Chapter 5: Safety and Side Effects of Allulose

The safety of allulose has been studied by several authorities worldwide.

In the United States, the Food and Drug Administration (FDA) granted allulose “Generally Recognized As Safe” (GRAS) status in 2012, meaning it was generally recognized as safe for use in the food industry.

This classification means that, based on the scientific evidence available to date, allulose can be considered safe under the specified conditions of use.

Based on the FDA's decision, allulose is not considered an added sugar, and its calorie content must also be indicated with a reduced value on the nutrition label (0.4 kcal/g).

In contrast, allulose is currently not a permitted food ingredient or sweetener in the European Union.

The EFSA (European Food Safety Authority) has not yet issued an official approval, so the use of allulose in the EU is only possible if it undergoes a preliminary safety assessment and is authorized under the Novel Foods regulation.

This process can take several years, so allulose cannot currently be sold as a food on the European market.

Safety studies and toxicological data

The safety of allulose is supported by numerous animal studies and human clinical trials. These studies evaluated the effects of allulose from several aspects:

• Toxicity

In animal studies (e.g., on dogs, mice), allulose consumption for 12 weeks or longer did not cause any measurable toxic effects or organ damage.

• Human studies

It did not cause any adverse side effects in humans at doses of 5–15 g/day for up to 48 weeks.

• Blood sugar and insulin

Allulose does not raise blood sugar or insulin levels, so it may be suitable for diabetics .

• Blood fats and uric acid

In clinical studies, neither blood lipids nor uric acid levels were significantly affected by allulose, even at higher doses.

To obtain GRAS status, manufacturers submitted detailed toxicological, metabolic, genotoxicological, compositional, and human tolerance data.

Based on the data available to date, allulose has not shown carcinogenic, mutagenic or reproductive toxicity.

Side effects

Digestive system tolerance

One of the most common, but usually mild, side effects of allulose is digestive discomfort, which mainly occurs when consuming larger amounts.

These symptoms may include:

• Bloating

• Gas formation

• Diarrhea

• Abdominal pain, cramps

• Nausea, rarely headache

Symptoms mainly occur when a single dose or total daily amount of allulose exceeds the recommended level .

Several studies confirm that the maximum recommended single dose is 0.4 g/kg of body weight, while the total daily intake should not exceed 0.9 g/kg of body weight.

For example, for a 60 kg adult, this means 24 g/occasion and a maximum of 54 g/day.

In clinical studies, symptoms occurred mainly at single doses above 0.5 g/kg, while below 0.4 g/kg most participants remained symptom-free.

The symptoms are usually temporary and disappear when consumption is reduced.

Individual sensitivity and comparison with other sweeteners

Allulose has a more favorable digestive tolerance than many other sugar alcohols (e.g. erythritol, xylitol), which more often cause diarrhea or bloating even in smaller doses.

However, individual sensitivity varies, so it is recommended to increase allulose consumption gradually, paying attention to the body's reactions.

Sweetener / Recommended maximum single dose (g/kg) / Main side effect / Tolerance

Allulose / 0.4 / Bloating, diarrhea / Good

Erythritis / 0.3 / Diarrhea, bloating / Moderate

Xylitol / 0.2 / Diarrhea, bloating / Weak

Special risks and warnings

Diabetics and insulin treatment

Allulose does not raise blood sugar levels, but due to its carbohydrate content, it may be listed on labels as part of the total carbohydrate count.

Therefore, diabetics treated with insulin should consult their doctor to avoid using excessive insulin doses, which can lead to hypoglycemia.

Allergic reactions

Rarely, a skin rash or more serious allergic reaction may occur. In such cases, you should stop consuming it immediately and consult a doctor.

Long-term effects

Although allulose appears to be safe in the short and medium term, there is still little data available on the effects of long-term, large-scale consumption.

In some animal studies, an increase in liver and kidney weight was observed at extreme doses, but no functional abnormalities or damage occurred.

Dental safety

Allulose does not cause tooth decay because oral bacteria cannot ferment it, so they do not produce acid that would damage tooth enamel.

This is an advantage over traditional sugar, which contributes significantly to the development of tooth decay.

Summary

Recommended consumption and practical advice

Allulose is considered safe based on current scientific data if daily consumption does not exceed 0.9 g/kg of body weight.

A gradual introduction, starting with small doses, is recommended so that individual tolerance can be assessed.

In larger quantities (especially above 0.5 g/kg), digestive complaints may occur, but these are usually temporary.

People with diabetes, those treated with insulin, or those with known allergies should consult a doctor about consuming allulose.

In the case of long-term, large-scale consumption, further studies are necessary to assess full safety.

Allulose is therefore a promising, well-tolerated, low-calorie sweetener that is a safe alternative to sugar for most people when used in moderation.