Dietary Supplements -- Dispelling the Myths

Dietary supplements of all kinds make incredible claims -- this product will help you lose vast amounts of weight; this product will help you improve your memory; this product will increase your energy level to new highs.

But with all the hype, which of these claims can you really believe? Just what is a "dietary supplement" and who is regulating these products. The U.S. Food and Drug Administration provides information that may help you sort through some of the issues surrounding the dietary supplement craze.

Q. What is a dietary supplement?

A dietary supplement is any product taken by mouth that contains a so-called "dietary ingredient" and its label clearly states that it is a dietary supplement. 

The "dietary ingredients" in dietary supplements may include vitamins, minerals, herbs, and amino acids as well as substances such as enzymes, organ tissues, metabolites, extracts or concentrates. Dietary supplements can be found in many forms such as pills, tablets, capsules, liquids or powders. They must be identified on the label as a dietary supplement.

Q. Where do dietary supplements fit in the priorities for FDA?
The Center for Food Safety and Applied Nutrition (CFSAN) oversees the agency's activities related to dietary supplement products. Dietary supplements are one of the high priority areas for CFSAN.
Q. How are dietary supplements regulated?
The label of a dietary supplement must contain enough information about the composition of the product for the consumers to make an informed choice. This information must be presented in a format specified by FDA. The information must be truthful and not misleading. The manufacturer is also responsible for making sure that all dietary ingredients in the supplements are safe. However, manufacturers and distributors do not need to register with FDA or get FDA approval before producing or selling dietary supplements.
Q. How do I report a problem or illness caused by a dietary supplement?
FDA can be contacted to report general complaints or concerns about food products, including dietary supplements.

If you think you have suffered a serious harmful effect or illness from a dietary supplement, your health care provider can report this by calling FDA's MedWatch hotline at 1-800-FDA-1088 or using the website http://www.fda.gov/medwatch/report/hcp.htm. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.

Consumers may also report an adverse event or illness they believe to be related to the use of a dietary supplement by calling FDA at 1-800-FDA-1088 or using the website http://www.fda.gov/medwatch/report/consumer/consumer.htm. FDA would like to know when a product causes a problem even if you are unsure the product caused the problem or even if you do not visit a doctor or clinic.

Q. Are advertisements for dietary supplements regulated by FDA?
No. The Federal Trade Commission (FTC) handles advertising for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but their work is directed by different laws.
Q. Does FDA routinely analyze the content of Dietary Supplements?
FDA has limited resources to analyze the composition of food products, including dietary supplements. So, FDA focuses first on public health emergencies and products that may have caused injury or illness. Then products thought to be fraudulent or in violation of the law are analyzed. FDA uses the remaining funds for routine monitoring of products pulled from store shelves. FDA does not analyze supplement products before they are sold to consumers. The manufacturer is responsible for ensuring that the ingredient list is accurate and that the ingredients are safe. They are also required to make sure that the content matches the amount declared on the label.FDA does not have adequate resources to analyze dietary products sent by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory.
 Are all ingredients required to be declared on the label? Other ingredients in the product must be listed in the ingredient statement beneath the "Supplement Facts" panel. The types of ingredients listed there would include gelatin, sugars, starch, colors, stabilizers and preservatives.


Q.  Are there restrictions on size of the pill or how much of a nutrient can be in one serving of a Dietary Supplement?

There are no rules that limit a serving size or the amount of nutrients in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval. For one dietary ingredient, ephedrine alkaloids, FDA has proposed to permit serving sizes of 8 mg or less.


 Q. What kinds of claims can be made on the labels of Dietary Supplements?

As with other food products, the manufacturer can put certain claims on the product label. These claims tell consumers about the nutritional value of the product. Claims defined by FDA to describe the nutrient content of a product, like "good source" or "high", can appear on the label if one serving meets the definition. There are specific rules as to which substances can be listed using these nutrient content claims.

Manufacturers can also put FDA-approved "health claims" on a product label. Health claims describe the connection between a nutrient or food substance and a disease or health-related condition. Claims about these diet/disease relationships can appear on the label if the content of the product meets the FDA requirements and if the claim is one of the approved health claims.


 Q. 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"?

Certain statements may be included on the label that give the manufacturer's description of the role of the dietary supplement. These statements are not authorized by FDA. The manufacturer is responsible for ensuring that these statements are accurate and truthful. For this reason, the law says that if a dietary supplement label includes this information, it must also state that FDA has not evaluated the statement.


Q. Where can I get information about a specific Dietary Supplement?

Manufacturers do not need FDA approval to sell their supplement products. This means that FDA does not keep a list of manufacturers or products on the market. If you want more specific information than the label tells you about the products, you may contact the manufacturer directly.



 

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