On January 14, 2015, Patterson Companies, LLC, announced that it is formalizing its efforts to shore up its supply chain integrity for its dental customers. The program will assure that dental products that Patterson Dental distributes are sourced directly from the manufacturer and not through secondary markets carrying deeply-discounted gray market products.  Such efforts promote supply chain integrity and help protect against potentially unsafe products from entering the dental product marketplace.

The FDA defines “gray market” goods as products sold outside established, authorized distribution channels, usually at a deeply discounted price. “For example, a supplier may purchase products intended for a foreign market and then import and sell the product in the U.S. The original manufacturer did not intend the product for the U.S. market, and it may or may not comply with U.S. laws and regulations,” according to a statement from the FDA Center for Devices and Radiological Health.

Secondary and tertiary market channels frequently carry counterfeit, adulterated, expired, or other black-market products and pose a significant health threat. Such products may not meet FDA standards or other applicable laws and regulations. One major concern is that products flowing through gray-market channels are frequently indistinguishable from defective or counterfeit products moving through the same channels. “If the gray market version is not the legally marketed version, it may not meet U.S. safety and effectiveness standards. It may lack essential information in labeling or the labeling may not even be in English,” according to the FDA. “A significant concern is that products available on the gray market may be defective products that have been diverted from planned destruction or products that may have been recalled.”

“The program that we will put in place is designed to help protect our dental customers and their patients from products that may be potentially unsafe,” said Paul Guggenheim, president of Patterson Dental. “By further reinforcing the integrity of Patterson’s supply chain, we can safeguard against the distribution of products that may be unsafe, have been mishandled or are illegal. As a result of our efforts, and as their trusted partner, our customers will know that Patterson Dental is providing them with products that come directly from the manufacturer or its authorized distributors. We are proud to continue to deliver on our commitment to customers and their patients.”

Recognizing that the diversion of legitimate products into authorized gray markets has been an issue in the dental distribution industry, Patterson Companies’ Chief Executive Officer, Scott P. Anderson, said:

We have worked hard for years to ensure the highest integrity of our supply chain, and we hope that the rest of the dental supply industry will show a similar commitment to secure their own supply chains. . . . .Given the potential for dentists to unknowingly purchase counterfeit or dangerous products, we believe that this is a very important matter. Among our highest priorities are our customers’ reputation and their patients’ safety.

The American Dental Association (ADA) has encouraged all manufacturers and distributors to be selling products authorized for sale in the United States, and urges dentists to purchase products that meet all FDA safety regulations. Product selling for half the price of what a legitimate dealer sells it for should send up a red flag for dentists. Consumers can also be exposed to gray-market oral care products such as toothpastes and mouth rinses. The ADA advises that consumers should check to see if the products they purchase bear the ADA Seal of Acceptance. Questions about specific products or companies can be directed to the FDA at 1-800-638-2014 or dsmica@fda.hhs.gov.