Dietary supplements are a category of products that contain vitamins, minerals, herbal ingredients (such as ginger or elderberry), amino acids (the building blocks of proteins), enzymes (supports biochemical processes like food breakdown), and other ingredients. Dietary supplements come in various forms, including tablets, capsules, gummies, powders, and liquids as a way supplement the diet, but should not be considered a substitute for food.
Examples of commonly used dietary supplements:
- Omega-3 Fatty Acids
- St. John’s Wort
- Chondroitin Sulphate
- Saw Palmetto
- Acidophilus (a probiotic)
Why Consumers Use Dietary Supplements
Vitamins are essential for good health through every stage of life. Our bodies require a broad variety of vitamins and minerals to function properly, yet it can be challenging to get all the nutrients we need from food alone.
Consumers should strive to maintain an overall healthy lifestyle that includes regular exercise, eating a healthy diet, getting enough sleep, and visiting a healthcare provider regularly. Dietary supplements can be used responsibly as a way to fill nutritional gaps and enhance health.
People use dietary supplements for a number of reasons, including:
- Maintain their overall health and wellness
- Fill nutrient gaps
- Support bone health
- Promote healthy digestion and elimination
Dietary Supplements and Health Claims
It is important to note that dietary supplements are not medicines. Dietary supplement manufacturers are prohibited from claiming that their products can diagnose, cure, treat, or, with special exceptions, prevent disease. For instance, a dietary supplement cannot claim to “reduce arthritis pain” or “treat heart disease.” However, based on scientific evidence, manufacturers can say that their dietary supplement contributes to health maintenance, well-being, or supports a function of the body.
Where backed by sufficient evidence and approved by the U.S. Food and Drug Adminsitration (FDA), certain supplements may make claims about the role of an ingredient in preventing certain diseases. For example, FDA allows the claim: “Adequate folate in healthful diets may reduce a woman’s risk of having a child with a brain or spinal cord birth defect.”
Government Oversight of Dietary Supplements
The FDA is responsible for regulating dietary supplement manufacturing, labeling, and safety. However, unlike drugs, FDA does not pre-approve dietary supplements for safety and efficacy before being sold. FDA does require pre-market safety information for dietary supplements that contain a ‘new ingredient’ that was not available before October 1994.
Manufacturers of dietary supplements are responsible for their product integrity and safety, so they must follow rigorous standards meant to ensure quality in the manufacturing, packaging, and labeling of their products. Dietary supplement manufacturers must keep track of product complaints and adverse events reported in association with their products and report all serious adverse events to the FDA.
The Federal Trade Commission (FTC) regulates advertising and marketing claims for dietary supplements. All claims must be truthful, not misleading, and substantiated by credible scientific evidence. If companies make false and misleading claims FTC can take enforcement actions against the company.
Important Tips for Safe Use
Used as directed on the label, dietary supplements have a wide margin of safety, but they do contain ingredients that have biological effects on the body. Like any consumer health and wellness product, there can be adverse events associated with the use of the product.
- Always follow the instructions on the label when taking dietary supplements and do not take more than the recommended servings.
- Inform your healthcare provider about any supplements you are taking, especially if you plan to have a surgical procedure.
- If you think you have suffered a serious harmful effect or illness in association with the use of a dietary supplement, contact your healthcare provider immediately.
- Report adverse events to FDA’s MedWatch Hotline at 1-800-FDA-1088.
Can I take dietary supplement products with prescription or OTC medicines?
Yes. However, because dietary supplements have biological effects, they can interact with OTC medicines or prescription drugs. Healthcare providers may identify potential adverse drug supplement interactions to avoid. However, there are times when healthcare providers may recommend a supplement because a drug depletes a nutrient from the body. Prior to taking any dietary supplement, consumers should inform their healthcare provider about ALL of the products they are taking—prescription drugs, OTC medicines, AND dietary supplements.
Is there any scientific research on dietary supplement products?
Yes, but the amount of scientific evidence available to substantiate the claims of various dietary supplement ingredients can vary. Researchers have studied dietary supplement ingredients like calcium and vitamin D extensively, so their health benefits are well known and well documented. Other dietary supplement ingredients have less scientific evidence to support their use. Regulations require that dietary supplement companies keep the scientific evidence in their files to show that claims they make are truthful and not misleading. The National Institute of Health, Office of Dietary Supplements is an independent source for scientific information.
Where can I buy dietary supplements?
Dietary supplements are available at a wide variety of stores, including supermarkets, health food stores, direct sellers, and convenience stores and are also available for purchase via the Internet. It is best to purchase dietary supplements, and all self-care products, from trusted retailers. Responsible retailers evaluate the companies they work with. On the Internet there are ways companies try to avoid regulations and sell fraudulent products. If you decide to purchase a supplement through an online retailer, it is important to do your homework and to be sure that the company is well-known and trusted.
How can I be sure that the dietary supplement I am taking is safe?
FDA regulations require dietary supplement companies to follow manufacturing and labeling standards that ensure product quality and safety. When consumers use dietary supplements as directed, they should feel secure that supplements are safe to take.
While dietary supplements can improve your health or help you meet your daily nutrient requirements, supplements can have adverse health effects. For example, individuals may be allergic to a particular herb, or a supplement may interact with a prescription medication. If a supplement causes a serious adverse health effect, manufacturers or health care providers report it to FDA. FDA has the authority to determine a supplement is unsafe and remove it from the market.
It is important to bean informed dietary supplement user. There are credible resources on internet that can provide a great deal of helpful information, however the internet can also be a source of unreliable information, so it is important to check the source.
A basic rule of thumb to remember is that if a claim sounds too good to be true, it is. Avoid purchasing dietary supplements that promise miracle results, claim to treat a disease, or claim drug-like effects (e.g., “works instantly for depression and anxiety”). You can always speak to your healthcare provider or contact the manufacturer of the product directly if you have questions.
Have there been any safety issues with dietary supplements?
FDA has reported on manufacturers attempting to market illegal products labeled as dietary supplements that contain extra ‘hidden’ drug ingredients not listed on the product label. This criminal activity has occurred mostly in products intended for weight loss, body building, and male sexual enhancement.
FDA maintains a website on health frauds that includes tainted products that masquerade as dietary supplements. For more information, please visit the FDA’s website.
Are dietary supplements labeled “natural” free of side effects?
Not necessarily. Do not assume that a product labeled as “natural” means that the product is safe or free from side effects.
What is a structure/function claim?
Structure/function claims are an FDA regulatory term used to describe the role of a supplement ingredient in affecting the structure or function of the body. Dietary supplements cannot claim to treat a disease, but they can claim to support a structure or function of the body. An example of a dietary supplement structure function claim is, “fish oil supports heart health.” An example of a prohibited fish oil claim is, “fish oil treats hypertension”.
If a dietary supplement label includes a structure/function claim, the claim must include a disclaimer on the label that states that FDA has not evaluated the claim and that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease.” Structure function claims are also submitted to FDA.