DSHEA Dietary Supplement

Under the DSHEA, dietary supplements are not considered over-the-counter drugs in the USA but rather food supplements. Although dietary supplements are regulated as food, consumers may use them in the same fashion as drugs and even use them in place of drugs or in combination with drugs. 

Abbreviations. CAM, complementary and alternative medicine DSHEA, Dietary Supplement Health and Education Act EEC, European Economic Community ESCOP, European Societies Cooperative of Phytotherapy HPB, Health Protection Branch NCCAM, Natiohal Cehter for Complementary and Alternative Medicine OTC, over the counter U.S. FDA, United States Food and Drug Administration WHO, World Health Organization. 

By the year 2010, FDA will have a science-based regulatory program that fully implements the DSHEA. The plan addresses safety, labeling, clarification of the differences between drugs and dietary supplements, and enforcement activities. 

Regarding DSHEA, a pharmacist may be in violation if he or she displays a published article about a product beside that product in the pharmacy. DSHEA states that articles must be physically separated from the dietary supplements, but the distance is undefined [26]. Also, DSHEA states that another publication with a contrary view must be displayed, if available. 

Israelsen LD, Blumenthal M. FDA issues final rules for structure/function claims for dietary supplements under DSHEA. HerbalGram 48 32-38, 2000. 

A Roper survey of 1480 persons age 50 or older, conducted in 2001, found that about 75% of the respondents wanted the government to review safety data and approve dietary supplements before sale and fo verify all health-related claims before they can be included in advertisements and on product labels. This is just contrary to what DSHEA permits, but there is little hope that Congress will modify its provisions. 

Government agencies have never had sufficient resources to cope with the enormous amount of deception in the marketing of herbs, dietary supplements, and homeopathic products. Dietary Supplement Health and Education Act made the problem worse. Without an adequate law, the FDA cannot curb the deceptive marketing of what DSHEA calls dietary supplements. Regulators have the power to ban homeopathic remedies but have shown no interest in doing so. 

The kind of natural products listed in the table above, however, are not defined in the United States today as drugs hut as dietary supplements, nutritional supplements, natural foods, or some similar nondrug product. Such products are not subject to the same standards of testing as are synthetic drugs. They are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994 (Public Law 103-417). According to that law, the makers of natural products used... 

The lack of such scientific evidence does not automatically mean that such products are dangerous or ineffective. Many people are willing to trust traditional practices that have been used for hundreds of years whether there is scientific evidence for them or not. They are willing to accept the claims of healers from fields other than modern medicine about the benefits of such products. Indeed, an important reason for the adoption of the DSHEA in 1994 was to allow individuals the right to make choices about dietary supplements without the intervention of the federal government in that process. 

The fourth safety concern in the use of dietary supplements, that they may actually be harmful to users, is anything hut benign. Recall that the DSHEA places the responsihihty for safety testing with supplement manufacturers themselves. Consumers can only assume that products they purchase are safe for their use and will not cause health problems. It is only when such problems actually arise and the EDA is notified that regulators can deal with the safety of a supplement. 

In the decade following the 1994 adoption of the DSHEA, a number of problems related to the manufacture, advertising, and sale of dietary supplements had become apparent. Findings accumulated that such products are often contaminated with a variety of impurities, such as bacteria, glass, lead, and pesticides. For example ... 

All of the vitamins are used as specific treatments for their respective deficiency diseases. The dosages required will vary depending on the severity of the disease and the vitamin. Vitamins have also been used like drugs to treat diseases. However, unlike drug products, vitamins are not reviewed by the U. S. Food and Drug Administration before formulations appear on the market. Vitamins are considered to be dietary supplements under the Dietary Supplement Health and Education Act (DSHEA). Vitamins and other dietary supplements are not permitted to be marketed as a treatment or cure for a specific disease or condition unless the vitamin is approved as a drug for that purpose. However, under DSHEA, supplement manufacturers may make health claims, such as the link between a food substance and a disease or health-related condition. This may make it difficult for patients to assess the need for vitamin supplementation. 

DSHEA severely limited when the FDA could take action to protect the public and what actions could be taken. The burden of proof to show harm is now placed on the FDA. Moreover, dietary supplement manufacturers are not required to report adverse dietary supplement events. In fact, between 1994 and 1999 fewer than 10 of the 2500 adverse events associated with dietary supplements and reported to the FDA were reported by the manufacturer (53). The Office of Inspector General concluded the spontaneous adverse event reporting system has difficulty generating signals of possible public health concern due to limited medical information, product information, manufacturer information, consumer information, and ability to analyze trends (57). One weight loss supplement manufacturer is reported to have withheld from the FDA 14,684 complaints of adverse events regarding ephedra, which included heart attacks, strokes, seizures, and deaths (53). 

Recently, the FDA has begun to enforce DSHEA more assertively. Ephedra was banned as a dietary supplement in April of 2004 because ephedra presented an unreasonable risk. However, this ban does not include foods containing ephedra, approved drugs, or Asian medicines, which are allowed to... 

Dietary Supplement Health and Education Act (DSHEA) Public Law 103 17 103rd Congress, October 1994. 

DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT (DSHEA) Passed in 1994, this law allows manufacturers to sell dietary and nutritional supplements without federal regulation. According to this act, supplements can be regulated only after they are proven to be harmful to users. 

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