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Dental companies combating sale of gray market materials, educating dentists

June 16, 2014

By Kelly Soderlund

Image of figure with globe in shopping cart 
When discussing dental materials in the gray market, it's appropriate to rely on a pun and say it's a gray area.

The term gray market generally refers to products that are sold outside the established distribution chain, according to the U.S. Food and Drug Administration.

"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.

The legalities are different, depending on the sale, the FDA says. If a product is identical to what’s legally marketed in the U.S., gray market sales may not violate any FDA-related requirements. But versions of products sold in the U.S. may be different than ones sold in foreign markets, even if they have the same name. In that case, the foreign market device is an unapproved device in the U.S. and sales within the U.S. would be illegal, the FDA said.

"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."

"As an association, we encourage all manufacturers and distributors to be selling parts that are authorized for sale in the United States," said Fred Freeman, vice president of member services at the Dental Trade Alliance.

The DTA encourages dentists to purchase products that have met all FDA safety regulations.

"We never want anybody to be accidentally hurt or injured by a product that was approved for use here in the United States," Mr. Freeman said. "Nobody should be selling or promoting or using nonrecognized products."

DENTSPLY International Inc. is also taking a stand against gray market products. The company announced in May that it obtained a consent decree that permanently enjoins Omni Dental Supply Inc.—a Brooklyn, New York-based dental products distributor—and its principals from directly or indirectly acting as unauthorized resellers of DENTSPLY brand products.

The permanent injunction was issued in a federal lawsuit that DENTSPLY filed challenging Omni’s unauthorized distribution of gray market DENTSPLY brand products. It came after both companies entered into a settlement agreement providing for monetary and injunctive relief.

Under the terms of the settlement, Omni must discontinue all sales of DENTSPLY products by July 30.

"In the utmost interest of patient safety, DENTSPLY is committed to combatting the unauthorized sale of its products in the U.S. and intends to take appropriate action against unauthorized resellers," according to a DENTSPLY news release.

Executives with Midwest Dental Equipment and Supply, a dental products manufacturer based in Wichita Falls, Texas, believe the company has a responsibility to educate its dentist clients, said Tim Cluley, chief operating officer. Midwest Dental Equipment and Supply has partnered with larger companies—3M ESPE, DENTSPLY, and DMG America, for example—and publishes an article quarterly to educate dentists on gray market products, he said.

If dentists see a product that is half the price of what the legitimate dealer is selling it for, that should be a trigger point that it may be a gray market product, Mr. Cluley said.

"As a legitimate dealer, obviously it's in our best interest to promote that the doctors buy from someone who's an authorized dealer of a product. It's also in the best interest of the patient," Mr. Cluley said. "There are a lot of reasons why the gray market is bad for all aspects of the industry: bad for the patients, bad for the doctors, bad for the manufacturers."

The gray market isn't just related to professional products that dentists use. It can also include oral care products that consumers can buy over the counter, such as toothpastes and mouth rinses.

In June 2007, the FDA Center for Drug Evaluation and Research warned consumers to avoid using any toothpaste labeled as "Made in China" because it found levels as high as 3-4 percent of diethylene glycol—a poisonous chemical typically used in antifreeze, said Clifford Whall, Ph.D., director of the ADA's Seal of Acceptance Program. One of those was a junior brand, presumably for children’s use, he said. Following this, the FDA issued an import alert to prevent Chinese manufactured toothpaste containing diethylene glycol from entering the United States.

"Consumers can be confident that the formulations of over-the-counter oral care products that bear the ADA Seal of Acceptance have been thoroughly checked before the Seal is awarded," Dr. Whall said. "In addition, products with the ADA Seal have gone through a rigorous, independent, scientific review by the ADA Council on Scientific Affairs, to ensure that the products are safe and effective for their intended use."

To check out which products have the ADA Seal and to learn more about the ADA Seal Program, visit ADA.org/seal.

Dentists who have questions about specific products or companies should contact the FDA at 1-800-638-2041 or dsmica@fda.hhs.gov.