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.

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.

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