Understanding the Pharmaceutical and Medical Device Act (PMD Act) is the first step in selling cosmetics and health related foods and supplements. This article covers basic points to keep in mind when creating ads and includes a checklist for you to ensure the risk of administrative guidance on your ads is kept to a minimum.

Pharmaceutical and Medical Device Act (PMD Act) Basics

—Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

The official name of the PMD Act is the “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.” As the name suggests, this law was enacted to ensure that pharmaceuticals and medical devices, including quasi-drugs, cosmetics, and regenerative medicine products, are properly manufactured, delivered to those who need them, and used properly.
Manufacturers, as well as retailers that provide consumers with information to make decisions about purchasing products, must ensure that they are in compliance with this law.
Affiliate marketers and influencers are also subject to this law, which is why it’s important to have basic knowledge before selling.

—Why Many Ads are Puzzling

Most of you have probably seen advertisements for dietary supplements and cosmetics that are often vague in description, give only a slight idea of the effects that can be expected from the ingredients, or unclear about the results altogether. The reason behind this is the restrictions on expressions imposed by the PMD Act.
Let’s take a look at cosmetics, which fall under the scope of the law, and “health foods,” which do not, barring the use of expressions permitted for pharmaceutical products.

*This article is meant to provide a basic overview. Please be sure to check with the Ministry of Health, Labour and Welfare for the latest information.

Cautionary Points

—What to Watch for in Practice

It’s difficult to grasp the salient points of the law if you just read the text. The first product I was in charge of happened to be a dietary product. Most of the text used in my draft was not permitted under the law, so I remember having a tough time checking what was permitted and what was not.
My recommendation is to simply read the slip of paper and the packaging found on pharmaceutical products. The reason is simple. If the text is permitted for pharmaceutical products, it isn’t for all other products, including cosmetics and “health foods.”
Expressions permitted only for pharmaceutical products often fall under 3 major categories.

1. Phrases that imply prevention or cure of diseases
   The effects found on the packaging of pharmaceutical products fall under the scope. This includes improving or relieving the symptoms of or curing headaches, joint pain, and muscle pain.
   
   
2. Phrases that imply the strengthening or amplification of bodily functions
   The previous category assumes the restoration of bodily functions from a negative state, whereas this category includes phrases for strengthening an already healthy body. This includes anti-aging, increases in body strength, and immune function improvement.
   
   
3. Phrases that imply medical grade effects
   The last category includes phrases that don’t fall under either of the other two categories but influence the customer’s decision on purchasing the product. This includes statements on dosage and application methods, as well as recommendations from doctors or scholars, and quoting theories.
   

Examples of Violations

—For cosmetics

• Effective on dermatitis
• Cures

—For “health foods”

• Effective in disease prevention
• Unrivaled effects

A Simple Checklist for Your Ads

Now that you have a general idea of what’s allowed and what’s not, let’s use a handy checklist and review using ordinary facewash and supplements as examples.

—Cosmetics (ordinary facewash)

1. Are references to efficacy kept within the scope of the Ministry of Health, Labor and Welfare’s “Scope of Indications for Cosmetics”?

Cosmetics are subject to the law, so only verified effects can be expressed. Exaggerations and false statements are prohibited.
There are a total of 56 approved effects for cosmetics. Each product category has its own scope of phrases available for use. For ordinary facewash, phrases 17 to 32 are permitted for use.

*Note 1: “Replenish” can be used to mean “maintain” as well.
*Note 2: The indications in parentheses ( ) are not included in the indications, but are limited in consideration of the form of use.

2. Are testimonials limited to “sense of use”?

Be careful so that testimonials don’t imply guarantees of effects. In the case of facewash, it’s essential to limit the testimonials to impressions after using the product with expressions such as “The product feels smooth after application and doesn’t stick to my hands.” Make sure that the context is such that it is clear that the testimonial and the effects of the product are separated.

—“Health foods” (supplements)

1. Are expressions limited to what can be said for foods?

Many health food products are shaped like medicines, such as pills or powders, but they are not actually medicine. Instead of using a preconfigured expression like with cosmetics, just remember that all phrases permitted for pharmaceutical products cannot be used for “health foods.” Think of “health foods” as ordinary food with nutrients.

For example, if an advertisement stated that “eating lettuce cures headaches,” many of you would probably feel that the expression is an exaggeration. Think of advertisements for “health foods” and supplements in the same way. 

2. Are descriptions of efficacy limited to ordinary physical facts of effects on the human body?

On the other hand, references to nutrients such as “Tomatoes are rich in lycopene,” or expressions that describes the supplementation of lycopene are not related to the efficacy of the ingredients and can be expressed in the same way as general food products. However, be sure to pay attention to context as misleading phrases are not permitted.

Summary

We covered the Pharmaceutical and Medical Device Act (PMD Act), basic precautions, examples of violations, and a simple checklist that you can use to review actual advertisements. The content summarized here is only an overview, so please be sure to check the latest information from the Ministry of Health, Labour and Welfare during production.

We also take into account trends in media screening in our creative production, and there have been cases where we have improved results while complying with the PMD Act.

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