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FDA Should Rescind Outdated Import Alert on Stevia

The US Food and Drug Administration (FDA) should rescind its 1991 Import Alert on the South American herb stevia (Stevia rebaudiana, Asteraceae). The agency has held that stevia is an “unsafe food additive” and has banned its importation for use as a food sweetener. There are now 2 exceptions: If stevia is labeled for use as a dietary supplement or if the safety of herb or an extract has been established per the criteria of the GRAS (generally recognized as safe) self-affirmation process.

In light of increasing evidence of the safety of several types of stevia extracts, FDA’s policy appears unreasonable and illogical; it does not reflect the current scientific and medical information supporting the safety of stevia when consumed in relatively small amounts in foods to give them a sweet taste.

Since 1995 FDA has allowed stevia to be imported into the United States only if it is labeled for use in dietary supplements because the Dietary Supplement Health and Education Act of 1994 specifically stipulates that dietary ingredients (DI) are not food additives. After passage of DSHEA, the SunRider Corporation petitioned the FDA to allow stevia imports if they were intended for sale in DIs. FDA agreed.

In 2007 a tectonic shift occurred in the stevia market which may be viewed by historians as the beginning of a new era for stevia, and the sweetener industry—Coca Cola and agribusiness giant Cargill announced a joint venture to produce a proprietary stevia extract. In May 2008 Coke and Cargill announced the results of numerous animal studies and human clinical trials on its proprietary stevia extract, demonstrating its safety.

A month prior, stevia pioneer Wisdom Natural Brands completed it GRAS self-affirmation, conducted by GRAS Associates and confirmed by the Life Sciences Research Organization. Wisdom began marketing SweetLeaf® stevia as a sweetener, foregoing the “dietary supplement” labeling under which stevia has been subject for 13 years.

Other big companies are getting into stevia, including coke’s chief rival Pepsi. Corn Products International has purchased a South American stevia extraction plant.

After several years of intensive research on stevia safety, in June 2008 the Joint Expert Committee on Food Additives of the United Nations Food and Agriculture Organization and the World Health Organization concluded that stevia extract containing 95% stevia glycosides was safe for human use in the range of 4mg/kg body weight per day. This paves the way for more regulatory approvals around the world.

A scientific book on stevia published in 2000, edited by plant-sweetener expert Dr. Doug Kinghorn, reviewed the scientific evidence until then, concluding that stevia is safe for human use. Kinghorn believes that additional research during the intervening decade continues to support stevia safety.

The FDA’s import alert is an outdated policy, based on the market and regulatory conditions prevalent in the late 1980s. FDA could take refuge under the provisions of its food additive laws, in which a new food additive must be proven safe before FDA will allow it onto the market. An ingredient without demonstrated toxicity must undergo pre-market approval, which presumes that it is unsafe before safety is demonstrated unless the ingredient was known to be commonly used in foods prior to 1958.

The common use in food exemption is precisely the tactic that the American Herbal Products Association (AHPA), the leading trade association dealing with issues related to herbs, employed in a petition it filed with FDA in 1992. AHPA stated that stevia was commonly used in foods before 1958 (elsewhere, not in the US) and thus should be exempt from FDA’s regulation as a food additive requiring premarket approval. FDA responded by saying that if the industry believed that stevia was so safe, it should file a petition to affirm the GRAS status.

AHPA did so, but FDA refused to accept the petition, so it was never posted for public comment. FDA said it needed more information to accept the petition, and AHPA supplied such information, but FDA still refused to publish it. In 1994 tea maker Thomas J. Lipton Co. filed its own GRAS petition with FDA, presumably based on basically the same data included in the AHPA petition. Again, FDA refused to accept the petition.

If FDA were to rescind it stevia Import Alert, importers of stevia would still have the burden of confirming safety for use in conventional foods by conducting a GRAS review.

There is currently a compelling public health imperative for safe, low-cost, non-caloric sweeteners. The current rates of obesity and associated medical problems of diabetes and cardiovascular disease suggest a bright future for stevia. In the public’s interest, FDA should rescind its outdated Import Alert.