Inviting comments started about the partial revision(draft) “Matters to be Noted relating to Health Foods under the Act against Unjustifiable Premiums and Misleading Representations and the Health Promotion Act” (Japan)

By | October 5, 2022

On August 9, 2022, the Consumer Affairs Agency(CAA) prepared and announced a partial revision (draft) of “Matters to be Noted relating to Health Foods under the Act against Unjustifiable Premiums and Misleading Representations and the Health Promotion Act”. From the same day until September 7, comments were invited through public comments. The purpose of the partial revision is to “contribute to the proper advertising activities by business operators with clearer indication of the concept against labeling that may cause a problem under the Act against Unjustifiable Premiums and Misleading Representations and the Health Promotion Act after many years since the full revision of these precautions”. I would like to summarize the outline of the proposal as follows.

Major Revisions (The old and new comparative table)

1) Revised or supplemented by revision (partial excerpt) (revised parts are underlined in red letters)

◆ Addition of the statement that general food items (that are clearly recognized as such) are targeted as well to this precaution”

Article 65, Paragraph 1 of Health Promotion Act prohibits false and exaggerated labeling of health maintenance and promotion effects, etc. with regard to products 1 offered for sale as food, including not only food in the form of tablets or capsules, but also vegetables, fruits, cooked products, etc. that are clearly recognized as general food from their appearance, shape, etc.

◆ Supplemental notes on the applicability of “labeling”

When the advertisements, such as a booklet containing information on health-promoting effects of a specific food or ingredient as well as a booklet containing information on a specific product with such effects and free samples of the product, are all deemed to induce general customers who make inquiries to the contact point listed in the advertisement regarding the health maintenance/promotion effects of the specific food or ingredient, etc, to purchase the specific product.
When circumstances are found that may remind general consumers who are exposed to advertisements regarding the health maintenance/promotion effects of a specific food or ingredient, etc. of a specific product because the name of the specific food or ingredient is used as the product name or brand name.

◆ Supplemental notes on the labeling subjectivity of affiliate advertisements

With regard to such labeling on affiliate sites, if the advertiser is evaluated as having been involved in determining the content of the labeling, even though the advertiser is not specifically aware of the content of the labeling, the advertiser is an entity subject to measures under the Act against Unjustifiable Premiums and Misleading Representations and Health Promotion Act, such as in cases where the advertiser entrusts the affiliate to determine the contents of the labeling despite being able to determine themselves. (snip) it is necessary.

2) Newly added due to revision (partial excerpt)

◆ Addition of examples related to health maintenance and improvement effects

(1) “Effect of maintaining and improving health”

  1. (a) Effect aimed at treatment or prevention of disease: Addition of “prevention of coronavirus” and “prevention of dementia”
  2. (b) Effects with the main purpose of general enhancement or enhancement of body tissue functions: Addition of “anti-aging”, “activation of cells”, etc.
  3. (c) Effect of being suitable for a specific health use: addition of “help to lose body fat”, etc.
  4. (d) Nutritional effects: Addition of “vitamin D is a nutrient that facilitates the absorption of calcium in the intestine and helps bone formation”

(3) Those that implicitly or indirectly express “health maintenance/promotion effects, etc.”

  1. (a) Labeling made as part of a product name or marketing claims
    Addition of “Fertility,” “Intestinal activity,” “Slim XX,” “Reduced fat XX,” “Detox XX,” and “Clean up the excess accumulated in your body”
  2. (d) Labeling problematic issues such as anxiety and worries related to the body’s organizational functions, etc., with examples
    Addition of “The lack of XX may be the cause why I feel weak these days”, etc.

◆ Addition of examples where the labeled effects do not adequately correspond to the verified effects
e.g. A report of a human study using a product with a claim for slimming effect was submitted, but there was a significant discrepancy between the demonstrated content and the indicated effect on visceral fat and body weight loss.
e.g. Addition of items in which a report of a human study using a product that claims that a slimming effect can be obtained only by taking the product without any particular exercise or dietary restriction was submitted, but in fact subjects in the human study were provided with intervention guidance on exercise and dietary restriction, etc.

◆ Addition of the concept of advertising part of the post-check Guidelines for Foods with Function Claims

(2) Foods with Function Claims

(a) Labeling exceeding the contents of the submitted documents
e.g. Although the content of the labeling is “Has the functionality to help obese people reduce visceral fat”, the labeling as a whole makes it appear as if anyone can easily obtain the effect of slimming the abdomen without any special exercise or dietary restrictions.

(d) When the scientific evidence supporting the labeling lacks rationality
As for Foods with Function Claims, please refer to a detailed explanation of the concepts that may lead to false and exaggerated representations, etc. as advertisements and other labeling that may be problematic under the Act against Unjustifiable Premiums and Misleading Representations in the “Guidelines (draft) on ensuring the transparency of ex-post regulations (post-checks) based on relevant laws on food labeling for Foods with Function Claims”.

◆ Addition of examples of “health maintenance/promotion effects, etc.”

2 Examples of problematic labeling in health foods (so-called health foods) other than Foods with Health Claims

(1) Examples of problematic issues such as anxieties, worries, etc. related to the body’s organizational functions, etc. that have not yet been resolved
Labeling problematic issues such as anxiety and worries related to the body’s organizational functions, etc., such as symptoms of diseases that cannot be resolved by the health maintenance/promotion effects, etc. of health foods, etc. with examples(snip) Labeling changes in body tissue functions, etc., which totally cannot be obtained with the functionality of the food or the functional component from health maintenance/promotion effects, etc. that health foods have, by using illustrations or photographs (snip)

(4) In the case of use of superlative or similar expressions
(snip)When the No. 1 indication of the quality of the contents of the goods, etc. or the superiority of the terms of trade is not based on reasonable grounds or is otherwise different from the facts in the cases where labeling such as “No. 1 in sales in the diet category” or “No. 1 in customer satisfaction ranking” (so-called “No. 1 labeling”) is seen (snip)

(5) Inappropriate use of the experience report (addition of underlined parts in red letters)
In addition, when even the statements in the labeling such as “These are my personal opinions,” “The effects are not guaranteed,” or “These are the results of light exercise in combination with the product,” does not affect the determination of whether or not the product constitutes false and exaggerated labeling, etc. and the general consumers are led to believe that the product has health maintenance/promotion effects, etc. from the labeling that claims the effects of the ingredients contained in the product or the entire content of the labeling, including testimonials, etc., but the product does not actually have such effects (snip)

◆ Supplemental notes on Fine print* (*also known as “disclaimer”)

In cases where the effects of health food are mentioned in the testimonials, in order to avoid misleading consumers, it is recommended to clearly indicate.

  1. the number and attributes of persons with the experience
  2. the percentage of those who experienced the same effects as persons with the experience
  3. the percentage of those who did not experience the same effects as persons with the experience based on a survey conducted by the business operator when labeling such testimonials

Future schedules

After a public comment period until September 7, 2022, the results will be publicly announced on December 1, 2022, after the announcement of the result. This will be an important revision for those who handle foods with health and functional claims. I think it would be good to confirm at first the partial revision of the invitation for comments.

References


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