Special Dietary Use Research Articles

Comparative evaluation of Food for Special Dietary Use (FSDU) and Food for Special Medical Purpose (FSMP) product regulatory framework in India, EU and US

Nutraceuticals are naturally occurring compounds that is used globally due to its varied health benefits that extends beyond to basic nutrition. Various types of compounds are included in the umbrella term of nutraceuticals, including vitamins, minerals, herbal extracts, and dietary supplements. For better understanding and defined use of specific nutraceuticals in specific conditions, nutraceuticals are classified into various types, including Foods for Special Medicinal Purpose (FSMP) and Foods for Special Dietary Use (FSDU). FSMP are foods or nutraceuticals that are formulated in such a way to meet specific nutritional needs for managing medical conditions. FSMPs are designed to complement medical treatments, aiding in recovery, and improving quality of life. FSDU are formulated to meet the nutritional needs of individuals with specific dietary requirements or restrictions. FSDU are essential for ensuring individuals receive adequate nutrition while adhering to dietary restrictions. The regulatory framework for FSDU and FSMP varies significantly between countries. Each country has its own set of laws and regulations governing the production, labelling, and distribution of these products. These regulations ensure that FSDUs and FSMPs meet specific safety, efficacy, and nutritional standards relevant to local health policies and consumer protection laws. The review aimed to compare the regulatory frameworks for FSMP and FSDU across India, the US, and the EU. It focused on understanding differences in regulatory requirements for these products in each jurisdiction. By analyzing these regulatory landscapes, the study sought to highlight variations that impact manufacturers, healthcare providers, and consumers in these regions.

Development of food for special dietary uses of diabetes based on oyster mushroom and brown rice

Diabetes patients often struggle to meet their energy requirements, prompting the suggestion of utilizing Food for Special Dietary Uses (FSDU). Previous research has shown the efficacy of oyster mushrooms’ B-glucan in controlling hyperglycemia and insulin resistance. Brown rice, high in magnesium and fiber with a low glycemic index, is known to lower blood glucose levels. Utilizing both ingredients in FSDU may provide products with recommended energy value, nutrient ingredients, and glycemic index. This study aimed to measure the energy, protein, fat, carbohydrate, fiber, glucose, and glycemic index of four mixed formulations of oyster mushrooms and brown rice, along with a control.The study used a true experimental design with a completely randomized research design. The formulations included: P1=9% mixture of moringa and fish flour, P2=10% mixture of carrot and fish flour, F3=11% mixture of moringa and tempeh flour, and F4=12% tempeh flour. The total energy was measured using various methods: adiabatic oxygen bomb calorimeter for energy, Kjeldahl for protein, Soxhlet for fat, by-difference for carbohydrates, AOAC enzymatic-gravimetric for total dietary fiber, anthrone for total sugar, and blood glucose tests at 0, 15, 30, 45, 60, 90, and 120 minutes post-test-food ingestion for glycemic index measurements. Statistical analysis was performed using the One-Way ANOVA and Kruskal-Wallis tests.The research results indicate significant differences in energy, protein, fat, carbohydrates, total sugar, and fiber values among groups (p<0.01). The lowest glycemic index was found in P4 (44.32, medium category). Further analysis indicated that P4 had higher total energy and fat, but lower carbohydrates, total sugar, and glycemic index. According to the Multiple Attribute Zeleny Method, the P4 formula was the best formula for all parameters.The most effective formula, containing brown rice, oyster mushrooms, and tempeh flour (P4), could be a beneficial option for improving the health of individuals with diabetes in the community.

A Comparative Study of Registration Process of Nutraceuticals in different countries

Nutraceuticals, which are defined as any food or component of food that has health benefits, such as the ability to prevent or treat disease, have become essential for consumers in both developed and developing nations. Functional elements like vitamins, minerals, and other nutrients are becoming more important due to the changing lifestyle. This category now includes things like probiotics, amino acids, and fatty acids, among others. In light of the fact that these items are intended for human consumption, regulatory bodies worldwide are concentrating on the Product Quality and Safety. This paper looks into the nutraceutical registration processes in different countries. The India have developed the Food for special dietary use registration process whereas the USA have put into place Dietary supplement registration process and the Japan have developed registration process for Foods for specified dietary use (FOSHU) whereas the China have developed registration process for Health foods. It also includes the marketed formulation of nutraceuticals. The aim of this paper is to compare the regulation processes between the different countries.

Baby food industry interference with infant feeding international regulation-A case study on the standard for follow-up formula.

Globally, first-food systems have changed and breastfeeding has decreased due to the increased growth in commercial breast milk substitute (BMS) consumption, which includes both follow-up and toddler formulas. These products are manufactured by a small number of corporate leaders in international BMS sales. Discussions for global regulation of these products take place in the Codex Alimentarius and are permeated by the strong participation of these corporations in the Codex committees. In the present study, the participation of the baby food industry in the review of the follow-up formula standard in the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) was analyzed. The analysis of the CCNFSDU documents was based on the period from 2009 to 2019 and used quantitative and qualitative approaches. Compositional and participation data from country delegations and observer organizations on the representative profiles of the involved institutions and the baby food industry's involvement in this process were established systematically. In total, 134 out of the 189 Codex Alimentarius member countries engaged in the standard review process, of which 28% were involved in the entire process. The private sector was present in 81% of the most assiduous member state delegations to the meetings. Furthermore, ~60% of the observer organizations involved in the review process were business associations representing industry interests. Moreover, the International Special Dietary Foods Industries was the only business association with observer status in the CCNFSDU that was specifically dedicated to representing the baby food industryduring the review process. These research results expand the body of evidence confirming the expressive and disproportionate participation of baby food industries and their representatives in the discussion processes within the scope of the CCNFSDU. However, studies investigating the Codex and the public documents of its respective committees are limited. Thus, this was the first study to analyze the influence of the baby food industry on BMS global regulatory compliance.

Role and Importance of Functional Food Packaging in Specialized Products for Vulnerable Populations: Implications for Innovation and Policy Development for Sustainability

Specialized products can be needed to help meet the nutrition requirements of vulnerable populations, including infants and young children, those who are ill, and older adults. Laws and regulations delineate distinct categories for such products including medical foods or formulated liquid diets, foods for special dietary use (FSDUs), infant formulas, and natural health products (NHPs). Yet, the literature is limited regarding the role and importance of functional and sustainable packaging for specialized products. This perspective review describes these unique product categories and the role of packaging as well as regulatory considerations. Furthermore, reviewed are how waste reduction strategies and emerging legislative/regulatory policies in the United States and Canada may not adequately address the functional packaging requirements for specialized products. The paper concludes by offering perspectives for emerging innovations and policy development for sustainability.

Article: What is Codex, and Why is it Important?: The Codex Committee on Nutrition and Foods for Special Dietary Uses: Report November 2021.

Keywords advocacy, breastfeeding, Codex Alimentarius, follow-on formula, growing up milks, infant formula, International Code of Marketing of Breast-Milk Substitutes, ready to use therapeutic foods, World Health Organization

The Challenge of Measuring Sweet Taste in Food Ingredients and Products for Regulatory Compliance: A Scientific Opinion.

The Codex Alimentarius Commission, a central part of the joint Food and Agricultural Organization/World Health Organizations Food Standards Program, adopts internationally recognized standards, guidelines, and code of practices that help ensure safety, quality, and fairness of food trade globally. Although Codex standards are not regulations per se, regulatory authorities around the world may benchmark against these standards or introduce them into regulations within their countries. Recently, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) initiated a draft revision to the Codex standard for follow-up formula (FUF), a drink/product (with added nutrients) for young children, to include requirements for limiting or measuring the amount of sweet taste contributed by carbohydrates in a product. Stakeholders from multiple food and beverage manufacturers expressed concern about the subjectivity of sweetness and challenges with objective measurement for verifying regulatory compliance. It is a requirement that Codex standards include a reference to a suitable method of analysis for verifying compliance with the standard. In response, AOAC INTERNATIONAL formed the Ad Hoc Expert Panel on Sweetness in November 2020 to review human perception of sweet taste, assess the landscape of internationally recognized analytical and sensory methods for measuring sweet taste in food ingredients and products, deliver recommendations to Codex regarding verification of sweet taste requirements for FUF, and develop a scientific opinion on measuring sweet taste in food and beverage products beyond FUF. Findings showed an abundance of official analytical methods for determining quantities of carbohydrates and other sweet-tasting molecules in food products and beverages, but no analytical methods capable of determining sweet taste. Furthermore, sweet taste can be determined by standard sensory analysis methods. However, it is impossible to define a sensory intensity reference value for sweetness, making them unfit to verify regulatory compliance for the purpose of international food trade. Based on these findings and recommendations, the Codex Committee on Methods of Analysis and Sampling agreed during its 41st session in May 2021 to inform CCNFSDU that there are no known validated methods to measure sweetness of carbohydrate sources; therefore, no way to determine compliance for such a requirement for FUF.

Efficacy of newly developed food for special dietary use in the diet of patients with non-alcoholic steatohepatitis

Although diet plays a leading role in treatment of non-alcoholic fatty disease (and, in particular, non-alcoholic steatohepatitis), specialized foods for the treatment of these patients have not yet been developed. The aim of the study was to assess efficacy of the food for special dietary use (FSDU) in patients with non-alcoholic steatohepatitis. Material and methods. New FSDU contained (% of the RDAs): protein - 8%; fat - 7% (including ω-3 PUFA - 40%); soluble dietary fiber - 180%; phospholipids - 25%; alpha-lipoic acid - 33%; betaine - 10%; 12 mineral substances - 13-44%; 13 vitamins - 24-140%. The study (NCT04308980) was approved by local ethics committee and enrolled patients with diagnosis of NASH. Subjects were randomized to the following groups: those received iso-calorie diet (according to resting energy expenditures, by indirect calorimetry) alone (ICD) and iso-calorie diet + FSDU (2 portions per day, 14 days) (ICD + FSDU group). Safety was assessed based on clinical and laboratory data. Repeated measurements (baseline vs those on the 15th day of the study) of body composition assessed by bioelectrical impedance analysis, and blood chemistry were compared. Results. The results of complex examination of 20 subjects (12 in ICD + FSDU and 8 in ICD group) served as a source for the study. Initially, groups did not differ by age, sex, and body mass index (BMI). The product was well tolerated. In contrast to ICD group, those in ICD + FSDU group demonstrated greater decrease of weight: BMI initially (BMI0) (M±σ): 38.7±5.4 kg/m2 vs BMI at the end-point (BMIEOT) 36.7±5.1 kg/m2, p=0.003 in ICD + FSDU group, whereas in the ICD group BMI0=38.9±7.2 vs BMIEOT=38.9±7.3 kg/m2, p=0.08. These results were reached predominantly by a decrease of fat mass: body fat weight (BFW0) 50.2±10.7 vs BFWEOT=48.5±10.8 kg, p=0.002 in ICD + FSDU group, whereas BFW0=48.9±11.4 vs BFWEOT=47.8±11.6 kg, p=0.07 in ICD group. The activity of alanine and aspartate aminotransferase, gamma-glutamil transpeptidase and alkaline phosphatase decreased in ICD + FSDU group (р=<0.05), whereas in ICD group the difference between initial and control assessment was not significant (р=<0.10). Conclusion. The new FSDU is well tolerated by patients with NASH. In combination with iso-calorie diet, it may increase efficacy of weight loss, predominantly by fat.

Dietary correction of metabolic disorders in patients with diabetic nephropathy

One of the ways to optimize the complex treatment of patients with diabetic nephropathy (DN) is the use of therapeutic nutrition with the inclusion of foods for special dietary use (FSDU) that correct carbohydrate and lipid metabolism disorders and have antioxidant and anti-inflammatory, properties. The aim of the research was to study the effect of a low-protein diet with the inclusion of FSDU on some clinical and biochemical parameters in patients with DN. Material and methods. 30 patients with DN and concomitant obesity of I-III stages were examined, which were divided into two groups of 15 people each. Patients of the main group received a low-protein diet for 14 days (protein 62.4 g/day, energy value 1360 kcal/day) with the inclusion of FSDU (124 kcal per portion), modified by protein, fat and carbohydrate profile (dry instant mixture), and the comparison group - a low-protein diet without the inclusion of FSDU. In blood serum, the content of glucose, glycated hemoglobin (HbA1c), total cholesterol (CH), triglycerides, cholesterol of low and high density lipoproteins (LDL, HDL), urea, creatinine, total protein, albumin, total bilirubin, alanine and aspartate aminotransferase activity, levels of potassium, phosphorus, calcium. Glomerular filtration rate was calculated and body composition indicators were studied using the bioimpedancemetry. Results. Patients of the main group showed a statistically significant decrease in fat mass by an average of 5.5% (p=0.0001) and a tendency to increase muscle mass by 1.7% (p>0.05) from the initial level. Among the patients of the comparison group, the decrease in fat mass was 4.9% (p=0.0001) against the background of a decrease in lean body mass by 2.5% (p>0.05). When comparing biochemical parameters, positive dynamics of glycemic control indicators was noted in both groups: the level of glucose in blood serum decreased (p<0.005) by 10.9 and 9.3% from the initial level in the main group and the comparison group. A more pronounced decrease in LDL and triglycerides was noted in patients of the main group (29.4 and 26.2%, respectively, p=0.005), in the comparison group the decrease in these indicators was less pronounced and statistically insignificant. Conclusion. The results obtained indicate an increase in the effectiveness of therapeutic nutrition in patients with DN and concomitant obesity when an FSDU with a modified protein, fat and carbohydrate profile is included in a low-protein diet.

Gluten-Free Pasta Enriched with Fish By-Product for Special Dietary Uses: Technological Quality and Sensory Properties.

Gluten-free pasta enriched with fish can support a nutritive and suitable option for people with celiac disease that allows achieving the benefits of fish consumption, especially the consumption of Ω-3 fatty acids; however, this requires that the pasta has adequate technological and sensory properties. For this purpose, four optimal formulations, obtained with an iterative process, were analyzed to determine the effect of the different ingredients (yellow corn flour, white corn flour, and rice flour) in gluten-free pasta compared to commercial wheat pasta. An evaluation of the color, texture, and technological properties were conducted, and the pasta was sensorially characterized. The enriched gluten-free pasta required shorter cooking times (≈3 min) and was characterized by lower hardness, springiness, gumminess, chewiness, and fracturability, and had higher values of adhesiveness than wheat pasta. In addition, the incorporation of yellow corn gives gluten-free pasta a similarity in color to commercial pasta, with a value of ∆E between 5.5 and 8.0. Regarding the sensory analysis, gluten-free pasta was characterized by slight fishy aromas and flavors with some aftertaste compared to commercial pasta. Finally, the use of different cereals to obtain gluten-free pasta could be a good and feasible alternative despite the technological and sensory modifications observed.

The Politics of Regulating Foods for Infants and Young Children: A Case Study on the Framing and Contestation of Codex Standard-Setting Processes on Breast-Milk Substitutes.

Breastfeeding is important for the health and development of the child, and for maternal health, in all country contexts. However, global sales of breast-milk substitutes (BMS), including infant, follow-up and toddler formulas, have 'boomed' in recent decades. This raises the importance of international food standards established by the Codex Alimentarius Commission (Codex) on the safety, composition and labelling of BMS. Such standards appear to be strongly contested by governments, industry and civil society groups, yet few studies have investigated the politics of Codex standard-setting processes. The aim of this paper is to understand who participates in decision-making, and how actors frame and contest proposals to revise the Codex Standard on Follow-up Formula (FUF). We adopted a case study design involving two steps. First, we enumerated government, industry, civil society, and international organization stakeholders participating in standard-setting processes of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). Second, we conducted a framing analysis of stakeholder inputs during the FUF standard revision in CCNFSDU meetings. Publicly available online meeting reports (2015-2019) were retrieved, analyzed using a theoretical framework, and organized thematically. High-income country (HIC) delegates greatly outnumbered those from other country income categories. Industry representation was higher compared with other observer categories. Member state delegations included more industry representation than civil society representation, and were occasionally the only member state delegates. Industry stakeholders framed arguments in terms of trade implications, science, and flexible standards. Civil society groups used public health, science, and pro-breastfeeding frames. Codex BMS standard-setting procedures are dominated by HICs and industry groups. Limited representation of civil society, and of low- and middle-income countries (LMICs), suggest actions are needed to substantially increase support for their involvement at Codex. Such representation may help to counteract power asymmetries and commercial influences on food standards for infants and young children.

Quality Control and Quality Assurance for the Intermediate Zone between Food and Drug: Rational Use of Such Products and the Need to Modify the Pharmacy Education

General views on three aspects were discussed. The first aspect is regulatory categories, which can range from "soft to hard", an expression using the English and Japanese translation of the French term, "drogue douce" (soft drug). This categorization starts with "so-called health foods" and extends to Foods with Health Claims [Foods with Nutrient Functional Claims (FNFC); Foods with Functional Claims (FFC); Foods for Specified Health Uses (FOSHU)], OTC drugs, and ethical drugs. "The Basic Policy for New Drug Approval" (1967) made a distinction between OTC and prescription drugs. FOSHU (1991) originally included foods for "patients", such as low allergen rice with preventive "health claims". Foods for Medical Uses (FMU) later became an independent subcategory under Foods for Special Dietary Uses. On the other hand, manufacturers of FFC can make various "health claims" on the basis of randomized controlled trial or systematic review (2015). Products in the intermediate zone between food and drug have an annual market of over 2 trillion yen (US$ 20 billion). The second aspect is the five elements, i.e., quality, safety, efficacy, information, and cost, which are derived from WHO's "The rational use of drugs" (1985). The adoption of Sustainable Development Goals (SDGs) by the UN General Assembly (2015) led to the addition of "ecology" as the sixth element, which is applicable for herbal and animal raw materials. The third aspect is quality control and quality assurance. This initially began with manufactured products and was expanded to the service fields handled by various health workers including pharmacists.

Medical Foods: Science, Regulation, and Practical Aspects. Summary of a Workshop.

ABSTRACTOn August 13–14, 2019, the Healthcare Nutrition Council and the ASN held the Medical Foods Workshop: Science, Regulation, and Practical Aspects. Medical food products help patients manage their disease and improve their quality of life. Yet many hurdles exist to getting patients new products. In this workshop, participants addressed some of these hurdles, with specific emphasis on topics like the statutory term distinctive nutritional requirements, the regulatory term modification of the diet alone, the role of clinical guidelines, the requirement that medical foods be used under medical supervision, and differentiation of foods for special dietary use from medical foods, as well as product innovation and future research. Real-world examples were discussed for intractable epilepsy, diabetes, end-stage renal disease, and inflammatory bowel disease.

Determination of Vitamin B&lt;sub&gt;12&lt;/sub&gt; and Biotin in Foods for Special Dietary Uses with Immunoaffinity Column

Determination of Vitamin B&lt;sub&gt;12&lt;/sub&gt; and Biotin in Foods for Special Dietary Uses with Immunoaffinity Column

官能評価による特別用途食品えん下困難者用食品許可基準（案）の検証

官能評価による特別用途食品えん下困難者用食品許可基準（案）の検証

Optimizing foods for special dietary use in Canada: key outcomes and recommendations from a tripartite workshop.

Many health conditions result in unique nutritional requirements (e.g., protein restriction, low energy, fortification) and the need to consume foods in nontraditional formats (e.g., liquid diets, supplements, tube feeding). In Canada, 45% of hospital patients are malnourished upon admission, resulting in prolonged hospital stays, increased health care costs, and higher mortality rates. Fortunately, advances in nutrition and food science enabled the development of products that provide nutritional support for individuals in hospital and at home. In Canada, these products are defined as Foods for Special Dietary Use (FSDUs). Canada's regulation of FSDUs (Division 24 of the Food and Drug Regulations) is particularly stringent and outdated, which results in products that do not meet current nutritional recommendations or allow application of current technologies, and lack harmonization with other countries. Many of these issues also apply to the Infant Food regulations in Canada. To provide vulnerable populations with optimal nutrition, experts have suggested modernization of Canadian FSDU regulations. A multi-stakeholder workshop established several recommendations and goals toward that end while ensuring the safety of consumers. These include (i) assessing other jurisdictions' regulations; (ii) tracking products currently on the market; (iii) temporary marketing authorizations to permit products on the market and collect data; (iv) use of incorporation by reference for compositional requirements; (v) support for research of FSDU and nutritional needs of special population; and (vi) better understanding accessibility to these products. Overall, the proposed vision is for a modern, safe, flexible, innovative, and health-driven regulatory framework for FSDU in Canada.

小型の測定容器を用いた特別用途食品えん下困難者用食品の物性測定方法の開発

【目的】特別用途食品（えん下困難者用食品）の表示許可に係る試験では，直径 40 mm×高さ 15 mmの容器を用いて，物性（硬さ，付着性，凝集性）が測定されてきた（従来法）。ところが，近年この容器に満たない体積の食品が流通している。そこで，小型の容器を用いて試験を行う方法を開発し，その性能を試験室内で評価した。【方法】食品の物性はクリープメータを用いて測定した。直径 30 mm×高さ 15 mmの小型の容器に適したプランジャーのサイズについて検討し，新法を構築した。従来法及び新法を用いて，えん下困難者用食品の許可基準ⅠまたはⅡに相当する10種類の市販食品の測定を行い，両者の物性を比較した。さらに，試験者間の再現性についても検討した。【結果】直径 30 mmの小さな容器に適したプランジャーは，直径 16 mmの円柱型であった。食品の測定結果は，従来法と新法の間でいずれの項目も非常に高い直線性（R2≧0.987）を示した。ただし，新法による測定値は従来法と比較して，硬さで95％程度，付着性で142％程度，凝集性で85％程度であった。新法の分析精度は概ね従来法と同程度であり，試験者間における測定値のばらつきは同一試験者のそれに比べて1～2.3倍であった。【結論】小包装の食品について，従来の方法では適用困難な場合の分析方法を構築した。本検討と類似した物性を有する食品については，新法で得られた測定結果に，硬さは1.1，付着性は0.7，凝集性は1.2を乗じて補正することで，従来通り評価できると考えられた。

PHYSICOCHEMICAL AND MICROBIOLOGICAL PROPERTY OF PROBIOTIC MICROENCAPSULATED ENRICHED INFANT FORMULA

Breast milk is the natural optimal source of nutrition for the infants. In case of its non availability or mother’s inability to feed her child, nutrient fortified infant formula can be considered as its substitute. Infant formula can be described as “A food which claims to be or is represented for special dietary use solely as a food for infants by reason of its simulation and as a complete or partial substitute for human milk”. Recently researches are carried out to improve the chemical and microbiological value of infant formula in terms of formulation and techniques. This study was carried out to check prebiotic (5% Partially Hydrolyzed Guar Gum (PHGG)) effect in the matrix of microcapsules on physico-chemical and microbiological qualities of probiotic microorganism containing infant formula. Gross composition of control (excluding prebiotic in matrix material) and experimental infant formula (including 5% PHGG in matrix material) prepared were meeting with the Indian standard. No significant difference was found in physicochemical properties i.e . dispersibility, bulk density, free fat and solubility index of control and experimental infant formula. Initial probiotic count in both control and prebiotic containing microcapsules were 10 8 -10 9 cfu/gm. Prepared infant formula was containing 5-6 log cfu/gm of viable count in control powder and experimental infant formula was containing 6-7 log cfu/gm of viable count. Prebiotic containing probiotic microcapsules had positive effect on the viability of probiotic bacteria and had no adverse effect on physico-chemical property of infant formula.

Significant differences in coeliac immunotoxicity of barley varieties

The only treatment available for coeliac disease (CD) is a strict diet in which the intake of wheat, barley, rye, or oats is avoided. Barley is a major cereal crop, grown mainly for its use in brewing, and it has high nutritional value. The identification of varieties with a reduced toxicity profile may contribute to improve the diet, the quality of life and health of CD patients. Searching for harmless barleys, we investigated accessions of malting and wild barley, used for developing new cultivated cereals. The CD toxicity profile of barleys was screened using G12 antibody and cell proliferation and IFN-γ release from peripheral blood mononuclear cells and intestinal biopsies from CD patients. We found a direct correlation between the reactivity with G12 and the immunogenicity of the different barleys. The malting barleys were less immunogenic, with reduced levels of toxic gluten, and were possibly less harmful to CD patients. Our findings could raise the prospect of breeding barley species with low levels of harmful gluten, and the attractive goal of developing nontoxic barley cultivars, always taking into account the Codex standard for foods for special dietary use for persons intolerant to gluten.

Interlaboratory Study for Determination of Vitamin B&lt;sub&gt;12&lt;/sub&gt; in Fortified Food Measured by Microbiological Assay

Currently, approval and license examinations of Food for Special Dietary Uses (FOSDU) have been held by six testing institutions. For proper operation of the FOSDU system, it is important to maintain the analytical accuracy, however, the accuracy of analysis among the groups has never been discussed. For that reason, we carried out a study to clarify the factors affecting the interlaboratory analytical accuracy with vitamin B12 contents in fortified food. As a result, it was found to be important that it has to adhere closely to the analytical method for the assurance of reproducibility, and has to use the most suitable approximate method against the calibration curve and/or to take account the proliferation potential of strain for improvement of reproducibility in the microbiological assay for the vitamin B12 quantitation.