Health & Medical Pain Diseases

"Miracle" Health Claims: Add a Dose of Skepticism

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Updated April 24, 2015.

Assessing Claims for Dietary Supplements

The array of dietary supplements - vitamins and minerals, amino acids, enzymes, herbs, animal extracts and others - has grown tremendously over the years. Although the benefits of some of these products have been documented, the advantages of others are unproven.

For example, claims that a supplement allows you to eat all you want and lose weight effortlessly are false.


To lose weight, you must lower your calorie intake or burn more calories - for example, by increasing exercise. Most medical experts recommend doing both.

Similarly, no supplement can cure arthritis or cancer in five days. Such claims are false. Consumers should be wary of any claims for a dietary supplement that say it can shrink tumors, cure insomnia, cure impotency, treat Alzheimer's disease, or prevent severe memory loss. These kinds of claims deal with the treatment of diseases, and companies that want to make such claims must follow the FDA's pre-market testing and review process required for new drugs.
  • FDA Regulation of Health Claims

    Federal law allows for certain claims to be made in the labeling of food and supplements. These include claims approved by the Food and Drug Administration that show a strong link, based on scientific evidence, between a food substance and a disease or health condition. These approved claims can state only that a food substance reduces the risk of certain health problems - not that it can treat or cure a disease. Two examples of approved claims are: "The vitamin folic acid may reduce the risk of neural tube defect-affected pregnancies," and "Calcium may reduce the risk of the bone disease osteoporosis."

    Dietary supplements also may carry claims in their labeling that describe the effect of a substance in maintaining the body's normal structure or function, as long as the claims don't imply the product treats or cures a disease. The FDA does not review or authorize these claims. An example of such a claim is, "Product B promotes healthy joints and bones." When a dietary supplement is promoted with a claim like this, the claim must be accompanied with the disclaimer, "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease."

    To learn more about the kinds of labeling claims that can be made for foods and dietary supplements, see www.cfsan.fda.gov/~dms/hclaims.html.



    Safety Concerns

    Prescription drugs must undergo clinical testing and receive the FDA's full review for safety and effectiveness before they are sold. Over-the-counter medicines are subject to the OTC drug review process, which determines safety and effectiveness of the products. Dietary supplements are not required to undergo government testing or review before they are marketed. Yet, supplements may have drug-like effects that could present risks for people on certain medicines or with certain medical conditions. This is true, even if the product is marketed as "natural." For example, St. John's Wort can have potentially dangerous interactions with a number of prescription drugs, including anticoagulants, oral contraceptives, antidepressants, antiseizure medicines, drugs for HIV, and drugs to prevent transplant rejection.

    If you take a prescription medicine, always consult your healthcare professional before starting a dietary supplement.

    Some dietary supplement substances require further scrutiny and study before they can be considered safe for all people. Though many supplements have a history of use, that history does not necessarily guarantee safety in every circumstance.

    Some substances for which safety concerns have been raised are comfrey, chaparral, lobelia, germander, aristolochia, ephedra (ma huang), L-tryptophan, germanium, magnolia-stephania and stimulant laxative ingredients, such as those found in dieter's teas. The herb comfrey, for example, contains certain alkaloids that can cause serious liver damage. Consumers should not take any product containing comfrey either orally or as a suppository and should not apply comfrey products to broken skin.

    Even some vitamins and minerals, when consumed in excessive quantities, can cause problems. For example, high intakes of vitamin A over a long period can reduce bone mineral density, cause birth defects and lead to liver damage, according to the National Academy of Sciences.

    To ensure the safe use of any healthcare product, read the labels and package inserts, follow product directions and check with your healthcare professional.

    >>Please follow the links below to continue<<

    Assessing Claims for Dietary Supplements

    The array of dietary supplements - vitamins and minerals, amino acids, enzymes, herbs, animal extracts and others - has grown tremendously over the years. Although the benefits of some of these products have been documented, the advantages of others are unproven.

    For example, claims that a supplement allows you to eat all you want and lose weight effortlessly are false. To lose weight, you must lower your calorie intake or burn more calories - for example, by increasing exercise. Most medical experts recommend doing both.

    Similarly, no supplement can cure arthritis or cancer in five days. Such claims are false. Consumers should be wary of any claims for a dietary supplement that say it can shrink tumors, cure insomnia, cure impotency, treat Alzheimer's disease, or prevent severe memory loss. These kinds of claims deal with the treatment of diseases, and companies that want to make such claims must follow the FDA's pre-market testing and review process required for new drugs.
    • FDA Regulation of Health Claims

      Federal law allows for certain claims to be made in the labeling of food and supplements. These include claims approved by the Food and Drug Administration that show a strong link, based on scientific evidence, between a food substance and a disease or health condition. These approved claims can state only that a food substance reduces the risk of certain health problems - not that it can treat or cure a disease. Two examples of approved claims are: "The vitamin folic acid may reduce the risk of neural tube defect-affected pregnancies," and "Calcium may reduce the risk of the bone disease osteoporosis."

      Dietary supplements also may carry claims in their labeling that describe the effect of a substance in maintaining the body's normal structure or function, as long as the claims don't imply the product treats or cures a disease. The FDA does not review or authorize these claims. An example of such a claim is, "Product B promotes healthy joints and bones." When a dietary supplement is promoted with a claim like this, the claim must be accompanied with the disclaimer, "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease."

      To learn more about the kinds of labeling claims that can be made for foods and dietary supplements, see www.cfsan.fda.gov/~dms/hclaims.html.

    Safety Concerns

    Prescription drugs must undergo clinical testing and receive the FDA's full review for safety and effectiveness before they are sold. Over-the-counter medicines are subject to the OTC drug review process, which determines safety and effectiveness of the products. Dietary supplements are not required to undergo government testing or review before they are marketed. Yet, supplements may have drug-like effects that could present risks for people on certain medicines or with certain medical conditions. This is true, even if the product is marketed as "natural." For example, St. John's Wort can have potentially dangerous interactions with a number of prescription drugs, including anticoagulants, oral contraceptives, antidepressants, antiseizure medicines, drugs for HIV, and drugs to prevent transplant rejection.

    If you take a prescription medicine, always consult your healthcare professional before starting a dietary supplement.

    Some dietary supplement substances require further scrutiny and study before they can be considered safe for all people. Though many supplements have a history of use, that history does not necessarily guarantee safety in every circumstance.

    Some substances for which safety concerns have been raised are comfrey, chaparral, lobelia, germander, aristolochia, ephedra (ma huang), L-tryptophan, germanium, magnolia-stephania and stimulant laxative ingredients, such as those found in dieter's teas. The herb comfrey, for example, contains certain alkaloids that can cause serious liver damage. Consumers should not take any product containing comfrey either orally or as a suppository and should not apply comfrey products to broken skin.

    Even some vitamins and minerals, when consumed in excessive quantities, can cause problems. For example, high intakes of vitamin A over a long period can reduce bone mineral density, cause birth defects and lead to liver damage, according to the National Academy of Sciences.

    To ensure the safe use of any healthcare product, read the labels and package inserts, follow product directions and check with your healthcare professional.

    >>Please follow the links below to continue<<
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