The Food and Drug Administration (FDA) has a significant role in the assessment of dietary supplements. The Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug and Cosmetic Act (Act FD&C) to create a new regulatory framework for dietary supplements. According to the DSHEA, the FDA does not have the authority to approve supplements before they are marketed. However, there is an exception for dietary supplements that contain a new dietary ingredient that is not present in the food supply, such as an item used as food in a form in which the food has not been chemically altered.
At least 75 days before introducing such dietary supplement into interstate commerce or delivering it for introduction into interstate commerce, the manufacturer or distributor must submit a notification to the FDA with information on the basis of which the company has concluded that it is reasonable to expect the dietary supplement containing NDI to be safe. In addition, FDA regulations require that those who manufacture, package, or preserve dietary supplements follow current good manufacturing practices that help ensure the identity, purity, quality, concentration, and composition of dietary supplements. The FDA generally does not approve claims on dietary supplements or other labels before use. The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer or distributor 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, unless the new dietary ingredient is present in the food supply as an item used as a food in a form in which the food has not been chemically altered.
The notification must be sent to the FDA at least 75 days before introducing the product into interstate commerce or delivering it for introduction into interstate commerce. Along with information about the new dietary ingredient and the dietary supplement in which it will be marketed, the notification must include safety information on which the notifier has based its conclusion that the new dietary ingredient is reasonably expected to be safe when used under conditions recommended or suggested on the dietary supplement's labeling. FDA regulations require that dietary supplement labels include the name of the product and a statement stating that it is a dietary supplement or an equivalent term that replaces “dietary” with the name or type of dietary ingredient in the product (e.g., “vitamin”). The supplement information panel should indicate size and number of servings per package, state each dietary ingredient in product and, with exception of dietary ingredients that are part of patented blend, provide information on amount of dietary ingredient per serving.
Depending on type of ingredient, amount per serving should be stated as quantitative amount by weight, as percentage of daily value, or both. Finally, dietary supplement labels must include national address or national telephone number to report serious adverse events to manufacturer, packer or distributor whose name and place of business appear on label. Yes, ingredients that are not listed on supplement information panel should be included in list of other ingredients below. Types of ingredients listed there could include sources of dietary ingredients if they are not listed on supplement information panel (e.g., gelatin, starch, stabilizers, preservatives and flavors).
Additional examples of ingredients that are commonly stated in this list include flavors and preservatives. In addition to manufacturers' responsibility to comply with safety regulations and labeling requirements for dietary supplements and meet current standards of good manufacturing practices, there are no laws or regulations limiting serving size or amount of a dietary ingredient per serving. This decision is made by manufacturers and does not require FDA approval. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) is primarily responsible for overseeing these products.
The FDA's role in regulating dietary supplements includes (among other things) inspecting manufacturing facilities; reviewing new dietary ingredient (NDI) notifications and other regulatory requests; investigating complaints; monitoring market; examining imported products; and reviewing adverse event reports from businesses, consumers and healthcare providers to identify potentially unsafe products. However, by law, FDA does not approve dietary supplements or their labeling although certain types of claims used on labels require pre-marketing review and authorization (e.g., health claims). The Department of Agriculture (USDA) regulates use of term “organic” within framework of National Organic Program (NOP). The FDA would like to know if you have health problem believed to be related to a dietary supplement even if you're not sure which product caused problem and even if you don't visit doctor or clinic.
Anyone can report an adverse event considered related to a dietary supplement directly to FDA by accessing safety reporting portal. In conclusion, while FDA does not approve dietary supplements or their labeling prior to marketing them, it plays an important role in evaluating these products by monitoring adverse event reports submitted by companies, health professionals and consumers; inspecting manufacturing facilities; reviewing NDI notifications; investigating complaints; examining imported products; and reviewing adverse event reports from businesses, consumers and healthcare providers.
