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What are the 5 FDA approved artificial sweeteners?

4 min read

Over 50% of adults in the United States consumed sugar-sweetened beverages on a given day, according to a report by the Centers for Disease Control and Prevention. To cut down on sugar and calories, many turn to artificial sweeteners, which undergo a rigorous evaluation process before being deemed safe for public consumption by the U.S. Food and Drug Administration (FDA).

Quick Summary

The FDA regulates six high-intensity sweeteners: saccharin, aspartame, acesulfame potassium, sucralose, neotame, and advantame. These are used as food additives to provide sweetness with little to no calories. The FDA conducts a premarket review to ensure safety before these compounds can be used in the food supply.

Key Points

  • FDA Approval: The FDA approves six high-intensity artificial sweeteners as food additives after a rigorous safety review process.

  • Six Approved Sweeteners: The six approved sweeteners are saccharin, aspartame, acesulfame potassium, sucralose, neotame, and advantame.

  • Acceptable Daily Intake (ADI): The FDA establishes an ADI for each sweetener, which is a safe daily consumption limit over a person's lifetime.

  • GRAS Status: Other sweeteners, like high-purity stevia extracts and monk fruit extract, are regulated under the "Generally Recognized as Safe" (GRAS) status.

  • Heat Stability: Some artificial sweeteners, like sucralose and neotame, are heat stable and suitable for baking, while others, like aspartame, are not.

  • Phenylketonuria (PKU): People with PKU must avoid aspartame, and products containing it are required to carry a warning label.

  • Controversy and Safety: While the FDA considers approved sweeteners safe, some debate exists regarding long-term health effects, though research remains inconsistent.

In This Article

What is the FDA's Role in Regulating Sweeteners?

In the United States, any new food ingredient, including artificial sweeteners, must be approved by the Food and Drug Administration (FDA) before it can be sold to the public. This process involves a comprehensive premarket review where manufacturers must provide scientific data to prove the substance is safe for consumption under its intended use. The FDA establishes an Acceptable Daily Intake (ADI) for each approved sweetener, which is the maximum amount considered safe to consume daily over a person's lifetime. This strict oversight ensures that the sweeteners added to our foods and drinks meet a high standard of safety.

FDA-Approved High-Intensity Sweeteners

While the question asks for five, the FDA has actually approved six high-intensity sweeteners as food additives. These synthetic compounds provide sweetness many times greater than sugar, meaning only tiny amounts are needed. The six FDA-approved sweeteners are:

  • Saccharin: The oldest artificial sweetener, first discovered in 1879. It is 200–700 times sweeter than sucrose and is often found in tabletop sweeteners like Sweet'N Low.
  • Aspartame: First approved in 1974, aspartame is made from two amino acids and is about 200 times sweeter than sugar. It is a key ingredient in many diet sodas and is sold under brand names like Equal and NutraSweet.
  • Acesulfame Potassium (Ace-K): Approved in 1988, Ace-K is often blended with other sweeteners to create a more sugar-like taste. It is 200 times sweeter than sugar and is heat stable, making it suitable for baking.
  • Sucralose: Approved in 1998, sucralose is about 600 times sweeter than sugar and is famously sold under the brand name Splenda. It is heat stable and can be used in baked goods.
  • Neotame: Approved in 2002, neotame is one of the most potent sweeteners, being 7,000–13,000 times sweeter than sugar. It is heat stable and used in a wide range of foods and beverages.
  • Advantame: The most recently approved artificial sweetener, getting FDA clearance in 2014. Advantame is the most intense, at about 20,000 times sweeter than sugar.

Comparison of FDA-Approved Artificial Sweeteners

This table highlights the key characteristics of the main FDA-approved artificial sweeteners.

Sweetener Relative Sweetness (vs. Sugar) Common Uses Heat Stability Common Brand Names
Aspartame ~200x Diet sodas, frozen desserts, chewing gum No (breaks down under high heat) Equal, NutraSweet
Acesulfame Potassium ~200x Dairy products, baked goods, beverages Yes Sweet One, Sunett
Saccharin 200-700x Baked goods, beverages, tabletop sweetener Yes Sweet'N Low, Necta Sweet
Sucralose ~600x Beverages, baked goods, frozen desserts Yes Splenda
Neotame 7,000-13,000x General-purpose sweetener, flavor enhancer Yes Newtame
Advantame ~20,000x General-purpose sweetener, flavor enhancer Yes No specific brand names yet

Other FDA-Regulated Sweeteners (GRAS Status)

Beyond the six approved food additives, the FDA also regulates sweeteners under a category known as "Generally Recognized as Safe" (GRAS). This status applies to substances with a long history of safe use or that are determined to be safe by scientific experts. Some sweeteners with GRAS status include:

  • High-purity Steviol Glycosides: Derived from the stevia plant, these are used in products like Truvia and PureVia. This is different from crude stevia, which does not have GRAS status.
  • Monk Fruit Extract: Obtained from Siraitia grosvenorii fruit, also known as luo han guo. Extracts containing mogrosides are recognized as safe.
  • Sugar Alcohols: Compounds such as erythritol and xylitol are also regulated by the FDA and can be used in many products, though excessive consumption can cause digestive issues.

Potential Health Considerations and Safety

Despite FDA approval, the use of artificial sweeteners has generated some controversy over the years. Concerns have been raised regarding potential impacts on weight management, glucose tolerance, and gut microbiota, though evidence remains inconsistent and research is ongoing. In 2023, the International Agency for Research on Cancer (IARC) classified aspartame as "possibly carcinogenic to humans," but the FDA strongly disagreed with this conclusion, stating that aspartame is safe at approved usage levels. For consumers with phenylketonuria (PKU), a rare genetic disorder, aspartame must be avoided due to its phenylalanine content, which is why products with aspartame are required to include a specific warning label. As with any dietary component, moderation and individual response are key considerations. Consulting a healthcare professional can help determine the best approach for individual health needs.

Conclusion

The FDA's approval of six specific artificial sweeteners—saccharin, aspartame, acesulfame potassium, sucralose, neotame, and advantame—provides a scientific assurance of their safety for the general population when consumed within established acceptable daily intake levels. While the initial focus may be on five, knowing all six offers a more complete picture of the landscape of FDA-approved artificial sweeteners. The FDA's rigorous review process, which includes extensive scientific testing, aims to ensure these low- or no-calorie alternatives are safe for their intended use. For those looking to reduce sugar intake, these sweeteners offer viable options, but staying informed about their properties and potential considerations remains important. For more official information on high-intensity sweeteners, visit the FDA's page on food additives.

Frequently Asked Questions

An FDA-approved food additive requires premarket review and formal approval, while a "Generally Recognized as Safe" (GRAS) substance is determined to be safe by scientific experts based on publicly available information and does not require this formal review.

Yes, according to the FDA, aspartame is safe for the general population when used under approved conditions. The FDA disagrees with the 2023 IARC classification that labeled it as "possibly carcinogenic to humans," citing flaws in the studies on which the IARC relied.

Some artificial sweeteners, like sucralose, acesulfame potassium, neotame, and advantame, are heat stable and safe for baking. Aspartame, however, breaks down at high temperatures, which reduces its sweetness.

The FDA evaluates a sweetener's safety through a premarket review of scientific data provided by the manufacturer. This includes toxicological studies and clinical research to determine if there is a reasonable certainty of no harm under the intended conditions of use.

An Acceptable Daily Intake (ADI) is the maximum amount of a substance, such as an artificial sweetener, that is considered safe to consume each day over a person's lifetime. This level is set with a large safety margin based on scientific evidence.

Some studies have raised questions about potential links between artificial sweetener consumption and changes in gut bacteria, metabolism, and cardiovascular risks. However, research has yielded inconsistent results, and a clear cause-and-effect relationship has not been established.

Advantame is the sweetest FDA-approved artificial sweetener, being about 20,000 times sweeter than sugar.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.