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.

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.

Combination OTC painkillers gaining ground

Following the approved switch of Voltaren Arthritis Pain by the FDA in mid-February, there was more positive news for GSK’s US analgesics portfolio over the weekend with the FDA approval of Advil Dual Action. This is the first FDA-approved OTC combination of ibuprofen and paracetamol (acetaminophen) in the USA, and GSK is expected to launch the product later this year.

Franck Riot, Head of R&D at GSK Consumer Healthcare, said: “For decades, many consumers have been using ibuprofen and acetaminophen (paracetamol) to get the benefits of both active ingredients when safely treating their headaches, muscle aches, backaches, arthritis and other joint pain. Now Advil, the No. 1 selling OTC pain reliever, will offer US consumers the first-ever alternative option – a single, fixed-dose combination pain reliever.” According to the reported clinical research, this fixed-dose combination achieves superior efficacy compared to the individual monocomponents of ibuprofen (250mg) and acetaminophen (500mg) alone.

Dolostop Plus, another recent combination launch

Another combination OTC painkiller we tracked recently, formulated with both ibuprofen and paracetamol, is Kern’s September 2019 launch of Dolostop Plus in Spain. Indicated to provide symptomatic relief from mild to moderate pain in adults, these film-coated tablets are formulated with paracetamol 500mg and ibuprofen 150mg, with a stated dose of 1-2 tablets every 6 hours, and claimed to be the first and only OTC paracetamol and ibuprofen combination available in Spain.

In several markets around the world, such as the UK, Russia, Japan and Indonesia, combination paracetamol + ibuprofen OTC remedies are already well-established, but these recent developments in the USA and Spain point to growing acceptance among global regulators about the safety of fixed-dose OTC analgesic combinations.

Where will NPD take the CHC market in the future? Find out in our upcoming report, Innovation in CHC: NPD & Innovation in CHC under the Spotlight! This report, drawing on Nicholas Hall’s CHC New Products Tracker, assesses the global picture of CHC innovation in 2019, featuring ingredient trends, delivery format trends, analysing innovation trends by region and by marketer, plus much more! To pre-order your copy and save with the pre-publication discount, or for more information, please contact melissa.lee@NicholasHall.com.

GSK and Alcon get FDA approval for US switches

Following on from our recent blog highlighting the need for a new wave of Rx-to-OTC switches to kickstart growth in the global consumer healthcare industry, this week we cover the welcome news that the FDA has approved three drugs for non-prescription use. As well as GSK’s topical analgesic gel Voltaren Arthritis Pain (diclofenac sodium 1%), two Alcon eye care allergy products (available as solution / drops) have also switched to OTC status – Pataday Twice Daily Relief (olopatadine 0.1%) and Pataday Once Daily Relief (olopatadine 0.2%).

Karen Mahoney, Acting Deputy Director of the Office of Nonprescription Drugs at the FDA’s Center for Drug Evaluation & Research, said: “Approval of a wider range of non-prescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription. This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”

Olopatadine is available OTC in a handful of other countries worldwide, but this is the first time it’s been switched in a major market. One of the countries where the ingredient can be purchased without a prescription is Singapore, which approved the Rx-to-OTC switch of olopatadine 0.1% and 0.2% in December 2016. More recently, Poland’s Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) approved the Rx-to-OTC switch of Polfa Warszawa’s Starelltec Alergia eye drops (olopatadine 1mg / ml; 5ml bottle) in July 2019 and Adamed’s Oftahist eye drops (olopatadine 1mg / ml; 5ml bottle) in November 2019.

Voltaren currently ranks fifth among the world’s leading consumer healthcare brands, according to CHC DASHBOARD, and this switch could see it move up the rankings and even move ahead of its new GSK stablemate Advil into the No.3 position globally within the next few years. While the US switch of Voltaren has long been mooted, the news is all the more welcome at a time when the world’s No.1 CHC market is in desperate need of an injection of growth, and US arthritis sufferers are also in need of a wider pool of OTC non-opioid treatment options.

For the full story, be sure to read tomorrow’s edition of CHC.NewDirections, a weekly e-newsletter sent out every Tuesday. CHC.NewDirections focuses on innovation, science and regulation, and coverage spans Rx-to-OTC switch, CBD, relevant medical research, probiotics, medical devices, digital health / AI, e-cigarettes and much more! For more information, or to arrange a free trial, please contact Melissa.Lee@NicholasHall.com

Ranitidine under regulatory spotlight

Two weeks ago, the FDA put out a statement saying it had learned that some ranitidine medicines were found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels, which it classifies as a probable human carcinogen. In response, the FDA is conducting an ongoing investigation, working with international regulators and industry partners to determine the source of this impurity. Though the FDA made clear it is not calling for individuals to stop taking ranitidine, its advice to people taking OTC ranitidine was to consider using other OTC medicines approved for their condition.

Last week, the FDA alerted healthcare professionals and patients to a voluntary recall of OTC ranitidine tablets (75mg and 150mg) labelled by Walgreens, Walmart and Rite-Aid, and manufactured by Apotex. Sandoz (Novartis) also said it would no longer be distributing generic versions of ranitidine. This was followed by an announcement over the weekend that US retailer CVS is pulling the No.1 ranitidine-based OTC brand, Zantac (Sanofi), from its shelves over the possible links to cancer. CVS’ own generic ranitidine-based OTC products will also not be carried in the stores moving forward.

Heartburn remedy Zantac is comfortably the No.1 ranitidine-based OTC brand, with global sales of around US$160mn (the vast majority of which are generated in North America). Chattem (Sanofi) markets Zantac in the USA in 75mg and 150mg OTC versions, while Aspen markets the brand in Australia and Perrigo is the UK marketer. In August 2018, Chattem extended its Zantac 150 line-up with two larger, value size 90-count SKUs, boosting sales significantly.

In a statement published in USA Today, Sanofi spokeswoman Ashleigh Koss said the company has no plans to halt shipments in the US market, adding: “The FDA reported that the levels of NDMA in ranitidine in preliminary tests barely exceed amounts found in common foods. We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards.”

Take an in-depth exploration of the Lower GIs market in Nicholas Hall’s Lower GIs: Trends & Opportunities in Laxatives, Antidiarrhoeals, Probiotics, Antispasmodics & IBS remedies report. This key title includes dedicated case studies, NPD, innovative line extensions, coverage of 10 major markets, sales data and forecasts, plus much more! To find out more or to order your copy today, please contact melissa.lee@NicholasHall.com.

E-cigarettes under the spotlight in USA

A few months ago, Nicholas Hall applauded the decision by US District Judge Paul Grimm (Maryland) to set a 10-month deadline (to 12th May 2020) for e-cigarette manufacturers to apply to the FDA and submit their products for public health review if they want to keep them on the market. The judge also imposed a one-year deadline for approval, as suggested by the FDA. Nicholas Hall said “there’s a chance that e-cigarettes will be regulated as drug products with all the opportunities and problems that brings” and predicted that “vaping could be a US$5bn OTC-registered industry by 2025, but at the moment that looks very unlikely.”

Since then, concerns in the USA about the safety of e-cigarettes have been growing. The Centers for Disease Control (CDC) recently indicated that, as of 6th September 2019, over 450 possible cases of lung illness associated with the use of e-cigarettes have been reported to CDC from 33 states and 1 US territory, while five deaths have been confirmed in California, Illinois, Indiana, Minnesota and Oregon.

Map of reported US lung illness cases linked to e-cigarettes. Source: Office on Smoking & Health, National Center for Chronic Disease Prevention & Health Promotion

Meanwhile, the Federal Trade Commission is investigating Juul’s marketing practices and whether the company targeted minors, according to the WSJ. US House Energy & Commerce Chairman Frank Pallone recently wrote to Juul, which is 35% owned by tobacco group Altria, and the three other dominant players of the US e-cigarette market — Fontem Ventures, Japan Tobacco International and Reynolds American — requesting more information about their research into the public health impact of their products, their marketing practices and their role in e-cigarette use by adolescents. 

E-cigarettes are also under the regulatory spotlight at the US state level, with Michigan the first US state to ban flavoured nicotine vaping products. After Chief Medical Executive Dr Joneigh Khaldun found that youth vaping constitutes a public health emergency, Governor Gretchen Whitmer ordered the Michigan Department of Health & Human Services to issue emergency rules to ban the sale of flavoured nicotine vaping products in retail stores and online, and ban misleading marketing of vaping products, including use of terms like “clean”, “safe” and “healthy”. She also ordered the Michigan Department of Transportation to enforce an existing statute to prohibit advertising of vapour products on billboards.

American Heart Association CEO, Nancy Brown, commented: “Governor Whitmer has taken bold and appropriate action in response to the epidemic of youth e-cigarette use. In the absence of robust regulation by the FDA, we know shockingly little about the health impact of e-cigarettes being widely marketed to youth and adults. The recent outbreak of respiratory illnesses associated with e-cigarette use has only added to the uncertainty and increased the need for immediate action … We urge the FDA to move urgently to protect public health and exercise strict oversight over all e-cigarette products.”

Only two months to go until our OTC.NewDirections Executive Conference, taking place in London on 14 November 2019! Nicholas Hall will be joined by experts from companies including Bayer, Mundipharma and J&J to review key issues impacting our industry, including the status of Medical Cannabis in Europe, Embracing Tech, Growing Brands through Innovation alongside exploring the ultimate theme of ensuring that you are Keeping Consumers in the Spotlight. Save GB£100 when you book your seat before 13 September! To find out more, or to reserve your place, please contact jennifer.odonnell@NicholasHall.com without delay!

Gottlieb calls for action on “CBD craze”

In an opinion piece for the Washington Post entitled, “The CBD craze is getting out of hand. The FDA needs to act“, former FDA commissioner Scott Gottlieb described many of cannabidiol’s purported benefits, from cancer to depression treatment, as “fanciful” and said the FDA must act now to ensure “commercial interests don’t strip away any legitimate value the compound might have.”

Pointing to the potential risks of CBD use (i.e. damage to the liver at high doses), and the misperception that the 2018 US farm bill “legalised” CBD, Gottlieb suggests the best way forward is a legal pathway based on an “efficient regulatory process and sound science”. Recently, the FDA sent a warning letter to Curaleaf about “unsubstantiated” claims on its website and social media accounts linking CBD with cancer, Alzheimer’s, etc.

In response to Gottlieb’s opinion piece, Steve Mister, President & CEO of the Council for Responsible Nutrition (CRN), said his organisation aligned with the FDA on the need to establish a “clear and legal pathway forward”, but said that CBD’s status as a dietary supplement does not necessitate legislation, nor a “multiyear process requiring FDA to gather safety data on CBD”.

In an article for Whole Foods Magazine, Mister is quoted as saying that the “FDA has the authority to make cannabidiol a supplement under DSHEA [The Dietary Supplement Health and Education Act of 1994], even though it’s already been studied as a drug.” Mister envisages a future in which CBD can be sold as both a drug and a supplement, and that is certainly how Nicholas Hall also sees the market evolving in his newly published New Paradigms report.

CBD is one of the topics in our new report, Nicholas Hall’s New Paradigms for CHC 2019: Over the Horizon, personally written by Nicholas himself! Focusing on a wide range of major issues surrounding the CHC Market, including Innovation, Distribution, Digital Engagement, Competition and much more, this is an essential read for all players striving to compete in this evolving marketplace. In addition to this, you can upgrade your purchase to include a customised in-house presentation or webinar with Nicholas. To find out more or to place your order, please contact melissa.lee@NicholasHall.com.

OTC Innovation Report 2018

Lamenting the fact that Scott Gottlieb is stepping down as FDA Commissioner, Nicholas Hall commented in Friday’s OTC.Newsflash that: “Although producing few tangible results so far, FDA under Gottlieb has displayed a greater openness to finding new switch models at a lower cost and with shorter lead times, including the use of new technologies.” Nicholas Hall also said that “government support is vital to our industry” and that “more liberal regulations are at the heart of a successful self-care sector”.

A drop-off in switch activity over the past year is part of the explanation for lower levels of high-quality OTC innovation. In 2018, OTC New Products Tracker awarded just six products with 4 stars – eye care brands Lumify (USA) and Zabak Eye Drops (Poland), antacid Reza Band (USA) and antispasmodic Scopolan Compositum (Poland), plus Viagra Connect (UK) and allergy remedy Talerc (Brazil). Compared to previous years, this marked a falling-off in terms of 4-star innovations.

The number of total OTC innovations (3,747) in 2018 was roughly in line with the previous year, and still much higher compared to 2014, 2015 and 2016. However, the number of 2* (528), 3* (94) and 4* (6) innovations was much lower, while the number of 1* innovations (3,119) was at an all-time high.

VMS continues to be a major source of innovation, with three of the Top 5 subcategories in 2018 – probiotics, multivitamins and hair & beauty supplements. Derma is another key source of innovation, with three of the Top 10 – acne remedies, eczema & psoriasis and lip care. The three other innovative subcategories which complete the Top 10 are sedatives & sleep aids, topical analgesics and sore throat.

Please contact us for the full report. You can also review 17,000+ new launches and innovations with OTC New Products Tracker, the ultimate competitive intelligence tool! Products are given a star rating, with “me too” items ranked 1*; launches / line extensions in a new category / adjacency 2*; major launches / line extensions with strong new benefits / positioning 3*, and 1st Rx-to-OTC switches in a category, creation of a new OTC class or other major leaps in innovation 4*. With a recently-released major update including eye-catching new graphics and powerful search filters that help you visualise and explore the vast archive according to your exact requirements, now is the ideal time to set up your free trial. For a demo or more information, contact waisan.lee-gabell@NicholasHall.com.

Further FDA delays to NSURE guidance on Rx-to-OTC switch

One of the key topics at our North American OTC Conference to be held in Morristown, New Jersey this week (20-21 June) is Rx-to-OTC switch, and opportunities for marketers in the dynamic US regulatory climate. Hopes that the FDA would publish guidance this year on the Nonprescription Safe Use Regulatory Expansion (NSURE) were recently dashed after the Notice of Proposed Rulemaking date was changed to February 2019.

NSURE was introduced in 2012 to encourage utilisation of technology to “ensure” the safe use and self-selection of innovative Rx-to-OTC switches, but the programme has been stalled for several years.

At the Consumer Healthcare Product Association’s recent Regulatory, Science & Quality meeting, FDA Deputy Director for Regulatory Programs, Dr Doug Throckmorton, assured attendees that the 5-year delay had “nothing to do with our interest and support”, but was a result of administrative priorities. He encouraged sponsors to bring ideas to the FDA. This request has been voiced for several years, but manufacturers appear to be waiting for the draft guidance.

For those that can’t make this week’s meeting, Nicholas Hall’s Opening Address will be live-streamed here at 8.30-9.10 on Wednesday 20 June.

Following this, you can also view these live presentations:

Dave Wendland, Hamacher Resource Group, will be presenting on Independent Pharmacy Opportunity: Myth or Reality? on Wednesday 20 June 09:40-10:10 here 

Join the CHC Institute Launch with Steve Sowerby and Ed Rowland on Wednesday 20 June 14:15-15:15 here 

See Joseph McGovern, Everything Health, review the Key Issues of Switch on Thursday 21 June 09:00-09:30 here 

Plus, join Everything Health’s Mary Alice Lawless & Joseph McGovern to review how you can Change the Words to Change the World in the move from OTC to Non-Prescription, followed by Nicholas Hall’s Summary & Close of the meeting on Thursday 21 June 12:40-13:30 here 

All timings EST. To ensure you enjoy the event in full (download the brochure here), including panel sessions and networking opportunities, reserve your place now by contacting lianne.hill@NicholasHall.com