The joint health ingredients market is seeing a flurry of new activity as demand for a new generation of products leads formulators to eschew legacy ingredients like glucosamine and chondroitin in favor of emerging ingredients like collagen and turmeric. To gain validation, these next-generation joint health ingredients are focusing on robust clinical trials and formulation.

Collagen supplements recently made the leap from the beauty aisle to the joint health aisle based on studies showing it may relieve joint pain. Research on the interactions between the various types of collagen is now opening up new opportunities for synergistic, combination joint health supplements blending complementary ingredients in a single product.

 examined the effects of Fortigel, a branded bioactive collagen peptide by Gelita (Eberbach, Germany), on knee pain in 180 physically active adults aged 18 to 30 with activity-related joint pain and scores above 20 on the Visual Analog Scale (VAS) for pain. The subjects were given the McMurray test for meniscus injury, the Steinmann I and II tests, and the Butler drawer test to assess ligament stability at baseline and on study conclusion. Subjects received either 5 g of Fortigel (n = 98), or a placebo (n =82), daily for 12 weeks. After 12 weeks, the group receiving collagen peptides experienced an improvement in activity-related joint pain as assessed on the VAS, by the physician, and through self-report. The study authors concluded collagen peptides can reduce knee pain during activity.

Angie Rimel, marketing communications manager for Gelita, says collagen is becoming popular in multi-ingredient products especially. “Collagen is very easy to formulate with,” Rimel says. “There’s a growing trend of blend products, like protein blends or with vitamins or prebiotics.”

Abdul Alkayali, vice president of Certified Nutraceuticals Inc. (Temecula, CA), says some of the most exciting innovation in collagen has to do with a new source: jellyfish. In fact, Alkayali expects invertebrates to replace mammals as the primary source of collagen in the coming years.

“Jellyfish collagen supplies the body with multiple types of collagen peptides and essential minerals that are only found in edible jellyfish collagen,” Alkayali says. “New research on jellyfish has increased tremendously.”

A 2017 60-day prospective single-center observational study

 assessed Certified Nutraceuticals’ branded TendoGuard, a joint health blend including Types I, II, V, and X collagen, as well as hyaluronic acid, chondroitin sulfate, and mucopolysaccharides. This study examined the effects of a 750 mg/day dose of TendoGuard on joint pain and range of motion in 20 men and women aged 45 to 75 with a history of a knee disorder. Subjects were assessed for range of motion via goniometer, pain via the Borg scale, and muscle strength via a sphygmomanometer. After 60 days, the subjects saw improvements in range of motion, pain, and muscle strength. While this study lacked a control group, the study authors concluded that TendoGuard reduced symptoms of joint discomfort.

Studies like these are driving sales of collagen products in the joint health market. Douglas Jones, global sales and marketing manager for Biocell Technology LLC (Irvine, CA), says consumers are looking for clinically validated ingredients that provide noticeable benefits. He expects the joint health market to present opportunities for collagen brands that have clinical research behind them.

“Biocell has seen our collagen sales increase with some customers by over 100% within the last 18 months,” Jones says. “We see consumers looking for at-home solutions to maintain their joint health. The future in joint health is very bright. Millennials are now in their 30s, and this population is very focused on supply-side transparency and branded ingredients with clinical evidence.”

While Millennials represent a growing opportunity for future growth, most joint health consumers are still older adults. A 2021 consumer survey by Lonza (Basel, Switzerland) found that the average joint health consumer is between the ages of 45 and 64. According to Lonza’s research, joint health supplement consumers tend to be well educated and have high incomes. Lindsey Toth, RD, associate director of health ingredients for Lonza, says that with one in six people projected to be 65 years old or older by 2050, now is the time to begin laying the groundwork of consumer education campaigns.

“While collagen has taken center stage in recent years, there is largely little known by consumers about the different types of collagens and the difference in benefits they confer,” Toth says. “Lonza has invested significant research in understanding the benefits of undenatured type II collagen.”

Lonza’s branded UC-II collagen, an undenatured type II collagen ingredient, has been found to increase mobility and reduce joint discomfort in clinical studies, Toth says. One of the advantages of this type of collagen, Toth notes, is convenience of delivery. “UC-II collagen can be taken in a tiny, once-daily, easy-to-swallow dose. Pill fatigue and swallowability concerns are a huge barrier for most aging consumers.”

While collagen is an effective ingredient for joint health, not all types of collagen are created equal. Jaume Reguant, healthcare director for Bioiberica (Barcelona, Spain), says formulators who want to work with collagen will need to consider which type of collagen is best for their application.

“Native type II collagen is an effective joint health ingredient and compared to its hydrolyzed counterpart requires a much lower dosage,” Reguant says. “This means it can be incorporated alongside other beneficial ingredients to support joint health.”

“Emerging ingredients like this are facilitating a new era of mobility health that appeals to a wider range of people who see movement as a fundamental part of their physical and mental well-being,” he adds.

 examined the efficacy of combining Bioiberica’s branded Collavant n2 ingredient (formerly called 2Cool), which is an undenatured type II collagen, and Mobilee, which is a hyaluronic acid matrix ingredient, in a formula that also included Bioiberica’s chondroitin sulfate and glucosamine hydrochloride ingredients. The study assessed the blend’s effects on articular cartilage, synovial membrane, and subchondral bone in 54 rabbits with induced osteoarthritis. The rabbits were randomly assigned to receive a daily dose of either 1) chondroitin sulfate (CS) plus glucosamine hydrochloride (GH) and hyaluronic acid (HA) (n=18), 2) CS plus GH and HA with added Collavant n2 (n=18), or 3) nothing (n=18). Each group was divided into three subgroups (n=6) that were sacrificed after 28, 56, or 84 days. After sacrifice, the rabbits were dissected and evaluated. The rabbits that received the combination of CS, GH, and HA showed milder degenerative changes relative to the control group. The addition of Collavant strengthened this protective effect, the researchers concluded.

Other new research on collagen is demonstrating the viability of a personalized nutrition approach. Liz Clarke, CFS, technical marketing manager for Nitta Gelatin (Morrisville, NC), says new research on joint health ingredients goes beyond providing scientific substantiation of health benefits for the general population. Instead, studies are now zeroing in on clinical personalization for specific demographics like younger athletes or seniors with mobility issues.

One recent randomized, double-blind, placebo-controlled clinical trial

 on Nitta Gelatin’s branded Wellnex Replenwell collagen peptide examined the effects of collagen supplementation on joint pain in healthy male university students aged 18 to 21 who were members of the Josai University running club in Sakado, Japan. The students were randomly assigned to receive either 5 g of Replenwell per day (n = 25) or a maltodextrin placebo (n = 21), for eight weeks. After four weeks, the placebo group saw an increase in levels of interleukin-6 (IL-6), a biomarker of inflammation. The collagen peptide group did not see any significant changes in IL-6 levels. The study found that a daily dose of Replenwell taken for four weeks reduced joint discomfort.

“Personalization is the key here,” Clarke says. “We’re seeing significant results with lower dosage rates for active, younger participants than we have in previous studies looking at the effects on older populations with preexisting joint conditions. While it’s common-sense that different populations would have differing needs, being able to quantify that into dosage requirements is new for collagen.”

One relative newcomer to the joint health market is starting to shake things up and threaten the dominance of legacy ingredients. Recent research is showing that turmeric

can reduce joint inflammation in more ways than one.

Eric Anderson, managing director of NXT USA (Metuchen, NJ), says the company’s branded TamaFlex, a patent-pending blend of 

 seed and turmeric rhizome extracts, is proving to be effective in addressing joint health issues like comfort, flexibility, and function. One 2019 randomized, double-blind, placebo-controlled study

 examined the effects of TamaFlex in 90 non-arthritic subjects with knee pain and joint discomfort. Subjects were randomized to receive either 250 mg (n=30) or 400 mg (n=30) of TamaFlex per day, or a placebo (n=29), for 90 days. Subjects were assessed via the Six-Minute Walk Test and Stair Climb Test at baseline and after 90 days. Both TamaFlex groups saw an increase in average walking speed and improvements on Six-Minute Walk Test and Stair Climb Test scores compared to placebo, as well as reductions in pain and stiffness.

“The latest study on TamaFlex showed that it starts working in five days,” Anderson says. “This study, pending publication, explored how TamaFlex impacted subjects with mild to moderate joint pain from osteoarthritis. It showed improvements in pain, stiffness, physical activity, and stair climbing scores by day five.”

Other studies are demonstrating that turmeric can also be an effective joint health ingredient when incorporated into polyphenol blends. A recent open-label feasibility trial

 on Verdure Sciences’ (Noblesville, IN) branded curcumin/polyphenol blend Restoridyn examined the effects of the blend on blood inflammatory proteins and inflammation-associated RNA in 18 half-marathon runners for 29 days before, the day of, and the day after a race.

The participants received 1 g/day of Restoridyn for the first 26 days and 2 g/day on days 27 through 31. The subjects were also permitted to take an additional 1 g/day booster dose on days 1 through 26, but only on days when they ran more than 6 miles. Subjects were assessed for inflammation and soreness via testing for IL-10, IL-13, IL-4, TNF-alpha, and RNA biomarkers, among several others, on days 29 through 31.

The study found that Restoridyn altered several pathways associated with inflammation, B-cell activity, and muscle recovery. Restoridyn downregulated a type of long, non-coding RNA that is known to be involved in inflammation and COX-2 expression.

Kristen Marshall, digital marketing manager at Verdure Sciences, says the joint health market is beginning to diversify into more subcategories and specialized applications. Joint health brands are expanding into multiple functional arenas like exercise recovery and sports nutrition, joint comfort, pain and stiffness, inflammation, and overall healthy lifestyle.

“Joint health has evolved to include an ever-increasing array of applications, functions, and formats,” Marshall says. “We’re seeing many brands diversify their product offerings with innovative delivery forms like topicals, chocolates, functional beverages, and more.”

Research on other forms of turmeric is ongoing, and some of these studies show that an unconventional type of turmeric extract may offer substantial advantages. Brien Quirk, director of research and development for Draco Natural Products (San Jose, CA), says a water-soluble polysaccharide extract sourced from turmeric rhizomes was found to be very effective at relieving symptoms of osteoarthritis in a clinical trial

This study—a randomized, single-blind, placebo-controlled trial—examined the effects of NR-INF-02, a branded powdered curcumin rhizome product marketed as Turmacin by Natural Remedies Pvt. Ltd. (Bangalore, India), on pain and knee function in 120 subjects with knee osteoarthritis. Participants were randomly assigned to receive either 1) 400 mg of a placebo twice per day (n=30), or 2) 500 mg of Turmacin twice per day (n=30), 3) 750 mg of glucosamine sulfate twice per day (n=30), or 4) a combination of glucosamine sulfate and Turmacin twice per day (n=30), for 42 days. The subjects were assessed for pain via the VAS and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scales, and joint condition via the Clinical Global Impression Change (CGIC) scale, at baseline and after 21 and 42 days.

After 42 days, the subjects who received Turmacin showed a significant improvement in VAS, WOMAC, and CGIC scores and a significant decrease in the use of pain medication relative to placebo. The study authors concluded that Turmacin is a safe and effective option for relieving pain and improving knee function in osteoarthritis patients.

“Most of the turmeric extracts being sold on the market are standardized to a concentration of 95% curcumin and do not have water-soluble polysaccharides,” Quirk says. “Curcumin is very poorly absorbed, which explains why most turmeric extracts have not shown much benefit except in very large doses. Turmeric extracts that are rich in water-soluble polysaccharides have been ignored until now.”

Eggshell membrane ingredients are gaining popularity in joint health applications for their rich combination of joint-healthy compounds. Amanda Jepson, senior director of marketing and international sales for Biova LLC (Johnston, IA), says eggshell membrane is a source of multiple, naturally occurring compounds that promote joint health. These include ingredients like collagen, elastin, glucosamine, chondroitin, and several amino acids.

 on Biova’s branded BiovaFlex water-soluble egg membrane ingredient demonstrated robust results. The 12-week randomized, double-blind, placebo-controlled clinical trial examined the effects of a 450-mg daily dose of BiovaFlex (n = 44) on WOMAC scores and performance on the Six-Minute Walk Test relative to placebo (n = 44).

“The worst-performing subjects in the BiovaFlex group at baseline had the most significant improvement within five days,” Jepson says. “The BiovaFlex group also noted a reduction in joint stiffness within five days.”

New means of measuring the efficacy of ingredients are also lending momentum to the joint health space. Jacqueline Rizo, content coordinator for Stratum Nutrition (Carthage, MO), says that while joint health ingredients have typically been evaluated using pain and stiffness scales, recent innovations have made it possible to measure ingredient efficacy through objective biomarkers like CTX-II, the C-terminal telopeptide fragments of type II collagen.

“One of the significant developments related to NEM”—the company’s flagship eggshell membrane ingredient—“in recent months was the publication of research involved in the development of a clinical trial design for evaluating the effects of joint therapeutics on cartilage turnover,” Rizo says. “This clinical trial marked the first evidence suggesting CTX-II could be used to evaluate the chondroprotective efficacy of joint therapeutics in healthy individuals.”

 in question, sponsored by Stratum Nutrition’s parent company ESM Technologies (Carthage, MO), followed 60 healthy, postmenopausal women for 14 days. The women received either 500 mg of NEM per day (n=30), or a placebo (n=30), while doing step exercises (50-100 steps per leg) on alternating days. NEM administration resulted in faster recovery from exercise-induced joint pain and stiffness, as well as reduced discomfort, relative to placebo.

While the joint health benefits of methylsulfonylmethane (MSM) have been established for some time, recent clinical trials examining MSM in combination with other joint health ingredients have found that MSM has a synergistic effect.

Tim Hammond, vice president of sales and marketing for Bergstrom Nutrition (Vancouver, WA), says Bergstrom’s branded OptiMSM is ideal for new products because of its relative affordability, strong safety profile, and proven efficacy.

“Extensive research has shown that MSM decreases joint pain, improves stiffness and swelling, and increases the range of motion and physical function of individuals with osteoarthritis,” Hammond says. “OptiMSM’s likely mechanism stems from its ability to decrease pro-inflammatory cytokines, reduce oxidative damage, and supply a rich source of sulfur.”

One 2017 randomized, double-blind, placebo-controlled trial

 examined the performance of a glucosamine-chondroitin sulfate product both with and without MSM in relieving symptoms of osteoarthritis. The subjects, all of whom had either grade I or grade II osteoarthritis according to the Kellgren-Lawrence scale, received either 1) 1,500 mg of glucosamine and 1,200 mg of chondroitin sulfate (n=49), or 2) 1,500 mg of glucosamine, 1,200 mg of chondroitin sulfate, and 500 mg of MSM (n=50), or 3) a matching placebo (n=48) daily for three months. The subjects were assessed for joint pain on the WOMAC and VAS scales at baseline and after 4, 8, and 12 weeks. By the end of the study, the group that received the combination of glucosamine, chondroitin sulfate, and MSM exhibited the most significant improvements in WOMAC and VAS scores.

Various botanicals are showing promise as joint health supplements in clinical trials. Several of these products may present considerable advantages over legacy ingredients. Steve Fink, vice president of marketing for PLT Health Solutions (Morristown, NJ), says botanical ingredients like 

 take effect faster and require a lower dosage than some of the established ingredients in the market.

“If we look at the most commonly used natural solutions for mobility support, two things stand out: they require relatively large doses, and they require a long time to show efficacy,” Fink says.

 extracts and other botanicals have been found to take effect in as little as five days and to be effective with doses as low as 100 mg. PLT’s branded 

Dynagenix Muscle+Joint Formula, is a low-dose joint health ingredient that can be formulated in RTD products, powders, and more. One 2019 randomized, double-blind, placebo-controlled clinical trial examined the effects of Dynagenix Muscle+Joint Formula in 50 healthy, active men aged 25 to 40. In this unpublished study, subjects received 60 mg of 

 per day (n=25), or a matching placebo (n=25), for 10 days. Subjects underwent an eccentric exercise regimen, which involves muscles contracting and lengthening in quick succession, on day 7. The subjects were assessed for muscle and joint soreness via the VAS, knee range of motion, overall stiffness, and biomarkers of inflammation like IL-6 and cytokines at baseline and once daily on days 7 through 10. The subjects who received 

 experienced a reduction in joint soreness and a faster recovery of knee range of motion relative to the control group.

Another rich source of emerging joint health botanicals is the world of traditional Chinese medicine. David Liu, PhD, is the chief technology officer for Chenland Nutritionals (Irvine, CA). Liu says the reputation of certain joint health ingredients in traditional folk medicine systems like traditional Chinese medicine and Ayurveda is prompting researchers to take a closer look at these ingredients.

“With the development and utilization of omics and bioinformatics in these research fields, the scientific implication of herbal formulas has been elucidated, which has led to a better understanding of and acceptance by the western science community,” Liu explains. “Herbs like 

Dioscorea nipponica, Andrographis paniculata, 

have been clinically studied for their efficacies in relieving joint discomfort related to knee osteoarthritis.”

Chenland recently completed a six-month, open-label human clinical trial on its JointAlive ingredient, which contains extracts of 

 Bunge. Liu says that in this yet-to-be-published trial, JointAlive was 85% effective at reducing WOMAC scores. He says this trial also found that JointAlive begins to relieve joint discomfort in as little as two days.

Chenland is also actively pursuing a randomized, double-blind, placebo-controlled clinical trial

 on JointAlive in partnership with KGK Science (London, ON, Canada). This study, which is currently recruiting participants, will examine the efficacy of JointAlive in alleviating joint pain and improving knee function in an otherwise healthy population with mild to moderate knee osteoarthritis. Liu says the last subject will be enrolled in September 2021, and a final report on the clinical trial is expected by the end of this year.

Formulators are also looking toward botanical ingredients that are quite well known for applications in food. Steve Holtby, president and CEO of Soft Gel Technologies Inc. (Los Angeles, CA), says one emerging joint health ingredient is better known for its role in making beer.

“Hops, the ingredient used to add a touch of bitterness to most brews, has been studied because of its joint health properties,” Holtby explains. Soft Gel Technologies’ Perluxan softgels, derived from hops 

 “contain a unique botanical anti-inflammatory agent that has been clinically demonstrated to quickly relieve minor joint pain.”

Soft Gel Technologies exclusively markets Perluxan as a resin. Pharmachem Laboratories (Kearny, NJ), a division of Ashland (Wilmington, DE) that has performed extensive research

 on Perluxan, owns the trademark for Perluxan as a powder.

One randomized, double-blind, parallel-design trial

 on 19 subjects pitted Perluxan against ibuprofen. The subjects were randomly assigned to receive either 1) 400 mg of ibuprofen once per day, 2) a softgel containing 450 mg of the hops resin once per day, or 3) a 300-mg capsule containing a powdered form of the hops resin four times per day, for 14 days. Both hops formulations inhibited COX-2 as well as ibuprofen starting nine hours after the initial dose; however, the hops formulations did not inhibit COX-1, while ibuprofen did.

“It was interesting to note that the hops resin softgel was only administered once over a nine-hour period but was as effective as ibuprofen,” Holtby says. “The Perluxan softgel had a faster onset of action and gradually reduced pain-causing enzymes over the period of the study.”

Other botanical blends are also showing promise in joint health. Indena’s (Milan, Italy) branded Mitidol, a blend of ginger 

 underwent a pilot study that was published in 2020. This study

, a single-group pretest-posttest quasi-experimental trial, examined the effects of Mitidol on pain, inflammation, and knee function in 50 subjects aged 40 to 75 with knee osteoarthritis. All subjects received two 350-mg tablets of Mitidol daily for four weeks (n=50); there was no placebo group. The subjects were assessed for WOMAC and Tegner Lysholm Knee Scoring Scale scores at baseline and after 15 and 30 days. They were also evaluated for pain on the Visual Analogue Scale, quality of life via the 36-Item Short-Form Health Survey, and biomarkers of inflammation via C-reactive protein and erythrocyte sedimentation rate testing at baseline and after 30 days.

The subjects saw a significant decrease in VAS scores in the left and right knees after 10 and 11 days, respectively. WOMAC scores also decreased throughout the study, from a group average of 44 to 38. The group’s average Lysholm score increased from 65 at baseline to 73 after 30 days, indicating an improvement in knee function.

While several of the studies on botanicals for joint health have focused on aging older adults, this market is beginning to see interest from younger consumers—and Annie Eng, CEO of HP Ingredients (Bradenton, FL), says the next generation of joint health supplement users is already looking for clinically validated preventative maintenance products.

“The joint support market continues on a fast track of development as the Millennial generation, who are very active and health-conscious, begin to be proactive about joint care,” Eng says. “To ensure they and like-minded older adults have access to products that work to preserve joint structure and promote joint function, we are launching a new human clinical trial.”

This new study, led by Juan Hancke, PhD, is a randomized, double-blind, placebo-controlled clinical trial. The study will examine the effects of daily consumption of HP Ingredients’ branded 

product, ParActin, on knee function in knee osteoarthritis patients. The study will follow the subjects for one year. Earlier this year, ParActin received a natural product license from Health Canada.

The joint health space is seeing significant disruption and innovation. Emerging ingredients are gaining momentum as clinical trials prove their efficacy, carving out a place in the market next to more established competitors. As the joint health market continues to grow, products like turmeric, botanicals, and collagen will gain further traction. As this space grows more competitive, success in joint health will depend on convincing consumers that your ingredient stands on a strong foundation of science.

Sidebar: Hyaluronic Acid Normalizes Synovial Fluid

Michael Grenner, sales manager of food and nutrition raw materials, North America, at Bloomage Biotechnology USA (Hawthorne, NJ), says natural, non-GMO, and organic ingredients are growing in the joint-health space.

Grenner says hyaluronic acid is showing up in joint health formulations in combination with MSM, chondroitin, and other ingredients. Bloomage’s Haplex Plus contains sodium hyaluronate, the salt form of hyaluronic acid (HA). Studies have shown that HA can normalize synovial fluid

, and protect cartilage from denaturation

opened the door for a new joint-health contender. A 2021 randomized, double-blind, placebo-controlled trial found that a 350-mg daily dose of Gencor’s (Irvine, CA) Levagen, a branded palmitoylethanolamide (PEA) ingredient, reduced Visual Analogue Scale scores for joint pain in healthy adults aged 25 to 70. While the placebo group (n = 39) also saw a reduction in scores, that reduction lasted only 10 days before scores began to rise again, while the PEA group’s (n = 35) scores decreased over the entire course of the study.

“PEA demonstrated in the study its anti-inflammatory and analgesic properties, along with its ability to influence the endocannabinoid system,” says Maggie McNamara, marketing director for Gencor. “PEA downregulates multiple pro-inflammatory and nociceptive pathways and is known to inhibit glial cell activity.”

Sidebar: New Form of Chondroitin Improves Knee Function in OA Patients

has a long history of use in joint health, concerns around sourcing are leading to innovations in this ingredient. Xavier Berger, marketing manager for mobility and joint health at Gnosis by Lesaffre (Lille, France), says consumer concerns around animal welfare and cross-contamination have prompted formulators to source chondroitin from plants. Gnosis’s branded chondroitin product Mythocondro is one example of this trend.

“Mythocondro helps reduce the risk of osteoarthritis and joint degeneration,” Berger says. “Additional benefits include pain relief, anti-inflammatory activity, and increased articular function.”

 on Mythocondro found that a 600 mg/day dose reduced inflammation, WOMAC scores, and C-reactive protein levels in obese adults with moderate knee osteoarthritis after eight weeks.

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Prospective single-center observational study of a new dietary supplement containing collagens type I, II, V, and X

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A combination of Tamarindus indica seeds and Curcuma longa rhizome extracts improves knee joint function and alleviates pain in non-arthritic adults following physical activity

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A randomized, double-blind, placebo-controlled, prospective clinical trial evaluating water-soluble chicken eggshell membrane for improvement in joint health in adults with knee osteoarthritis

Beneficial effects of natural eggshell membrane versus placebo in exercise-induced joint pain, stiffness, and cartilage turnover in healthy, postmenopausal women

Comparison of glucosamine-chondroitin sulfate with and without methylsulfonylmethane in grade I-II knee osteoarthritis: A double- blind randomized controlled trial

ClinicalTrials.gov Identifier: NCT04395547

Alternative joint-health ingredients are on the rise.

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The use of a new food-grade lecithin formulation of highly standardized ginger 

and Acmella oleracea extracts for the treatment of pain and inflammation in a group of subjects with moderate knee osteoarthritis

HP Ingredients’ ParActin granted product license from Health Canada for support of joint health

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Articles

Legacy ingredients are losing ground as emerging products gain validation. 

Joint health supplements: New ingredients are elbowing their way into the joint health market

If there’s a silver lining to the dark storm cloud that is the COVID-19 pandemic, it’s that it gave consumers time. Time away from the office. Time to cook at home again. And time to prioritize their health. The pandemic pushed Americans to focus on wellness and even revisit health issues that may have been put on the back burner. The good news? As life returns to almost-normal, consumers are eager to keep the holistic outlook they cultivated during quarantine. In fact, Mintel identified self-prioritization as one of consumers’ top priorities for 2021, citing the ongoing popularity of personal care and sexual health products, and the resurgence of “me time,” as proof of this shift.

 For the sexual health supplement market, all of this adds up to good news.

“Sex is a ‘feel good’ activity, and coming out of a pandemic when people are feeling more optimistic and ready to re-engage with their former full lives reignites sex drive,” says Annie Eng, CEO of HP Ingredients (Bradenton, FL). “The state of the market for sexual health ingredients remains strong, if not stronger [than in years past].”

According to market researcher SPINS (Chicago), sales of ingredients for vitamins and supplements marketed as intimacy products grew 9.35% during the 52 weeks ending July 11, 2021. Top performers included herbal formulations (up about 11%) and amino acids (up 18%).

Eng believes the main drivers at play here include a growing awareness of sexual wellness products, the increasing ease of purchasing those products, and the shrinking taboo surrounding sexual health issues.

“People are largely looking at sexual health as just ‘health,’ and it’s not a taboo subject to expect a healthy lifestyle to include healthy sexual activity,” agrees Charlotte Traas, board certified master herbalist and director of education for supplements brand New Chapter Inc. “This has a lot of new customers looking towards the supplement industry for natural ways to support a healthy libido.”

According to Shavon Jackson-Michel, director of medical and scientific affairs at DolCas Biotech LLC (Landing, NJ), consumers are elevating the importance of sexual health to that of physical and emotional health, partly because of a more liberal and open-minded generation, but also because the supplement consumer is “savvier than ever,” she says, “more educated, and willing to invest their time in researching where to put their dollars.” Because of this, successful marketing of sexual health products must evolve, too.

First, marketers must be mature, candid, and straightforward. “Communication on sexual health has evolved from the days of referring to our sexual organs by cute pet names,” says Traas. “Consumers are more comfortable and aware of their bodies and how they function, so talking about sex with an educational approach married with practicality is important. Respecting your body includes respecting your sexual health, so approaching the topic with dignity is important for credibility.”

Plus, science must be front and center, especially as FDA recently warned consumers to avoid certain male enhancement products due to hidden, potentially dangerous drug ingredients, casting doubt on the entire market.

Category mainstays like ashwagandha, ginseng, arginine, fenugreek, and sea buckthorn remain fertile ground for researchers as brands seek clinical substantiation for traditional and folk claims.

Fortiquin is a relatively new ayurvedic blend from DolCas Biotech for male sexual stamina and endurance. It features a variety of time-tested botanicals, including fenugreek, mucuna, ashwagandha, globe artichoke, and L-arginine. In a recent study, the effects of 1 g per day of Fortiquin were examined against placebo in 60 subjects over the course of eight weeks.

 Recruited participants started the study with baseline values of two minutes of sexual duration. By the end of the eight weeks, the men taking Fortiquin experienced a statistically significant 5.1-times increase in sexual stamina.

HP Ingredients’ longstanding ingredient LJ100 

 (tongkat ali) was the subject of another recent study, validating that supplementation preserves normal reproductive hormonal production and interaction.

 In the placebo-controlled, double-blind study, 32 healthy young men (average age 24.4 years) consumed either 600 mg LJ100 or placebo daily for two weeks. Researchers found that LJ100 was able to increase testosterone even in healthy young men when consumed in high doses. Significant increases in testosterone (14%) and free testosterone (34%) were recorded after two weeks.

Draco Natural Products’ (San Jose, CA) BaZiBuShen formula (BZBS), based on the traditional Chinese medicine concept of balancing yin and yang ingredients, was recently found to preserve testicular morphology and spermatogenesis in a rapid aging mouse model.

 Researchers posit that this outcome is a result of the ingredient’s ability to inhibit oxidative stress.

Continued research will be the way forward for this category, says Kartikeya Baldwa, CEO of Ixoreal Biomed Inc. (Los Angeles), which markets science-backed KSM-66 ashwagandha—especially as a new generation of educated supplement consumers turns its attention to sexual health support.

“More human clinical studies may help to establish some long-term bestsellers,” he says, “but in general this category has been so filled with bogus claims and poor products, we will need years of education and science to clean up the situation.”

If you ask Paul Clayton, scientific advisor for Gencor (Irvine, CA), the future of the sexual health supplement category won’t focus on hero ingredients; rather, supplements that support lifestyle and dietary changes with a blend of beneficial ingredients will find favor.

“We have had a lot of requests about our traditional formulas for female and male libido, more so than even single ingredients,” agrees Brien Quirk, director of research and development at Draco Natural Products, where yin tonic herbs with ancient libido-boosting benefits like rehmannia root, Chinese yam, asparagus root, and Solomon’s Seal root have been in demand.

Formulators and brands can also expect sexual health supplements to include other nutrients that offer holistic benefits, like vitamin D. “Expect the conversation of immune health to enter into our [conversations around] sexual health,” says New Chapter’s Traas. “The healthier your body is, the more likely you’ll improve your sexual function.”

.” Mintel.com. Published online January 20, 2021.

FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients

A randomized double-blind placebo-control study to assess the efficacy and safety of OLNP-05 versus placebo for the treatment of subjects with premature ejaculation

vol. 23, no. 9 (September 2020): 1006-1013

 on the regulation of reproductive hormones in young males

BaZiBuShen alleviates altered testicular morphology and spermatogenesis and modulates Sirt6/P53 and Sirt6/NF-κB pathways in aging mice induced by D-galactose and NaNO2

Blends and whole-body formulations resonate with today’s consumers over single ingredients.

Sexual health supplements go holistic

New product development in food is challenging the limits of food technology as manufacturers strive to offer products with improved taste and texture. Starches play a huge role in the quality and consistency of finished products. “Starches are the workhorses of the texturizing world, responsible for the gelling, thickening, and water-binding properties needed to create the tantalizing textures consumers love,” says Shiva Elayedath, senior technical services manager for Cargill (Minneapolis, MN). “Historically, we relied on modified starches, but in recent years, they’ve fallen out of favor with some consumers.”

For this reason, ingredient manufacturers have been hard at work developing functional clean-label starches that formulators can use to develop products that are not only clean-label but offer optimal texture. Cargill’s SimPure line of functional native starches, for example, offers high levels of process tolerance, allowing formulators to replace modified starches in a range of applications.

Compared to modified starches, however, clean-label starches are the minority, still requiring a good deal of research and development to achieve parity with modified starches despite the huge strides already made. “Consumer preferences aside, modified starches continue to have the edge with products that require enhanced process stability, such as dairy applications that must withstand high-shear or frozen applications with long shelf lives,” says Elayedath.

This is also true of plant-based meat and dairy alternatives, a category seeing immense consumer demand—which means increasing consumer standards as well as market competition.

“Plant-based alternatives definitely have formulators pushing the limits of what can be accomplished as they strive to create vegan cheeses that melt, stretch, and shred, and launch meat alternatives with the bite, succulence, and sliceability of their animal-based counterparts,” says Elayedath. “In response, ingredient suppliers are investing in R&D, looking for label-friendly solutions that address today’s texturizing challenges.”

Of course, not all products need high process tolerance, creating many opportunities for brands to differentiate from competitors by using clean-label starches that are easier to work with. Brands need to evaluate their needs and what they believe their end consumer will want. For example, in the natural product space, conscientious shoppers who read labels want to see simple ingredients they recognize rather than food additives. For brands competing for these shoppers, clean-label solutions are super important.

There are, however, many consumers who are relatively unconcerned about the ingredient deck than with the taste and texture of the product. “Nutritionally, there’s no difference between a modified starch and a label-friendly native starch. Some consumers, however, perceive label-friendly starches as a ‘less processed’ or more ‘natural’ choice,” explains Elayedath. “While modified starches rarely enable additional label claims, they can help brands create products with smooth, creamy, indulgent textures that are able to endure all kinds of harsh processing conditions. As consumers seek out products that deliver unique sensory experiences, there can be an opportunity for brands to tout these textures with ‘romance language,’ drawing consumers in with enticing, descriptive wording.”

The calculus behind the decision to use modified or clean-label starches will be unique to each company, with each option offering its own advantages and disadvantages. The key is to know your customers and effectively market your products’ qualities to capture their attention.

The decision to use modified or clean-label starches will be unique to each company, with each option offering its own advantages and disadvantages.

Modified versus clean-label starches: Which do you choose?

The fertility supplements market has been fraught with peril as of late. In March 2021, BBB National Programs announced that fertility supplement company FertilitySmart (Dover, DE) 

 seven advertising claims and several consumer testimonials in response to a challenge brought by dietary supplement association the Council for Responsible Nutrition (Washington, DC).

 Two months later, in May, FDA and the FTC issued joint 

 to five fertility supplement brands that had made illegal disease-treatment claims.

When bad actors in a particular category make unsubstantiated or illegal product claims, it makes credibility and validation all the more important for other brands. Manufacturers and marketers who can substantiate product claims with clinical research stand to benefit from the gap in the market left by the pretenders. Here are some of the fertility ingredients that are demonstrating efficacy in clinical trials.

Folate has long been linked to fertility and is a common ingredient in fertility supplements and various fortified foods. Not all folate, however, is created equal.

Silvia Pisoni, market manager, reproduction and women’s health, for Gnosis by Lesaffre (Lille, France), says most of the folate found in dietary supplements and functional foods is folic acid, an inactive compound that is not readily absorbed in the body.

“The folate naturally contained in food tends to be unstable and susceptible to oxidation, losing activity during processing, manufacturing, and storage,” Pisoni says. “That’s why folate is often utilized in fertility supplements [rather than functional foods]. But to ensure the best results, it’s critical that the folate used is active folate.”

Recent research linked an impairment in the folate cycle through methylenetetrahydrofolate reductase 

MTHFR) C677T polymorphism to infertility in both women and men, Pisoni says. This impairment limits the body’s ability to convert folate into its bioactive form, methyltetrahydrofolate (5-MTHF).

 published in 2018 followed 33 couples with a history of fertility problems lasting at least four years. The couples had experienced several different fertility problems, including abnormal sperm, fetal loss, or premature ovarian insufficiency. Twenty of the couples had previously attempted and failed to conceive using assisted reproductive technology (ART). One or more of the partners in each couple carried an MTHFR isoform. A majority of the female participants had previously received a course of high-dose folic acid (5 mg/day) without success.

For this case series, 33 women and 29 men received one daily dose of a combination product containing Parthenogen’s (Lugano, Switzerland) branded Impryl B vitamin complex, Nurilia’s (Lyon, France) branded Tetrafolic chelated zinc, and 800 micrograms of Gnosis’s branded Quatrefolic ingredient. Quatrefolic is a 5-MTHF glucosamine salt, a folate derivative and structural analogue of 5-MTHF. The subjects followed this regimen for four months before attempting spontaneous conception for two months and then beginning a 74-day round of assisted reproductive technology treatment.

Thirteen couples, or 39%, reported spontaneous conception by the end of the four-month intervention period. Another 13 couples reported pregnancy attained after ART treatment. One couple was not followed up with, and two couples were still receiving ART treatment at time of follow-up. The study authors determined that 5-MTHF glucosamine salt may be able to eliminate the need for assisted reproductive technologies.

Pisoni says it’s critical that fertility brands have clinically validated data behind their products. It’s this data, she says, that will give consumers the confidence to select a fertility supplement that meets their needs.

Product Development, Research Protocols Advance

Research on natural fertility ingredients has become more advanced in recent years, which has opened up new avenues for brands. Nicole Avena, PhD, is a New York–based research neuroscientist who studies prenatal and early-life nutrition. Avena is also the author of 

What to Eat When You Want to Get Pregnant, 

a fertility nutrition book for consumers that was published in March 2021.

Avena says that a new push to include more women in clinical trials, especially pregnant women, has been a boon for fertility research. “This is huge,” Avena says. “When it comes to fertility, it’s essential to be able to work with pregnant women to understand how the baby is doing during pregnancy, not just when it’s born.”

Fertility ingredient formulations have also advanced in a way that gives formulators more flexibility with delivery systems, Avena notes. Fertility supplements now come in the form of pills, gummies, functional foods, and powdered drink mixes.

Several fertility ingredients are currently trending as a result of ongoing research. Avena points to cassava (

), a South African tuber and a source ingredient for tapioca pudding, as an example of an emerging fertility ingredient that merits more in-depth research. “Cassava is believed to increase ovulation and increase the chance of having twins,” Avena says. “But the research is extremely limited in humans.”

Myo-inositol as another trending fertility ingredient for women. Research indicates it may help improve fertility in those undergoing 

fertilization. Avena says there is some evidence to suggest that ingredients like ashwagandha, maca root, zinc, and certain ingredients derived from the chaste tree (

Health Claims: Staying on FDA’s Good Side

Given that fertility supplements are an active area of ongoing FDA enforcement, brands in this space must devote special attention to regulatory requirements. In order to make a health claim on a supplement, a brand should be able to substantiate that claim, Avena says.

In some cases, a health claim can fall into the category of a qualified health claim, which has less evidentiary support than an FDA-authorized claim. However, Avena says the distinction between authorized and qualified claims isn’t as clear to consumers as it is to those in the industry. “Qualified health claims must come with a disclaimer that discloses the amount of evidence there is to substantiate the claim,” Avena explains. “Not providing such a disclaimer not only goes against the FDA dietary supplement guidelines but is also misleading to the consumer.”

The fertility ingredients market is full of promise for clinically validated ingredients. Research and development are fueling interest in a diverse array of fertility supplements, both in terms of active ingredient and product format. Some brands are now launching synergistic fertility blends, expanding the market beyond single-ingredient products. As further clinical studies reveal which fertility ingredients are the best validated, expect the fertility market to offer more opportunities for credible brands.

Certain Advertising Claims for FertilitySmart Conceive for Women Dietary Supplement Permanently Discontinued Following NAD Challenge

United States Food & Drug Administration press release. “

FDA, FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming to Treat Infertility

MTHFR isoform carriers. 5-MTHF (5-methyl tetrahydrofolate) vs folic acid: A key to pregnancy outcome: A case series

Journal of Assisted Reproduction and Genetics, 

Fertility supplements are establishing much-needed credibility through research.

Fertility supplements: Growing research and credibility

When it comes to the digestive health market, ingredient suppliers are doing more than just trusting their gut. They’re paying attention to market reports and gauging consumer interest, seeking to better understand the gut-brain connection, and exploring market expansion with new delivery methods, partnerships, and ingredients that complement the tried and true.

All in all, it’s adding up to a rosy post-COVID future for ingredients that may help comfort tummy woes, ease digestion, and play a role in general health and wellness.

“More people understand good digestive health is important for overall well-being, including immune function,” says June Lin, global vice president, marketing, health and wellness, ADM (Chicago). “Demand for digestive health products continues to grow, with a five-year compound annual growth rate (CAGR) of 2.5% and a 100% increase in new product launches with digestive health claims from 2015-2020.”

Rich Pelzel, business manager, Elemend Health LLC (Eden Prairie, MN), points to even better news for the market category from Grand View Research which, he says, shows that “the global dietary supplement market size was valued at $140.3 billion in 2020 and is expected to expand at a CAGR of 8.6% from 2021-2028.”

It’s not just companies in the industry that have a growing appreciation for the impact that a healthy gut can have on so many other things happening in our bodies.

For example, Sam Michini, vice president of marketing and strategy, Deerland Probiotics & Enzymes (Kennesaw, GA), finds that “consumers are learning and accepting that a healthy gut can impact immunity, mood, energy, and even skin.” He adds that more people are turning to digestive health ingredients to help support their overall wellness. “Google Trends shows that interest in the search term ‘digestive health’ has risen steadily over the past five years,” Michini adds.

Granted, while the lion’s share of the digestive health supplements market is still rooted in probiotics, their popularity piqued consumer interest overall in the broader category and created an opportunity for companies to look at the market from a different perspective.

Anurag Pande, PhD, vice president, scientific affairs, Sabinsa Corp. (East Windsor, NJ), explains it this way: “The digestive system is one of the largest organs in the body. Products to support healthy digestive function constitute a major dietary supplements category.”

It’s an exciting time to be in the gut health market.

Nutritional Outlook Vol. 24 No. 7

Joint health supplements: New ingredients are elbowing their way into the joint health market

Sexual health supplements go holistic

Modified versus clean-label starches: Which do you choose?

Fertility supplements: Growing research and credibility

Gutsy Moves: The best digestive health supplements are yet to come

Let the good times last: Can the botanicals market maintain momentum through 2021 and beyond?

Switching Gears: COVID crimped sports routines, but it didn’t stop sports-nutrition needs

Curcumin as a stress and sleep management supplement

Mineral Glow-Up: The growing popularity of minerals, COVID and beyond

Black seed’s immune-health benefits get scientific validation

Bad news for CBD: FDA objects to two NDI notifications for full-spectrum hemp ingredients

How COVID-19 shaped botanical adulteration