Furthermore, it must also conform to the following criteria:
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 have been based on a misunderstanding of the 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 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 were 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 was 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.
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 hormone melatonin helps establish normal sleep patterns"). 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.
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.
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.
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.
The industry's potential excipient folly: what companies should know about "everything" that goes into the manufacture of a dietary supplement or ingredient. (Capitol Comments).
Jun 01, 2003; The proposed dietary supplement current good manufacturing practices (cGMPs) regulations raise an important issue regarding...