OrVance Reports Coalition Letter To The FDA, FTC, And U.S. Customs And Border Protection Regarding Misbranded Dental Wax
OrVance LLC, in the interests of the health and safety of patients in orthodontic treatment, reports that today 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 pervasive 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.
Typical dental wax sold to orthodontic and dental practices: No FDA required labeling (manufactured and distributed globally with blatant disregard for in-country medical device labeling regulations – including the U.S. and European Union), no hygienic/unit-of-use packaging, no tamper-evidence or safety seals, no disclosure of ingredients. Most is imported – most commonly from China.
Ron Schutt, CEO of OrVance stated, “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 healthcare 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.”
OrVance LLC is a Michigan company that has borne the cost of developing and manufacturing the first orthodontic wax to meet all the aforementioned quality and regulatory standards – and as a result faces unfair trade from the many companies that avoid the cost of meeting these quality and regulatory standards.
Dr. Eric Hannapel, Orthodontist and co-founder of OrVance stated, “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.”
The letter’s signatories express their “strong support of the FDA, FTC, and U.S. Customs and Border Protection to investigate the identified companies responsible to ensure they comply with regulations and are not misleading consumers or causing them harm.” The full letter with a “Summary of Evidence against Conventional Dental Wax” can be viewed here.
OrVance LLC is a developer of proprietary oral care products and is based in Grand Rapids, Michigan. It is over 90% owned by orthodontists, dentists and its managing partners.