Overview of Dietary Supplements
A dietary supplement is a product taken by mouth containing a dietary ingredient intended to supplement the diet, including vitamins, minerals, herbs or other botanicals, and amino acids. Regulation of Dietary Supplements covers marketing, manufacturing, labeling, and advertising enforced by FDA and the Federal Trade Commission.
Regulatory Requirements for Dietary Supplements
The dietary supplement current good manufacturing practice (CGMP) rule requires persons who manufacture, package, label, or hold a finished dietary supplement to establish and follow CGMPs to ensure the quality of the dietary supplement and that it is appropriately labeled. The FTC has responsibility for claims in advertising. Advertising for any product, including dietary supplements, must be truthful, not misleading, and substantiated.
Labeling Requirements for Dietary Supplements
- What is required on dietary supplement labels? According to the FDA, dietary supplement labels must include the name of the dietary supplement, the net quantity, a Supplement Facts panel, directions for use, and an ingredient list that declares the presence of any major allergens. Labels should also include the name and address of the manufacturer, packer or distributor, along with the FDA disclaimer and any required warning statements.
Composition and Consumption of Dietary Supplements
A dietary supplement is a product intended for ingestion that, among other requirements, contains a "dietary ingredient" intended to supplement the diet. The term "dietary ingredient" includes vitamins and minerals; herbs and other botanicals; amino acids; "dietary substances" that are part of the food supply, such as enzymes and live microbials; and concentrates, metabolites, constituents, extracts, or combinations of any dietary ingredient.
FDA Regulations and Enforcement
FDA regulates both finished dietary supplement products and dietary ingredients. Manufacturers and distributors of dietary supplements and dietary ingredients are also prohibited from marketing products that are adulterated or misbranded. FDA regulations for dietary supplements are different from those for prescription or over-the-counter medicines.
Testing and Requirements for Manufacturers
The regulations for dietary supplements require manufacturers to ensure the identity, purity, quality, strength, and composition of both their ingredients and their finished dietary supplements. The regulations include the 100% identity testing requirement for incoming raw materials and finished product testing to ensure identity, purity, quality, strength, and composition of dietary supplements.
Classification and Safety of Dietary Supplements
Dietary supplements are considered a special category of food and are safe unless the manufacturer decides to add harmful ingredients. FDA regulations require that dietary supplement labels bear the name of the product and a statement stating that it is a dietary supplement or equivalent term. The FDA evaluates reports of potential adverse effects related to supplements to identify safety risks to consumers.