Steviol glycosides are safe food ingredients and are permitted in foods globally. Stevia sweeteners have been studied and reviewed by leading medical, scientific, and regulatory authorities, including the Joint Expert Committee on Food Additives (JECFA), the U.S. Food and Drug Administration, and the European Food Safety Authority
- Is Stevia Safe?
- How has safety been established?
- How are stevia sweeteners metabolized?
- Regulatory Milestones for Stevia
- Can I Have Too Much Stevia?
Is Stevia Safe?
Stevia’s safety is clearly supported by extensive scientific studies and expert evaluations. In fact, clinical studies show that stevia sweeteners have no effect on either blood pressure or blood glucose response, indicating they are safe for use by all individuals including children and those with diabetes.
Stevia has been assessed in short- and long-term safety studies, including human clinical studies. The Joint FAO/WHO Expert Committee on Food Additives (JECFA), an international scientific expert committee tasked with evaluating the safety of food additives, has conducted a thorough review of all of the existing scientific data on steviol glycosides and concluded that they are safe for use in food and beverages.
How has safety been established?
What is GRAS status?
In order for a new ingredient to enter the U.S. food supply, it must either be approved by the Food and Drug Administration (FDA) as a direct food additive or determined to be Generally Recognized As Safe (GRAS). The GRAS concept was created through the 1958 amendments to the Food, Drug, & Cosmetic Act and refers to substances that are generally recognized by qualified experts to have been adequately shown to be safe under their intended conditions of use. The quality and quantity of scientific evidence required for a substance to achieve GRAS status are the same as for FDA food additive approval. In addition, the pivotal safety data to support a GRAS conclusion must exist in the public domain; this is not the case for an approved food additive, where the pivotal safety data may be privately held. Publication in a peer reviewed scientific journal is the mechanism normally used to establish that the necessary scientific information is generally available. Click here to learn more.
What is the Acceptable Daily Intake (ADI) for stevia?
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is an international scientific expert committee tasked with evaluating the safety of food additives. For each additive it evaluates, JECFA develops an Acceptable Daily Intake level (ADI), which is “An estimate of the amount of a substance in food or drinking water, expressed on a body-weight basis, that can be ingested daily over a lifetime without appreciable risk (standard human = 60 kg). The ADI is listed in units of mg [milligram] per kg [kilogram] of body weight.” Consuming more than the ADI does not mean an effect will occur because the ADI includes a wide margin of safety above what is deemed the “No Observed Effect Level.” JECFA has assigned an ADI of 4 mg/kg bw/day for steviol glycosides, expressed as steviol. Data shows that even for consumers who consume a high amount of stevia, the ADI would not be exceeded.
Based on the wealth of published research, independent scientific experts in both the U.S. and globally have concluded that stevia sweeteners are safe for all populations. Research shows the estimated intake of steviol glycosides, even among the highest amounts used by consumers, does not exceed the ADI.
Which authorities have reviewed stevia?
Stevia sweeteners have been reviewed and determined safe by scientific and regulatory authorities around the world, including:
- European Food Safety Authority (EFSA)
- Joint Expert Committee on Food Additives (JECFA)
- Food Standards Australia/New Zealand (FSANZ)
- French Agency for Food, Environmental, and Occupational Health & Safety (ANSES)
- U.S. Food and Drug Administration (FDA)
How are stevia sweeteners metabolized?
Based on scientific data, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) has concluded that stevia sweeteners are metabolized by a common pathway. Once consumed, stevia sweeteners are broken down in the gut and then rapidly eliminated from the body.
Regulatory Milestones for Stevia
United States: In response to Generally Recognized As Safe (GRAS) notifications submitted to the US Food and Drug Administration (FDA), the FDA has stated it has no questions regarding the conclusion of expert panels that stevia is GRAS for use as a general purpose sweetener in foods and beverages, excluding meat and poultry.
European Union: EFSA assessed the safety of steviol glycosides from stevia and established an Acceptable Daily Intake (ADI) of 4 mg/kg bw/day for their safe use. Based on this conclusion, the European Commission authorized the use of steviol glycosides as a sweetener in foods and beverages. It is also approved as a dietary supplement in the EU.
Canada: Stevia was approved for use as a tabletop sweetener and as a sweetener in certain food categories in 2012. For more information, visit Health Canada.
Global: Stevia sweeteners are approved for use in more than 60 other countries, including Korea, Mexico, Taiwan, China, Russia, Australia, Argentina, New Zealand, Colombia, Peru, Uruguay, Brazil and Malaysia.
Can I Have Too Much Stevia?
As consumers look to reduce the amount of added sugars and total calories in their diet, low- and no- calorie sweeteners (LNCS) may be considered to help achieve this goal. Click here to learn more about how much you can have without posing a health risk.
Carakostas M, et al. Overview: the history, technical function and safety of rebaudioside A, a naturally occurring steviol glycoside, for use in food and beverages, Food and Chemical Toxicology (2008) vol 46:S1-S10., doi: 10.1016/j.fct.2008.05.003
Joint WHO/FAO Expert Committee on Food Additives Monograph
For more information, visit the FDA GRAS process page.