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The guidelines'draft for the ex-post review on Foods with Function Claims has been published.

The Consumer Affairs Agency (CAA) published "The guidelines' draft to ensure transparency of the ex-post regulations (ex-post review) of Foods with Function Claims based on related legislations on food labeling, etc." and started receiving public comments on January 16, 2020. There are cases judged to be clearly inappropriate as a scientific evidence, as well as other cases that may be problematic in advertisements and other labels, not only for Foods with Function Claims but also for health foods in general that you can refer to, and which I would like to feature here.

Improve the predictability of business operators and simplify the process of voluntary inspections

This guidelines were announced due to the fact that the issue, "how business operators are having difficulties dealing with labeling regulations and ex-post regulations of Foods with Function Claims", was discussed at the Regulatory Reform Promotion Council (Cabinet Office) in November 2018. Following the meeting discussions at the Regulatory Reform Promotion Council, the guidelines came to be published, and the main purposes were "to improve the predictability by business operators for inappropriate labeling" as well as "promote voluntary inspections by business operators and voluntary regulations by industrial groups".

Items related to scientific evidence

The 1st in the guideline is on "Items related to scientific evidence". It is shown in more detail with a view to contributing to ensuring the transparency of ex-post review notifications based on the following guidelines ("the Guidelines on notifications of Foods with Function Claims") and considering the health foods ("Notes on the Premium Labeling and Health Promotion Acts for Health Foods")

"Specific examples of cases considered clearly inappropriate as scientific evidences" were described, so I would like to list some of them as follows. More detailed contents are included such as the cases where "there are no reasonable explanations" and "there are some deficiencies". Therefore, these will be used as standards to check the relevance of the explanation as a scientific evidence in the future.

  • In the report, cases where research questions are set according to the functionality to be displayed on the label, but the labeling content is excessive compared to the content of the scientific evidence, or its relativity/link with the evidence is unrecognizable (e.g.: No significant results were obtained for the labeled functionality in the primary outcome measure (usually one set), etc.)
  • Cases of insufficient equivalence between the ingredients in the research review and functionally relevant ingredients in the notified food (e.g.: When the form and dosage at the time of ingestion of which efficacies are confirmed in the research review and those in the notified food are different, the equivalence of the effective amount of the functionally-related component whose effectiveness has been confirmed cannot be rationally explained, etc.)

About Advertising and other labeling concepts

The 2nd guideline is related to "Advertising and other labeling concepts" If the advertisement or other labeling of Foods with Function Claims deviates from the scope of the reported functionality, it may be legally problematic. Items which business operators should pay attention to are described per display category, particularly about Act against Unjustifiable Premiums and Misleading Representations, which prohibits "claiming that a product is significantly better than it actually is or better than a product made by another business operator, which is not true".

Items that may deviate from the scope of the reported functionality and become a problem according to Act against Unjustifiable Premiums and Misleading Representations (excerpts)

  1. Example of problems related to the body tissue's functions that cannot be resolved
    "Indication and display of problems such as anxiety and worries related to the body tissue's functions, falling under a disease's symptoms which cannot be resolved by the functionality of the notified food or functional ingredients."
    "Indicate/display changes in the body tissue's functions, which cannot be obtained from the functionality of the food or the functional ingredients, by using illustrations or pictures."
  2. Description of the notified functionality
    "Despite the limited range of subjects for whom the scientific evidence's effectiveness of the reported functionality has been obtained, appeals the effectiveness of similar functionality to subjects outside the scope," etc.
  3. Experimental results and graphs
    "Test conditions (subjects, number of people, intake method, etc.) are not clearly and visibly displayed", etc.
  4. Recommendations from doctors and specialists, etc.
    "When the recommendations, etc. do not fully affirm the effect of the food product, but refers only to the affirmative part", etc.
  5. Experiences
    "Use of assertive expressions to assure the effectiveness or expressions which suggest that no medical care ( treatment or medication) is needed", etc.

In addition, it is also necessary to pay attention to the following description of "Experiences":

"It is obligatory to make an effort to display it clearly
1. the number of the experiences and their attributes,
2. the percentage of subjects who achieved the same effect as the experiences,
3. the percentage of subjects who did not achieve the same effects,
in the survey conducted by the business operator to display the relevant experiences."

In addition, since the experiences are referred to in the item of "fine print" in the guidelines, it is particularly necessary to confirm when using the experience story in advertisements and other displays.

6. Descriptions cited from a part of notified description or notified material
"Cases where the label description deviates from the scope of the reported functionality by cutting out and highlighting a part of the notified description"

The above are considered as the guidelines for "improving the predictability of the business operators for inappropriate labeling".

The enforcement date is scheduled for April 1st, 2020.

At the end of these guideline, if an issue such as inadequate notification materials is clarified, the contents that "will not be considered problematic under the Premiums Display Law" are arranged. One of them explains "the case where the scientific evidence of labeling is not considered as the lack of rationality by an appropriate objective evaluation, such as being evaluated as appropriate by an organization or an institution recognized for scientific knowledge and an objective position regarding Foods with Function Claims". Such systems according to the guideline are expected to be created in the future for the purpose of "facilitating efforts such as voluntary inspection by business operators and voluntary regulation by industry groups"

They are still soliciting public comments, but the enforcement date is scheduled to be April 1st, 2020. I think that these guidelines affect not only those who handle Foods with Function Claims but also those who handle health foods in general, so I would recommend checking them once.

References:
"The guidelines' draft to ensure transparency of the ex-post regulations (ex-post review) of Foods with Function Claims based on related legislations on food labeling, etc."

March 2020