Is xanthan gum FDA approved? Understanding its GRAS status

The U.S. Food and Drug Administration (FDA) first approved the use of xanthan gum as a food additive in 1969. This regulatory classification, known as Generally Recognized as Safe (GRAS), ensures the ingredient is safe for its intended use in food products.

Quick Summary

Xanthan gum is officially designated as Generally Recognized as Safe (GRAS) by the U.S. FDA, permitting its use as a food additive with no specified maximum limits under good manufacturing practices.

Key Points

• FDA Approved: Xanthan gum was approved by the FDA in 1969 and holds the status of Generally Recognized as Safe (GRAS).

• No Limits: The FDA places no maximum limits on the amount used, as long as it adheres to good manufacturing practices.

• Common Use: It is widely used as a thickener, stabilizer, and emulsifier in foods like sauces, dressings, and gluten-free baked goods.

• Digestive Effects: At normal food-level consumption, it is generally safe; however, very high doses may cause gas and bloating due to its soluble fiber content.

• Allergen Caution: Individuals with severe allergies to corn, soy, or wheat may need to be cautious, as these are common fermentation sources.

• International Acceptance: Global organizations like JECFA and regional bodies like the EU's EFSA also consider xanthan gum safe.

The FDA's Official Position on Xanthan Gum

Xanthan gum holds the status of "Generally Recognized as Safe" (GRAS) from the U.S. Food and Drug Administration (FDA), a classification it received in 1969 after safety evaluations. This designation means qualified experts consider the substance safe for its intended uses in food. Xanthan gum functions as a thickener, stabilizer, and emulsifier in various food items. The FDA permits its use under current good manufacturing practices without specific maximum quantity limits, as long as it achieves the desired technical effect. Its regulatory status is detailed in the Code of Federal Regulations, 21 CFR §172.695.

How Xanthan Gum is Produced

Xanthan gum is a polysaccharide created through the fermentation of simple sugars by the bacterium Xanthomonas campestris. This process, developed by USDA scientists in the 1950s, yields a substance that is then dried and milled into a powder. The resulting product is stable and consistent, making it suitable for both commercial food production and home use, particularly in gluten-free recipes.

Safety Profile and Potential Side Effects

Xanthan gum is generally safe for consumption in typical food amounts. Since humans cannot digest it, it acts as a soluble fiber in the digestive system. While most individuals experience no issues, consuming large amounts (over 15 grams daily) might cause digestive problems like gas, bloating, or diarrhea.

Specific considerations:

• Allergies: The sugars used to make xanthan gum can come from sources like corn, soy, or wheat. Those with severe allergies to these ingredients should be cautious or inquire about the gum's source, despite purification.
• Digestive Sensitivity: Individuals with certain gastrointestinal issues may be sensitive to xanthan gum's fiber content; personal tolerance varies.
• Premature Infants: Thickeners using xanthan gum are not advised for premature infants due to a risk of necrotizing enterocolitis (NEC).

Comparison of Xanthan Gum Regulations: FDA vs. International Bodies

Detailed regulatory comparisons and information about the role of xanthan gum in food and beyond can be found on {Link: bshingredients.com https://www.bshingredients.com/legal-status-of-xanthan-gum/}.

Conclusion

Xanthan gum is FDA-approved, having received its GRAS status in 1969. U.S. and international food safety bodies have confirmed its safety at typical consumption levels. While generally safe, those with certain sensitivities or severe allergies to source ingredients should exercise caution. For most people, xanthan gum is a safe and widely used additive. For more detailed regulatory information, you can consult the FDA's official records on GRAS substances.(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=172.695)

Frequently Asked Questions

When did the FDA approve xanthan gum?

The U.S. Food and Drug Administration (FDA) approved xanthan gum for use as a food additive in 1969, classifying it as Generally Recognized as Safe (GRAS).

What is GRAS status for xanthan gum?

GRAS stands for "Generally Recognized as Safe." It is a designation given by the FDA to substances that, based on extensive use and expert opinion, are considered safe for their intended use in food.

Are there any restrictions on how much xanthan gum can be in food?

The FDA does not impose a maximum limit on the amount of xanthan gum in food. Its use is limited only by what is needed to achieve the desired technical effect, as per good manufacturing practices.

Can xanthan gum be harmful if I eat too much?

Consuming excessive amounts of xanthan gum, typically over 15 grams per day, can cause digestive issues such as bloating, gas, and diarrhea, as it acts as a soluble fiber.

Is xanthan gum a natural ingredient?

While xanthan gum is created through a fermentation process involving bacteria and plant-based sugars, it is not considered a natural ingredient by most standards. The process is industrial, involving purification steps.

Is xanthan gum safe for people with allergies?

Xanthan gum is generally safe, but people with severe allergies to corn, soy, or wheat should be cautious. The sugars used for fermentation can come from these sources, and trace amounts of allergens might remain.

Can xanthan gum be used in organic foods?

Yes, xanthan gum can be used in certified organic foods, provided it meets specific production standards and does not use methods like genetic engineering, according to both U.S. and EU regulations.

Why is xanthan gum in so many different products?

Xanthan gum's ability to act as a thickener, stabilizer, and emulsifier in a wide range of conditions makes it highly versatile. It improves texture, prevents separation, and extends shelf life in many foods and other products.