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. 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. For products regulated by the FDA, the NAD and the DSSRC will apply the FTC's advertising guidelines, which analyze what claims are reasonably conveyed in the advertisement and whether there is adequate scientific support for the reported claims.
As with all products on the market, advertising for dietary supplements must be truthful and well-founded. Most dietary supplement sellers will be familiar to some extent with FDA laws and regulations, including the Dietary Supplement Health and Education Act of 1994 (DSHEA), and may also be aware of the role played by the Federal Trade Commission (FTC) in overseeing dietary supplement advertising under the FTC Act. Sellers of health-related products, including dietary supplements, should be familiar with the requirements of FDA and FTC laws, according to which labeling and advertising claims must be truthful, not misleading and substantiated. In 1998, the FTC published commercial guidance on dietary supplement advertising, which the NAD and the DSSRC have applied in their own review of the case.
While both the FTC and the FDA require that the marketing of dietary supplements and other health-related products be truthful and accurate, there are some key differences in legal frameworks and agency approaches that sellers must consider. In 1085-86 (rejecting the defendants' argument that the FDCA's distinctions between foods, drugs, or dietary supplements are binding on the FTC's application of sections 5 and 12 of the FTC Act). .
