Friday, May 4, 2007

Dietary Supplement

A dietary supplement is intended to supply nutrients, (vitamins, minerals, fatty acids or amino acids) that are missing or not consumed in sufficient quantity in a person's diet. This category may also include herbal supplements which claim to treat or prevent certain diseases or conditions.

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994[1] (DSHEA) as a product that is intended to supplement the diet and bears or contains one or more of the following dietary ingredients:

  • a vitamin
  • a mineral
  • an herb or other botanical (excluding tobacco)
  • an amino acid
  • a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or
  • a concentrate, metabolite, constituent, extract, or combination of any of the above

Furthermore, it must be:

  • intended for ingestion in pill, capsule, tablet, powder or liquid form
  • not represented for use as a conventional food or as the sole item of a meal or diet
  • labeled as a "dietary supplement"

Pursuant to the DSHEA, the Food and Drug Administration regulates dietary supplements as foods, and not as drugs. The FDA does not approve dietary supplements based on their safety and efficacy; the FDA can take action only after a dietary supplement has been proven harmful. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements. The FDA claims that their rationale for a lack of regulation is a "freedom to choose" by the consumer, but there are economic benefits as well. The FDA chooses not to regulate dietary supplements because clinical trials are lengthy and costly. They tend to believe that the supplement is beneficial until problems arise.[2]

The claims that a dietary supplement makes are essential to its classification. If a dietary supplement claims to cure, mitigate, or treat a disease, it would be considered to be an unauthorized new drug and in violation of the applicable regulations and statutes. As the FDA states it in a response to this question in a FAQ:

Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.

Dietary supplements are permitted to make structure/function claims. These are broad claims that the product can support the structure or function of the body (e.g., "glucosamine helps support healthy joints"). The FDA must be notified of these claims within 30 days of their first use, and there is a requirement that these claims be substantiated.

Other claims that required approval from FDA include health claims and qualified health claims. Health claims are permitted to be made if they meet the requirements for the claims found in the applicable regulations. Qualified health claims can be made through a petition process, including scientific information, if FDA has not approved a prior petition.

European Union

The Food Supplements Directive[3] requires that supplements be demonstrated to be safe, both in quantity and quality. Some vitamins are essential in small quantities but dangerous in large quantities. Some herbal remedies, notably St Johns Wort, may interact with drugs or render them less effective. Such an issue has been raised in the case of oral contraceptives. Consequently, only those supplements that have been proven to be safe may be sold without prescription. In practice, the number of reported incidents with food supplements is nevertheless low.

In Europe, it is also an established notion that food supplements should not be labeled with drug claims but can bear - to a degree that differs from one member state to the other - health claims.

Legal challenge

The dietary supplements industry in Europe strongly opposed the Directive. A large number of consumers throughout Europe, including over one million in the UK, and many doctors and scientists, have signed petitions against what are viewed by the petitioners as unjustified restrictions of consumer choice [4]. The European Court of Justice ruled[5] on 12 July 2005 that the Directive is valid, although the court's own Advocate General advised that the declaration was invalid under EU law [4]. The court made clear, however, that it must be possible for manufacturers to add vitamins and minerals to the list of ingredients of a food supplement, that refusal must be on scientific grounds, and that there should be a right to appeal.

Russian legislation, Ministry of Health's order number 117 dated as of 15 April, 1997, under the title "Concerning the procedure for the examination and health certification of Biologically Active Dietary Supplements", provides the usage of the following terminology:

As a rule, BADSs are foodstuffs with clinically proven effectiveness. BADSs are recommended not only for prophylactics, but can be included into a complex therapy for the prevention of pharmaceutical therapy's side effects and for the achievement of complete remission.

The development of BADSs and their applications has been very fast moving. They were originally considered as dietary supplements for people who had heightened requirements for some normal dietary components (for example, sportsmen). Later, they were employed as preventive medicines against chronic diseases.

Criticisms of vitamin supplementation

Regular supplementation with vitamin E, beta carotene and vitamin A may increase mortality by four, seven and sixteen percent respectively.[6] The same study found that vitamin C and selenium had no effect, positive or negative on longevity.

Q. How do I know if I need a dietary supplement?

A. Because many products are marketed as dietary supplements, it is important to remember that supplements include vitamins and minerals, as well as herbs, botanicals and other substances.

Some supplements may help ensure that you get adequate amounts of essential nutrients or help promote optimal health and performance if you do not consume a variety of foods, as recommended in the MyPyramid and Dietary Guidelines for Americans.

However, dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions.

Do not self diagnose any health condition. Work with your health care provider to determine how best to achieve optimal health and always check with your health care provider before taking a supplement, especially when combining or substituting them with other foods or medicine.

You can use the checklist at the following link to talk to your health care provider about your nutritional status and whether taking a dietary supplement(s) is right for you:

http://dietary-supplements.info.nih.gov/pubs/partnersbrochure.asp#firsttool

Q. How can I get more information about a particular dietary supplement such as whether it is safe and effective?

A. Scientific evidence supporting the benefits of some dietary supplements (e.g., vitamins and minerals) is well established for certain health conditions, but others need further study. This is partly due to the way dietary supplements are regulated by the U.S. Food and Drug Administration (FDA).

Research studies in people to prove that a dietary supplement is safe are not required before the supplement is marketed, unlike for drugs. It is the responsibility of dietary supplement manufacturers/distributors to ensure that their products are safe and that their label claims are accurate and truthful. If the FDA finds a supplement to be unsafe once it is on the market, only then can it take action against the manufacturer and/or distributor, such as by issuing a warning or requiring the product to be removed from the marketplace.

The manufacturer does not have to prove that the supplement is effective, unlike for drugs. The manufacturer can say that the product addresses a nutrient deficiency, supports health, or reduces the risk of developing a health problem, if that is true. If the manufacturer does make a claim, it must be followed by the statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions. Whatever your choice, supplements should not replace prescribed medications or the variety of foods important to a healthful diet.

Do not self diagnose any health condition. Work with your health care provider to determine how best to achieve optimal health and always check with your health care provider before taking a supplement, especially when combining or substituting them with other foods or medicine.

In addition to talking with your health care provider about dietary supplements, you can search on-line for information about a particular dietary supplement. It is important to ensure that you obtain information from reliable sources such as:

For tips on evaluating sources of healthcare information on the internet, please see the following document: How to Evaluate Health Information on the Internet: Questions and Answers.

Q. Where can I find information about the use of dietary supplements for a particular health condition or disease?

A. Scientific evidence supporting the benefits of some dietary supplements (e.g., vitamins and minerals) is well established for certain health conditions, but others need further study. Whatever your choice, supplements should not replace prescribed medications or the variety of foods important to a healthful diet.

Dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions.

Do not self diagnose any health condition. Work with your health care provider to determine how best to achieve optimal health and always check with your health care provider before taking a supplement, especially when combining or substituting them with other foods or medicine.

In addition to talking with your health care provider about dietary supplements for a particular health condition or disease, you can search on-line for information. It is important to ensure that you obtain information from reliable sources such as:


Dr Marwah

Posted by at

No comments:

Post a Comment

Subscribe to: Post Comments (Atom)