Recently, the State Administration of Market Supervision issued the Label Guide for Formulated Foods for Special Medical Uses, which is not only an important measure to do a good job in the safety supervision of formulated foods for special medical purposes, but also an important step in the standardized development of the formulated foods for special medical purposes, and will become the basis for the stable and healthy development of the industry in the future.
Recently, the State Administration of Market Supervision issued the "Guidelines for the Identification of Formulated Foods for Special Medical Use" (hereinafter referred to as the "Guidelines") in order to guide enterprises to standardize product labels and instructions, and to guide doctors, clinical nutritionists and consumers to use the foods for special medical purposes scientifically and rationally.
The Guide clarifies the 13 items of product name, product category, ingredient list, nutrient composition list and the main display layout of special medical food labels and instructions. At the same time, it also clarifies the "prohibition requirements" of special medical food labels and instructions, and prohibits related enterprises from using false and exaggerated words including "special effects" and "full effects" in product promotion, so as to avoid misleading consumers as much as possible.
The industry evaluation pointed out that the publication of the Guide is not only an important measure to do a good job in the safety supervision of special medical food, but also an important step in the standardized development of the special medical food industry, which will become the basis for the stable and healthy development of the industry in the future.
Strengthen the management of identification labels
Special medical food refers to the formula food specially processed and prepared to meet the special needs of people with food restriction, digestive absorption disorder, metabolic disorder or specific disease state for nutrients or diet, and must be used under the guidance of doctors or clinical nutritionists. The well-known special medical foods include infant formula for special medical use suitable for 0-12 months old, and formula for special medical use suitable for people over 1 year old, such as patients with digestive tract surgery, patients with tumor radiotherapy and chemotherapy, diabetic patients, renal dialysis patients and so on.
Judging from the strictness of relevant management laws and regulations in China, special medical foods are second only to medicines, and far higher than ordinary foods and health foods. To strengthen the market supervision of special medical foods, we must first strengthen the management of labels.
The "Guide" emphasizes that the identification of special medical food should comply with the provisions of relevant laws, regulations, rules and national food safety standards. If the contents of the special medical food registration certificate are involved, they should be consistent with the contents of the registration certificate. It is required that the labels and instructions of special medical foods should be true and standardized, scientific and accurate, easy to understand, clear and easy to distinguish, and must not contain false, exaggerated or absolute language.
The Guide systematically summarizes 13 items that need to be marked in the labels and instructions of special medical foods, refines the font requirements of enterprises for product names, commodity names and trademarks, clarifies the requirements for clinical trials of specific total nutrition formula foods, and puts forward the font and warning language requirements for "warning instructions and precautions".
In view of the fact that the contents of the main display pages of some products are numerous and complicated, which is not conducive to consumers’ clear identification, the Guide clearly puts forward the contents that should be marked on the main display pages, and puts forward for the first time that the minimum sales package of special medical food should be marked with the special medical food exclusive symbol "Little Blue Flower". The logo should be marked in the upper left corner or upper right corner of the main display page of the label, which can be changed in proportion to the style. Non-special medical food shall not be fraudulently used or stolen.
With the continuous development of China’s economy and society, the continuous improvement of people’s health needs and the continuous increase of aging social groups, the special medical food industry is in a period of rapid development.
The "Guide" issued by the General Administration of Market Supervision is a technical guidance document, which aims to standardize the logo of special medical food enterprises, guide doctors, clinical nutritionists and consumers to use it scientifically and rationally, and further enhance the awareness and recognition of special medical food in the whole society.
Li Liangqiu, executive vice president of China Nutrition and Health Food Association, said that the use of "Little Blue Flower", the exclusive symbol of special medical food, was clarified in the Guide, which provided an "identity mark" for the positioning, use and understanding of special medical food. The formulation and release of the Guide is not only an important measure for the General Administration of Market Supervision to implement the "four strictest" requirements and effectively supervise the safety of special medical food, but also an important step in the standardized development of the special medical food industry, which will become the basis for the stable and healthy development of the industry in the future.
Avoid false and exaggerated propaganda
The world’s first special medical food was born in the United States in the 1950s, and was used for the dietary treatment of phenylketonuria. Subsequently, many developed countries began to widely use special medical foods to solve the problem of nutritional absorption of infants and young children, and formulated strict management measures and standards for their use.
At present, China’s special medical food industry is still in the primary stage of development, but the groups with special nutritional needs in China are very large, and the existing special medical food can not meet the market demand. The special medical food market is "mixed" and chaotic.
In May 2019, the Market Supervision Bureau of Huangdao District, Qingdao City, Shandong Province inspected Qingdao Jindayang Dairy Co., Ltd., a company involved in the media disclosure that "solid drinks pretended to be special medical milk powder and sneaked into hospital stores in several hospitals in Beijing", and then made administrative punishment decisions on illegal acts such as its production and operation labels not complying with the provisions of the Food Safety Law.
In May, 2020, the General Administration of Market Supervision specifically instructed the market supervision department of Hunan Province to thoroughly investigate the media’s disclosure that the Aiyingfang maternal and infant store in Yongxing County, Chenzhou City, Hunan Province sold a solid beverage as a special medical food to children with milk allergy, and falsely publicized special functions and suspected consumer fraud, and announced the investigation results to the public in time. In the end, yongxing county market supervision bureau made an administrative penalty decision of 2 million yuan for the operators involved, and compensated nearly 1.03 million yuan for 63 consumers who complained.
In August, 2021, Nanshan Supervision Bureau of Shenzhen Market Supervision Bureau of Guangdong Province made an administrative penalty decision on Yikangyuan (Shenzhen) Health Technology Co., Ltd., which was fined 14,525,700 yuan and fined 2,846,200 yuan for illegal acts such as operating foods (solid drinks) with substandard labels, failing to establish a food sales record system and failing to save relevant sales vouchers.
In recent years, there are still many cases of punishment for special medical food. On the whole, the main features are ambiguous introduction to the ingredients of special medical food, or "fishing in troubled waters" and exaggeration.
To this end, in the "Guide" issued by the General Administration of Market Supervision, the "prohibitive requirements" for the labels and instructions of special medical foods have also been clearly required, and the behavior of enterprises in product promotion has been constrained to avoid misleading consumers as much as possible. The Guide stipulates that words involving falsehood, exaggeration, violation of scientific principles or absoluteness, such as "special effects" and "full effects", shall not be marked in the labels and instructions of special medical foods; Words related to the prevention and treatment of diseases, such as "prevention", "treatment", "quick recovery" and "excellent technique"; Words involving vulgarity or feudal superstition, such as "miraculous effect".
In this regard, Li Liangqiu pointed out that the composition of special medical food is numerous and complex, which directly affects the health and safety of people in disease state. The contents related to the labeling of special medical foods are clearly detailed in the Guide, which will better guide and help industry enterprises to standardize the labeling and instructions of special medical foods, and will also effectively promote the scientific use of special medical foods and consumers’ rational cognition, reduce improper publicity in marketing links, and avoid misleading or confusing consumers.
Gradually improve relevant standards.
With the development of society, people pay more and more attention to their own nutritional status. More and more nutritionists, doctors, clinical nutritionists and patients attach importance to the clinical use of special medical food, and China’s special medical food market has ushered in new development opportunities. The gradual improvement of laws, regulations and standards related to special medical food will help medical groups to accept and guide consumers to better use special medical food in clinic.
In 2010 and 2013, China successively issued General Rules for Infant Formula Food for Special Medical Use, General Rules for Formula Food for Special Medical Use and Good Manufacturing Practice for Formula Food for Special Medical Use.
These normative documents have made detailed provisions on the definition, category, nutritional requirements, technical requirements, labeling requirements and production specifications of special medical food, and it is clear that the formula of special medical food should be based on the research results of medicine or nutrition, and its safety and clinical application (effect) need to be scientifically confirmed.
The Administrative Measures for the Registration of Formulated Foods for Special Medical Use, which came into effect on July 1, 2016, and the Detailed Rules for the Examination of the Production License of Formulated Foods for Special Medical Use, etc., have been continuously improved in terms of administrative examination and approval and market access.
This time, the "Guide" has strengthened the supervision of the special medical food market from the label management of special medical food.
Chen Wei, chief physician of the Department of Clinical Nutrition of Peking Union Medical College Hospital, said that the standardized labeling of special medical food labels and instructions can better help consumers understand the characteristics of products and avoid treating special medical food as a "magic medicine". Similarly, doctors and clinical nutritionists can better understand the applicable population and scope of special medical food, and promote the standardized application of special medical food in clinical practice.
With the continuous improvement of the policy, all kinds of chaos and problems in the special medical food market are expected to be solved, and the special medical food market is expected to usher in further breakthroughs.
□ Our reporter Wan Jing