Gottlieb calls for action on “CBD craze”

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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.

Avon enters VMS category

As this week’s OTC DASHBOARD infographic shows, the percentage of Americans that consume dietary supplements continues to grow, hitting an all-time high of 76% in 2017. This has helped create a vast US vitamins, minerals & supplements category, which in turn continues to attract the interest of companies not traditionally associated with the OTC market. For example, Amazon launched several supplements as part of its Amazon Elements line in spring 2017, including vitamin D, turmeric and calcium products, all of which have a strong emphasis on ingredient traceability.

Another new entrant in 2018 is Avon, a company that is undergoing a rapid transformation to become the “leading social selling company in North America”, according to CEO Scott White. Part of the company’s strategy is a return to the health & wellness market, including the launch of a new Espira line of 11 dietary supplements.

Launched in January 2018, and available at a retail price of US$12-35 through Avon Representatives or http://www.avon.com, Espira for Avon is categorised into three principles of wellness:

  • Restore contains 2 sedatives & sleep aids and 2 multivitamins, with ingredients that help to reduce occasional stress and enhance restful sleep, including Sensoril, L-theanine, vitamin B, magnesium, fish oil + antioxidants from fruits & vegetables
  • Boost is subdivided into Metabolism Boost and Natural Energy products, with ingredients such as protein, probiotic, fibre, green tea, cacao + whole coffee fruit to help maintain a healthy metabolism, clear out the system and control hunger
  • Glow contains 3 health & beauty supplements formulated with antioxidants, biotin, vitamin C + collagen peptides to help hair, skin and nails look their best by protecting from daily damage and restoring cells while you sleep

As with the Amazon Elements range, Avon’s new products will be sold via the e-commerce channel, while the company will also be looking to steal share from multilevel and direct marketers such as Herbalife and Amway.

New advice says eat 10 fruit & veg per day

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A study by Imperial College London has suggested we should eat 10 portions of fruit & vegetables a day. The study said that such eating habits could prevent 7.8 million premature deaths each year. The study also identified particular fruit & vegetables that reduced the risk of cancer and heart disease.

A portion counts as 80g (3oz) of fruit or vegetables, which is equal to a small banana, a pear, or three heaped tablespoons of spinach or peas. The findings were based on pooled data on 95 separate studies, involving the eating habits of two million people.

Lower risk of cancer was linked to eating green vegetables such as spinach and kale, yellow vegetables and cauliflower. Lower risk of heart disease and strokes was linked to eating apples, pears, citrus fruits and leafy greens.

The results, published in the International Journal of Epidemiology, also assessed the risk of dying before your time. Compared with eating no fruit or veg a day, it showed:

  • 200g cut the risk of cardiovascular disease by 13% while 800g cut the risk by 28%
  • 200g cut the risk of cancer by 4%, while 800g cut the risk by 13%
  • 200g cut the risk of a premature death by 15%, while 800g cut the risk by 31%

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The researchers do not know if eating even more fruit & vegetables than the newly suggested 10 portions would have even greater health benefits, as there is little evidence out there to review.

Dr Dagfinn Aune, one of the researchers, said: “Fruit & vegetables have been shown to reduce cholesterol levels, blood pressure and to boost the health of our blood vessels and immune system.” He continued: “This may be due to the complex network of nutrients they hold, including many antioxidants, which may reduce DNA damage and lead to a reduction in cancer risk.”

However the study also said that the benefits of this would be hard to integrate as many people struggle to even eat the five a day (400g) which is recommended by the World Health Organization. In the UK, only about one in three people eat this recommended portion, showing the huge potential for VMS marketers in terms of targeting their supplements at people that don’t eat their 10 fruit & veg a day.

Natural products tipping into mainstream

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A lollapalooza of healthy food, home care, beauty and health & wellness brands were promoted by 2,000 exhibitors at last week’s Natural Products Expo East, held in Baltimore, MD.

But which products are most relevant to mainstream consumers? Eric Pierce, Director, Strategy & Insights, New Hope Network, presented data from the NEXT Trend Concept Lab that used data to predict which natural product innovations are tipping into the mainstream consumer channel:

  • “Mission-based” brands
  • Pre/probiotics
  • Local sourcing
  • Paleo
  • “Hidden veggies”
  • Brain health
  • Compostable packaging
  • Grass-fed dairy

The partnership between Vitamin Angels, which supplies vitamins to undernourished people worldwide, and Walgreens, which donates vitamins based on consumer brand selection, is a great example of the tip towards “mission-based” brands. Walgreens is also donating immunisation to underserved communities when people get their flu shots in the pharmacy. Another trend that has tipped is probiotics, already a mainstream OTC category, and every week more scientific proof of their benefits is published.

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But what about “hidden veggies” for parents trying to appease picky eaters? Can mainstream OTCs provide the nutritional benefits of greens? There were many drinks, sachets and capsules offering several servings of vegetables at the show.

Brain health has proven a challenging claim, in terms of demonstrable and clinical efficacy. Which consumer healthcare player (or start-up) will meet the brain claim challenge?

Compostable packaging may be the gold standard, but without a doubt mainstream marketers can adopt more eco-friendly attire for their brands. This will increasingly appeal to all consumers.

Local sourcing, grass-fed dairy and Paleo (based on the diet regimen) are of course trends in food, but the “clean” philosophy that underpins these trends is being adopted by consumers in all lifestyle segments, including supplements.

These trends are tipping to the mainstream now … will your brand meet consumer demand for healthy and sustainable healthcare products?

Military Potential of Omega-3

A new study will determine if omega-3 supplementation can improve cognitive processes in high-performing soldiers.

Military interest in omega-3 is not new; a 2014 edition of Military Medicine focused on the fatty acids as “nutritional armour”. The interest surrounding military use of omega-3 is mainly related to its reported indication of mood improvement, and possibly reducing suicide rates among serving and ex-military personnel. It is also believed that a faster recovery from traumatic brain injury and the improved reaction times of fighter pilots could also be other benefits found from consistent omega-3 use.

Furthering ongoing studies, a new study is set to officially determine whether omega-3 supplementation can improve cognitive processes in high-performing soldiers. The Ranger Resilience and improved performance on Phospholipid bound Omega-3s (RRIPP-3) study will be conducted by the medical University of South Carolina (MUSC), and will include second lieutenants entering the Infantry Basic Officer Leaders Course (IBOLC) and subsequent Ranger Training at Fort Benning.

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The purpose of the study is to investigate whether supplementation with krill oil concentrate can improve specific cognitive processes that underpin key elements of soldier performance, which may have a measurable impact on performance and mental health under psychophysiological stress of military officer training.

This will be an extension of a study recently published in the Journal of Affective Disorders which outlined that omega-3 could potentially help sufferers of post-traumatic stress disorder (PTSD), which is known to produce psychophysiological symptoms such as a pounding heart.

The study will overall seek to answer three questions:

  • Will treatment with krill oil concentrate containing the omega-3 HUFAs improve cognitive and psychiatric functioning during US Army Infantry Basic Office Leadership Course?
  • Will treatment with krill oil concentrate containing the omega-3 HUFAs improve the performance of officers during portions of the U.S Army Infantry Basic Office Leadership Course and Ranger Training?
  • Do the effects of the supplements continue once a person stops taking them? Are there any group differences in functioning observed two months after treatment is discontinued (i.e. after Ranger Training?)

OTCs In Action: New “It” Water Core Making Waves

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This week OTCs are in action in the US where the new “it” fortified bottled water Core (Core Hydration) is said to be an ultra purified H20. Core is enhanced with minerals and electrolytes to achieve the body’s “perfect pH” of 7.4.

Boasting the slogan, “be true to your core”, the celebrity praised water promises to help the body effectively assimilate the vitamins, minerals and food supplements we need to survive.
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Countless brands selling superior, health-endorsing water have emerged in the beverage market and are growing rapidly. It seems that “good old” water, as simple and unfussy as it once was, has a lot more nuance to it these days.

Higher pH, coconut and charcoal are few of the elements involved in modern H20 consumption; there are now cafés across the globe with water-tasting menus and, wait for it, water sommeliers!

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Of course, when it comes to health, water is vital and if you’re drinking it consistently, you’re already doing something good for your health. So what exactly are the benefits of drinking alkaline water? Tap water contains different dissolved elements that influence its pH level, so the idea is that to create a more alkaline balance in your body, you should drink water with a higher pH.

However, much of the research on alkaline diets shows that consuming water according to pH levels only changes the pH of urine, not of the body’s blood. Alison Childress, a programme director and instructor of nutritional sciences at Texas Tech University says, “We can’t really change the pH of our body”.

However, it’s argued that physically active people benefit from drinking alkaline water. Intense exercise provokes muscles to produce more hydrogen ions increasing acidity and causing fatigue. It has been proven that drinking alkaline water enhances the body’s buffering capacity, tempering acidity and ultimately improving performance.

So will alkaline water ever truly be considered an OTC supplement that contributes to our physical wellbeing? I guess we will have to hit the markets with our tastevins at the ready and decide for ourselves!

OTCs in Action Episode 57: IBgard, consumer healthcare trailblazer

The woman stands at her workstation, cringing and holding her stomach while the voiceover gently suggests: “Abdominal pain. Bloating. You may have IBS. Ask your doctor if the nonprescription IBgard is right for you. IBgard – calms the angry gut. Available at CVS and Walgreens.”

This week, IBgard is our OTC in Action as its blazes a new trail for self-medication. The February issue of the prominent medical journal, Digestive Diseases and Sciences, features a randomised, double-blind, placebo-controlled study which demonstrated that IBgard provides reduction in symptoms including abdominal discomfort, bloating, diarrhoea, constipation and gas.

It’s amazing that these stellar claims are not made by an Rx drug or an OTC – IBgard is a medical food that should be used under the supervision of a doctor, and does not require FDA pre-authorisation or a New Drug Application. Interestingly, its capsule formulation of peppermint oil could also be a dietary supplement, but would not be able to make disease-related claims. IM HealthScience also protected its investment by using patented Site Specific Technology in its clinically-tested peppermint oil mixture, preventing other peppermint oils from making the same claims.

OTC marketers have been endlessly searching for innovative products without dangerous side-effects; the dietary supplement folks have been craving claims substantiation and patented formulations. Oh, and by the way, over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard for their patients, according to IM HealthScience.

Last week, the company launched an independent spin-off called Physician’s Seal to focus on the development and commercialisation of novel and science-based dietary supplements and over-the-counter (OTC) drugs. Its non-executive Chairman is OTC veteran Fred Hassan, who stated: “We are proud to expand our family of businesses to a wider market using our exceptional science base and our broad intellectual property portfolio. We also will be leveraging the success of our initial medical foods product, IBgard, specially formulated for the dietary management of Irritable Bowel Syndrome.”