Dietary supplements are a type of product that is meant to add to or supplement the diet, and are distinct from conventional foods. Generally, if a product is intended to diagnose, treat, cure, or prevent diseases, it is classified as a drug, even if it is labeled as a dietary supplement. The term “dietary supplement” refers to a product that is meant to supplement the diet and contains one or more dietary ingredients. These ingredients can be vitamins, minerals, herbs or other botanicals, amino acids, dietary substances used to increase total dietary intake, concentrates, metabolites, constituents, extracts, or combinations of any of the above. Dietary ingredients are categorized as “old” or “new” dietary ingredients.
The supplement information panel should indicate the size and number of servings per package, list each dietary ingredient in the product and provide information on the amount of the dietary ingredient per serving. Additionally, dietary supplements may include other statements on the label that are not defined by law or regulation. In accordance with the Dietary Supplement Health and Education Act (DSHEA), dietary supplements are limited to delivery formats such as capsules, powder, soft capsules, softgels, gel capsules, tablets, or liquids. Nutrition information panels and information on dietary supplements are mandatory in most foods and supplements. Unlike drugs that must be proven safe and effective for their intended use before they can be marketed, the law does not require the FDA to approve the safety of dietary supplements before they reach consumers.
To ensure safety and quality of dietary supplements, FDA regulations require manufacturers to follow current good manufacturing practices (cGMPs).The FDA and the FTC share responsibility for overseeing dietary supplements and related promotion. The FDA is generally responsible for safety, quality and labeling while the FTC is generally responsible for advertising. St. John's Wort, curcumin, blueberry, glucosamine, collagen and resveratrol are some natural products that are used as dietary supplements in the form of extracts or intact sources.
Other minerals such as sodium, potassium, calcium, phosphorus, magnesium, iron, zinc, manganese, copper, iodine, chromium, molybdenum, selenium and cobalt can also be taken as dietary supplements. If a manufacturer intends to market a dietary supplement in the United States that contains a new dietary ingredient (NDI), they must notify the FDA in advance and submit safety information unless the NDI is already present in the food supply as an item used as food in its unaltered form. Along with information about the NDI and the dietary supplement in which it will be marketed, the notification must include safety information on which the notifier has based their conclusion that the NDI is reasonably expected to be safe when used under conditions recommended or suggested on the supplement's labeling. Dietary supplement regulations require manufacturers to guarantee the identity, purity, quality, concentration and composition of both their ingredients and their finished products. Consumers can contact manufacturers or commercial laboratories to analyze product contents. The Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food Drug and Cosmetic Act (FFDCA) to create a new regulatory framework for dietary supplements. In summary: Dietary supplements are products meant to add to or supplement your diet with vitamins, minerals or other substances.
They are distinct from conventional foods because they are intended for therapeutic purposes. The FDA does not require approval of these products before they reach consumers but manufacturers must follow current good manufacturing practices (cGMPs). The FDA and FTC share responsibility for overseeing these products while DSHEA amended FFDCA to create a new regulatory framework for them.
