According to the 2017 CRN Consumer Survey on Dietary Supplements, fully 79% of women are supplement users-six points ahead of the men’s team, of whom only 73% profess regular supplement use.

That stat alone should be enough to turn supplement brands’ attention toward this powerful audience. Women are often the custodians of family health, and there are evolving opportunities for reaching female shoppers with a spate of new ingredients, delivery systems, and supplement products.

The numbers are pretty convincing, too. According to SPINS (Chicago), female-positioned supplements grew at a rate of 6%, netting a total of $628.1 million in U.S. sales in the 52 weeks ending July 15, 2018. Meanwhile, though supplements targeting men saw 9% growth, they still attained a market share barely more than half that of women’s at $364.3 million.

But most of all, says Kimberly Kawa, retail reporting analyst for SPINS, “Reviewing some products added to our reporting in the past year, it seems that some of the standout supplements belong to female-centric sets.” So if brands want to stand out from the crowd themselves, they’d be wise to put women’s formulas to work.

 women buy more supplements than men? “Yes, for the most part,” says Keena Roberts, senior consumer health analyst, Euromonitor International (Chicago).

“Women tend to be more proactive about preventive health and more likely to incorporate supplements into an established health and wellness regimen,” she notes. “There’s also some evidence to suggest that women more readily incorporate supplements into their daily routines when they’re addressing premenstrual symptoms, and this makes it easier to incorporate other supplements at the same time because they’re just more accustomed to their use.”

And as with their interest in supplements for premenstrual relief, women’s pursuit of supplements across the board is frequently motivated not just by a general desire to be healthy, but by a desire to address specific health issues, as well.

Indeed, says Roberts, “The most popular supplements are positioned around need states. We see the whole vitamin and dietary supplement industry shifting toward products directed at terms like 

Michael Chernyak, president of CK Nutraceuticals (Oakville, ON, Canada), a supplier of many ingredients to support women’s health, says, “Today’s female consumer is interested in many areas encompassing health and wellness. It very much depends on a women’s specific life stage. Generally speaking, health concerns can revolve around osteoarthritis and osteoporosis, cognition, energy, menopause, digestion, cardiometabolic health, and more. One area where we’ve focused a great deal of our recent effort is mood balance. Lifestyles are very hectic in today’s society, and myriad daily demands are imposed on today’s female consumer. Mood support is an area of particular interest for us, as we see healthy mood being a key foundation for optimal wellness and healthy aging.”

Euromonitor’s Roberts has observed growth in immune-boosting formulas that include vitamins C, B6, B12, and E, plus zinc, calcium, magnesium, and iron-“all of which are ingredients that women in particular know they need,” she says. B vitamins overall appear on an upward trajectory with women, Roberts adds, “because of the perception that they combat fatigue and increase energy.”

Like Chernyak, Kawa points to sales of supplements for cognitive health and mood support-up 93% and 50% in the U.S., respectively, among women-as addressing an “emerging health focus in the female gender set.” And while such supplements capture a smaller market share than some other formulas, they “do report positive growth rates in the double digits,” Kawa says.

So, too, do supplements aimed at digestive health, which, among female customers specifically, brought in $46.7 million in U.S. total sales at a growth rate of 22%, Kawa says. “That’s a lot of growth, and mirrors broader interest in digestive health.” And whenever discussing winners in the women’s supplement space, products for urinary tract health will come up, which, Kawa says, are “perennially popular with women.” To wit, such supplements garnered $22.6 million in U.S. sales among women over SPINS’s 52-week reporting period, representing growth of 5%.

But not all lines lead upward with women’s supplements. Perhaps surprisingly, SPINS numbers show that though they make up a $38.3 million U.S. market, bone health supplements saw sales to women fall 7%. Sales of energy-support supplements to women were also down 8% for a total U.S. market share of $30.1 million. But the steepest drop of all was for weight-loss products among women, which SPINS data show brought in a trim $8.9 million while seeing their sales totals cut in half.

Regardless of the supplement category they choose, female consumers “want to feel as if they’re taking a product that can help them with a specific prevention plan that works with their overall health and wellness-rather than just ‘taking a vitamin,’” Roberts says.

And yet, SPINS found that good old-fashioned multivitamins topped the list of delivery formats in terms of total U.S. sales, with multivitamins for women earning $395.7 million and seeing 6% growth.

Market data from IRI (Chicago) also found that traditional pills-specifically, tablets and capsules-remain the dominant form in the women’s category, holding onto a 65% share. But liquid and softgels as well as gummies account for a respective 25% and 3% of supplements available, IRI says, and though pills and liquid/softgel products saw dollar gains during the 52 weeks ending August 12, 2018, gummies declined.

Nevertheless, Roberts remains bullish on gummies “because of their ease of use and better absorption potential.” Similarly, supplement powders also show potential “since sachets are light and portable and easily incorporated into the shakes and other drinks women already take,” Roberts says.

Finally, developments in personalized nutrition promise to shape the women’s supplement space. “Consumers are wary of side effects and reluctant to take anything they don’t believe they need,” Roberts says. Consequently, “There’s a lot of interest in this industry about genetic mapping and how increased knowledge of human genetics can help consumers identify their own specific needs, and whether future innovation in this space can help companies develop personalized supplement regimens for individuals based on their genetics.”

While we’ve got a long way to go before such advances start trickling down to supplement shelves, there’s plenty of innovation in the women’s category for us to celebrate now. Ahead are just a handful of female-friendly supplements to keep your eyes on.

According to SPINS, prenatal health is the most popular focus in the women’s supplement category, with total sales of $139.4 million and 4% growth.

As an example, Kawa points to Traditional Medicinals’ line of lozenges and chews, which target pre- and postnatal women with ingredients like raspberry leaf, ginger, fennel, anise, coriander, and fenugreek-galactogogues that promote breastmilk production. “These may be popular for women interested in the convenience of a chew or lozenge from a well-established company in the herbal-botanical space,” she notes.

Rainbow Light also promotes its Vibrance line of products as supporting women from preconception through each trimester and even to the postnatal phase. Key ingredients include active forms of the important vitamins B12 (methylcobalamin) and folate (methyltetrahydrofolate), as well as supportive botanicals for immunity, digestion, nausea, and other pregnancy-related issues, Kawa says.

Among multivitamins for women, those targeting an older demographic brought in $70.1 million in the U.S. for the year ending July 15, 2018, up 10%, per SPINS.

“Natural Factors has a line specific to women with an array of focuses,” Kawa notes, “and their Multi Factors Women’s 50+ Vitamin & Mineral Formula contains botanicals, enzymes, and whole-food antioxidants as well as highly bioavailable forms of vitamins and minerals. The supplement also highlights the delivery method: easy-to-swallow vegetarian capsules.”

Kawa calls Rainbow Light’s Teen Girl’s Multivitamin plus Healthy Skin Support product “a top pick” among the female-friendly supplement set that SPINS tracked.

Ginger root extract, spirulina, bioflavonoids, carrot root, and chlorophyll are ingredients that purportedly promote clear and healthy skin. The formula’s iron and bioavailable B vitamins help teen girls maintain energy levels, ease stress, and keep their moods steady. And for improved digestion and gut health, 100 million CFU of probiotics plus prebiotics and plant-sourced digestive enzymes do their best to ease those butterflies that anyone who’s ever been a teen girl will remember.

Anecdotally, women tend to be more conscientious about eating right-choosing plenty of fruits, vegetables, whole grains, and lean sources of dairy and protein. But frustrating even their best-laid efforts is what’s known as the “enzyme gap”-that is, the difference between what a woman eats and what her body’s complement of enzymes can actually help her body digest and absorb.

Apparently, this gap widens as women age, and can lead to a litany of complaints ranging from digestive trouble, fatigue, and a weakened immune system to skin problems, mood swings, joint pain, and more.

So Phoenix-based gastroenterologist Liz Cruz, MD, created Everyday Enzymes, an organic, “all-natural” formulation of amylase, protease, lipase, cellulase, invertase, diastase, lactase, 

Lactobacillus acidophilus, Bifidobacterium longum,

 and cellulose, designed to aid digestion and absorption of all those healthful nutrients that women work so hard to eat.

In December of 2017, biotech firm Biosearch SA signed a license and supply agreement with Nestec SA, a division of the NestlÃ© group, to market the former’s probiotic strain 

Nestec aims to include the Hereditum strain in a supplement designed to help breastfeeding women maintain healthy lactation-which makes sense, given that Biosearch chose this particular probiotic strain from among the hundreds that occur naturally in breastmilk.

In fact, clinical trials have demonstrated the Hereditum strain’s ability not only to eliminate the painful symptoms of mastitis-an inflammation of breast tissue-but to allow women to continue breastfeeding, and to continue reaping its benefits for their and their babies’ health.

Women’s search for products that provide premenstrual relief may never end. But it may have gotten closer to the finish line earlier in 2018 when results of a clinical study

 showed that Lipogen PMS, a natural phospholipid supplement formulation, exhibits positive effects on treating and relieving premenstrual syndrome (PMS) symptoms.

The randomized, double-blind, placebo-controlled trial involved 40 women aged 18 to 45 with physician-diagnosed PMS. After observing the subjects during an initial baseline menstrual cycle, the researchers administered to the subjects either a daily dose of the supplement complex (400 mg phosphatidylserine and 400 mg phosphatidic acid) or a placebo for the following three menstrual cycles.

Results showed that subjects in the Lipogen PMS treatment group saw an ongoing decline in their PMS symptoms, while the placebo group returned to initial PMS-symptom levels.

Schmidt K et al. “A lecithin phosphatidylserine and phosphatidic acid complex (PAS) reduces symptoms of the premenstrual syndrome (PMS): Results of a randomized, placebo-controlled, double-blind clinical trial.” 

Articles

According to SPINS, female-positioned supplements grew at a rate of 6%, netting a total of $628 million in U.S. sales in the 52 weeks ending July 15, 2018.

Female shoppers remain a powerful audience for dietary supplements. But how can manufacturers reach them?

In 1929, a Danish biochemist by the name of Henrik Dam was studying cholesterol metabolism in chicks when he noticed an unusual incidence of anemia, hemorrhage, and delayed blood clotting among birds fed a fat-deprived diet. He later identified the syndrome’s cause as a deficiency in the fat-soluble vitamin that we now call vitamin K1, after the German 

Dam, along with the American biochemist Edward A. Doisy, received the 1943 Nobel Prize in Medicine for their efforts. Two years later, however, the dentist and nutritional gadfly Weston A. Price received no such nod when he described “a new vitamin-like activator” apparently able to ameliorate everything from tooth decay to heart disease-a compound we now know to be vitamin K2.

And though nobody’s arguing that Price deserved a Nobel for bringing attention to this elusive “Activator X,” as he called it, he at least deserves some kudos. Because vitamin K2, independent of vitamin K1, is an essential factor in an equation linking it, calcium, and vitamin D3 not only to healthy teeth, but to healthy bones and vessels, as well. And though the public has yet fully to appreciate vitamin K2, advocates are working overtime to change that. Our health may depend on it.

When Dam and Doisy first characterized vitamin K1, they had no idea that the substance they were exploring wasn’t a single vitamin, but rather a member of a vitamin family. That family includes both vitamin K1-or phylloquinone, as it’s formally known-and a group of 10 homologous menaquinone compounds collectively known as vitamin K2.

“It’s been more than 30 years that the research community has been investigating and recognizing differences between vitamins K1 and K2,” says Chris Speed, senior vice president, global sales and marketing, NattoPharma ASA (Oslo, Norway). And among the things they’ve learned is that both K1 phylloquinone and the K2 menaquinones share the structural similarity of a quinone ring.

Where their structures differ is in the side chains attached to it. On K2 menaquinones, those side chains comprise a series of linked isoprene units, with the shortest chain-four units-appearing on menaquinone 4, or MK-4, and the longest, at 13 isoprene units, appearing on MK-13.

Among commercial forms of the vitamin K2 menaquinones, MK-4 and MK-7 are the most common. But thanks to the nature of its side chain, MK-7 has a longer half-life in the body-three-plus days compared to just a few hours for MK-4-granting MK-7 greater access to tissues beyond the liver, Speed says. “So although they have the same molecular mechanism of action, vitamin K2 as MK-7 is more bioavailable than MK-4. And because of MK-4’s short half-life and poor bioavailability, it requires multiple doses per day at milligram levels versus MK-7’s microgram doses for measurable efficacy.”

Just what is this molecular mechanism of action? In short, all K vitamins are cofactors for the enzyme gamma-glutamyl carboxylase, which carboxylates-and thus activates-a number of K-dependent proteins. Two of these proteins are osteocalcin, produced in the osteoblasts and essential to depositing calcium in bone, and matrix-Gla protein (MGP), which inhibits calcium deposition in soft tissues.

Vitamin K2, and the MK-7 particularly, kicks these proteins into action. In so doing, says Jim Beakey, communications lead, Kappa Bioscience AS (Oslo, Norway), the vitamin forges its link with calcium and vitamin D3.

“Everybody knows that calcium is important for bones,” Beakey explains. “And people are starting to understand that vitamin D3 is also important for bones by pulling calcium from the intestines and into the blood, where it can go to work for bone building.” But “the missing leg of the stool,” as he calls it, is vitamin K2.

Why? Because carboxylated-that is, K2-activated-osteocalcin is necessary both for shuttling calcium into the bone matrix and for binding it there. “So for proper bone health you need calcium, vitamin D3, and vitamin K2,” Beakey concludes. “Vitamin K2’s primary role, and what it does best, is balancing or regulating calcium transport in the body.”

And the bones aren’t the only site where it does this.

Researchers have long observed a correlation between bone disease and heart disease. And one possible explanation involves vitamin K2. Consider that vitamin K2, primarily as MK-7, helps osteocalcin shunt calcium out of the blood and into the bones. But, as Beakey notes, “any additional calcium in the blood can be absorbed by the soft tissues”-arteries and blood vessels included.

When this happens, arteries and vessels harden. “They absorb the calcium and stiffen even in the absence of any sort of plaques,” he says. “But when plaques build up, they can lead to even further stiffening and reduce the diameter of the vessels. Both these forms of calcification lead to heart attacks and strokes.”

Where does vitamin K2 come in? It carboxylates, and thus activates, MGP, the vitamin K–dependent protein that binds circulating calcium and prevents it from laying down in the vessels. Both Beakey and Speed point to the Rotterdam

 as convincingly demonstrating vitamin K2’s cardio-supportive effects. And, Beakey adds, “There’s another great study

 from Knapen”-conducted on NattoPharma’s MenaQ7 natural vitamin K2 MK-7-“showing that arterial stiffening can even be reversed-people can actually return to a previous state of health, which, in terms of longevity, healthy aging and wellness, is a fantastic finding.”

So by helping to activate osteocalcin and MGP, vitamin K2-again, MK-7 especially-keeps calcium in the bones, where we want it, and out of the vessels, where we don’t. The upshot: We should want plenty of vitamin K2 in our diets. But try though we might, it’s tough to harvest sufficient amounts from the foods most of us regularly eat.

Vitamin K2 is a product of bacterial fermentation, and the single best food source is natto, a Japanese fermented-soybean dish that one might politely describe as an “acquired taste.” Beyond that, certain fermented cheeses, dairy products, liver pate, meat, eggs, and fish also contain vitamin K2. “But for the most part,” Beakey notes, “the K2 is in the less-efficient MK forms and not the high-bioavailability MK-7. So you’d have to eat kilos of cheese and gallons of milk every day just to meet the daily requirement.”

 even examined the vitamin K2 content of cheeses and found that despite their being the best sources of long-chain menaquinones in the Western diet, they vary widely in that content-from 3 to 802 ng/g. Given the researchers’ recommendation to consume 180 to 360 µg of vitamin K2 per day, they conclude, “[Y]ou need to eat at least 225/445 g of French cheese a day (MÃ¼nster) and at least two times more in case of cheese from Scandinavia” to get your K2 fill.

So how did humans evolve to need a vitamin that’s so challenging to obtain from food? “This is the big conundrum,” Beakey opines. And as a potential explanation, he points to a theory posited by the naturopath and author Kate RhÃ©aume-Bleue-namely, that industrial changes in food preparation and storage precipitated the current vitamin K2 deficiency.

To wit, refrigeration and chemical preservation made natural food fermentation-vitamin K2’s key generator-both less necessary and less common. The prevalence of grain-fed over grass-fed beef might also play a part. “When livestock is grazed on grasses,” Beakey explains, “their stomachs have a chance to ferment the grasses, which leads to higher levels of MK in the dairy products and meat of those animals. So maybe we used to get enough K2 from our diets, but changes in our environment and our relationship with food are creating a deficiency.”

That deficiency is widespread, with some studies showing 97% of the Western population deficient in vitamin K2, based upon food-intake surveys and evaluations of subjects’ circulating levels of activated osteocalcin and MGP. Given vitamin K2’s links to bone health, and its relationship to osteoporosis, osteopenia, and cardiovascular diseases, how serious is vitamin K2 deficiency?

“If you fall and break your hip,” Beakey says, “you may not die immediately. But the osteoporosis that led to that was the first domino to fall. And when you run through the list of cardiovascular diseases, the most lethal among them have a genesis in calcium mediation, calcification of soft tissues, and calcified plaques. Strokes, heart attacks: all come back to calcium. So if you wonder, ‘Well, why aren’t people just dropping dead from vitamin K2 deficiency?’ To some extent, they are.”

Yet you wouldn’t know it from talking to consumers. For unlike probiotics, protein, and other “celebrity” nutrients, vitamin K2 flies surprisingly under their radars-surprising considering its health implications.

Beakey wagers that’s because not long after vitamin K2 emerged in the first half of the twentieth century, “it was essentially forgotten. There was little real study on it.” We had to wait until the early 1990s for glimmers of inquiry to surface in Japan, and by the early 2000s more research was in motion. “But 2007 is probably when it really started to kick in,” he continues. “The real, serious studies-clinical studies and not just epidemiological studies or studies of biomarker activation-started around 2007, and the results are just becoming apparent and publicized for the first time.”

Also stifling vitamin K2’s rise was the near nonexistence of a K2/MK-7 industry to champion its virtues. “The first synthesis of K2 on a commercial scale only happened in 2009,” Beakey says, “and companies didn’t really start rolling into the K2 space until around 2012 or so.”

Fortunately for us all, the convergence of maturing science and a growing community of vitamin K2 suppliers means that “we can finally bring this scientific and consumer education to the dietary supplements industry,” Beakey says. “And this is all happening as we speak.”

It’s about time it does. Yet a remaining challenge, Beakey continues, “is that K2 is a relatively expensive ingredient.” So if a multivitamin manufacturer were to include it in a formulation that already contains vitamin K1, that manufacturer would probably need some convincing to do so.

And vitamin K2’s bone and vascular arguments are nothing if not convincing. But what would strengthen them further would be an official recommended daily intake (RDI) value specific 

 vitamin K2. As it stands, no such RDI exists. Rather, current international vitamin K RDIs address solely the amount of vitamin K1 needed for proper blood clotting: 1 µg/kg body weight/day according to the European Food Safety Authority (EFSA), and 90 µg/day for women and 120 µg/day for men according to the U.S. FDA and Health Canada.

Moreover, these recommendations rest on median vitamin K1 intakes estimated from national surveys dating back to 2001. But “with all epidemiological and interventional studies showing that only K2 is cardio-protective or has a beneficial effect on arteries,” Speed says, it may be time to calculate new requirements that account for the benefits of menaquinones, too.

NattoPharma has embarked on just such a project to establish a much-needed RDI for vitamin K2. As Speed explains, “The program will begin with a team of researchers at Maastricht University, in the Netherlands, which has already led the way to discovering and validating the health benefits of vitamin K2, guided by Dr. Leon Schurgers, professor of biochemistry of vascular calcification at Cardiovascular Research Institute at Maastricht University, or CARIM.”

Joining Schurgers’s team will be the International Science and Health Foundation (ISHF), a research consortium that directs the educational portal 

, and a group of PhD students-sponsored by NattoPharma-who will work to understand the RDI values that FDA, Health Canada, and EFSA have already set. These students will then produce a comprehensive literature review of K2’s bone and cardiovascular benefits to support the argument in favor of updating the RDIs.

The effort could go a long way not only toward advancing vitamin K2 science, but toward improving public health, too. “It’s imperative for global human health that a vitamin K2 RDI be established,” Speed says. “An established RDI will help consumers best select the supplements to meet their health needs, while also giving clear guidance to companies seeking to make the most effective supplements.”

And it’ll put the vitamin on the radar, where it belongs. Then again, for some consumers vitamin K2 may already be on their radar. “In one recent study, half of those we reached out to on a general supplements panel were aware of K2 and were interested in it,” Beakey says. “And studies on product concepts and even actual market data demonstrate that products with K2 for bone health or heart health actually outperform identical products that don’t include K2: purchase intent, uniqueness scores, concepts tests, and actual on-the-ground sales in places where comparisons can be made.”

And this, Beakey concludes, is “the elegant solution and promise of K2. It’s one of those nutrients that could have a fundamental change on populations’ and individuals’ health, wellness, and longevity. It’s such a simple thing. We’re not talking about an exotic root from the jungle. It’s an essential vitamin. And they don’t make those every day.”

Geleijnse JM et al. “Dietary intake of menaquinone is associated with a reduced risk of coronary heart disease.” 

vol. 134, no. 11 (November 2004): 3100-3105

Beulens JW et al. “High dietary menaquinone intake is associated with reduced coronary calcification.” 

Gast GC et al. “A high menaquinone intake reduces the incidence of coronary heart disease.” 

Nutrition, Metabolism & Cardiovascular Diseases, 

Knapen MHJ et al. “Menaquinone-7 supplementation improves arterial stiffness in healthy postmenopausal women. A double-blind randomised clinical trial.” 

Vermeer C et al. “Menaquinone content of cheese.” 

 vol. 10, no. 4 (April 4, 2018), pii: E446.

Although the public has yet fully to appreciate vitamin K2, advocates are working overtime to change that. Here’s how an official recommended daily intake (RDI) value could help.

Vitamin K2’s promising future

Mood-boosting supplements are increasingly popular as modern lifestyles become more demanding and stressful. This growth is giving rise to copious amounts of new research and innovative products.

Sam Kwon, president of Vesta Pharmaceuticals (Indianapolis, IN), says that current sales trends in the mood and anxiety supplement space are moving the market toward sustainable, clean-label, natural ingredients that consumers-Millennials, in particular-prefer over pharmaceuticals.

“People are more stressed than ever,” Kwon says, “and consumers are looking for a supplement to help them relax, decrease stress, and reduce depressive symptoms.”

Consumers also prefer more convenient product formats that can be consumed quickly. “That’s why functional foods…and performance drinks are emerging as popular product formats,” Kwon adds. “Consumers still prefer something easy that they can take at the start or end of the day without an unpleasant taste or cumbersome wrapper.”

The global brain health market is expected to be worth USD $11.6 billion in 2024, expanding at a compound annual growth rate of 19.6%, according to Research and Markets.

 While the mood and anxiety niche is only one piece of the overall brain health market, these emotional health and wellness supplements are also expected to see significant growth as research continues to prove the value of mood-boosting supplements. As the mood supplement space continues to grow, expect these six ingredients to become top performers.

A staple of Ayurvedic medicine, ashwagandha 

is quickly gaining popularity in the United States as a mood enhancer and stress-reduction supplement thanks to its adaptogenic properties. In September, the American Botanical Council (Austin, TX) published its 

 Herb Market Report on 2017 U.S. retail sales of herbal supplements, reporting that ashwagandha sales in the natural retail channel grew 25.6% in 2017 to $10.6 million.

George Polson, PhD, is the vice president of technology for Innophos (Cranbury, NJ). Polson says that ashwagandha’s growth in the West is being driven by Americans’ need for stress-reduction and mood-support supplements. “Adaptogens like ashwagandha help to protect the body against emotional and physical stressors,” Polson says. “Clinical trial research is demonstrating that ashwagandha’s health benefits are now based on science-backed testing, not just traditional use.”

One randomized, double-blind, placebo-controlled clinical trial followed 98 men and women between the ages of 18 and 60 for 60 days.

 Participants were evaluated on a modified Hamilton anxiety scale (mHAM-A) prior to the trial and were admitted to the trial if they scored between 24 and 42, which indicates moderate stress or anxiety.

Participants were then randomly assigned to one of four dosage groups and were given varying dosages of ashwagandha extract. The ashwagandha extract used in the study, Sensoril (also called Essentra), is proprietary to Natreon Inc. (New Brunswick, NJ) and distributed by NutraGenesis LLC (Brattleboro, VT). (Innophos acquired NutraGenesis last year.) Group A (n=30) received a once-daily 125-mg dose, Group B (n=35) received the same 125-mg dose twice per day, Group C (n=35) received a 250-mg dose twice per day, and Group D (n=30) received a placebo. Participants were assessed for mHAM-A scores at days 0, 30, and 60, and for serum cortisol, dehydroepiandrosterone sulfate (DHEAS), C-reactive protein, fasting blood glucose, serum total cholesterol, serum triglycerides, serum low-density lipoprotein cholesterol (LDL-C), serum very-low-density lipoprotein cholesterol (VLDL-C), and serum high-density lipoprotein cholesterol (HDL-C) at days 0 and 60.

All experimental groups reported a statistically significant increase in subjective feelings of well-being at day 30 and day 60. All experimental groups also showed significant decreases in mHAM-A scores relative to the placebo group, with higher doses of 

 associated with greater score reductions. Group A exhibited a 62.2% reduction in mHAM-A scores (P<0.001) after 60 days, while the placebo group did not exhibit a statistically significant change.

Natreon funded this study. Polson says this study showcased Sensoril ashwagandha’s stress-reducing properties. “For both doses, consumption of Sensoril extract resulted in significant reductions in serum levels of the stress hormone, cortisol, as well as improvements in self-reported levels of stress and anxiety. Generally, higher doses provided greater benefits, but both doses had statistically significant effects compared to the placebo group.”

Benny Antony, PhD, is the joint managing director for Arjuna Natural Ltd. (Kerala, India). Antony says that 

 has demonstrated itself effective in alleviating anxiety through multiple pathways. “

 has traditionally been used as a tranquilizer,” Antony says. “Animal and human studies have demonstrated its anti-stress, anti-anxiety, monoamine-modulating, and cortisol-lowering properties. Ashwagandha extracts show promise as a potential adjunctive treatment for cognitive impairments as well as mood exacerbations.”

Shaheen Majeed, worldwide president of Sabinsa (East Windsor, NJ), says that ashwagandha is thought to act through the hypothalamic-pituitary-adrenal axis to alleviate stress-induced insomnia and fatigue. In one animal study, ashwagandha was found to induce differential activation of multiple types of GABA receptors, which the study authors say could explain ashwagandha’s adaptogenic properties.

Majeed says he expects the mood and anxiety supplement market to continue growing due to the inherent complexity of the human condition. “Hectic lifestyles, confusing current events, and the normal ups and downs of life all contribute to increased incidence of anxiety and mood disruptions. This has increased the demand for anti-anxiety products, especially natural alternatives. The World Health Organization has projected that depression will be the second leading cause of disability worldwide

, and given the growing preference for natural alternatives, the specialized sector of herbal brain health supplements has a significant role to play in improving human life.”

Probiotics are a recent entry to the mood supplement category, but their entry is supported by science. Research demonstrating the gut-brain connection and an increase in consumer awareness around probiotics are paving the way for probiotic mood supplements.

Tom Bayne, DC, is a chiropractic physician and scientific advisor for Probiogen (Scottsdale, AZ). Bayne says that the gut-brain connection is more powerful than was previously known, which is why probiotics are ideal for the mood supplement market. “Research has shown that gut bacteria can produce their own neurotransmitters and essentially hijack the brain,” Bayne says. “This can trigger food cravings, feelings of anxiety, feelings of depression, and other mood imbalances.”

BÃ©rengÃ¨re Feuz, marketing director for Lallemand Health Services (Montreal, QC, Canada), notes that probiotics are gaining popularity as mood supplements due to their efficacy as well as their tolerability. She cites the results of a double-blind, placebo-controlled, randomized clinical trial on 110 patients with major depressive disorder that found an eight-week course of probiotic supplementation improved Beck Depression Inventory (BDI) scores relative to a placebo.

Eighty-one subjects completed the trial. This trial separated participants into prebiotic (n=27), probiotic (n=28), and placebo (n=26) groups. Participants were administered either 1) 5 g of a probiotic supplement containing 

 probiotic strains, 2) 5 g of a prebiotic supplement containing galactooligosaccharide, or 3) a matching placebo, once daily for eight weeks. Participants were assessed for serum tryptophan and branched-chain amino acids (BCAAs). Researchers recorded participants’ dietary intake and physical activity at baseline. Relative to a placebo, probiotic supplementation resulted in a statistically significant decrease in BDI score (p=0.042), while prebiotic supplementation failed to produce a statistically significant effect.

Says Feuz: “Last June, Caroline Wallace from Queen’s University (Kingston, ON, Canada) revealed at Probiota Americas the promising results of this pilot study on Lallemand’s probiotic formulation on symptoms of depression in treatment-naÃ¯ve depressed patients. This study and others like it reinforce the scientific basis of this probiotic formulation for alleviating both physiological

is quickly gaining popularity as a mood supplement thanks to its strong performance in clinical trials. Sebastien Merchet, nutrition business development manager, North America, for Seppic (Fairfield, NJ), says that saffron extract’s mood-boosting and anxiolytic properties have been demonstrated in more than 10 clinical trials.

Says Merchet: “Studies have even shown that saffron extract may provide similar effectiveness to well-known pharmaceutical mood stabilizers, such as fluoxetine and imipramine, without the side effects. These clinical studies showed that the mood-stabilizing effects were linked to multiple native actives from saffron, including safranal, crocin, crocetin, picrocrocin, and other derivatives present in sargol, the richest part of saffron.”

A 2014 research review of six randomized, double-blind, placebo-controlled clinical trials found that “saffron had large treatment effects and, when compared with antidepressant medications, had similar antidepressant efficacy.”

Seppic is the exclusive distributor of Activ’Inside products for North America. Merchet says that Activ’Inside’s branded saffron extract, Safr’Inside, contains 10 times more safranal than generic saffron extracts when measured by HPLC, and has standardized concentrations of 25 native active compounds associated with saffron’s mood-stabilizing properties that Activ’Inside has dubbed “Safromotivines.”

Merchet says the mood and anxiety supplement market is diversifying its product formats, with powdered drinks quickly becoming popular. “Chewables, gummies, and other formats are also trending, but powders are quite popular. Consumers want to be able to prepare their own drink, yogurt, or shake-and making your own recipe might be relaxing in and of itself.”

Last year, another saffron supplier, Pharmactive Biotech Products (Madrid, Spain), a partner of Gencor (Irvine, CA), funded a first-of-its-kind clinical study on the effects of the company’s proprietary, patented Affron ingredient in an adolescent population. Researchers found that Affron may help reduce depression and anxiety symptoms in teenage children and improved feelings of separation anxiety, social phobia, and depression in young people. The company says Affron is the first saffron extract standardized by HPLC to Lepticrosalides, the trademarked bioactive compounds said to help to improve mood disorders.

The randomized, double-blind, placebo-controlled study

 included 68 young people between the ages of 12-16 with mild-to-moderate anxiety or depressive symptoms. According to data from the World Health Organization, the study authors write, psychiatric disorders including anxiety and depression are among the leading causes of disability in young people, with as much as 15%-20% of the youth population experiencing an anxiety or depressive disorder before the age of 18. Saffron, they add, has been shown to be effective in reducing feelings of depression and anxiety in adults with mild-to-moderate depression; however, saffron for depression and anxiety had not yet been studied in a youth population prior to publication of the current study, they said. 

The researchers divided participants into two groups. One group received 14 mg Affron, while another group received the same dosage of a placebo. Both group were instructed to take one tablet of either Affron or the placebo twice daily for a total of eight weeks. In order to determine what effects supplementation with Affron had on parameters of anxiety and depression, participants completed a 47-item questionnaire called the Revised Child Anxiety and Depression Scale (RCADS). RCADS includes subscales on separation anxiety, social phobia, general anxiety, panic, obsessions and compulsions, and depression. Subjects’ parents also completed the parent-report version of RCADS; those results served as the secondary outcome measure.

The group supplemented with Affron reported improvements in overall internalizing symptoms, separation anxiety, social phobia, and depression, compared with the placebo group. Parental reports of improvement in the subjects’ mental health were inconsistent. The researchers thus concluded that “administration of a standardized saffron extract (Affron) for eight weeks improved anxiety and depressive symptoms in youth with mild-to-moderate symptoms, at least from the perspective of the adolescent.” Affron was also found to be safe and well-tolerated.

The study authors write that while the results are encouraging, the self-reporting nature of this study represents a limitation. The limited study duration, single treatment dose, and non-clinical sample used in this study likewise limit the overall generalizability of the results, warranting the need for further investigation. Pharmactive Biotech Products funded the study.

Imke Marks, commercial director of Pharmactive Biotech Products, says that combination saffron products, such as with curcumin, are also gaining in popularity due to their increased efficacy relative to single-ingredient products.

Lorena Carboni, product support specialist for Gnosis S.p.A. (Desio, Italy), says that SAMe (S-adenosyl-L-methionine) and L-methylfolate (5-MTHF) are continuing to enjoy privileged positions as top sellers in the mood and anxiety supplement market due to the critical roles they play in the methylation process of monoamines.

“In particular,” Carboni says, “SAMe may improve depressed mood through enhanced methylation of catecholamines and increased serotonin turnover, reuptake inhibition of norepinephrine, enhanced dopaminergic activity, decreased prolactin secretion, and increased phosphatidylcholine conversion.”

Carboni points to a 2016 literature review and meta-analysis that shows SAMe and 5-MTHF are effective adjuncts to antidepressant medications in reducing the occurrence of depressive symptoms.

 Folate deficiency is common among people with depressed mood, Carboni says; however, not just any folate supplement will be effective in supporting emotional health. Carboni explains that according to studies like one published in the 

, not all consumers will benefit from the same kind of folate supplement.

“Up to 70% of patients with depression test positive for a polymorphism of the MTHFR enzyme,” Carboni says, “which means they cannot convert folic acid into L-methylfolate. For that reason, the active form of folate (5-MTHF) is the right approach to raise folate levels, instead of folic acid that is biologically non-active.”

Carboni sees the mood and anxiety supplement market moving toward more natural ingredients in the future, and expects that consumers will first pursue naturally sourced supplements before attempting pharmaceuticals.

Bayne notes that hemp cannabidiol (CBD) from

 is becoming competitive as a mood supplement ingredient due to the fact that it induces the same calming effects as marijuana, but without the psychoactive tetrahydrocannabinol (THC). Stuart Tomc, vice president of human nutrition for CV Sciences Inc. (Las Vegas, NV), says that hemp extracts have become a go-to product in the mood and anxiety supplement market.

Says Tomc: “Consumers are actively seeking natural alternatives to pharmaceuticals that induce rapid, sustained effects with better safety profiles. Hemp extracts are trending for these applications because they are natural, safe, and effective.”

While Tomc says CBD oil softgels are currently an industry favorite, the cannabinoid industry is quickly launching new product formats that are expected to greatly disrupt existing offerings as research continues to prove out the mood-boosting benefits of CBD. In September, CV Sciences made a milestone announcement, stating it secured the industry’s first Generally Recognized as Safe (GRAS) self-affirmation for a hemp extract, for its PlusCBD Gold Formula.

“CV Sciences is the only hemp CBD nutraceutical company to invest in the scientific evidence necessary to achieve this sought-after designation, recognizing an ingredient as presumably safe among experts under the conditions of its intended use,” the company said in a press release. At the same time, the company announced that its PlusCBD Oil launched what the company says is the industry’s first CBD gummy in the natural products space.

Tomc speaks to CBD research findings. “A landmark paper published in June 2018

 presented data supporting CBD as a new fast-acting option,” Tomc explains. “The rapid antidepressant effect was accompanied by an increase in brain-derived neurotrophic factor levels as well as markers of synaptic plasticity. CBD potentiated nerve growth factors and new neuron-to-neuron connections, making it one of the most promising tools in our natural mental health toolbox.”

The study that Tomc references is an animal experiment on male Swiss mice and Wistar rats. The animal study involved administering injections of CBD at concentrations of 7, 10, and 30 mg/kg, or an inert vehicle at 10 ml/kg, to groups of mice or rats. Group size varied from n=6 to n=13. The mice and rats were then subjected to the forced swim test and the learned helplessness paradigm, and were assessed for changes in postsynaptic density protein 95 (PSD95) and brain-derived neurotrophic factor (BDNF) levels.

The experiment found that administration of CBD increased BDNF levels and markers of synaptic plasticity, while also reducing immobility time during the forced swim test. The study authors concluded that CBD induces a rapid and long-lasting antidepressant effect.

Tomc says that CBD products are already becoming category leaders, with retailers reporting that they are receiving weekly pitches from new hemp startups. Tomc explains this “green rush” signals the successful evolution of hemp into a mainstream health and wellness product.

“Any health food store that sells hemp CBD products will tell you that hemp CBD extract is the bestselling and most effective product to hit store shelves, ever,” Tomc says. “We’re seeing tremendous competition among cannabinoid-based products, and we expect massive disruption for preexisting offerings.”

Market statistics confirm Tomc’s claims. Market research firm Technavio (London, UK) predicts that global annual sales of CBD oil products will reach $2.7 billion USD by 202212, growing at a compound annual rate of 31%.

 And in September, the nonprofit group Vote Hemp (Washington, DC) released predictions from a new 

 report that total U.S. retail sales of hemp-derived CBD products will surpass $646 million by 2022.

The mood and depression supplement category is expected to see significant growth in the coming years, making it an ideal market segment for new innovations and new products. Manufacturers and brands need to invest in quality science and effective marketing. Many opportunities lie ahead for brands that can meet this challenge. 

Sidebar: Not all companies moving forward with CBD

Shaheen Majeed, worldwide president of Sabinsa (East Windsor, NJ), says that while hemp cannabidiol (CBD) is becoming a competitive anti-anxiety ingredient, some companies like Sabinsa are hesitant to enter the CBD space due to CBD’s unresolved legal status. FDA did recently approve GW Pharmaceuticals’ Epidiolex CBD drug to treat severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, and the DEA is now in the process of determining whether CBD will be reclassified as a Schedule II or Schedule III drug.

 Until these regulatory questions are resolved, however, some manufacturers and brands may consider their opportunities to be limited.

Says Majeed: “CBD’s popularity is growing for issues like anxiety and pain. It is also thought to be neuroprotective. In June 2018, the U.S. FDA approved the oral use of cannabidiol as an anti-seizure drug for use in rare and severe forms of childhood epilepsy. It was also approved by Health Canada in 2005 for addressing the pain associated with multiple sclerosis. However, as of this date cannabidiol remains a Schedule I drug under U.S. federal law (Schedule II in Ohio), and therefore Sabinsa is not active in this category.”

Sidebar: Mood supplements may be unconventional solution to societal problems

Depression and anxiety are only two aspects of mood regulation, and new research into omega-3 fatty acids is opening up potential new avenues of addressing other aspects of mood dysfunction. A recent randomized, double-blind, placebo-controlled, stratified, parallel-group clinical trial on 200 children between 6 and 16 years of age, and 139 adult caregivers, examined the effects of omega-3 supplementation on aggressive behavior in the children and intimate partner violence in the adults.

All participants received a 200-ml dose of a liquid omega-3 supplement. The experimental group (n=100) also received an additional 1 g of omega-3 fatty acids, while the control group (n=100) received a matching placebo. Participant aggression was measured using the physical assault and psychological aggression subscales of the Conflict Tactics Scales, and omega-3 concentration was assessed through blood analysis.

The study authors found that omega-3 supplementation resulted in long-term statistically significant reductions in psychological aggression and psychopathic tendencies in adult caregivers as measured via the Conflict Tactics Scales. While the study authors note several limitations to the trial and claim their current findings require replication, they also highlight several strengths of the study. The trial had a longer duration, a lower attrition rate, and better compliance relative to prior studies.

Research and Markets. “Global $11.6 Billion Brain Health Supplements Market to 2024.” 

www.prnewswire.com/news-releases/global-116-billion-brain-health-supplements-market-to-2024-300517802.html

 extract significantly reduces stress-related parameters in chronically stressed humans: A double-blind, randomized, placebo-controlled study.”

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Brodwin, E. “A drug derived from marijuana has become the first to win federal approval, and experts predict an avalanche effect.” 

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 vol. 44, no. 5 (September/October 2018): 491-500

New research and market stats demonstrate that mood supplements are both in demand and effective.

Bright outlook for mood supplements

Spawned from a spike in the number of foodborne illnesses in the early 2000s, the Food Safety Modernization Act (FSMA) was developed to take a more proactive rather than reactive approach when it comes to food contaminants. Though signed into law in January 2011, implementation continues through 2019 as FDA and food manufacturers alike remodel how they approach food safety practices. While the new rules don’t directly impact dietary supplements-“those areas are already addressed within GMP [Good Manufacturing Practices] requirements,” says Steve Holtby, president and CEO of Soft Gel Technologies Inc. (Los Angeles, CA)-they completely change the landscape of expectations when it comes to dietary ingredients, sending a ripple effect across the entire industry.

Among other regulations, dietary ingredient manufacturers must be sure to use approved suppliers, verify them (and figure out how to do so), ensure that preventative controls are implemented and effective, and document all of it. Plus, the FDA now has recall authority-the ability to mandate that companies recall products deemed unsafe-as well as the ability to conduct inspections to ensure compliance. Finally, and perhaps most notably, FSMA brings with it much tougher standards when it comes to imports, requiring importers to ensure that their foreign suppliers have compliant controls in place. At minimum, FSMA demands on-site audits; without them, FDA can block entry. 

The good news is that everyone knew this was coming and had ample time to prepare. Still, the question remains: is the industry ready? According to Gisele Atkinson, vice president of quality and technical affairs at the Council for Responsible Nutrition (CRN; Washington, DC), approximately 60% of GMP inspections on dietary supplement companies in 2017 resulted in the FDA issuing a Form 483. “And this compliance report is in relation to a regulation that became mandatory 10 years ago,” she says. “FSMA regulations started rolling out seven years ago, with some compliance dates still a few years ahead; and these regulations are much more far reaching than dietary supplement GMPs alone. So we have yet to see the results of FSMA inspections.”

Still, if you ask Atkinson, FSMA is a good step for the dietary supplement and ingredients industry because a rising tide lifts all boats: holding the industry to a higher standard at every step of the supply chain can only increase consumer confidence as bad actors are eliminated from the market. Responsible companies with a strong track record of quality and compliance will likely go beyond what’s required, she says, and will be prepared for the changes. “The industry has been highly anticipating the passage of FSMA, since it now holds the entire business supply chain accountable to higher standards for food safety and prevention,” agrees Holtby. “This is important because the food industry governs our raw material manufacturers and distributors, and now they are held accountable to food safety regulations.”

However, as Atkinson points out, there remain a lot of mid-size and smaller companies with less experience that will “continue to struggle with what is required,” she says. “And, unfortunately, there are still some outliers that ignore the law altogether.” Overall, CRN supports FDA enforcement actions against companies that are non-compliant, says Atkinson, since “FDA needs to get these bad actors to come into compliance or face consequences.”

That doesn’t mean, though, that new challenges in the wake of FSMA passage are limited to the bad actors alone. Even well-meaning and well-prepared companies that prioritize transparency and quality will face a few growing pains as FSMA compliance hits its stride.

When it comes to outsourcing, the impacts of FSMA are widespread and, regardless of size, companies are bound to run into some challenges.

First, there is a huge amount of responsibility placed on the shoulders of ingredient manufacturers to verify and document their raw materials and ingredients, which didn’t exist in the past. Ingredient suppliers must evaluate hazards, develop written analysis, create and validate (and monitor) preventative controls, and take corrective action if any missteps are discovered. This evaluation needs to happen at every step of the supply chain, from receiving raw materials through processing, packaging, and storing. And it applies to suppliers worldwide. “The Foreign Supplier Verification rule stipulates that the same preventative safety standards apply to food and supplements consumed in the U.S. regardless of where they are produced,” explains Robin C. Koon, executive vice president at Best Formulations (City of Industry, CA). This complicates matters for contract manufacturers who source ingredients from overseas, especially since “the majority of raw materials in the dietary supplement industry come from overseas,” he says. As a result, Koon expects “more possible delays and potential price increases in receiving material shipments from overseas, due to suppliers needing to be compliant with FSMA.”

Indeed, Soft Gel Technologies, a softgel contract manufacturer, has seen both raw material costs and lead times increase, which impacts productivity and profitability. “We’ve also discovered that it is too risky to do business with smaller companies who offer unique ingredients and reasonable minimum order quantities,” adds Holtby, since they’re often unable to comply with the new regulations. As a result, the quality assurance and regulatory department at Soft Gel Technologies has requested that the purchasing and product development groups eliminate several previously approved suppliers “to help prevent delays with securing certain raw materials in a timely manner,” says Holtby.

When it comes to compliance, rising costs will also come into play for suppliers who don’t do in-house testing, says Frank Cantone, president of ABH Pharma Inc. (Brentwood, NY), since the new regulations require stringent documentation. Hiring third-party labs, of course, adds another line item to the budget. Plus, additional challenges exist for manufacturers who source from suppliers that don’t provide sources for the raw materials they sell. “This lack of transparency is problematic, as it creates a compliance issue for the receiving facility who must establish and implement a written supplier verification program,” says Holtby. This is not a problem at Soft Gel Technologies, he notes, as the company must know the origin of all raw materials used and have supporting documentation from the manufacturers and distributors demonstrating compliance.

Another challenge plaguing the industry overall as this transition enters its final stages is that dietary supplement brands aren’t as educated on the nuances of FSMA since it doesn’t impact them directly, says Atkinson. But this isn’t entirely true. “Supplement manufacturers are exempt from some parts of FSMA but there are significant sections like the Foreign Supplier Verification Program and the International Adulteration Rule that fully apply as new requirements,” she adds.

Brand awareness is a challenge that Koon has also faced. “They need to ensure their supply chain is compliant, so as to not cause an interruption of products,” she says. “Currently, most brands are not really aware of FSMA and its potential effects.”

The good news is that, as Cantone explains, the industry is generally “very prepared from a compliance standpoint.” Not ready? Never fear, says Atkinson, as the FDA has stated it will educate as it regulates. “If companies are showing effort toward compliance, FDA is willing to help educate to help get you all the way there,” she says. “But, if you are ignoring the new FSMA regulations, FDA will be sure to give warning letters.”

In the end, Atkinson thinks the investment and challenges will be worth it, as “there will be overall savings as the food industry shifts to a proactive food safety system and not a reactive one.” The result will be increased confidence in the supplement industry as better-quality products are verified and documented at every step in the supply chain. Is there a more worthy effort?

FSMA is reaching its final stages of compliance, and contract manufacturers are finding a few challenges in its wake.

How FSMA changed the outsourcing industry for dietary supplements

Children are still a niche audience within the food and drink market. Innova Market Insights data indicate that just 2.5% of U.S. food and drink launches in the 12 months ending April 2018 targeted children. Many products widely consumed by children are instead marketed with a more general family-friendly positioning.

Sectors with the most developed children’s markets include impulse-type purchases such as chocolate and confectionery, savory snacks, ice cream, and soft drinks, as well as a wide range of products mainly bought as planned purchases during the regular family shopping trip, including fresh dairy products, cereal and fruit snacks, and bakery products.

Even so, children are still a niche audience within the food and drink market.

Nutritional Outlook Vol. 21 No. 8

Female shoppers remain a powerful audience for dietary supplements. But how can manufacturers reach them?

Vitamin K2’s promising future

Bright outlook for mood supplements

How FSMA changed the outsourcing industry for dietary supplements

Which are key children’s health markets? Supplements and oral health.

What will it take to grow the U.S. probiotic market?

Reference standards for dietary supplements are more important than ever to combat adulteration and fraud

Omega-3s for cardiometabolic wellness

U.S. herbal supplement sales are breaking records. Here’s why.

Prebiotic research going beyond the gut

Why are probiotics in the media crosshairs, and how can industry take control?

5 Functional water trends

Omega-3 Cochrane meta-analysis is highly flawed, researcher writes