Recently, health food related policies have been issued frequently. In this regard, the industry believes that it will have a greater impact on registered health food, but overall, it is good news for related companies.
On November 24, the State Administration for Market Regulation issued a notice for public comment on the "Non-nutrient Supplements in the Catalogue of Health Functions Allowed for Health Food Claims (2020 Edition) (Draft for Comment)". The solicitation of opinions includes the "Health Food Function Evaluation Method (2020 Edition) (Draft for Soliciting Comments)", as well as the supporting "Interpretation of Health Food Function Claims (2020 Edition) (Draft for Soliciting Comments)" and "Guiding Principles of Health Food Function Evaluation (2020 Edition) ) (Draft for Soliciting Comments) "Guiding Principles for Ethical Review of Health Food Crowd Consumption Trials (2020 Edition) (Draft for Soliciting Comments). At the same time, in view of the fact that the original Ministry of Health no longer accepts the approval of the health care functions of inhibiting tumors, assisting tumor suppression, anti-mutation, and delaying aging, the original functions of promoting lactation, improving growth and development, and improving skin oil functions are in line with the existing "Measures". The positioning of health care functions does not match, and the above functions are no longer included in the list of health care functions allowed for health food claims. For other approved health functions that have not yet been recommended to be included in the "Catalogue", health food registrants should be included in the "Catalogue" in accordance with the "Measures" and subsequent supporting regulatory requirements. The deadline for comments is December 23, 2020.
On December 1, the State Administration for Market Regulation issued two important documents, No. 54 and No. 55. These two documents clarify that there are 87 kinds of raw materials for the record of health food, including 82 kinds of nutrient supplements, and 5 kinds of non-nutrient supplements, namely functional raw material Coenzyme Q10, broken ganoderma spore powder, spirulina, fish oil, Melatonin.
It is understood that since July 1, 2016, the "Health Food Registration and Filing Management Measures" was implemented, and the dual-track health food system was officially launched. Among them, the health food raw material catalog has always been a hot spot in the industry. On December 27, 2016, the "Health Food Raw Material Catalog (1)" and the "Health Function List of Allowed Health Food Claims (1)" (2016 No. 205) were successively released. ); In December 2019, the "Nutrient Supplement Health Food Ingredients List (Draft for Comment) (2019 Edition)" and the "Health Function Catalogue of Nutrient Supplements Health Food Claims (Draft for Comment) (2019 Edition)" were released; 2020 A new version will be released every year.
In the "Non-nutrient Supplements in the Catalogue of Health Functions Allowed for Health Food Claims (2020 Edition) (Draft for Comment)", the health functions have never been defined or explained in the previous official documents related to health foods, only in 2016 The "Opinions on the Management of Health Food Function Claims (Draft for Comment)" issued by the CFDA showed the interpretations of 6 functions, but they were not officially released. Therefore, the "interpretation" for 24 functions was set in the health food science Significant progress in sex. The industry believes that once the release of the draft for comments is of great significance, the path of "blocking" the registration of health foods for nearly three years and the raw material catalog (functional catalog) of non-nutrient supplements will finally be opened up.
Health function claims adjusted again
Regarding the adjustment of health care functions, the State Administration for Market Regulation issued an announcement on soliciting opinions on the adjustment of health care functions of health foods on March 28, 2019, and made adjustments after receiving feedback. The purpose of this time is to solicit opinions again. The purpose is to further strengthen the management of health food health function claims and plug the loopholes of false publicity of health food function claims. Comparing the functions of the current health food, the 2019 draft and the 2020 draft, we can find that the content has been adjusted as follows.
Adjust the list of health functions allowed for health food claims
Cancel the three major health functions. The "Draft for Comments" adjusted the original 27 categories of health care functions into 24 categories, and cancelled the original three categories of health care functions of "promoting lactation", "improving growth and development" and "improving skin oil". This move is taking into account that these three types of health function claims are not in line with the current health food regulatory positioning and health needs, especially for children, pregnant women, nursing mothers and other special populations whose health functions should be subject to stricter supervision and management, so the cancellation These three types of health care functions. At the same time, given that the former Ministry of Health has no longer accepted and approved the health care functions of inhibiting tumors, assisting in inhibiting tumors, anti-mutation, and delaying aging, this time it has not been included in the list of health functions that allow health food claims.
Industry analysts believe that these types of health care functions are highly likely to be cancelled. If companies have strategic plans for similar functions, they should make adjustments as soon as possible.
Standardize the expressions of health care functions. The "Draft for Comments" regulates the expressions of the remaining 24 categories of health care functions. For example, the "assisted hypolipidemic" is standardized as "helps to maintain a healthy level of blood lipids (cholesterol/triglyceride)" and " "Assisted blood sugar lowering" is standardized as "helping to maintain healthy blood sugar levels", "assisted blood pressure lowering" is standardized as "helping to maintain blood pressure healthy levels", and "weight loss" is standardized as "helping to regulate body fat functions" "Wait. And the expression "helps...function" is added to most of the original health care functions.
This has solved the phenomenon that health foods have been falsely or exaggeratedly used in the market due to inaccurate expressions of health care functions, and can also lead consumers to a large extent to correctly understand the role of health foods.
Increase the interpretation of health function claims
"Interpretation of Health Food Function Claims (2020 Edition) (Draft for Solicitation of Comments)" adds the interpretation of claims for 24 categories of health functions. Previously, opinions were solicited on the interpretation of health functions claimed by nutrient supplements and health foods. This move can be said to be in line with the interpretation of the health claims of nutrient supplements and health foods. However, this consultation draft does not explicitly mention that the interpretation can be claimed on the label, like the consultation draft for the interpretation of nutrient supplement function claims. If you can use the terms in the paraphrase to make claims, it will not only provide companies with more possibilities and diversity in the promotion of health foods, but also can be used as popular science content to popularize consumers, allowing consumers to choose more suitable for themselves product. However, there is still some uncertainty as to whether the interpretation content can be marked on the label in the future, depending on the requirements of the official draft.
Fill in the missing gaps in functional evaluation of some health foods
While this "Draft for Comment" adjusted the health functions, it also released the corresponding "Health Food Function Evaluation Method (2020 Edition) (Draft for Comment)" and its supporting "Guiding Principles for Health Food Function Evaluation ( (2020 Edition) (Draft for Comment)", which fills in the gaps in which some health food functions have not been evaluated.
Previously, the health food function evaluation method was implemented with reference to the "Technical Specification for Health Food Inspection and Evaluation" (2003 Edition) issued by the former Ministry of Health. After it was abolished on June 7, 2018, it can only refer to the original State Food and Drug Administration. The “Notice on Printing and Distributing Nine Health Function Evaluation Methods, Including Antioxidant Function Evaluation Methods” in 2012 resulted in the lack of 18 health food function evaluation methods among 27 categories of health functions, which led to companies registering health food products. There is no evidence to rely on, and the product functional categories that can be registered are greatly restricted. Therefore, this move is extremely good news for health food companies and provides necessary support for companies to enrich their product lines.
In addition, the functional evaluation method solicitation draft released this time is basically consistent with the content in the "Notice on Printing and Distributing 9 Health Function Evaluation Methods including Antioxidant Function Evaluation Methods", which realizes the integration and coverage of regulatory content and avoids subsequent releases. There are contradictions in the laws and regulations, and it is also convenient for enterprises and relevant testing institutions to smoothly carry out evaluation work with reference to relevant evaluation methods.
Since the release of this evaluation method fills the missing gaps in current regulations, once it is implemented, the number of related health food applications and registrations may increase greatly.
Further improve the legal system of registered health food
The "Guiding Principles for Ethical Review of Health Food Crowd Trials (2020 Edition) (Draft for Comment)" further improved the regulatory system for registered health foods. Previously, the "Notice on Further Strengthening the Work Related to Human Tasting Tests of Health Foods" stated that the health food product registration application materials should include a copy of the certification documents issued by the ethics committee that permits the testing of human foods. It did not specifically address registration Relevant regulations for the ethical review of the trial diet test of the health food population.
The release of the "Draft for Comment" means that the ethics related work of the population trial diet has been clarified at the regulatory level, and it also shows that the regulatory system for registered health foods is becoming more and more perfect.
This "Draft for Comment" not only fills in the lack of regulations, but also gradually improves the legal system, which is conducive to the rapid development of the health food market. In addition, combined with the current common problems and ills in the health food market, this "Draft for Comments" also has related deletions and adjustments to functions, which is more convenient for consumers to understand, and it also helps companies to promote. A win-win situation is more conducive to the healthy development of the overall industry.
The list of health food ingredients is clear
Added non-dimensional mineral raw material catalog for the first time
In Document No. 54, a non-dimensional mineral health food raw material list was added for the first time. On December 27, 2016, the former Food and Drug Administration issued the "Health Food Raw Materials Catalog (1)". Since the "Catalog" uses vitamins and minerals as raw materials, companies have great restrictions on product varieties when they develop and produce health foods for record. These five registered health food raw materials catalogs are the first addition of non-dimensional mineral health food raw materials since the implementation of the "dual track system" for health foods. Therefore, the release of these five raw materials catalogs is not only for the expansion of other registered health food raw materials in the future Laying a certain foundation will further promote the rapid development of the health food industry.
Document 54 also specifies requirements for the use of relevant raw materials. The announcement specifies the dosage range, suitable and unsuitable people, precautions, and efficacy of the five health food raw materials catalogs. At the same time, it also sets clear requirements for the corresponding raw material technical requirements and product formulations. In addition, it should be noted that in the five health food raw material catalogs announced this time, except for melatonin which can be used with vitamin B6, the other raw materials cannot be used with any other health food raw material catalogs.
In addition, document No. 54 expanded the function of filing health food. Previously, the function of the registered health food was only to supplement vitamins or minerals. The release of the five health food raw materials catalogue not only increased the raw materials of the registered health food, but also clarified the corresponding health food functions. This means that the functions of non-nutrient supplements have been expanded on the basis of the functions of existing registered health foods. For example, the health food function of coenzyme Q10 is to enhance immunity and anti-oxidation; the health food functions of broken Ganoderma lucidum spore powder and spirulina are to enhance immunity; the health food function of fish oil is to assist in lowering blood lipids; the health food function of melatonin To improve sleep. It is worth noting that the list of available excipients in the five health food raw materials catalogues has not been released together, but on August 12, 2020, the State Administration for Market Regulation put the product technical requirements for the record in the five health food raw materials catalogues including Coenzyme Q10 (draft for comments) ) Solicited opinions on available excipients.
Interpretation of nutritional supplement raw materials to increase health care function
In Document 55, compared with the previous two editions, the new version of the health food ingredient list released this time has added 5 ingredients and deleted 1 ingredient.
The new version of 2020 adds potassium gluconate, sodium ferrous citrate, zinc chloride, selenoprotein, and sodium D-pantothenate to the 2019 draft. In addition, β-carotene in the 2016 edition is a compound of vitamin A, and the effective ingredient is calculated by retinol. In the 2019 and 2020 editions, β-carotene is also listed separately as a nutrient. Its efficacy The ingredients are calculated as β-carotene.
The 2019 version of the opinion draft adds the compound name of folic acid "(6S)-5-methyltetrahydrofolate, glucosamine salt", which is applicable to people other than pregnant women and nursing mothers. The product dosage form is limited to solid preparations, but this new version The raw material is deleted.
In addition, the effective ingredients of vitamin K2 in the new version of the health food raw material catalog are calculated as heptaene menadione, which is more scientific than the 2016 version.
Compared with the previous two lists of health functions that allow health food claims, the interpretation of health functions has been added. In the catalog released in 2016, there is no interpretation of health care functions; while the new version of 2020 and the 2019 version of the opinion draft added the interpretation of 15 health functions such as calcium, magnesium, iron, and zinc.
Delivering the latest product trends and industry news straight to your inbox.
(We'll never share your email address with a third-party.)
Novel self-healing material for potential application in space coatings
Novel antiviral coating to reduce the spread of COVID-19
A major investment project of 6 billion high-end new materials settled
Top 30 best-selling oncology drugs in the world in 2020
The tight supply of ethylene glycol is difficult to change
Thermoplastic polyurethane (TPU) price increase!