Compliance Challenges for Promotional Activities of Whitening Products in Japan

Whitening products are a significant segment of the Japanese cosmetics industry. In cosmetics marketing promotions, phrases like "whitening" are particularly effective. However, it is important to note that expressions of "whitening" effects must be in line with strict rules. These rules are outlined in the Pharmaceutical and Medical Device Act (PMDA), which prohibits the use of misleading expressions that may lead consumers to believe that the cosmetic product has medicinal effects.

Moreover, Japan has implemented a penalty system for false and exaggerated marketing promotions since August 2021, which emphasize financial consequences for non-compliant companies. Previously, fines were only imposed to companies which were arrested for violating regulations, but now fines may be imposed to those without being arrested. As revealed by the PMDA, the penalty is set at 4.5% of the sales revenue of the offending products. This represents a significant financial burden for companies.

Therefore, how to correctly promote whitening effects in "general cosmetics" and "quasi-drugs"?

General Cosmetics Products

In general cosmetics, only the efficacy claims specified within the List of Allowed Efficacy Claims for Cosmetics are allowed. Since the "whitening" effect is not included in this range, enterprises are prohibited to promote it as an efficacy claim.

However, it is permissible to express makeup effects in addition to efficacy claims. If the expression indicates that the makeup effect makes the skin appear whiter, this kind of expression is permissible.

(1) Allowed expressions and specific examples

a) Expressions indicating that makeup effects make the skin look whiter or conceal blemishes:

• "Effectively hides blemishes and freckles, making your skin look whiter."

• "Covers your skin's blemishes to make them less visible."

(2) Prohibited expressions and specific examples

a) Expressions that do not clearly indicate makeup effects and may lead to misunderstanding:

• "Freckles and blemishes disappear with whitening powder."  (This suggests a treatment effect beyond makeup, potentially misleading consumers.)

Medicated Cosmetic (Quasi-drugs) Products

Medicated cosmetic is regulated as quasi-drugs product, which mainly refer to products, with active ingredients approved by MHLW added in a prescribed dose, whose efficacy is between pharmaceuticals and cosmetics and is safe as cosmetics, with no side effects. In the case of medicated cosmetic, the range of permissible efficacy claims is broader than that of general cosmetics, provided they fall within the approved scope.

However, the "whitening effect" itself is not recognized an efficacy claim under the PMDA, even for medicated cosmetics. Therefore, it is necessary to express the meaning of "whitening" through recognized efficacy claims for medicated cosmetics.

(1) Allowed expressions and specific examples

a) When expressing "whitening" in accordance with approved efficacy claims, the following descriptions should be included:

• "This whitening cosmetic inhibits melanin production, preventing blemishes and freckles."

• "Whitening: *Inhibits melanin production, preventing blemishes and freckles."

b) Expressions indicating that makeup effects make the skin look whiter or conceal blemishes:

Even in the case of medicated cosmetics, it is permissible to claim makeup effects, just as with general cosmetics.

(2) Prohibited expressions and specific examples

a) Expressions indicating that the natural color of the skin itself changes (or becomes whiter):

• "Whitening effect that gradually lightens dark skin."

• "The more you use it, the whiter your skin becomes."

b) Expressions related to eliminating (or treating) existing blemishes and freckles:

• "Whitening effect that leaves no traces of blemishes and freckles."

• "I can't believe that the blemishes I have had for XX years can fade so much!"

• "Treating blemishes."

c) Expressions related to blemishes and pigmentation that are not part of the approved efficacy claims:

• "Whitening effect on stubborn blemishes and age spots."

• "Addresses darkening from acne scars and inflammation."

• "Prevents pigmentation from acne marks."

d) Expressions that imply improvement in skin quality:

• "Whitening can transform your skin."

• "Make skin less prone to blemishes and freckles ?."

e) Expressions that correspond to guarantees of efficacy and superlative claims:

• "Visible results in whitening."

• "Blemishes and dullness become less noticeable, allowing you to experience the whitening effect."

• "Whitening serum with whitening ingredients that penetrate up to X times more (compared to the product of the enterprise)."

• "Clearly demonstrate the effectiveness and safety of whitening ingredients."

f) Expressions that may make one additive mistaken for another effective ingredient:

• XX whitening (XX is the ingredient name of additives such as non-additive moisturizing ingredients)

• XX formulation, the birth of a new whitening (same as above).

Summary

1. In general cosmetics, "whitening" cannot be used.

2. In quasi-drugs, the expression "whitening" can be used, but the descriptions must be "inhibits melanin production, preventing blemishes and freckles" or "prevents blemishes and freckles caused by sun exposure."

3. If the whitening effect is due to makeup, both general cosmetics and quasi-drugs can have "whitening" claims.

ChemLinked suggestions

Consumers are highly concerned about the safety and effectiveness of skincare products, but misleading expressions can negatively impact the trust they have in a brand. Therefore, enterprises must use clear and accurate language in their marketing promotion to avoid vague and misleading statements. For example, they can emphasize the product's "makeup effect" rather than its "treatment effect," or highlight the source and effects of effective ingredients in promotion, such as "contains XXX, which inhibits melanin production, preventing blemishes and freckles" and ensure that these claims are backed by scientific evidence.

To avoid damages on the brand's reputation, enterprises can prioritize a review of approved efficacy claims to ensure compliance with regulations. Besides, they can also implement a compliance review for marketing materials to avoid the above misleading claims.