Health food is facing the lack of many standards of extract

In the health food industry, which is keen on the concepts of "pure nature" and "plant extraction", the State Food and Drug Administration investigated and dealt with the turmoil of Ginkgo biloba extract industry in a "land scraping" way, which undoubtedly brought a capsizing crisis to large and small enterprises According to the data released by the State Food and drug administration, there are about 203 enterprises using ginkgo biloba extract to produce health food Among them, 129 are in production and 74 are out of production It is preliminarily found that 12 of the enterprises in production purchased and used unqualified Ginkgo biloba extract raw materials It is found that 30.864 tons of health food are suspected to be unqualified At present, 10.4 tons of products have been recalled, 0.024 tons have been destroyed, and 20.44 tons have been removed from shelves and sealed On July 9, Harbin Pharmaceutical Group Co., Ltd (hereinafter referred to as "Harbin Pharmaceutical Group") released the progress of self inspection on Ginkgo biloba products, and announced that during the self inspection, the Pharmaceutical General Factory of Harbin Pharmaceutical Group, a subsidiary of Harbin Pharmaceutical Group, found that 2350kg of unqualified Ginkgo biloba extract raw materials were detected according to the new supplementary inspection method for Yinxingye drugs newly issued by the State Food and drug administration, Among them, 661.15 kg is used to produce ginkgo leaf soft capsule, and the rest has been sealed The news is shocking Previously, the State Food and Drug Administration announced that 21 health food enterprises, such as Dalian Zhenao group, Tangshen Beijian and limitless Co., Ltd., purchased unqualified production processes from Guilin Xingda Pharmaceutical Co., Ltd and Ningbo Lihua Pharmaceutical Co., Ltd., or even Ginkgo biloba extract without approval number "Downstream enterprises are also victims" the staff of one of the above-mentioned well-known health food enterprises feel aggrieved about the company's involvement in the "ginkgo leaf incident", the company has authorized a third party to test the finished products, and the test results are qualified; "downstream enterprises are also victims, they lack methods to identify the authenticity of ginkgo leaf extract provided by upstream suppliers." "There are 14000 kinds of health food approved in China, and only 2000 to 3000 kinds of products are in circulation in the market Some of them can't enter the market, some of them can't enter the market and have to exit the market The main reason is that the quality is not up to the standard." Jin Zonglian, director of the functional testing center of health food, School of Applied Arts and science, Beijing Union University, believes that "ginkgo leaf incident" exposes that there is a high risk in outsourcing raw materials of health food enterprises To improve the quality of raw materials and strengthen testing is the key to ensure the vitality of enterprises Many extracts involved in health products lack of standard Jin Zonglian and told the media that in addition to the currently exposed illegal extraction process, the content of heavy metals in Ginkgo biloba extract is also prominent "In fact, many of the extracts involved in health food lack national standards." Jinzonglian said that, taking the current popular antioxidant health food as an example, there have been many products with grape seed extract as raw material on the market, and the production process, raw material extraction and matching principle of raw material extract are lack of standards and specifications, so the quality is difficult to control - the plant extract standard of the solution is expected to come out, Jin Zonglian believes that the new food safety law puts forward the "health food raw material catalog" for the first time, which will play a normative role in the plant extract Market after its establishment, and consumers will have an authoritative basis for purchasing According to China business daily, Huang Jiansheng, Deputy Secretary General of China Health Care Association, said that after finding the problem of Ginkgo biloba extract, the State Food and Drug Administration will make relevant regulations on plant extract to fill the blank of standard of plant extract in health food raw materials However, this standard specifically refers to the testing standard or other standards such as production process Huang Jiansheng did not make it clear In 2010 and 2015 edition of Chinese Pharmacopoeia, the production process of Ginkgo biloba and other plant extracts has corresponding standards But whether this standard is reasonable and can be widely observed by most enterprises remains to be further tested by this "storm" of Ginkgo leaves Enterprises can legally apply for the modification of extraction process Some enterprise personages put forward to the media that they can produce Ginkgo biloba extract completely according to the process specified in the Pharmacopoeia The cost is too high According to the current domestic price of Ginkgo biloba extract, no enterprise can make profits In this regard, the relevant experts of the National Pharmacopoeia Commission said that enterprises have always had legal application channels due to the demands of ensuring cost, modifying extraction process and improving production process The application shall be submitted by the enterprise first, and the process can be changed after being approved legally The expert pointed out that any product has production standards, and the national standards should be implemented In terms of production process, the description in the Pharmacopoeia may be rough, and it is impossible to be as detailed as the process mastered by the enterprise itself The enterprise can do it according to the process standard approved by its product application However, if the process is to be changed, taking Ginkgo biloba extract as an example, it is necessary to evaluate which effect is better between the Ginkgo biloba extract extracted with hydrochloric acid and that extracted with dilute ethanol According to the current domestic price of Ginkgo biloba extract, no enterprise can make profits In this regard, the expert pointed out that the process change should be linked with the effect and safety, not in accordance with the process standards, and the enterprise should give the risk assessment report on the effectiveness and safety, and speak with the data "It can't be evaluated by reducing the production cost It's a problem that enterprises should consider that the efficacy and safety are not affected As far as I know, no enterprise has applied for the extraction of Ginkgo biloba extract with hydrochloric acid Change the extraction method without authorization, without scientific verification, what can we do if there is a problem? "- how to manage the illegal standards for observation by reporters? Some people also say that it is obvious that the regulatory standards for natural plant extracts in the United States and Europe are more stringent To this end, Tu Pengfei stressed that the standard is for products produced by enterprises according to law If you want to fake or add, it is very difficult to use the standard "Only using standard can't control illegal activities", Tu Pengfei believes that for pharmaceutical enterprises, it is the basic way to survive and develop to purchase and use plant extracts with national approval number and complete raw material quality detection methods Whether it is medicine or health food, the production and consumption chain of Ginkgo biloba extract in China is the largest in the world This time, the State Food and Drug Administration launched a "storm" to rectify the safety risks of Ginkgo biloba extract, which seems to have a "domino" effect The next step and the final result will depend on the determination of the State Food and Drug Administration and the scale industry chain to carry out security game.