How many non-nutritive sweeteners have been approved for use by the FDA?

January 9, 2026 •

4 min read

Over the past 50 years, the U.S. Food and Drug Administration (FDA) has approved six specific non-nutritive sweeteners as food additives, while also accepting the "Generally Recognized As Safe" (GRAS) status for several others. This regulatory complexity often causes confusion for consumers trying to understand which sugar substitutes are permitted in the American food supply. The distinction between these two pathways—formal food additive approval and GRAS notification—is crucial for manufacturers and transparent labeling.

Quick Summary

The FDA permits several non-nutritive sweeteners, including six formally approved as food additives and others deemed Generally Recognized As Safe (GRAS). The approval process ensures safety through scientific review, distinguishing between high-intensity synthetic sweeteners and naturally derived options like monk fruit and stevia extracts.

Key Points

Six Formally Approved Sweeteners: The FDA has formally approved saccharin, aspartame, acesulfame potassium (Ace-K), sucralose, neotame, and advantame as food additives following a comprehensive safety review.
GRAS for Natural Sweeteners: Sweeteners like high-purity steviol glycosides and monk fruit extract are permitted for use under a 'Generally Recognized As Safe' (GRAS) status, based on scientific consensus.
Regulatory Distinction: The FDA has two main pathways for authorizing food sweeteners: the pre-market food additive approval process and the GRAS notification program.
Phenylketonuria Warning for Aspartame: Aspartame contains phenylalanine and requires a specific warning label for individuals with the rare genetic disorder phenylketonuria (PKU).
Crude vs. High-Purity Stevia: Only highly purified steviol glycoside extracts have GRAS status. The use of crude stevia leaf or extracts is not approved by the FDA.
Safety Standard: Both approved food additives and GRAS substances must meet the FDA's safety standard, which requires a 'reasonable certainty of no harm' for the intended use.

The Two Paths to FDA Authorization

In the United States, the Food and Drug Administration (FDA) is responsible for regulating food additives, including non-nutritive sweeteners (NNS). A sweetener can be authorized for use in the food supply through one of two primary pathways: a formal food additive petition or a Generally Recognized As Safe (GRAS) notification.

Formally Approved Food Additives

The FDA has formally approved six high-intensity, non-nutritive sweeteners as food additives after a rigorous, pre-market review process. The manufacturer must submit extensive data to the FDA to demonstrate the ingredient is safe under the proposed conditions of use. The agency reviews all scientific studies, including toxicological assessments, to ensure there is a "reasonable certainty of no harm". These approvals are published in the Code of Federal Regulations, and the agency also establishes an Acceptable Daily Intake (ADI) level for each.

The six formally approved non-nutritive sweeteners are:

Saccharin: Discovered in 1879, it was regulated as a food additive in 1977. It is 200 to 700 times sweeter than sugar.
Aspartame: First approved in 1974, it is approximately 200 times sweeter than sugar. It is not heat-stable and contains phenylalanine, requiring a warning label for those with phenylketonuria (PKU).
Acesulfame Potassium (Ace-K): Approved in 1988, this heat-stable sweetener is about 200 times sweeter than sugar and is often blended with other sweeteners to improve taste.
Sucralose: Approved in 1998 for specific uses and as a general-purpose sweetener in 1999, it is about 600 times sweeter than sugar and is heat-stable for baking.
Neotame: Approved in 2002, neotame is 7,000 to 13,000 times sweeter than sugar and is also heat-stable.
Advantame: The most recent approval, granted in 2014, with a sweetness intensity around 20,000 times that of sugar.

Generally Recognized as Safe (GRAS) Status

Some non-nutritive sweeteners are not formally approved food additives but are considered safe based on a history of use or extensive scientific evidence available to the public. In these cases, a company can voluntarily submit a GRAS notice to the FDA, detailing the basis for their safety conclusion. The FDA then reviews this notice and responds with a letter indicating whether it has any questions regarding the GRAS determination. This pathway is common for naturally derived sweeteners.

GRAS non-nutritive sweeteners include:

High-Purity Steviol Glycosides: Derived from the stevia plant, these are used as general-purpose sweeteners. The FDA has issued 'no objection' letters for the GRAS status of highly purified extracts, but has not approved crude stevia leaf or crude extracts.
Monk Fruit (Luo Han Guo) Extract: Derived from a fruit native to southern China, this extract has been granted GRAS status for its use as a general-purpose sweetener.
Thaumatin: A protein-based sweetener isolated from the West African Katemfe fruit, thaumatin has received GRAS 'no objection' letters from the FDA.

Comparison of FDA-Authorized Sweeteners

This table outlines the key differences between the major non-nutritive sweeteners permitted by the FDA, including their regulatory status, sweetness intensity relative to table sugar (sucrose), and general properties.


Sweetener	Regulatory Status	Relative Sweetness	Heat Stability	Common Uses
Saccharin	Formally Approved	200–700x	Good	Beverages, processed foods, tabletop
Aspartame	Formally Approved	~200x	Poor	Diet drinks, gum, tabletop (Equal)
Acesulfame K	Formally Approved	~200x	Good	Baked goods, confections, drinks
Sucralose	Formally Approved	~600x	Good	Baked goods, beverages, tabletop (Splenda)
Neotame	Formally Approved	7,000–13,000x	Good	General-purpose, baking, beverages
Advantame	Formally Approved	~20,000x	Good	General-purpose, flavor enhancer
High-Purity Steviol Glycosides	GRAS Status	200–400x	Good	Beverages, tabletop (Truvia)
Monk Fruit Extract	GRAS Status	100–250x	Good	Beverages, tabletop (Monk Fruit in the Raw)
Thaumatin	GRAS Status	2,000–3,000x	Good	Confectionery, beverages

Regulation and Safety Standards

The FDA's approval process is a multi-step procedure that thoroughly evaluates a sweetener's safety. Manufacturers must submit a food additive petition containing all relevant information and scientific data, including an assessment of potential consumer exposure. The FDA then conducts an independent review to ensure the substance is safe under its intended conditions of use. This is how an Acceptable Daily Intake (ADI) is established for formally approved additives. For GRAS substances, the scientific standard is the same—a finding of "reasonable certainty of no harm" based on publicly available information. However, companies are not required to notify the FDA of their GRAS determination, though most do so voluntarily through the GRAS Notification Program.

Concerns about sweeteners, such as the initial link between saccharin and bladder cancer in rats, have prompted re-evaluations and subsequent changes to regulations, demonstrating the system's ability to adapt based on new scientific evidence. The process is designed to be ongoing, with the FDA continuing to monitor scientific literature for emerging safety data.

Conclusion

In summary, the FDA permits the use of several non-nutritive sweeteners, with six having undergone formal pre-market approval as food additives: saccharin, aspartame, acesulfame potassium, sucralose, neotame, and advantame. Additionally, several others, such as high-purity steviol glycosides and monk fruit extract, are permitted for use based on Generally Recognized As Safe (GRAS) determinations. Both regulatory pathways are built upon a foundation of scientific safety evaluation, ensuring that consumers have a variety of safe, low-calorie sweetening options. It is important for consumers to distinguish between these different types of authorization and to consult ingredient labels for specifics.

Frequently Asked Questions

An FDA-approved sweetener undergoes a formal, rigorous pre-market review process initiated by a manufacturer's food additive petition. A GRAS (Generally Recognized As Safe) sweetener, in contrast, is an ingredient for which qualified experts have publicly established a consensus of safety, and does not require pre-market FDA approval, although companies often notify the agency.

No, the FDA has not approved whole-leaf stevia or crude stevia extracts for use as a sweetener in foods. Only high-purity steviol glycoside extracts, which have been determined to be Generally Recognized As Safe (GRAS), are permitted.

Aspartame is safe for the general population but should be avoided or restricted by individuals with the rare genetic disorder phenylketonuria (PKU). Foods containing aspartame must have a label warning about the presence of phenylalanine, which people with PKU cannot metabolize properly.

Yes, the FDA prohibits the use of cyclamates and their salts in the United States. Additionally, whole-leaf stevia and crude stevia extracts are not permitted for use as sweeteners.

The GRAS (Generally Recognized As Safe) designation applies to substances with a history of safe use in food or those supported by scientific evidence publicly available to qualified experts. Many naturally derived sweeteners like monk fruit extract fall under this category, bypassing the formal, time-consuming food additive petition process.

An Acceptable Daily Intake (ADI) is an estimated amount of a substance that can be safely consumed daily over a lifetime. The FDA establishes an ADI for each formally approved food additive, based on extensive safety reviews, to ensure that typical consumption levels remain well below any dose that could cause adverse effects.

Several FDA-authorized non-nutritive sweeteners are heat-stable and suitable for baking, including acesulfame potassium, sucralose, neotame, and advantame. However, aspartame is not heat-stable and loses its sweetness when exposed to high temperatures.