Understanding What Sugar Substitutes Are Approved by the FDA

According to research, approximately 41% of adults regularly incorporate low-calorie sweeteners into their diets. Understanding what sugar substitutes are approved by the FDA is crucial for making informed decisions about these widely used ingredients, which include artificial, natural-origin, and sugar alcohol options.

Quick Summary

This article details the various sugar substitutes permitted for use by the FDA, including high-intensity artificial sweeteners, natural-origin GRAS substances, and sugar alcohols. It explains the different regulatory pathways and provides a comparison of key characteristics for each type.

Key Points

• Two Approval Pathways: The FDA approves sweeteners either through a formal food additive petition or by acknowledging a Generally Recognized as Safe (GRAS) determination.

• Six FDA-Approved Food Additives: Saccharin, Acesulfame Potassium (Ace-K), Aspartame, Sucralose, Neotame, and Advantame are the six high-intensity sweeteners approved as food additives.

• Natural-Origin GRAS Sweeteners: High-purity steviol glycosides and monk fruit extract have been successfully submitted through the GRAS notification process.

• Important Safety Considerations: Individuals with PKU must avoid or restrict aspartame, and while saccharin was once a concern, human studies have shown its safety.

• Sugar Alcohols Offer Options: Polyols like erythritol and xylitol are permitted sugar substitutes with fewer calories and can be used in sugar-free products.

• Continued FDA Oversight: The FDA monitors new scientific evidence related to sweeteners and has established Acceptable Daily Intakes (ADIs) for many to ensure safe consumption levels.

The FDA's Approval Process for Sweeteners

The U.S. Food and Drug Administration (FDA) regulates sweeteners and other food ingredients through two primary pathways. The first is the formal food additive petition process, which requires premarket review and approval based on extensive scientific safety studies. The second is a determination that a substance is "Generally Recognized as Safe" (GRAS) by qualified experts based on publicly available scientific data. Companies can make an independent GRAS determination or voluntarily submit their findings to the FDA for review.

For any substance to be approved, the FDA must conclude with "reasonable certainty of no harm" under the intended conditions of use. This rigorous process ensures a high level of safety for consumers.

High-Intensity Sweeteners Approved as Food Additives

The FDA has formally approved six high-intensity sweeteners as food additives. These are typically much sweeter than table sugar, meaning only tiny, non-caloric amounts are needed.

• Saccharin: One of the oldest artificial sweeteners, discovered in 1879, with a sweetness 200–700 times that of sugar. After safety concerns based on rat studies in the 1970s, subsequent human studies demonstrated no link to cancer, and the warning label was eventually removed. It is heat-stable but can have a metallic aftertaste.
• Acesulfame Potassium (Ace-K): Approved in 1988, Ace-K is about 200 times sweeter than sugar and is often combined with other sweeteners to mask a slight bitter aftertaste. It is heat-stable, making it suitable for baked goods.
• Aspartame: A widely-used artificial sweetener, approved in 1974, that is approximately 200 times sweeter than sugar. It is not heat-stable and should be avoided by individuals with phenylketonuria (PKU), a rare genetic disorder, due to its phenylalanine content.
• Sucralose: Derived from sucrose by replacing three hydrogen-oxygen groups with chlorine atoms, sucralose is about 600 times sweeter than sugar. It was approved in 1998 and is known for its excellent heat stability, making it popular for baking.
• Neotame: Approved in 2002, neotame is structurally similar to aspartame but is 7,000–13,000 times sweeter than sugar. Unlike aspartame, it does not pose a risk to individuals with PKU and is heat-stable.
• Advantame: The most recent high-intensity sweetener approved as a food additive in 2014. It is extremely potent, about 20,000 times sweeter than table sugar, and is also safe for those with PKU.

Natural-Origin Sweeteners with GRAS Status

In addition to food additives, the FDA has evaluated and issued "no objection" responses to GRAS notifications for several plant- and fruit-based sweeteners. This signifies that the agency has no questions regarding the notifier's conclusion that the substance is safe under its intended conditions of use.

• High-purity steviol glycosides: Extracted from the leaves of the stevia plant, these are 200–400 times sweeter than sugar. While highly purified extracts are considered GRAS, whole-leaf stevia and crude stevia extracts are not.
• Monk fruit extract: Also known as Luo Han Guo, this extract contains mogrosides that are 100–250 times sweeter than sugar. The FDA has not objected to GRAS notifications for its use as a general-purpose sweetener.
• Thaumatin: A protein extracted from the katemfe fruit, thaumatin is 2,000–3,000 times sweeter than sugar and is used as both a sweetener and a flavor modifier.

Sugar Alcohols

Sugar alcohols, or polyols, are another class of sweeteners that are permitted for use. The FDA does not regulate them as food additives, as they are not artificially synthesized. Examples include sorbitol, xylitol, mannitol, and erythritol.

• Characteristics: Sugar alcohols have a sweetness ranging from 25% to 100% of table sugar. They contain fewer calories and are often used in sugar-free gums and candies. They do not promote tooth decay and generally do not raise blood glucose levels significantly.
• Potential Side Effects: Consuming large quantities of sugar alcohols may cause mild gastrointestinal discomfort, such as bloating, gas, or diarrhea, due to incomplete digestion.

Comparison of FDA-Approved Sweeteners

Sweetener	Type	Caloric Value	Heat Stability	Common Uses
Saccharin	Artificial	Non-caloric	Stable	Tabletop, beverages, processed foods
Acesulfame K	Artificial	Non-caloric	Stable	Beverages, baked goods, dairy
Aspartame	Artificial	4 kcal/g (negligible)	Not stable	Soft drinks, gum, cereals, instant coffee
Sucralose	Artificial	Non-caloric	Stable	Baked goods, beverages, dairy, frozen desserts
Neotame	Artificial	Non-caloric	Stable	Baked goods, beverages, dairy, frozen desserts
Advantame	Artificial	Non-caloric	Stable	Baked goods, beverages, frozen desserts
Steviol Glycosides	Natural-Origin	Non-caloric	Stable	Beverages, tabletop sweeteners
Monk Fruit Extract	Natural-Origin	Non-caloric	Stable	Beverages, tabletop sweeteners
Sugar Alcohols	Natural/Synthetic	Lower than sugar	Varies	Sugar-free gum, candy, baked goods

FDA Monitoring and Consumer Considerations

The FDA establishes an Acceptable Daily Intake (ADI) for each food additive, representing the amount that can be consumed safely over a lifetime. For many GRAS substances, an ADI is not specified but is still considered safe at anticipated consumption levels.

Beyond initial approval, the FDA continuously monitors the safety of sweeteners by reviewing new scientific literature and international safety evaluations. For instance, recent studies and reviews have focused on potential long-term effects on the gut microbiome, with the FDA confirming it will continue to monitor such information.

Conclusion

The FDA's approval process for sugar substitutes is a multi-step process that relies on rigorous scientific review to determine safety. The variety of approved sweeteners—from artificial high-intensity products like sucralose and aspartame to natural-origin options like high-purity stevia and monk fruit, as well as sugar alcohols—offers consumers and food manufacturers numerous options for reducing sugar intake. While approved sweeteners are deemed safe for general consumption within established ADIs, specific health conditions, such as PKU, require special attention. Staying informed about the latest scientific findings and consulting with a healthcare provider remains the best approach for choosing the right sugar substitutes for your dietary needs. The FDA website is a valuable resource for detailed information on the regulatory status of these and other food ingredients.

Frequently Asked Questions

Which sugar substitutes are approved by the FDA as food additives?

The FDA has approved six high-intensity sweeteners as food additives: saccharin, aspartame, acesulfame potassium (Ace-K), sucralose, neotame, and advantame.

What is the difference between an FDA food additive and a GRAS sweetener?

A food additive requires a formal premarket approval petition based on extensive safety studies reviewed by the FDA. A GRAS (Generally Recognized as Safe) substance is determined safe by qualified experts and does not require premarket approval, though companies can submit notifications to the FDA.

Are natural-origin sweeteners like stevia and monk fruit FDA approved?

Yes, certain high-purity steviol glycosides from the stevia plant and monk fruit extracts have been successfully reviewed through the FDA's GRAS notification program, which means the FDA has no objection to their use.

Are sugar alcohols like erythritol and xylitol included in the FDA's approved list?

The FDA does not classify sugar alcohols as food additives but permits their use as sugar substitutes. They are considered safe for consumption.

Does aspartame have any special warnings?

Yes, products containing aspartame must include a statement for people with phenylketonuria (PKU), a rare genetic disorder, because they cannot properly metabolize phenylalanine, a component of aspartame.

Which FDA-approved sweeteners are safe for baking?

Sucralose, acesulfame potassium, neotame, and advantame are all heat-stable, making them suitable for baking. Aspartame, however, loses its sweetness when heated.

Are there any sugar substitutes that are not allowed by the FDA?

Yes. The FDA prohibits the use of cyclamates in the U.S. and also prohibits the use of crude or whole-leaf stevia as sweeteners, unlike the highly purified extracts that have GRAS status.