Stevia (Leaf & Crude Extracts)

Why was stevia banned in 1991?

Stevia comes from the leaves of Stevia rebaudiana, a shrub native to Paraguay and Brazil, where people have sweetened drinks with it for centuries. By the late 1980s, US companies were importing the leaves and crude extracts as a natural, zero-calorie sweetener.

On May 17, 1991, the FDA issued an import alert that let border officials detain stevia leaves, crude stevia extracts and foods containing them without inspection. The agency’s position was simple: stevia had never been approved as a food additive, and nobody had shown it was safe. In the FDA’s eyes, that made it an unsafe food additive.

Three concerns sat behind that decision:

• Possible cancer risk. Early lab studies suggested that steviol, a compound the body forms when it breaks stevia down, could damage genetic material under certain test conditions. Damage of that kind can be an early warning sign for cancer.
• Fertility questions. Older animal studies, and reports of stevia’s traditional use in Paraguay, raised questions about effects on reproduction.
• Missing safety data. There were no long-term human studies, no agreed safe daily dose and no approval file from any manufacturer.

Most of the worrying results came from very high doses given to rats, far beyond what a person would eat. Later research did not confirm them at normal intake levels. In 1991, though, the data simply was not there yet.

Timeline: how stevia went from banned to “partly allowed”

Is stevia still banned in the US today?

Partly. The FDA now treats two kinds of stevia very differently. Highly purified steviol glycosides, at least 95% pure, have gone through the FDA’s GRAS (“generally recognized as safe”) notification process many times, and the agency has not objected to them. Whole-leaf stevia and crude extracts have not, so they are still covered by the 1991 import alert.

This is why you can buy a box of stevia packets in any grocery store, while a bag of dried stevia leaves is usually sold as a “dietary supplement” or “herbal tea” rather than a sweetener.

What is Import Alert 45-06?

An import alert is an instruction to FDA staff at US ports of entry. Import Alert 45-06 tells them they may detain shipments of stevia leaves, crude stevia extracts and foods containing them “without physical examination”. In practice, the importer has to prove the product is legal before it can enter the country, instead of the FDA having to prove it is unsafe.

The alert has never been withdrawn. When the FDA cleared purified extracts in 2008, it did so through separate GRAS notices for specific high-purity ingredients, and left the old alert in place for everything else. That is why stevia can be “approved” and “banned” in the US at the same time: the answer depends on how refined the product is and what it is sold as.

For small brands, this matters. A company that imports raw stevia leaf and markets it as a sugar replacement risks having shipments held at the border, while a company selling a 95%-pure extract under a GRAS notice does not.

Why did only purified stevia get approved?

Three practical reasons explain why regulators cleared the refined extracts but not the leaf:

• Known chemistry. A 95%-pure extract is mostly one or two compounds, such as rebaudioside A. Scientists can test exactly those compounds. A dried leaf contains hundreds of substances, and its makeup changes from plant to plant.
• Taste. Early stevia powders were ground leaves with a bitter, liquorice-like aftertaste, mostly from a compound called stevioside. Isolating rebaudioside A gave food companies a cleaner, more sugar-like sweetness.
• Money behind the paperwork. GRAS notices cost time and money. Large companies such as Cargill (Truvia) and Whole Earth Sweetener Company with PepsiCo (PureVia) funded the safety files for their own purified ingredients. Nobody did the same for the raw leaf.

That is why most stevia you see today, in tabletop packets, diet sodas, flavoured waters and yogurts, is a purified extract rather than the plant itself.

Is stevia banned anywhere today?

Purified steviol glycosides are now approved in the US, the European Union, Canada, Japan, China, Australia and many other markets. What still differs from country to country is which forms are allowed and how much can go into each type of food. In the US, the leaf and crude extracts remain blocked as sweeteners. In the EU, the authorisation covers the purified E960 additive, and each food category has its own maximum level. So the honest answer is: stevia is not fully banned anywhere major, but it is still restricted almost everywhere in some form.

Why was stevia banned in Europe?

Europe’s story runs on a similar track. In 2000, the European Commission refused an application to sell the stevia plant and its dried leaves as a “novel food”, a category for foods not widely eaten in the EU before 1997. Regulators said the safety evidence was not strong enough.

The turning point came after the European Food Safety Authority reviewed newer studies and set a safe daily intake for steviol glycosides. In late 2011, the EU approved purified steviol glycosides as food additive E960. As in the US, that approval covers the purified extracts, not the raw leaf as a general food ingredient.

How the US, EU, Japan and Canada compare

Did the artificial sweetener industry get stevia banned?

This is one of the most repeated claims online. The idea is that makers of aspartame and other artificial sweeteners pushed the FDA to block a natural, cheap competitor.

Here is what can and cannot be said. The 1991 action reportedly followed a complaint whose source was never made public, and the timing came while aspartame dominated the US sweetener market. Critics, including the American Botanical Council, later called the import alert outdated and asked the FDA to lift it. But no public document shows that a sweetener company requested the ban, and the FDA’s stated reasons were the safety gaps described above. The fairest verdict: the theory is plausible to many people, but unproven.

Is stevia safe now?

According to the FDA, purified steviol glycosides have been studied extensively, including long-term and human clinical studies that showed no adverse effects at normal intake. International experts at JECFA set an acceptable daily intake of 4 mg per kg of body weight, measured as steviol. The FDA estimates a 60 kg (132 lb) adult would need about 27 packets of a Reb A sweetener a day to reach that limit.

One more point is worth knowing. In May 2023 the World Health Organization advised people not to rely on non-sugar sweeteners, stevia included, for weight control. That guideline is about weight loss, not about stevia being unsafe, and it did not change stevia’s legal status anywhere.

Whole-leaf and crude extracts are a different matter: they have not gone through the same review, which is exactly why they remain restricted. This page explains the legal history and is not medical advice. If you have a health condition, are pregnant or take medication, check with a doctor before changing sweeteners.

Stevia is one of several food ingredients whose legal status depends on which side of the Atlantic you are on. Browse more cases in our list of banned foods around the world, see everything else restricted in America on the USA banned list, or read how a common stomach remedy ended up in a similar position in our entry on Pepto-Bismol in France.