Health products OEM will be called off Small and medium-sized enterprises face survival crisis
As one of the five pillar industries of the health service industry established by the State Council, the domestic health care product industry, with a huge market of about 300 billion yuan per year, may usher in a major reshuffle.
"From January 1 next year, OEM health food will not be produced, operated or imported; the approval number of a health food can only be applied to one product." A few days ago, Zhang Jinjing, deputy director of the third Department of Safety Supervision of the State Food and Drug Administration (CFDA), said at the "Big Health and Big Future" high-end forum held in Zhuhai.
As the main regulatory authority for health food, CFDA recently issued the Announcement on Further Regulating the Supervision and Administration of Health Food and Severely Cracking Down on Violations of Laws and Regulations (Draft for Comment) (hereinafter referred to as the Announcement), which stipulates that health food names shall not Add other trademarks or trade names without authorization; health food labels with the same approval number should use the same trademark; from January 1, 2014, no OEM health food shall be produced, operated or imported.
This means that "OEM", which is very common in the health food industry, will be stopped, and the survival mode of small and medium-sized health food enterprises relying on OEM sales without capacity will also be fatally impacted, while large companies with a large number of approval documents and production capacity will benefit from it.
Small and medium-sized enterprises face survival crisis
Collagen efficacy doubt cloud, spirulina heavy metals exceed the standard storm, poison capsule incident ...... all kinds of health care products around the quality and safety of the product storm has long evolved into a public event, health care products enterprises and regulatory authorities of the pressure has also been unprecedentedly magnified.
Although the new regulations have not yet been formally promulgated, from the perspective of the policy direction of eliminating health food labeling in multiple links of production and operation, a major reshuffle of the industry is inevitable.
This year's stormy weight loss product, Xianlibao brand Yurin capsule, is the OEM product of Guangdong Green Thin Health Information Consulting Co., Ltd. (hereinafter referred to as "Guangdong Green Thin"). On the CFDA database, the applicant for the "Guoshijianzi G20050898" of Libao brand Yuren capsule is Xi 'an Sanqi Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Xi 'an Sanqi Pharmaceutical"), which expired on December 12, 2010.
Guangdong Lvshou's earlier official statement showed that Xi 'an Sanqi Medicine had submitted a re-registration application to CFDA before the health food approval number expired. CFDA formally accepted and issued an acceptance notice on December 10, 2010. At present, the product approval number is in the acceptance period of re-declaration. According to relevant regulations, during the product re-registration review period, the original health food approval certificate continues to be valid, so the normal sales of Yuren capsules are completely legal and compliant.
A person in the health food industry who is familiar with Guangdong green thin told the first financial daily that the performance outbreak of Guangdong green thin in recent years mainly relies on advertising and marketing means. The approval number of health food purchased from cooperative enterprises is renamed, and the production enterprise is commissioned to produce, then packaged and sold. But this "OEM" type of product route for the long-term development of enterprises has brought potential risks.
Recently, Yang Dongshan, vice president of Guangdong green thin, also told reporters that the company's sales volume last year was 0.4 billion yuan, and the net profit was 70 millions or 80 millions yuan. However, this year's market turmoil has greatly increased the company's marketing expenses, and there is little profit to speak. "CFDA's cancellation of the ban on health food labeling has a greater impact on us, but the company has long been prepared. Two years ago, we began to build a production base of nearly 60000 square meters in the East Industrial Zone of Rongcheng Town, Jianli County, Hubei Province. The annual production capacity can reach 1 billion yuan." Yang Dongshan told reporters.
In addition, the CFDA Announcement stipulates that "products that use tablets, capsules, oral liquids, granules, pills and other forms that need to be consumed in a quantitative amount and have a daily consumption limit are not included in the scope of the food production license (QS mark). For the above-mentioned products that claim health functions, a health food approval number must be obtained before they can be produced and sold."
Xie Yilin, chairman of Guangzhou Yanruyu Pharmaceutical Technology Co., Ltd., told this newspaper that there are currently a large number of ordinary foods in the form of tablets, capsules, oral liquids, granules, pills, etc. that claim to have health functions, which can easily mislead consumers. "According to the new regulations, these ordinary foods that have not obtained the batch number of health food must also be changed in the future product form before they can continue to be produced and operated. For example, 90% of collagen oral liquids on the market do not have blue hats, so they cannot be produced and circulated in the form of oral liquids in the future."
Guangzhou Muscle Hall Biotechnology Co., Ltd. sold 60 million yuan last year, 90% of which came from the company's collagen oral liquid. However, due to the lack of a health food batch number, this collagen oral liquid, which is popular in Watsons, Wanning and Dashenlin all over the country, is likely to be removed from the shelves after the implementation of the new health food regulations in 2014.
Big companies have big cakes.
According to data from the China Health Care Association, the total sales of health food in China in 2010 was 260 billion yuan. It is expected that the total sales of health food in 2013 will reach 400 billion yuan. By 2015, the total sales of health (nutrition) food are expected to be No less than 1 trillion yuan.
However, the growing industry "cake" has failed to put an end to the secondary industrial chain chaos. According to incomplete statistics in the industry, 30% ~ 40% of the current local health care products are OEM products.
Zhang Yong, executive vice president of Guangdong Health Care Association, told reporters that this kind of OEM mode means that enterprises with blue hats authorize product approval documents to be used by several sales companies, and these sales companies attach their own brand to the product approval documents. As a result, a health food approval document corresponds to dozens or even hundreds of products.
As of December 9, the database of CFDA's official website shows that there are 12861 records of domestic health food and 708 records of imported health food approved by CFDA since December 12, 2003.
"Up to now, only more than 10000" blue hats "have been approved in China, but more than tens of thousands of" blue hats "have been sold in the market. The degree of confusion caused by OEM can be seen." When talking about the necessity of OEM production rectification, Zhang Yong said, "at present, the phenomenon that the approval documents of the health care industry are rented out layer by layer is very serious. Some enterprises directly apply for the approval documents and then lease them to a number of shanzhai factories, charging transfer fees ranging from 80000 yuan to 100000 yuan every year."
In fact, in the past two years, the relevant state departments have become more and more stringent in the examination and approval and supervision of health food, which can be seen from the number of health food approved in the past two years. In 2012, 576 domestic health foods and 11 imported health foods were newly approved; in 2013, 659 domestic health foods and 9 imported health foods were newly approved; compared with the past, the number of blue hats approved in the past two years has decreased significantly.
"The implementation of the new health food regulations is a good thing for large enterprises, and the market will be more standardized." Regarding the upcoming New Deal, an analyst in Shenzhen told this newspaper that with the start of industry rectification, large companies will become market beneficiaries, and the market share of large companies with good approval reserves and obvious brand and channel advantages will increase significantly.
The reporter inquired about the CFDA official database and found that Beijing Tongrentang Health Pharmaceutical has 73 health food approval documents, Tomson Beijian has 59, Jiaotong University Onli has 32, etc. As for foreign enterprises, Sanofi Minsheng Pharmaceutical has 21 health food approval documents.
As an important city in the national health care industry, health care products in Guangdong Province account for more than 60% of the country's share. After the introduction of the New Deal, capacity expansion projects that cost hundreds of millions of yuan seem to be becoming more and more like a high-threshold game for large companies.
On November 29, Haiwang Biology announced that the company's wholly-owned subsidiary Hangzhou Haiwang intends to invest in the establishment of a wholly-owned subsidiary Jiangsu Haiwang in Taizhou China Medical City, Taizhou City, Jiangsu Province, and build a health care product production base to meet the company's health care products. Development needs in the field.
Yang Dongshan also told reporters that after the completion of the Hubei production base, the expected production capacity in the first year will be 0.5 billion -0.6 billion yuan. In addition to putting some core products into the new factory for production, overseas products such as Japanese probiotics will also be further introduced.
At the same time, the CFDA "Announcement" also stipulates that since January 1, 2014, the production, operation and import of products claiming health care functions that have not obtained the health food approval number are prohibited.
"Large companies like Amway Nutrilite have already applied for health food batch numbers, but many multinational companies like GNC have not yet started to apply for health food approval documents in China." Xu Ming, vice president of the China Chamber of Commerce for Import and Export of Medicines and Health Products, told this newspaper that the registration time for health food batch numbers generally takes two years. The CFDA ban does not set a buffer period for imported health products. The promulgation of the New Deal next year will affect a large number of domestic imported health products. Distributors have an impact.