Federal whitening controls?

March 21, 2012

January 20, 2010 | dentalproductsreport.com Web Exclusive Federal whitening controls? The ADA asks the FDA to step in to monitor the currently unregulated market of tooth whitening product

January 20, 2010 | dentalproductsreport.com
Web Exclusive

The ADA asks the FDA to step in to monitor the currently unregulated market of tooth whitening products.

by Noah Levine, Senior Editor

Over the counter whitening products are currently not regulated by the U.S. Food and Drug Administration, but the American Dental Association hopes that will soon change.

Photo: Jose Luiz Pelaez/Getty Images

Finding a product that purports to deliver a brighter, whiter smile is not in any way difficult. With whitening products on sale via late night television ads, Web sites and shopping mall kiosks, a dentist’s office or a pharmacy might be the last place consumers looking for whiter teeth begin their search.

But with public safety in mind, the American Dental Association is hoping the U.S. Food and Drug Administration will enter this arena and enact some form of regulation on tooth whitening products. In November, based on a resolution from its House of Delegates and after receiving complaints from consumers and dental professionals, the ADA officially petitioned the FDA to take action.

“The focus was primarily on some of the products that were being used in shopping malls and kiosks and were being advertised late night on television and on the Internet,” said Dr. Daniel Meyer, ADA Senior Vice President, Science/Professional Affairs. “Since these are unregulated products we don’t know what’s in those products. The position of the ADA is that any time you use these products, you should know what’s being put in your mouth. We were very concerned about the safety affects of these products.”

Regulation supporters

While regulation can often be seen as a bad thing in the business world, this effort seems to be one that is being welcomed by both consumers of whitening products and manufacturers of dentist-administered products such as Discus Dental, maker of the Zoom! light and Dash in-office whitening system.

“It’s our belief that tooth whitening materials should be administered by dentists. If left unregulated then what's next, do it yourself endo?” said Robert Cartagena, Chief Operating Officer for Discus Dental. “We are big supporters of the ADA’s push here. We think the ADA is being very responsible, and they’re being very proactive in ensuring that patient safety is being considered when these products are being used.”

Cartagena said regulation would not impact legitimate manufacturers such as Discus who already comply with many FDA guidelines in their production and distribution. However, he believes federal oversight will help stem the flood of whitening-based credit card scams, as well as reign in the unsafe practices when whitening procedures are conducted in non-dental settings. In the end, that should be good for the business of companies making and selling legitimate whitening products and procedures.

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“These scams and these mall whiteners definitely have an affect on the patients that get duped into buying these products or enrolling in these systems. First, they don’t see the results that are expected and secondly, they end up getting a bad taste in their mouth about tooth whitening in general, and eventually become disinterested in the procedure,” he said. “I believe that there are a lot of consumers out there that are very interest in improving their smiles, but they end up buying one of these products on the Internet or get duped into having their teeth whitened in the middle of a shopping mall. After being disappointed they quite often believe that all teeth whitening products or procedures are the same. The simple fact is; they are not. There’s simply no comparison between these scams and the proven, effective and safe options offered by a dentist.”

20%of dentists don't endorse use of OTC whitening products because their use is unsupervised.

82%

of dentists said patients are very satisfied or satisfied with the results of their in-office chairside whitening.

Source: October 2008 DPR Whitening Survey

That’s a sentiment shared by Web developer Sasha Sienkiewicz who runs the Web site teethwhiteningreviews.com and has worked to expose companies selling fraudulent whitening systems. While his Web site tries to clear up some of the confusion present in the marketplace, he welcomes any FDA effort to make sure the public is not being fooled by potentially harmful products.

“We currently have no way of knowing if whitening products being sold through the Internet and mobile kiosks are safe for the consumer,” Sienkiewicz said via e-mail. “I think the Internet is littered with ‘quick-buck’ businesses selling whitening products that have originated from China. If the FDA is willing to monitor Chinese produced toothpaste for ingredients like diethylene glycol (used in engine coolants), I think it is a good idea that the FDA takes some steps to regulate whitening products, even if it increases costs for the manufacturer and consumer.”

Public safety is key

The FDA has not yet officially responded to the ADA’s request, but Dr. Meyer said any potential regulation process would begin with a period of public comment. During that period the ADA would be sure to make sure the FDA understands that the efficacy and safety of whitening services can be impacted by a number of intraoral factors, making it important for consumers to receive some form of professional consultation prior to treatment.

“The ADA does recommend that you consult with your dentist. Any time that you seek treatment you should know why you need the treatment,” he said.

Cartagena agrees with that concept. There are many situations where whitening products can have a negative impact. Patients with composite fillings might whiten around the filling, making the restoration stand out against the surrounding teeth, or even more seriously, some whitening products can exacerbate serious oral health concerns.

He thinks FDA regulation could have a huge impact on consumers in two ways. It would protect them from the plague of online whitening scams, and he hopes regulation also would force those providing whitening services outside of a dental setting to comply with infection control and other safety procedures.

“We’re very interested in both buckets being addressed and the whitening being regulated by the FDA,” Cartagena said. “If this happens, then there won’t be any confusion in the marketplace and patient safety will be in the hands of the professionals that are trained to manage this.”

While there is no strict timeframe for the FDA to act on new regulation requests, this one seems to enjoy widespread support.

Noah Levine is a senior editor for DPR. Contact him at nlevine@advanstar.com.

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