Stevia's path from a South American herbal remedy to a global sweetener is paved with regulatory hurdles and controversy. While its use has been widespread in Japan since the 1970s, Western regulators took a much more cautious approach. This disparity stems from differing regulatory philosophies and market pressures that have historically painted stevia as a potential health risk, despite decades of safe use in other regions.
The Early Bans and Regulatory Scrutiny
In the late 20th century, food regulatory agencies in the U.S. and Europe, including the U.S. Food and Drug Administration (FDA) and the European Commission, took a highly restrictive stance on stevia. These bans were primarily based on early, flawed studies, as well as an overall lack of comprehensive toxicological information on crude stevia extracts and the whole leaf.
- U.S. FDA (1991): The FDA issued an import alert banning stevia leaves and crude extracts as food additives, citing inadequate toxicological information. The ban was largely influenced by questionable studies that raised safety concerns, some allegedly funded by the artificial sweetener industry to protect its market share.
- European Commission (1999): The EU similarly banned stevia for use in food products, classifying it as a "Novel Food" requiring extensive pre-market safety evaluation. Early animal studies suggesting risks to the reproductive system and a weak link to cancer at high doses fueled this cautionary approach, even though these findings were later dismissed or deemed irrelevant to human consumption at normal levels.
The Crucial Distinction: Crude vs. Purified Extracts
A critical element in understanding stevia's regulatory journey is the difference between the whole leaf or crude extracts and the highly purified steviol glycosides (like Rebaudioside A) that are now widely approved.
- Crude extracts and the whole leaf: For regulatory bodies like the FDA, the whole stevia leaf and less-refined extracts represent an unknown. There is a lack of sufficient data on the potential long-term effects and toxicity of all the various compounds found in the natural leaf. Because of this, regulators classify them differently and have often restricted their use in foods and beverages.
- Highly purified steviol glycosides: These are the isolated, intensely sweet compounds, like Reb-A, that have undergone extensive testing and purification. Manufacturers were able to submit detailed data on these specific compounds, leading to widespread approval. The purification process ensures consistent quality and purity, addressing earlier toxicological concerns.
Regulatory Timelines: Reversals and Current Status
| Region | Initial Restriction | Reversal/Approval | Current Status (Purified Stevia Extracts) |
|---|---|---|---|
| United States | 1991 FDA Import Alert on crude stevia. | 1995 (allowed as supplement), 2008 (GRAS status for purified Reb-A). | Approved as a food additive (GRAS), but crude extracts are still restricted. |
| European Union | 1999 ban as "Novel Food". | 2011 approval of steviol glycosides as food additive. | Approved as a food additive (E960). |
| Japan | Never banned. | N/A | Used since the 1970s; fully approved. |
| Canada | Restricted until 2012. | 2012 approval of steviol glycosides. | Approved as a food additive. |
| Australia/New Zealand | Restricted until 2008. | 2008 approval of steviol glycoside extracts. | Approved as a food additive. |
Potential Health Concerns and Drug Interactions
While highly purified stevia extracts are generally regarded as safe by major health organizations, a few potential health considerations and side effects warrant mentioning. It is important to note that many of these are associated with raw stevia or occur with very high consumption.
- Digestive Issues: Some stevia products, especially blends, contain sugar alcohols like erythritol, which can cause bloating, nausea, and diarrhea in sensitive individuals. The stevia extract itself is not typically the cause.
- Low Blood Pressure/Blood Sugar: Stevia may have blood pressure and blood sugar-lowering effects. While not dangerous for most people, those on medication for diabetes or hypertension should monitor their levels carefully and consult a doctor.
- Endocrine Disruption: Some early, and largely unsubstantiated, concerns existed about stevia's potential to affect hormone production, based on its molecular structure. However, current evidence does not suggest that purified stevia is an endocrine disruptor in humans at normal doses.
Conclusion: The Evolution of Stevia's Acceptance
Stevia's history of being banned or restricted in certain countries is less about an inherent danger and more about the stringent, data-driven nature of food regulation. The initial bans in the U.S. and E.U. were a result of insufficient scientific data and safety concerns surrounding crude, whole-leaf products. Once manufacturers provided rigorous, concentrated data on the safety of highly purified steviol glycosides, these restrictions were lifted. Today, high-purity stevia is widely accepted as a safe, zero-calorie sweetener worldwide. The lingering notion of a global ban is a misconception rooted in outdated regulatory measures, though certain regions, like the Russian Federation, still regulate crude extracts. Ultimately, the regulatory shift highlights a move from blanket caution towards a more nuanced, science-backed approach to novel food ingredients.
Who Regulates Stevia?
Key international and national bodies that regulate the use of stevia include the following:
- JECFA: The Joint FAO/WHO Expert Committee on Food Additives sets standards for global food safety, including acceptable daily intake (ADI) for steviol glycosides.
- U.S. FDA: The U.S. Food and Drug Administration designates highly purified steviol glycosides as "Generally Recognized as Safe" (GRAS) for use in food.
- EFSA: The European Food Safety Authority provides scientific advice and risk assessments on food additives, approving steviol glycosides for use in the EU.
- FSSAI: The Food Safety and Standards Authority of India has permitted the use of steviol glycoside as a non-nutritive sweetener.
- FSANZ: Food Standards Australia New Zealand approved all steviol glycoside extracts in 2008.
How Regulatory Bodies Assess Food Additives
Regulatory bodies worldwide generally follow a cautious, evidence-based approach to approving food additives. For a new substance like stevia, it must pass rigorous safety evaluations to ensure it poses no risk to public health. These evaluations often involve toxicology studies on animals, metabolic studies, and, when possible, human clinical trials. The historical controversy surrounding stevia highlights the challenge of applying modern, high-standard regulation to a naturally derived substance with a long history of traditional use.
Market Competition and Misinformation
Historically, market competition from established artificial sweetener companies like NutraSweet (Monsanto) likely played a role in slowing stevia's approval. Lobbying efforts and the dissemination of questionable research against stevia were tactics used to protect existing market shares. This created an environment of skepticism that regulators had to navigate, ultimately demanding more comprehensive data to confirm safety.
Navigating the Label: What to Look For
As a consumer, it's helpful to understand the different forms of stevia and how they are regulated. When purchasing stevia-sweetened products, look for labels that specify "highly purified stevia extract" or "steviol glycosides" to ensure it meets the safety standards set by health authorities. Be aware that other components in blends, like sugar alcohols, may cause side effects for some individuals.
In recent years, biotechnological methods have been developed to produce steviol glycosides through fermentation, offering a more sustainable and cost-effective alternative to traditional plant extraction. This innovation addresses some of the supply chain and quality issues that have plagued the stevia market historically.
By understanding the complex interplay of science, regulation, and market forces, consumers can make informed choices about stevia and other sweeteners. Stevia's journey from a restricted substance to a globally approved one serves as a powerful case study in the evolution of food safety standards and consumer demand for natural alternatives.
Conclusion
The perception that stevia is banned in some countries is a legacy of past regulatory caution and not an accurate reflection of its current, widespread legal status. While historical bans in the US and Europe were based on inconclusive early studies and a lack of data on crude extracts, both regions have since approved highly purified steviol glycosides. The key takeaway is the distinction between the unprocessed stevia leaf, which remains unapproved for food use in many places, and the refined, extensively tested steviol glycoside extracts that dominate today's market. This evolution demonstrates that as scientific evidence accumulated, so too did regulatory acceptance, solidifying purified stevia's place as a safe alternative to sugar for billions of consumers globally.
