Dietary supplement

Assistant Editor-in-Chief: Nelofar Adnan, M.D. [mailto:nelofar.adnan@gmail.com]

Overview
A dietary supplement (also known as food 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 may have added health benefits.

United States
In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 (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 people 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"

Regulation
Pursuant to the DSHEA, the Food and Drug Administration regulates dietary supplements as foods, and not as drugs. Unlike pharmaceutical companies, supplement manufacturers are not required to prove the safety or effectiveness of their products; the FDA can take action only after a dietary supplement has been proven harmful. In addition, the purity and quality of individual brands of dietary supplements are unregulated. 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 DSHEA, passed in 1994, was the subject of extensive lobbying efforts by the manufacturers of dietary supplements. As such, the true level of popular support for the deregulation of the supplement industry is unclear. A large survey by the AARP, for example, found that 77% of respondents (including both users and non-users of supplements) believed that the federal government should review the safety of dietary supplements and approve them before they can be marketed to consumers.

Similar confusion about the implications of DSHEA was noted in an October 2002 nationwide Harris poll. Here, 59% of respondents believed that supplements had to be approved by a government agency before they could be marketed; 68% believed that supplements had to list potential side effects on their labels; and 55% believed that supplement labels could not make claims of safety without scientific evidence. All of these beliefs are incorrect as a result of provisions of the DSHEA.

A 2001 study, published in Archives of Internal Medicine, found broad public support for greater governmental regulation of dietary supplements than is currently permitted by DSHEA. The researchers found that a majority of Americans supported pre-marketing approval by the FDA, increased oversight of harmful supplements, and greater scrutiny of the truthfulness of supplement label claims.

Permissible claims
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 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, notably Vitamin A. 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 view that food supplements should not be labeled with drug claims but can bear health claims, although to a degree that differs from one member state to the other.

Legal challenge
The dietary supplements industry in the United Kingdom 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. The European Court of Justice ruled 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. 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.

Russia
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
A 2007 study found that regular supplementation with vitamin E, beta carotene and vitamin A increased mortality by four, seven and sixteen percent respectively. The same study also suggested that vitamin C and selenium had no effect, positive or negative on longevity.