies will grow by 1.1% in 2023, while Emerging Market and Developing Economies will rise by 3.7%, led by India (+6.1%) but dragged down by Russia (-2.3%).

When asked what leaves her hopeful, Georgieva said: “I know when we work together, we can overcome the most dramatic challenges. In 2020, the world came together in the face of tremendous threat and was able to overcome this threat. In 2023, we have to do the same.” 

Nicholas Hall Writes: For most of 2022 I wrote in CHC.Newsflash about a market performing surprisingly well, but there was an implicit warning that the party would come to an end one day. Kristalina Georgieva, head of the IMF, has issued a stark warning of tough times ahead economically, but that is light reading compared with Nouriel Roubini’s new book, “Megathreats”, which highlights the 10 trends that imperil our future. Known by some as Dr Doom, Roubini prefers to be known as Dr Realistic, but in my estimation he is Dr Right as he called out many past mistakes with great foresight, including the debt binge that has made the global economy today almost unmanageable.

So how will these megathreats affect Consumer Health? In one sense, we are privileged as healthcare is a must-have category, and self-care will fill part of the vacuum left by the inability of healthcare providers to meet the needs of a growing and demographically-unbalanced population, about which Dr Roubini also writes persuasively. But consumers can only spend the money in their pockets, regardless of whether it is earned or borrowed, which is why I am so concerned about the future of CHC brands and why generics and private labels are now seen as the new growth segment.

I’m also concerned about the viability of retailers and even e-Commerce platforms, as the economic crisis will lower customer footfall and push up costs including the cost of borrowing, forcing thousands of outlets to close. We are already seeing that as a sub-plot of today’s global medicine shortages. Partly this is a story of unpredictable demand caused by the afterwave of the Covid-19 pandemic, but it also seems to me that the supply chain has become very fragile as companies look for ways to cut costs by reducing inventory to breaking point. So our 2023 mission here at the Nicholas Hall Group is to reassess the Strategic Narrative for Consumer Health and offer advice to clients and the industry at large on how to survive mega- and microthreats.

We are pleased to announce that experts from Haleon, Perrigo and PAGB, plus our sponsors Pharmalinea will take the stage alongside Nicholas at our 33rd European CHC Conference! See the all-new agenda here. Taking place in London on 19-21 April 2023, save with the early bird booking discount when you book your place before 19 January! For more information, or for group booking discounts and sponsorship opportunities, please contact elizabeth.bernos@NicholasHall.com.

CRN 2022 survey: Vitamin D in high demand

To mark World Vitamin D Day (2nd November), CRN published initial findings from its 2022 Consumer Survey on Dietary Supplements, which was conducted (in collaboration with Ipsos) in August 2022 among 3,133 US adults aged 18+ years. This includes 2,342 who report consuming dietary supplements seasonally, occasionally or regularly. The survey highlighted the Top 5 single ingredient supplements (see chart below), while also indicating that more than half of consumers (52%) who take supplements report taking a specialty supplement, the most reported of which are omega-3s, probiotics, melatonin and fibre.

CRN states that many more people could experience enhanced quality of life, as well as healthcare cost savings, if they were to follow the dietary supplement regimens discussed in the CRN Foundation Supplements to Savings report. For example, if all US adults aged 50+ years took calcium 1,000mg and vitamin D 15mcg per day, the US healthcare system could save US$17.3bn and avoid 361,507 medical events on average per year from 2022–30. “A steadily growing body of clinical research shows investing in preventive care through supplementation helps Americans avoid chronic conditions. This strategy is what we call a no-brainer,” said CRN SVP Scientific & Regulatory Affairs Andrea Wong.

Nicholas Hall Writes: As CHC.Newsflash reported recently, overall supplement usage stands at 75% of the entire US population, an astonishingly high level. Multivitamins remains the top dietary supplement (taken by 70%) and reported consumption of immunity-boosting supplements – including vitamin D, vitamin C and zinc – remains steady vs last year. Immune health is a top reason for taking supplements (40%), second only to overall health & wellness (44%). Yet there is still room for more growth, which would benefit both individual consumers and our industry, and the healthcare system at large. According to CRN, the annual savings from wider usage of calcium and vitamin D could reach US$17bn.

This data joins a torrent of basically good news about consumer health that makes me think that we are at the beginning of a golden age for our industry, which is how I described our prospects when I gave the final presentation at the Ceuta London conference. We used to say that CHC was dependent on three main drivers of growth. It is true that the cough & cold market is once again boosting demand, but we now no longer rely on the Emerging Markets to the same extent, and Rx-to-OTC is virtually non-existent. No, it is the broader acceptance of self-care by the US and European population that is delivering the most impressive results this year.

In just over two weeks, you can log on to hear from Nicholas and industry experts during our Asia-Pacific e-Conference on 23 November! Topics on the agenda include the go-to-market model, self-care collaborations and sustainability through accessibility. For more information, or to register, please contact elizabeth.bernos@NicholasHall.com without delay.

GSCF publishes v2.0 of Self-Care Readiness Index

The Global Self-Care Federation has launched the second edition of the Self-Care Readiness Index, examining how self-care policies are being implemented across the world. Both editions, together covering 20 countries, demonstrate very clearly that there is a widespread lack of a coherent view of self-care and its benefits. The SCRI is a research and policymaking tool, which explores the key enablers of self-care in support of designing a better model for healthcare systems. It evaluates countries based on four self-care enablers – stakeholder support and adoption, consumer & patient empowerment, comprehensive self-care health policies, and the appropriate regulatory environment – supported by measurable indicators of self-care readiness. The new SCRI is available here.

This latest version of the SCRI report highlights the regulatory environment as one of the key enablers of self-care, advising countries to “focus on regulations and processes governing approval of new health products, from prescriptions to over-the-counter medications.” For example, the approval time for Rx-to-OTC switch applications can vary from as little as one month in Mexico to 11-13 months in Germany and 24-30 months in Canada.

Nicholas Hall Writes: The concept of self-care needs additional drive, which is why we support the excellent work of the Global Self-Care Federation. As GSCF Director General, Judy Stenmark, said when announcing the second edition of the Self-Care Readiness Index: “Self-care has to be a political priority for every single government across the world.”

In many respects we are pushing against an open door! The latest survey of US consumers shows that they want to live longer, but are unaware that their current lifestyles mean that the last lap of life will most likely be miserable. Our industry can help and prosper by meeting the needs of a growing and highly-demanding older population.

Trevor Gore, Founder of Maestro Consulting is part of the online presenting panel joining Nicholas for our upcoming Asia-Pacific e-Conference on 23 November, exploring Opportunities with Collaboration in the Self-Care space. For more information, or to register, please contact elizabeth.bernos@NicholasHall.com.

CRN Survey: Branded ingredients favoured by VMS consumers

The Council for Responsible Nutrition has revealed initial findings from its 2022 Consumer Survey on Dietary Supplements. The survey was conducted online in August 2022 among 3,133 US adults aged 18+ years, including 2,342 who report consuming dietary supplements seasonally, occasionally or regularly.

Liz Cummings, our Regional VP North America, reports from CRN’s Now New Next conference: 

US dietary supplement use has reverted to the pre-pandemic level of 75%, with multivitamins remaining the favourite among users. A wealth of regulation, science, economic and consumer insights was unveiled over the 3-day conference, which will be shared in future NHC publications. However, with CHC Newsflash highlighting the dynamic activity related to ingredients suppliers such as DSM, Kerry and ChromaDex, we thought it was timely to share the following results from the CRN survey: 

  • 71% of supplement users agree that they “find more confidence using supplements made with branded ingredients”
  • 62% perceived that supplements with branded ingredients cost more because they are more effective and better quality, and men were more likely to say that branded ingredients work better
  • 61% are willing to pay higher prices for branded ingredients. Adults aged under 55 years are willing to pay more for branded ingredients
Source: CRN / Ipsos

Nicholas Hall Writes: It seems we are awash with consumer research that confirms the importance of self-care, especially with regards to immunity, even though demand is returning to pre-pandemic levels. In many respects, consumers seem ahead of marketers (let alone regulators) in how they respond to the mega-trends of the day: the pandemics, economic pressures and the energy crisis.

As I wrote last week: “I see a paradox in matching this consumer U&A data with the relative failure of specific immunity products such as antiviral nasal sprays … So why is it that consumers who fear Covid-19, and who subscribe to the concept of immunity, are content to rely on, say, a multivitamin the category grew by 13.5% globally in Year 1 of the pandemic — and not divert to specialist products? I am still searching for an answer.” Another paradox is that, while the top CHC players are reporting excellent sales and the global sales data for the 12 months to June 2022 which we reported in late September is at a record high, retailers and e-Commerce platforms are reporting reduced traffic. And there are signs that many consumers are trading down to smaller packs or cheaper generics and private labels, which you would expect in a recession.

One of the joys of working in consumer health is its resilience. It truly is a “must have” category, but it is in the detail where we will make or lose our reputations. It seems that we must switch focus from macro-trends to the micro and to understand better what makes everything tick rather than the size of the clock. So, expect more springs, wheels and cogs to be presented in the autumn and winter months ahead.

Immune health is the focus of our recent Immunity hot topic report. With profiles of key brands across categories including antivirals, vitamins, foods & beverages and probiotics for immunity, our report explores the latest trends & developments, predicting likely future scenarios. To order your copy, or for further details, contact melissa.lee@NicholasHall.com.

CDC Report Shows Further Falls In US Life Expectancy

Life expectancy in USA has fallen for the second consecutive year, according to provisional data published by the US Centers for Disease Control & Prevention. For 2021, US life expectancy at birth was 76.1 years, the lowest since 1996 and down from 77.0 years in 2020. Male (73.2 years) and female (79.1) life expectancy also declined to levels not seen since 1996.

The almost one-year decline between 2020-21 was primarily owing to increases in mortality because of Covid-19 (50% of the negative contribution), unintentional injuries, heart disease, chronic liver disease & cirrhosis and suicide. This would have been greater were it not for the offsetting effects of decreases in mortality owing to influenza & pneumonia, chronic lower respiratory diseases, Alzheimer’s & Parkinson’s disease and perinatal conditions.

Nicholas Hall Writes: Does falling life expectancy matter? Yes, it matters a lot, to individuals and their friends and families; and to society, especially as some of the early deaths are among members of the economically-active population who financially support both the younger and older age groups. It also matters to our industry in that it continues to change the demographics, which may present new marketing opportunities.

As is his wont, tech billionaire Elon Musk has repeated his warning of a global underpopulation crisis, most recently tweeting that “population collapse due to low birth rates is a much bigger risk to civilisation than global warming”. Experts disagree. Demographer Joseph Chamie hit back: “He’s better off making cars … than at predicting the trajectory of the population. Yes, [in] some countries, their population is declining, but for the world, that’s just not the case.” This is backed by the UN’s World Population Prospects 2022 report, as we reported back when it was first published in July, which predicts that on 15th November 2022 the global population will reach 8bn and that it could grow to around 8.5bn in 2030 and 9.7bn in 2050, before peaking at around 10.4bn people during the 2080s.

Benchmark leading brands and track competitor activity across major and local players with CHC New Products Tracker. Featuring 36,000+ entries, this ultimate competitive intelligence tool allows you to create your own customised searches. Please contact david.redford@NicholasHall.com to set up a demo.

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.

CHPA Self-Care Leadership Summit

From Nicholas Hall’s Regional VP, North America, Liz Cummings

USA: “If there was ever any doubt, the world has learned what we knew all along – that consumer healthcare is absolutely essential to public health and that good healthcare starts with good self-care,” observed Consumer Healthcare Products Association President & CEO Scott Melville during his keynote at the CHPA annual Self-Care Leadership Summit last week.

Two areas of self-care – dietary supplements and diagnostics – were especially important to consumers during the pandemic, he noted, and CHPA’s membership expansion into those categories positions the association well to support the full scope of the industry in the future. One example is the data-driven Dietary Supplement Index (USA), which identifies supplements sales by region and provides a tool for the industry to educate healthcare providers and insurers to make the case for nutrition as essential to healthcare.  

During the meeting, the CHPA awarded its Ivan D Combe Lifetime Achievement Award to longtime industry leader – and former Chair – Gary Downing. Praised by many former employees at the event for his leadership, Downing has spent his career growing CHC companies, with a resume that includes sales and management at the Richards-Vicks Company. He later co-founded MedTech Labs, which eventually sold for a 400% rate of return, joined the Lansinoh Laboratories Board of Directors and became CEO of Insight Pharmaceuticals, then Clarion Brands, which was recently sold to Bridges Consumer Healthcare.

The audience also appreciated with standing ovations the 40-year CHPA career of Phyllis Taylor, Sr Director of Membership and Sponsorship, when her retirement was announced by Melville. We at the Nicholas Hall Group of Companies send her our very best wishes for a happy next chapter with her family.

The CHPA meeting will be reviewed in detail in the forthcoming March / April issue of CHC Insight North America. To review the latest trends and developments across the region, please contact melissa.lee@NicholasHall.com to find out more, or to receive a sample copy of a recent issue.

Two Rx-to-OTC allergy switches approved by FDA

In a clear sign of a more favourable attitude to Rx-to-OTC switch, the US FDA last week approved two new allergy products for non-prescription use.

Lastacaft alcaftadine ophthalmic 0.25% solution (Allergan / AbbVie) is now available without a prescription online and in retail stores for individuals aged 2+ years with ocular allergies. As demonstrated in clinical studies, one drop works in as little as three minutes to provide relief from itchy eyes for up to 16 hours. Following the recent FDA Rx-to-OTC switch approval, the original patented prescription-strength formulation of Lastacaft is available in a 5ml multidose bottle containing a 60-day supply, as well as a twin pack with two 5ml multidose bottles.

Perrigo also received final approval last week from the FDA for the OTC use of Nasonex 24HR Allergy (mometasone furoate monohydrate 50mcg). This marks the first branded Rx-to-OTC switch for the company, which expects to begin offering the nasal spray later this year. Nasonex is a registered trademark of Organon and is used by Perrigo and its affiliates under licence.

Nicholas Hall’s Touchpoints: This development will no doubt lead to an increase in switch activity after House and Senate committee members cited concerns that “very few products in recent years have switched from prescription drugs to nonprescription drugs” and pointed out that the FDA is expected to “meet the goals of the Fall 2021 Unified Agenda and publish and subsequently finalise the proposed rule titled Nonprescription Drug Product with an Additional Condition for Nonprescription Use.”

The appropriations committees are also: “Concerned about dietary supplement products that are adulterated or misbranded, in particular with imported products. The agreement provides an increase of US$2mn in the FDA’s budget [US$6.1bn in total] to be used for inspections, as well as enforcement of the Dietary Supplement Health & Education Act of 1994”. My sense is that in the biggest market for both switch and dietary supplements, we could see a correction in the prevailing trend from treatment to prevention.

Take a look at the latest CHC innovations in our forthcoming 2022 edition of Innovation in CHC from CHC New Products Tracker. This report offers a look at Rx-to-OTC switch activity, as well as innovation by region, marketer and 20 individual countries. To pre-order your copy and save up to £1,350 with the pre-publication discount, or for further information on this report, please contact melissa.lee@NicholasHall.com.