When asked if there are any regulatory controls on herbal or dietary supplements, the nurse responds to the client by informing him that herbal and dietary supplements are regulated by the:

A. Food, Drug and Cosmetic Act:

The Food, Drug, and Cosmetic Act (FD&C Act) is a federal law that regulates the manufacturing, labeling, and distribution of food, drugs, cosmetics, and medical devices in the United States. While the FD&C Act does provide some regulatory authority over certain aspects of dietary supplements, such as labeling requirements and good manufacturing practices, it is not the primary law governing the regulation of herbal and dietary supplements.

B. Joint Commission on the Accreditation of Healthcare Organizations:

The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), now known as The Joint Commission, is an independent, nonprofit organization that accredits and certifies healthcare organizations and programs in the United States. However, The Joint Commission is not responsible for regulating herbal and dietary supplements.

C. Health and Human Services (HHS):

The Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government. While HHS oversees various health-related agencies, including the Food and Drug Administration (FDA), it is not the primary regulatory authority for herbal and dietary supplements.

D. Dietary Supplement Health and Education Act (DSHEA):

The Dietary Supplement Health and Education Act (DSHEA) of 1994 is the primary law that regulates herbal and dietary supplements in the United States. DSHEA defines dietary supplements, sets forth labeling requirements, establishes good manufacturing practices, and outlines the responsibilities of manufacturers and distributors of dietary supplements. Under DSHEA, dietary supplements are regulated as a category of food rather than as drugs.

1. Do not have to demonstrate effectiveness:

This statement is generally true under DSHEA regulations. Unlike pharmaceutical drugs, dietary supplements are not required to undergo rigorous testing to demonstrate their effectiveness in treating, preventing, or curing specific health conditions before they are marketed. However, manufacturers are prohibited from making unsubstantiated claims about the effectiveness of their products.

B. Are determined to be safe before being placed on the market:

Under DSHEA regulations, dietary supplement manufacturers are responsible for ensuring the safety of their products before they are marketed. However, unlike pharmaceutical drugs, dietary supplements do not undergo premarket approval by the Food and Drug Administration (FDA) to verify their safety and efficacy. Instead, manufacturers are required to notify the FDA of their intent to market a new dietary ingredient (NDI) and provide evidence of the ingredient’s safety.

C. Are checked for label accuracy:

The FDA regulates dietary supplements to ensure that their labels are accurate and truthful. However, the extent of label accuracy checking varies, and the FDA does not routinely test every dietary supplement product on the market. Instead, the FDA relies on postmarket surveillance, consumer complaints, and other mechanisms to identify and address inaccuracies or violations of labeling regulations.

D. Are tested prior to marketing:

Unlike pharmaceutical drugs, dietary supplements are not required to undergo premarket testing to demonstrate their safety or efficacy before they are marketed. While manufacturers are responsible for ensuring the safety of their products, there is no formal premarket testing requirement under DSHEA regulations.