Boning Up on Dietary Calcium

Here's how to get it and its nutrition 'partner,' vitamin D

SUNDAY, Feb. 11 (HealthDay News) -- In the life of a human bone, it's all downhill after 30.
That's the typical cut-off point for bone-building, so experts say it's crucial that younger people take in enough calcium and another nutrient, vitamin D, to maximize the skeleton's potential.

After age 30, those same two nutrients are key to slowing the gradual bone loss that comes with age.
Calcium isn't just important to bones, though.

"It's also important to help prevent colon cancer and for good muscle contraction, including heart muscle," said Katharine Tallmadge, a Washington, D.C., dietitian and a spokeswoman for the American Dietetic Association. "It might even be important for lowering blood pressure and helping to burn off fat."
In fact, calcium is so important to so many aspects of health that "if we don't get enough in our diet, our body pulls it from the bones," Tallmadge said. "It's a critical mineral."

The U.S. Department of Agriculture's recommended daily allowance of calcium amounts to about 1,000 milligrams a day for adults ages 19 to 50 years of age and 1,200 milligrams a day for adults over 50. While many people turn to supplements for their calcium, Tallmadge said food is always a better bet.

"I encourage people to get three high-dairy foods per day, each containing about a third of the daily requirement" she said. "That could be a cup of milk, fortified soy milk, fortified orange juice, a cup of yogurt, one-and-a-half ounces of hard cheese." Lactose-intolerant individuals should still be able to consume skim or lactate-free varieties of milk, or they can turn to fortified non-dairy products.

There are also calcium-laden food sources besides dairy products -- such as grains and vegetables -- but it's tougher for the body to get enough of the nutrient from these foods, Tallmadge said.
Bone-building doesn't rely just on calcium, however.
"The really other important factor here is vitamin D -- it's just as important, if not more important, than calcium," Tallmadge said. Without this nutrient, the body's intestines simply cannot absorb dietary calcium.
There's one big hitch, though: Vitamin D isn't found naturally in most foods. Instead, human skin uses ultraviolet sunlight to manufacture the body's own supply of this nutrient.
That was a great system in prehistoric days, when humans spent most of their lives outside and poorly clad. But it's not so ideal today.
"People aren't out so much anymore and when they do go out, they cover themselves with sunscreen," Tallmadge said. "So, we are experiencing a rash of vitamin D deficiencies -- rickets -- in children. That causes a softening of bones that can lead to bow-legs."

The problem is more pronounced in black children because natural pigments in darker skin block out much of the sun's rays. The problem has gotten so bad, Tallmadge said, that "the U.S. National Academy of Sciences is now working on a new report on vitamin D, and I believe that, unofficially, we're going to double the daily requirement from 400 units to 800 or even 1,000 units per day."

Spending more time outside -- at least a half hour or an hour at midday -- is one way of boosting vitamin D levels.

Foods and supplements can also help, according to Tallmadge. "In a cup of milk, you usually get 100 units, and in a multivitamin, you might get 300 or 400 units," she said. Makers of multivitamins are now formulating higher-dose supplements based on the expected change in daily requirements, she added.
The bottom line is that everyone needs to get adequate daily amounts of both of these "partners in health," calcium and vitamin D, beginning in childhood and continuing throughout the life span.

"After our 30s, that will really help to prevent bone loss," Tallmadge said. "And remember, those losses start to really accelerate after our 50s.

"HealthDayCopyright (c) 2007

ScoutNews, LLC. All rights reserved.

Garlic (Allium sativum L.)

Background

Numerous controlled trials have examined the effects of oral garlic on serum lipids. Long-term effects on lipids or cardiovascular morbidity and mortality remain unknown. Other preparations (such as enteric-coated or raw garlic) have not been well studied.

Small reductions in blood pressure (<10mmhg),>

Numerous case-control/population-based studies suggest that regular consumption of garlic (particularly unprocessed garlic) may reduce the risk of developing several types of cancer, including gastric and colorectal malignancies. However, prospective controlled trials are lacking.

Multiple cases of bleeding have been associated with garlic use, and caution is warranted in patients at risk of bleeding or prior to some surgical/dental procedures. Garlic does not appear to significantly affect blood glucose levels.

Synonyms

Aged garlic extract (AGE), ajoene, alisat, alk(en)yl thiosulfates, allicin, Allicor®, Allii sativi bulbus, alliinase, allium, allitridium, allyl mercaptan, alubosa elewe, Amaryllidaceae (family), ayo-ishi, ayu, banlasun, camphor of the poor, clove garlic, da-suan, dai toan, dasuan, dawang, diallyl, diallyl disulphide (DADS), diallyl sulfide (DAS), diallyl sulphide, diethyl disulfide, diethyl hexasulfide, diethyl monosulfide, diethyl pentasulfide, diethyl tetrasulfide, diethyl trisulfide, dipropyl disulphide, dipropyl sulphide, dra thiam, (E)-ajoene, foom, garlic clove, garlic corns, garlic extract, garlic oil, garlic powder extract, Gartenlauch, hom khaao, hom kia, hom thiam, hua thiam, Karinat® (beta-carotene 2.5mg, alpha-tocopherol 5mg, ascorbic acid 30mg and garlic powder 150mg per tablet), kesumphin, kitunguu-sumu, knoblauch, kra thiam, Krathiam, krathiam cheen, krathiam khaao, Kwai®, Kyolic®, l'ail, lahsun, lai, la-juan, lasan, lashun, la-suan, lasun, lasuna, lauch, lay, layi, lehsun, lesun, Liliaceae (family), lobha, majo, methyl allyl, naharu, nectar of the gods, Ninniku, pa-se-waa, poor man's treacle, rason, rasonam, rasun, rust treacle, rustic treacles, S-alk(en)yl cysteine sulfoxide, S-allylcysteine (SAC), seer, skordo, sluon, stinking rose, sudulunu, tafanuwa, ta-suam, ta-suan, tellagada, Tellagaddalu, thiam, thioallyl derivative, thiosulfinates, toi thum, tum, umbi bawang putih, vallaippundu, Velluli, vellulli, verum, vinyl dithiin, vinyldithiin, (Z)-ajoene.

Dosing

The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy.
Adults (18 years and older)

Human studies report the use of 4-12.3 milligrams of garlic oil by mouth daily. Some sources report that steam-distilled oils, oil from crushed garlic, and aged-garlic in alcohol may be less effective for some uses, particularly as a blood thinner.

600 to 900 milligrams daily of non-coated, dehydrated garlic powder in three divided doses, standardized to 1.3% allicin content, has been used in human studies. The European Scientific Cooperative on Phytotherapy (ESCOP) recommends 3 to 5 milligrams allicin daily (1 clove or 0.5 to 1.0 gram dried powder) for prevention of atherosclerosis. The World Health Organization (WHO) recommends 2 to 5 grams fresh garlic, 0.4 to 1.2 grams of dried powder, 2 to 5 milligrams oil, 300 to 1,000 milligrams of extract, or other formulations that are equal to 2 to 5 milligrams of allicin daily.

The European Scientific Cooperative on Phytotherapy (ESCOP) recommends 2 to 4 grams of dried bulb or 2 to 4 milliliters of tincture (1:5 dilution in 45% ethanol), by mouth three times a day for upper respiratory tract infections.
Children (younger than 18 years)
Safety or effectiveness of garlic supplements has not been proven in children. Garlic in amounts found in food is likely safe in most children.

Safety

The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.
Allergies

People with a known allergy to garlic, any of its ingredients, or to other members of the Liliaceae (lily) family, including hyacinth, tulip, onion, leek, and chives, should avoid garlic. Allergic reactions have been reported with garlic taken by mouth, inhaled, or applied to the skin. Some of these reactions are severe including throat swelling and difficulty breathing (anaphylaxis). It has been suggested that some cases of asthma from inhaling garlic may be due to mites on the garlic. Fresh garlic applied to the skin may be more likely to cause rashes than garlic extract.

Side Effects and Warnings

Bad breath, body odor, and allergic reactions are the most common reported side effects of garlic. Fresh garlic has caused rash or skin burns, both in people taking garlic therapy and in food preparers handling garlic. Most reactions improve after stopping garlic therapy. Garlic products should not be applied to the skin of infants or children due to multiple reports of skin burns, and should be used cautiously in adults. Other reported side effects include dizziness, increased sweating, headache, itching, fever, chills, asthma flares, and runny nose.

Bleeding is a potentially serious side effect of garlic use, including bleeding after surgery and spontaneous bleeding. Several cases of bleeding are reported, which may be due to effects of garlic on blood platelets, or to increased breakdown of blood clots (fibrinolysis). There is debate about the effects of garlic in people treated with warfarin (Coumadin®), but studies suggest that garlic does not alter the International Normalized Ratio (INR) values that are used to measure the effect of warfarin on blood thinning. Garlic should be stopped prior to some surgical or dental procedures due to an increased risk of bleeding. Caution is urged for people who have bleeding disorders or who take blood thinning medications (anticoagulants, aspirin/anti-platelet agents, non-steroidal anti-inflammatory drugs such as ibuprofen or naproxen) or herbs/supplements that may increase the risk of bleeding. Dosing adjustments may be necessary.

Garlic or its ingredients may lower blood sugar levels and increase the release of insulin. However, studies in humans do not show changes in blood sugar control in people with or without diabetes. Nonetheless, caution is advised in people with diabetes or hypoglycemia, and in those taking drugs, herbs, or supplements that affect blood sugar. Blood sugar levels may need to be monitored by a healthcare professional, and medication adjustments may be necessary. Informal reports describe low iodine absorption in the thyroid and low levels of thyroid hormone (hypothyroidism) with garlic supplementation. A few reports suggest that garlic and garlic-like plants may be linked to nodules or tumors of the thyroid. Reduced sperm counts have been reported in rats.

Dehydrated garlic preparations or raw garlic taken by mouth may cause burning of the mouth, bad breath, abdominal pain or fullness, poor appetite, gas, belching, nausea, vomiting, irritation of the stomach lining, changes in the bacteria in the gut, heartburn, diarrhea, or constipation. One report describes bowel obstruction in a man who ate a whole garlic bulb. Garlic should be used cautiously by people with stomach ulcers or who are prone to stomach irritation.

Multiple studies show a small reduction in blood cholesterol levels after garlic supplements are taken by mouth. Small reductions in blood pressure are also commonly reported. One case of heart attack is noted in a healthy man after taking a large amount of garlic by mouth.

Contamination of garlic products has been reported.

In Vancouver, British Columbia, a commercial preparation of chopped garlic was linked to botulism. One report describes overdose of colchicine and even death after meadow saffron ( Colchicum autumnale ) was mistaken for wild garlic ( Allium ursinium ).

Garlic and pycnogenol have been shown to increase human growth hormone secretion in laboratory experiments.
Pregnancy and Breastfeeding

Garlic is likely safe during pregnancy in amounts usually eaten in food, based on historical use. However, garlic supplements or large amounts of garlic should be avoided during pregnancy due to a possible increased risk of bleeding. In addition, early animal studies suggest that garlic may cause contraction of the uterus. Many tinctures contain high levels of alcohol, and should be avoided during pregnancy.

Garlic is likely safe during breastfeeding in amounts usually eaten in food, based on historical use. However, some mothers who take garlic supplements report increased nursing time, milk odor, and reduced feeding by the infant. The safety of garlic supplements during breastfeeding is not known.

Interactions

Most herbs and supplements have not been thoroughly tested for interactions with other herbs, supplements, drugs, or foods. The interactions listed below are based on reports in scientific publications, laboratory experiments, or traditional use. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy.
Interactions with Drugs

Human reports suggest that garlic may increase the risk of bleeding when taken with drugs that also increase the risk of bleeding. Examples include aspirin, anticoagulants ("blood thinners") such as warfarin (Coumadin®) or heparin, anti-platelet drugs such as clopidogrel (Plavix®), and non-steroidal anti-inflammatory drugs such as ibuprofen (Motrin®, Advil®) or naproxen (Naprosyn®, Aleve®). Animal and human studies show that garlic can lower blood pressure. Use caution when combining with other medications that lower blood pressure. Several human studies report lower cholesterol in people taking garlic. These effects may be increased if garlic is taken with medications that lower blood cholesterol like lovastatin (Mevacor®) or other "statins" (HMGCoA reductase inhibitors).

Levels of the drug saquinavir, used in HIV treatment, may be reduced if garlic is taken, and its effectiveness may therefore be reduced. Other antiviral drugs like ritonavir may also be affected.

Garlic may lower blood sugar levels. Although this is theoretical in humans, caution is advised when using medications that may also lower blood sugar. Patients taking drugs for diabetes by mouth or insulin should be monitored closely by a qualified healthcare professional. Medication adjustments may be necessary. Individuals with thyroid disorders or who take thyroid medications should use caution in taking garlic supplements as they may affect the thyroid.

Garlic may alter levels of certain drugs metabolized by the liver's CYP450 enzyme system.

Many tinctures contain high levels of alcohol, and may cause nausea or vomiting when taken with metronidazole (Flagyl®) or disulfiram (Antabuse ® ).

Garlic may alter levels of various anti-cancer drugs. Check with your oncologist and pharmacist before starting to take garlic supplements.

Interactions with Herbs and Dietary Supplements

Garlic may increase the risk of bleeding. In theory, this risk may be further increased when garlic is taken with other herbs or supplements that also increase the risk of bleeding. Multiple cases of bleeding have been reported with the use of Ginkgo biloba and two cases with saw palmetto. Numerous other agents may theoretically increase the risk of bleeding, although this has not been proven in most cases.

Garlic may have a small effect in lowering blood pressure. Caution should be used if taken with other supplements that can lower blood pressure.

Garlic may lower blood sugar levels. Caution is advised when using herbs or supplements that may also lower blood sugar. Blood glucose levels may require monitoring, and doses may need adjustment.

Garlic may lower cholesterol a small amount. These effects may be larger than expected if taken with other cholesterol-lowering supplements such as fish oil.

Garlic may interact with herbals and dietary supplements that are metabolized by the liver's CYP450 enzyme system.

Garlic and pycnogenol have been shown to increase human growth hormone secretion in laboratory experiments.

Effects of herbs and supplements that act on the thyroid may be affected by garlic.

Methodology

This information is based on a professional level monograph edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com): Ethan Basch, MD (Natural Standard Research Collaboration); Samuel Basch, MD (Mt. Sinai School of Medicine, NY); Paul Hammerness, MD (Harvard Medical School); Sadaf Hashmi, MD, MPH (Johns Hopkins School of Hygiene and Public Health); Jens Hasskarl, MD (Harvard Medical School); Michael Smith, M.R.PharmS, ND (Canadian College of Naturopathic Medicine); Anne P. Spencer, PharmD (Medical University of South Carolina); Catherine Ulbricht, PharmD (Massachusetts General Hospital); Mamta Vora, PharmD (Northeastern University); Wendy Weissner, BA (Natural Standard Research Collaboration).

Selected references
Ackermann RT, Mulrow CD, Ramirez G, et al. Garlic shows promise for improving some cardiovascular risk factors. Arch Intern Med 2001; 161(6):813-824.
Andrianova IV, Fomchenkov IV, Orekhov AN. [Hypertensive effect of long-acting garlic tablets allicor (a double-blind placebo-controlled trial)]. Ter Arkh 2002; 74(3):76-78.
Ashraf R, Aamir K, Shaikh AR, et al. Effects of garlic on dyslipidemia in patients with type 2 diabetes mellitus. J Ayub Med Coll Abbottabad. 2005 Jul-Sep;17(3):60-4.
Bordia A. [Garlic and coronary heart disease. Results of a 3-year treatment with garlic extract on the reinfarction and mortality rate]. Deutsche Apotheker Zeitung 1989;129(28 suppl 15):16-17.
Fleischauer AT, Arab L. Garlic and cancer: a critical review of the epidemiologic literature. J Nutr 2001;131(3s):1032S-1040S.
Hassan HT. Ajoene (natural garlic compound): a new anti-leukaemia agent for AML therapy. Leuk Res 2004;28(7):667-671.
Josling P. Preventing the common cold with a garlic supplement: a double-blind, placebo-controlled survey. Adv Ther 2001;18(4):189-193.
Kwon SK, Moon A. Synthesis of 3-alkylthio-6-allylthiopyridazine derivatives and their antihepatocarcinoma activity. Arch Pharm Res 2005;28(4):391-394.
McCrindle BW, Helden E, Conner WT. Alternative medicine -- a randomized double blind placebo-controlled clinical trial of garlic in hypercholesterolemic children [white diamond suit] 661. Pediatric Res 1998;43(4 suppl 2):115.
McNulty CA, Wilson MP, Havinga W, et al. A pilot study to determine the effectiveness of garlic oil capsules in the treatment of dyspeptic patients with Helicobacter pylori. Helicobacter 2001;6(3):249-253.
Sabitha P, Adhikari PM, Shenoy SM, et al. Efficacy of garlic paste in oral candidiasis. Trop Doct 2005;35(2):99-100.
Siegel G. Long-term effect of garlic in preventing arteriosclerosis - results of two controlled clinical trials. Eur Phytojournal 2001;Symposium posters(1):1.
Sobenin IA, Prianishnikov VV, Kunnova LM, et al. [Reduction of cardiovascular risk in primary prophylaxy of coronary heart disease]. Klin Med (Mosk) 2005;83(4):52-55.
Stevinson C, Pittler MH, Ernst E. Garlic for treating hypercholesterolemia. A meta-analysis of randomized clinical trials. Ann Intern Med 2000;133(6):420-429.
Turner B, Molgaard C, Marckmann P. Effect of garlic (Allium sativum) powder tablets on serum lipids, blood pressure and arterial stiffness in normo-lipidaemic volunteers: a randomised, double-blind, placebo-controlled trial. Br J Nutr 2004;92(4):701-706.

Tips for Older Dietary Supplement Users

Can Dietary Supplements Help Older Consumers?

Even if you eat a wide variety of foods, how can you be sure that you are getting all the vitamins, minerals, and other nutrients you need as you get older? If you are over 50, your nutritional needs may change. Informed food choices are the first place to start, making sure you get a variety of foods while watching your calorie intake. Supplements and fortified foods may also help you get appropriate amounts of nutrients. To help you make informed decisions, talk to your doctor and/or registered dietitian. They can work together with you to determine if your intake of a specific nutrient might be too low or too high and then decide how you can achieve a balance between the foods and nutrients you personally need.

What Are Dietary Supplements?

Today's dietary supplements are not only vitamins and minerals. They also include other less-familiar substances, such as herbals, botanicals, amino acids, enzymes, and animal extracts. Some dietary supplements are well understood and established, but others need further study. Whatever your choice, supplements should not replace the variety of foods important to a healthful diet.

Unlike drugs, dietary supplements are not pre-approved by the government for safety or effectiveness before marketing. Also, unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. But some supplements can help assure that you get an adequate dietary intake of essential nutrients; others may help you reduce your risk of disease. Some older people, for example, are tired due to low iron levels. In that case, their doctor may recommend an iron supplement.

At times, it can be confusing to tell the difference between a dietary supplement, a food, or over-the-counter (OTC) medicines. This is because supplements, by law, come in a variety of forms that resemble these products, such as tablets, capsules, powders, energy bars, or drinks. One way to know if a product is a dietary supplement is to look for the Supplement Facts label on the product.

Are There Any Risks, Especially to Older Consumers?

While certain products may be helpful to some older individuals, there may be circumstances when these products may not benefit your health or when they may create unexpected risks. Many supplements contain active ingredients that have strong biological effects in the body. This could make them unsafe in some situations and hurt or complicate your health. For example:

Are you taking both medicines and supplements?

Are you substituting one for the other? Taking a combination of supplements, using these products together with medications (whether prescription or over-the-counter), or substituting them in place of medicines your doctor prescribes could lead to harmful, even life-threatening results. Be alert to any advisories about these products. Coumadin (a prescription medicine), ginkgo biloba (an herbal supplement), aspirin (an over-the-counter drug), and vitamin E (a vitamin supplement) can each thin the blood. Taking any of these products alone or together can increase the potential for internal bleeding or stroke. Another example is St. John's wort that may reduce the effectiveness of prescription drugs for heart disease, depression, seizures, certain cancers, or HIV.

Are you planning surgery?

Some supplements can have unwanted effects before, during, and after surgery. It is important to fully inform your healthcare professional, including your pharmacist, about the vitamins, minerals, herbals, and any other supplements you are taking, especially before surgery. You may be asked to stop taking these products at least 2-3 weeks ahead of the procedure to avoid potentially dangerous supplement/drug interactions - such as changes in heart rate, blood pressure, or bleeding risk that could adversely affect the outcome of your surgery.

Is taking more of a good thing better?

Some people might think that if a little is good, taking a lot is even better. But taking too much of some nutrients, even vitamins and minerals, can also cause problems. Depending on the supplement, your age, and the status of your health, taking more than 100% of the Daily Value (DV) (see the Supplements Facts panel) of certain vitamins and minerals, e.g. Vitamin A, vitamin D, and iron (from supplements and food sources like vitamin-fortified cereals and drinks) may actually harm your health. Large amounts can also interfere with how your medicines work.

Remember: Your combined intake from all supplements (including multivitamins, single supplements, and combination products) plus fortified foods, like some cereals and drinks, could cause health problems.

Web Sites with Information on Dietary Supplements and Nutrition from Government Agencies and Others:
Links to non-Federal government organizations found on this site are provided as a service to our users and do not represent FDA endorsement of these organizations or their materials.

Federal Government Agencies
Administration on Aging, DHHS: http://www.aoa.gov/

Food and Drug Administration, DHHS, Center for Food Safety and Applied Nutrition:

http://www.cfsan.fda.gov/~dms/supplmnt.html
http://www.cfsan.fda.gov/~dms/ds-savvy.html
http://www.cfsan.fda.gov/label.html
Federal Trade Commission: www.ftc.gov

National Institutes of Health, DHHS:

National Center for Complementary & Alternative Medicine:
http://nccam.nih.gov/(Clearing house) 1-888-NIH CAM
Office of Dietary Supplements: http://dietary-supplements.info.nih.gov

Office on Women's Health, DHHS, http://www.4woman.gov/owh/aboutowh.htm or 1-800-994-WOMAN

U.S. Department of Agriculture, Food and Nutrition Information Center: www.nal.usda.gov/fnic

Others
American Dietetic Association: http://www.eatright.org
American Pharmacists Association: www.pharmacyandyou.org
Food Marketing Institute: www.fmi.org
International Food Information Council Foundation: http://ific.org
National Council on Patient Information and Education: http://www.talkaboutrx.org/compliance.html#dietary
AARP: http://www.aarp.org

Botanical Dietary Supplements: Background Information

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.

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 (http://www.fda.gov/opacom/laws/dshea.html#sec3), 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.

How are botanicals commonly sold and prepared?

Botanicals are sold in many forms: as fresh or dried products; liquid or solid extracts; and tablets, capsules, powders, and tea bags. 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 a decoction, 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.

Are botanical dietary supplements standardized?

Standardization is a process that manufacturers may use to ensure batch-to-batch consistency of their products. In some cases, standardization involves identifying specific chemicals (also known as markers) that can be used to manufacture a consistent product. The standardization process can also provide a measure of quality control.Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists for standardization in the United States as it applies to botanical dietary supplements. Because of this, the term "standardization" may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word "standardized" on a supplement label does not necessarily indicate product quality.Ideally, the chemical markers chosen for standardization would also be the compounds that are responsible for a botanical's effect in the body. In this way, each lot of the product would have a consistent health effect. However, the components responsible for the effects of most botanicals have not been identified or clearly defined. For example, the sennosides in the botanical senna are known to be responsible for the laxative effect of the plant, but many compounds may be responsible for valerian's relaxing effect.

Are botanical dietary supplements safe?

Many people believe that products labeled "natural" are safe and good for them. This is not necessarily true because the safety of a botanical depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the dose used.The action of botanicals range from mild to powerful (potent). A botanical with mild action may have subtle effects. Chamomile and peppermint, both mild botanicals, are usually taken as teas to aid digestion and are generally considered safe for self-administration. Some mild botanicals may have to be taken for weeks or months before their full effects are achieved. For example, valerian may be effective as a sleep aid after 14 days of use but it is rarely effective after just one dose. In contrast a powerful botanical produces a fast result. Kava, as one example, is reported to have an immediate and powerful action affecting anxiety and muscle relaxation. The dose and form of a botanical preparation also play important roles in its safety. Teas, tinctures, and extracts have different strengths. The same amount of a botanical may be contained in a cup of tea, a few teaspoons of tincture, or an even smaller quantity of an extract. Also, different preparations vary in the relative amounts and concentrations of chemical removed from the whole botanical. For example, peppermint tea is generally considered safe to drink but peppermint oil is much more concentrated and can be toxic if used incorrectly. It is important to follow the manufacturer's suggested directions for using a botanical and not exceed the recommended dose without the advice of a health care provider.

Does a label indicate the quality of a botanical dietary supplement product?

It is difficult to determine the quality of a botanical dietary supplement product from its label. The degree of quality control depends on the manufacturer, the supplier, and others in the production process.FDA is authorized to issue Good Manufacturing Practice (GMP) regulations describing conditions under which dietary supplements must be prepared, packed, and stored. FDA published a proposed rule in March 2003 that is intended to ensure that manufacturing practices will result in an unadulterated dietary supplement and that dietary supplements are accurately labeled. Until this proposed rule is finalized, dietary supplements must comply with food GMPs, which are primarily concerned with safety and sanitation rather than dietary supplement quality. Some manufacturers voluntarily follow drug GMPs, which are more rigorous, and some organizations that represent the dietary supplement industry have developed unofficial GMPs.
What methods are used to evaluate the health benefits and safety of a botanical dietary supplement?Scientists use several approaches to evaluate botanical dietary supplements for their potential health benefits and safety risks, including their history of use and laboratory studies using cell or animal studies. Studies involving people (individual case reports, observational studies, and clinical trials) can provide information that is relevant to how botanical dietary supplements are used. Researchers may conduct a systematic review to summarize and evaluate a group of clinical trials that meet certain criteria. A meta-analysis is a review that includes a statistical analysis of data combined from many studies.

What are some additional sources of information on botanical dietary supplements?

Medical libraries are one source of information about botanical dietary supplements. Others include Web-based resources such as PubMed (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=nih) and FDA (http://www.cfsan.fda.gov/~dms/ds-info.html). For general information about dietary supplements see Dietary Supplements: Background Information (http://ods.od.nih.gov/factsheets/dietarysupplements.asp) from the Office of Dietary Supplements (ODS), available at ods.od.nih.gov.

About ODS
General Safety Advisory
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Posted Date:6/21/2003
Updated:4/11/2006 2:59 PM

DisclaimerReasonable care has been taken in preparing this fact sheet and the information provided herein is believed to be accurate. However, this information is not intended to constitute an "authoritative statement" under Food and Drug Administration rules and regulations.

About ODSThe mission of the Office of Dietary Supplements (ODS) is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.