Are Dietary Supplements Monitored by the FDA? - An Expert's Perspective

Dietary supplements are regulated by the Food and Drug Administration (FDA) as foods, not as drugs. However, many dietary supplements contain ingredients that have strong biological effects that may conflict with a medication you are taking or with a medical condition you may have. 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 dietary supplements before they are marketed. A company generally does not have to provide the FDA with the evidence it relies on to demonstrate safety before or after marketing its products; 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 the safety information on which the notifier has based its conclusion that the new dietary ingredient is reasonably expected to be safe when used under the 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 the size and number of servings per package, state each dietary ingredient in the product and, with the exception of dietary ingredients that are part of a patented blend, provide information on the amount of the dietary ingredient per serving. Depending on the type of ingredient, the amount per serving should be stated as a quantitative amount by weight, as a percentage of daily value, or both. Finally, dietary supplement labels must include a national address or a national telephone number to report serious adverse events to the manufacturer, packer or distributor whose name and place of business appear on the label. Yes, ingredients that are not listed on the supplement information panel should be included in the list of other ingredients below. The 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).

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 of a dietary supplement or amount of a dietary ingredient that a serving of a dietary supplement can contain. This decision is made by manufacturer and does not require FDA approval. Because dietary supplements fall under food category, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is primarily responsible for agency's oversight of these products. The FDA's role in regulating dietary supplements includes (among other things) inspecting manufacturing facilities for dietary supplements; reviewing new dietary ingredient (NDI) notifications and other regulatory requests on dietary supplements; investigating complaints; monitoring market for dietary supplements; examining dietary supplements and ingredients offered for import to determine if they meet U. S.

requirements; and reviewing adverse event reports from businesses, consumers and healthcare providers to identify products that may not be safe. 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).No, product sold as a dietary supplement and explicitly or implicitly represented for treatment, prevention or cure of specific disease or class of diseases meets definition of drug and is subject to regulation as drug. Department of Agriculture (USDA) regulates use of term “organic” within framework National Organic Program (NOP). NOP is federal regulatory program develops and enforces consistent national standards organically produced agricultural products sold United States. FDA would like know if you have health problem believed related to a dietary supplement even if you're not sure which product caused problem even if you don't visit doctor or clinic.

Anyone can report adverse event considered related to a dietary supplement directly to FDA by accessing safety reporting portal. FDA monitors manufacture and labeling of supplements regularly.

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