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The FDA does not review and approve dietary supplements based on their safety and effectiveness. FDA evaluates the safety of marketed dietary supplements through adverse event monitoring and research.
While dietary supplement manufacturers must ensure that their products are safe prior to marketing, FDA has several post-marketing responsibilities to ensure the safety of dietary supplements. Among those is enforcement of Good Manufacturing Practices to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplement products.
FDA also oversees mandatory adverse event reporting by dietary supplement manufacturers. Serious adverse events associated with the use of a dietary supplement should be reported to FDA's MedWatch Program.
In addition, the U.S. Federal Trade Commission (FTC) regulates dietary supplement advertising.
Under the law, manufacturers of dietary supplements have three different categories of truthful and not misleading claims that can be used: health claims, structure/function claims, and nutrient content claims.
Health claims describe the connection between a nutrient or food substance and reduced risk of a disease or health-related condition and are regulated by the FDA. FDA can authorise a health claim in one of the following three ways: “Authorized health claim, Authoritative statements, Qualified health claims”.
Structure/function claims are statements that describe the role of a nutrient, the mechanism of how it helps to maintain that structure or function, or general wellbeing. Because FDA does not pre-clear structure/function claims, they must be accompanied by the disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Nutrient content claims describe the level of a nutrient in a food or dietary supplement.
Under Canadian law, a nutraceutical can either be marketed as a food or as a drug; the terms "nutraceutical" and "functional food" have no legal distinction, referring to "a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food [and] is demonstrated to have a physiological benefit or provide protection against chronic disease."
Generally, developed countries have regulations in place, but there are some countries, such as those in the Asia Pacific regions or in Association of Southeast Asian Nations (ASEAN) countries, that have not yet fine-tuned their regulations for nutraceutical products. In the APAC market, most countries require a product to be registered with the country-specific Health Authority before it can be marketed. Certain countries like Singapore and Hong Kong are compliance-based markets—meaning once the product is compliant with the local regulations, the products can be launched on to the market. Certain markets like Thailand, Malaysia, Indonesia, the Philippines, Vietnam, and Taiwan require product registration with their respective Health Authority. Countries like Japan, South Korea, and China have stringent rules and regulations for product registration. Documentation and testing details are required to be submitted based on the formula and claims of the product.
A special unit of the Traditional Medicine and Health Supplements Product Working Group (TMHA PWG) helps manufacturers understand the regulatory procedures of these countries. Despite countries' own special requirements, manufacturers can follow the standards and harmonised guidelines put forth by TMHA PWG.