A History of Caution and Re-evaluation
The story of stevia's journey to American grocery store shelves is one marked by careful consideration and changing scientific perspectives. Originating from the Stevia rebaudiana plant native to South America, stevia leaves have been used for centuries by indigenous peoples to sweeten foods and drinks. However, its path to widespread commercial use in the United States was far from straightforward. The initial apprehension from the U.S. Food and Drug Administration (FDA) stemmed from early, and later disputed, studies suggesting potential health risks associated with the raw leaf and crude extracts. This led to a 1991 import alert, effectively banning the substance from being marketed as a food additive.
For many years, this restriction fueled public belief that stevia was permanently banned. During this period, the product was only available as a 'dietary supplement,' preventing manufacturers from labeling it as a sweetener in foods and beverages. This regulatory hurdle created a dual market: a health-food niche for crude supplements and a large, untapped market for mainstream sweetening applications.
The Crucial Distinction: Raw Leaf vs. Purified Extracts
To understand the FDA's current position, it is essential to differentiate between the various forms of stevia. The regulatory approval is not for the whole stevia plant, but specifically for highly refined extracts called steviol glycosides.
- Whole-leaf and Crude Stevia Extracts: The raw, unprocessed leaves of the stevia plant and their crude extracts are not approved by the FDA as a food additive. This is due to inadequate toxicological information and a lack of rigorous safety testing on these specific forms.
- High-Purity Steviol Glycosides: These are extracts that have been refined to a minimum purity of 95% steviol glycosides. It is this purified form that the FDA has designated as "Generally Recognized as Safe" (GRAS). The most common of these is Rebaudioside A (Reb A), which is widely used in commercial food and drink products.
This distinction is the core reason for the confusion. The FDA never lifted the restrictions on the raw leaf but instead responded to extensive scientific data submitted by manufacturers showing the safety of the purified extracts.
The Path to GRAS Status
- Early Restrictions (1991): The FDA issued an import alert on stevia leaf and crude extracts, citing insufficient safety data.
- Dietary Supplement Use (1995): The Dietary Supplement Health and Education Act allowed for the sale of stevia as a dietary supplement, though not as a food additive.
- GRAS Notices (2008): Following safety assessments, the FDA issued a "no-objection" response to GRAS notices for highly purified steviol glycosides, such as Reb A.
- Commercialization: Major food companies like Coca-Cola and PepsiCo quickly introduced products using these purified extracts under brand names like Truvia and PureVia.
- Ongoing Oversight: The FDA continues to monitor the safety of stevia products, with additional oversight placed on non-purified forms.
Comparison of Stevia Forms and FDA Status
| Feature | Raw Stevia Leaf | Crude Stevia Extract | High-Purity Steviol Glycosides |
|---|---|---|---|
| Origin | Dried, ground stevia plant leaves | Extracted from leaves via simple methods | Highly processed extract from leaves |
| FDA Status | Not approved as a food additive | Not approved as a food additive | Generally Recognized as Safe (GRAS) |
| Available For Sale | Can be sold as a dietary supplement | Can be sold as a dietary supplement | Approved for use as a general-purpose sweetener in foods and beverages |
| Purity Level | Contains less than 95% steviol glycosides | Contains less than 95% steviol glycosides | Must be 95% or greater steviol glycosides |
| Taste Profile | Strong, sometimes bitter aftertaste | Variable, often with a bitter aftertaste | Clean, sweet taste with minimal aftertaste |
Common Concerns and Considerations
While high-purity stevia extracts are generally considered safe, some questions and concerns persist. A key issue is the presence of other ingredients in commercially available products. Brands like Truvia and PureVia often blend steviol glycosides with other additives like erythritol or dextrose to improve taste and function. These additional ingredients can potentially cause gastrointestinal issues for some people.
Furthermore, the long-term impact on the gut microbiome from non-nutritive sweeteners, including stevia, has been a topic of recent research. Some studies suggest a potential link between these sweeteners and gut flora disruption, while other research has shown no harmful effects within short-term study periods. As with any dietary ingredient, moderation is advised. For pregnant or breastfeeding women, reputable agencies confirm the safety of high-purity stevia extracts when consumed within the acceptable daily intake (ADI) limits.
Conclusion
The notion that the FDA banned stevia is an oversimplification of a much more nuanced regulatory history. The truth is that a long-standing restriction on the unprocessed, raw stevia leaf was in effect for years due to a lack of safety data. However, following extensive research and the submission of scientific evidence, the FDA granted high-purity steviol glycoside extracts—the active sweetening compounds—the "Generally Recognized as Safe" (GRAS) status in 2008. This pivotal decision paved the way for the stevia-sweetened products now ubiquitous in food and beverage markets. Consumers should remember the difference: while the raw leaf remains unapproved as a food additive, the purified extract is a safe and regulated option for sweetening.
Where to Find More Information
For additional details on the FDA's regulatory stance on stevia and other food additives, the official FDA website is a reliable source. For example, their database of high-intensity sweeteners provides up-to-date information. The International Food Information Council (IFIC) also offers valuable, easy-to-understand resources on the safety of stevia extracts for various populations.
What are steviol glycosides?
Steviol glycosides are the sweet-tasting compounds naturally found in the leaves of the Stevia rebaudiana plant. These compounds, which include Rebaudioside A, are extracted and purified to create the zero-calorie sweetener used in many food and beverage products.
Is stevia safe for diabetics?
Yes, high-purity stevia leaf extracts are considered safe for people with diabetes. They do not raise blood glucose or insulin levels and can be a beneficial alternative to sugar for managing carbohydrate intake. However, it is always important for individuals to monitor their blood sugar and consult a healthcare provider, especially if using a product that contains other added ingredients.
How can I tell if a stevia product is FDA-approved?
To ensure a product is FDA-approved, check the ingredients list for high-purity steviol glycosides, such as "stevia extract," "Rebaudioside A (Reb A)," or "steviol glycosides." The FDA has not approved whole-leaf or crude extracts for use as a sweetener in food.
Why was stevia originally banned?
Stevia was never permanently banned, but an import alert was issued by the FDA in 1991 due to early safety concerns and a lack of adequate toxicological information on the raw leaf and crude extracts. The ban was on its use as a food additive, not on the entire plant or all its uses.
Is there a link between stevia and cancer?
There is no scientific evidence to support a link between high-purity stevia extracts and cancer. Studies suggesting mutagenic effects were often based on crude extracts or high doses in lab settings and have not been replicated in real-world human consumption levels. Some research even indicates potential anti-cancer properties.
Does stevia have side effects?
Most people can consume stevia in moderation without side effects. In high amounts, some stevia products (especially those with added sugar alcohols like erythritol) can cause mild gastrointestinal issues like bloating or nausea. The acceptable daily intake (ADI) is quite high, meaning most people won't consume enough to experience issues.
Is stevia a natural sweetener?
Stevia is derived from the leaves of a plant, making it a natural-origin sweetener. However, the highly purified extracts that are FDA-approved undergo significant processing to isolate the sweet compounds, making them different from the raw leaf.
Can I grow my own stevia and use the leaves?
While you can grow the stevia plant at home, the FDA has not evaluated or approved the whole, raw leaf for use as a food sweetener. For commercial products, only the high-purity steviol glycosides are permitted. Using the leaves from your garden is different from using a regulated commercial product.
What is the difference between "stevia" and "Reb A"?
"Stevia" is a broad term that can refer to the plant, its leaves, or its extracts. "Reb A" (Rebaudioside A) is a specific, highly purified steviol glycoside derived from the stevia leaf. Most commercial stevia sweeteners use Reb A because it is the sweetest and has the least bitter aftertaste.
Does the FDA approve all sweeteners derived from the stevia plant?
No, the FDA only approves high-purity steviol glycoside extracts that have been rigorously tested and deemed safe under the GRAS process. Other forms, such as crude extracts or whole leaves, are not approved for use as food additives.
