Introductory material from an overseas supplier is usually built out of sales figures, awards and a claim to be number one at home. We are often asked whether that can go straight into Japanese promotional copy.

We previously set out what may and may not be said in advertising under the pharmaceutical law. This article takes the other side — the Act against Unjustifiable Premiums and Misleading Representations, which is built around a different demand: if you say it, hold the grounds for it.

"True" and "not misleading" are two different tests

The starting point is Article 5 of the Act, under which no business operator may, in connection with transactions in goods or services it supplies, make a representation falling under any item of that Article. The operative words are "misleading to general consumers". A figure in the supplier's file may be perfectly true, and the representation still falls inside the Article if what a Japanese consumer takes from the representation as a whole departs from the facts.

  • Item 1 (misleading superiority) — representing content as markedly superior to what it actually is, or to a competitor's
  • Item 2 (misleading advantage) — price or other terms represented as markedly more advantageous than they are, or than another operator's

The representation is deemed unjustifiable without anyone proving it false

The provision that bites is Article 7(2). The Prime Minister may, where necessary, set a period and require the operator to submit material showing reasonable grounds supporting the representation. The paragraph then continues:

In this case, if the business operator fails to submit the material, the representation shall be deemed to be a representation falling under that item for the purposes of the application of that paragraph.

"Deemed" is the whole mechanism. The authority does not have to prove that the product lacks the represented effect. The bare fact that nothing arrived within the period is enough for the representation to be treated as misleading superiority. The scope is narrow: it applies where the question is Article {CITE["a5"]}, item {CITE["n1"]}, and there is no such device for misleading advantage under item {CITE["n2"]}.

The period is 15 days, and "we will look into it now" does not extend it

How long that period runs is fixed by Article 7(2) of the Ordinance for Enforcement.

The period provided for in Article 7(2) and Article 8(3) of the Act shall be the period up to the day on which 15 days elapse from the day on which the document referred to in the preceding paragraph was delivered.

An extension is possible for justifiable reasons, and the Consumer Affairs Agency guideline goes as far as naming what does not qualify: "a reason such as the need to conduct a new or additional test or survey is not recognised as a justifiable reason".

If the material sits with the counterparty, with no original, no description of method and no translation, 15 days will not reach it — and "we will now ask them and investigate" buys no time. In practice the requirement is therefore that the material is already in your own hands before the representation goes out.

Two requirements when the data is someone else's

For submitted material to count as "reasonable grounds", the guideline sets 2 requirements.

  • Requirement 1 — the material is objectively substantiated (results of tests or surveys, or the views of experts and expert institutions, or academic literature)
  • Requirement 2 — the represented effect or performance and what the material actually substantiates correspond appropriately

For an importer-distributor, the decisive passage is the one the guideline devotes to sellers. A seller is not always required to re-run the testing itself: it may instead submit documents showing that the seller itself checked whether data from the manufacturer's tests or surveys exists, and checked the objectivity of the method and results. What is needed is not a repeat test but a record of that check — which means obtaining, roughly, the following.

  • The survey report itself, with a translation — not a summary deck or a promotional extract
  • The method — how respondents were selected, the sample size, the actual question wording
  • When the survey was run and by whom, and which products and operators were included for comparison

Material that is objective in itself but does not correspond to the representation is not accepted as grounds. Applied to overseas performance, the line is clear. Units sold or a ranking in another market does not substantiate the effect or performance represented on the product. And the guideline defines the represented effect broadly — the effect "that general consumers recognise from the representation as a whole". A photograph or a testimonial beside the number is part of the representation too.

Writing "No.1 overseas" — the 4 requirements from the survey report

On 26 September 2024 the Consumer Affairs Agency published its survey report on No.1 representations, drawing on 368 advertising samples, an attitude survey of 1,000 consumers, and interviews with 15 advertisers and others.

For a No.1 representation resting on subjective evaluation to have reasonable grounds, the report states that at least the following 4 must hold.

  • The goods or services compared are appropriately selected
  • The survey respondents are appropriately selected
  • The survey is conducted by a fair method
  • The content of the representation and the survey results correspond appropriately

The report also sets out typical failures: surveys that leave the market's main comparable products out of the comparison, and surveys whose respondents are the operator's own repeat customers or its own staff. A footnote stating the conditions does not cure this where its position or type size leaves it unclear to general consumers.

The finding that lands hardest in practice comes from the interviews. Of 15 advertisers, only 1 knew the basic content of the survey behind its own claim — the question items, which competitors had been selected for comparison, what respondents had actually been shown. Carrying a number somebody else produced leaves you in exactly that position unless you do something about it.

What to settle before the copy goes out

Article 22(1) obliges operators to put in place the systems and take the other measures necessary to manage matters relating to representations properly. Where overseas performance is involved, that comes down to roughly this.

  • Tie each sentence you publish to a specific piece of supporting material
  • Keep the original and a translation in your own files — material in the counterparty's hands does not count as material you hold
  • State the date, subject and scope of the survey next to the claim, in type general consumers can read
  • Write "selling well in that market" as the fact that it is, without carrying it over into a conclusion about effect or performance

Within the range your material covers, overseas performance can be written about. What is prohibited is not recounting a record, but leaving general consumers with an impression of superiority or advantage that nothing supports.

Primary sources

Note: this article describes the framework. Whether a particular representation is permissible is judged by what general consumers take from the representation as a whole.

We import and wholesale pharmaceuticals, quasi-drugs and cosmetics. Where overseas material is to be carried into Japanese labelling and copy, we work from obtaining the supporting records and mapping them to each claim.