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.