Japan’s Food with Function Claims: Limited consumer understanding of regulatory details
FFC was introduced in April 2015 to allow manufacturers make limited health claims without having to go through the more stringent Foods for Specified Health Uses (FOSHU) process.
For FOSHU, the government evaluates the claimed effects and safety, and the Consumer Affairs Agency (CAA) gives approval for the labelling of each food product that satisfies the requirements.
The Foods with Function Claims (FFC), however, is only a notification system, where manufacturers need to meet six criteria ahead of launch.
Since the more relaxed laws were introduced, there have been around 1,000 products making FFC claims.
A recent online survey of 2,060 consumers, 515 physicians and 515 pharmacists found that 81% of consumers, 93% of physicians and 98% of pharmacists were aware of the new system.
However, only 16% of consumers, 23% of physicians, and 44% of pharmacists correctly understood the key characteristics of the regulation.
Furthermore, only 12% of consumers were using or had used FFC products.
Among those, just 26% had checked the information on the website of the Consumer Affairs Agency, where the details of how a product meets the six requirements must be lodged.
The survey, carried out by the National Institute of Health and Nutrition, also found that very few consumers (8%) discussed their FFC use with a physician or pharmacists.
Consequently, only 2% of physicians and pharmacists had had consultations with their patients on the potential adverse events associated with using FFC products alongside medications.
Meanwhile a separate study found that the accompanying information lodged with the Consumer Affairs Agency was poor.
The paper, published in the journal Nutrition Research, highlighted “very poor descriptions and / or implementations regarding the registration (2%), evaluation of publication bias (12%), and appropriate conclusions based on scientific quality of the included studies (27%).”