Dietary supplements: safety and effectiveness

Dietary supplements are a huge industry, and growing rapidly due to the interest in taking them for a variety of reasons: rejuvenation, staying youthful, to treat ailments like arthritis, or used as insurance against eating a diet poor in nutritional quality. Scientific research on the associations between supplements and health is accumulating rapidly.

What are Dietary supplements?

In 1994, Congress passed the Dietary Supplement Health and Education Act, a comprehensive law that spells out what supplements are and what claims can be made about them. Dietary supplement (also called nutritional supplement) is a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, mineral, amino acid, herb or other botanical. Dietary supplements come in various forms, such as pills, tablets, capsules, liquids, or powders.

Examples of dietary supplements

How are dietary supplements regulated?

The U.S. Food and Drug Administration (FDA) does not regulate dietary supplements in the same way it regulates medication. Currently, the FDA regulates dietary supplements as foods rather than drugs. In general, the laws about putting foods (including dietary supplements) on the market and keeping them on the market are less strict than the laws for drugs.

Under the Dietary Supplement Health and Education Act, the dietary supplement manufacturer is responsible for the safety of a supplement before it is marketed. Manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. They do not have to prove supplement quality and effectiveness. Manufacturers must make sure that product label information is truthful and not misleading. All ingredients must be listed on the label. FDA can only take action against the manufacturer and/or distributor of the products that are not safe or products that make false claims after they are for sale. FDA can issue a warning or require the product to be removed from the marketplace. To file a complaint about a dietary supplement, go to: http://www.cfsan.fda.gov/~dms/hclaims.html.

Manufacturers of dietary supplements cannot legally say that dietary supplements can diagnose, cure, treat, or prevent disease. However, they can say that these supplements contribute to health maintenance and well-being.

The Federal Government also regulates supplement advertising, through the Federal Trade Commission. It requires that all information about supplements be truthful and not mislead consumers.

Why should we use dietary supplements?

People use supplements for a variety of reasons, from improving health and wellbeing to preventing and treating specific conditions, and maintaining general health. The body needs an optimum amount of vitamins and minerals to function healthily and resist diseases.

Not everyone eats properly, so there may be times when extra vitamins or a mineral supplement could be beneficial. Certain vitamins and minerals when taken in quantities greater than the minimum can protect against some diseases, such as heart disease, hypertension, stroke, cancer, diabetes, arthritis, osteoporosis, and others, as well as to correct the effects of pollution on our bodies. Research on some herbs and plant products has shown that they may have some of the same effects that conventional medicines do. Historically, people have used herbs to prevent illness, cure infection, reduce fever, and heal wounds. Herbal supplements can also treat constipation, ease pain, or act as relaxants or stimulants.

Reasons to take dietary supplements unclude the following:

  • to supplement a poor diet
  • maintain overall health and fitness
  • maintain vitality and help maintain good health as age increases
  • when feeling run-down or after illness
  • on the recommendation of a health professional
  • when preparing for a pregnancy, during pregnancy when nutritional needs may be higher
  • when the diet may be low or lower in certain nutrients e.g. during slimming
  • to help combat the effects of smoking
  • for the athletes to ensure a regular supply of essential nutrients
  • to treat or prevent diseases (such as osteoporosis, colds and flu)
  • for memory improvement
  • to boost energy

Who needs supplements?

Many factors need to be taken into consideration when assessing whether or not a dietary supplement is needed. These include age, health status, sex, environment, diet and even nationality. The following people may benefit from dietary supplements:

  • Infants and children
  • Adolescents. Teenagers often have irregular eating habits and may not eat a balanced diet
  • Women preparing for pregnancy
  • During pregnancy. Vitamins and minerals are needed during pregnancy for the maintenance of the mother's health, to support the developing infant's growth, and to help prevent developmental defects
  • Breast-feeding mothers
  • The elderly
  • Those individuals with limited exposure to sunlight may be at risk from vitamin D deficiency
  • Strict vegetarians or vegans whose diets may be deficient in key nutrients. Vegetarians are advised to take a multivitamin with iron, B12 and other minerals each day
  • Dieters or anyone avoiding certain food groups due to illness or a special or restricted diet
  • People dealing with eating disorders, deficiency diseases, absorption problems, or who are lactose intolerant
  • People with busy lifestyles who find it difficult to eat a balanced diet.
  • Athletes in training. To fulfill the extra nutritional requirements, athletes may turn to dietary supplements such as vitamin, mineral, protein and carbohydrate supplements.

Are supplements safe?

Vitamins and essential minerals are relatively harmless when taken in amounts close to the recommended doses because these recommendations are deliberately conservative. Taking heavy doses of dietary supplements has not proven to be effective. In fact, it can be toxic. The National Institutes of Health (NIH) does not recommend supplementing the diet with vitamins and/or nutrients beyond the recommended daily allowances (RDA).

In some cases, dietary supplements may have unwanted effects: cause side effects, trigger allergic reactions, or interact with prescription and nonprescription medications or other supplements you might be taking. Inform your your doctor, pharmacist or nurse about any dietary supplements you are considering taking, especially if you:

  • are pregnant or breast-feeding
  • take other supplements or medicines (prescription or over-the-counter)
  • plan to have surgery (some supplements can have unwanted effects during surgery)
  • have diabetes, high blood pressure, or any other health problems
  • under age 18, age 65 or older
  • unsure about taking the supplement after analyzing the label
  • unsure if you need the supplement or not

Some safe guidance:

  • When selecting a multi-vitamin, select one with no more than 100% of the RDA for vitamins and minerals
  • Dietary supplements should not be used instead of prescription medicine
  • Take any supplements according to label directions unless otherwise advised by a qualified practitioner

How to choose a high quality product?

It is difficult to determine the quality of a dietary supplement product from its label. The degree of quality control depends on the manufacturer, the supplier, and others in the production process.

When you choose the health supplement, look for the following:

  • An established brand. Certain companies have been manufacturing quality supplements for decades. While newcomers can be selling a superior supplement, it makes sense to start your research with the tried-and-true.
  • The Latin name of an herb, including genus and species, or the common name of the herb you want. Most herbs have more than one species, and not every species has medicinal value. If you're unsure, ask for assistance.
  • Customer service information. Ideally, either a toll-free phone number to call, a website, or both.
  • Recommendations for use. Does the bottle or other container clearly state how much of the supplement to take and when?
  • Function statement. Tells how the product can maintain healthy or normal bodily structures or functions. Note that claims must be accompanied by the following disclaimer: "These statementshave not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease".
  • Amount per serving and % Daily Value (the latter will say "Daily Value not established" for herbs).
  • Other ingredients. Some supplements contain just the vitamin, mineral or herb itself, but the vast majority contain minor amounts of additional ingredients as binders, fillers, or for flavor, such as gelatin, silica, magnesium stearate, and artificial colors or flavors. If you are unfamiliar with an ingredient, find out its purpose before buying the product.
  • Additives statement. The product should state whether it is free of common allergens, such as corn, wheat, and milk.
  • Warning statement. For example, "Do not use if you are pregnant."
  • Lot number. Helps manufacturers locate the original batch if problems arise.
  • Expiration date. Make sure it's post-dated for at least the length of time you will spend using up the contents.
  • Storage instructions.
  • Avoid supplements that provide "megadoses." In general, choose a multivitamin-mineral supplement that provides about 100% Daily Value (%DV) of all the vitamins and minerals instead of one that supplies, for example, 200%DV of one vitamin and only 30%DV of another. The exception to this is calcium. You may notice that calcium-containing supplements don't provide 100%DV.
  • Look for “USP” on the label. This ensures that the supplement meets the standards for strength, purity, disintegration and dissolution established by the testing organization, U.S. Pharmacopeia (USP).
  • The potency of the nutrients. When the label says that there is a standardized amount of a certain nutrient in the supplement, this means that the balance of herbs has been developed to make sure that each and every capsule contains the same amount of active ingredient.
  • Whether or not the nutritional supplements contain natural or synthetic ingredients. While synthetics are of course less expensive, their natural counterparts are much more potent and effective, and have the added bonus of being more readily utilized by the body. Some people can even have reactions to the synthetic version of a nutrient who have never had a problem before.
  • Safety.

Bottom Line

Dietary supplements are intended to supplement the diet, not to cure, prevent, or treat diseases or replace the variety of foods important to a healthful diet. Supplements can help you meet daily requirements for certain nutrients, but when you combine drugs and foods, too much of some nutrients can also cause problems. Many factors play a role in deciding if a supplement is right for you, including possible drug interactions and side effects. Do not self-diagnose any health condition. Together, you and your healthcare team can make the best decision for optimal health.

Additional resources on dietary supplements






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