Skip to content

If It Works As Well As a Drug, It May Be One

Products to treat erectile dysfunction (ED) remain extremely popular online, and so many federal agencies around the world search the internet for products that are dangerous or otherwise illegal. Because card brands may issue fines based on the warnings and alerts issued by regulatory bodies around the world, it's important for payment service providers to keep abreast of regulatory warnings regarding ED products.

In Japan, the Japanese Ministry of Health, Labor and Welfare (MHLW) and local governments routinely conduct tests on supplements they purchase from the internet for the purpose of detecting tainted products. The suspected products are mainly so-called "health foods" touted for their tonic effects or slimming effects, and are typically sold on websites that list an offshore business address - if they list contact information at all, which is mandated by Japan's Specified Commercial Transactions Act.

These test buys often reveal supplements that are laced with active pharmaceutical ingredients (APIs) such as sildenafil and tadalafil, which are typically used to treat ED. MHLW publishes the results of their annual testing, listing the name of products found to be tainted, and warns the public to avoid taking these supplements, as the potential health hazards are significant with these undeclared pharmaceutical ingredients. In some cases, the detected amounts of APIs were considerably higher than what is typically included in approved pharmaceuticals.

It is not just supplements - typically in capsule or tablet form - that are routinely found to contain undeclared APIs. Several food items have been found to be tainted. For example, a line of coffee marketed as "coffee for men" was found to contain undeclared APIs typically used to treat ED. Supplements or food products that are marketed as having the effects of pharmaceuticals warrant additional scrutiny.

Many supplements sold online are shipped from overseas under the guise of an often-misunderstood rule called "personal importation." In this context, the consumer is directly importing something for their personal use; however, the rule does not apply because the product being purchased is something that is unpermitted to cross the border because it lacks appropriate safeguards. Therefore, the consumer is assuming various risks associated with the act of purchasing, including risk to their health.

The personal importation justification is often used by rogue internet pharmacies targeting Japanese customers to sell not only unapproved prescription drugs and tainted supplements, but also e-liquids that contain nicotine, cosmetics that contain problematic ingredients, and highly controlled medical devices such as contact lenses.

The marketing of unapproved drugs and unauthorized medical devices would be a violation of the Pharmaceutical and Medical Device Act in Japan, and would pose elevated risk of BRAM and GBPP fines to payment service providers. LegitScript continuously monitors the internet space for unapproved pharmaceuticals, including tainted supplements, to safeguard the public and help members of the payments industry avoid merchants engaged in problematic activity.

 

Want to learn about other problematic supplement ingredients? Download LegitScript's free guide, Top 10 Problematic Supplement Ingredients to Avoid.

 

Recent Blog Articles

Levels of risk.

What You Need to Know About the Different Levels of Merchant Risk

Many risk mitigation approaches focus on high-risk merchants, but what about medium-risk merchants? Being aware of the various levels of risk and which category your merchant falls into is a critical step in quantifying risk. Let's delve into what low-, medium-, and high-risk merchants are and the v...
Northern Colorado Hemp Exposition (NOCO)

Navigating Compliance: LegitScript’s Insights from NOCO

Join LegitScript on a journey to the 10th annual Northern Colorado Hemp Exposition (NOCO), where we immersed ourselves in the heart of the CBD industry. LegitScript shared critical compliance knowledge, exchanged insights with industry peers, and absorbed vital regulatory updates from the FDA and US...

What’s Hiding on Your Marketplace? A Look at How Risk Infiltrates Your Platform

You monitor seller listings on your e-commerce marketplace, but do you know what's going on behind the scenes - or, rather, behind the screens? Illegal and brand-damaging activity isn't always easy to spot, and the risk only compounds as your platform scales. In this post, we explore violative activ...
Addiction Treatment Advisory Committee

Harnessing Collaboration: Highlights from LegitScript’s First Advisory Committee Meeting of the Year

Last year, LegitScript set out to relaunch its Addiction Treatment Certification Advisory Committee in order to strengthen avenues of communication and ensure the continued improvement of its Certification solutions. On March 27, 2024, the revitalized committee convened for the first time. Keep read...