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The publication is available at https://www.gov.uk/government/publications/uknhcc-scientific-opinion-white-mulberry-leaf-extract-and-blood-glucose-levels/scientific-opinion-for-the-substantiation. getting-claims-for-health-on-single-component-from-white-mulberry-extract-and-help-healthy-bl
The UKNHCC Code of Conduct states that official observers attend UKNHCC meetings to provide up-to-date information on current scientific and policy issues in their countries while respecting the independence of the UKNHCC.
UKNHCC (UK Nutrition and Health Claims Council), 2023 Reserved Scientific Opinion (EC) No 1924/2006, Nutritional Regulations (Amendments etc.) (Leaving the EU) and Nutritional Regulations (Amendments etc.) .) (withdrawal from the EU) 2020 as amended.
This opinion is not and should not be construed as a marketing authorization for the mulberry leaf extract, a positive assessment of its safety, nor is it a judgment as to whether the mulberry leaf extract is classified as a food product. It should be noted that this type of regulation was not provided for under the Food (Amendment, etc.) (Leaving the EU) Regulation 2019 and the Food Preservation (Amendment) Regulation (EC) No 1924/2006 [footnote 1], etc.) (Leaving the EU) Regulation 2020
It should also be emphasized that the scope, the proposed wording of the claims and the conditions of use proposed by the Applicant are subject to change before the completion of the grant procedure provided for in Article 18(4) of the Savings Regulation (EC) No 1924/2006 [footnote 1] As amended, by the Food (Amendment, etc.) (Leaving the EU) Regulations 2019 and the Food (Amendments, etc.) (Leaving the EU) Regulations 2020.
Applications were received by UKNHCC on 5 August 2022 and the scientific evaluation process began immediately.
On August 19, 2022, the scientific evaluation was suspended after a “clock-stopping” process requiring applicants to provide additional information.
On 4 September 2022, the UKNHCC received additional information and re-initiated the scientific assessment in accordance with Article 16(1) of Regulation (EC) No 1924/2006.
Authorization to make health claims under Article 14(1)(a) Surviving Regulation (EC) No 1924/20061 as amended by the Nutrition (Amendment, etc.) Regulation (withdrawal from the European Union) 2019 and issued by the UK competent authority. Authority on Ascarit UK application. In the Nutrition (Amendment, etc.) (Leaving the EU) Regulations 2020, the UK Nutrition and Health Claims Committee (UKNHCC) was asked to comment on the scientific basis for the health claims of mulberry (M. alba) leaves. extracts are “clinically proven to help maintain healthy blood sugar levels.”
It was proposed that the scope of the application be subject to health requirements related to disease risk reduction, including a request for privacy protection, which was subsequently withdrawn.
The nutritional product claimed to be healthy is a single component extract of M. alba (white mulberry) leaves.
In the opinion of the Committee, the nutritional extract of M. alba leaves is not sufficiently characterized for the proposed claims.
The applicant’s claim is that M. alba leaf extract is “clinically proven to help maintain healthy blood sugar levels.” The putative risk factor was elevated blood sugar and the associated risk disorder was type 2 diabetes. The proposed target group is “patients with type 2 diabetes”. Such claimed effects are outside the scope of Article 14(1)(a) health claims. As defined in Article 2(6) of Regulation (EC) No 1924/2006, a “disease risk reduction claim” is any health claim that states, recommends or implies the consumption of a food category, food or one of the its components. Significantly reduced risk factors for the development of human diseases. According to the Diet, Nutrition and Allergy (NDA) Panel of the European Food Safety Authority (EFSA), the Commission believes that health claims should refer to the general (healthy) population. The Committee also considered that if a health claim relates to a function or effect that may be associated with a disease, subjects with the disease are not the target population for the claim (EFSA, 2021).
The Committee was not aware of the methodology used in the literature review submitted by the applicant and therefore could not assess whether all the evidence had been submitted for consideration. The Applicant has identified a total of 13 publications that it believes are relevant to the claims, including:
Of the evidence provided by Applicant, 2 RCTs (Lown et al. 2017; Thondre et al. 2021) did not evaluate the evidence supporting this claim. The randomized controlled trial (Mudra et al., 2007) was a summary report and was considered to have a potentially high risk of bias. An uncontrolled study (Chatterji and Fogel, 2018) did not evaluate evidence to support this claim. Five publications (Bensky, 1993; Asano et al., 2001; Saudek et al., 2008; Gomyo et al., 2004; NIH, 2008) did not report food products and/or claimed effects. Three publications (Lown, 2017; Drugs.com, 2022; Gordon-Seymour, 2021) were non-scientific publications. One publication (Thaipitakwong et al., 2018) was a review article on mulberry leaves and their potential impact on cardiometabolic risk. In the opinion of the Committee, no conclusions can be drawn from these publications to support this assertion.
Based on the information provided, the Committee concluded that a causal relationship between consumption of the M. alba leaf extract and the claimed effects could not be established. The committee also concluded that no evidence was provided of an association between the claimed effects and the risk of developing type 2 diabetes.
The application contained a request for the protection of confidential data, which was subsequently withdrawn.
The food that was the subject of the health claim was M. alba (white mulberry), which accounted for 50% of the roundworm content.
The presence of mulberry significantly reduced the amount of glucose from the control level to a lower level and significantly increased the level of insulin compared to the control level. In a clinical study, roundworms were tested for their ability to lower glucose levels. A single-centre open prospective intervention study was conducted in Israel.
The Applicant proposes the following wording of the health benefit claim: “Clinically proven to help maintain healthy blood sugar levels.”
The applicant did not propose specific conditions for the use of the M. alba food that is the subject of the declaration. Suggested terms of use are provided for the Ascarit supplement. The proposed target group is patients with type 2 diabetes.
Pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006 [footnote 1] Modified by nutrition claim (amendment) regarding health claims of mulberry leaf extract and maintenance of healthy blood sugar levels, etc. d.) (EU Rejection) Regulation 2019 and Food Regulations (Amendments, etc.) (Leaving the EU) Regulation 2020 Application ID: 002UKNHCC. Presented by Ascarit UK.
1.1 In response to a UKNHCC request for clarification of the food product that is the subject of the health claim, the applicant confirmed that the food product is an extract of M. alba (white mulberry leaf). The Applicant did not provide details on the composition, batch-to-batch variability, or stability studies of the M. alba leaf extract.
1.2 The Applicant provided an overview of the Ascarite manufacturing process described as a multi-component additive containing:
Leaves and flowers are cleaned and freshly processed (i.e. retaining their original color, shape, and swelling) by a combination of cutting, pressing, and heat extraction with brewing to maximize the recovery of plant products, including sheet latex. After that, the liquid is quickly cooled to 20-30 degrees Celsius, and then filtered. The root and bark components are cleaned, then processed using heat removal and cooling. The mixed solution contains (as a percentage by weight of the total mass of the solution) 50% Morus, 20% Artemisia, 10% Urtica, 10% Cinnamon and 10% Taraxacum.
The applicant requested that the proprietary nature of Ascarit’s composition and manufacturing process be retained, but later withdrew this requirement.
1.3 In the opinion of the Committee, the nutritional extract of the leaves of M. alba, which is the subject of the health claim, has not been adequately characterized with regard to the implications of the proposed claim.
2.1 Applicant states that type 2 diabetes is a metabolic disease characterized by elevated blood glucose levels. In response to a UKNHCC request for evidence characterizing the relationship between a putative risk factor (elevated blood glucose) and the risk of an associated disease (type 2 diabetes), the applicant submitted 3 studies (DCCT, 1995; Rohlfing et al., 2002; Sveta, 2014). Both the Diabetes Control and Complications Trial (DCCT) study group (1995) and Rolfing et al. (2002) reported DCCTs including patients with insulin-dependent diabetes (type 1) but not with type 2 diabetes. type (disease for which risk reduction is required). ). Swetha (2014) calculated the correlation between HbA1c (glycosylated hemoglobin) and various outcomes (fasting, postprandial and resting glucose) to assess their usefulness for monitoring glycemic control in diabetic patients. In the opinion of the committee, the applicants did not provide evidence of a causal relationship between elevated blood glucose levels and the risk of developing type 2 diabetes, or whether elevated blood glucose levels are an independent predictor of type 2 diabetes.
2.2 The Applicant provided some additional information in response to a UKNHCC request for information on outcome, outcome variables and proposed interventions for assessing risk factors in human studies. However, based on the information provided, it is not clear to the Committee what results the applicants are proposing and how they will be evaluated.
2.3 Applicant’s claimed effect is “clinically proven to help maintain healthy blood sugar levels”. The target group proposed by the applicant are patients with type 2 diabetes.
2.4 The Committee notes that the proposed target group of patients with type 2 diabetes is not subject to health claims under Article 14(1)(a) of Regulation (EC) No 1924/2006. As defined in Article 2(6) of Regulation (EC) No 1924/2006, a “disease risk reduction claim” is any health claim that states, recommends or implies the consumption of a food category, food or one of the its components. Significantly reduced risk factors for the development of human diseases. According to the Diet, Nutrition and Allergy (NDA) Panel of the European Food Safety Authority (EFSA), the Commission believes that health claims should refer to the general (healthy) population. The Committee also considered that if a health claim relates to a function or effect that may be associated with a disease, subjects with the disease are not the target population for the claim (EFSA, 2021).
2.5 To achieve the claimed effect, the applicant recommends taking 2 roundworm capsules with water 30 minutes before meals 3 times a day. Applicants do not suggest concentration, dosage or duration of use.
2.6 The Committee noted that a reduction in the postprandial glycemic response may be considered beneficial for individuals who already suffer from impaired glucose tolerance, but the Committee considered that the proposed wording did not meet the criteria for consideration in Article 14(1)(a), nor did it make statements on health benefits Population criteria against which claims of reduced risk of disease can be made.
3.1 When requested by the UKNHCC, applicants are requested to provide details of the literature review, including authorship, objectives, eligibility criteria, full search strategy and each database searched. The information provided was so limited that the Committee was unable to assess whether all the evidence had been submitted for consideration.
3.2 The Applicant has identified a total of 13 publications that it believes are relevant to the claims, including:
The Committee considers that no conclusions can be drawn from these publications as there is no verified evidence to support this claim.
3.4 Contains a link to a book on Chinese herbal medicine (Bensky, 1993). No chapter information, page numbers, or excerpts from the book were submitted to the committee for consideration, so they could not be graded.
3.5 The fact sheet (NIH, 2008) summarizes studies on diabetes control and complications and follow-up studies, but does not evaluate the evidence supporting this claim, so no conclusions can be drawn from this publication.
A laboratory study (Asano et al., 2001) described the release of M. alba alkaloids and their inhibitory effect on glycosidases, but evidence to support this claim has not been evaluated. The Committee considers that no conclusions can be drawn from these publications.
3.7 In three RCTs (Lown et al., 2017; Thondre et al., 2021; Mudra et al., 2007), participants were randomly assigned to receive mulberry leaf extract. Lown et al. (2017) and Thondre et al. (2021) were double-blind, randomized, repeated measures, crossover trials evaluating the use or non-use of a proprietary mulberry leaf extract (Reducose®) versus placebo in healthy subjects participants’ glycemic responses to a carbohydrate challenge. In the opinion of the Committee, no conclusions can be drawn from these publications because they did not evaluate the evidence supporting this claim. Mudra et al. (2007) is a summary report summarizing a randomized crossover study that evaluated the effect of mulberry leaf extract or placebo on the blood glucose response of healthy participants (10 participants) and patients with type 2 diabetes (10 people). The Committee considered that the study may have been at high risk of bias due to lack of information about the randomization process, potential bias associated with the intended intervention, and potential bias in the selection of reported results.
3.8 An uncontrolled study (Chatterji and Fogel, 2018) included patients with type 2 diabetes. Chatterji and Fogel (2018) evaluated the effect of herbal composition SR2004 (consisting of M. alba leaves, U. dioica leaves, cinnamon bark, A. dracunculus leaf extracts and T. officinale root extracts) on HbA1c levels once a week for 12 days. weeks and then at 24 weeks. In the opinion of the Committee, no conclusions can be drawn from this uncontrolled study, which did not evaluate the evidence supporting the claims.
3.9 The Committee therefore considers that no conclusions can be drawn from the evidence presented by the complainant on the effect of albaflora leaf extract on blood glucose concentrations.
4.1 In evaluating the evidence, the committee considered 1 randomized controlled trial (Mudra et al., 2007) from which conclusions could be drawn.
4.2 The Committee concluded that, based on the evidence presented, it was not possible to establish a causal relationship between consumption of Albiflora leaf extract and the claimed effects. The committee also concluded that no evidence was provided of an association between the claimed effects and the risk of developing type 2 diabetes.
Morus Alba (Muscus alba) Leaf Extract The subject matter of the proposed health claims has not been adequately characterized in relation to the implications of the claims
Effect claims for patients with type 2 diabetes do not meet the criteria set out in Regulation (EC) No 1924/2006. in accordance with Section 14(1)(a).
A causal relationship between consumption of mulberry leaf extract and the claimed effects could not be established, and there was no evidence of an association between the claimed effects and the risk of developing type 2 diabetes.
Post time: Jan-29-2023