As a natural dietary fiber, inulin and its secondary enzymatic hydrolysis product fructooligosaccharide can not only provide the effect of dietary fiber, but also promote the growth of beneficial bacteria, and prevent constipation and diarrhea, inhibit harmful fermentation products, and prevent colon cancer. play a positive role. At the same time, inulin also has the properties of improving the bioavailability of mineral elements, lowering blood sugar, lowering blood lipids, and controlling body weight.
Development status of formula foods for special medical purposes
The European Union officially promulgated the FSMP standard in 1999, and in 2001, it promulgated the "List of Additive Substances that Can Be Used in Foods for Special Nutritional Purposes", which clearly stipulates the nutrients that can be used in FSMP and are intended to be added to medical food. The new ingredients/new raw materials in the product need to be approved by the European Food Safety Authority (EFSA). For pre-market approval, member states have also formulated their own national regulations on the basis of EU standards. For example, countries such as the Netherlands and Spain need to file with relevant government departments before listing, while France, Germany, Poland, and other countries require companies to provide information for technical review, mainly reviewing the safety and effectiveness of products, but the review procedures are relatively simple. The period is generally 3 months.
In 1988, the United States first clearly defined medical food in the revised version of the Drug Act "Orphan Drug Act Amendments". In the same year, the U.S. Food and Drug Administration (FDA) issued guidelines for the production and supervision of formula foods for special medical purposes for the first time, including production, sampling, inspection, determination, etc. New ingredients/new raw materials in formula food for use need to be evaluated and generally recognized as safe (GRAS), not required
Premarket registration and approval.
The Australia/New Zealand Food Regulation Commission issued a final assessment report on the FSMP standard in May 2012, which does not require premarket registration approval requirements.
Is inulin harmful to the body?
Inulin is a natural ingredient that exists in a variety of vegetables and fruits. Many European and American countries believe that it is not harmful to the human body and classify it as a natural food ingredient. Subacute toxicity tests in rats showed that 4.5 g of fructooligosaccharides with an average degree of polymerization of 3.5 per kilogram of body mass per day was safe for 6 weeks. Acute toxicological tests on mice and rats show that the median lethal dose of fructooligosaccharides with an average degree of polymerization of 3.5 is greater than 9 g/kg body weight. Mutagenicity test proved that fructooligosaccharides have no potential genotoxicity. The rat chronic toxicity test and carcinogenicity test showed that fructooligosaccharides have no potential carcinogenicity. The only side effects in human trials were gasses such as carbon dioxide, hydrogen, and methane produced by the fermentation of inulin in the gut, which caused gas and diarrhea after overeating. Studies have found that eating too much short-chain inulin with a degree of polymerization of 3 to 5 at one time can cause diarrhea, but eating multiple times in a row can make the body tolerate it, while long-chain inulin is usually fermented in the back of the colon. Usually does not cause flatulence.
There are great differences in the regulations on the dosage of inulin in various countries because there is no international standard at present. In 2003, the U.S. FDA confirmed that inulin is a recognized safe substance. The recommended maximum daily intake is 15-20 g, and the daily effective intake is 5 g so inulin is widely used as dietary fiber in food, biology, chemical industry, and feed. and other fields. The current daily diet of Americans contains about 1 to 4 g of inulin, and the daily diet of Europeans contains about 3 to 11 g of inulin.
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