Allulose was once considered an unreliable "fake sugar" in the international nutrition community. The media spread the view that this sugar was banned because it was harmful to the liver and disrupted metabolism.
Allulose is being widely studied and legally recognized in the United States and has an outstanding safety profile. This rare sugar is naturally derived, provides almost no energy, and does not increase blood glucose.
The legal differences between countries create serious misunderstandings in public awareness. This article will separate the line between scientific truth and market myth.
Why is allulose banned?
What Is Allulose? (Brief Recap)
Allulose is no longer a foreign term in food science and nutrition. As the trend of reducing sugar spreads globally, this rare sugar appears as a powerful solution for dieters and anyone concerned about metabolic health.
Rare Sugar in Nature
Allulose occurs naturally in fruits such as figs, raisins, and maple syrup. It is a monosaccharide – a simple sugar – with a similar structure to fructose, but its biological activity is completely different. The body absorbs allulose but does not convert it into energy, making it almost calorie-free.
Low metabolic impact
With a glycemic index of nearly zero and a negligible effect on insulin, allulose is suitable for diabetics, ketogenic dieters, and even obese people who are controlling their weight. Unlike many other sugar substitutes, it is highly regarded for its tolerability.
Approved and classified separately in the US
The US Food and Drug Administration (FDA) has recognized allulose as generally recognized as safe (GRAS). At the same time, the FDA allowed allulose to be removed from the total and added sugars on nutrition labels – an unprecedented move for any sugar.
The original analysis, Benefits and Applications of Allulose in Modern Nutrition, provides more in-depth information.
Where Is Allulose Banned or Not Approved?
The legal distribution of allulose across the world map reflects the disparity in the approach of food regulators. While some countries have been quick to embrace the potential of this rare sugar, many regions remain cautious and require more time to evaluate.
European Union: Waiting for EFSA approval
In the EU, allulose is classified as a "Novel Food," which requires a rigorous review process by the European Food Safety Authority (EFSA). Although a scientific dossier has been submitted, no allulose-containing products are officially marketed in this region.
Canada: Restricted and under evaluation
Canada is still reviewing data on toxicity and tolerability. Some products may be imported under special food regulations, but allulose is not yet classified as a sweetener widely approved for manufacturing use.
Other countries: Fragmented and inconsistent
Australia, New Zealand, and many Asian countries are still in the process of gathering evidence. The lack of uniformity in the approval system makes allulose a significant barrier to commercialization in potential markets.
Why Allulose Faces Regulatory Barriers
Allulose is an innovation in the dietary supplement industry and a challenge for the global regulatory system. The difference between biological novelty and strict appraisal requirements means that allulose encounters many barriers on the journey to international market integration.
Lack of long-term and large-scale data
Many regulatory agencies require years' clinical data to assess metabolic and cumulative effects. Current studies focus on the short term, creating a gap that requires more time and resources to complete the licensing dossier.
Classification as "Novel Food"
In Europe, allulose is classified as a "Novel Food" - a category that requires comprehensive scientific evidence, including toxicity, absorption, metabolism, and impact on the intestinal microflora. This is a mandatory standard before it can be approved for inclusion in the supply chain.
Regulatory frameworks are conservative and slow to update
Some countries adopt a regulatory system based on the absolute precautionary model, requiring every new component to undergo multiple rounds of review. This reflects a high level of consumer protection but slows down the progress of innovative innovations in practice.
US FDA Stance on Allulose
The US Food and Drug Administration (FDA) played a central role in establishing the regulatory foundation for allulose in the US market. With its progressive stance and deep scientific data, the FDA has opened a new door for products that reduce sugar while retaining natural sweetness.
Official GRAS Recognition
The FDA has classified allulose as "Generally Recognized As Safe" (GRAS), which is recognized as safe based on scientific evidence and expert opinion. The GRAS grant reflects the regulatory agency's confidence in the safety of allulose in foods and beverages.
Exempt from traditional sugar declaration
The FDA allows allulose to be removed from the total sugar and added sugar content on nutrition labels. This groundbreaking decision allows businesses to be more transparent about product benefits while helping consumers easily control their sugar intake.
Based on Comprehensive Trial Data
The FDA's decision was based on extensive research on metabolism, absorption, and effects on blood sugar levels. The findings showed that allulose does not increase blood glucose and does not cause side effects at commonly used doses.
Scientific Research Supporting Allulose's Safety
Allulose's legal basis and approval is not based on assumptions, but on a system of interdisciplinary scientific evidence. Studies designed according to rigorous clinical standards have repeatedly confirmed this rare sugar's safety and high tolerability in many different groups of subjects.
Blood sugar control and energy metabolism
Many clinical trials have demonstrated that allulose does not increase postprandial plasma glucose. Allulose supports postprandial blood sugar control in overweight or prediabetic people and reduces insulin resistance, contributing to stable carbohydrate metabolism.
No acute or chronic toxicity
Toxicological assessments in animals and humans have shown that allulose does not damage the liver or kidneys or negatively affect the immune system. Hematological and biochemical indices are all within safe limits for long-term use.
Improved Body Composition and Gut Microbiota
Several studies have documented the positive effects of allulose on visceral fat loss and improved body composition in obese individuals. At the same time, positive changes in the gut microbiota suggest that allulose has the potential to support sustained digestive and immune health.
Myths vs. Facts: Why It's Not Truly "Banned"
The ambiguity in media coverage has led many to misunderstand allulose's legal status. Labeling a substance not formally approved as "banned" creates a negative perception that does not reflect the scientific and legal realities. It is important to analyze the difference between popular information and legal reality.
"Unapproved" does not mean "banned"
Allulose is not yet listed as permitted in many countries because its application is still under review. This legal status reflects administrative progress, not the existence of a health risk. No official document imposes an absolute ban on allulose in major markets.
Disagreement in regulatory systems
Countries use different regulatory frameworks, leading to inconsistent approval timelines. The status "pending approval" is often misinterpreted as "banned" in popular media language.
Misperceptions due to a lack of scientific information
The spread of unverified information has increased unnecessary anxiety. Consumers need to access authoritative data from international food safety agencies to understand the reality.
What This Means for Consumers
The differences in allulose approvals between countries are not only a legal issue, but also directly affect consumer behavior, product choices, and access to safe sugar alternatives. Global consumers are at a crossroads between scientific potential and administrative barriers.
Limited product choices
In countries that have not yet approved allulose, it is almost impossible for consumers to find products containing allulose on the official market. This affects individuals who are controlling their blood sugar, following a ketogenic diet, or needing to reduce their consumption of added sugar.
Import and customs clearance issues
Some individuals choose to purchase allulose from overseas via e-commerce. However, the product may be held up at customs because it is not recognized as a legal food. Legal risks arise from the regulatory incompatibility between countries.
Advice for International Consumers
Consumers should monitor information from agencies such as the FDA, EFSA, or Health Canada for the latest regulatory status. Understanding the source, licensing, and labelling is key to using allulose safely, legally, and effectively.
Will Other Countries Approve Allulose Soon?
Allulose is entering the global regulatory system, supported by strong clinical data, safety records, and practical needs. Increasing pressure from the scientific community, food companies, and consumers has prompted many countries to expand their assessment and approval pathways for this sweetener.
Review progress in Europe, Canada, and Australia
The European Union is reviewing its "Novel Food" dossier with detailed clinical reports, toxicology, and metabolic data. Canada has received proposals from several manufacturers and is beginning to evaluate the possibility of formal approval. In Australia and New Zealand, public consultations have been launched to gather expert and community feedback.
Proactiveness from the food industry
Global companies are actively submitting scientific dossiers, conducting new research, and pressuring for data transparency. Collaboration between businesses and authorities opens up a clearer legal space for allulose.
Impact from market demand and public health
The rapid increase in metabolic diseases forces many countries to seek effective sugar reduction solutions. With its clear safety profile and clinical benefits, Allulose is becoming a bright choice for strategies to improve public health and restructure the food chain.
Conclusion
Allulose is a pure substance with high scientific value and potential for wide application in modern food industries. The available research laboratories and the FDA's toxicological and environmental profiles all confirm the safety of this type of sugar.
The difference is that the approval process between countries reflects the specific management model and is not related to health risks. Allulose is on the way to becoming a globally recognized new-generation sweetener.
Users can proactively update the formula and make appropriate choices based on the main data source. To understand the origin of the configuration and manufacturer, please refer to the in-depth article What is allulose made from.
Frequently Asked Questions (FAQs)
- Why is allulose banned? – Allulose is considered "banned" because it has not been approved in many countries. This is due to the cautious evaluation process, lack of long-term data, and incomplete legal documents under the "New Food" framework.
- Is allulose safe for daily use? – Many studies have shown that allulose does not cause acute or chronic toxicity and does not negatively affect the liver, kidneys, or immune system when used at common doses in daily meals.
- Why does the FDA not count allulose in total sugar? – The FDA confirmed that allulose does not affect blood glucose and insulin and does not create significant metabolic energy, so it allows it to be excluded from the "total sugar" and "added sugar" indicators on food labels.
- Can diabetics use allulose? – Allulose does not increase blood sugar, supports insulin stability, and is suitable for people with type 2 diabetes, especially when combined with a carbohydrate-controlled diet as directed by experts.
- Can allulose be brought from the US to other countries? – Transporting allulose across borders may encounter legal barriers due to differences in standards. Consumers should check the list of permitted foods in the importing country before using them.
