QUESTIONS ON HORMONES
A hormone is a chemical substance, secreted directly into the blood, which carries them to organs and tissues of the body to exert their functions. Some of the major endocrine glands in the body include pituitary gland, thyroid, testes and ovaries
There are many types of hormones that act on different aspects of bodily functions and processes. Some of these include the growth, sexual function & reproductive growth and cognitive function and mood.
The amount and levels of hormones change daily. The sex hormones, estrogen and testosterone, are secreted in short bursts, and vary from time to time (between night and day). Very slight imbalance of hormone secretion can lead to disease states.
Testosterone is secreted by the testis in humans Testosterone belongs to a class of male hormones called androgens. But women also have testosterone. The ovaries produce both testosterone and estrogen. Relatively small quantities of testosterone are released into the bloodstream by the ovaries and adrenal glands.
Testosterone is a powerful hormone. low testosterone levels can cause changes in sexual function, including: reduced sexual desire, or low libido, fewer spontaneous erections, impotence (erectile dysfunction), infertility. Testosterone is converted in many target tissues to the much active DHT.
Both men’s and women’s bodies produce androgens, but in different amounts. In a woman’s body, androgens are converted into the female hormones estrogens.
The principal androgens are testosterone and androstenedione. They are present in much higher levels in men and play an important role in male traits and reproductive activity. Other androgens include dihydrotestosterone (DHT), dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEA-S).
DHEA, regarded as the ‘fountain of youth’, is the major secretory product of adrenal gland, (although the testis produces a small quantity). DHEA is metabolized to form dehydroepiandrosterone sulfate (DHEA-S) and both hormones are metabolically interconvertible.
In general, androgens are essential for the development of the male external genitalia, the male secondary sexual characters and also in the regulation of erectile response. Sexual desire and activity as well as the nocturnal penile erections are dependent on the circulating androgen levels.
In women, androgens are produced in the ovaries, adrenal glands and fat cells. Women may produce too much or too little of these hormones. Disorders of androgen balance (excess or deficiency) are among the more common hormonal disorders in women. In adult women, androgens are necessary for estrogen synthesis and have been shown to play a key role in the sexual desire & satisfaction and cascade that kick-starts puberty,
Low androgen levels result in low libido and decreased sense of well-being. Androgen levels begin dropping in a woman’s 20s, and by the menopause time, the decline could be 50 percent or more from their peak as androgen production declines in the adrenal glands.
Follicle-Stimulating Hormone (FSH) is synthesized and secreted by the anterior pituitary gland, and regulates the development, growth, pubertal maturation, and reproductive processes of the body. FSH and luteinizing hormone (LH) work together in the reproductive system.
FSH stimulates the ovarian follicle, causing an egg to grow. It also triggers the production of estrogen in the follicle. The rise in estrogen tells the pituitary gland to stop producing FSH and to start making more LH. The shift to LH causes the egg to be released from the ovary, a process called ovulation
Also called luteotropic hormone (LTH) or luteotropin. Prolactin is named because of its role in lactation. It is produced by the pituitary gland of mammals that acts with other hormones to initiate secretion of milk by the mammary glands.
A prolactin test measures the level of the hormone prolactin. During pregnancy, prolactin levels increase by 10 to 20 times.
Estrogen is a general term used to describe one of the hormones produced in a woman’s body. Estrogens are normally produced by the ovaries from puberty through menopause. Primarily, there are three forms of estrogen. The first of these estrogens is E1 (Estrone), a “weak” estrogen produced by the ovaries and fat tissue. E2 (Estradiol) is the most active estrogen produced by the ovaries before menopause. It is important in the regulation of the estrous and menstrual female reproductive cycles and is essential for the development and maintenance of female reproductive tissues. E3 (Estriol) is the weakest of the three forms of estrogen and is made in the body from other estrogen. The amounts of the differing estrogens in the body vary not only over the course of the menstrual cycle, but over the years of reproductive life.
QUESTIONS ON FERTILITY
There are many forms of male infertility, includes erectile dysfunction, sexual insufficiency, reduction in sperm density and semen volume and abnormal sperm morphology.
The aphrodisiac are the substances, which stimulates sexual desire. According to the Oxford Learners Dictionary aphrodisiac means substance or drug arousing sexual desire, while Encyclopedia of Medicinal plants explained aphrodisiac as the one which excites libido and sexual activity.
In a systematic review by Byung-Cheul Shin et al. (2010), authors wrote:
“Sexual problems (or sexual dysfunction) are widespread and adversely affect mood, well-being, and interpersonal relationships. They occur in 20%-30% of men and 40-45% of women according to 18 descriptive epidemiological studies from around the world.
Current pharmacological interventions for the management of sexual problems include oral drugs, intrapenile therapies and penile prosthesis implantation for males and hormonal therapy for females. Although considerable advances have been made, the ideal treatment for ED has not been identified. Furthermore, pharmacological treatments have been shown to result in several adverse effects, including risk of cancer, headache, rhinitis and dyspepsia”.
Cleary, the most preferred product by men is a product that improve their sexual function but should not have any significant side effects. The use of a natural product that has got a good efficacy on the erection quality and on the sexual desire could be the right way to enhance male sexual activities.
Herbal therapies for sexual dysfunction include many herbs such as yohimbine (Pausinvstalia vohimbe), which is burdened with serious adverse effects, ginkgo and red ginseng. Several other botanical therapies for sexual dysfunction have also been introduced. Maca, Tribulus terrestris, and Horny Goat Weed, have been reported to be effective for improving sexual function.
In our product Dr. J. Horny OX-XS, we included these key medicinal ingredients because they are known traditionally and in modern medicine that its use improves sexual functioning.
It is estimated to be 20–25% with hypogonadism being the most frequent cause. In ageing, there seems to be a continuous decline in the levels of androgen leading to andropause (a term akin to menopause in females).
The hormonal preparations currently used as a replacement therapy can lead to hypofunction of the hypothalamo-hypophyseal-gonadal axis and also produce adverse effect on prostate gland and liver function, when used indiscriminately.
A phytochemical with similar properties to that of the steroids that can bring about the changes necessary for restoration of general well-being, sexual interest and activity without producing the side effects associated with the current hormone replacement therapy will contribute significantly to the management of erectile dysfunction (ED).
Premature ejaculation is uncontrolled ejaculation either before or shortly after sexual penetration. It happens with minimal sexual stimulation and before the person wishes. It may result in unsatisfactory sex for both partners. This can increase the anxiety that may add to the problem. It is one of the most common forms of male sexual dysfunction. It has probably affected every man at some point in his life.
According to the European Association of Urology (EAU), the aetiology of PE is unknown, with few data to support suggested biological and psychological hypotheses, including anxiety and penile hypersensitivity
Premature ejaculation may occur with a new partner. It may happen only in certain sexual situations or if it has been a long time since the last ejaculation. Psychological factors such as anxiety, guilt, or depression can also cause it. In some cases, it may be related to a medical cause such as hormonal problems, injury, or a side effect of certain medicines.
PE can be either lifelong (primary) or acquired (secondary). Lifelong PE is that which has been present since the person’s first sexual experiences, while acquired PE is that which begins later following normal ejaculation experiences. PE can occur secondary to another condition such as erectile dysfunction or prostatitis
PE cannot be cured, but can be managed with behavioural and/or pharmacological treatment. Please click here to learn about our product “Dr. J. EJA Control”. The product is in Gel form for topical use to helps in the prevention of premature ejaculation
QUESTIONS ON HERBAL & OTHER MEDICINAL INGRDIENTS
In a systematic review, it was reported that Ginseng is very popular worldwide, and has traditionally been used for stimulating sexual function in men of all ages. The review pointed out that in the USA approximately 6 million people use this plant for improving sexual dysfunction. The single dose studies used quantities ranging from 1800 mg to 3000 mg of its extracts (Dai-Ja Jang et al., 2008).
One of the RCTs that tested the effects of red ginseng for sexual function is De Andrade group study, where workers in a double-blind, placebo-controlled study examined the efficacy of Korean Red Ginseng (KRG) in impotent men with erectile dysfunction (ED). The study showed that KRG can be an effective alternative to the invasive approaches for treating ED (De Andrade et al., 2007).
Also, it was indicated that Ginseng extract showed an increase in spermatozoa number per ml and progressive oscillating motility, an increase in plasma total and free testosterone, dihydrotestosterone (DHT), follicle-stimulating hormone (FSH) and LH, but a decrease in mean prolactin. It is suggested that ginsenosides may have an effect at different levels of the hypothalamus-pituitary-testes axis (Han H. Aung et al., 2004).
In brief, collectively these RCTs provide suggestive evidence for the effectiveness of red ginseng in the treatment of erectile dysfunction
Ginkgo is one of the oldest living tree species. It is also one of the best-selling herbal supplements in the United States and Europe.
It is well established that flavonoids protect the nerves, heart muscle, blood vessels, and retina from damage. Terpenoids (such as ginkgolides) improve blood flow by dilating blood vessels and reducing the stickiness of platelets (Source: The University of Maryland Medical Centre http://umm.edu/health/medical/altmed/herb/ginkgo-biloba.
Also, quoting from the “Alternative Medicine Review” (1998), clinical research indicates that ginkgo extract may be efficacious in the treatment of a wide array of conditions associated with age-related physical and mental deterioration. These include:
- Alzheimer’s Disease/senile dementia: Ginkgo extracts appear to be capable of stabilizing and in some cases, improving the cognitive performance and the social functioning of patients with dementia)
- Cardiovascular Disease: Treatment with Ginkgo biloba extract lowers fibrinogen levels and decreases plasma viscosity. Ginkgo administration might improve the clinical outcome following cardiopulmonary bypass by limiting oxidative stress.
- Administration of Ginkgo biloba extracts has been shown to improve a variety of conditions associated with cerebral insufficiency, including visual field disturbances associated with chronic lack of blood flow, oculomotor and complex choice reaction, vigilance and reaction times, depressive mood, memory and mental performance, dizziness, and decreased blood flow.
- Other therapeutic applications include: diabetes, impotence, liver fibrosis, congestive symptoms of premenstrual syndrome (particularly breast symptoms) and neuropsychological symptoms of PMS. (Alternative Medicine Review, Volume 3, Number 1, 1998)
Are there enough clinical trials to support the claim that Maca increases the sperm count and mobility and improving sexual function in humans?
The answer is yes.
In a study by Gonzales and others (2001) to determine the effect of a four-month oral treatment of Lepidium meyenii on seminal analysis, serum luteinizing hormone (LH), follicle stimulating hormone (FSH), prolactin (PRL), testosterone (T) and estradiol (E2) were measured before and after treatment. Study results indicated that treatment with Maca resulted in increased seminal volume, sperm count per ejaculum, motile sperm count, and sperm motility.
Zenico and others carried out a double-blind clinical trial on 50 Caucasian men affected by mild erectile dysfunction (ED), randomised to treatment with Maca root (2400 mg), or placebo. Study data supported a small but significant effect of Maca supplementation on subjective perception of general and sexual well-being in adult patients with mild ED. (Zenico, et al., 2009).
To summarize, the above studies and many others show that there are significant effects of Maca for increasing sperm count and mobility and improving sexual function in humans.
The plant Tribulus terrestris (TT) popularly known as puncture vine is a perennial creeping herb with a worldwide distribution. Since ancient times it is regarded as an aphrodisiac. The TT extract contains steroidal glycosides (saponins) of furostanol type, the predominant furostanol being Protodioscin (PTN), which has been clinically proven to improve sexual desire and enhance erection via the conversion of protodioscin to De-Hydro-Epi-Androsterone (DHEA). Improvement in sperm count and motility has been reported in patients with low seminological indices following treatment with TT for 3 months.
IS THERE CLINICAL EVIDENCE ON TRIBULUS TERRESTRIS?
Yes, the following are two examples:
- Recently, Sixty-five men with abnormal semen evaluation were included in a study. Complete semen analysis evaluated at the end of treatment showed significant enhancement in sperm concentration, motility and liquefaction time. Protodioscin, (the main phytochemical component of Tribulus) is known to convert testosterone into dihydrotestosterone, which plays important roles in male attributes. (Salgado et al. Effect of oral administration ofTribulus terrestris extract on semen quality and body fat index of infertile men. Andrologia 2016; 1–6. wileyonlinelibrary.com/journal/and)
- In another study based on hospital records of female patients of reproductive age, presenting sexual dysfunction, and treated with 250 mg Tribulus extract (one tablet thrice daily for 90 days). It is concluded that the T extract is safe and effective in the treatment of female sexual dysfunction (Barboza Gama et al., 2014).
Herba Epimedii is recognized in Chinese herbal medicine with proven efficacy in treating cardiovascular diseases and in improving sexual and neurological functions. This efficacy is found to be related to the potent anti-oxidative ability of Herba Epimedii and its flavonoid components, with icarrin (has the same target as sildenafil) as the main effective constituent, along with polysaccharides and vitamin C. These ingredients have been proven to be effective against oxidative-stress related pathologies., In the “Chinese Herbal Medicine: Materia Medica” the herb tonifies the kidney and fortify the yang for patterns of kidney yang deficiency with such symptoms as impotence and infertility
The recommended dose is 3 to 9 grams per day (Bensky D. et al., 2004).
Also, in the “Oriental materia medica: a concise guide” (Hsu H-Y, et al., 1996). It is indicated that the traditional application of this herb is the impotence. The herb has aphrodisiac actions mainly because it stimulates secretion of semen causing the filling up of the scrotum, thereby stimulating the sensing nerves and indirectly promoting sexual desire.
Rutin is a natural substance found in a number of plants and foods. The name ‘rutin’ came from a plant known as Ruta graveolens that also contains rutin. It is found in high concentrations in teas and fruits. Buckwheat seeds are the richest source. It is also found in the fruits and fruit rinds mainly of citrus fruits (like orange, grapes, lemon, lime) and in berries such as mulberry and cranberries. It is also found in Hawthorn, Horse tail, Bilberry
Rutin has been sold as an herbal supplement approved by US FDA. It is used in many countries and is an ingredient of numerous multi-vitamin and herbal preparations.
Rutin was found to inhibit thrombus (formation of blood clots) at concentrations that are well tolerated
Rutin therapy can be used for prevention and treatment of heart attacks and stroke, as well as in deep vein thrombosis (DVT) and pulmonary embolism.
Health Canada approved the ingredient as an antioxidant and as a capillary/blood vessel). As per HC monograph the dose should not exceed 1000 mg per day for antioxidant purpose and should be between 400 – 1000 mg per day for capillary/blood vessel protectant uses.
Honey and other bee products, such as royal jelly and propolis may be used as functional foods because of their naturally high antioxidant potential.
Royal jelly is the exclusive food of the queen honeybee (Apis millifera) larva. Chemically royal jelly comprises water (50% to 60%), proteins (18%), carbohydrates (15%), lipids (3% to 6%), mineral salts (1.5%), and vitamins together with a large number of bioactive substances
Royal jelly possesses numerous functional properties such as antioxidant activity, vasodilative, hypotensive activities, and antihypercholesterolemic activity
Administration of antioxidants to infertile men has been assessed in numerous clinical studies with at least 20 reports highlighting its effect on measures of oxidative stress in human spermatozoa.
Studies results revealed that 19 of the 20 showed a significant reduction relating to some measure of oxidative stress in these cells. Strong evidence also supports improved motility, particularly in asthenospermic patients. However, of these studies, only 10 reported pregnancy-related outcomes, with 6 reporting positive associations.
(Parviz Gharagozloo and R. John Aitken. The role of sperm oxidative stress of oral antioxidant therapy. Human Reproduction, Vol.26, No.7 pp. 1628–1640, 2011)
In a systematic review of randomized studies to evaluate the effects of oral antioxidants on sperm quality and pregnancy rate in infertile men. Trials showed an improvement in either sperm quality or pregnancy rate after antioxidant therapy. Ten trials examined pregnancy rate and six showed a significant improvement after antioxidant therapy (Ross et al. A systematic review of the effect of oral antioxidants on male infertility. Reproductive Healthcare Ltd. Published by Elsevier Ltd. Reproductive Bio Medicine Online (2010) 20, 711– 723)
L-Arginine is a Nitrite Oxide precursor acting on dilatation of vessels. As people age, the production of L-Arginine decreases and many experts believe this is responsible for many degenerative processes related to aging, thus it plays an important role in maintaining health (including sexual health). L-Arginine dilates and expands the blood vessels in the penis and clitoris, facilitating erections in males and genital responsiveness in females. L-Arginine assists with maximum sexual performance by increasing the supply of nitric oxide in the body, resulting in strong erections and increased sexual functions.
Doses of arginine used in clinical research have varied considerably, from as little as 500 mg per day for oligospermia to as much as 30 g per day for cancer, preeclampsia, and premature uterine contractions. Typical doses fall into either the 1-3 g per day range, or the 7-15 g per day range, depending on the condition being treated (Jeremy Appleton, 2002).
Antioxidants protect the body from damage caused by harmful molecules called . Many experts believe this damage is a factor in the development of blood vessel disease (), cancer, and other conditions.
You are exposed to free radicals through by-products of normal processes that take place in the body (such as the burning of sugars for energy and the release of digestive enzymes to break down food), when the body breaks down certain medicines and through pollutants.
Antioxidants include some vitamins (such as vitamins C and E), some minerals (such as selenium), and flavonoids, which are found in plants. The best sources of antioxidants are fruits and vegetables. You can find flavonoids in red wine, and teas. You can also buy antioxidant supplements.
Antioxidants may play a role in the management or prevention of some medical conditions, such as some cancers, Alzheimer’s disease, and some arthritis-related conditions.
ARE ANTIOXIDANTS SAFE?
It is best to get your antioxidants from fruits and vegetables rather than from supplements. Taking supplements in high doses can be harmful. No single antioxidant alone can protect the body.
Source: University of Pittsburgh Medical Center
TRADITIONAL CHINESE MEDICINE (TCM)
Traditional Chinese medicine (TCM) originated in ancient China and has evolved over thousands of years. TCM practitioners use herbal medicines and various mind and body practices, such as acupuncture and tai chi, to treat or prevent health problems
IS IT SAFE?
There have been reports of Chinese herbal products being contaminated with drugs, toxins, or heavy metals or not containing the listed ingredients. Some of the herbs used in Chinese medicine can interact with drugs, have serious side effects, or be unsafe for people with certain medical conditions.
IS IT EFFECTIVE?
For most conditions, there is not enough scientific evidence to know whether TCM methods work for the conditions for which they are used. (Source: National Center for Complementary and Integrative Health
The following definitions represent USA-FDA’s current thinking on the meaning of the terms below in the context of the new dietary ingredient provisions of the FD&C Act and regulations.
Acceptable daily intake (ADI): The daily intake of a substance that, during the human lifetime, appears to be without appreciable risk on the basis of all known facts at the time.73 In the context of an NDI notification, the ADI of an NDI or dietary supplement is calculated as the ratio of the NOAEL to the total safety factor (determined from the studies submitted in the notification).
Amino acid: An alpha-amino carboxylic acid used as a constituent of proteins or peptides.
Botanical or herbal: A plant, alga, or fungus; a part of a plant, alga, or fungus (e.g., bark, leaves, stems, roots, flowers, fruits, seeds, berries, or parts thereof); or an exudate (secretion) of a plant, alga, or fungus.
Botanical raw material: Whole or physically processed (e.g., cleaned, frozen, dried, or sliced) parts of a single species of plant or a fresh or processed alga or fungus.
Chronic: Chronic exposure is exposure for more than 3 months. Periods of daily use interspersed with periods of non-use would be considered chronic exposure. In the context of toxicology studies, the term “chronic” generally refers to studies with at least 1 year of repeated dosing. Repeated exposure is divided into 3 categories: subacute, sub chronic, and chronic. Subacute exposure refers to repeated exposure to a substance for 1 month or less, sub chronic for 1 to 3 months, and chronic for longer than sub chronic.
Component: A substance that is part of a mixture. Includes substances that cannot be isolated from the whole, as well as those that can. Once isolated, a component of a mixture is also a constituent (see definition below).
Concentrate: An article in which constituents are more concentrated than in the original. An herbal concentrate is an extract from which all or most of the solvent has been removed, reducing the product to a solid, semi-solid, or syrupy form. The solvent and the process by which the concentrate is made are part of the definition of the concentrate.
Constituent: An article that is a physical part of the whole and can be isolated from the whole.
Dietary ingredient: A dietary ingredient is (A) a vitamin, (B) a mineral, (C) an herb or other botanical, (D) an amino acid, (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in (A) through (E).
Dietary substance: A substance that is commonly used as human food or drink.
Estimated daily intake (EDI): For purposes of an NDI notification, the EDI is the highest possible total daily intake level (in mg/day or mg/kg/day) of an NDI, as determined from the proposed conditions of use in the notification and any background exposure from other dietary sources. It is the maximum amount that would be consumed based on the conditions of use proposed in the notification, taking into account cumulative exposure from other dietary sources. The EDI should not be higher than the ADI.
Extract: A product consisting of a solvent (menstruum) combined with a dietary substance or botanical biomass by a process that physically separates constituents from the dietary substance or botanical and dissolves them into the solvent. The extract can be further concentrated through drying to a dry powder or semi-solid form.
Formulation: A formula that (1) lists the identity and quantity of each dietary ingredient and other ingredients (formulation aids) of a dietary supplement, and (2) describes the administered form (e.g., powder, liquid, capsule, etc.).
Ingestion: Taking an article, such as a dietary supplement or other food, into the stomach and gastrointestinal tract by swallowing.
Live microbial dietary ingredient: A single-celled prokaryotic or eukaryotic microorganism that is intended to be viable at the point of ingestion.
Margin of safety: A measure of how close the estimated daily intake (EDI) is to the level that has been shown to have no adverse effect in animal or human studies (the NOAEL). It is calculated as the ratio of the NOAEL to the highest total daily intake level (EDI) of the NDI or dietary supplement, as determined from the proposed conditions of use in the NDI notification, and is usually expressed in terms of fold change (e.g., a ten-fold margin of safety).
Maximum tolerated dose (MTD): The highest dose that causes no more than a 10 percent reduction in body weight and does not produce mortality, clinical signs of toxicity, or pathologic lesions that would be predicted to shorten the natural life span of an experimental animal for any reason other than the induction of neoplasms.
Metabolite: A metabolite is a product of metabolism. In the dietary supplement context, a metabolite of a dietary ingredient is a molecular intermediate that incorporates structural elements of the ingested dietary ingredient and whose flux or net production in the human body increases on ingestion of the dietary ingredient. A metabolite can be part of (or an intermediate of) the catabolic or metabolic pathway of a dietary ingredient.
FDA considers X to be a metabolite of Y if ingestion of Y by humans results in net production of/increased flux of X, incorporating structural elements of Y.
Mineral: A substance of defined chemical composition which provides a form or source of inorganic elements to the diet. An element is one of a class of substances that cannot be separated into simpler substances by chemical means. Examples: calcium, iodine, and zinc.
New dietary ingredient: A dietary ingredient that was not marketed in the U.S. before October 15, 1994.80
No-Observable-Effect Level (NOEL): The highest dose or total daily intake level at which no effects (beneficial, neutral, or adverse) are observed in a properly designed and executed toxicological study.
No-Observed-Adverse-Effect Level (NOAEL): The highest dose or total daily intake level that did not elicit an adverse effect in a properly designed and executed toxicological study.
Pre-DSHEA dietary ingredient: A dietary ingredient that was marketed in the U.S. before October 15, 1994.
Safety factor or uncertainty factor: A multiplier used to account for uncertainty about the extent to which data gathered in one context can be used to predict the safety of a substance in other contexts. For example, safety factors attempt to account for differences between animals and humans (uncertainty factor of interspecies variation), differences in sensitivity among humans (uncertainty factor of intraspecies variation), and extrapolation of sub chronic to chronic data (uncertainty factor of extrapolated data from sub chronic to chronic). Safety factors can be combined multiplicatively to account for multiple sources of uncertainty. Safety factors are used in calculating an acceptable daily intake (ADI) for various FDA-regulated products, including color additives, food additives, and new animal drugs.
Sub chronic: Refers to toxicological studies that are 1 to 3 months in duration.
Target Population: The target population for a dietary supplement means the population group or groups (defined by gender, age, and/or health status) that a manufacturer or distributor identifies (e.g., in product labeling, promotional materials, or in an NDI notification) as those for whom the product is appropriate or recommended. Examples of target populations include adults, children 14 and over, and women going through menopause.
Tincture: An aqueous alcoholic solution (e.g., an aqueous alcoholic extract of leaves or other plant material). A tincture is characterized by the ratio of the weight of the dried botanical to the volume or weight of the finished product. A 1:5 ratio is 1 part botanical to 5 parts solution.
Vitamin: An organic substance that is a minor component of foods, is essential for normal physiological functions (e.g., maintenance, growth, or development), is normally not produced endogenously (within the body) in amounts adequate to meet normal physiologic needs, and which causes, by its absence or underutilization, a clinically defined deficiency syndrome
Source: Food and Drug Administration new guideline (2016) on “Dietary Supplements: New Dietary Ingredient (NDI) Notifications (US-FDA Website)