What is the difference between dietary supplements and pharmaceutical drugs? Both come as pills, capsules, liquids and more, and both are taken for health purposes. Because both go into our bodies, you would think they are regulated the same way – but this is not so. One significant difference is how they are regulated by the US Food and Drug Administration (FDA).
Key takeaways
- Dietary supplements are regulated differently from medicines.
- Good Manufacturing Practices (GMP) assure the identity, strength, quality and purity of products.
- Celebrate Vitamins uses only GMP certified facilities.
What are dietary supplements?
According to the FDA, dietary supplements include products such as "vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet."1 They can be taken for a number of reasons specific to the dietary ingredient in the product, but the most common objective is to fill gaps in nutrition or to optimise wellness. Discuss all dietary supplements with your doctor because of the risk of drug–nutrient interactions and potential adverse effects.
How are supplements monitored?
A healthy dose of caution is warranted with supplements, but that is not to say there is no oversight of their safety. A new product does not need to meet FDA requirements to enter the market, but once it is introduced, it can be monitored. Per the FDA: "Once a dietary supplement is on the market, the FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, the FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion."1
What is GMP?
The FDA ensures the quality of drug manufacturing through the Current Good Manufacturing Practices (CGMP) standards. The FDA writes: "Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories."2
The FDA inspects GMP certified facilities to ensure they are following the protocols and testing needed to assure the highest quality standards. Despite the use of these standards not being required by law, Celebrate Vitamins uses only GMP certified facilities to produce the highest quality products to bring to market for the safety and peace of mind for our customers.
Sources
- FDA 101: Dietary Supplements. (15 July 2015). Retrieved 6 November 2020, from https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements
- Center for Drug Evaluation and Research. (25 June 2018). Facts About the Current Good Manufacturing Practices (CGMPs). Retrieved 6 November 2020, from https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
This article is for general information only and does not replace personal medical advice. Always discuss your situation, blood test results and supplementation with your bariatric team or healthcare provider.