Dietary supplement

A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supply nutrients, such as vitamins, minerals, fatty acids or amino acids, that are missing or are not consumed in sufficient quantity in a person's diet. Some countries define dietary supplements as foods, while in others they are defined as drugs.

Supplements containing vitamins or dietary minerals are recognised by the Codex Alimentarius Commission, the United Nations' highest authority on food standards, as a category of food.


Regulation

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 contains any 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 also conform to the following criteria:

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"
The hormones DHEA (a steroid), pregnenolone (also a steroid) and the pineal hormone melatonin are marketed as dietary supplements in the US.

Pursuant to the DSHEA, the Food and Drug Administration regulates dietary supplements as foods, and not as drugs. While pharmaceutical companies are required to prove the safety or effectiveness of their products, supplement manufacturers are not, and the FDA can take action only after a dietary supplement has been proven harmful.

The DSHEA, passed in 1994, was the subject of lobbying efforts by the manufacturers of dietary supplements. At the time of its passage DSHEA received strong support from consumer grassroots organizations, and Members of Congress. In recognition of this, President Bill Clinton, on signing DSHEA into law, stated that "After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law." He also noted that the passage of DSHEA "speaks to the diligence with which an unofficial army of nutritionally conscious people worked democratically to change the laws in an area deeply important to them" and that "In an era of greater consciousness among people about the impact of what they eat on how they live, indeed, how long they live, it is appropriate that we have finally reformed the way Government treats consumers and these supplements in a way that encourages good health."

Popular support may be based on a misunderstanding of the present situation after the deregulation of the supplement industry. 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. In an October 2002 nationwide Harris poll, 59% of respondents believed that supplements must 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.

 

Legal challenge

The dietary supplements industry in the UK, one of the 27 countries in the European Union, strongly opposed the Directive. In addition, 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. In 2004, along with two British trade associations, the Alliance for Natural Health had a legal challenge to the European Union's Food Supplements Directive referred to the European Court of Justice by the High Court in London.

Although the European Court of Justice's Advocate General subsequently said that the EU's plan to tighten rules on the sale of vitamins and food supplements should be scrapped, he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements - and not to vitamins and minerals normally found in or consumed as part of the diet.

Nevertheless, the European judges did acknowledge the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add a product to the list must be open to challenge in the courts.