The Food and Drug Administration (FDA) is responsible for regulating both finished dietary supplements and dietary ingredients. The FDA has established different regulations for dietary supplements than those that cover conventional foods and medications. The Council for Responsible Nutrition (CRN) is an organization that represents manufacturers of dietary supplements and functional foods, as well as ingredient suppliers. Board members are expected to comply with certain state and federal regulations that govern the manufacture, quality control, marketing, and safety of dietary supplements.
Many adults and children in the United States take one or more vitamins or other dietary supplements. These products come in a variety of forms, including tablets, capsules, gummies, powders, energy drinks, and bars. Popular supplements include vitamins D and B12; minerals such as calcium and iron; herbs such as echinacea and garlic; and products such as glucosamine, probiotics, and fish oils. Each supplement comes with a supplemental information label that lists the active ingredients, the amount per serving (dose), and other ingredients, such as fillers, binders, and flavorings. Dietary supplements can help you get adequate amounts of essential nutrients if you don't eat a variety of nutritious foods.
However, they cannot replace the variety of foods that are important to a healthy eating routine. For more information on what constitutes a healthy eating routine, the Dietary Guidelines for Americans and MyPlate are good sources of information. Many other supplements need more studies to determine if they have value. The FDA does not determine if dietary supplements are effective before they are marketed. It is important to be aware of the potential side effects of taking dietary supplements.
Many supplements contain active ingredients that can have strong effects on the body. Always be alert to the possibility of a bad reaction, especially when taking a new product. Manufacturers can add vitamins, minerals, and other supplement ingredients to the foods you eat, especially breakfast cereals and beverages. As a result, you might get more of these ingredients than you think, and more may not be better.
Taking more than you need costs more and may also increase the risk of side effects. For example, too much vitamin A can cause headaches and liver damage, reduce bone strength, and cause birth defects. Excess iron causes nausea and vomiting and can damage the liver and other organs. Be careful when taking dietary supplements beyond a standard prenatal supplement if you are pregnant or breastfeeding. Also be careful when giving supplements to a child unless recommended by their healthcare provider. The safety of many supplements has not been well evaluated in children or in people who are pregnant or breastfeeding.
If you think you've had an adverse reaction to a dietary supplement, tell your health care provider. They may report their experience to the FDA. You can also send a report directly to the FDA by calling 800-FDA-1088 or filling out an online form. You should also report your reaction to the manufacturer using the contact information on the product label. The FDA has established good manufacturing practices (GMP) that companies must follow to help ensure the identity, purity, concentration and composition of their dietary supplements.
These GMPs can prevent the wrong ingredient (or too much or too little of the right ingredient) from being added and reduce the chance of contamination or of incorrectly packaging and labeling a product. The FDA regularly inspects facilities that manufacture supplements. Tell your healthcare providers (including doctors, dentists, pharmacists, and dieticians) about any dietary supplements you are taking. They can help you determine which supplements might be valuable to you. Keep a complete record of all dietary supplements and medications you take.
The Office of Dietary Supplements website has a useful form called My Dietary Supplement and Medicine Record which you can print out at home. For each product write down the name, dose taken, how often taken, and reason for using it. You can share this record with your healthcare providers to discuss what is best for your overall health. Dietary supplements are products intended to supplement the diet but they are not medicines nor intended to treat diagnose mitigate prevent or cure diseases. The FDA is the federal agency that oversees both supplements and drugs but FDA regulations for dietary supplements are different from those for prescription or over-the-counter drugs.
Drugs must be approved by the FDA before they can be sold or marketed while supplements do not require this approval. Supplement companies are responsible for having proof that their products are safe and that claims on labels are truthful and not misleading. However as long as products do not contain a “new dietary ingredient” (one introduced since October 15 1999) companies do not have to provide safety tests to FDA before product is marketed. Dietary supplement labels may include certain types of health-related claims such as promoting health or supporting part or function of body (such as heart health or immune system).
These statements should be followed by “This statement has not been evaluated by Food & Drug Administration” “This product is not intended to diagnose treat cure or prevent any disease”. Manufacturers must follow good manufacturing practices (GMP) to ensure identity purity strength & composition of their products. If FDA believes dietary supplement is unsafe it can recall product from market or ask manufacturer to voluntarily recall it & FDA monitors market for potential illegal products that may not be safe or make false/misleading claims. The Federal Trade Commission which oversees product advertising also requires information about complementary product be truthful & not misleading & federal government can take legal action against companies who violate these regulations.
