In the natural products industry, women have overshadowed men. Women's health issues, including breast cancer, osteoporosis and menopause, are talked about much more frequently than conditions affecting men, and more research dollars have been devoted to women as well. In fact, the National Cancer Institute (NCI), Bethesda, MD, in 2002, spent $522,000,000 on breast cancer research, compared to $278,400,000 for prostate cancer. This discrepancy is reflected in the variety of gendered products in the market where there is a much wider selection available for women. In addition, the Office of Women's Health was established within the U.S. Department of Health and Human Services (HHS) in 1999, however, it was not until last year that Congress proposed the Men's Health Act of 2003 to amend the Public Health Service Act to establish an Office of Men's Health within HHS to help improve the quality of life for men.


Men's Health Issues
Are women more innately concerned, or "in tune", with their bodies and men conditioned culturally to suppress their problems? Or is it because women do most of the shopping that marketers set their sights upon them more often? The lines separating genders, culture and marketing may be hazy, however, one thing is certain: there is a silent health crisis affecting the health and well-being of men.

When compared to women, men have a shorter lifespan and also have a higher death rate for each of the top 10 leading causes of death. In the Men's Health Act of 2003, Congress reported that the life expectancy gap between men and women has increased from one year in 1920 to almost six years in 2001. Confronted with such evidence, steps have been taken by industry and government to promote a more widespread recognition of men's health issues. In addition to Congress' proposal to establish an Office of Men's Health, other initiatives have been put into action, such as the "Shoot for 9" program set forth by NCI to get men to eat nine servings of fruits and vegetables a day. According to NCI, men only eat about four-and-a-half servings of fruits and vegetables a day on average and only 4% of men say they eat the nine servings of fruits and vegetables a day recommended as part of an active lifestyle. In addition, men are significantly less likely than women to recognize the health benefits of fruits and vegetables.

According to Mitch Skop, sales and new product development, Pharmachem Laboratories, Kearny, NJ, the market for quality men's products is steadily growing, but the challenge is getting the male consumer to understand the direct health benefit of a product and how easy it is to maintain his health. "For the business to thrive, this message has to be driven home to men the way it is to women," he said. "Women's products are widely recognized and understood, but I think men's health products have been left behind and that is because of the lack of marketing focus geared toward men's products."

Karen Todd, senior marketing manager, DSM Nutritional Products, Inc., Parsippany, NJ, says the growth potential in the men's health market is huge. "Five years ago you couldn't find too many products for men's health, but now it is common to see a handful of products on the shelf targeted toward them," she said. "It's still a small market, but it is growing and expanding as new research becomes available. The question we face is how do we get men to take multiple tablets instead of just one multivitamin?"

As men become more aware of their well-being, prostate health and sexual function are two areas of concern for aging men that have continued to grow over the years into two of the major trends in the men's health arena. Both conditions represent two separate categories of nutraceuticals, however, prostate health and sexual function are inextricably linked together. Because of its anatomical position, a swollen prostate can drastically interfere with a man's sex life.

Prostate Wellness
The prostate is a male sex gland about the size of a walnut that lies below the bladder and surrounds the urethra, which carries urine from the bladder out through the tip of the penis. The prostate gland is responsible for secreting prostatic fluid, which is a major component of the male seminal fluid that increases sperm mobility and lubricates the urethra to prevent infection.

Prostate cancer is the most frequently diagnosed cancer in the U.S. among men, accounting for 30% of all cancer cases in men. An estimated 180,000 men will be diagnosed with prostate cancer this year and over 30,000 will die. However, despite the severity of this growing epidemic, according to the National Prostate Cancer Coalition, only about 7% of federal cancer research dollars have been devoted to beat the disease.

Benign prostatic hyperplasia (BPH) is another condition affecting the prostate. BPH is a non-cancerous condition where the prostate becomes enlarged. An enlarged prostate pinches off the urethra causing a number of uncomfortable symptoms. The American Urological Association estimates that half of all men ages 50-60 and up, to 90% of men over the age of 80, suffer from BPH. Once diseases of the elderly, prostate cancer and BPH are being diagnosed increasingly in men in their 40s and 50s. Medical treatment of BPH is available, however, the use of supplements as adjuvant therapies to manage prostate health is becoming more common.

Flax. Flax lignans are phytonutrients found in unrefined grains, legumes, certain vegetables and seeds that act as powerful antioxidants and phytoestrogens, which can have a balancing effect on hormones. Studies have shown that flaxseed is one of the richest sources of lignans, providing up to 800 times more than any other plant.

The exact cause of BPH and prostate cancer is unknown, but male hormones seem to play a role, according to Jocelyn Mathern, technical specialist, Acatris, Inc., Minneapolis, MN. "In the body, testosterone is converted into a more potent form called dihydrotestosterone (DHT). Normal, healthy prostate cells require DHT for growth," she explained. "However, it is thought that too much of the hormone can cause abnormal growth, leading to an enlarged prostate (BPH) or causing prostate cancer cells to divide. Therefore, maintaining prostate health depends on balancing the levels of these hormones."

Ms. Mathern went into further detail explaining the role lignans may play to offset BPH and prostate cancer. "Because lignans are phytoestrogens, they may play a valuable role in influencing hormone metabolism, including testosterone," she said. "Because testosterone and its metabolites are linked to the development of BPH and prostate cancer, lignans may help maintain a healthy prostate by influencing the metabolism of these hormones."

Research has demonstrated that lignans from flax can contribute to prostate health naturally. One study found that lignan concentrations in the prostatic fluid of men are significantly higher in populations at low risk of prostate cancer, compared to those at increased risk. In a Duke University Medical School study, men with prostate cancer were given flaxseed for 34 days. At the end of the study, the men had a reduction in testosterone levels, lower rates of cancer cell growth and a trend toward lower prostate specific antigen (PSA) levels-a marker for prostate cancer. Another study, using purified lignans derived from flaxseed, found that lignans inhibited the growth of human prostate cancer cells in a test tube.

Lycopene. Lycopene is the main active constituent in tomatoes, and it has been gaining attention in prostate cancer research. However, there is some debate within the industry as to which is better-lycopene alone or lycopene in combination with other natural phytochemicals found in tomatoes.

LycoRed-Biodar USA, New York, NY, supplies Lyc-O-Mato, an all-natural extract of tomatoes standardized to contain 6% lycopene, in addition to a variety of other phytonutrients that occur naturally in tomatoes, including beta-carotene, tocopherols, phytosterols, phytoene and phytofluene. According to the company, research published in the November 5th issue of the Journal of the National Cancer Institute, indicated that a combination of the natural phytochemicals found in tomatoes, not just lycopene alone, can help lower the risk of deaths resulting from prostate cancer. The study conducted by researchers from the University of Illinois, Urbana-Champaign, and Ohio State University of Columbus, showed that rats fed diets containing whole tomato powder, which contained all the important tomato phytonutrients, had a lower risk of death from prostate cancer than rats fed diets containing synthetic lycopene.

Scientists from DSM Nutritional Products, I nc. have also recently released research about lycopene's role in reducing the risk of prostate cancer. In a study, which was published in the April issue of the FASEB (Federation of American Societies for Experimental Biology) Journal, DSM scientists found that pure lycopene significantly reduced the effect of the male hormone androgen on the prostate. According to the company, androgens are thought to play a key role in the development of prostate cancer in men over a lifetime. In co-operation with the Charite Hospital in Berlin, Germany, scientists used an animal prostate cancer model to mimic human cancer. The animals were fed lycopene, vitamin E, a combination of both or a placebo mixture for four weeks, and then received an injection of prostate cancer cells into their prostates. These cancer cells grew into tumors within two weeks. Feeding lycopene, as well as vitamin E, caused an enhanced killing rate of tumor cells, which was shown by larger areas of dead tissue in the prostate tumors.

According to DSM's research leader, James Elliot, researchers found that lycopene interfered with local androgen activation by down-regulating 5-alpha-reductase, the key enzyme for the transformation of testosterone to DHT. In addition, lycopene decreased the expression of two prostatic cytokines, IGF-I and IL-6, both regarded as risk factors for prostate cancer.

Saw Palmetto. Saw palmetto, which comes from the berries of the fan palm, Serenoa repens, has remained a mainstay in the area of men's health over the years due to its long track record in reducing the severity of BPH. Well designed clinical studies have established that saw palmetto extracts can provide relief from symptoms of BPH, comparable to standard prescription medications. It is the lipophilic fraction containing fatty acids and sterols that are considered the active fraction of saw palmetto, which work to inhibit 5-alpha-reductase and prevent DHT from binding to androgen receptors.

In one study, researchers compared a saw palmetto extract with finasteride, a conventional BPH drug. The study involved 1098 men diagnosed with BPH, and researchers concluded that both treatments relieved BPH symptoms in about two-thirds of them. Finasteride is a specific 5-alpha-reductase inhibitor, and while saw palmetto is not as strong, it is thought that because of its actions, it is just as effective in mild to moderate BPH. However, while the finasteride reduced the prostate size, it also decreased sex drive and potency. On the other hand, saw palmetto displayed no such side effects and has even been sold as an aphrodisiac to increase sexual performance.

While the market for saw palmetto has grown steadily over the years, it did face a decline a few years back because of an influx of cheap, commodity ingredients. According to Gregory Zaino, president, Saw Palmetto Berries Co-op, Naples, FL, there was a lot of over supply of product, which drove prices way down. "The market was very cheap because of competition. Prices were driven down to $39 per kilo from $150," he said. "However, that trend has reversed and the market is back up around the $70 mark this year."

Chuck Wanzer, vice president of sales, US Nutra, Eustis, FL, also maintains a positive outlook for the future. "Every male over 50 should be taking saw palmetto," he said. "The word has spread that it is a botanical that really works without any negative side effects." However, Mr. Wanzer says that while awareness has grown steadily every year, in addition to positive reports, it still has to fight the label of a commodity ingredient. The only solutions to this problem, according to Mr. Wanzer, are good scientific studies backed with marketing and advertising dollars to push the market forward.

Going into further detail, Pharmachem's Mr. Skop added that due saw palmetto's commodity status, the market is so competitive. As a result, there is not much margin in selling a saw palmetto product at retail, and nobody has continued to educate men about it, which is why it's fallen off from where it was a few years ago. "We used to sell quite a bit more standardized saw palmetto extract than we do now and I'm sure that reflects market trends at retail too," he said. "It's an ingredient that is safe and very effective, but the market needs a leader that will educate men and bring it back."


Sexual Support
For men, especially those fighting prostate cancer and BPH, sexual health is a major concern as they grow older. The lack of sexual performance and loss of sex drive typically increases naturally as men age.

Almost half of all men experience impotence occasionally, according to Yousry Naguib, manger of new product development, Soft Gel Technologies, Inc. (SGTI), Los Angeles, CA. "Impotence is defined as a consistent inability to achieve or sustain a penile erection sufficient for sexual intercourse," he explained. "Aging is most often associated with impotence. About 5% of men at the age of 40, and 15-25% of men at the age of 65, experience impotence. However, impotence is treatable in all age groups." SGTI offers an all-natural herbal sexual enhancer, Amorin, which contains a proprietary blend of herbs like horny goat weed, yanhusuo, yohimbe and tribulus.

The problem with the sexual function ingredients category, according to Mr. Naguib, is that consumers want fast results, which can be achieved with something like Viagra. "When you tell people they have to take a product for a month or two, and they may or may not see improvement, they get disappointed and it turns them off. People always want to compare things to Viagra, so unless there is a comparison study, this will remain a marketing challenge," he said. "Another thing that hurts the category is the amount of outlandish claims made on products, which make it hard to gain consumer confidence."

The biggest trend in the sexual function ingredients market is that companies are moving away from virility supplements with nasty side effects, according to Pharmachem's Mr. Skop. "About a year ago companies started moving more toward ingredients with fewer side effects," he said. "Most larger companies are shying away from controversial men's ingredients like yohimbe, in favor of ingredients that are more likely to achieve the goal safely."

Alex Moffet, president, Renaissance Herbs, Inc., Chatsworth, CA, also discussed the category's move towards safer ingredients. "Sexual function ingredients constitute one of the strongest categories in the industry, but it wasn't long ago that the only aphrodisiac herb with any western-based clinical research to back it up was yohimbe, which became the subject of several placebo-controlled clinical trials demonstrating its efficacy. Since side effects of yohimbine, the major active, became apparent, including high blood pressure, headache, anxiety, diarrhea, dizziness and others, the herb has been largely replaced with safer botanicals for sexual health, " he said. "Today, the category has evolved from herbal supplements without any placebo-controlled clinical trials to back them up, to the present where a growing number of traditional treatments used for sexual function are finally undergoing quality research."

There are several factors contributing to the attention and growth of the sexual function ingredients market, according to Mr. Moffet, including an aging population, a growing world market for botanicals, bioassays that allow herbs to be more readily screened for potential sexual activity-enhancing properties, phytochemical methodologies that allow for rapid characterization of active constituents and the growing need for and awareness of less costly ways to optimize one's own well-being. "Taken together, these factors foretell a steadily growing market that will become increasingly competitive as research distinguishes the most effective and beneficial botanicals in this category," he said.

Horny Goat Weed. Horny goat weed is a time-tested aphrodisiac that is known in China as Yin Yang Huo. This name comes from the Chinese myth about an animal called yin yang, which is reported to have one hundred sexual climaxes every day after taking the herb. Known also as epimedium, because, explained Mr. Naguib, it is akin to a plant found in the ancient southwest Asia kingdom of Media, now a part of Iran, it has been shown to increase libido in men and women, as well as improve erectile function in men. Horny goat weed was first described in ancient classical Chinese medicinal texts and today holds an important place in Traditional Chinese Medicine (TCM) . Used by practitioners for over 2000 years, horny goat weed, which grows most abundantly at higher altitudes, contains a variety of flavonoids, polysaccharides, sterols and an alkaloid called magnaflorine in its leaves, however, its mechanism of action is not known for sure.

According to Mr. Naguib, research has shown that animals that took Epimedium breviconum had an elevated level of adrenaline, noradrenaline, serotonin and dopamine. "The pro-sexual effect of the herb was ascribed to the increased level of dopamine, which helps to release the leutenizing hormone from the pituitary gland, which in turn stimulates the testes to produce testosterone," he said.

Going into further detail about horny goat weed's mechanism of action was Mr. Moffet. "Based on activity studies in animals, horny goat weed may be contributing to healthy sexual function by enhancing peripheral circulation, and through androgenic, vasodilatory and neurological activities involving the potentiation of various neurotransmitters, including dopamine, norepinephrine and serotonin," he explained. "Among its active constituents, a flavonoid known as icariin was shown to relax the smooth muscle of the corpus cavernosum, an effect known to facilitate an increase of blood flow in the penis. Icariin was recently shown to significantly inhibit cyclic nucleotide phosphodiesterases (PDE5 and PDE4), an action that would spare cyclic GMP, which is needed to signal smooth muscles of the penis to relax. In rabbits, icariin produced significant increases in cGMP levels of the clitoris and the corpus cavernosum of the penis."

Yohimbe. Yohimbe is a popular herb coming originally from South Africa, and is widely known for its aphrodisiac properties. Yohimbe comes from the inner bark of the tropical West African tree, Coryanthe Yohimbe. Natives of South Africa have used the bark of the tree for centuries to enhance sexual performance and pleasure. Yohimbe has been shown in several double-blind studies to help treat men with impotence.

However, yohimbe is not recommended for excessive or long-term use, according to Mr. Naguib, and it may potentiate MAO inhibitors and hypotensive drugs. "Yohimbe has received some negative press for possible side effects, which could result in a rise in blood pressure if not used as recommended," he said. "The safe daily dose of the active component in yohimbe-yohimbine-is 15-30 mg."

Tribulus. Tribulus terrestris has been gaining in popularity for its ability to raise testosterone levels. According to Brian Alexis, president, Pharmabul, Santa Monica, CA, tribulis has been used for centuries in ancient Greece, India and the Balkans as a medicinal herb for treating a variety of health problems, including loss of libido, impotence, infertility, loss of muscle strength, heart problems and immune system ailments. Tribulus terrestris is sold under the trademark Trilovin 250 by Pharmabul. Outside of Bulgaria, only Pharmabul has the scientific background and trade rights for the development of the Bulgarian formula.

Renaissance Herbs' Mr. Moffet said that clinical studies on the sexual activity-enhancing effect of tribulus have shown that an extract of the herb standardized to contain protodioscin, a saponin constituent, improved libido in men with impotence due to various causes; libido in women with menopausal symptoms; and sperm motility in infertile and subfertile men.

Going into further detail, Mr. Alexis said the active phytochemicals in Bulgarian Tribulus terrestris might treat various sexual disorders and regulate sexual energy levels and strength by increasing the percentage of free testosterone levels in men. "Studies in Bulgaria have shown Trilovin to have considerable effects on the serum levels of the luteinizing hormone and the follicle-stimulating hormone (FSH)," he said.

In one study involving 59 men, ages 22-67, suffering from a range of sexual dysfunctions, Trilovin was prescribed three times daily, totaling 750 mg per day. All of the men were followed for a minimum of 90 days, and in cases of severe dysfunction or sterility, up to six months. An increase of sexual desire and fantasies, as well as sexual self-confidence, were reported in almost all of the patients. The subjective experience of pleasure, joy and satisfaction was reported in 80% of the men; erection improved in over 75% of the men; and the duration of intercourse before ejaculation was prolonged in 25% of the men.

Maca. Maca, or Lepidium meyenii, is a plant that grows in Peru's Andean mountains at altitudes of more than 10,000 feet and has been used for centuries by native Peruvians for both nutrition and medicinal purposes. During the Incan Empire, maca was cultivated for use as both a nutritious food and for its enhancement of energy and sexual function. Today, as a nutritional supplement, maca has been gaining increasing attention, as research touts the plant's ability to enhance overall energy, strength and libido, as well as the fertility and sexual performance of men and women.

According to research conducted by Qun Yi Zheng, president, and his colleagues at Pure World Botanicals, South Hackensack, NJ, maca contains macamides and macaenes, the novel compounds believed to impart maca's sexual enhancement properties. Pure World markets MacaPure, a concentrated extract of maca standardized to contain 0.6% macamides and macaenes. Through a series of animal experiments, researchers at Pure World have demonstrated that rats fed MacaPure extract increased their energy and stamina. The rats also showed an increase in their levels of sexual activity compared to those that were not fed MacaPure.

Dr. Zheng said that because maca is a relatively new nutraceutical, its mechanism of action is not well known, but the number of studies conducted on maca are growing and sales figures over the past few years reflect maca's growth in the market. "Since 2000, 68 studies have been conducted on maca, which support its ability to improve fertility and sexual function," he said. "Additionally, in 2000, maca sales were below $1 million, however, between 2002 to 2003, sales grew to $20-$30 million."

According to Ellen Schutt, marketing director, RFI Ingredients, Blauvelt, NY, the market for maca is growing, however, it must overcome some hurdles in order for growth to continue in the future. "I believe awareness of maca is growing in the U.S., but there are still challenges to overcome in terms of the stigma attached to the 'sexual function' category," she said. "I believe that as more research is done on the ingredient, the level of usage will increase as consumers become more comfortable with the scientific basis upon which this ingredient is based."