Credibility doubts arise: Japan set to revise Foods with Function Claims scientific evaluation

Systematic review, which is the most common method that companies use to support the functional claims and science of FFC products, will be required to comply with Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 (PRISMA 2020​), said the CAA in a press conference held this month.

The CAA is currently collecting public feedback on how the guidelines stated in PRISMA 2020 could be implemented.

Events leading to the revision ​

The development comes after the discovery of two FFCs that made functional claims not well supported by the research reviews submitted to the CAA.

One of the products, "Kinari Takumi (きなり匠)" claims to lower neutral fats or triglycerides with the use of DHA and EPA, lower blood pressure due to the use of monoglucosyl hesperidin, and inhibit LDL cholesterol oxidation using hydroxytyrosol derived from olive.

The other product, "Kinari Kyoku (きなり極)”, also claims to lower neutral fats with the use of DHA and EPA. Both products are manufactured by the firm Sakura Forest.

The CAA had found discrepancies between the claims and the systematic review evidence that the firm had submitted to support the claims.

The problem came to light after the CAA was notified of the types of claims that the company was making through its online advertisements.

“On its website, Sakura Forest had claimed Kinari Takumi as a product that ‘lowers blood pressure dramatically’. The Agency found this to be an exaggerated claim that deviated from a health claim and thus found it to be an unfair labelling or a case of misleading representation,” ​Hisaaki Kato, president of consultancy firm Smooth Link Inc told NutraIngredients-Asia. ​

It later turns out that the firm had also made the claim “lowering neutral fats / triglycerides”, although its products contained only between four and 500mg of DHA / EPA. The amount was only about half of that studied in the systematic reviews that the firm had cited.

In addition, systematic reviews on hydroxytyrosol did not report a significant difference between the intervention and placebo groups in their ability in inhibiting LDL cholesterol oxidation.

“The CAA, however, did not recognise the discrepancy between the systematic review and the reported claims [at first],” ​said Kato.

The CAA eventually categorised the issue as a problem of “misleading representation” and on June 30, issued an order to take measures regarding the two products based on the Act against Unjustifiable Premiums and Misleading Representations.

The two products have since been withdrawn from the market.

Others affected​

Subsequently, the CAA decided to re-assess FFCs making similar functional claims using the same ingredients as the two products from Sakura Forest. 

The CAA has since identified 88 products containing similar ingredients as the two products from Sakura Forest. 

Thirty-one of these products contained DHA/EPA, 14 contained monoglucosyl hesperidin, and 47 contained olive-derived hydroxytyrosol. Four contained both monoglucosyl hersperidin and hydroxytyrosol.

The CAA has received requests to withdraw the notification for 15 products, with nine containing DHA/EPA and six containing olive-derived hydroxytyrosol.

All companies making FFCs could also request five related organisations, such as Japan Alliance of Health Foods Associations (JAOHFA), to re-verify the scientific basis of their products, so as to uphold the credibility of the FFC system, said the CAA. The other four organisations are Japan Health and Nutrition Food Association (JHNFA), Japan Direct Marketing Association (JDMA), Japan Anti‐Aging Foundation, Inc (JAAF), and Japan Association of Chain Drug Stores (JACDS). 

“In light of this incident, in order not to undermine the trust in the food with function claims system as a whole based on the Food Labelling Act, we sent a written request dated July 3 to the relevant organisations to re-verify the scientific basis for all foods with function claims that have already been notified and published as needed,” ​the CAA said.

The CAA had stated that there was “no problem with the safety” with the remaining 73 products.

The system affected  ​

The actions taken against Sakura Forest differed from previous cases, as it subsequently spiralled into the re-evaluating how FFCs and systematic reviews should be assessed, said Kato.

With the introduction of PRISMA 2020, Kato believes it would help manufacturers in having a better idea of the types of systematic reviews that they should use to support the science behind their product claims.   

“Sakura Forest appears to have received information on systematic reviews from raw materials or OEM manufacturers. ​

“Many [FFC manufacturing] companies tend to specialise in sales. They concentrate on selling the products and leave the important manufacturing to other companies. I hope that this case [Sakura Forest] will be a catalyst for such customs to be put to rest,” ​said Kato.

Asked whether consumer trust would be affected by the recent shakeup, he believes that this would be unlikely, as Sakura Forest had responded and apologised quickly after the incident came to light.

“Consumers may not have negative feelings, as Japanese like sincere and quick responses to misconduct,” ​he said, adding that consumers also do not understand the extent of the problem associated with the FFC and the systematic review system.

What is PRISMA 2020​

The PRISMA 2020 statement is an international guideline that sets out the 27 types of information that should be present in systematic reviews.

This includes the rationale for the review, the methods used to decide whether a study met the inclusion criteria of the review, and a general interpretation of the results in the context of other evidence.

“To ensure the appropriateness of ‘research reviews’ in evaluating the efficacy of functional foods, the CAA has revised its notification guidelines to require compliance with the PRISMA Statement (2020),”​ said Kato.

As of July 20, over 95 per cent of the FFCs used systematic reviews in supporting their functional claims, said Kato.

At present, companies select the types of systematic reviews for providing the scientific basis of their products using the PRISMA 2009 statement.

As compared to PRISMA 2009, PRISMA 2020 has included new reporting guidelines to reflect advances in the methods used to identify, select, appraise, and synthesise studies.

“Amid concerns over the reliability of scientific evidence for functional foods, Commissioner Arai of the Consumer Affairs Agency announced at a regular press conference on July 6 that the Guidelines for Notification of Foods with Functional Claims will be revised.​

“To comply with the PRISMA Statement (2020), the guidelines will be revised promptly after public comments on the implementation period and other issues, considering the feasibility of business operators submitting new notifications and revalidating existing notifications,”​ said Kato.