Unravelling the Regulatory Framework of Dietary Supplements

This article explains how US Food & Drug Administration (FDA) & Federal Trade Commission (FTC) regulate dietary supplements & supplement claims & labeling through Dietary Supplement Health & Education Act (DSHEA). It also explains how manufacturers & retailers must

Unravelling the Regulatory Framework of Dietary Supplements

The United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are the two federal agencies responsible for overseeing the regulation of dietary supplements and supplement claims and labeling. The FDA has the primary responsibility for regulating the category through the Dietary Supplement Health and Education Act (DSHEA) of 1994, which established a regulatory framework to ensure the safety of the category. This Act gave the FDA authority to create regulations on the manufacture of dietary supplements, health claims, and labeling. The FTC, on the other hand, is responsible for monitoring dietary supplement advertising and promotion. Studies that do not adhere to basic principles are more prone to biases and other confounding factors, are unlikely to yield reliable results, and generally do not meet the FTC's competent and reliable standard of scientific evidence to support health-related claims.

Manufacturers of dietary supplements are responsible for complying with these regulations. For labeling dietary supplements, section 5 of the DSHEA provides an exemption from labeling requirements for articles in scientific journals, books, and other publications used in the sale of dietary supplements. The FDA also enforces the law on retailers who sell dietary supplements, especially if their advertisements or websites contain claims about their products or if they sell supplements that don't comply with cGMP. The FTC and FDA require that the marketing of dietary supplements and other health-related products be truthful and accurate. Information for consumers on the use of dietary supplements includes updates for consumers, information from other agencies, and other educational materials for users of dietary supplements.

The first step in evaluating the veracity and accuracy of advertising and marketing materials is to identify all the express and implicit statements that are transmitted to consumers who act reasonably.

A good example

of this growing trend is the increase in the use of dietary supplements in the United States. Supplements continue to play an increasingly important role in consumers' health and well-being, thanks to the regulatory framework established through the DSHEA. For more information on how to read the information label on a dietary supplement, visit the interactive label of the CHPA Education Foundation. The regulatory framework surrounding dietary supplements is complex but necessary to ensure consumer safety. It is important for manufacturers, retailers, and consumers alike to understand this framework in order to make informed decisions about their health.

Consumers should be aware that not all dietary supplements are created equal; it is important to research any supplement before taking it. The FDA has put in place regulations to ensure that dietary supplement manufacturers adhere to good manufacturing practices (GMPs). These GMPs include quality control measures such as testing raw materials, verifying product identity, ensuring product purity, testing finished products for potency, and monitoring product stability. Retailers should also be aware that they are responsible for ensuring that any dietary supplement they sell meets these GMPs. In conclusion, understanding the regulatory framework surrounding dietary supplements is essential for manufacturers, retailers, and consumers alike. It is important for manufacturers to adhere to GMPs in order to ensure product safety; retailers should be aware of their responsibility to ensure that any product they sell meets these standards; and consumers should be aware that not all dietary supplements are created equal.