Safe Use of Dietary Supplements

WebMD Public Information with the FDA

The FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Click on any of the following questions you might have about supplements to get more information.

1. What is a dietary supplement?
2. What is a "new dietary ingredient" in a dietary supplement?
3. What is the FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?
4. When must a manufacturer or distributor notify the FDA about a dietary supplement it intends to market in the U.S.?
5. What information must the manufacturer disclose on the label of a dietary supplement?
6. Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?
7. Should I check with my doctor or healthcare provider before using a supplement?
8. Where can I get information about a specific dietary supplement?
9. Who has the responsibility for ensuring that a dietary supplement is safe?
10. Do manufacturers or distributors of dietary supplements have to disclose any evidence they have about their product's safety or to back up claims about them?
11.How can I know if claims about a product are accurate?
12. What is the FDA's oversight responsibility for dietary supplements?
13. Does the FDA routinely analyze the content of dietary supplements?
14. Who validates claims, and what kinds of claims can be made on dietary supplement labels?
15. Why do some supplements have wording that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
16. How are advertisements for dietary supplements regulated?
17. How can a problem or illness caused by a dietary supplement be reported to the FDA?

1. What is a dietary supplement?

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress defined the term "dietary supplement" as a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.

Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet.

Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

2. What is a "new dietary ingredient" in a dietary supplement?

The law defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:

• a vitamin,
• a mineral,
• an herb or other botanical,
• an amino acid,
• a dietary substance for use by humans to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
• a concentrate, metabolite, constituent or extract.

A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.

3. What is the FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?

Under DSHEA, a company is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from the FDA before they are marketed.

Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide the FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.

Also, manufacturers do not need to register themselves nor their dietary supplement products with the FDA before producing or selling them. There are no FDA regulations that are specific to dietary supplements that establish a minimum standard of practice for manufacturing dietary supplements.

However, the FDA intends to issue regulations on good manufacturing practices that will focus on practices that ensure the identity, purity, quality, strength, and composition of dietary supplements. Currently, the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.

4. When must a manufacturer or distributor notify the FDA about a dietary supplement it intends to market in the U.S.?

DSHEA requires that a manufacturer or distributor notifies the FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.

There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new," and if it is not, for documenting that the dietary supplements that contain the dietary ingredient were marketed before October 15, 1994.

5. What information must the manufacturer disclose on the label of a dietary supplement?

FDA regulations require that certain information appear on dietary supplement labels including a descriptive name of the product stating that it is a "supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.

Each dietary supplement (except for some small volume products or those produced by eligible small businesses) also must have nutrition labeling in the form of a "Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.

6. Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?

Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.

7. Should I check with my doctor or healthcare provider before using a supplement?

This is a good idea, especially for certain population groups. Dietary supplements may not be risk-free under certain circumstances. If you are pregnant, nursing a baby, or have a chronic medical condition such as diabetes, hypertension, or heart disease, be sure to consult your doctor or pharmacist before taking any supplement.

While vitamin and mineral supplements are widely used and generally considered safe for children, you may wish to check with your doctor or pharmacist before giving these or any other dietary supplements to your child.

If you plan to use a dietary supplement in place of drugs or in combination with any drug, tell your healthcare provider first. Many supplements contain active ingredients that have strong biological effects and their safety is not always assured in all users. Some supplements may interact with prescription and over-the-counter medicines, resulting in adverse effects -- some potentially life-threatening.

8. Where can I get information about a specific dietary supplement?

Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that the FDA does not keep a list of manufacturers and distributors or the dietary supplement products they sell. If you want more detailed information than the label tells you about a specific product, you may contact the manufacturer of that brand directly. The name and address of the manufacturer or distributor can be found on the label of the dietary supplement.

9. Who has the responsibility for ensuring that a dietary supplement is safe?

The manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for the FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer.

Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate, or forward to the FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once the product is marketed, the FDA has the responsibility for showing that a dietary supplement is "unsafe" before it can take action to restrict the product's use or removal from the marketplace.

10. Do manufacturers or distributors of dietary supplements have to disclose any evidence they have about their product's safety or to back up claims about them?

No, except for rules described above that govern "new dietary ingredients," there is no provision under any law or regulation that the FDA enforces that requires a firm to disclose the information they have about the safety or purported benefits of their dietary supplement products.

Likewise, there is no prohibition against them making this information available either to FDA or to their customers. It is up to each firm to set its own policy on disclosure of such information.

11. How can I know if claims about a product are accurate?

Ask yourself: Does it sound too good to be true? Do the claims seem exaggerated or unrealistic? Are there simplistic conclusions being drawn from a complex study to sell a product? Learn to distinguish hype from evidence-based science. Nonsensical lingo can sound very convincing.

Also, be skeptical about anecdotal information from persons who have no formal training in nutrition or botanicals, or from personal testimonials (store employees, friends, or online chat rooms, and message boards) about incredible benefits or results obtained from using a product. Question these people on their training and knowledge in nutrition or medicine.

Be wary of results claiming a "quick fix" that depart from previous research and scientific beliefs. Keep in mind science does not proceed by dramatic breakthroughs, but by taking many small steps, slowly building towards a consensus.

A dietary supplement cannot be promoted as a treatment, prevention, or cure for a specific disease or condition. That would be considered an unapproved -- and thus illegal -- drug.

12. What is the FDA's oversight responsibility for dietary supplements?

Because dietary supplements are under the "umbrella" of foods, the FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.

13. Does the FDA routinely analyze the content of dietary supplements?

The FDA focuses its limited resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law.

The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers.

14. Who validates claims, and what kinds of claims can be made on dietary supplement labels?

The FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, the FDA, and, in the case of advertising, with the Federal Trade Commission.

By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product.

15. Why do some supplements have wording that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?

This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA.

For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure, or prevent any disease," because only a drug can legally make such a claim.

16. How are advertisements for dietary supplements regulated?

The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. The FDA works closely with the FTC in this area, but FTC's work is directed by different laws. Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service.

17. How can a problem or illness caused by a dietary supplement be reported to the FDA?

If you think you have suffered a serious harmful effect or illness from a product FDA regulates, including dietary supplements, the first thing you should do is contact or see your healthcare provider immediately. Then, you and your healthcare provider are encouraged to report this problem to FDA.

Your healthcare provider can call the FDA's MedWatch hotline at 1-800-FDA-1088, submit a report by fax to 1-800-FDA-0178 or online at http://www.fda.gov/medwatch/report/hcp.htm. The MedWatch program provides a way for healthcare providers to report problems believed to be caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements.

You, or anyone, may report a serious adverse event or illness directly to FDA if you believe it is related to the use of any of the above-mentioned products, by calling FDA at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or reporting on-line at http://www.fda.gov/medwatch/report/consumer/consumer.htm.

The FDA would like to know when you think a product caused you a serious problem, even if you are not sure that the product was the cause, or even if you do not visit a doctor or clinic. The identity of the reporter and/or patient is kept confidential.

Medically reviewed November 2002.