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BOX 1-3
Regulation of Stevia Under the Dietary Supplement and Health Education Act (DSHEA) Versus as a Food Additive

The status of the botanical stevia illustrates how the different starting assumptions for dietary supplements and for food additives, based on the FDCA and its amendments, result in different regulatory decisions. Stevia leaves are a product of Brazil and Paraguay, and stevia, or its extract, stevioside, has been in use in other countries, such as Japan, but not in the United States. It is described as a “natural” noncaloric sweetener and is discussed as an alternative to other non-nutritive sweeteners, such as saccharin and aspartame. Studies relevant to the safety of stevia include those that found reduced sperm production and testicular cell proliferation in rodents when high levels of stevia were ingested. Other experiments suggested that offspring were smaller and fewer in number when pregnant rodents ingested large amounts of steviol (a stevioside derivative). In vitro experiments indicated that steviol could be metabolized into a mutagenic compound. The FDA concluded that toxicological data on stevia was inadequate to determine safety as a food additive or to affirm its status as GRAS and, as a result, rejected food additive petitions to approve stevia (as have the European Community regulatory authorities).

However, when considered as a new dietary supplement ingredient, FDA has not found the same safety-related information on stevia to be sufficient to determine that stevia presents a significant or unreasonable risk, the standard required in order for the agency to take action to remove supplements containing it from the marketplace.

That the same information can simultaneously be insufficient to demonstrate safety when intended to be used as a food additive, while also insufficient to conclude that it presents a significant or unreasonable risk of illness or injury when used in a dietary supplement, presents an interesting dichotomy.

The result is an FDA policy to seize, as adulterated, foods for sale to which stevia leaves or stevioside have been added, unless the items are labeled as dietary supplements. That is, the starting assumption of DSHEA, that dietary supplement ingredients, like conventional foods, are safe unless proven otherwise, results in substantial differences in how the data are interpreted and applied.

SOURCE: Cardello et al., 1999; FDA, 1995; Pezzuto et al., 1985; Scientific Committee on Food, 1999; Wasuntarawat et al., 1998; Yamada et al., 1985.

included botanicals and amino acids, as well as vitamin and mineral products. This expansion during the late 1970s and the 1980s was accompanied by some reports of serious illnesses attributed to a few of the dietary supplements available at that time. In 1978, for example, an infant with colic was reportedly given a fatal dose of a potassium chloride supplement based on erroneous advice in a parenting book, despite medical knowledge that use of such doses of the supplement would induce cardiac arrest (Wetli and



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