The FDA is not authorized to approve dietary supplements due to their safety and effectiveness. The Dietary Supplement Health and Education Act (DSHEA) of 1994, which amended the Federal Food, Drug and Cosmetic Act, changed the FDA's authority to regulate dietary supplements. This means that many dietary supplements can be marketed without notifying the FDA. The challenge is that the FDA relies heavily on post-marketing approaches, such as Internet searches for illegal marketing claims, inspections of manufacturing facilities, and reports from consumers or companies to identify products that may be causing harm.
To learn more about possible serious reactions and how to report an adverse event, visit the FDA website entitled How to Report a Problem with Dietary Supplements. In comparison to other higher-income countries, the United States is an outlier as all regulatory agencies in Canada, Australia, China and Europe require some type of registration or central quotation for dietary supplements. This mandatory requirement would ensure that the FDA has the information it needs to properly monitor the supplement market. Companies can legally introduce dietary supplements to the market without notifying the FDA. The Federal Food, Drug and Cosmetic Act (FD&C Act) was amended in 1994 by the Dietary Supplement Health and Education Act (DSHEA), which defined the “dietary supplement” and established the authority of the FDA with respect to such products. To file a general, non-serious complaint or concern about dietary supplements, contact the local FDA consumer complaint coordinator. The FDA may require the recall of dietary supplements from the market, but this authority does not extend to drugs, which must be voluntarily recalled from the market by manufacturers.
This lack of basic information about the market raises serious questions about whether the FDA can take effective action when problems arise with supplements. Calcium and vitamin D can help strengthen bones, while fiber can help maintain bowel regularity. A study published in JAMA Internal Medicine revealed that several brands of supplements containing at least one of four banned stimulants are still on the market despite warnings from the FDA. This highlights how important it is for Congress to pass legislation that gives the FDA the authority and funding it needs to implement reforms. The Food and Drug Administration needs to regulate dietary supplements in order to ensure that consumers are using them safely. The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended the Federal Food, Drug and Cosmetic Act and changed the FDA's authority to regulate dietary supplements.
The challenge is that due to this lack of regulation, there is a lack of basic information about dietary supplement products on the market. This raises serious questions about whether or not the FDA can take effective action when problems arise with supplements. To learn more about possible serious reactions and how to report an adverse event, visit the FDA website entitled How to Report a Problem with Dietary Supplements. In comparison to other higher-income countries, all regulatory agencies in Canada, Australia, China and Europe require some type of registration or central quotation for dietary supplements.
This mandatory requirement would ensure that the FDA has all of the information it needs to properly monitor the supplement market. Companies can legally introduce dietary supplements to the market without notifying the FDA. However, it is important for Congress to pass legislation that gives the FDA more authority and funding so that they can properly regulate these products. It is also important for consumers to be aware of potential risks associated with taking dietary supplements so they can make informed decisions about their health.
