Drugs & Medication

A prescribed 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 may include herbal supplements which have a history of claims that they cure or prevent certain diseases. The medical utility and regulatory status of dietary supplements is controversial.

Contents 1 United States 2 European Union 2.1 Legal challenge 3 Russia 4 Notes 5 See also 6 External links

United States

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994^[1] as a product that meets each of the following criteria:

1. It 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 daily intake (e.g., enzymes or tissues from organs or glands),
   • a concentrate, such as a meal replacement or energy bar, or
   • a metabolite, constituent, or extract.
2. It is intended for ingestion in pill, capsule, tablet, or liquid form.
3. It is not represented for use as a conventional food or as the sole item of a meal or diet.
4. It is labeled as a "dietary supplement".

The FDA regulates dietary supplements as foods, and not as drugs. The FDA does not pre-approve dietary supplements on their safety and efficacy, unlike drugs. In contrast, the FDA can only go after dietary supplement manufacturers after they have put unsafe products on the market. 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 claims that a dietary supplement makes are essential to its classification. If a dietary supplement claims in any way 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. Nevertheless, many critics claim that dietary supplements overstate their importance and their impact on overall health. Evidence of many of the claimed benefits of certain dietary supplements has yet to meet standard scientific criteria of credibility, based on large scale, double blind testing with statistically significant outcomes.

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^[2] 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 ^[3]. The European Court of Justice ruled^[4] 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 ^[3]. 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 № 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.

Notes

1. ^ US Dietary Supplement Health and Education Act of 1994
2. ^ Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements
3. ^ ^a b "Controversial EU vitamins ban to go ahead" (the Times, July 12 2005)
4. ^ The Court confirms the validity of the Community Directive on food supplements (Press release)

See also

• Vitamin

External links

• Dietary Supplement Further information
• US FDA/CFSAN Dietary Supplements
• Monitoring the Adverse Health Effects of Dietary Supplements Further information
• What's in the Bottle? An Introduction to Dietary Supplements (NCCAM)
• BBC Health: Vitamins on the BBC website. Note especially warnings [1] to pregnant women on Vitamin A (Retinol) and unspecified multivitamins.
• NIH info on herbal supplements
• National Nutritional Foods Association
• Supplements and Health Conditions Further information