China in 2009 passed the Food Safety Law which included 27 approved health claims, but some of them including sleep and fatigue were not backed with clinical, human data, and are set to be revoked if none is forthcoming.
Commenting on the proposed changes, Belgian consultancy, European Advisory Services’ regional regulatory affairs manager, Wai Mun Poon, said the mooted changes were part of an ongoing review of the regulations conducted by the State Food and Drug Administration (SFDA).
“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,” Poon said.
“However, animal studies would still be allowed for certain other claims substantiations where relevant test methods using human models are not yet available.”
The draft proposal would remove certain claims such as ‘increases bone density’ and ‘assists liver protection against injury’ and group others into more general claims.
“Claims relating to eradicating acne and freckles, for example, are replaced in the draft by the single claim ‘promoting facial skin health’,” said Poon.
Consultation on the draft amendment is open until August 31. The current list of 27 claims can be found here.
Like the European Union and some other regions, China seeks to tighten health food claim making. When the legislation, three years in the drafting, was passed that mandated the 27 claims in 2009, it stated:
"The regulation has been formulated to ensure citizens' health and life safety, and to strictly monitor the health food industry.”
At the time, Wang Dahong, secretary general of the China Healthcare Association, said: "The improvement of health food law system will stimulate more investment and consolidation in the industry.”
China also recently banned about 100 books for making what it considered to be unsubstantiated health claims.
Different regulatory markets
EAS is hosting a seminar in Brussels on October 13 that will consider how to market food supplements in various regions where regulations often differ greatly, including between Asian nations.
“Launching food supplements in the increasingly global arena requires a clear understanding of the different regulatory markets when devising market strategies,” said EAS food law adviser, Elodie Lebastard.
“Companies marketing in the EU, for example, face a number of complexities when navigating the borderline between national and EU-wide rules, and in ASEAN too, while harmonisation is underway, diverse national regulations still exist for putting products onto the markets in Asia.”