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OrVance Reports Coalition Letter to the FDA, FTC, and More Regarding Misbranded Dental Wax

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Posted: June 1, 2020
Edited by Orthotown staff

GRAND RAPIDS, Mich.—OrVance, a Michigan-based company that develops and manufactures orthodontic wax, recently announced that a coalition including over 100 orthodontists and dentists sent a letter to the Food and Drug Administration (FDA), Federal Trade Commission (FTC), and U.S. Customs and Border Protection to express concern regarding the importing, repackaging and distribution of misbranded dental wax.

According to the letter, “The vast majority of dental wax dispensed to patients has been unlabeled (or misbranded) for decades by many manufacturers and suppliers in the orthodontic industry. There is also concern that the adverse event reporting itself has been compromised by blatantly omitting lawfully required labeling to inform patients of the product’s origin and who to contact to report an adverse event. And as a result, there is no credible data to prove conventional dental wax is safe, as the misbranded product offers patients no information or traceability on a commodity product that comes from many manufacturers all over the world.”

The letter also expresses concern that virtually none of the commodity dental wax sold to practices for end patient use offers other universally accepted quality and safety standards. Not only is most dental wax misbranded, but it also lacks hygienic packaging, tamper evidence, and disclosure of ingredients. Additionally, the majority of the “dental wax” composite dispensed to patients and on the retail shelves is imported from outside the U.S., most commonly from China.  

“When considering that most conventional dental wax does not comply with current quality and regulatory standards, is imported from outside the U.S., and offers no disclosure of ingredients, we believe this presents a public health risk and the identified companies should be held accountable. In my over 25 years of consumer health care product experience, I’ve never witnessed such collective and blatant disregard for such fundamental quality and regulatory standards. This should be of greater concern since dental wax is given to virtually every patient in orthodontic treatment where most are children. The companies that continue to sell noncompliant wax to practices are not only knowingly putting their customers’ patients at risk but they are also undermining the public’s trust in the orthodontic profession," said Ron Schutt, CEO of OrVance.

“In our two years of advocacy for compliance within our industry, we’ve not been able to find a single company or industry association willing to defend conventional dental wax as compliant and appropriate for use by the millions of patients in our profession—all we found was collective indifference which is putting our patients and the integrity of our profession at risk. If these companies want to develop their own solution to comply with current quality and regulatory standards, by all means they should.  But we do not accept that our company should be the only one to play by the rules and be forced to compete with suppliers that avoid the costs of meeting current quality and regulatory standards," said Dr. Eric Hannapel, orthodontist and OrVance co-founder.
 
For more information, visit orvance.com.
 
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