Walk into any pharmacy and you will see rows and rows of vitamins and dietary supplements. While many nutritionists and doctors agree that supplements can help fill gaps in nutrition, you might not know what they are and how they help. This article written with the help of https://healthy.co.id/id
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 vitamins, minerals, herbs or botanicals, amino acids, and other substances; is intended for consumption by mouth in pill or liquid form; and is labeled on the front as being a dietary supplement. Congress further explained that these were not sold before 1994. The Food and Drug Administration requires specific safety information from a manufacturer intending to market a dietary supplement containing these new ingredients.
Are dietary supplements different from foods and drugs?
Although dietary supplements are regulated by the FDA as foods, they are regulated differently from other foods and from drugs. Whether a product is classified as a dietary supplement, conventional food or drug is based on its intended use. Most often, classification as a dietary supplement is determined by the information that the manufacturer provides on the product label or in accompanying literature, although many food and dietary supplement product labels do not include this information.
What claims can manufacturers make for dietary supplements and drugs?
The types of claims that can be made on the labels of dietary supplements and drugs differ. Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat or prevent a disease. Such claims may not legally be made for dietary supplements.
The label of a dietary supplement or food product may contain one of three claims: a health claim, nutrient content claim, or structure/function claim. Health claims describe a relationship between a dietary supplement ingredient and reducing the risk of a disease or health-related condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product. A structure/function claim is a statement describing how a product may affect the organs or systems of the body and it cannot mention any specific disease. Structure/function claims do not require FDA approval but the manufacturer must provide the FDA with the text of the claim within 30 days of putting the product on the market. Product labels containing such claims must also include a disclaimer that reads: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease."
What methods are used to evaluate the health benefits and safety of a dietary supplement?
Dietary supplements are not required by federal law to be tested for safety and effectiveness before they are marketed, so the amount of scientific evidence available for various supplement ingredients varies widely. Some ingredients in dietary supplements have been carefully evaluated. For example, scientists know that calcium and vitamin D are important for keeping bones strong. Other supplements, such as many herbal products, need more study to determine their value.
Scientists can use several approaches to evaluate dietary supplements for their potential health benefits and risks. They may investigate history of use, conduct laboratory studies using cell or tissue cultures, and experiment with animals. Studies on people (e.g., individual case reports, observational studies, and clinical trials) provide the most direct evidence of a dietary supplement's effects on health and patterns of use.