The New Guidance on the Label of Dietary Supplement
时间(Date) : 2015-08-18
作者(Author) : CIRS
Dietary supplements are different from common food in China. In order to distinguish with the common food, CFDA issued the Administrative Measures on the Labeling of Dietary Supplement (draft) on July 28th 2015. This measure stipulates the format and content of the labels and instructions for registered and notified dietary supplement products, respectively. CIRS speculated that the final version of the Administrative Measures on the labeling of Dietary Supplement will have slight modification compared with the draft version, and will be issued before Opt 1st 2015.
According to the measure, labeling of dietary supplement includes the instruction manual, label, logo, etc.
Before the new measure issued, the label and instruction of dietary supplement should in compliance with the related stipulations of “General Principles of Prepackaged food labels (GB 7718-2011)”, “the Administrative Measure of Dietary Supplement Registration (trial implementation)”, “Naming Regulations and Guidelines of Dietary Supplement”, “Labeling of Dietary Supplement” and “General Principles of Dietary Supplement GB 16740-1997”. The relevant regulations are a little bit redundant. With the publishing of the final version of the Administrative Measures on the labeling of Dietary Supplement, CIRS speculated that the labels of dietary supplement can be developed only in accordance with the regulations of “the Administrative Measures on the labeling of Dietary Supplement (final version)”,“Naming Regulations and Guidelines of Dietary Supplement” and “General Principles of Prepackaged food labels (GB 7718-2011)”.
The new measure stipulates that contents of the dietary supplement label should include: manufacturer information, entrusted manufacturer information, product name, raw materials, active ingredients and their content, function, logo, approval number, specification and net content, production date, shelf life, production license number, product standard, production batch number, consumption method and dosage, suitable and non-suitable crowds, notice, storage method, the claims of “this product cannot replace the medicine”. For notified dietary supplement, the claims of “this product has not been evaluated by FDA department” and “this product has been notified by FDA department” are also needed. For nutrient supplement, the words of “nutrient supplement” and the claim of “add XX nutrient supplement” after healthy function are needed. For irradiated raw materials or products, “XX material is irradiated” or “this product is irradiated” is needed. And for imported dietary supplement, the information of importers and original countries is additionally needed.
1. The changes of the product name
The new measure stipulates that the product name should consist of brand name, common name and property name. As brand name becomes a mandatory part of the product name, this new added article may lead a trend of brand name registration in China. And function name, which can be used in the product name before, is forbidden in the new measure, the registered dietary supplement with function name should conduct the product name modification.
2. The changes of mandatory claims
Claim of “this product cannot replace the medicine” and the additional claim for notified dietary supplement of “this product has not been evaluated by FDA department” are mandatory on the label of dietary supplement. And the font size, color and position of these claims are specified. Enterprise which in violation of this regulation will be fined between 1000 and 20000 RMB, so manufacturers and importers should pay more attention to it. The difference between registered and notified dietary supplement is that the notified product is mandatory to add the claim of “this product has not been evaluated by FDA department”. With the frequent occurrence of food safety issues in China, whether Chinese customers could accept the dietary supplement which has not been evaluated by Chinese government, and whether this claim would have any effects on the product sales, both remain to be seen.
3. The requirements of font size and instruction manual
As the dietary supplement label contains all stipulated labeling information, instruction manual is not mandatory to be provided. No matter how large or small of the maximum surface area of the package, the font height of the words, symbols and numbers on dietary supplement label should be ≥ 1.8 mm. This is different from the regulation of common prepackaged food, which only stipulates the font height ≥ 1.8mm when the maximum surface area of the package is ≥ 35cm2.
4. The requirements of mandatory contents on the main layout
The mandatory contents on the main layout of dietary supplement package include: the logo of dietary supplement, approval number, product name, net content and specification. For nutrient supplement, the words of “nutrient supplement” is needed, and for irradiated materials or products, “XX material is irradiated” or “this product is irradiated” is required.
5. The requirements for the size and position of dietary supplement logo
The logo of registered dietary supplement is “Blue Hat”, and if the logo of notified dietary supplement will also be ”Blue Hat”, it should depend on the publishing of related regulations. The dietary supplement logo is very important, as it is the special pattern stipulated by Chinese government to distinguish from common food and medicines. The size, position and approval number or notified number under the logo are all specified, and information about whether the dietary supplement has been registered or notified in China can be found on CFDA’s website. So if manufacturers or importers have not got the logo and the below approval number or notified number, they must conduct the dietary supplement registration or notification in China. According to the new food safety law which will be implemented on Opt 1st 2015, manufacturers or importers, who do not have the logo or the number on the dietary supplement label, or try to counterfeit, will be severely punished.
6. The mandatory contents on the label with small package size.
In the old regulations, there are no differences in mandatory contents for the maximum package surface area more than 10cm2 and less than 10cm2. But now the new measure stipulates that when the maximum surface area of the package is less than 10cm2, the mandatory contents on the label are: the logo of dietary supplement, product name, approval number, specification, shelf life, notice, storage method, manufacturer, production license number, product standard, production date, and production batch number. Other information, such as suitable and non-suitable crowds, consumption method and dosage, and function, is not mandatory, but those contents didn’t show on labels must be expressed in the instruction manual.
7. Other forbidden claims on the label
Exaggerated description on the label is forbidden. For example, “pure green”, ”no pollution”, “do not contain any additives”, “product of national gold medal enterprise”, “secret recipe handed down from generations”, “no toxic or side effect”, ”no dependence”, “famous trademark”, “fire-sale”, “floor price” and other similar claims are prohibited. Expressions or implied expressions of disease prevention and treatment on the label are also forbidden.For example, “clearing heat and removing toxin”, “treatment”, ”cure”, “heal”, “curative effect” and other similar claims, patterns or symbols are all not allowed.
8. CFDA implements more specific and strict regulations for dietary supplement, and the punishment is more severe
In this new measure, CFDA adds the definition of defect for the label and instruction manual and the corresponding punishment rules. The defect evaluation criteria are that it does not affect the safety and function of the product, and will not mislead consumers. CIRS speculated that CFDA will publish specific regulation for the scopes and contents of the defect. But the exact time still needs to wait for the notice of CFDA.
In addition, this new measure stipulates more strict requirements for the dietary supplement label and instruction manual. The penalty clauses are increased and the penalty amount becomes larger. For manufacturers and importers of dietary supplement, it is very important to make sure that the contents of dietary supplement label and instruction manual are in compliance with this regulation.
Ms. Cathy Yu Team Leader of Food Safety and Regulatory Affairs Department, CIRS China
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Tel : +86 571 8720 6538 | Fax : +86 571 8720 6533
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