China health claims concerns: Huge industry uncertainty as regulator embarks on regulations review

A key part of the review​ is to consider the cancellation of existing health claims targeted at 'special consumer groups', ​such as teenagers, children, pregnant women, and breastfeeding mothers. These claims include "promoting lactation"​, "promoting / improving growth"​, and "improving oily skin".​

Another part of the review is to formally do away with health claims that are no longer accepted by the regulator. There are at least 18 such claims, including "preventing tooth decay" and "reducing wrinkles"​.

For these claims, the regulator had previously stopped granting approval to make these products, but there was no formal announcement to void these claims. 

Therefore, at present, manufacturers who had earlier received approval to make such claims can still make these products.

However, if these claims were formally cancelled, manufacturers will no longer be able to make these products.

Third, the review also suggested to relook health claims that require further research evidence. Six claims, which include “aids in lowering of blood pressure” ​and “aids in lowering of blood sugar”​, would be affected.

Lastly, the review plans to rephrase existing 18 existing health claims.

According to the SAMR, the review was to “further strengthen the management of health food claims, to bridge loopholes and prevent fake promotion, to improve consumers’ scientific knowledge and exercise a more accurate judgement of health food claims, and to avoid a confusion with medical prevention and treatment.”​

The one month public consultation will end on April 28.

If approved, the new regulations would be applied to both domestic and foreign enterprises.

Regulatory advice ​

Regulatory experts have advised manufacturers to halt the R&D of products that bear claims which may require additional scientific research.

This was because these claims might not be approved eventually, thus, if manufacturers were to proceed with R&D of these products, their past efforts would go down the drain, Charles Diao, regulatory manager at US-China Health Products Association told NutraIngredients-Asia. ​

“Moreover, the regulator had requested the public to suggest other means of testing the effectiveness and validity of these claims. This means that there might even be changes to the testing methods eventually and so, I suggest to wait for further announcement before making any moves,” ​Diao said.

Regulatory expert, Cathy Yu, general manager of food business division at Hangzhou REACH Technology Group also advised manufacturers to avoid producing health foods that fall into the aforementioned categories, although the regulations were still at the stage of public consultation.

“For claims that require further research evidence, previously, many of these products have been approved and many companies have embarked on R&D of these products. However, my advice is, the best thing that companies should do now is to stop developing new products with these claims, because these claims might not be approved in the end,”​ Yu said.

Asked her views on the possible review, she said that that would bring about a clearer boundary between the different health food claims for the government and third parties such as regulatory consultancies.

However, for manufacturers who are already producing products with such claims, this would be an unpleasant news, since past efforts would go down the drain.

On the other hand, she added that it might take a few years to impose new regulations. Alternatively, the draft recommendations might not even be introduced eventually.

Claims to be rephrased​

For claims that might be rephrased, the terms “aids in” ​and “alleviate” ​would be added in.

For instance, the present claim “strengthen immunity” ​will be adjusted to “aids in strengthening immunity”​. Other adjustments include changing “improving sleep” ​to “aids in improving sleep”.​

SAMR explained that they were concerned that fake or exaggerated claims and in turn mislead consumers.

“These claims are being intentionally rephrased to show that the products do not provide effective cure,” ​Diao added. 

If this change is implemented, the manufacturers and the certificate holder of health food production can directly adjust the product packaging, labelling, instruction on use, and the description of the claims. Their existing batch of products which are already in the market can still be sold until the date of expiry. 

For products which are pending production approval, the organisation giving the approval will directly help to rephrase the products’ health claims.

More ingredients approved ​

On the bright side, the SAMR also announced last week a separate public consultation to consider the expansion of the current Health Food Raw Materials Directory. 

Five new ingredients, namely co-enzyme Q10, melatonin, fish oil, ground ganoderma lucidum powder, and spirulina, would be considered. 

The current Health Food Raw Materials Directory consists of only basic vitamins and minerals, and the process of obtaining approval​ to produce these types of supplements takes up a shorter time - at about six months - as compared to other types of supplements. 

As such, Diao noted that the addition of new ingredients would be a piece of good news for enterprises.