Supplements

Dietary supplements and over-the-counter drugs may look the same to consumers on the drugstore shelves, but they are regulated in very different ways. A drug is defined as a product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Over-the-counter drugs must be proven to be safe, effective, pure, and accurately labeled as well as approved by the US Food and Drug Administration (FDA) before they go on the market.

In contrast, dietary supplements are regulated much more like food products. They must be safe and pure but they are not required to show that they are effective or provide any benefit. In terms of safety, the burden of proof is on the FDA to show that a product presents a significant risk of illness or injury. Dietary supplements may include vitamins, minerals, herbs, amino acids, and enzymes in a variety of forms.

The labels of dietary supplements look like the labels for food products and include basic information about the content of the product. The FDA authorizes a small number of health claims that food and supplement manufacturers can use if their products meet certain requirements. Supplements can also make claims about improving the structure or function of the body or overall well-being. These structure/function claims are not regulated or approved by the FDA, and they must carry a disclaimer stating that the product is not designed to treat or prevent a disease.

A dietary supplement is a product taken by mouth that is intended to supplement the diet and that contains one or more “dietary ingredients.” The “dietary ingredients” in these products may include

Do we need nutritional supplements?

Nutritional supplements contain nutrients that can also be ingested through a healthy diet. According to the regulations, it is illegal to claim or to render the impression that a balanced and varied diet in general will not provide a sufficient supply of vitamins and minerals. The Directorate of Health has defined the recommended intake of various vitamins, minerals and other nutrients. If the diet does not provide these, nutritional supplements can increase the body’s level of them, and thereby prevent symptoms of deficiencies.

Are Supplements Safe?

Many dietary supplements have clean safety histories. For example, millions of Americans responsibly consume multi-vitamins and experience no ill effects.

Some dietary supplements have been shown to be beneficial for certain health conditions. For example, the use of folic acid supplements by women of childbearing age who may become pregnant reduces the risk of some birth defects.

Some supplements have had to be recalled because of proven or potential harmful effects. Reasons for these recalls include

• microbiological, pesticide, and heavy metal contamination
• absence of a dietary ingredient claimed to be in the product
• the presence of more or less than the amount of the dietary ingredient claimed on the label

In addition, unscrupulous manufacturers have tried to sell bogus products that should not be on the market at all.

Before taking a dietary supplement, make sure that the supplement is safe for you and appropriate for the intended purpose.

What is a natural dietary supplement?

Herbal supplements are non-pharmaceutical, non-food substances marketed to improve health. Herbalism (herbal medicine, botanical medicine) is the use of plant-derived substances, and sometimes other environmental substances, to treat or cure medical conditions.

People use dietary supplements for a wide assortment of reasons. Some seek to compensate for diets, medical conditions, or eating habits that limit the intake of essential vitamins and nutrients. Other people look to them to boost energy or to get a good night’s sleep. Postmenopausal women consider using them to counter a sudden drop in estrogen levels.

What is considered an herbal supplement?

Herbal supplements are non-pharmaceutical, non-food substances marketed to improve health. Herbalism (herbal medicine, botanical medicine) is the use of plant-derived substances, and sometimes other environmental substances, to treat or cure medical conditions.

Are herbal supplements regulated by the FDA?

Herbal supplements are regulated by the FDA, but not as drugs or as foods. They fall under a category called dietary supplements. The rules for dietary supplements are as follows: Manufacturers don’t have to seek FDA approval before putting dietary supplements on the market.