The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements. The FDA and the FTC share responsibility for overseeing dietary supplements and related promotion. The FDA is generally responsible for safety, quality, and labeling, and the FTC is generally responsible for advertising. The Federal Trade Commission (FTC) regulates the advertising of supplements and most other products sold to consumers.
Many adults and children in the United States take one or more vitamins or other dietary supplements. In addition to vitamins, dietary supplements may contain minerals, herbs or other botanical ingredients, amino acids, enzymes, and many other ingredients. Dietary supplements come in a variety of forms, including tablets, capsules, gummies, and powders, as well as drinks and energy 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.
Products sold as dietary supplements come with a supplement information label that lists the active ingredients, the amount per serving (dose), and other ingredients, such as fillers, binders, and flavors. The manufacturer suggests serving size, but your healthcare provider may decide that a different amount is more appropriate for you. Some dietary supplements can help you get adequate amounts of essential nutrients if you don't eat a nutritious variety of foods. However, supplements cannot replace the variety of foods that are important for 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 are of value. The Food and Drug Administration (FDA) does not determine whether dietary supplements are effective before they are marketed. Many supplements contain active ingredients that can have strong effects on the body.
Always be aware of 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 cereals and breakfast drinks. As a result, you may be getting more of these ingredients than you think, and more may not be better. Taking more than you need costs more and could 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. Too much iron causes nausea and vomiting and can damage the liver and other organs. Use caution 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 your healthcare provider.
Many supplements have not been adequately tested for safety in children and in women who are pregnant or breastfeeding. If you think you have had an adverse reaction to a dietary supplement, tell your healthcare provider. They may report their experience to the FDA. You can also submit a report directly to the FDA by calling 800-FDA-1088 or completing an online form.
You must 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 avoid adding the wrong ingredient (or too much or too little of the right ingredient) and reduce the chance of contamination or of improperly packaging and labeling a product. The FDA regularly inspects facilities that manufacture supplements.
Tell your healthcare providers (including doctors, dentists, pharmacists, and dietitians) about any dietary supplement you are taking. They can help you determine what supplements, if any, might be valuable to you. Keep a complete record of all the dietary supplements and medications you take. The Office of Dietary Supplements website has a useful form, My Dietary Supplement and Medicine Record, that you can print and complete at home.
For each product, write down the name, the dose you take, how often you take it, and the reason for your use. You can share this record with your healthcare providers to discuss what's best for your overall health. Dietary supplements are products intended to supplement the diet. They are not medicines and are not intended to treat, diagnose, mitigate, prevent or cure diseases.
The FDA is the federal agency that oversees both supplements and drugs, but the FDA's 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. Supplements do not require this approval. Supplement companies are responsible for having proof that their products are safe, and label claims are truthful and not misleading.
However, as long as the product does not contain a “new dietary ingredient” (one introduced since October 15, 1999), the company does not have to provide this safety evidence to the FDA before the product is marketed. Dietary supplement labels may include certain types of health-related claims. Manufacturers may say, for example, that a supplement promotes health or supports a part or function of the body (such as heart health or the immune system). These statements should be followed by the words: “This statement has not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure or prevent any disease. Manufacturers must follow good manufacturing practices (GMP) to ensure the identity, purity, strength and composition of their products. If the FDA considers that a dietary supplement is not safe, it may recall the product from the market or ask the manufacturer to recall it voluntarily. The FDA monitors the market for potential illegal products that may be unsafe or make false or misleading claims.
The Federal Trade Commission, which oversees product advertising, also requires that information about a supplement be truthful and not misleading. The federal government can take legal action against companies and websites that sell dietary supplements when companies make false or misleading statements about their products, if they promote them as treatments or cures for diseases, or if their products are not safe. NIH supports research and provides educational materials on dietary supplements. The FDA issues rules and regulations and oversees the labeling, marketing, and safety of dietary supplements.
Recall notices are also posted on the FDA website or you can sign up to receive notices from the FDA about recalls, recalls and safety alerts. The FTC regulates the health and safety statements made in the advertising of dietary supplements. The USDA provides information on a variety of topics related to food and nutrition. HHS provides information on wellness, personal health tools and health news.
If you're concerned about the content of your vitamins, minerals, herbs, botanicals, protein bars, or other supplements, you're not alone. This fact sheet from the Office of Dietary Supplements (ODS) of the National Institutes of Health (NIH) provides information that should not replace medical advice. Manufacturers, including claims on the label of a dietary supplement, must be substantiated to ensure that the claim is truthful and not misleading. The main exception is for products that introduce a new dietary ingredient, where a pre-market review of safety data and other information is required.
For example, a supplement containing at least 200 milligrams (mg) of calcium per serving could contain the claim that it is high in calcium. Companies, regulators and consumers are turning to the NSF to develop public health standards and services that help protect the world's food, water, consumer products and the environment. The Food and Drug Administration (FDA) is responsible for overseeing safety and has the authority to eliminate any unsafe dietary supplement. Several independent organizations offer quality tests and allow products that pass these tests to show a quality assurance seal that indicates that the product was manufactured correctly, contains the ingredients listed on the label, and does not contain harmful levels of contaminants.
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