In the year 2025, regulatory developments concerning functional beverages in India, the US, and the EU revolve mainly around safety and health claims, albeit with varying specific requirements. Efforts are being made toward updating the Food Safety and Standards Act (FSSA) of India, unlike the US and EU, where the laws on functional foods have been set with separate guidelines concerning health claims and ingredient safety.
Fructooligosaccharidoses (FOS) are oligosaccharides present naturally from certain plant species like onion, banana, and chicory. These types of oligosaccharides have significant applications in functional beverages backed by health claims, particularly for prebiotics which promote good gut health by stimulating beneficial bacteria in the digestive tract.
In India, the Food Safety and Standards Authority of India (FSSAI) plays a key role in ensuring food safety, including the use of ingredients like Fructooligosaccharides (FOS) in food and beverages.
While FSSAI does not specify an upper limit for FOS in functional beverages, it does provide helpful guidelines for its safe use.
The Food and Drug Administration (FDA) regulates the usage of FOS in foods under the Federal Food, Drug, and Cosmetic Act, and makes no explicit limit for FOS in functional beverages other than stressing that the ingredient should be safe for human consumption as per current Good Manufacturing Practice.
Limit for FOS: The FDA has classified the FOS substance as Generally Recognized as Safe (GRAS), which means it is considered safe when used properly. Hence, while no maximum limit is defined, there is a recommendation by the FDA to limit the intake of FOS to 5g daily, which is a common practice in many parts of the world. This limit was mainly encouraged not to produce any type of uneasiness within digestion such as bloating or gas. The FDA’s GRAS notice for FOS (GRAS Notice 623) states that FOS is safe for use in foods in general at levels up to 20g/day for the general population and up to 4.2g/day for infants.
Rather than imposing a fixed upper limit, the FDA focuses on:
In the EU, the European Food Safety Authority (EFSA) is responsible for FOS regulation by conducting scientific evaluations and making recommendations regarding food ingredient safety. The European Commission lays down the overriding food law which sets the rules for the use of such ingredients as FOS in functional beverages.
FOS Limit: As per EFSA, the ADI for FOS has been established at 0.6 g/kg body weight; the estimated ADI for a person of 60 kg is therefore about 36 g per day.
Nevertheless, it is relatively uncommon for functional beverages to be formulated with a limit of over 5 g per serving of FOS. This amount has been found effective in imparting prebiotic benefits and, therefore, is considered safe for consumption.
FOS in functional beverages must meet EU requirements relating to safety and labeling:
Overall, FOS regulations cover topics that seem to make functional beverages similar across these three regions, namely India, the USA and the EU. Specific upper limits for FOS in functional beverages have not been set yet; rather safety guidelines and recommended daily intake levels in these areas assume protection for the consumer.
Below is the comparison of FOS regulations in the three regions: [8]
Region | Regulatory Authority | Maximum Limit for FOS | General Guidelines |
India | FSSAI | No specific limit: 5 grams per serving recommended | General safety guidelines apply; must comply with FSSAI standards |
USA | FDA | No specific limit; GRAS status | Typically, 5 grams per day; compliance with FDA’s labeling and safety standards |
EU | EFSA, European Commission | 36 grams per day (for a 60 kg adult) | Must comply with EFSA safety assessments and EU health claims regulations. |
In all three regions, regulatory authorities prioritize ensuring the safety and efficiency of functional beverages with FOS. The guidelines make sure that the consumption of FOS does not lead to any harmful effects, such as gastrointestinal discomfort. The manufacturers must carry out the required safety assessments and good manufacturing practices.
There are slight differences in health claims regarding FOS in the three regions. The FDA and EU require that any health claim regarding the prebiotic effects of FOS must be scientifically substantiated. In the EU, all health claims must also be approved by the EFSA. Meanwhile, India’s FSSAI is in the process of developing a more tight-knit framework for health claims and generally follows the rule that any health claim must be substantiated with scientific proof. [9] [10]
The dosage regulation of FOS in functional beverages mainly ensures that such products are well safe and healthy. At the same time, the FDA, EFSA, and FSSAI do not set any strict maximum limit on FOS in functional beverages but rather keep the focus on ensuring safe consumption to minimize gastrointestinal side effects. Generally, in all regions, the recommended limit for FOS in all drinks is 5 grams per serving. The growing popularity of functional beverages presents an increasing need for manufacturers to comply with their local regulators, making sure that ingredients such as FOS are safe and beneficial. Complying with these rules enables beverage manufacturers to formulate products that enhance digestive health in strict accordance with the safety standards set by the Indian, U.S. and EU regulatory authorities. At, Food Research Lab we have followed the regulatory guidelines for the FOS limit in the functional beverage.
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