Product that is added to the diet is known as a nutritional supplement. It is taken orally and usually contains one or more dietary ingredients such as vitamins, minerals, herbs, amino acids, and enzymes.
Dietary supplements
are products intended to supplement the diet, but they are not medicines and are not intended to treat, diagnose, mitigate, prevent, or cure diseases. The FDA is the federal agency responsible for regulating both supplements and drugs, but the regulations for dietary supplements are different from those for prescription or over-the-counter drugs.Nutritional and dietary supplements are not considered foods or medications, and are not heavily regulated. Surveys have revealed that most people mistakenly assume that these protections extend to all products sold on shelves, including dietary supplements, but this is not the case. Dietary supplements can be found in many forms such as pills, tablets, capsules, gummies, softgels, liquids and powders. The Dietary Supplement Health and Education Act (DSHEA) requires manufacturers or distributors to notify the FDA in advance and submit safety information if they intend to market a dietary supplement in the United States that contains a new dietary ingredient.
In addition to vitamins, dietary supplements may contain minerals, herbs or other botanical ingredients, amino acids, enzymes, and many other ingredients. The FDA's role in regulating dietary supplements includes (among other things) inspecting manufacturing facilities, reviewing new dietary ingredient notifications and other regulatory requests on dietary supplements, investigating complaints, monitoring the market, examining dietary supplements and ingredients offered for import to determine if they comply with U. S. regulations.
More information on reporting adverse events associated with the use of dietary supplements can be found in How to Report a Problem with Dietary Supplements. Be cautious when taking dietary supplements beyond a standard prenatal supplement if you are pregnant or breastfeeding. The safety of many supplements has not been well evaluated in children and in people who are pregnant or breastfeeding. You're more likely to experience side effects from dietary supplements if you take them in high doses or instead of prescription drugs, or if you take many different supplements. The dietary supplement category generally excludes items approved as new drugs, authorized as biological products, or authorized for clinical research pursuant to an effective new investigational drug (IND) application (IND), unless the item was previously marketed as a dietary supplement or as a food. No product that is sold as a dietary supplement and that is explicitly or implicitly represented for the treatment, prevention, or cure of a specific disease or class of diseases meets the definition of a drug and is subject to regulation as a drug. Two less common types of statements on the labeling of dietary supplements defined by law are claims for a benefit related to a classic nutrient-deficiency disease (when accompanied by a statement that reveals the prevalence of nutrient-deficiency disease in the United States) and general well-being statements derived from the consumption of a nutrient or other dietary ingredient. Because the FDA doesn't approve dietary supplements before they are marketed, the agency often doesn't know when new products come to market.
