The Controversial History of Stevia Regulation
For decades, stevia, a natural sweetener derived from the plant Stevia rebaudiana, has faced a complex regulatory path. In the early 1990s, the U.S. Food and Drug Administration (FDA) placed an import alert on the plant's leaves and crude extracts, citing inadequate safety data and concerns stemming from some early studies. This initial action created widespread public confusion and gave rise to the enduring myth that stevia was an unsafe, banned substance. During this period, stevia could only be marketed as a dietary supplement, a category with far less stringent safety requirements than a food additive.
The Shift Towards High-Purity Extracts
The turning point came with the introduction of purified steviol glycosides, the specific compounds responsible for stevia's sweetness. Manufacturers submitted scientific evidence to the FDA, arguing that these highly refined extracts were safe for general consumption. This was a critical distinction, separating the concentrated, purified components from the less-refined whole leaf and crude extracts. In December 2008, the FDA issued a 'no objection' letter in response to a petition, effectively granting high-purity steviol glycoside extracts Generally Recognized As Safe (GRAS) status. This landmark decision opened the door for its use as a mainstream food additive, and the market for stevia-sweetened products has grown exponentially since.
A Global Perspective on Stevia Regulation
While the U.S. regulatory story is well-documented, stevia's acceptance has varied globally.
Stevia's Path to Acceptance in the European Union
Like the U.S., the European Union initially took a cautious approach. The EU banned its use in food products in 1999 but reversed its stance in 2011 after reviewing extensive safety data. The European Food Safety Authority (EFSA) approved steviol glycosides as a food additive (E 960), confirming their safety for consumption within an acceptable daily intake (ADI).
Early Adoption and Continued Use in Japan
In stark contrast to the West, Japan was an early adopter of stevia as a sweetener, approving its use as far back as the 1970s. This long history of use and research in Japan played a significant role in accumulating the safety data that later influenced regulatory decisions in other countries.
Crude vs. High-Purity Stevia: A Critical Distinction
Understanding the difference between the forms of stevia is key to comprehending its regulatory status. Here are the main categories:
- Whole Leaf Stevia: The unprocessed, dried leaves of the Stevia rebaudiana plant. This form, along with crude extracts, remains unapproved as a food additive by the FDA due to a lack of toxicological information. Concerns exist over potential effects on kidney and reproductive function, though long-term studies are lacking.
- Crude Stevia Extracts: Less refined extracts from the stevia leaf that contain various compounds in addition to the sweet steviol glycosides. Like the whole leaf, these are not considered GRAS and have an active FDA import alert.
- High-Purity Steviol Glycoside Extracts: The purified compounds (minimum 95% purity) that have been deemed safe for consumption by regulatory bodies worldwide. These are the forms found in commercial sweeteners like Truvia and PureVia and used in a wide range of food and beverages. It is this form that is no longer banned.
Stevia vs. Other Sweeteners: A Comparison
To contextualize stevia's place in the sweetener market, here is a comparison with table sugar and a common artificial alternative.
| Feature | High-Purity Steviol Glycosides | Sucrose (Table Sugar) | Aspartame (Artificial) |
|---|---|---|---|
| Origin | Natural, plant-derived | Natural, plant-derived (sugarcane/beet) | Artificial, synthetic |
| Caloric Value | Zero calories | 16 calories per tsp | Zero calories |
| Relative Sweetness | ~200-350x sweeter than sugar | Standard benchmark (1x) | ~200x sweeter than sugar |
| Regulatory Status (US) | GRAS since 2008 | GRAS | FDA Approved (1981) |
| Taste Profile | Intensely sweet with some lingering aftertaste, can be slightly bitter | Classic, universally recognized sweetness | Intensely sweet, no aftertaste for most, can be metallic for some |
| Health Concerns | Gastrointestinal issues in high doses, interactions with certain meds possible | High caloric intake linked to obesity, diabetes, dental issues | Headaches, dizziness, side effects reported by some sensitive individuals |
Conclusion: The Final Verdict on the Ban
So, is stevia still banned? The simple answer is no, not in the way most people think. While the whole leaf and crude extracts are not approved for use as food additives, highly purified steviol glycoside extracts are widely approved and considered safe by major regulatory bodies globally, including the FDA and EFSA. The 'ban' was a regulatory action from decades past based on incomplete information, and since then, extensive research has established the safety of the purified extracts. For consumers, this means that the stevia-based products found on store shelves today are safe to consume within recommended daily limits. FDA GRAS Notice for Steviol Glycosides