DSHEA

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. 

The marketplace would be safer if the FDA could regulate the upper dosage limits of vitamins and minerals and could hold other nutritional supplements to at least the same standards as those for OTC drugs. But DSHEA prevents the FDA from doing this unless a product poses an imminent hazard. 

Under DSHEA, manufacturers who make statements of nutritional support must have substantiation that such statements are truthful and not misleading. The law also requires that the Secretary of Health and Human Services (HHS) be notified no later than 30 days after the first marketing of a supplement for which the statement is made. The law does not define substantiation. 

The passage of DSHEA was spearheaded by an avalanche of communicahon fo Congress from people who expressed fears fhaf wifhout special profechon consumers would lose fheir freedom fo buy vifamins. These fears were unfounded, buf many congressional rep-resenfafives concluded fhaf fhe FDA should be restrained. ... 

Ironically, by the time DSHEA was enacted, the OTC drug review had rid the marketplace of nearly all fhe sfandard OTC products that had been marketed with unsubstantiated claims. In contrast, few diefary supplements promoted with disease-related claims can live up to such claims. A few years ago, a review of 964 herbs and diefary supplemenf products listed in the Natural Medicines Comprehensive Database found fhaf only 15% had been proven safe and only 11% had been proven effective for the indications for which fhey were advocafed. ... 

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 DSHEA allows manufacturers to make certain kinds of claims for their products (called structure/function claims ), but not specific health claims. For example, a manufacturer can say that its product "supports the immune system," "promotes healthy joints," or "reduces stress." It cannot say that it "reduces the pain of arthritis," "improves the health of a person with a compromised immune system" (such as HIV infection), or "works as effectively as Prozac . Manufacturers also have to include the following disclaimer on their labels and packages ... 

The benefits of the DSHEA to the manufacturers of natural products is obvious. They can claim a variety of health benefits for their products in very general terms that may sound to consumers like health claims but usually are not. They also can (although they are unlikely to attempt to) sell products that do not contain the chemicals listed on the label, are not safe for human consumption, or are not effective at treating the conditions for which they are recommended. In some ways, this situation sounds similar to the conditions that existed at the beginning of the 20th century, when the FDA was created to deal with the false and misleading claims of patent medicine suppliers. 

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... 

As a result of DSHEA, botanical supplements are presumed safe by virtue of being grandfathered by the FDA if the product was marketed before October 15, 1994. Products brought to market after that date only require 75-day premarket notification to the FDA with information that substantiates that the ingredients will reasonably be expected to be safe (65). FDA cannot take action until patients are injured but it is increasingly clear relatively rare adverse events may not be detected until a significant number of patients are killed or injured. 

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

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. 

In 1994, the United States Congress, influenced by growing "consumerism" as well as strong manufacturer lobbying efforts, passed the DSHEA. DSHEA required the establishment of Good Manufacturing Practice (GMP) standards for the supplement industry however, it was not until 2007 that the FDA issued a final rule on the proposed GMP standards. This... 

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