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Dietary Supplements

 

What Makes Up a Dietary Supplement

Dietary supplements are products that may contain vitamins, minerals, botanical or herbal ingredients, amino acids (the building blocks of proteins), and enzymes (complex proteins that speed up biochemical reactions). They are sold in various forms including tablets, capsules, softgels, gelcaps or liquids. They are meant to supplement a diet but should not be considered a substitute for food.

Examples of commonly used dietary supplements:

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 a healthy lifestyle with a balanced diet and exercise, and can continue to rely on vitamins and minerals to fill nutritional gaps and enhance health.  

Dietary supplements should be used responsibly as part of an overall healthy lifestyle including regular exercise, eating a healthy diet, getting enough sleep, and visiting a healthcare professional regularly. People use dietary supplements for a number of reasons, including:

Dietary Supplements and Health Claims

It is important to note that dietary supplements are not medicines. Manufacturers of dietary supplement products are not allowed to say that their products can diagnose, cure, treat, or, with special exceptions, prevent disease. For instance, a dietary supplement cannot make a claim to "reduce arthritis pain" or “treat heart disease.” However, based on evidence, manufacturers can say that their dietary supplement contributes to health maintenance, well-being, or supports a function of the body. 

 Where back by sufficient evidence, some supplements may make claims about the role of an ingredient in preventing certain conditions. For example, “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 does not approve dietary supplements for safety before they are marketed. If a dietary supplement contains a new ingredient (one that was not marketed before October 1994) that ingredient will be reviewed for safety by the FDA prior to marketing.

 Manufacturers of dietary supplements are responsible for the safety of their products and they must follow a number of standards meant to ensure quality in the manufacturing, packaging, and labeling of their products. Dietary supplement manufacturers must also keep track of adverse events reported in association with their products and report all serious adverse events to the FDA. Advertising of dietary supplements is regulated by the Federal Trade Commission.

Important Tips for Safe Use

 Used as directed, dietary supplements have a wide margin of safety. But dietary supplements do contain ingredients that have biological effects on the body. In some situations this could lead to an adverse event associated with the use of the product.

Commonly Asked Questions About Dietary Supplements

Can I take dietary supplement products with prescription or over-the-counter (OTC) drugs?

Yes; however, because they have a number of biological effects on the body, dietary supplements can interact with some OTC medicines or prescription drugs, potentially leading to an adverse event. Prior to taking any dietary supplement, consumers should inform their healthcare professional 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 demonstrate the claims of various dietary supplement ingredients can vary. Some dietary supplements ingredients, like calcium and vitamin D, have been studied extensively, and their health benefits are well known and well documented. While other dietary supplement ingredients may have not been studied as much, the makers of supplements must have evidence in their files to show that their claims are truthful and not misleading. Manufacturers of new dietary ingredients (those not sold as a dietary supplement before October 1994) must notify FDA of their intent to market a dietary supplement containing the new dietary ingredient and provide information on the safety of the product.

Where can I buy dietary supplements?

Dietary supplements are available from a wide variety of stores including supermarkets, health food stores, direct sellers, and convenience stores, and are also available for purchase via the Internet. When buying a dietary supplement from an Internet site it is important 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?

Most of the dietary supplements on the market today have an excellent safety record and their manufacturers comply with all requirements for product ingredients, claims, and labeling.

The FDA does occasionally find dietary supplement products that do not comply with these requirements.

 It is always best to purchase dietary supplements (and any health product) from a trusted company. Be especially careful when purchasing dietary supplements from the Internet. If a claim sounds too good to be true, it probable is too good to be true. Avoid purchasing dietary supplements that promise miracle results or say that they work in a short amount of time (i.e., ‘fast’ or ‘rapid action’), or that claim to be “totally safe.”

Have there been any safety issues with dietary supplements?

More recently, the FDA has observed a small number of manufacturers attempting to market dietary supplements containing extra ingredients not listed on the product label. This has occurred mostly in products intended for weight loss, body building, and sexual enhancement.  Know what you are taking.   The FDA maintains a website on health fraud scams. For more information please visit http://www.fda.gov/ForConsumers/ProtectYourself/HealthFraud/default.htm.

Are dietary supplements labeled ‘natural’ free of side effects?

Not necessarily. Do not assume that a product labeled as ‘natural’ will be safer than a product which is not.

What is a structure/function claim?

Structure/function claims describe the role of a nutrient or dietary ingredient in affecting the structure or function of the body in humans. An example of this would be "calcium builds strong bones." If a dietary supplement label includes a structure/function claim, it must also state that FDA has not evaluated the claim and that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease". 

 

Commonly Asked Questions About Dietary Supplements

Can I take dietary supplement products with prescription or over-the-counter (OTC) drugs?

Yes; however, because they have a number of biological effects on the body, dietary supplements can interact with some OTC medicines or prescription drugs, potentially leading to an adverse event. Prior to taking any dietary supplement, consumers should inform their healthcare professional 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 demonstrate the claims of various dietary supplement ingredients can vary. Some dietary supplements ingredients, like calcium and vitamin D, have been studied extensively, and their health benefits are well known and well documented. While other dietary supplement ingredients may have not been studied as much, the makers of supplements must have evidence in their files to show that their claims are truthful and not misleading. Manufacturers of new dietary ingredients (those not sold as a dietary supplement before October 1994) must notify FDA of their intent to market a dietary supplement containing the new dietary ingredient and provide information on the safety of the product.

Where can I buy dietary supplements?

Dietary supplements are available from a wide variety of stores including supermarkets, health food stores, direct sellers, and convenience stores, and are also available for purchase via the Internet. When buying a dietary supplement from an Internet site it is important 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?

Most of the dietary supplements on the market today have an excellent safety record and their manufacturers comply with all requirements for product ingredients, claims, and labeling.

The FDA does occasionally find dietary supplement products that do not comply with these requirements.

 It is always best to purchase dietary supplements (and any health product) from a trusted company. Be especially careful when purchasing dietary supplements from the Internet. If a claim sounds too good to be true, it probable is too good to be true. Avoid purchasing dietary supplements that promise miracle results or say that they work in a short amount of time (i.e., ‘fast’ or ‘rapid action’), or that claim to be “totally safe.”

Have there been any safety issues with dietary supplements?

More recently, the FDA has observed a small number of manufacturers attempting to market dietary supplements containing extra ingredients not listed on the product label. This has occurred mostly in products intended for weight loss, body building, and sexual enhancement.  Know what you are taking.   The FDA maintains a website on health fraud scams. For more information please visit http://www.fda.gov/ForConsumers/ProtectYourself/HealthFraud/default.htm.

Are dietary supplements labeled ‘natural’ free of side effects?

Not necessarily. Do not assume that a product labeled as ‘natural’ will be safer than a product which is not.

What is a structure/function claim?

Structure/function claims describe the role of a nutrient or dietary ingredient in affecting the structure or function of the body in humans. An example of this would be "calcium builds strong bones." If a dietary supplement label includes a structure/function claim, it must also state that FDA has not evaluated the claim and that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease".

Important Tips for Safe Use

 Used as directed, dietary supplements have a wide margin of safety. But dietary supplements do contain ingredients that have biological effects on the body. In some situations this could lead to an adverse event 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 dose. 
  • Inform your health-care 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, see your healthcare provider immediately.
  • You are also encouraged to report this event to FDA’s MedWatch Hotline at 1-800-FDA-1088.

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