EAS Comments on China’s Proposal to Require Human Data for Health Claims

Regulatory consultant EAS has commented on a proposal that would require that health claims in China be backed by human clinical data. As of August, the proposal was being reviewed by the Chinese State Food and Drug Administration (SFDA). The draft amendment was open for public comment until August 31.

EAS says that the proposal states that human data should be used to substantiate health claims unless it is not possible due to test method limitations.

“Since the implementation of the Food Safety Law in February 2009, the SFDA has been intensively reviewing the country’s health food regulations,” stated EAS regional regulatory affairs manager Wai Mun Poon. “The substantiation criteria change means that claims such as ‘improves sleep’ and ‘relieves fatigue,’ which currently only require substantiation from animal studies, will require human studies.”

“However,” she added, “animal studies would still be allowed for certain other claims substantiations where relevant test methods using human models are not yet available.”

EAS says that the draft also proposes reducing the number of permitted health food claims from 27 to 18, “based on safety concerns and insufficient scientific evidence or evaluation methods,” and that similar claims have been grouped together into one claim.

“Claims relating to eradicating acne and freckles, for example, are replaced in the draft by the single claim ‘promoting facial skin health,’” Poon stated.