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Is Stevia Still Banned by the FDA? A Look at Its Approval Status

4 min read

Over a decade ago, the Food and Drug Administration (FDA) initially raised concerns about stevia, causing many consumers to question its safety. However, the current regulatory landscape is much different, with purified stevia extracts no longer banned but classified as Generally Recognized as Safe (GRAS).

Quick Summary

This article examines the different forms of stevia and their respective regulatory statuses with the FDA, detailing the historical context, the distinction between crude and purified versions, and the current 'Generally Recognized as Safe' (GRAS) designation for high-purity extracts.

Key Points

  • No, stevia is not banned: The FDA granted 'Generally Recognized as Safe' (GRAS) status to highly purified stevia extracts in 2008.

  • Raw stevia leaves are not approved: The ban still applies to whole stevia leaves and crude stevia extracts due to insufficient toxicological data.

  • Purity is key: Only stevia products with a minimum of 95% steviol glycosides are considered GRAS for use as sweeteners.

  • Different forms have different tastes: High-purity extracts like Reb M and Reb D offer a cleaner, less bitter taste than less-refined versions.

  • Potential side effects are minor: Some individuals may experience digestive issues from added sugar alcohols in blended products, but pure stevia is generally well-tolerated.

  • It's used worldwide: Stevia has been used for centuries in South America and is approved as a sweetener in many countries, including Japan and the European Union.

In This Article

The Confusing History of Stevia and the FDA

The journey of the natural, plant-based sweetener known as stevia to mainstream acceptance in the United States is marked by a complex history involving regulatory scrutiny and evolving scientific understanding. Hailing from the leaves of the Stevia rebaudiana plant, native to South America, stevia was a traditional sweetener used for centuries in regions like Paraguay and Brazil. Yet, despite its long history of use abroad, its introduction to the U.S. market in the late 20th century was met with intense opposition, largely from competing artificial sweetener manufacturers.

In 1991, the Food and Drug Administration (FDA) issued an import alert on stevia leaves and crude stevia extracts, citing inadequate toxicological information to prove their safety as a food additive. This effectively banned stevia from being marketed as a sweetener in the U.S.. The action was a major setback for the burgeoning natural products market, leading to widespread consumer confusion and skepticism about the safety of stevia, a misunderstanding that persists for some even today.

The Shift to Generally Recognized As Safe (GRAS) Status

Over the years, scientific research and advocacy efforts from major food and beverage companies helped pave the way for a change in stevia's regulatory status. The turning point came in 2008, when the FDA responded with "no objection" to several Generally Recognized as Safe (GRAS) notices submitted by manufacturers. This marked a crucial shift, classifying high-purity steviol glycosides—the sweet compounds extracted and purified from the stevia leaf—as safe for use as a general-purpose sweetener in foods and beverages.

Today, the use of purified stevia extract is no longer banned and is widely used in countless products, from soft drinks and yogurt to baked goods and tabletop sweeteners. This approval was specifically for the highly-refined compounds, like Rebaudioside A (Reb A) and Rebaudioside D (Reb D), which must meet a minimum purity standard of 95% total steviol glycosides.

The Continuing Ban on Raw Stevia

It's important to recognize that the FDA's approval does not extend to all forms of stevia. The import alert on whole stevia leaves and crude stevia extracts remains in effect, and these products are still not permitted to be marketed as sweeteners. The FDA maintains that it lacks sufficient toxicological information to determine the safety of these less-processed forms.

For consumers, this creates a critical distinction: the pure white powder or clear liquid stevia extract found on grocery store shelves is considered safe, but the green, whole-leaf stevia often found in herbal or dietary supplement sections is not approved for use as a food additive. While some people may grow the plant for personal use or use the raw leaves as a dietary supplement, the FDA has not sanctioned its use as a sweetener in commercial food products.

Comparison: Purified Stevia vs. Raw Stevia

Feature Purified Stevia Extract (GRAS) Raw Stevia (Not Approved)
FDA Status Generally Recognized as Safe (GRAS) Banned as a food additive
Purity Minimum 95% steviol glycosides Contains crude, unrefined compounds
Common Forms Powder, liquid drops, granules Dried green leaves, crude extracts
Regulatory Path Accepted through GRAS notice process FDA cites lack of safety data
Usage General-purpose sweetener in foods and drinks Can be sold as a dietary supplement
Taste Profile Clean, sugar-like taste (depending on specific glycosides like Reb M) Often has a bitter or licorice-like aftertaste
Commercial Availability Widely available in supermarkets Restricted and not intended for commercial food use

Potential Side Effects and Considerations

While high-purity stevia is considered safe, some users may experience side effects, particularly if consuming it in large quantities. Some stevia products are blended with sugar alcohols, such as erythritol, which can cause gastrointestinal issues like bloating, gas, or nausea in sensitive individuals. As with any substance, it's essential to monitor your own body's reaction. Additionally, those taking medication for conditions like diabetes or high blood pressure should consult a healthcare provider, as stevia can affect blood sugar and blood pressure levels.

Types of Purified Stevia

Not all purified stevia extracts are created equal. Different steviol glycosides contribute different taste profiles and sweetness intensities. Common types include:

  • Rebaudioside A (Reb A): The most common and abundant glycoside, known for its intense sweetness, though some find it has a slight aftertaste.
  • Rebaudioside M (Reb M): Often praised for its cleaner, more sugar-like taste with less aftertaste, though it's typically more expensive.
  • Rebaudioside D (Reb D): Offers a rapid onset of sweetness with a clean profile, making it a desirable blending component.

The Current Status and the Future

Today, the status of stevia is clear: the ban on highly purified stevia extracts is long gone, replaced by a GRAS designation that has allowed it to become a staple in the food and beverage industry. Meanwhile, the ban on raw stevia leaves and crude extracts remains, a cautionary measure by the FDA until further toxicological data is available. For consumers, this means enjoying the benefits of a zero-calorie, natural-origin sweetener, but with the necessary awareness of the different forms and their distinct regulatory standings. As research continues and consumer demand for natural alternatives grows, the stevia market will likely continue to innovate with new purified versions and refined blending techniques.

Conclusion

The FDA's regulatory history with stevia is a story of nuance, not outright prohibition. The initial 1991 ban was a response to insufficient data on crude stevia, but subsequent research and formal GRAS notifications led to the approval of highly purified steviol glycoside extracts in 2008. Therefore, the answer to the question "Is stevia still banned by the FDA?" is a definitive no, but with a critical clarification: only the purified, high-purity extracts are approved as general-purpose sweeteners, while raw and crude versions remain off the market as food additives. This distinction is key for anyone trying to understand stevia's place in modern food and health. For more official information, visit the FDA's page on sweeteners.

Frequently Asked Questions

The FDA banned stevia leaves and crude extracts in 1991 due to a lack of adequate toxicological information to confirm their safety as a food additive.

The stevia in stores is a highly purified extract (at least 95% pure) and has GRAS status from the FDA. Raw stevia, like the whole leaf, is not approved for commercial food use.

Yes, high-purity stevia extract is considered safe for most people when consumed in moderate amounts, and the FDA has deemed it 'Generally Recognized as Safe' (GRAS).

Some stevia products blended with sugar alcohols can cause digestive issues like bloating or gas in sensitive individuals. Pure stevia is generally well-tolerated.

Yes, high-purity stevia is a zero-calorie sweetener that does not impact blood sugar levels, making it a suitable sugar substitute for those with diabetes.

Yes, there are different steviol glycosides like Reb A, Reb M, and Reb D, which offer varying taste profiles. Reb M, for example, is known for having a cleaner, more sugar-like taste.

While it's not illegal to grow stevia for personal use, the FDA has not approved raw stevia leaves as a food additive, citing a lack of safety data.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.