What Are Quasi-Drugs and How Do They Differ from Cosmetics?

Japanese cosmetics don't all share the same classifications as hygiene and beauty products do in other parts of the world. For instance, products whose categorization falls somewhere between cosmetics and pharmaceuticals form a separate group – quasi-drugs. Here's what you need to know about quasi-drugs: definition, labeling requirements, and explanations.

What Are Quasi-Drugs? Definition

When western cosmetic manufacturers come across the concept of quasi-drugs, the definition may not seem obvious. The closest equivalent you may find is cosmeceuticals. The term refers to products with characteristics that belong to both cosmetics and pharmaceuticals. However, cosmeceuticals have no official status and don't obey any legal requirements.

This is where quasi-drugs come in. The Japanese Ministry of Health, Labor, and Welfare apply this classification to Japanese cosmetics with formulations that warrant a specific license. These products possess a recognized effect authorized by the institutions, but their action is not as potent as that of a 'drug', or pharmaceutical. Hence the denomination 'quasi-drug'.

What Is the Difference Between a Drug, a Quasi-Drug, and a Cosmetic in Japanese Law?

Japanese Pharmaceutical Affairs Law grants a limited range of claimable effects to cosmetics. These effects primarily relate to moisturizing or cleansing properties and don't encompass skin correction or any kind of 'treatment' – such as anti-acne or anti-dandruff agents, for example.

Yet, shampoos, lotions, and other products in this category do not have any strong healing claims as such, which means they aren't drugs either.
Here is where the main differences lie:
  • Japanese cosmetics are limited to the following categories:
    • Skincare products
    • Hair care products
    • Makeup
    • Perfume and cologne
    • Sunscreen and other special-purpose cosmetics
    • Cosmetic soaps
  • Quasi-drugs are cosmetics with a mild correction or healing effect. These include:
    • Medicated soaps and cosmetics
    • Products formulated for heat rash and mosquitoes
    • Products for preventing nausea
    • Whitening products
    • Shampoos and lotions that promote hair growth
    • Acne treatments
    • Anti-aging products
    • Etc.
  • Drugs are pharmaceuticals with a strong correction or healing effect.

What Are the Requirements for Selling a Quasi-Drug in Japan?

The main benefit of the quasi-drug stipulation is that it enables manufacturers to make specific claims as to the effects of their products. This is something they couldn't do under the 'cosmetic' categorization. In other words, a quasi-drug can be marketed openly under various claims, including 'preventing dandruff' or 'fighting acne'.

The legislation is also laxer when it comes to labeling obligations. In Japan, products sold as cosmetics are required to display a full list of ingredients (concentration of 1% or higher in the finished product) on their packaging in decreasing order of concentration. Quasi-drugs, on the other hand, are not bound by such restrictions. They can omit preservatives or give a more prominent place to an active component even if it is not present in high concentration in the formula.

With that said, the formulation of quasi-drugs is governed by strict guidelines, especially regarding the ingredients that may be used, and in what concentrations. Once a formulation has been approved, there is no flexibility when it comes to possible alterations, and creating differentials can be a prohibitively expensive endeavor. Formulations must be approved individually, with an application period that can range from six to eight months.
  • Cosmetic Formulation Software: A Comprehensive Solution for Quasi-Drug Manufacturing
The key to successful and swift quasi-drug product approval is understanding proper product classification, ingredient assessment, label compliance, and other regulatory obligations. Foreign manufacturers may find this challenging, as even a slight inaccuracy on a translated label could send them back to square one.

Cosmetic formulation software can make all the difference when it comes to your formula review. It will help you get the INCI and Japanese ingredient names, concentrations, margins of safety, allergen thresholds, and other restrictions right before you submit your formula for approval.

Thanks to its global, comprehensive regulatory database, the Coptis solution is designed to ensure compliance with Japanese standards.