FDA 101: Dietary Supplements

 

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Multivitamins, vitamin D, echinacea, and fish oil are among the many dietary supplements lining store shelves or available online. Perhaps you already take a supplement or are thinking about using one. Dietary supplements can be beneficial to your health, but they can also involve health risks. So, it’s important that you talk with a health care professional to help you decide if a supplement is right for you.

Read on to learn what dietary supplements are (and are not), what role the U.S. Food and Drug Administration has in regulating them, and how to make sure you and your family use supplements safely.

What Are Dietary Supplements?

Dietary supplements are intended to add to or supplement the diet and are different from conventional food. Generally, to the extent a product is intended to treat, diagnose, cure, or prevent diseases, it is a drug, even if it is labeled as a dietary supplement. Supplements are ingested and come in many forms, including tablets, capsules, soft gels, gel caps, powders, bars, gummies, and liquids.

Common supplements include:

• Vitamins (such as multivitamins or individual vitamins like vitamin D and biotin).
• Minerals (such as calcium, magnesium, and iron).
• Botanicals or herbs (such as echinacea and ginger).
• Botanical compounds (such as caffeine and curcumin).
• Amino acids (such as tryptophan and glutamine).
• Live microbials (commonly referred to as “probiotics”).

What Are the Benefits of Dietary Supplements?

Dietary supplements can help you improve or maintain your overall health, and supplements can also help you meet your daily requirements of essential nutrients.

For example, calcium and vitamin D can help build strong bones, and fiber can help to maintain bowel regularity. While the benefits of some supplements are well established, other supplements need more study. Also, keep in mind that supplements should not take the place of the variety of foods that are important for a healthy diet.

What Are the Risks of Dietary Supplements?

Before buying or taking a dietary supplement, talk with a health care professional—such as your doctor, nurse, registered dietician, or pharmacist—about the benefits and risks.

Many supplements contain ingredients that can have strong effects in the body. Additionally, some supplements can interact with medications, interfere with lab tests, or have dangerous effects during surgery. Your health care professional can help you decide what supplement, if any, is right for you.

When taking dietary supplements, be alert to the possibility of a bad reaction or side effect (also known as an adverse event).

Problems can occur especially if you:

• Combine supplements.
• Mix medicines and supplements.
• Take too much of some supplements.
• Take supplements instead of medications.

If you experience an adverse event while taking a dietary supplement, immediately stop using the supplement, seek medical care or advice, and report the adverse event to the FDA.

How Are Dietary Supplements Regulated?

The Law

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 “dietary supplement” and set out FDA’s authority regarding such products. Under existing law:

• The FDA does NOT have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public.
• Under the FD&C Act, it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law.
• Dietary supplement labels are required to have nutrition information in the form of a Supplement Facts label that includes the serving size, the number of servings per container, a listing of all dietary ingredients in the product, and the amount per serving of those ingredients. They also must have a statement on the front of the product identifying it as a “dietary supplement” or similar descriptive term (e.g., “herbal supplement” or “calcium supplement”). 

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 subject to all requirements that apply to drugs.

The FDA’s Role and Actions to Help Keep You Safe

Even though the FDA does not approve dietary supplements, there are roles for the agency in regulating them.

• Since companies can often introduce a dietary supplement to the market without notifying the FDA, the agency's role in regulating supplements primarily begins after the product enters the marketplace.
• The FDA periodically inspects dietary supplement manufacturing facilities to verify companies are meeting applicable manufacturing and labeling requirements.
• The FDA also reviews product labels and other labeling information, including websites, to ensure products are appropriately labeled and that they do not include claims that may render the products drugs (e.g., claims to treat, diagnose, cure, or prevent diseases).
• The FDA monitors adverse event reports submitted by dietary supplement companies, health care professionals, and consumers as well as other product complaints for valuable information about the safety of products once they are on the market.
• If a product is found to be unsafe or doesn’t otherwise comply with the law, the FDA can:
  • Work with the company to bring the product into compliance.
  • Ask the company to voluntarily recall the product.
  • Take action to remove a dangerous product from the market.

Tips to Be a Safe and Informed Consumer

Before taking a dietary supplement, talk with your health care professional. They can help you decide which supplements, if any, are right for you. You can also contact the manufacturer for information about the product.

• Take only as described on the label. Some ingredients and products can be harmful when consumed in high amounts, when taken for a long time, or when used in combination with certain drugs or foods.
• Do not substitute a dietary supplement for a prescription medicine or for the variety of foods important to a healthy diet.
• Do not assume that the term "natural" to describe a product ensures that it is safe.
• Be wary of hype. Sound health advice is generally based upon research over time, not a single study.
• Learn to spot false claims. If something sounds too good to be true, it probably is.

Why Is It Important to Report an Adverse Event?

If you experience adverse event, also known as a side effect or bad reaction, the FDA encourages both you and your health care professional to report the adverse event to the FDA.

You can help the FDA, yourself, and other consumers by reporting an adverse event. A single adverse event report can help us identify a potentially dangerous product and possibly remove it from the market.

For a list of potential serious reactions to watch for, and to learn how to report an adverse event, please see the FDA’s webpage, How to Report a Problem with Dietary Supplements.

Adverse events can also be reported to the product's manufacturer or distributor through the address or phone number listed on the product's label. Dietary supplement firms are required to report serious adverse events they receive about their dietary supplements to FDA within 15 days.

For a general, nonserious complaint or concern about dietary supplements, contact your local FDA Consumer Complaint Coordinator.

Additional Resources:

• Dietary Supplements, FDA
• Information for Consumers on Using Dietary Supplements, FDA
• Dietary Supplement Fact Sheets, National Institutes of Health