Food Regulations Research Articles

Nutrient Profiling Model Towards Recommendation of A Healthy Diet: A Scoping Review

The objective of this study is to identify the availability of Nutrient Profiling (NP) models worldwide and discuss their application. This scoping review is based on the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for the Scoping Review (PRISMA-ScR) and the Arksey and O’Malley framework. Articles related to NP among adults published from 2012 to 2022, written in English, were retrieved from the Web of Science, Science Direct, Scopus, and Pubmed databases. Mendeley software was used for database acquisition and MS Excel for the syntesis process. Only 17 articles out of 2,019 article titles identified met the inclusion criteria for the review. This review discovers that the applications of NP in nutrition policies include food labelling, Front-Of-Pack (FOP), and regulations on food marketing, health, and nutrition. Fibre is the nutrient that needs to be included in the NP application compared to saturated fats, fatty acids, sodium, and total sugar. This scoping review demonstrates the scientific basis of the NP model’s development in public health policy, leading to advocacy and the recommendation of healthy diets.

Functional Foods Regulation System: Proposed Regulatory Paradigm by Functional Food Center

In response to the rising demand for functional foods driven by health-conscious consumers, a robust regulatory framework is imperative. The absence of specific guidelines creates uncertainties for both manufacturers and consumers. In response to the rising demand for functional foods driven by health-conscious consumers, a robust regulatory framework is imperative. The absence of specific guidelines creates uncertainties for both manufacturers and consumers. This article discusses the Functional Food Center's pioneering 17-step approval processfor functional foods, emphasizing scientific validation and transparent communication. However, challenges persist within the FDA approval system, including a protracted timeline and the lack of a dedicated category for functional foods. Drawing inspiration from the efficient kosher labeling system, the Functional Food Center could serve as a certification agency. Certified functional foods could display a designated symbol, ensuring credibility and trustworthiness. This approach streamlines the approval process, fostering innovation, ensuring consumer safety, and meeting the evolving health needs of consumers in a transparent, credible, and regulated functional food market.Keywords:Functional Food Classification, Functional Food Regulation, Functional Food Products, Bioactive Compounds, Functional Food Safety, Kosher Labeling Model, Regulatory Paradigm.

How Do Consumers Living in European Capital Cities Perceive Foods with Sustainability Certificates?

Certification aims at ensuring food quality and safety, as well as confirming other beneficial credence attributes, such as local origin and sustainability. In order to explore the visibility and credibility of such certification labels functioning in the European Union, a study was conducted among residents of two EU Member States, Poland and Belgium. Face-to-face questionnaire-based interviews and focus group interviews were conducted among 701 adults living in Warsaw and Brussels-the capital cities of these countries. Almost 44% of Belgian respondents and 33% of Polish respondents considered certified foods as being of better quality compared to unlabeled products. Focus group interviews demonstrated that Belgian consumers had more extensive knowledge and a higher level of trust in certified foods compared to Warsaw inhabitants. Our findings suggest that certificates are moderately important factors of food choice due to the wide variety of certificates, leading to consumer confusion, a lack of label uniformity, greenwashing, limited visibility and availability at points of sale, consumer price sensitivity and the prioritization of other factors. These constraints can be alleviated by introducing food labeling standards and regulations. Increasing consumer awareness and the availability and affordability of certified foods can also boost the demand for sustainable products in the region.

Comparison of volatile aroma and sensory characteristics of doenjang and Korean‐style doenjang

AbstractDoenjang is a traditional soybean fermented food ingredient in Korea. According to the Korean Food Code, different categories were defined: doenjang and Korean‐style (Hansik) doenjang. Two different categories were classified according to its main ingredient called “Meju.” The purpose of this study was to compare the flavor characteristics including sensory characteristics and volatile aroma profiles of doenjang and Korean‐style doenjang according to the categories listed in the Korean Food Code. A total of six samples, including four doenjang and two Korean‐style doenjang samples, were included in this study. Sensory characteristics were analyzed by a highly trained panel (n = 7) using Spectrum™ method. Volatile flavor analysis was conducted using gas chromatography–mass spectrometry in conjunction with the Solvent Assisted Flavor Extraction method. Differences in sensory characteristics were documented between doenjang and Korean‐style doenjang categories, and one sample under doenjang category had distinctive aroma characteristics. Samples under doenjang were characterized with high intensities of fruit‐related aroma, possibly due to the presence of ester compounds, ethyl acetate, and phenyl ethyl alcohol. Korean‐style doenjang had characteristics related to the so‐called “traditional doenjang” in previous studies, such as meju and fish sauce aromatics, and these aromas may have been caused by the presence of 1,2‐dimethyl benzene and 3‐hydroxy‐2‐butanone.Practical ApplicationsAccording to the Korean Food Code, doenjang is divided into two categories based on the use of major ingredients called meju: doenjang and Korean‐style doenjang. To this date, studies related to flavor analysis of doenjang majorly focused on the final product, doenjang, while this study was conducted on the flavor analysis of doenjang categorized by the Korean Food Code. Finding from this study can aid small and mid‐sized doenjang manufacturers to strategically manage their flavor characteristics according to Korean food law and regulations.

Role of Aflatoxin B1 as A Risk for Primary Liver Cancer in India

The most well-known primary liver cancer in the world is Hepatocellular Carcinoma (HCC). Its prevalence is alarmingly increasing and has drawn public attention on a global scale. With regard to regional variation, racial differences, and socioeconomic level, it occurs more frequently in underdeveloped countries than in industrialised ones. Aflatoxin use is one of the main risk factors for HCC. Aflatoxin B1, a genotoxic hepatocarcinogen, is thought to induce cancer by causing DNA adducts in target liver cells that result in genetic alterations. HCC may result from a mutational impact caused by DNA adducts at the codon 249 hotspot in exon 7 of the P53 tumour suppressor gene, which interacts with the guanine bases of liver cell DNA. Aflatoxin-contaminated food affects about 4.5 billion people worldwide, mostly in developing nations with poor incomes. Treatment of crops that are prone to fungal contamination, proper food handling techniques, and the use of chemopreventive intervention are all part of prevention. Additionally, in order to maintain efficient food regulation systems and reduce the risk of aflatoxins contaminating food, a networked collaboration of several sectors, including public health, agricultural departments, and the media, is needed.

Scarabaeidae as human food – A comprehensive review

Abstract Rising global population and sustainable protein demand have sparked interest in unique food sources. Entomophagy, or insect consumption, presents a solution and Scarab beetles, part of the Scarabaeidae family, offer a novel food option. The comprehensive review underscores their potential as human food, with strong nutrition, low environmental impact, and the ability to ease strain on conventional agriculture. Nutritional analysis reveals rich protein content, essential amino acids, vitamins, and minerals. Scarab beetles’ beneficial fatty acid profile and healthy fats position them as a superior protein source to traditional livestock. Scarabaeidae excel in feed conversion, emit fewer greenhouse gases, and require minimal land, establishing them as an ecologically sustainable protein source. Cultural attitudes towards insect consumption vary; history exists in some regions while skepticism prevails in others. Highlighting nutritional advantages, organizing outreach, and introducing processed scarab products could enhance acceptance. The review addresses challenges including mass rearing, processing, allergens, and toxins. Evolving insect-based food regulations require cautious consideration. Success depends on multidisciplinary efforts including nutrition, environmental sustainability, cultural openness, and regulatory alignment. Continued research and collaboration are essential to fully unlock Scarabaeidae’s potential as a sustainable, nutritious food source for our growing global population.

The Mifepristone Litigation: Untangling the Implications of the Fifth Circuit's Decision for Abortion Access and the U.S. Food and Drug Administration.

In August 2023, a federal appeals court issued an opinion in Alliance for Hippocratic Medicine v FDA, a case wherein a group of antiabortion medical organizations and physicians have challenged U.S. Food and Drug Administration (FDA) approval and regulation of mifepristone. This opinion contained some good news for the FDA, drug makers, and patients: the appeals court declined to halt the marketing of mifepristone altogether (as the trial court judge would have). But the court also decided that the FDA's 2016 and 2021 actions expanding the indication for mifepristone, lowering the drug's dose, and loosening restrictions on its distribution and use were likely unlawful, and it thus affirmed the trial court's order staying these actions. In this article, we explain key aspects of the opinion to health care professionals and consider the ways in which the appeals court's reasoning and conclusions, if followed by the Supreme Court, could undermine abortion access and public health going forward.

Navigating Next-Generation Sequencing Laboratory Developed Tests: A Critical Look at Proficiency Testing, US Food and Drug Administration Regulations, and Clinical Laboratory Performance.

Navigating Next-Generation Sequencing Laboratory Developed Tests: A Critical Look at Proficiency Testing, US Food and Drug Administration Regulations, and Clinical Laboratory Performance.

Why do people accept or reject climate policies targeting food consumption? Unpacking justifications in the public debate in online social forums

A shift in dietary habits will be required to meet global climate targets. However, from a social dilemma perspective, major voluntary shifts in diet patterns are unlikely. Hence, government interventions are called for. This may be a perilous political endeavor, since food habits and choices are assumed to be personal and contentious matters and any food regulation policy risks stepping over the line for what people accept, risking policy legitimacy. In order to construct feasible policy measures, it is therefore important to gain knowledge of the prerequisites for support of climate food regulations and to understand why people accept or oppose regulations. The aim of this paper is to do so by analyzing the public debate concerning meat-free days in school canteens and a tax on meat in two public online social forums in Sweden. We seek to 1) map the arguments supporting (non)acceptability of the two food consumption regulation issues and 2) analyze what policy-specific and factual beliefs are reflected in the arguments and then detangle their meaning and content as revealed in the arguments. We find that policy-specific beliefs around freedom, fairness, and effectiveness are commonly used in support of or objection to these policies, but to different degrees, and often linked to factual beliefs about consequences for health or disadvantaged social groups. We conclude that the general reluctance of policy makers to interfere with what people eat is not necessarily well founded, and that better policy design, framing, and communication have the potential to increase policy support.

Cell-Based Meat Labeling – Current Worldwide Legislation Status – A Review

Abstract A growing interest has been noted among both industry operatives and consumers in cell-based meat (CBM), as visible in the increasing investment into this technology by major food industry corporations. However, in almost all countries worldwide, there is a lack of clear legislation with regard to the labeling of such products. The aim of the article is to collect and review current legal regulations concerning the international approval and labeling of these types of products. In the manuscript, we review and analyze the legal situation of CBM and its labeling in countries from 4 different continents (EU members, the UK, the USA, Canada, Australia and New Zealand, Japan, Singapore and Israel). Aside from Singapore, no other country has approved CBM for placement on the market. The US has reached an agreement and established regulatory frameworks on CBM matters, where both the USDA and the FDA will be the control institutions. Within the European Union, CBM products will be evaluated under the Novel Food Regulation. The most anticipated process in other countries is the evaluation of CBM under the legislation on novel foods and subsequent amendments. Since local laws are still being developed, special care should be taken by the policymakers to avoid implementing local laws which could cause a negative approach to the technology by the consumers.

Early Introduction of Novel and Less-Studied Food Allergens in the Plant-Based Era: Considerations for US and EU Infant Formula Regulations

Early life feeding practices may affect the long-term health of individuals, particularly in terms of the development of non-communicable diseases, such as metabolic and allergic diseases. Accumulating evidence suggests that the interplay of breastfeeding and/or formula feeding followed by the introduction of solids plays a role in the occurrence of non-communicable diseases both in the short and long term. International food allergy guidelines recommend that breastfeeding women do not need to avoid food allergens and do not recommend any infant formula for allergy prevention. Guidelines regarding solid food introduction for food allergy prevention recommend the introduction of well-cooked eggs and peanuts around 4–6 months of age, and not to delay the introduction of other food allergens. There is also an increasing trend to feed infants a plant-based or plant-forward diet and have access to infant formulas based on plant-based ingredients. The use of novel plant-based infant formulas raises a few questions reviewed in this paper: (1) Do fortified, plant-based infant formulas, compliant with US Food and Drug Administration (FDA) regulations and European Food Safety Authority (EFSA) (European) guidelines, support adequate infant growth? (2) Are plant-based infant formulas suitable for the management of cow’s milk allergy? (3) Does feeding with novel, plant-based infant formulas increase the risk of food allergies to the food allergens they contain? (4) Does feeding infants plant-based food allergens in early life increase the risk of allergic and severe allergic reactions? The review of the literature indicated that (1) plant-based formulas supplemented with amino acids and micronutrients to comply with FDA regulations and EFSA guidelines, evaluated in sufficiently powered growth studies, can support adequate growth in infants; (2) currently available plant-based infant formulas are suitable for the management of CMA; (3) an early introduction and continuous intake of food allergens are more likely to prevent food allergies than to increase their risk; and (4) an early introduction of food allergens in young infants is safe.

Translating risk-benefit assessment evidence for policy making: outcomes of an international workshop

Abstract Background Transitioning to sustainable, healthy, and inclusive food systems requires a multi-domain risk analysis approach. Integrated methods, such as health risk-benefit assessment (RBA), can support the formulation of coherent regulations by providing comparative information on potential trade-offs within the areas of food safety and nutrition. Despite extensive scientific developments and applications, RBAs have not yet been fully adopted by regulatory bodies. Hence, participatory science is needed to identify obstacles for implementation and communication of RBAs to optimize and ensure that generated evidence is compatible to regulatory needs. Methods As part of the EU funded project HOLiFOOD, an international workshop held in May 2023 brought together food regulators and other stakeholders from across Europe to identify bottlenecks in the use of RBA outputs in decision-making. The meeting included a key-note presentation, surveys, and group discussions. Results Thirty-seven participants from 19 institutions based in 13 countries attended the workshop. Obstacles identified were classified into one of the following themes: challenges of using RBAs to inform policymaking, opportunities and needs (e.g., reliability of methods), and communication of RBA outputs. Case studies targeting various foods groups or diets in different contexts is recommended. Conclusions Health RBA is a multidisciplinary method useful for prioritizing actions and ensuring transparency in decision-making. Case studies addressing the identified obstacles could increase the reliability of RBA methods and favour the adoption by regulatory bodies. Finally, moving towards holistic approaches may require further cross-departmental collaboration and, potentially, organizational changes of authorities in the future. Key messages • Risk-benefit assessment of foods is a robust tool to support public health policymaking. • Engagement with risk managers and other stakeholders is essential to deliver, and effectively translate, fit-for-purpose scientific evidence.

Acid adaptation increased the resistance of Escherichia coli O157:H7 in bok choy (Brassica rapa subsp. chinensis) juice to high-pressure processing.

Based on the U.S. Food and Drug Administration regulations, E. coli O157:H7 is a pertinent pathogen in high acid juices that needs to be inactivated during the pasteurization process. The results of this study suggest that the effect of acid adaptation should be considered in the selection of HPP parameters for E. coli O157:H7 inactivation to ensure that pasteurization objectives are achieved.

Evaluation of pesticide residues in selected vegetables from Kuala Lumpur, Malaysia using modified QuEChERS and assessment of washing methods

Growing population in Malaysia has resulted in increased production of local vegetables as well as pesticide usage. This constitutes a health risk to human health. In the present work, the level of ten pesticide residues namely chlorpyrifos, profenofos, aldrin, endrin, cypermethrin, lambda-cyhalothrin, carbendazim, propamocarb, imidacloprid, and thiamethoxam in ten types of vegetables collected from six local markets were measured using modified QuEChERS (quick, easy, cheap, effective, rugged, and safe) coupled with gas chromatography-tandem mass spectrometry (GC-MS/MS) and ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). Results showed that 13.3% samples contained pesticide residues above the maximum residue limit (MRL) prescribed by the Malaysian Food Regulations 1985, 55.0% of samples contained pesticide residues below the MRL, and no pesticide residues were detected in 31.7% of samples. Carbendazim and chlorpyrifos were among the highest pesticides detected in the samples. For the type of vegetables, kale and spinach contained high concentrations of pesticide residues above the MRL. In order to produce safe vegetables, the efficiency of different washing methods (tap water, 10% sodium bicarbonate solution, and 10% acetic acid solution) in reducing carbendazim and chlorpyrifos residues in a kale model system was evaluated. Results showed that the levels of carbendazim and chlorpyrifos reduction for all three methods were significantly different (p < 0.05) with 10% acetic acid solution being the most effective followed by 10% sodium bicarbonate solution, and tap water. Washing kale with 10% acetic acid reduced 76.0 and 41.2% of carbendazim and chlorpyrifos, respectively. Therefore, it is recommended for consumers to practice 10% sodium bicarbonate washing method by soaking vegetables with an acidic solution followed by rinsing with tap water to reduce pesticide residues, and minimise the exposure to hazardous pesticides.

Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.

Microbial challenge in-use studies are performed to evaluate the potential for microbial proliferation in preservative-free single-dose biological products after first puncture and potential accidental contamination during dose preparation (e.g., reconstitution or dilution) and storage. These studies, in addition to physicochemical in-use stability assessments, are used as part of product registration to define in-use hold times in Prescribing Information and in the pharmacy manual in the case of clinical products. There are no formal guidance documents describing regulator expectations on how to conduct microbial challenge in-use studies and interpret microbial data to assign in-use storage hold times. In lieu of guidance, US Food and Drug Administration (FDA) regulators have authored publications and presentations describing regulator expectations. Insufficient or unavailable microbial challenge data can result in shortened in-use hold times, thus microbial challenge data enables flexibility for health care providers (HCPs) and patients while ensuring patient safety. A cross-industry/FDA in-use microbial working group was formed through the Innovation & Quality (IQ) Consortium to gain alignment among industry practice and regulator expectations. The working group assessed regulatory guidance, current industry practice via a blinded survey of IQ Consortium member companies, and scientific rationale to align on recommendations for experimental design, execution of microbial challenge in-use studies, and a decision tree for microbial data interpretation to assign in-use hold times. Besides the study execution and data interpretation, additional considerations are discussed including the use of platform data for clinical stage products, closed system transfer devices (CSTDs), transport of dose solutions, long infusion times, and the use of USP <797> by HCPs for preparing sterile drugs for administration. The recommendations provided in this article will help streamline biological product development, ensure consistency on assignment of in-use hold times in biological product labels across industry, and provide maximum allowable flexibility to HCPs and patients while ensuring patient safety.

Survey of Food Product Labels to Assess Compliance With Labelling Provisions in Canada

Food product labels are a public health tool that guides consumers in making food choices. In December 2016, the Government of Canada amended the Food and Drug Regulations (i.e., nutrition labelling, list of ingredients, and food colour requirements). Health Canada and the Canadian Food Inspection Agency (CFIA) developed an implementation plan that focussed on education and compliance promotion of the new labelling provisions (Canadian Food Inspection Agency, 2022a). This progressive approach allows regulated parties to transition to the new changes gradually. As of December 15, 2021, the former regulations are no longer in effect, and the new labelling requirements apply. This study will survey food labels on products available in the marketplace, regarding the current labelling requirements, and determine whether there is a discrepancy in properly labelled food products between chain versus independent grocery stores of different ethnicity.

Advertising on Video-Sharing Platforms in the Toy and Food Categories in Spain

This article reviews the advertising content on the YouTube channels featuring kid influencers with the highest number of subscribers in Spain. The goal is to observe the evolution of the elements that define this type of content as advertising content, even though the vast majority of the advertising content is not labelled as such. An analysis was conducted of all the videos posted during the 2022 Christmas period on the 15 YouTube channels with the largest audiences, which produced a sample of 61 videos that possessed the pertinent characteristics. Content analysis was applied and the degree to which the content complied with food and toy advertising regulations was examined.

The Relationship between the Level of Nutritional Knowledge and Physical Activity on the Nutritional Status of Volleyball Athletes at the Attack Volleyball Club Samarinda

The need for nutrients in the world of sports is an important factor in supporting athlete performance. At present the related attention regarding the regulation of good food for athletes is still lacking. Nutritional issues are very important in achieving sports achievements. This study aims to analyze the relationship between the level of nutritional knowledge and physical activity on the nutritional status of volleyball athletes at the Attack Volley Ball Club Samarinda. The research design was cross-sectional involving 34 Attack Volley Ball Club Samarinda athlete respondents. Data were analyzed using Fisher Exact Test. The results showed that there was no significant relationship between nutritional knowledge and nutritional status (p-value = 0,116), then there is no significant relationship between physical activity and nutritional status (p-value = 0,125).

CFTR Function Restoration upon Elexacaftor/Tezacaftor/Ivacaftor Treatment in Patient-Derived Intestinal Organoids with Rare CFTR Genotypes.

Cystic fibrosis (CF) is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene. The combination of the CFTR modulators elexacaftor, tezacaftor, and ivacaftor (ETI) enables the effective rescue of CFTR function in people with the most prevalent F508del mutation. However, the functional restoration of rare CFTR variants remains unclear. Here, we use patient-derived intestinal organoids (PDIOs) to identify rare CFTR variants and potentially individuals with CF that might benefit from ETI. First, steady-state lumen area (SLA) measurements were taken to assess CFTR function and compare it to the level observed in healthy controls. Secondly, the forskolin-induced swelling (FIS) assay was performed to measure CFTR rescue within a lower function range, and to further compare it to ETI-mediated CFTR rescue in CFTR genotypes that have received market approval. ETI responses in 30 PDIOs harboring the F508del mutation served as reference for ETI responses of 22 PDIOs with genotypes that are not currently eligible for CFTR modulator treatment, following European Medicine Agency (EMA) and/or U.S. Food and Drug Administration (FDA) regulations. Our data expand previous datasets showing a correlation between in vitro CFTR rescue in organoids and corresponding in vivo ppFEV1 improvement upon a CFTR modulator treatment in published clinical trials, and suggests that the majority of individuals with rare CFTR variants could benefit from ETI. CFTR restoration was further confirmed on protein levels using Western blot. Our data support that CFTR function measurements in PDIOs with rare CFTR genotypes can help to select potential responders to ETI, and suggest that regulatory authorities need to consider providing access to treatment based on the principle of equality for people with CF who do not have access to treatment.

Policy instruments to reduce food loss prior to retail – Perspectives of fruit and vegetable supply chain actors in Europe

Food loss and waste burdens the food system with an unnecessary use of natural resources such as soil, land and water as well as with the avoidable generation of further climate-relevant emissions. These negative externalities may provide a rationale for public sector intervention where feasible and efficient.Semi-structured interviews with 22 experts (farmers, producer organisations and retailers) in Germany and a questionnaire survey with 215 suppliers of a retailing company from Germany, Spain and Italy were conducted. The material reveals the perspectives and claims of relevant actors in upstream fruit and vegetable supply chains on political intervention.Stakeholders identified policy instruments from four overarching thematic categories: (I) communicative and cooperative policies, (II) subsidisation and food prices, (III) regulation and political framework conditions and (IV) questioning of necessity and effectiveness of food loss interventions. Four further categories of private sector measures were identified: (I) mechanisation, innovation and process optimisation, (II) communication and cooperation, (III) reconditioning and repackaging and (IV) processing, alternative marketing and redistribution.Issues that should be addressed by policy include consumer education and awareness, supply chain cooperation and power relations, food prices, marketing standards, alternative marketing and processing and promotion of technologies, infrastructure and agronomic practices to reduce food loss. The study shows that additional leverage points for policy action are still unrecognised and that stakeholders should be more involved in tackling the root causes of food loss. These policies should be holistically embedded in the sustainability transformation of the food system.