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PRODUCT SUMMARY

Botanical - Prostate Support Softgels with Phytosterols (60 Count)

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Stock Number :SCF-112-SG-060
  • Hormone Support
  • Sexual Performance Support
  • Prostate Health
  • Quick Notes:

    • Scientifically formulated blend of vitamins, minerals, botanicals, and botanical extracts designed to support prostate health!
    • Over 2000 mg of potent synergistic botanical herbs..

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    Product Information

    Quick Notes:

    • Scientifically formulated blend of vitamins, minerals, botanicals, and botanical extracts designed to support prostate health!
    • Over 2000 mg of potent synergistic botanical herbs and extracts including 1200 mg of pumpkin seed oil, 300 mg Saw Palmetto, 150 mg Nettle, 100 mg of Phytosterols, 100 mg of Green Tea Extract, 100 mg Pygeum, 50 mg of Soy Isoflavones, and 5 mg of Lycopene per serving!
    • Saw palmetto (Serenoa repens) is a leading men's health botanical. Our berry extract is standardized to 85-95% fatty acids and sterols!
    • Contains 5 mg of lycopene, a natural extract derived from red, ripe tomatoes! It is an important super potent antioxidant carotenoid!
    • Green tea extract contains several beneficial flavonoids and antioxidants including Catechins and Theaflavins!
    • Helps support prostate and urinary health!
    • High amounts of phytosterols, which support a healthy vascular system!
    • Contains several potent antioxidants protect against damage from free radicals!
    • Uses only standardized herbal extracts!
    • Convenient, easy-to-swallow softgel!
       

    Overview:

    Prostate Support Softgels pack a potent and powerful combination of vitamins, minerals, and botanical herbs designed to support the function of the prostate. The prostate is a small walnut-sized gland surrounding the urethra below the bladder. It is responsible for producing the largest component of the male reproductive seminal fluid.

    As men advance into their 40s and 50s prostate’s cells often enlarge. A condition commonly referred to as Benign Prostatic Hyperplasia or BPH. Studies indicate that more than 50% of all men over the age of 50 suffer from an enlarged prostate and its associated symptoms. As men mature the likelihood of BPH can increase up to 80%. Fortunately, in most cases BPH is a non-cancerous growth. However the enlargement of the prostate gland can cause urological issues such as frequent or urgent urination, poor urinary flow due to constriction of the urethra, nighttime urination that often disrupts sleep, and even lower back pain.

    Male hormones such as testosterone and dihydrotestosterone (DHT) may contribute to BPH. The prostate is a site in which testosterone is converted to dihydrotestosterone (DHT). In turn, DHT activates cellular division in the prostate. This results in an increased number of prostate cells. DHT levels are often up to five times greater in those who suffer from BPH than in subjects with normal sized prostates. If the conversion of testosterone to DHT is prevented, BPH does not occur and in some cases can even be reversed.

    Luckily, scientists have identified certain nutrients found in nature, as well as common micronutrients, which may play a role in prostate health. Our formula combines these well-researched ingredients in amounts known to benefit prostate health. Pumpkin seed oil, Saw Palmetto, Nettle and Pygeum contain natural DHT blockers and phytosterols.

    Men 40 years and older should consult with their healthcare provider for information on their prostate health.

    The following list provides a concise summary of the ingredients included in Prostate Support. For more detailed information, please refer to individual product sheets where available.


    Pumpkin:

    Pumpkin is native to North America, tropical regions of Africa, and South Asia. The origins of its use can be traced back to Native American healers. Researchers conducting population studies observed a correlation with diets high in pumpkin with lower instances of prostate issues. Scientist speculate the essential fatty acids content of pumpkin seed is driving the results.  Pumpkin is most effective when combined with nettle and or saw palmetto.

    Saw Palmetto:

    Saw palmetto or Serenoa serrulata is native to North America’s Atlantic coast and the West Indies. The fruit and berries of the Saw Palmetto plant are harvested for their rich active constituents such as free fatty acids and phytosterols. Our Saw Palmetto is standardized and guaranteed for fatty acids and phytosterols content. Saw palmetto is the most popular men’s health herbal supplement in the United States. It tops the charts in Europe and Canada as well. Scientific research supports its use for men’s health especially prostate and urinary tract health.  Saw palmetto may relieve symptoms of BPH such as: urinary frequency and urgency, excessive night-time urination, or delayed urination. Additionally, saw palmetto may promote optimum anti-inflammatory responses in the prostate to reduce swelling and promote normal urine flow. Studies indicate saw palmetto may inhibit the conversion of testosterone to DHT which contributes to swelling and enlargement of the prostate.

    Nettle:

    Nettle is gaining recognition for its positive effects in supporting prostate, bladder, and urinary tract health. It also promotes urine flow and supports less frequent urination.

    Pygeum Africanum:

    Pygeum africanum has been used for centuries for maintaining and improving prostate health. The bark of this African tree is an excellent source of beta sitosterol. It has been shown to reduce inflammation. Research indicates that Pygeum africanum and saw palmetto work synergistically. It has been used extensively in Germany and France where it is approved to support a healthy prostate.

    Beta Sitosterol:

    Beta sitosterol is a plant hormone derived from plant oils. Studies suggest a minimum of 20 mg per day of beta sitosterol may substantially increase urine flow and decrease residual urine volume. Research also suggests that beta sitosterol inhibits prostaglandin synthesis which subsequently reduces inflammation.

    Green Tea Extract:

    Green tea contains several compounds that have antioxidant and thermogenic properties. The active constituents are the polyphenols such as catechins and tannins. The catechin epigallocatechin gallate (EGCG) may be a much more potent antioxidant than both vitamin C and E. In a recent double-blind trial, men with precancerous changes in the prostate received a green tea extract. The men receiving the green tea extract observed favorable statistically significant results.

    Lycopene:

    Lycopene is an antioxidant that is abundant in tomatoes and certain other fruits and vegetables like watermelon, pink grapefruit, pink guava, papaya, red bell pepper, and rose hip. About 85% of dietary intake of lycopene is from tomatoes, tomato sauces, ketchup, and tomato juice. Lycopene is a carotenoid and is not an essential nutrient, nevertheless it is biologically significant. Lycopene can be present in the blood, skin, liver, adrenal glands, lungs, prostate and colon. Lycopene functions as an antioxidant carotenoid and free radical scavenger. It is a quencher of singlet oxygen. Lycopene is one of the most widely studied compounds today and has been shown in numerous studies to promote prostate health. It is highly regarded for promoting men’s health and is the subject of ongoing studies for its anticarcinogenic effects. Lycopene is the most abundant carotenoid present in the prostate gland and serves as an antioxidant by protecting against free radical damage in the prostate.

    Ingredients

    beta-sitosterol

    Camellia Sinensis

    D-alpha tocopherol succinate

    Green Tea Extract

    Lyc-O-Mate

    Lycopene

    Nettle (leaf)

    Phytosterols

    Prunus africana

    Pumpkin Seed Oil

    Pygeum africanum (bark)

    Serenoa repens

    Soy Isoflavones

    Urtica dioica

    Vitamin E

    Zinc

    Zinc picolinate

    Suggested Use: Take 2 softgels per day

    Storage: Keep in a cool, dry place.

    Allergy Warnings:

    This product is contraindicated for individuals with hypersensitivity to any of its ingredients.

    Interactions:

    • Everyone has unique body chemistry. All patients should be aware of potential drug and supplement interaction. You are encouraged to consult with your primary health care professional before taking any supplement product.

    • This product contains multiple ingredients. Please refer to the individual vitamin or mineral product page for interaction information. Always consult with your primary care professional before taking any supplement product.

    Pregnancy Warning:

    If you are pregnant, nursing, have any health condition, or are taking any medications please consult with your health care practitioner before using this product.

    Keep out of reach of children.

    Disclaimer:

    • The following scientific literature references, articles, and statements have not been evaluated by the Food and Drug Administration (FDA).
    • This product is not intended to treat, cure or prevent any disease.
    • Information about this product is intended for your general knowledge only and is not a substitute for professional medical advice or treatment.
    THANKS!

    Saw Palmetto (Serenoa repens)



    1. Barry MJ, Meleth S, Lee JY, et al. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA. 2011;306(12):1344-1351.

    2. Avins AL, Bent S, Staccone S, et al. A detailed safety assessment of a saw palmetto extract. Complement Ther Med. 2008;16:147-154.

    3. Bent S, Kane C, Shinohara K, et al. Saw Palmetto for Benign Prostatic Hyperplasia. N Engl J Med. 2006; 354:557-66.

    4. Gerber GS, Kuznetsov D, Johnson BC, et al. Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms. Urology. 2001;58:960-964.

    5. Marks LS, Partin AW, Epstein JI, et al. Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia. J Urol. 2000;163:1451-1456.

    6. Plosker GL, Brogden RN. Serenoa repens (Permixon). A review of its pharmacology and therapeutic efficacy in benign prostatic hyperplasia. Drugs Aging. 1996;9:379-395.

    FAQ

    Frequently Asked Questions - Botanicals

    • What is the “special processing” that reduces odor in the Garlic Softgels 500 mg?

      It is the encapsulation process of the softgel. It is not enteric-coated.

    • What bioflavonoids are in Ginkgo Biloba 60 mg?

      This outline summarizes the relationship of the active compounds found in ginkgo biloba tree leaves.

      Ginkgo biloba extract’s (GBE) active constituents:

      A. Ginkgo flavone glycosides (24%) - bioflavonoids

      - quercetin
      - kaempferol
      - isohamnetin

      B. Terpene lactones (6%)

      - ginkgolides A, B, and C
      - bilobalide

    • Are there ginkgolic acids in Ginkgo Biloba 60 mg?

      Based on Chinese Pharmacopeia, ginkgolic acid should be no more than 10 ppm. Based on this standard, ginkgolic acid content in our Ginkgo Biloba 60 mg is less than 0.0006 mg (0.6 micrograms), which is well below the maximum level.

    • What are the German Commission E Monographs?

      The Commission E of the German Federal Health Agency was the group responsible for researching and regulating the safety and efficacy of herbs and phytomedicines in Germany.

       

      This group began publishing monographs in 1978 and ceased developing monographs in 1993.It has been called the world’s most rational system for assessing the traditional uses and modern scientific research on herbal medicines. This information is an unbiased resource, showing how botanical extracts can be used responsibly. The actual monographs assessed and approved or disapproved herbs for sale in Germany.


    • How much caffeine is in one capsule of your Green Tea Extract?

      There is approximately 1.5 mg of caffeine per capsule. A cup of coffee contains about 120-240 mg of caffeine per cup.

    • What type of alcohol is used in those Ultimate Extract® products that require alcohol extractions?

      It is called Specially Denatured Alcohol, Formula 3-C.It contains 95% grain-based ethanol and 5% isopropyl alcohol. The isopropyl alcohol is needed to denature the ethanol, making it unfit for consumption as an alcoholic beverage. However, this denaturant becomes negligible since practically all the solvent is evaporated off the powdered extracts. (Denatured alcohols are used as solvents because they are not taxed at consumer alcohol levels.) This highly refined formula is approved by the Code of Federal Registry. Your Ultimate Extract® products never contain more than 0.5% residual alcohol.

    • Does Saw Palmetto 160 mg have any counteractive effect with Uroxytrol?

      Uroxytrol is not recommended to take with saw palmetto due to Saw Palmetto’s alpha-adrenergic blocking effect.

    • Is there beta sistosterol in Saw Palmetto 160 mg? If so, how much?

      Our Saw Palmetto contains 0.15% of beta sistosterol or 0.24 mg per softgel cap.

    • Is the Milk Thistle, 350 mg free from pesticides and herbicides?

      To have never come in contact with pesticides or herbicides, it would have to be organic, which ours is not. Our raw material partner’s tests the end product for heavy metals, arsenic and solvents, to which there are maximum limits allowed.

       

    • What is a botanical?

      A botanical is a plant or plant part valued for its medicinal or therapeutic properties, flavor, and/or scent. Herbs are a subset of botanicals. Products made from botanicals that are used to maintain or improve health may be called herbal products, botanical products, or phytomedicines.

      In naming botanicals, botanists use a Latin name made up of the genus and species of the plant. Under this system the botanical black cohosh is known as Actaea racemosa L., where "L" stands for Linneaus, who first described the type of plant specimen. In the Office of Dietary Supplements (ODS) fact sheets, we do not include such initials because they do not appear on most products used by consumers.
       

      Source: National Institute of Health – Office of Dietary Supplements

    • Can botanicals be dietary supplements?

      To be classified as a dietary supplement, a botanical must meet the definition given below. Many botanical preparations meet the definition.

      As defined by Congress in the Dietary Supplement Health and Education Act , which became law in 1994, a dietary supplement is a product (other than tobacco) that

      - is intended to supplement the diet;
      - contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;
      -is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
      -is labeled on the front panel as being a dietary supplement.

      Source: National Institute of Health – Office of Dietary Supplements

    • How botanicals are commonly sold and prepared?

      Botanicals are sold in many forms: as fresh or dried products; liquid or solid extracts; tablets, capsules, powders; tea bags; and other forms. For example, fresh ginger root is often found in the produce section of food stores; dried ginger root is sold packaged in tea bags, capsules, or tablets; and liquid preparations made from ginger root are also sold. A particular group of chemicals or a single chemical may be isolated from a botanical and sold as a dietary supplement, usually in tablet or capsule form. An example is phytoestrogens from soy products.

      Common preparations include teas, decoctions, tinctures, and extracts:
      - A tea, also known as an infusion, is made by adding boiling water to fresh or dried botanicals and steeping them. The tea may be drunk either hot or cold.
      - Some roots, bark, and berries require more forceful treatment to extract their desired ingredients. They are simmered in boiling water for longer periods than teas, making adecoction, which also may be drunk hot or cold.
      - A tincture is made by soaking a botanical in a solution of alcohol and water. Tinctures are sold as liquids and are used for concentrating and preserving a botanical. They are made in different strengths that are expressed as botanical-to-extract ratios (i.e., ratios of the weight of the dried botanical to the volume or weight of the finished product).
      - An extract is made by soaking the botanical in a liquid that removes specific types of chemicals. The liquid can be used as is or evaporated to make a dry extract for use in capsules or tablets.

      Source: National Institute of Health – Office of Dietary Supplements

    • What is the difference between a botanical herb and a vitamin?

      Vitamins are naturally occurring compounds present in most foods, which are essential for all body functions. Herbs are also natural products consisting of plant material or plant extracts. Herbs and or botanicals usually have unique phytochemical compounds

    • What are some examples of these phytochemicals?

      There are several phytochemical groups currently under investigation by researchers. A few examples are as follows:

      - Vitamins
      - Carotenoids
      - Flavonoids
      - Triterpenes
      - Xanthones
      - Phytosterols
      - Polyphenols|
      - Allylic sulfides (found in onions and garlic)
      - Sulforaphane (found in broccoli and cauliflower)
      - Saponins (found in soybeans and ginseng)
      - Capsaicin (found in peppers)

      Carotenoids such as beta carotene are among the most popular phytochemical compounds. Many have drawn attention as possible cancer preventives among other health benefits. Lycopene, Lutein and zeaxanthin are other carotenoids being studied.

    • What are carotenoids?

      Carotenoids are a family of phytochemical compounds found in fruits, vegetables and leafy green plants. They provide the bright yellow, orange and red pigments to the fruits and vegetables we eat. Of more than 600 known carotenoids in nature, only about 20 are found in human plasma and tissues. The principal carotenoids found in humans are alpha-carotene, beta-carotene, beta-cryptoxanthin, lutein, lycopene and zeaxanthin. Researchers are currently studying the many health benefits of these compounds.


    • Why should I use herbal products?

      The decision to use herbs for their health promoting value is, as with all health decisions, a personal one. There are, however, many good reasons to consider herbal products as complements to your own health care. The best reason, however, may be the fact that herbs and herbal products, with their incredibly wide use throughout time and place, continue to provide real health benefits while maintaining a remarkable safety profile. Readily available natural substances were the first medicines used by humans. Primitive and ancient civilizations as well as contemporary cultures throughout the world have always relied on herbs to provide the benefits that have been observed with their use. In fact, the World Health Organization has estimated that 80% of the world's population continues to use traditional therapies, a major part of which are derived from plants, as their primary health care tools. (3) In our own time and culture, most herbs are available in the form of "herbal supplements." (4) These products are found in the form of teas, tablets, capsules, liquid extracts, and others. We now have ready access to products that bring the herbal traditions from all over the world in a variety of convenient forms. In addition, scientific inquiries continue to develop our knowledge of the benefits of plants, and often validate the observations made over the past centuries. 

       

      Source:  American Botanical Council - American Herbal Products Association

    • Are herbs safe?

      Plants that enjoy broad culinary and therapeutic usage are generally safe. We can flavor our food with any number of herbs to make a meal more flavorful. We can appreciate a delicious cup of peppermint leaf or ginger root tea, or benefit from the soothing properties of marshmallow root or the bark of slippery elm. We can take an herbal supplement containing dandelion root or saw palmetto berries, or any number of the other herbs. Although allergies and reactions have been recorded for a few herbs that are widely used in foods and supplements, such individual concerns are also seen with many foods, and do not diminish the safety profile of the many herbs that are generally recognized as safe. On the other hand, and as everyone knows, there are any number of plants that are highly toxic, even deadly. Every ten-year-old hiker knows to stay away from poison ivy (Toxicodendron spp.) when walking in the woods. The death sentence imposed on Socrates by an Athenian jury 2400 years ago was carried out with a fatal dose of hemlock (Conium maculatum). The poison curare, a blend of several equatorial rain forest plants (e.g., species of Chondrodendron, Curarea and Strychnos (5) is used by some South American hunter cultures to make their arrows more deadly. Just this year, in the "concrete jungle" of Los Angeles, two young boys died from ingesting a few leaves of the ubiquitous oleander (6) (Nerium oleander). Federal law (7) and good common sense, however, prevent the use of any such highly toxic plant in products that are readily available to consumers. The better question then, for today's American consumer, is "Are herbal supplement products safe?"

       

      Source:  American Botanical Council - American Herbal Products Association

    • Are herbal supplement products safe?

      Federal law requires that every food product, including herbal supplements, is free of "adulteration" and is not "misbranded." This legal language translates into a requirement that all foods and supplements have a reasonable expectation of safety when offered for sale and when used as directed. So manufacturers of soups, cereals, and supplements all have an obligation to sell only safely made and properly labeled goods, and can find their products subject to seizure should they fail to do so. In addition, manufacturers of herbal products are specifically required to limit their ingredients to either those that were already in the market prior to passage of landmark legislation in 1994 or those that a company can convincingly show, by providing information to the Food and Drug Administration, to be safe. What that means is that any manufacturer who wants to introduce a new herbal ingredient must first provide FDA with information that shows that the herb will be "reasonably expected to be safe" (8) Additionally, the safety of herbal products as a general class has been well established by both their long history of traditional use worldwide and by their broad contemporary use by a significant proportion of the population, estimated to be nearly half of the U.S. population. (9)There are so few credible reports of unexpected side effects due to herbal products that most experts consider problems with herbal products to be of only minor or occasional concern. Norman Farnsworth, Director of the WHO Collaborating Centre for Traditional Medicine and Research Professor of Pharmacognosy at the University of Chicago at Illinois, is generally considered to be one of the most respected experts on the scientific research of botanical medicines. In a 1993 article written on the subject of herbal safety (10), Dr. Farnsworth concluded, "...side effects or toxic reactions associated with herbal medicines in any form are rare. In fact, of all classes of substances reported to cause toxicities of sufficient magnitude to be reported in the United States, plants are the least problematic." This is not to say that every herbal ingredient that is sold as an ingredient in a supplement is appropriate for every consumer or in any quantity. Responsible and informed use by consumers is essential to insure that herbal products maintain their established safety profile. Accurate product labeling must provide consumers with all information that is material to the use of the product, and such disclosure is required by Federal law

                                                            

      (11) To assist in assuring that herbal manufacturers provide material information about their products, the American Herbal Products Association (AHPA) has developed specific labeling guidelines for a number of botanical ingredients. Labeling recommendations exist for products containing chaparral (Larrea tridentata); comfrey (Symphytum spp.); ephedra (Ephedra spp.); kava (Piper methysticum); saw palmetto (Serenoa repens); and St. John's wort (Hypericum perforatum), among others. In addition, AHPA published an entire volume of information related to established herbal safety concerns, entitled Botanical Safety Handbook. (12) This reference classifies over 500 herbs with safety categories that can assist both manufacturers in their labeling and consumers in making informed choices in their use of herbs. A general rule for assuring responsible use of an herbal product is to follow all of the labeled directions. If the product bears a caution that suggests that the product is inappropriate for your use, you should take that message seriously. More information can often be provided by a qualified expert, and often from well-informed retail personnel.

      Source:  American Botanical Council - American Herbal Products Association

    • Are herbal supplements effective?

      Botanicals have remained a primary source of traditional medicine for millennia. They have made contributions over the last centuries to the development of some of the most widely used and effective modern drugs. In the last several decades, there has been a resurgence of research in the clinical efficacy of herbs. The results of such studies often verify that the empirical observations of the past centuries were accurate. For example, recent studies on the effect of valerian have produced results that led researchers to conclude that valerian root can produce "significant improvement in sleep quality" (13) and that valerian root extract can be "recommended for the treatment of patients with mild psychophysiological insomnia" (14).

      But can a consumer have confidence in the claims made for the products that are available in the market? To begin with, Federal labeling law and regulations for supplements limit allowable claims to those for which a manufacturer "has substantiation that such statement is truthful and not misleading" (15). The manufacturer therefore has a legal burden to assure that the claim that is made for their products has scientific evidence to back it up. Because there is a greater acceptance of herbal therapies by conventional physicians in Europe, a significant body of clinical data supporting the use of herbs has been developed there. More recently, a number of U.S. companies have designed clinical studies for their branded products. It is estimated that there are over 1,000 clinical trials now being undertaken in the U.S. to increase our knowledge about herbs. The National Institutes of Health has even set up a center with a special focus on "alternative" medicine, and is now concentrating much of its resources on the study of herbal products. 
       

      Source:  American Botanical Council - American Herbal Products Association

       

    • How soon can I expect to notice the benefits of an herbal product?

      Herbs are rich mixtures of diverse natural compounds. Although the effects of certain herbs will be observed within a short time after consumption, others are more subtle and provide their health promoting benefits gradually. If you have ever used ginger root (Zingiber officinale) or peppermint leaf (Mentha × piperita) tea to promote healthy digestion, you know that you can feel the comforting effects of these herbs almost as you drink the soothing brew. The effect of ephedra (Ephedra spp.) in promoting bronchodilation or better breathing is usually felt within ten or twenty minutes of use. The sense of well-being that results from the use of kava root (Piper methysticum) should manifest in only a short time when using a well manufactured product. Similarly, all of the herbs that contain anthrones, such as rhubarb root (Rheum spp.) or cascara sagrada bark (Frangula purshiana), will produce a laxative effect within a half a day or so.

       

      Other herbs are known to produce noticeable benefits only after several days or weeks. For example, improvement in sleep when using an extract of valerian root (Valeriana officinalis) has been shown to be somewhat dependent on continued use (16). With saw palmetto (Serenoa repens), the berries of which are used to promote the health of the prostate, the full benefits have been shown in one study to be achieved after 12 to 18 months (17). Other herbs, such as those that are rich in antioxidants, work to improve your health without a noticeable effect. For more information about what to expect from an herbal product (and when to expect it), consult with the product's manufacturer or an herbal health practitioner. You can find a regional list of herbalists the American Herbalists Guild's professional member referral list at http://www.healthy.net/herbalists, or your local acupuncturist at the American Association of Oriental Medicine http://www.aaom.org. 

       

      Source:  American Botanical Council - American Herbal Products Association

    • How do I know how much to use?

      Two different parts of the Federal laws that govern dietary supplements present manufacturers with guidelines for providing quantitative recommendations on the package of their products. First, all supplement manufacturers are responsible for assuring that their products do not present significant or unreasonable risks under conditions of use recommended in labeling or under ordinary conditions of use (18). In addition, all dietary supplements, including herbal supplements, are required by Federal regulation to identify the "serving size" (19). A general recommendation then, with regard to how much of an herbal product to use: the amount recommended on the label. The idea that "more is better" is no more relevant for an herbal supplement than for any other food that, while it might be delicious, refreshing or nutritive in moderation, becomes unhealthful when consumed in excess. It may also be useful to speak with a qualified herbal expert. A regional list of herbalists is maintained on the American Herbalists Guild's professional member referral list athttp://www.healthy.net/herbalists. Similarly, a local acupuncturist may be found at the American Association of Oriental Medicine athttp://www.aaom.org and naturopathic physicians can be located through the American Association of Naturopathic Physicians athttp://naturopathic.org

       

      Source:  American Botanical Council - American Herbal Products Association

    • How are herbal supplements regulated?

      All supplements, including herbs, vitamins, minerals, etc., must conform to Federal regulations that control their manufacture, labeling, and advertising. In order to sell an herbal supplement, a manufacturer must meet many different Federal (and sometimes state) regulations, and must also adhere to state and local health and business regulations. Since supplements are legally classified as a specifically defined type of food, all supplements are required to be manufactured to the same high standards that are required of all foods. These mandated good manufacturing practices (20) establish basic guidelines to assure that supplements are manufactured under sanitary conditions that result in properly identified products that are not contaminated or adulterated, and that are fit for consumption. Any supplement that does not conform to these basic guidelines is subject to regulatory action by FDA. In addition, all supplement products are required by law to provide certain information about their formulation.

       

      Like foods, supplements must provide consumers with nutritional information. Unlike foods, supplements must state the quantity of each of the contained ingredients, or of the "proprietary blends" that make up a product. All herbal products are required to identify the parts used of each of the plant ingredients, and to label them with their commonly accepted names. One of the areas of the most detailed Federal regulation of supplements is in the area of product claims, whether on product labels or in advertising. The Food and Drug Administration specifies exactly what kind of claims are allowed, and prohibits the use of any statement that would brand the product as a drug (21). Herbal supplements are not allowed to make statements regarding prevention, cure, mitigation or treatment of diseases. Instead, their claims are limited to statements that are legally defined as "statements of nutritional support" or "structure/function statements."

       

      Unfortunately, some uninformed writers have published statements that infer that the entire supplement industry is unregulated. Although this unfortunate "fact" has been broadly reported, it is absolutely false. While the details noted above provide some response to this misrepresentation, perhaps the most compelling refutations are in the form of statements made by Dr. Jane Henney, the current Commissioner of FDA. In testimony before Congress last year (22), Dr. Henney stated that "FDA has tools at its disposal to take enforcement actions against dietary supplements found to have safety, labeling, or other violations...," and also that she believes that current law "...provides FDA with the necessary legal authority to protect the public health." 

       

      Source:  American Botanical Council - American Herbal Products Association

    • What about interactions with drugs?

      Humans have been learning about the diverse effects of ingesting plants throughout our evolution. We have, by trial and error, found both good and bad effects that are related to specific plants, some of which we use as food, and others that are used for therapeutic purposes. The introduction of synthetic and highly purified drugs is an extremely modern development. As researchers observe the interactions that drugs have with common foods and herbs, surprises continue to surface. For example, less than 10 years ago it was found that drinking grapefruit juice increases the serum drug concentration when patients take certain drugs (23). This effect, which can last for up to (24) hours after consumption, is now thought to inhibit specific enzymatic activities responsible for breaking down the drugs 24. Similarly, both avocado and leafy vegetables that are high in vitamin K can diminish the effectiveness of blood-thinning drugs (25). These concerns are not widely known by the public, but now that medical professionals are aware of these effects, they can routinely monitor their patients to assure effective treatment.

      Similar information has surfaced about some of the herbs that we use. For example, we now know that the use of an extract of St. John's wort (Hypericumperforatum) may cause certain prescription medications to be eliminated more quickly (26, 27), leading one researcher to caution that, "As with grapefruit juice, a food product, physicians should also be aware of potential drug-herb interactions" (26). In response to this new information, the American Herbal Products Association has recommended that products containing St. John's wort be labeled to suggest that the advice of your prescribing physician be requested if you are taking any prescription drugs. Speculation on the exact mechanism of St. John's wort has led to reports that the use of this herb might affect oral contraceptives, leading to ineffectiveness and unwanted pregnancies. To date, there have been no reports of any such actual occurrence. Nevertheless, women taking oral contraceptives such as ethinyl estradiol and desogestrel should be aware that, if you experience break-through bleeding, you might experience a reduction in protection against pregnancy.

      As can be seen by the above examples, the effect of a drug can be either increased or decreased in the presence of other factors in the diet, including herbal use. Although it is likely that most such factors have little or no influence on drug metabolism, continued research will add to our knowledge of such interactions and responsible food and supplement manufacturers will be expected to inform their customers of any new findings. There is now an ongoing interest in other drugs that are suspected of interacting with certain specific herbs, with most contemporary emphasis on the use of herbs with blood-thinning drugs such as warfarin. Although the current concerns are either conceptual or based on isolated and inconclusive reports, it is advisable to inform your prescribing physician or pharmacist that you are using herbs when undergoing any drug therapy. As close monitoring of the effect of warfarin is an established standard of medical practice, this additional information will assist your physician in maintaining good supervision of your drug levels. In order to understand the potential for an herbal product to interact with prescription drugs, it may also be useful to consult with a qualified herbal expert. You can find a regional list of herbalists the American Herbalists Guild's professional member referral list at http://www.healthy.net/herbalists, or your local acupuncturist at the American Association of Oriental Medicine http://www.aaom.org. A similar database of naturopathic physicians is maintained by the American Assoc. of Naturopathic Physicians at http://naturopathic.org.

      Source:  American Botanical Council - American Herbal Products Association

    • What are "standardized" herbs?

      The U.S. herbal marketplace has seen the introduction of a number of "standardized" botanical extracts. The purpose of standardization is commonly believed to be control of the content of one or several "marker" compounds (29), which are perceived of as those constituents in the plant that are responsible for its therapeutic activity. In fact, standardization - when properly performed - entails a lot more than merely controlling the content of a particular marker compound. Rather, standardization consists of the body of information and manufacturing steps that ensure product consistency from one batch to the next. As such, it comprises a wide variety of raw material and process controls, as well as use of a consistent recipe.

      The goal in standardizing an extract is to control the complete chemical composition of the extract, rather than one particular identified constituent or group of constituents. The heightened interest in standardized products is due to the belief that standardization is directly related to the potency of the extract. This is not necessarily the case and can unfortunately lead to a "more is better" perception. It is important to know that the use of marker compounds is not essential to the production of quality botanical products and that many companies market high quality and consistent herbal extracts without reference to these. In addition, any manufacturing process that is too specifically concentrated on maximizing one constituent may place an undue emphasis on that single compound. On the other hand, there can be value in a manufacturing process that implements measures to control the entire spectrum of an herb's constituents and that also includes attention to marker compounds. Consumers should understand that label information about markers is usually provided to communicate product consistency and a degree of quality control rather than potency. 

      Source:  American Botanical Council - American Herbal Products Association

    • Should I tell my Doctor that I'm using herbs?

      Of course you should! And because your doctor is, ideally, your primary partner in managing your health, you should insist that your doctor, no matter their degree of training in herbs, receive that information respectfully. In telling your doctor of your decision to use an herbal product, however, don't be surprised to find that your knowledge of herbs is more advanced than theirs. You might suggest (again, respectfully) that they expand their education by using some of the internet resources listed below, or by purchasing and studying some of the written references identified there. At the same time, remember that your prescribing physician has a responsibility to safely oversee your use of any prescription drugs. If your doctor is concerned that a pharmaceutical substance might interact with an herbal product, it is prudent to accept such advice. 

    • What are the references for the botanical FAQ section?

      References

      3 Akerele, O. 1992. WHO Guidelines for the Assessment of Herbal Medicines. Fitoterapia 63(2):99-104.

      4 The broad category of "dietary supplements" was legally defined in 1994 by Congress' unanimous passage of a law called the Dietary Supplement Health and Education Act, or DSHEA.

      5 Schultes, RE and RF Raffauf. 1990. The Healing Forest.

      6 Garrison, J. Two Toddlers Died from Oleander Poisoning, Coroner Says. Los Angeles Times: July 26, 2000.

      7 Federal Food, Drug & Cosmetic Act, Section 301(a).

      8 Federal Food, Drug & Cosmetic Act, Section 350b(a)(2).

      9 Bennett, J. and CM Brown. 2000. Use of Herbal Remedies by Patients in a Health Maintenance Organization. Journal of the American Pharmaceutical Association 40(3):353-358.

      10 Farnsworth, NR. 1993. Relative Safety of Herbal Medicines. Herbalgram 29.

      11 Federal Food, Drug & Cosmetic Act, Section 201(n).

      12 McGuffin, M., C. Hobbs, R. Upton, and A. Goldberg. 1997. Botanical Safety Handbook. Boca Raton, FL: CRC Press. Available from AHPA.

      13 Leathwood, PD, et al. 1982. Aqueous extract of valerian root (Valeriana officinalis L) improves sleep quality in man. Pharmacol Biochem Behav 17(1):65-71.

      14 Donath, F, et al. 2000. Critical evaluation of the effect of valerian extract on sleep structure and sleep quality. Pharmacopsychiatry 33(2):47-53.

      15 DSHEA

      16 Donath, F., et al. 2000. Critical evaluation of the effect of valerian extract on sleep structure and sleep quality. Pharmacopsychiatry 33(2):47-53.

      17 Bach, D. and L. Ebeling. 1996. Long-term drug treatment of benign prostatic hyperplasia - results of a prospective 3-year multicenter study using Sabal extract IDS 89. Phytomedicine 3(2):105-111.

      18 Federal Food, Drug & Cosmetic Act, Section 402(f).

      19 Government Printing Office. 2000. Title 21 Code of Federal Regulation, Section 101.36. There are exemptions to the requirement for labeled "Supplement Facts," which includes a statement of serving size, for specifically identified small businesses and for foods in small packages. Exempt manufacturers nevertheless generally provide information about recommended serving.

      20 Government Printing Office. 2000. Title 21 Code of Federal Regulation, Section 110. "Current good manufacturing practice in manufacturing, packing, or holding human food."

      21 Government Printing Office. Revised Feb. 7, 2000. Title 21 Code of Federal Regulation, Section 101.93. "Certain types of statements for dietary supplements."

      22 Henney, J. Statement By Jane E. Henney, M.D., Commissioner, Food And Drug Administration, Department Of Health And Human Services, Before The Committee On Government Reform, U.S. House Of Representatives. March 25, 1999.

      23 Bailey DG, et al. 1991. Interaction of citrus juices with felodipine and nifedipine. Lancet 337(8736):268-9.

      24 Bailey DG, et al. 1998. Grapefruit juice-drug interactions. Br J Clin Pharmacol 46(2):101-10

      25 Wells, PS, et al. 1994. Interactions of warfarin with drugs and food. Ann Intern Med 121(9):676-83.

      26 Johne A, et al. 1999. Pharmacokinetic interaction of digoxin with an herbal extract from St John's wort (Hypericum perforatum). Clin Pharmacol Ther 66(4):338-45.

      27 Piscitelli SC, et al. 2000. Indinavir concentrations and St John's wort [letter]. Lancet 355(9203):547-8.

      29 Indeed, there is a common misconception in the U.S. that standardization is equivalent to adding purified compounds to an herb in order to achieve a desired level of the marker compound. In fact, nothing could be further from the truth. The addition of purified compounds in order to achieve "standardization" actually defeats the purpose of standardization. 

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