In Chenzhou, Hunan, there have been two consecutive incidents of solid beverages posing as special medical milk powder. The enterprises and products involved include "Beminamine" of Hunan Weile Health Industry Co., Ltd. and "Shuerla" of Shandong Fanhe Biotechnology Co., Ltd.
At present, the General Administration of Market Supervision has ordered the Hunan Provincial Market Supervision Bureau to strictly investigate the incident of "Beminamine" in Yongxing County. Chenzhou Market Supervision Bureau, Health and Health Commission and other relevant departments have also given the children's hospital doctors involved in the "Shuerla" incident a one-year suspension, and are negotiating compensation and medical examinations.
In the eyes of industry insiders, as long as two fake special milk powder incidents occurred in Chenzhou, the media reported on the problem of solid drinks posing as special milk powder, and now the fake special milk powder is reproducing, "it must be said that it is a tragedy." The emergence of this problem is not only related to the historical development of regulatory policies, but also to the ultra-high gross profit of the industry.
Multiple fake special doctor milk powder incidents exposed
Prior to the exposure of the two cases of fake special milk powder in Chenzhou, the media had repeatedly reported similar incidents of solid beverages posing as special milk powder, and related companies had been punished accordingly.
In May 2019, a reporter from the Beijing News visited the field survey in Beijing as the parent of an allergy child and found that the hospital's in-store stores were selling the products produced by Ningbo Teyi Food Co., Ltd. and Qingdao Jindayang Dairy Co., Ltd. with certain functional properties. "Formula Powder". After enquiry, these "formula powders" are actually solid beverages, and none of them have obtained the special medical food registration qualification.
On June 6, the same year, the official website of the State Administration for Market Supervision issued the "Notice on Investigating and Handling Violations of Ningbo Teyi Food Co., Ltd. and Qingdao Jindaiyang Dairy Co., Ltd.", pointing out that Ningbo Teyi Food Co., Ltd. and Qingdao Jindaiyang Dairy Co., Ltd. The two companies involved in the case did not obtain registration and production licenses for formula food for special medical purposes.
Ningbo Market Supervision Bureau Hangzhou Bay Branch and Qingdao Huangdao District Market Supervision Bureau dealt with two companies respectively, seized and seized 6 products including Jia Ruibao amino acid formula powder (solid beverage) produced by Ningbo Teyi Food Co., Ltd. 6643 listening and packaging cans of 20349; seized and seized 862 cans and 182771 cans of 5 products including "Teneng Shuan" amino acid formula powder (solid beverage) of various food protein allergy periods produced by Qingdao Jin Dayang Food Co., Ltd.
In July 2019, the media reported that the "Yaledi" solid beverage of Shandong Fanhe Biotechnology Co., Ltd. was posing as a special medical milk powder. According to the response of the market supervision department of Qixia City, Yantai, Shandong, Fanhe Company did not have the qualification to produce formula powder. In view of the unqualified quality of some of its products and the false promotion of product packaging, according to relevant laws, the market supervision department has confiscated its 12 kinds of illegal production and operation of food and unqualified pre-packaged food packaging cans, and imposed a fine of 456,000 yuan. On July 30, Fanhe Company initiated a recall of 13 related batches of products such as "Shuer", "Fu Anbao" and "Min Anbao" produced on the grounds that the product label did not comply with the provisions of the Food Safety Law.
In January 2020, the Zhejiang Provincial Market Supervision Bureau announced the top ten typical cases of illegal advertisements for general foods and health foods in 2019. Ningbo Teyi published "comfortable relief of milk allergy symptoms, eczema, and diarrhea" through the Internet during the sale of ordinary milk powder If the language is confused with drugs and medical devices, it will be fined 200,000 yuan in violation of the relevant provisions of the Advertising Law. In 3 years of 2020, the application of "Natural Hydrolyzed Formula for Infant Formula Milk Powder for Special Medical Purposes" applied by Ningbo Teyi was not approved.
Fake special doctor milk powder is related to the industry's high gross profit
From the perspective of dairy expert Song Liang, the appearance of "three noes" special medical food (no registration of infant formula milk powder, no special medical food registration, no special medical food production license) is related to regulatory policies and The industry's ultra-high gross profit is related.
He said that special medical milk powder is a high-end product and has a large profit margin. Some dairy companies that cannot obtain the organic milk powder and goat milk powder supply chain are likely to target this field. In addition, special medical milk powder can enter the medical care channel, which is helpful for enterprises to lead users from special medical milk powder to ordinary milk powder.
At present, the retail price of special medical foods on the market is generally more than 300 yuan, and the specifications are only about 400 grams. If it is converted into a unit price, it is equivalent to the price of 2 cans of ultra-high-end infant formula.
The Beijing News reporter learned from many parents of children in Chenzhou that the product involved in the fake milk powder incident in Yongxing County, Chenzhou, was priced at 298 yuan / can (400g). The doctor of Chenzhou Children ’s Hospital The product "Shuer", which falsely promoted the fake milk powder incident, has a retail price of up to 338 yuan / can (400g).
According to a previous investigation by a reporter from the Beijing News, the market price of a 400-gram jar of "Jia Ruibao Amino Acid Formula Powder" produced by Ningbo Te One is 338 yuan. If you take the medical channel, the price can be as low as 5.5%; The mother and baby channel takes the price of about 30% off. The sales price of the maternal and child channels given by the Jindayang market personnel is about 25% off, while the retail price of a 360-gram can of Jindayang "Te Nengshu jaundice small peptide formula powder" can reach 568 yuan, and the profit margin is much higher than Import special medical food.
Policy "gate" has not been opened for a long time
Formula foods for special medical purposes are commonly known as "special medical food" and "special powder". Among them, special medical use infant formulas are also commonly known as "special medical milk powder", which refers to the purpose of satisfying restricted eating, digestive and absorption disorders, metabolic disorders or specific diseases. The state population has special needs for nutrients or diets, specially formulated formula foods. According to China ’s Food Safety Law and other relevant regulations, special medical foods should be registered by the regulatory authorities, and production enterprises should obtain corresponding special medical food production licenses.
In March 2019, Beinmei announced that its lactose-free special medical milk powder has obtained a food production license, which means that its related products can enter the production process "justly." As early as February 2018, Beynmee's special powder has passed the registration of the formula, but it was not until February 2019 that the country's "Special Medical Use Formulation Review Rules" was officially released. Beinmei told reporters at the Beijing News at the time that the introduction of the "Rules" solved the dilemma in which domestic factory special medical foods had obtained product registrations but were still unable to produce.
China has issued national standards for Good Manufacturing Practices for Formulated Foods for Special Medical Purposes and General Rules for Formulated Foods for Special Medical Uses in 2010 and 2013, respectively, but related supporting standards such as production license review rules and clinical trial specifications are still missing, resulting in local milk Enterprises cannot achieve the production of special medical milk powder.
As early as June 2015, Gabrielle (Hunan) Food Co., Ltd. was reported by consumers for producing three special medical formula milk powders beyond the scope of the production license. Due to the lack of relevant standards, and the former State Food and Drug Administration's government information disclosure report to the informant did not clearly answer how such products are regulated, the original Hunan Food and Drug Administration was unable to characterize the case for a time, and a special person was assigned. Go to the General Administration for instructions on relevant matters in this case. In the end, Gabriel Company was fined a total of nearly RMB1,093,800 for violating the relevant provisions of the "Regulations on the Administration of Industrial Product Production License of the People's Republic of China".
Difficult to obtain registration according to drug management
Although the gate of domestic special medical food production and registration has been opened, the industry believes that special medical food implements more stringent product registration. Under the "most stringent" supervision system in the history, enterprises want to pass the registration is "difficult to add ".
According to the incomplete statistics of the Beijing News reporter, the only domestic brands that have passed the special medical food registration are only 10 products from 3 companies including Beinmei, Shengyuan, Hengrui Health, Tianjin Aos and Ai Younuo.
Shengyuan, who has obtained the registration qualification, once told the Beijing News that special medical food is not a drug, but the industry risk is extremely high, and it must be strictly regulated by referring to the drug management method. From the promulgation of the "Administrative Measures for the Registration of Formula Food for Special Medical Purposes" in March 2016 to May 2019, only more than 20 domestic and foreign products have passed the formula registration in China.
Dairy expert Song Liang believes that the quality of registered special medical food can be guaranteed, and the product needs to pass clinical trials, and the official registration requirements for special medical food are stricter than ordinary infant formula. "As far as I know, a series of special powders of a foreign-funded enterprise will cost 50 million yuan from R & D to formulation application." Some domestic companies simply do not have such a capability and professional background, and can only take advantage of regulatory loopholes and play solid beverages. Most of the product's formula is imitating foreign brands.
An article published on Arterial Network in July 2017 showed that about 10 years ago, the founder of Ningbo Teyi Food Co., Ltd. Yang Guomin and his wife took their children to seek medical treatment, and finally cured the child's eczema with an amino acid formula powder . At that time, foreign brands of special medical food occupied 90% of the market, and the domestic market was almost blank. As a result, Yang Guomin smelled the business opportunities and used the products of the Netherlands as a reference, "analyzed and improved a new formula", and selected infants and young children's amino acid formula powder with moderate-to-severe milk protein allergy as the first product. But it was not until 2017 that Ningbo Teyi established its own factory.
However, imitating formulas and building factories is only the first step. Nutrient companies such as Hunan VilleCo, Shandong Fanhe, Ningbo Teyi, Qingdao Jindayang, etc. are mostly stuck in the production qualification of special medical milk powder, taking solid drinks It has become a common practice in the industry to play the edge-ball with special medical milk powder.
In addition, the solid beverage that appears as a fuzzy identity of functional "formula powder" has a much higher degree of supervision than infant formula milk powder. According to the "Administrative Measures for the Registration of Formulas for Infant and Infant Formula Milk Powder", each infant formula manufacturer can only register up to 3 series and 9 formulas, and there must be significant differences between the formulas. However, the official website of Jindaiyang Dairy showed that its "formula powder" products have 7 series, and the official customer service said that the related products of its different series are "all the same." The reason for distinguishing these product lines is only to expand the company's market share and avoid Competition among distributors in the same region.
"Special" track welcomes more enterprises
The industry believes that the previous overseas imported special medical products do not need to apply for production licenses. The introduction of the "Rules" gives domestic dairy companies the opportunity to compete with overseas special matching companies. It is expected that more companies will join this track in the future. bright future.
According to statistics from the China National Nutrition and Health Food Association, the global annual consumption of special medical foods is between 56 billion and 64 billion yuan, and the market size is increasing at a rate of 6% per year. Nielsen data predicts that the sales of China's specialty products market will continue to grow, of which the milk protein allergy market has a compound annual growth rate of 20%. The market capacity in 2019 is about 1.2 billion yuan, and it is expected to reach 2.2 billion yuan by 2021.
As of now, the domestic special medical food industry is still in its infancy, but overseas companies have already been operating frequently.
On March 7, 2019, Abbott took part in the 6th International Nutrition and Growth Annual Conference with its HMO formula milk powder and a variety of special medical milk powder. Barbara Marriage, Abbott ’s global special formula science officer, said that all 6 Abbott ’s infant formula products for special medical purposes have been registered and approved in China. Special formula nutrients will also become Abbott ’s fourth independent e-commerce store.
As early as June 2018, Nestlé Health Sciences reached a cooperation with Renhe Pharmacy to directly target its specialty foods to people with nutritional deficiencies through the pharmacy. At present, Nestlé Health Sciences' market sales are increasing at a rate of more than 50% per year. Its infant formula milk powder has cooperated with more than 1,000 hospitals nationwide.
Song Liang pointed out that the local company's special medical milk powder is currently only at a medium technical level, and companies with medical backgrounds such as Nestlé and Abbott have more advantages in research and development and more product types. In the long run, foreign brands still dominate.
Beijing News reporter Guo Tie