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Gray market a murky issue for dentists

ADA News series aims to educate on various perspectives

August 03, 2015

By Kelly Soderlund

Editor's note: This is the first in a series focusing on the gray market and how it affects dentists, patients and manufacturers.

The path a dental product takes from the manufacturer to the dental office is typically a straight and trustworthy one.

By purchasing directly from the manufacturer or an authorized distributor, dentists can be assured the product they receive is the one they ordered.

But dentists or their staff may be intentionally or unintentionally turning to the gray market to purchase their dental products; a sometimes cheaper option but one that comes with risks.

"Gray market" is a generic term that primarily refers to products that are traded or sold outside of the manufacturer's authorized distribution channels. It's different than the black market, where products are illegally manufactured or illegally sold.

Selling or purchasing products on the gray market isn't necessarily illegal, but purchasers may not be getting what they paid for. For example, a supplier may buy products intended for a foreign market and then sell the product in the U.S., where it may or may not comply with U.S. laws or regulations.

Manufacturers, government agencies like the Food and Drug Administration, and organizations within dentistry like the Dental Trade Alliance and the National Association of Dental Laboratories have been trying to educate dentists on what it means to purchase a product from an authorized distributor who is involved in the gray market and the risks they're assuming by doing so. It may be cheaper but may compromise the quality of patient care.

A network of illegal distributors or nonauthorized distributors, easy access to Internet shopping and cheaper options all make it easy for dentists and staff to access and purchase gray market products.

But if a market product doesn't comply with U.S. safety regulations, dentists may be putting their patients at risk.

The ADA wants dentists and dental team members to be aware and understand the risks they take by purchasing products on the gray market, not only for themselves but for their patients.

"It is important that dentists have a complete understanding of the issues and concerns, along with the associated risks to providers, their staff and patients," said Dr. Daniel Meyer, ADA chief science officer, who is heading up the Association's effort to educate dentists on the issue. "Depending on the specific circumstances, oral health providers may be at risk of having little to no recourse with the manufacturer if a product purchased outside of the manufacturers authorized distribution chain does not perform as expected."

Unless a product is purchased from an authorized dealer or manufacturer, dentists or dental team members may not know what they are actually receiving, Dr. Meyer said.

It's a risky move because, in many instances, dentists and their staff wouldn't be able to spot a noncompliant product just on sight alone.

"They may be seeing a noncompliant product for the first time after it is out of the package," Dr. Meyer said. "The dental team may not even be aware that the product is not what they thought they had ordered."

In the coming months, the ADA News will explore the gray market issue from a variety of perspectives and break down what dentists should be paying attention to.