Australian agency investigates clear aligner providers

AHPRA has launched investigations into market leader Invisalign and the teledentistry providers SmileDirectClub, EZ Smile and WonderSmile. According to the Sydney Morning Herald, the four separate investigations are following up on complaints from within the dental industry about the business and marketing practices of the companies.

The complaints surfaced through articles in The Age and the Herald and accused health regulators of failing to enforce the rules. The authors of the articles said that federal regulators had received complaints about social media influencers promoting clear aligners without proper disclosure, which, if true, would be a breach of the law.

The Therapeutic Goods Advertising Code stipulates that any payments received for the advocacy of therapeutic goods—clear aligners, in this case—must be disclosed and a failure to do so carries a maximum fine of A$1.05 million (€649,000). Undisclosed promotion through social media would also breach the Health Practitioner Regulation National Law, the authors pointed out, which attracts fines of A$5,000 per advertisement for individuals and double that for companies.

“Nobody is even bothering to pretend to follow the law,” read one of the complaint letters from a dental industry insider, who believed that revealing his identity would cause him to lose his job.

One letter from a Melbourne prosthetist said the undisclosed promotion presented a “clear and present danger to vulnerable health customers”.

Industry insiders also complained to health regulators that Invisalign Australia was offering volume discounts to dentists. Based on the number of patients who ordered the Invisalign cases, the discounts, it was claimed, provided an incentive to dentists and orthodontists to sell the company’s clear aligners and could result in patients being sold an unsuitable product. Invisalign Australia confirmed to the Herald that volume discounts were being offered to accredited dentists. The company said that such discounts are permitted under Australian law and common in the industry.

In addition to the AHPRA investigations, the Therapeutic Goods Administration confirmed to the Herald that it had opened investigations into potential breaches of its advertising code with respect to clear aligners.

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