The State Administration of Market Regulation (SAMR) announced that it was seeking public consultation on the types of scientific assessment required for permitted health foods claims.
This follows a revamp of the permitted health foods claims that dates back to 2019, when it removed three claims from the list of 27 permitted claims – which are “promotes lactation”, “improves growth and development”, and “improves oily skin”.
Currently, there are 24 permitted health food claims, and all have been rephrased.
For example, the claim “modulates the immunity, strengthens the immunity” has been rephrased to “aids in strengthening the immunity”, while the claim “improves memory, aids in improving memory” has been rephrased to “aids in improving memory.”
The claim “anti-fatigue, alleviates physical fatigue” has been rephrased to “alleviates physical fatigue”.
To transition to the newly rephrased claims, the regulator last year drafted a new list of methods to assess the validity of products making the claims.
However, not all products that are already out in the market will need to undergo a reassessment of their functionalities.
The regulator is now proposing that only products making certain claims and that the functionalities were assessed based on an old set of standards published in 1996 will need to redo animal and human experiments.
Out of the 24 permitted claims, products making the following eight claims and were assessed based on the year 1996 standards will need to redo animal and human experiments.
The eight claims are: “aids in strengthening the immunity”, “aids in anti-oxidation”, “aids in improving memory”, “alleviates physical fatigue”, “could withstand hypoxia”, “aids in controlling body fats”, “aids in maintaining blood lipids (cholesterol/triglycerides) at a healthy level”, and “aids in protection against the harmful effects of ionising radiation”.
For example, products that claim to “aid in strengthening the immunity” will need to redo animal experiment.
Those that claimed to “aid in improving memory,” will need to redo human experiment if the products were previously assessed in human trials using the Wechsler Memory Scale.
The reason is because these claims were previously assessed using an old set of scientific standards which are now different from current scientific framework.
On top of redoing the experiments, these products will also need to be newly registered. Those that are approved will be given a new certificate of registration.
For products that need not redo the experiments and are already approved by the regulator, the authorities will directly rephrase the health functional claims of these products on the official documents.
However, manufacturers are still required to re-print their products labelling and packaging to reflect the rephrased claims.
Products which are already in the market but are printed with the not-yet-rephrased claims can still be sold until the date of expiry.
The public consultation will end on February 12.
Removed claims
On the other hand, for products making no longer approved claims, namely “promotes lactation”, “improves growth and development”, and “improves oily skin”, the regulator is proposing that these products will need to stop production immediately on the day the official announcement is made.
However, products that are already manufactured could still be sold in the market until the date of expiry.
The SAMR said that products making the above three claims were not in line with consumer health needs and the number of approved products was extremely low, especially those for promoting lactation and designed for lactating women.
On the other hand, there is a concern that products claiming to “improve growth and development” is intervening with adolescents growth and has thus been removed from the list of permitted claims.
On top of these three claims, the SAMR is also officially removing four other claims which are no longer considered for new health foods registration.
They are “inhibit tumours”, “aids in inhibiting tumours”, “anti-mutation” and “delay ageing”.
