China Food

Is “five questions” hyaluronic acid really OK from “external supplement” to “internal administration”?

“  
What is the mechanism of action of
hyaluronic acid after entering human body? Can oral hyaluronic acid be absorbed
 ”

Text: Eudora Chen   
Source: foodaily daily food (ID: foodaily)

Hyaluronic acid, the scientific name of hyaluronic acid, is a raw material ingredient in food, cosmetics, medicine, pets and other fields. It passed the examination of the National Health Commission on January 7 this year and was approved to be used in common food. I believe everyone can feel that hyaluronic acid has become a hot new food raw material in the food circle. Whether Huaxi bio, which is leading the application for the approval of hyaluronic acid, or traditional and cutting-edge brands such as Hankou No.2 factory and wonderlab, are all involved in this new “tuyere”.

Photo source: Health times,
 
But obviously, behind this vigorous market, the voice of support and doubt from the industry and consumers has never stopped. But at the same time, we can not deny that the popularity of hyaluronic acid not only reflects the brand’s satisfaction to the needs of new consumers, but also promotes the rapid development of the whole industry.
 
In order to promote the application and development of new food raw materials in food nutrition and health industry and functional food field, as well as face up to people’s dispute over hyaluronic acid, a roundtable Forum on “promoting the application of new food raw materials and developing food nutrition and health industry — development trend of functional food” was held in Beijing on May 28, Zhang Fenglou, former Vice Minister of the Ministry of health, and the food department of the National Health Commission, as well as authoritative food nutrition experts and industry representatives from China Center for Disease Control and prevention, China Nutrition Society, Jiangnan University, Shandong University and other institutions and universities attended the meeting to discuss the industrial development of functional food, calling for strengthening the research and development and application of hyaluronic acid and other new food raw materials.
 
Today, foodaily will also take you to all aspects of the new food star raw material “hyaluronic acid” to see if it can really help you solve your doubts through the following five questions?
 
1. Is hyaluronic acid a functional food?
2. What is the action mechanism of hyaluronic acid after it enters human body?
3. Can oral hyaluronic acid be absorbed? How much can it absorb? What can be achieved?
4. How to achieve the compliance of hyaluronic acid new food raw materials?
5. How does the industry regulate hyaluronic acid, a new food raw material? Through what channels?
 
Is hyaluronic acid a functional food?
What’s the difference with ordinary food?
 
In fact, functional food is not a legal concept in China, it is considered as a bridge between food and medicine in the industry, which meets the individual health needs. In some concepts, functional food is actually the concept of health food, which refers to the food with the functions of enhancing the body’s epidemic prevention, regulating the body’s rhythm, preventing diseases and promoting health. Only in academic and scientific research, “functional food” is more scientific.
 
Referring to the Japanese and European and American markets, the United States calls it food supplement, while Japan calls it functional food. Their management of this kind of food is relatively broad and has a long history, and the market is mature. But in China, what is the difference between functional food and health food?
 
As we all know, health food is often referred to as “little blue cap” because of its product logo characteristics. It is a kind of food with the function of regulating the body, not for the purpose of treating diseases, claiming to have specific health functions or for the purpose of supplementing vitamins and minerals. Generally speaking, enterprises need to go through extremely strict and cumbersome steps to apply for health food. In 2016, the State Food and Drug Administration announced 27 declaration functions of health food. However, in recent years, in the actual application process, in addition to improving immunity, the other items are almost no longer over approved.
 
In fact, Huaxi bio has been applying for new resource food raw materials since 2004. After four years, it was finally approved that hyaluronic acid can be used as health food raw materials in 2008, and successfully approved a small blue hat health product “Xianli ORF” with the main effect of replenishing water. However, there are two major limitations of hyaluronic acid raw materials: one is that it can only be used in health food, the other is that it only approves the effect of water supplement, so this leads to a contradiction: Although the little blue hat logo is a bonus item for consumers to make purchase decisions, it also makes other effects of the product can not be claimed, and limits the potential consumer groups, Product potential cannot be fully exploited.
 
Photo source: Huaxi bio brand self operated store
 
However, with the development and progress of the industry, we believe that the application scope of functional food will be wider, and the innovation and operability will be stronger. At present, functional food has experienced three generations of development in China.
 
The first generation of functional food is based on the composition of the base material to infer the function of the product, without verification, lack of functional evaluation and scientific. The second generation of functional food is confirmed to have physiological regulation function by animal and human experiments. The third generation of functional food is based on the second generation of functional food, to further study the structure, content and action mechanism of its functional factors, to keep the physiological active ingredients in food in a stable form.
 
To sum up, hyaluronic acid is a functional food because of its functional benefits for skin, gastrointestinal tract, eye health, bone and joint health. But since it is called “functional food”, what effective role does “hyaluronic acid” in hyaluronic acid food play? Is it a publicity stunt or a real one?
 
What is the action mechanism of hyaluronic acid after it enters human body?
Is it really feasible to go from “external supplement” to “internal administration”?
 
From our previous reports on hyaluronic acid food, we can clearly feel that not only ordinary consumers, but also many food professionals have doubts about the efficacy of hyaluronic acid, especially the mechanism of action after it enters the body.
 
Frankly speaking, this should be a great challenge for enterprises including Huaxi bio to actively promote the addition of hyaluronic acid in common food. What are the characteristics of hyaluronic acid? What is the effect of such food addition in the continuous use of consumers? Is there any authoritative scientific research result to explain to the public?
 
Photo source: Liu Yang, the extreme news of Chutian Metropolis Daily
 
In response to these questions, Professor Zang Hengchang, director of the Key Laboratory of pharmaceutical preparation technology research and evaluation of the State Drug Administration and vice president of the Academy of pharmaceutical regulatory Sciences of Shandong University, answered the questions with research reports from international authoritative literature
 
1. Can oral hyaluronic acid be absorbed?
 
Studies have shown that 90% of oral hyaluronic acid is absorbed in the digestive tract. In addition, after metabolism, it can be partially absorbed and utilized by organisms. Many literatures have reported on this aspect, among which three research reports published in international authoritative journals are the most representative. They are respectively “pharmacokinetics of c-14-labeled hyaluronic acid in rats after oral administration” published in the scientific world journal in 2014 by research and Development Department of kewpie company of Japan, The research results of degradation and absorption of oral hyaluronic acid in gastrointestinal tract published by Tokyo a & M University and research and Development Department of kewpie company in 2017, and the research results of metastasis of oral hyaluronic acid to lymphatic system and blood published by Hokkaido University in 2020.
 
These articles have a common and similar view that hyaluronic acid with large molecular weight can be degraded into oligohyaluronic acid with smaller molecular weight by microorganisms in the intestine, and the molecular weight is less than 10000. In this way, the molecular weight of hyaluronic acid can be absorbed by receptor-mediated endocytosis or non receptor mediated endocytosis of intestinal epithelial cells, and further transferred to the blood or lymph.
 
These experiments give us a scientific proof that hyaluronic acid can be absorbed. Moreover, after decomposition and absorption, about 76.5% of them are metabolized by the liver into energy consumption, and about 8.8% of them are transported to various tissues and organs, which has also been reported in a large number of literatures. This is the absorption, distribution and metabolism of hyaluronic acid.
 
Photo source: jmarkliving
 
2. What are the functions of oral hyaluronic acid?
First, in the gastrointestinal tract, oral hyaluronic acid has the effect of protecting gastric mucosa, alleviating intestinal inflammation and regulating intestinal flora. A number of clinical studies have found that oral hyaluronic acid can promote the expression of anti-inflammatory cytokine IL-10 by binding with intestinal receptor after it enters the intestine, so as to play an anti-inflammatory role. In addition, the relevant studies showed that hyaluronic acid can significantly regulate the structure of intestinal flora and maintain the balance of intestinal mucosal system. Through such experiments, hyaluronic acid is very beneficial to intestinal health.
 
Second, in terms of eye health, oral hyaluronic acid can alleviate dry eye. In 2019, several scientists in South Korea carried out a clinical study on oral hyaluronic acid to alleviate dry eye disease, and compared the clinical study of single use of hyaluronic acid eye drops and simultaneous use of hyaluronic acid eye drops with oral hyaluronic acid. It was found that oral hyaluronic acid combined with eye drops hyaluronic acid can significantly improve the symptoms, which is a statistically significant result.
 
Third, it plays an anti-inflammatory role in the development of bone and joint. Oral administration of high molecular weight hyaluronic acid combined with TLR4 of intestinal epithelial cells, then promoted the expression of IL-10 and cytokines, and inhibited the expression of pleiotropic growth factor, thus playing an anti arthritis role. There are many international studies show that oral hyaluronic acid can promote the symptoms and cartilage metabolism of patients with osteoarthritis.
 
Fourth, it can improve the physiological characteristics of the skin and enhance the firmness of the skin. Japan first published the clinical study of oral hyaluronic acid in improving dry skin in 2001, indicating that oral hyaluronic acid has the effect of maintaining cell structure, enhancing skin water retention and slowing down skin water loss. In addition, oral hyaluronic acid can also promote collagen synthesis, free radical scavenging and anti-oxidation, so as to improve the young skin and slow down skin aging.
 
3. Is oral hyaluronic acid toxic?
 
Korean scholars have conducted toxicological studies on oral hyaluronic acid, and found no toxicity of oral hyaluronic acid. Many countries have done a lot of clinical trials on oral hyaluronic acid, and no adverse events have been found. In particular, the Cleveland medical center in the United States published the results in 2019, proving that oral administration of hyaluronic acid is safe. In foreign countries, oral hyaluronic acid has a history of more than 20 years, but no adverse reports have been found.
 
As Zang Hengchang said: “we should believe in the support of material basis for function. Hyaluronic acid is in the human body, but with the aging of the human body, the content is getting lower and lower. Although the reports on the role of hyaluronic acid are based on literature reports, it is this material basis that ensures the human body function. When we take hyaluronic acid orally, it must have its reason as a supplement to the functional material base. “
 
Perhaps many research results are too academic for consumers to understand, but speaking from consumer experience is also a strong evidence to prove the efficacy of oral hyaluronic acid. We need to take a more objective view of this new raw material, and expand its influence through the beneficiaries, so that hyaluronic acid can release its own use as far as possible under the legal norms. Here we mentioned the laws and regulations. Next, let’s discuss how to regulate hyaluronic acid in the current industry?
 
How to verify the compliance of new food raw materials?
How to restrict the standardization of functional food?
 
In China, although the development of functional food and health food is relatively fast in the past two years, the legislation is gradually improving because of its late start. However, we are very sure that each new food raw material license can bring about the upgrading of the follow-up industry. It not only promotes the application and industrial innovation of new food raw materials, but also is an important step in the development of healthy China’s national strategy.
 
Hyaluronic acid, as a new raw material of biological fermentation, was applied to all kinds of beverages, alcoholic products, chocolate and candy products at the beginning of this year. It is the result of detailed demonstration and scientific investigation. But at the same time, we also encounter difficulties – after Huaxi biological promoted hyaluronic acid into food, a large number of hyaluronic acid food appeared in the market within one month. However, if the industry wants to develop healthily and in the long run, and let consumers consume clearly, it must have norms and standards to avoid shoddy and chaos.
 
In view of this, we need to clarify how to achieve the compliance of hyaluronic acid new food raw materials? How to regulate the next development of functional food industry?
 
Zhang Leishi, the first level inspector of the food department of the National Health Commission, said at the meeting that any new food raw materials need to be managed according to the administrative examination and approval. According to the food safety law, enterprises using new food raw materials to produce food should submit relevant safety assessment materials to the health Administration Department of the State Council; The administrative department of health under the State Council shall, after organizing the examination, grant licenses to the projects that meet the requirements of food safety and publish them. At present, the food department of the National Health Commission has entrusted the national food safety risk assessment center to set up a new food raw material review expert database, which will review the safety of new food raw material application materials declared by enterprises or individuals.
 
So how should the industry regulate hyaluronic acid, a new food raw material?
 
Foodaily learned that the sodium hyaluronate approved by the health commission as a common food additive is based on the relevant production process and technical standards of raw materials reported by Huaxi bio. Domestic hyaluronic acid enterprises need to produce food grade hyaluronic acid raw materials according to this standard.
Liu Ming, assistant director of the National Center for food fermentation standardization and professor level senior engineer of China Academy of food fermentation industry, said: “hyaluronic acid is a new raw material for biological fermentation. According to the management regulations and very detailed examination rules, we are responsible for the production of strains and production processes, as well as the toxicology of the raw materials produced, As well as dietary exposure and risk assessment
 
At the same time, Liu Ming also said that the approval of new food raw materials is only the beginning. From raw materials to scientific and reasonable application in food, it is also necessary to carry out the research and development of standardization of raw material quality specifications and product inspection methods. It is reported that in the food industry, some large enterprises will require relevant suppliers to provide “substantial equivalence” when purchasing raw materials to prove that the quality of the raw materials is the same as the raw material standard of hyaluronic acid approved by the National Health Commission. To a large extent, Huaxi bio has become the first choice for food enterprises to purchase hyaluronic acid raw materials. In addition, because the quality of raw materials will affect the content and efficacy of end products, the purity of hyaluronic acid (the content of sodium hyaluronate) approved for consumption this year is 87%, while that of leading enterprises such as Huaxi bio can reach more than 95%. Only through scientific research and formulation of raw material standards and the establishment of effective quality control and detection technology system can we ensure the content and efficacy of products and the true consistency of hyaluronic acid content of terminal products, so as to effectively protect the rights and interests of consumers and achieve value for money.  
Zhao Yan, chairman of Huaxi bio, also said that Huaxi bio will assist the industry association to promote the formulation of standards and clarify the standards for hyaluronic acid intake. At the same time, the enterprise will also set up research projects with other institutions to study and promote the standardization of hyaluronic acid intake. For example, before that, Huaxi biology and the gastrointestinal mucosa research center of Harvard Medical School in the United States carried out joint research on “the improvement effect of oral administration of hyaluronic acid with different molecular weight segments on the gastrointestinal tract”, and carried out research with other universities on the improvement of dry eye and bone and joint health…
 
Finally, Zhao Yan also said: “how to make a small material play a big role and create a big market requires our industry experts, friends from enterprises and media circles, including consumers, to discuss how the industry can develop healthily. In particular, we do not want or want to see people blindly follow suit. This year, hyaluronic acid has just been approved to enter the ordinary food industry. We really hope to have a correct voice to guide the healthy development of this industry. “
 
What is the development prospect of hyaluronic acid food industry?
 
According to the analysis report on the upstream, middle and downstream markets of China’s hyaluronic acid industry chain in 2021, the market scale of hyaluronic acid in China will increase from 4.52 billion yuan in 2015 to 13.6 billion yuan in 2019, with a compound annual growth rate of 27.5%. It is estimated that the market scale will reach 15.46 billion yuan in 2021. But in the field of food, how much potential does it have?
 
According to the data, oral hyaluronic acid has been widely used in Japan, the United States, the United Kingdom, South Korea and other countries; According to public information, in 2020, 161 kinds of food on the market in Japan contain hyaluronic acid.
 
Photo source: Coca Cola’s body tour website
 
According to the white paper on the application scenarios of hyaluronic acid released by iResearch this year, at the present stage, Chinese consumers’ cognition of hyaluronic acid is not high. Consumers’ cognition of hyaluronic acid application products still stays in the fields of traditional skin care products and medical beauty products, and their cognition of emerging fields such as medicine, food and pets is relatively low. However, after the introduction and explanation of the material characteristics and product efficacy of hyaluronic acid, more than 80% of consumers showed strong interest and purchase intention for hyaluronic acid products. Especially in the field of food, consumers’ acceptance of hyaluronic acid food reached 84% after suggesting the characteristics and efficacy of hyaluronic acid. At the same time, with the implementation of “healthy China” strategy and the further upgrading of health consumption, functional food with efficacy and nutrition will be favored by more and more people.
 
As mentioned in the recently released report on nutrition and chronic diseases 2020, the health status of Chinese people is getting better year by year, but there are also some problems, such as the coexistence of over nutrition and undernutrition or lack of nutrients, especially the insufficient intake of micronutrients. Therefore, it may be a good innovative idea for enterprises to consider combining the newly approved new food raw materials with some micronutrients to develop a new product.
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Read the original
Is “five questions” hyaluronic acid really OK from “external supplement” to “internal administration”?
新食品原料的合规性如何考证?
功能性食品的标准化如何约束?
 
在中国,功能性食品和保健食品虽然近两年发展比较快,但因为起步晚,所以立法才在逐步健全中。但我们非常确认的是,每一个新食品原料许可都能够带来后续产业的升级,它不仅推动了新食品原料的应用和产业创新,更是发展健康中国国家战略的重要一步。
 
透明质酸作为一种生物发酵的新原料,今年初被应用到各种饮料、酒类制品、巧克力和糖果制品中,是经过详细论证和科学考察后的结果。但我们同时也遇到困难——在华熙生物把透明质酸推动入食以后,一个月内市场上就出现了大量的玻尿酸食品,但行业要健康长远发展,并且让消费者消费得清楚明白,就必须要有规范、有标准,避免以次充好,导致乱象。
 
鉴于此,我们需要明确,透明质酸新食品原料的合规性如何做到?功能性食品产业接下来的发展该怎么规范?
 
国家卫健委食品司一级巡视员张磊时司长在会议中表示,任一新食品原料都需要按照行政审批进行管理,《食品安全法》规定企业利用新的食品原料生产食品,应当向国务院卫生行政部门提交相关的安全性评估材料;国务院卫生行政部门组织审查后,对符合食品安全要求的项目准予许可,并公布。且目前国家卫健委食品司已委托国家食品安全风险评估中心,组建了新食品原料审查专家库,会对企业或个人申报的新食品原料申请材料进行安全性审查。
 
那么针对透明质酸这一新食品原料,行业该如何监管呢?
 
Foodaily了解到,此次卫健委批准的透明质酸钠作为普通食品添加,是根据华熙生物提报的原料产品而制定的相关生产工艺和技术标准,国内各家透明质酸企业均需按照此标准生产食品级透明质酸原料。
国家食品发酵标准化中心主任助理、中国食品发酵工业研究院教授级高工刘明表示:“透明质酸是生物发酵的新原料,根据管理规定和非常详细的审查细则,我们对生产的菌种和生产工艺,对所产生的原料的各种毒理学,以及膳食暴露和风险评估都进行了详细的研究。”
 
同时,刘明也表示,新食品原料获批仅仅是个开始,从原料到在食物中科学合理的应用,还需要开展原料质量规格、产品检验方法等标准化的研究和制定。据悉,在食品行业,一些大型企业在原料采购时会要求相关供应商提供“实质等同”,以证明此原料质量与国家卫健委批准的玻尿酸原料标准相同。而华熙生物在很大程度上成为了食品企业采购玻尿酸原料的首选。此外,因为原料质量会影响终端产品的含量和功效,今年透明质酸入食获批的纯度(透明质酸钠的含量)是87%,而龙头企业比如华熙生物能达到95%以上。通过科学的原料标准研究制定,建立有效的质控检测技术体系,才能保证产品的含量和功效,保证终端产品透明质酸含量的真实一致性,从而有效保障消费者的权益,达到物有所值。 

华熙生物董事长赵燕也对此表示,华熙生物会协助行业协会一起推动标准的制定,明确透明质酸入食的标准,同时企业接下来也还会和其他机构共同成立研究课题,一起研究并推动玻尿酸入食的规范化。例如此前华熙生物就跟美国哈佛医学院的胃肠黏膜研究中心进行共同课题研究“口服不同分子量段的透明质酸对胃肠道的改善作用,以及与其他高校展开关于对干眼症和骨关节健康的改善等多方面的研究……
 
最后,赵燕也寄语道:“如何让一个小物质发挥大功能,做出一个大市场,需要我们的行业专家、企业和媒体界的朋友、包括消费者,大家一起探讨这个行业怎样才能健康的发展。我们特别不希望,也不愿意看到大家盲目跟风。今年玻尿酸刚批准进入普通食品的行业,我们真的希望有一个正确的声音去引导这个行业健康地发展。”
 
玻尿酸食品产业的发展前景如何?
 
根据《2021年中国玻尿酸行业产业链上中下游市场分析报告》显示,我国玻尿酸市场规模从2015年45.2亿元增长至2019年136.0亿元,年复合增长率为27.5%,预计在2021年市场规模可达到154.6亿元。但在食品领域来看,它的发展潜力究竟有多大呢?
 
据资料显示,口服玻尿酸在日本、美国、英国韩国等国家已普遍应用;且据公开资料显示,2020年,日本市面上有161种食品中包含玻尿酸成分。
 
图片来源:可口可乐身体巡茶官网
 
今年艾瑞发布的《透明质酸应用场景白皮书》显示,现阶段我国消费者对透明质酸这一物质的认知程度并不高,消费者对于透明质酸应用产品的认知仍然停留在传统护肤品和医疗美容产品领域,对医药、食品、宠物等新兴领域认知度相对较低。但经过对透明质酸物质特性以及产品功效的介绍和解释之后,80%以上的消费者表现出了对于透明质酸产品较强的兴趣和购买意愿。特别是在食品领域,提示透明质酸特性和功效后,消费者对透明质酸食品的接受程度达到84%。同时,随着“健康中国”战略落地,健康消费进一步升级,具备功效和营养的功能性食品将会受到越来越多人的青睐。
 
正如最近发布的《营养与慢病状况的报告2020》中提到,如今国人健康状况一年比一年好,但也存在一些问题,例如营养过剩和营养不足或者缺乏并存,尤其说到微量营养素摄入不足。所以企业们是否考虑将新批准的新食品原料和某些微量营养素结合,开发出一种新产品,这或许也是不错的创新思路。

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