INFORM January 2024

inform January 2024 Volume 35 (1)

Foods for SPECIAL MEDICAL PURPOSES

ALSO INSIDE: Whey protein phospholipid concentrates Oleaginous fungi Hydroxy fatty acids

2024 AOCS Annual Meeting & Expo

Palais des congrès de Montréal, Montréal, Québec, Canada

SHORT COURSE

Lipid Oxidation in Foods

Sunday, April 28, 2024

Lipids—essential for the quality and nutritional profile of foods—undergo oxidation, giving rise to hydroperoxides, aldehydes, ketones, acids, and alcohols, which can detrimentally influence food flavor, aroma, nutrition, and overall quality. This comprehensive course delves into the challenges posed by lipid oxidation in food systems and technologies that can help control these detrimental reactions to decrease food waste and increase food safety. Explore the diverse impacts of oxidation across various food systems, from bulk oils to low-moisture foods to frying oils and emulsions. Uncover the health implications of lipid oxidation products and discover innovative strategies that use natural antioxidants in food production. This short course will be held in conjunction with the 2024 AOCS Annual Meeting and Expo and Sustainable Protein Forum.

AOCS members receive discounted registration!

Learn more and register at annualmeeting.aocs.org/lipidox

January 2024 inform

10 FEATURES

Establishing specialized nutrition in China

Clinical nutritional support improves survival rates by shortening hospital stays and minimizing complications. So much so that China has established policies to systematize its use. Read about these foods for special medical purposes and how China sees them as a path to better healthcare for all.

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Concentrated forms of nutrition for next-generation dairy foods This article describes one research team’s effort to understand the physical properties of whey protein phospholipid concentrates with the objective of laying the foundation to someday produce foods that integrate these bioactive compounds. Oleaginous fungi Fungi can digest a variety of substrates and transform them into triacylglycerols. Read about research advancements for lipogenesis and predictions for its contribution to the future of human health. Novel oil biosynthetic pathway for hydroxy fatty acids Recent research indicates that a member of the Brassicaceae family uses multiple, unconventional pathways to convert carbon into lipids. The authors of this article describe how bioengineering the plant to generate more hydroxy fatty acid could lead to a new sustainable source for industrial products.

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CONTENTS

5 Index to Advertisers 15 AOCS Meeting Watch

7 Editor’s Letter 8 Division Update

29 Regulatory Review 31 Extracts & Distillates

2024 AOCS Annual Meeting & Expo

Palais des congrès de Montréal, Montréal, Québec, Canada

SHORT COURSE

Edible Fats and Oils Refining Basic Principles and Modern Practices

April 27–28, 2024

Delve into the intricacies of edible oil refining in this 2-day short course, which will be held in conjunction with the 2024 AOCS Annual Meeting & Expo and Sustainable Protein Forum. This course emphasizes practical applications and optimization, enabling participants to make informed decisions in their plant operations and refine edible oils effectively. Day 1—lays the foundation by exploring the extraction techniques of various oils, emphasizing their influence on oil content and quality, followed by an in-depth study of degumming processes, bleaching techniques, and filtration principles. Day 2—transitions into advanced topics such as deodorization, hydrogenation, inter-esterification, and fractionation. Engage with industry experts, explore innovations, and increase your knowledge of the oil refining landscape.

AOCS members receive discounted registration!

Learn more and register at annualmeeting.aocs.org/refining

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EDITORIAL ADVISORY COMMITTEE

Julian Barnes Etienne Guillocheau Jerry King

Gary List Thais L. T. da Silva Warren Schmidt Raj Shah

Ryan Stoklosa Ignacio Vieitez Bryan Yeh

AOCS OFFICERS PRESIDENT: Grant Mitchell, Process Plus, LLC, Cincinnati, Ohio, USA VICE PRESIDENT: Tony O’Lenick, SurfaTech, Lawrenceville, Georgia, USA TREASURER: Greg Hatfield, Bunge Limited, Oakville, Ontario, Canada SECRETARY: Gerard Baillely, Procter & Gamble, Mason, Ohio, USA PAST PRESIDENT: Silvana Martini, Utah State University, Logan, Utah, USA CHIEF EXECUTIVE OFFICER: Patrick Donnelly

AOCS STAFF EDITOR-IN-CHIEF: Rebecca Guenard MEMBERSHIP DIRECTOR: Travis Skodack

PAGE LAYOUT: Moon Design

The views expressed in contributed and reprinted articles are those of the expert authors and are not official positions of AOCS.

INDEX TO ADVERTISERS *Crown Iron Works Company. ........................................................................... C3 *Desmet Ballestra Engineering NA. ................................................................... C2

*Corporate member of AOCS who supports the Society through corporate membership dues.

Kick off the New Year with AOCS!

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EDITOR’S LETTER

inform January 2024, Vol. 35 (1) • 7

A great year ahead

Welcome to a new year of INFORM . We are grateful that you renewed your AOCS membership for 2024 and we look for ward to sharing in these pages all the exciting science news and updates that the year brings. Registration for the 2024 AOCS Annual Meeting & Expo opens this month. We hope you will join us from April 28 to May 1 at Palais des congrès de Montréal in Montréal, Québec, Canada. This year, the Annual Meeting will be co-located with the Sustainable Protein Forum. Forum presenters discuss the latest developments in research, policy, and industry that impact sustainable proteins and explore multidisciplinary solutions that will revolutionize

complex, integrated systems for future food production. Your AM registration will include access to the Forum, so take advantage of gaps in your schedule to attend and be inspired. Learn more about both programs by visiting annualmeeting.aocs.org. This month our cover story focuses on food for medical pur poses. The western world has conducted several studies that indicate prescribing a specific

“Your AM registration will include access to the Forum, so take advantage of gaps in your schedule to attend and be inspired.”

diet to sufferers of chronic dis ease reduces their symptoms and improves health outcomes. Small groups of diabetes and heart disease sufferers showed hopeful signs that better health outcomes are possible when providers have input into what the patient eats. In China, the government healthcare system has been using food as medi cine for decades. Our story describes the policies that estab lished the practice and how China uses food as medicine today. Our other feature articles relate to interesting science in keeping with the issue’s theme, Health & Nutrition. The first feature describes one research team’s ambition to bet ter understand the physical properties of whey protein phos pholipid concentrates. The group sees potential to one day integrate these bioactive compounds into food to increase its nutritional value. In the next feature article, the authors focus on bioengi neering plants to generate more hydroxy fatty acids. By study ing the metabolic pathways of a member of the Brassicaceae family, the researchers identified unconventional pathways

for converting carbon into lipids. They bred plants to promote these pathways and increase the production of fatty acids with a functional group that can lead to a variety of applications. Fungus is the main character in our next feature article. Read about how these microorganisms can produce triacyl glycerols under the right conditions. The article’s author shares his enthusiasm for the future potential of this source of essen tial lipids. We are off to a great start with the contents of this first issue of the year. We hope you enjoy reading it.

Yours in science,

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Your AOCS Community

Health and Nutrition Division News INFORM: How did you become acquainted with AOCS? How have you participated in the community?

AOCS Divisions are forums for sharing tech nical information while offering networking and mentorship for early career profession als. The Health and Nutrition Division pro motes and facilitates communication and cooperation among professionals whose interests in lipid biochemistry and physi ology relate to all aspects of dietary fats and health. The division encompasses the technical areas of dietary fats and general health. MEMBER SPOTLIGHT: MEET EMERSON NOLASCO This issue of INFORM presents an interview

Nolasco: I became acquainted with AOCS thanks to my advisor Kaustav Majumder and my lab mates. As a lab, we started partici pating in AOCS around 2018-2019, and I later participated for the first time in the virtual conference in 2020. Afterward, I participated in the Health and Nutrition and the Protein and Co-Products Division as a poster pre senter. I also participated in both Division’s sessions to brainstorm what topics could be featured in future meetings. I realized there are more things in common than we think between Divisions, and we can work together to enhance the science quality and relevance in our research areas. AOCS is a great way to network with peers in academia and research-based industry, the latter is something I would like to pursue after graduation. So, I will take advantage of the mentoring, networking, and the introduction to career oppor tunities AOCS offers. INFORM: How does AOCS currently support your profes sional goals? Nolasco: In my three years of being a member and partici pant in the annual meetings, AOCS has been a great platform to showcase my research and skills as well as an excellent plat form for networking with peers in academia and the indus try. This is important for early career researchers as we can make connections that will be beneficial in our careers after graduation. INFORM: How does the Health and Nutrition Division align with your interests and research area? Have you made any connections that have helped you in your field? Nolasco: The Health and Nutrition Division is great for our research area as it aligns with how food-derived compounds such as carotenoids, omega-3 fatty acids, peptides, or diges tion-resistant proteins can impact the health of consumers. It

Emerson Nolasco

with Emerson Nolasco, a graduate student member of the Health and Nutrition division. Nolasco has been a member of AOCS for three years and has participated in the poster pitch competition, winning second place in two consecutive years (2022 and 2023) in this Division, along with the People’s Choice Award in 2023. Moreover, Emerson has participated in the Protein and Co-Products Division poster pitch competition, winning second place as well as the People’s Choice Award in 2023. INFORM: What are your areas of research as a graduate student, and what led you to your interest in health and nutrition? Nolasco: I’m currently working with functional foods, which is a food that gives you a health benefit beyond nutrition. Specifically, I work with egg white hydrolysate and how it can impact different mechanisms of hypertension, delay ing its progression as a preventive approach. For my under grad, I mainly focused on food chemistry and food safety, but coming to the University of Nebraska-Lincoln expanded my knowledge on how food can have a positive impact on our body. Food compounds play a role in how our cells and gut microbiome respond to stress and inflammation, which I find fascinating.

inform January 2024, Vol. 35 (1) • 9

INFORM: Do you have any recommendations or advice for people early in their careers or students who are inter ested in Health and Nutrition? Nolasco: I would recommend engaging and participating in any opportunity AOCS or any other association has to offer. By engaging we network, build our community, exchange ideas that we would otherwise not consider, and develop soft skills which are very valuable in any environment where we perform. INFORM: What is your ideal next step after you graduate? Nolasco: I would like to take the skills I have learned in the Food BioPep Lab at the University of Nebraska-Lincoln and apply them in the industry. In the last five years, there have been companies that are applying concepts such as precision fermentation and molecular biology to produce food that is more sustainable and nutritious. I will take my experience and insights from the Health and Nutrition Division and help make food even healthier to maximize the benefits for consumers.

is hard to believe but there was not a conference specifically for proteins since it is a wide topic. AOCS has fostered research scientists in this area in a great way and now even more with the Sustainable Protein Forum. I have made valuable connections with the judges from my poster presentations, my advisor’s previous lab members, and fellow graduate students. I’m sure we will help each other down the road. INFORM: What is the greatest benefit that you have derived from your involvement in AOCS and the Health and Nutrition Division? Nolasco: I have been able to gain skills in communicating my science in an understandable and accessible way to peers in different areas while participating in the poster competitions. I have also been able to meet excellent professionals such as Dr. Ignacio Vieitez and Dr. Rinat Ran-Ressler. We shared some thoughts during the Division dinner in 2022 and it was nice to hear about their professional path and how they got involved in AOCS.

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10 • inform January 2024, Vol. 35 (1)

Establishing specialized nutrition in China Liang Song

Food as medicine is an idea starting to gain traction in the Western world, but in China provid ing patients with clinical nutritional support has been practiced since the 1970s. Foods for Special Medical Purposes (FSMP), as they are called, have shown potential to enhance survival rates by reducing hospitalization length and decreasing complications, hence minimizing readmission rates which lowers associated healthcare costs. China has adjusted policies, in recent years, to system atize medical foods and potentially reduce national healthcare spending while improving the physi cal well-being and quality of life of its citizens.

Distinct from pharmaceuticals, FSMP cannot prevent, treat, or substitute for medication in man aging disease or clinical disorders. However, FSMP do require medical prescriptions or advisors, so they occupy a unique position between pharmaceu ticals and health supplements. They do not claim health-related benefits or nutrient supplementation properties which differentiate them from health supplements. Due to increased government atten tion and improved policies, FSMP are being used more among the elderly, patients with chronic ail ments, and those undergoing surgery. China has implemented their policies in accor dance with the trajectory of the medical food industry. Over four decades, the government has developed and refined the regulatory framework for retail pharmacy sales of FSMP. Regulations govern ing the display, promotion, and sale (including online commerce) of FSMP are now explicitly outlined for multiple geographic regions within the coun try. Here we discuss those policies and the future of FSMP in China. FOOD-BASED MEDICINE The application of food as medicine varies according to a patient’s needs. However, there are some com mon ingredients worth discussing. Fat is one of the three essential nutrients for the human body. In FSMP, different functional fats are chosen as raw materials based on the metabolic characteristics of patients. For instance, in full-nutri ent specialized medical foods designed for liver dis -

• FSMP in China, tailored for conditions like diabetes, respiratory disorders, and inflammatory bowel diseases, have demonstrated promise in improving patient outcomes and meeting specific dietary requirements. • The development and market accessibility of these foods were impacted by regulatory policy, particularly the implementation of the Food Safety Law. • FSMP distribution in China encompasses both in-hospital and external channels, with in-hospital pharmacies often playing a key role. • China has established regional regulations for FSMP sales and collaborative ventures between distribution enterprises, manufacturers, and medical institutions aim to create comprehensive solutions. • China established dedicated regulatory divisions for FSMP to ensure food safety and oversee their registration. These divisions have contributed to industry growth and market consolidation through comprehensive oversight.

HEALTH & NUTRITION

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Examples of Food for Special Medical Purposes sold in China. Clockwise from the top-left: comprehensive fiber nutritional formula pow der, formula food containing protein, electrolyte formula beverage, formula food containing carbohydrates, formula food for preterm/ low birth weight infants, and comprehensive nutritional formula powder.

ease patients, medium-chain triglycerides (MCT) may be used as a fat source due to their unique metabolic pathway, which alleviates the burden on the liver. Proteins are large molecules that cannot be directly absorbed by the human body. They are valuable only after enzymatic hydrolysis that breaks them down into peptides and amino acids. Consequently, FSMP products include pro tein sources derived from plants and animals, as well as pep tides or amino acids obtained from animal or plant protein hydrolysates.

Carbohydrates are the primary energy source required to maintain vital bodily functions. Common carbohydrate sources in FSMP include glucose, lactose, maltodextrin, cornstarch, and dietary fiber sources such as soy fiber, soy polysaccharides, soy oligosaccharides. Vitamins are essential micronutrients. Both the FSMP Regulation (GB 29922-2013) and the Standards for the Use of Food Nutritional Enhancers (GB 14880-2012) specify the per missible range and sources of vitamins. Similarly, GB 29922 outlines limited standards for minerals, including sodium,

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TABLE 1. Primary technical requirements for common Non-Full-Nutrient Formula foods. Product Category Formula’s Key Technical Requirements

Protein (Amino Acid) Components: • Comprised of proteins and/or amino acids • Protein sources may include one or more amino acids, protein hydrolysates, peptides, or high-quality whole proteins Fat (Fatty Acid) Components: • Comprised of fats and/or fatty acids • Options include long-chain triglycerides (LCT), medium-chain triglycerides (MCT), or other legally approved fat (acid) sources

Nutrient Components

Carbohydrate Components: • Based on carbohydrates

• Carbohydrate sources may include monosaccharides, disaccharides, oligosaccha rides, polysaccharides, maltodextrin, glucose polymers, or other legally approved raw materials

Thickening Components

• Based on carbohydrates • Incorporates one or more thickening agents • May include dietary fiber • Primarily based on carbohydrates and proteins • Can include various vitamins and minerals • May contain dietary fiber

Liquid Formulation

Electrolyte Formulation

• Primarily based on carbohydrates • Contains appropriate electrolytes

Amino Acid Metabolic Disorder Formulation

• Mainly composed of amino acids but lacks or contains minimal amounts of amino acids related to metabolic disorders • Contains adequate fats, carbohydrates, vitamins, minerals, and/or other components • Meets partial protein (amino acid) requirements while addressing the patient’s need for certain vitamins and minerals

The General Guidelines for FSMP outlines 13 full-nutrient formula foods intended for patients with diverse medical con ditions. These include: • diabetes • chronic obstructive pulmonary disease (COPD) • kidney disease, malignant tumors (cachexia) • inflammatory bowel disease • food protein allergies • refractory epilepsy • obesity • weight-loss surgery • liver disease • muscle wasting syndrome • stress-related conditions (trauma, infection, surgery, and others) • fatty acid metabolism disorders • gastrointestinal absorption disorders In addition, there are non-full-nutrient formula foods designed for individuals requiring specific or partial nutrient supplementation (Table 1), those with metabolic disorders, or those with distinct dietary needs. Whether they are full-nutri ent or non-full-nutrient formulas, the key distinction in FSMP lies in the composition and content of the product.

potassium, copper, magnesium, iron, and others. In addition to essential nutrients, the standard permits the addition of optional nutrients to full-nutrient formula foods. While these nutrients are not mandatory, they contribute to human growth and development. Currently, in China, six optional nutrients have been added to registered products, including chromium, molybdenum, choline, taurine, L-carnitine, and dietary fiber. However, fluo ride, inositol, and nucleotides have not yet been incorporated. This opens new avenues for future research and development of FSMP. MEDICAL CONDITIONS AND DISTINCTIONS Foods for Special Medical Purposes are categorized into two main groups: Infant FSMP and Non-Infant FSMP. Infant FSMP in China are designed for patients aged 0-12 months and encom pass a variety of formulations. Examples include lactose-free or low-lactose options, partially hydrolyzed protein formula tions, premature or low birth weight infant formulas, breast milk supplements, and formula for amino acid metabolic disor der. On the other hand, Non-Infant FSMP are tailored for indi viduals over one year with specific nutritional requirements, digestive absorption disorders, metabolic disorders, or other medical conditions.

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IMPLEMENTATION METHODS The Chinese government developed and refined the regula tory framework for retail pharmacy sales of FSMP over many years. Presently, the distribution of FSMP in China happens through both in-hospital and external channels. Within the hospital premises, FSMP are retailed through on-site pharma cies, often affiliated with chain drugstores. Hospitals procure these products through bidding and purchasing mechanisms, typically upon recommendations or prescriptions from clinical nutritionists. FSMP are also available externally through vari ous outlets such as pharmacies, supermarkets, and maternity stores. Another approach to FSMP distribution involves collabo rative ventures between distribution enterprises or manufac turers and medical institutions, sometimes engaging all three parties. These collaborations leverage the financial strengths of distribution enterprises or manufacturers and aim to cre Food is Medicine in the US In the past five years, a ‘food is medicine’ movement has taken hold in the US. Some of that attention can be cred ited to research conducted by Seth Berkowitz, professor of medicine at the University of North Carolina at Chapel Hill. Berkowitz and his team conducted two studies on medically tailored meals, designed by dieticians for spe cific conditions. The first study, published in 2018, showed that when 100 patients participating in government healthcare pro grams received medically tailored meals, they visited the emergency room 70% fewer times and were admit ted to the hospital 52% less often. A follow-up study in 2019, involved around 1000 adults, half received medi cally tailored meals. When their admission rates to med ical facilities were compared to the half that did not receive meals, there was a similar decrease in admis sions as that seen in the smaller study ( https://doi. org/10.1377/hlthaff.2017.0999, https://doi.org/10.1001/ jamainternmed.2019.0198). These positive findings have sparked interest in fur ther research and the establishment of organizations ded icated to ‘food is medicine’ becoming a standard of care in the US. The current administration allocated $2 million in funding last year for a pilot program and the National Institute of Health dedicated grant money for develop ing centers of excellence where researchers will study implementation. However, before food is medicine becomes a norm, its advocates will have to navigate a few barriers. First, there are federal laws that require a waiver if a Medicaid program wants to offer any food interventions. Then, there is the fact that employer-provided coverage is sparce when it comes to medically tailored meals.

ate holistic solutions that encompass science, nutrition, and health. FSMP CASE STUDIES Chinese researchers have predominantly concentrated their efforts on developing disease-specific FSMP, notably for con ditions like diabetes, respiratory disorders, and inflammatory bowel diseases. Products meant to treat these ailments have successfully entered the domestic market. Diabetes, a prevalent metabolic disorder characterized by elevated blood glucose levels, has been a prominent area of research. For instance, Bao-quan Jiang, professor of Nutrition and Food Hygiene at the Third Military Medical University, used biotechnological fermentation to create a special ized medical yogurt designed to protect pancreatic function, improve sugar metabolism, and lower blood glucose and lip “If we don’t figure this out, our health-care costs are going to continue to skyrocket and we will continue to have some of the worst heart attacks, mortality rates and obesity rates in the world,” said Mitchell Elkind, the American Heart Association’s chief clinical science offi cer and a professor of neurology and epidemiology at Columbia University, in an interview with the Washington Post, last summer. “We have to be better on this.”

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TABLE 2. Regulatory framework for different stages of FSMP products. Stage Regulatory Approach Development Standards for food additives and nutrient fortification during the research and development process are clearly defined in “General Guidelines for Special Medical Purpose Infant Formula Foods” (GB 25596-2010) and “General Guidelines for FSMP” (GB 29922-2013). Clinical According to “General Guidelines for FSMP” (GB 29922-2013), specific full-nutrient formula foods require clini cal trials. Applicants must engage accredited clinical trial institutions to produce clinical trial reports, which must encompass comprehensive statistical analysis and data. Registration The materials supplementation period spans six months, with the typical registration process for a newly devel oped FSMP product taking around a year. The registration procedures and eligibility criteria are more rigorous compared to conventional food or health products. For specific full-nutrient formula foods, the inclusion of clini cal trial reports may extend the timeline to as long as three years. Production To standardize the production of FSMP, the State Administration for Market Regulation introduced the “Detailed Review Regulations for Production Permits of FSMP” in 2016. These regulations cover production facilities, equipment, layout, processes, personnel management, and corporate governance for FSMP manufacturers. Distribution The “Interim Measures for Reviewing and Administering Advertisements for Drugs, Medical Devices, Health Foods, and FSMP” (2019) stipulate that advertisements for FSMP must prominently specify their target audi ence, explicitly state that they are unsuitable for non-target audiences, recommend usage under the guidance of a physician or clinical nutritionist, and restrict the advertising of specific full-nutrient formula foods to medi cal and pharmaceutical professional publications jointly designated by the State Council’s health administration department and the State Council’s drug supervision and management department. Additionally, Article 19 of the “Measures for Investigating and Dealing with Illegal Acts in Food Safety on the Internet” (2017) specifies that specific full-nutrient formula foods for specialized medical purposes cannot be sold online.

ids. The findings laid a strong theoretical foundation for diabe tes-specific medical foods. Gestational Diabetes Mellitus (GDM), a condition caused by prolonged high blood sugar levels during pregnancy, poses substantial risks to both mother and fetus. Jin-feng Ji, deputy chief physician at Xiaolan Hospital, affiliated with Southern Medical University, conducted a study involving 103 GDM patients. The study integrated dietary management, edu cation, and diabetic nutritional supplements. The results suggested that this comprehensive approach effectively man aged and controlled GDM, consequently reducing pregnancy complications. Respiratory disorders, such as chronic obstructive pul monary disease (COPD), acute respiratory distress syndrome (ARDS), and acute lung injury (ALI), have received significant attention. FSMP for COPD often include high-fat, low-carbo hydrate formulations containing medium-chain triglycerides (MCTs) and omega-3 unsaturated fatty acids to preserve lung function and alleviate inflammation. Yan-li An, chief physician at Zhengzhou People’s Hospital, conducted research show casing the benefits of enteral nutritional support in reducing clinical symptoms and markers in ARDS patients. The results underscored the positive impact of early nutritional support for ARDS patients after mechanical ventilation, leading to bet ter patient conditions and reduced mortality rates. Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease, have also been a target of research. FSMP for IBD aims to mitigate inflammatory lesions by adjust ing dietary composition, often using easily digestible proteins and low fiber content. Lactose intolerance is common among

enteritis patients, necessitating lactose-free products. Xiu-fang Wang, chief physician at Xinhua Hospital of Hubei Provinces, conducted a study involving 131 ulcerative colitis patients, which emphasized the advantages of enteral nutrition in improving body weight, albumin, and total protein levels. In summary, the development of disease-specific FSMP in China, particularly for diabetes, respiratory disorders, and inflammatory bowel diseases, has shown promise in improving patient outcomes and addressing unique dietary needs associ ated with these conditions. HISTORY OF FSMP IN CHINA The first phase in the evolution of China’s FSMP policy began between 1970 and 2000. During this period, as clinical nutri tion advanced, the potential societal value of FSMP emerged. Reports of their clinical application first appeared in Beijing as early as 1974. In the 1980s, the Chinese healthcare system started recognizing the specialization of nutrition disciplines. Formal policies to regulate the use of clinical nutrition took hold in the early 2000s. In 2002, the Chinese Medical Association classified FSMP as a category, while government bodies indicated their relevance by including them on medical insurance policies. In 2006, the China Nutrition Improvement Action Plan emphasized proper nutrition for sustaining health. Comprehensive guidelines were established for enteral and parenteral nutrition to assist physicians in devising suitable nutritional support regimens and outline operational proto cols. This era established China’s specific technical and func tional requirements for FSMP. It also identified issues arising

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from policy disparities, laying the foundation for the country to refine and improve related policies. The third phase (post-2009) signifies a period of policy refinement. In the new Food Safety Law, FSMP were explicitly designated as ‘foods,’ a departure from their previous classifi cation under the Drug Administration Law. This shift influenced the development of these foods within China and restricted the entry of foreign products into the market. To address concerns related to product development and clinical demand, the National Health Commission introduced a ‘2+1’ standard management scheme. Concurrently, the China Food and Drug Administration issued the Regulations on the Registration and Management of FSMP (Trial), providing com prehensive regulatory framework and technical support. These policies layout legal stipulations, along with practical require ments for regulatory authorities and manufacturers to safe guard FSMP quality. REGULATORY PROCESS FOR FSMP DESIGNATION Recognizing the unique position of FSMP within the food industry, in April 2017, China established the Special Food Registration and Management Division under the China Food and Drug Administration. The primary role of this division was to develop and oversee the regulatory framework and asso ciated standards for registering special foods. These special foods include health foods, infant formula products, and FSMP. Additionally, in August 2018, a Special Food Safety Supervision and Management Division was established under the State Administration for Market Regulation. As part of the broader institutional reforms, China’s regulatory system for FSMP has undergone steady evolution. This regulatory framework relies on government-led oversight, supported by industry self-regulation and enterprise independent action. Together, these elements work to shape a new mechanism aimed at promoting the long-term and healthy development of the FSMP sector in China. As the food safety management system continues to evolve, regulatory agencies have intensified their oversight. This comprehensive regulatory approach spans the entire life cycle of FSMP, as outlined in Table 2. Government authorities

have played a crucial role in facilitating the steady growth of the FSMP industry. Consequently, certain brands have either voluntarily exited or been compelled to withdraw from the market, contributing to further market consolidation.

FUTURE DIRECTIONS FOR CHINA’S FSMP INDUSTRY

Despite the existence of a regulatory framework for over five years, certain categories within complete nutritional formula foods and non-complete formula foods lack approved prod ucts, and the specialized medical foods market faces several challenges: 1. FSMP are categorized as food, not pharmaceuticals, leading to higher prices compared to standard medica tions and limiting the possibility of reimbursement. 2. Stringent registration requirements, requiring approval from relevant authorities and clinical trial reports, result in high costs and lengthy timelines. 3. Advancements are needed in manufacturing processes, nutritional preparation stability, safety, efficacy, and clinical formulations. China lacks technical personnel and research funding in this field, with a limited variety of products, mostly imported. 4. FSMP require medical supervision, but the distribution network is inadequate, hindering access. 5. The FSMP industry in China is in its early stages, with challenges in understanding national policies and regis tration requirements. To promote growth and address these challenges, the industry needs proactive government policiesl. Recent invest ments in technological innovation within the nutrition and health-focused food industry, along with policy developments related to FSMP, are expected to drive significant demand within healthcare institutions. New standards for various med ical conditions are in the pipeline, enhancing the compre hensiveness of specialized medical purpose formula foods in China. Liang Song is an associate professor in the School of Food Science and Technology at Dalian Polytechnic University. He can be reached at ryo.song@foxmail.com. AOCS EVENTS WATCH April 28-May 1, 2024. AOCS Annual Meeting & Expo, Montréal, Québec, Canada. https://annualmeeting.aocs. org/about/save-the-date-for-2024 April 28-May 1, 2024. Sustainable Protein Forum, Montréal, Québec, Canada. https://sustainableprotein. aocs.org/ To advance your career and learn new skills, visit https:// www.aocs.org/education and register for our latest Continuing Education Program or contact us at general@ aocs.org, +1 217-359-2344.

16 • inform January 2024, Vol. 35 (1)

Milk is a complex fluid that provides all the nutrients necessary for growth and development. For centuries, milk has contributed prominently to human nutrition. As consumers strive for balanced, nutritious diets, they are beginning to appreciate the benefit of dairy. Beyond being a comprehen sive source of essential nutrients, milk offers a broad range of bioactive components that maintain human homeostasis and bolster immune function. Concentrated forms of nutrition for next-generation dairy foods Jerina Rugji and Gulustan Ozturk

Our lab’s objective is to produce next-generation dairy foods that integrate these biologically active compounds to promote healthier dietary habits and extract maximum value from dairy resources. With the support of the National Dairy Council, we are specifically investigat ing changes that occur in the whey protein phospholipid concentrate (WPPC) matrix during thermal treatment. This research is instrumental in comprehending the underlying effects of processing and allows us to tai lor the processing methods, thereby enhancing the efficiency of isolating compounds such as whey proteins, milk fat globule membrane proteins, and phospholipids, all of which hold substantial nutritional and economic value. THE COMPOUNDS IN MILK The unique structure and chemical composition of milk fat globules (MFG) sets them apart from less complex oils derived from plants. MFG serve as a unique delivery system that transport bioactive mol ecules to the gastrointestinal system (https://doi.org/10.1016/j. idairyj.2007.10.014). MFG are lipid globules with an average diameter of around 4 μm ( https://doi.org/10.1016/j.idairyj.2004.03.005 ). They consist of a core of triglycerides surrounded by a triple-layer biological membrane known as the milk fat globule membrane (MFGM) that originates from the mam mary gland’s epithelial tissue. (https://doi.org/10.1016/j.tifs.2008.07.006 ). The MFGM has a unique composition. It consists of 40% lipids, mainly phospholipids, and 60% proteins, including glycoproteins (https:// doi.org/10.1016/j.idairyj.2006.05.004). In detail, MFGM contain vari ous bioactive proteins, such as butyrophilin, glycosylation-dependent cell adhesion molecule 1, mucin 1 and 15, lactadherin, adipophilin, fatty

• Whey protein phospholipid concentrate is a by-product of whey processing with great potential for industrial application. • Bioactive compounds derived from whey protein phospholipid concentrate have the potential to be used as cutting-edge ingredients. • Understanding heat-induced alterations in whey protein phospholipid concentrate will enable us to tailor the processing methods to increase the yield for the extraction of bioactive compounds.

HEALTH & NUTRITION

inform January 2024, Vol. 35 (1) • 17

acid-binding protein heart, polymeric immunoglobulin recep tor, and platelet glycoprotein 4 (Figure 1). MFGM also con tain phospholipids, namely phosphatidylethanolamine (PE), phosphatidylcholine (PC), phosphatidylserine (PS), phospha tidylinositol (PI), and sphingomyelin (SM). The presence of MFGM proteins and phospholipids in bovine milk accounts for around 1-2% of the overall protein and fat content (https://doi. org/10.1016/j.tifs.2003.12.005). Due to its unique composition and valuable components, MFGM have been studied exten sively (https://doi.org/10.1093/nutrit/nuab099 ). ISOLATION TECHNIQUES Innovative technologies have advanced to significantly enhance the production and generation of dairy-derived compounds. Dairy processing yields a variety of by-prod ucts containing bioactive compounds, such as lactose, pro teins, non-protein nitrogen compounds, minerals, fats, and various solids (https://doi.org/10.1039/C8GC00517F ). Whey is a common by-product derived from the dairy industry and is typically categorized into two main types: sweet whey, a byproduct of cheese and yogurt production, and acid whey, obtained during the manufacturing of cottage cheese and Greek yogurt (https://doi.org/10.17113/ftb.59.02.21.6968). Different products are manufactured from these different types of whey, leading to variations in their protein levels, min eral composition, lipid content, and lactose concentrations. Advancements in processing technology, particularly membrane filtration, have enabled the successful separation of whey compounds. Pioneering techniques such as microfil tration and ultrafiltration during processing can separate fats and proteins from whey (https://doi.org/10.1108/NFS-01-2018 0017). For example, whey protein phospholipid concentrate is obtained from the microfiltration of whey protein concentrate (WPC) in the process of whey protein isolate (WPI) production (Figure 2, pg. 18). The American Dairy Products Institute (ADPI) has established a marketing standard sheet for WPPC, stating that WPPC should contain a minimum of 50% protein and 12% fat on a dry basis (https://www.adpi.org).

WPPC COMPOSITION A recent comprehensive analysis of a WPPC demonstrated that phospholipids constituted 20% of the total lipid pool and glyco sylated membrane-bound proteins, including milk fat globule membrane proteins, accounted for 23% of total proteins (1-2% in bovine milk and 1% in human milk) (Figure 3, pg. 18) (https://doi.org/10.1080/10408398.2017.1386158).

PAS6/7

Sphingomyelin

Butyrophilin

Cholesterol

Xanthine oxidase

Triglyceride core

XO

Adipophilin

A

CD36

TGC

Glycolipids

Phospholipids

Glycoproteins (MUC 1, MUC 15, Lactadherin

Whole Milk

Fat Globules

Milk fat globule membrane

FIG. 1. Milk fat globule membrane and related compounds. Source: Thum, C., et al. , Front. Nutr., 9, 2022.

Whey

Whole Milk

Fat Globules

Milk fat globule membrane

18 • inform January 2024, Vol. 35 (1)

PAS6/7

Sphingomyelin

Butyrophilin

Cholesterol

Whey

Xanthine oxidase

Triglyceride core

XO

Adipophilin

A

UF Retentate

CD36

TGC

Glycolipids

UF Permeate

Phospholipids

Glycoproteins (MUC 1, MUC 15, Lactadherin

Whey Protein Concentrate

Whey Permeate

Whole Milk

Fat Globules

Milk fat globule membrane

MF Retentate

MF Permeate

Whey Protein Phospholipid Concentrate

Whey Protein Isolate Whey

FIG. 2. Whey protein phospholipid concentrate production. Source: Ozturk, G., et al. , Dairy , 3 (2), 2022.

UF Retentate

UF Permeate

WPPC represents a concentrated MFGM protein source. The most prevalent protein in the MFGM is glycosylation-de pendent cell adhesion molecule 1 (GLYCAM-1), accounting for 7% of the total abundance. Following this, butyrophilin con stituted 5%, lactadherin made up 4.45%, xanthine oxidase comprised 2.25%, and fatty acid-binding protein heart had an abundance of around 2%. These MFGM proteins have been associated with positive effects, such as anti-carcinogenic, immunomodulatory, and antibacterial activities (https://doi. org/10.4049/jimmunol.165.5.2859). For example, xanthine oxi dase demonstrated antimicrobial properties similar to human milk. Whereas WPPC’s potent antimicrobial properties have been determined to be three times higher than bovine milk ( https://doi.org/10.3390/dairy3020022 ). WPPC is an exceptional reservoir of polar lipids. Researchers have identified MFGM phospholipids—namely phosphatidylethanolamine (PE), phosphatidylcholine (PC), 25 20 15 10 5 0 Human milk % Bovine milk MFGM Protein WPPC Whey Protein Phospholipid Concentrate MF Retentate

phosphatidylserine (PS), phosphatidylinositol (PI), and sphingo myelin (SM)—as a significant component of WPPC. Scientists have determined the relative quantities (Figure 4) of phospho lipids such as PE, PC, and PS are higher in WPPC in comparison to human and bovine milk (https://doi.org/ 10.1046/j.1442 200x.2000. 01169). Clearly, milk phospholipids are associated with multiple cellular functions, namely cell growth, devel opment, molecular transportation systems, absorption pro cesses, memory, stress responses, the onset of Alzheimer’s disease, anti-cholesterolemic effect, and the process of myelin ation in the central nervous system (https://doi.org/10.3168/ jds. S0022-0302(03)73822-3). Furthermore, a diet rich in MFGM components has shown a positive effect on cognitive development (https://doi.org/10.1016/j.jpeds.2023.113483). As an ingredient rich in MFGM proteins and phospholip ids, WPPC and its fractions could be successfully formulated into products designed to improve human nutrition, including WPPC Major Proteins Glycam 1 Lactadherin Fatty acid binding protein Adipophilin Butyrophilin Xanthine oxidase Mucin 15 Mucin 1 Whey Protein Isolate Whey Permeate

Whey Protein Concentrate

MF Permeate

% % %

WPPC Major Proteins

MFGM Protein

25 20 15 10 25 20 15 10 5 0

%

Phospholipid Distribution

Total Phospholipids

100 90 80 70 60 50 40 30 20 10 0

Glycam 1 Lactadherin Fatty acid binding protein Adipophilin

Butyrophilin Xanthine oxidase Mucin 15 Mucin 1

Human milk

Bovine milk

WPPC

%

5 0

FIG. 3. MFGM protein shared in human milk, bovine milk and WPPC. Source: Ozturk, G., et al. , Dairy , 3 (2), 2022 and Liao, Y., et al. , J. Proteome Res. , 10, 8, 2011.

Bovine milk

WPPC

Human milk

Human milk

Bovine milk WPPC