Dietary supplements are products such as vitamins, minerals, herbs and other supplements taken to enhance one’s health. They may come in pill form, capsule form, liquids or energy bars but do not fall under regulation like drugs and therefore don’t have to be tested before being sold on the market.
Many people take dietary supplements such as multivitamins, probiotics, fish oil and melatonin. But some of these have potential risks.
They are over-the-counter products
Dietary supplements are products designed to supplement any nutrients you might be lacking from your diet, and can be purchased without needing a valid prescription at pharmacies, supermarkets and other retail outlets without further authorization from healthcare professionals. They come in various forms such as tablets, capsules, powders or fizzy drinks that may even form part of complementary medical treatment; they should not however be considered drugs due to not possessing any pharmacological effects that drugs do.
The Food and Drug Administration regulates dietary supplements by creating rules and regulations manufacturers must abide by to ensure product safety, labeling and marketing oversight, adverse events reporting by consumers and health care professionals, etc. to help identify problems more quickly, take appropriate actions against these adverse events if required, etc. More information on reporting adverse events to FDA can be found on its website.
They are not drugs
Dietary supplements are dietary items designed to increase one’s consumption of specific nutrients. These dietary supplements come in the form of pills, capsules, tablets, drinks and energy bars and should only be taken with approval by a health care professional before pregnant women or those suffering from medical conditions take them; otherwise they could increase risk for anemia or birth defects. For instance, doctors may advise taking iron to combat anemia while others might suggest folic acid to decrease birth defect risk.
Under DSHEA, dietary supplement companies may make claims like “maintain healthy immunity” and “support cardiovascular function”, yet these products do not fall under drug classification and may have strong adverse reactions on your body. They could potentially interact with medication and interfere with lab tests and surgical procedures – therefore reporting any adverse events experienced when taking these dietary supplements is imperative to ensure safe usage and to report adverse events effectively. Depending on its ingredients and objectives of research, clinical investigations with these supplements may require an IND registration under 21 CFR 312.
They are not regulated by law
Dietary supplements are subject to federal regulation by both the Food and Drug Administration (FDA) and Federal Trade Commission (FTC), with extensive regulations regarding manufacturing, quality control, labeling and safety being in effect across the industry.
The Food and Drug Administration (FDA) monitors various categories of substances: food, food additives, added substances (man-made substances that end up in our food sources without our intention) and dietary supplements. Each category has specific standards enforced by the FDA.
If you experience adverse reactions while taking dietary supplements, it’s essential that you inform the FDA. Reporting incidents helps identify potentially hazardous products while alerting other consumers of possible danger. Adverse events can be reported by either speaking with your healthcare provider directly or using the Adverse Event Reporting Portal. Furthermore, both National Institutes of Health and FTC monitor product advertisements; should companies make false or misleading claims about their offerings they could take legal action against such businesses.
They are not a substitute for a balanced diet
Dietary supplements may provide our bodies with extra vitamins and minerals, but these should not be seen as a replacement for eating healthily. Food supplements should only be taken when required due to falling short of recommended daily nutrient intake levels.
Before taking any dietary supplements, it is advisable to speak to a health care provider first. While some supplements may be safe when taken in small doses or when combined with certain medicines, others can potentially be dangerous at higher dosages or when combined with certain prescription. It is also a good idea to check the labels of any products you purchase to see what ingredients they contain.
The FDA regulates dietary supplements by inspecting manufacturers, reviewing new dietary ingredient submissions, inspecting imported dietary ingredients, investigating consumer complaints and monitoring adverse event reports. Furthermore, they work with companies to recall dangerous products.
