On dietary supplement websites, you may often come across the following disclaimer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat,cure, or prevent any disease." While this statement might raise some doubts for the uninformed, it is actually a standard requirement mandated by the FDA in specific situations.
What is the FDA?
The FDA, also known as the U.S. Food and Drug Administration, is a federal agency entrusted with the regulation of various products that have a significant impact on public health. These products include food items, pharmaceutical drugs, medical devices, cosmetics, and even tobacco products. The FDA's primary mission is to ensure the safety, efficacy, and quality of the products that we encounter in our daily lives. However, it is important to note that the FDA does not provide pre approval for every industry it oversees.
What does the FDA have to do with supplements?
The FDA plays a crucial role in the dietary supplement industry by serving as an enforcement and regulatory agency. It is responsible for defining and enforcing the claims that supplement companies can make about their products. To safeguard public safety, the FDA has established Good Manufacturing Practices (GMPs), which are enforced through inspections. Furthermore, the FDA possesses the authority to prosecute, seize, and remove hazardous products from the market. Through careful review of evidence, the FDA can also determine if a product is Generally Recognized As Safe (GRAS).
What supplements are allowed to claim?
This regulatory oversight has a significant impact on what claims dietary supplements are allowed to make. The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the role of supplements and outlines the permissible statements that dietary supplement companies can make about their products. Since supplements are not classified as drugs, supplement companies are prohibited from implying, insinuating, or stating that their product can diagnose, treat, cure, or prevent any disease. Additionally, the FDA has interpreted some normal conditions as precursors or markers of diseases. Therefore, you may encounter somewhat vague language when describing the benefits of a supplement. This ambiguity in wording ensures compliance with the FDA's guidelines on approved dietary supplement claims. The disclaimer mentioned earlier is mandatory for dietary supplements if they make any claims regarding the impact on the structure and/or function of the human body. The FDA actively enforces these claims to ensure adherence to approved guidelines for dietary supplement claims.
Are supplements approved by the FDA?
It is important to note that no dietary supplements are "approved" by the FDA since the FDA's approval process applies to pharmaceutical drug products, not food or supplements. However, the FDA closely monitors the manufacturing and labeling practices of supplement companies and conducts regular inspections to ensure compliance with all regulations. Should a supplement company fail to comply with FDA regulations, the FDA has the authority to prohibit them from selling their products.