Herbal supplements, sometimes referred to as botanicals, are a type of dietary supplement that contains one or more herbs. The amount of scientific evidence on dietary supplements varies greatly; some have a wealth of information while others have very little. Dietary supplements can be beneficial to health, but they can also have risks. To help you stay safe, it is important to understand supplements and how the FDA regulates them.
Herbal substances come from plants and many are used in both dietary supplements and medicines. For instance, sage, ginseng, and garlic can be found in both dietary supplements and herbal remedies. Dietary supplements are vitamins, minerals, herbs and many other products. They can come in the form of pills, capsules, powders, drinks and energy bars. Unlike medications, dietary supplements do not have to go through the same testing process.
If you have a general complaint or concern about dietary supplements, contact the local FDA consumer complaint coordinator. Additionally, it is important to remember that supplements should not replace the variety of foods that are essential for a healthy diet. Dietary supplements are intended to add to or supplement the diet and are different from conventional foods. The Federal Food, Drug and Cosmetic Act (FD&C Act) was amended in 1994 by the Dietary Supplement Health and Education Act (often referred to as DSHEA), which defined the “dietary supplement” and established the authority of the FDA with respect to such products. Dietary supplements can help you improve or maintain your overall health, and supplements can also help you meet your daily needs for essential nutrients.
Dietary supplement companies must report serious adverse events they receive from their dietary supplements to the FDA within 15 days. Supplements are ingested and come in many forms, such as tablets, capsules, softgels, softgels, powders, sticks, gummies and liquids. The Food and Drug Administration needs to regulate them and how to ensure that you and your family use supplements safely. Therefore, it is important to talk to a health professional to help you decide if a supplement is right for you. In general, even if a product is labeled as a dietary supplement, a product intended to treat, prevent, cure, or alleviate the symptoms of a disease is a drug and is subject to all the requirements applicable to medications. The Health Information and Food Supplements Service is funded by PAGB, the consumer health care association, which represents manufacturers of over-the-counter medicines, personal care medical devices and branded food supplements in the United Kingdom. If you experience an adverse effect while taking a dietary supplement, stop using it immediately, seek medical attention or advice, and report the adverse event to the FDA.
In addition, some supplements may interact with medications, interfere with laboratory tests or have dangerous effects during surgery. Although the FDA does not approve dietary supplements, the agency has a role in regulating them. For a list of possible serious reactions to watch out for and to learn how to report an adverse event, see the FDA website: How to Report a Problem with Dietary Supplements. Multivitamins, vitamin D, echinacea and fish oil are among the many dietary supplements found on store shelves or available online.
