Ear Candles: the outcome of TGA complaint AC-5TMWIYHC/2018

Ear candling is a widely promoted alternative medical practice that involves inserting and lighting a hollow candle in the ear canal.

It is claimed that candling creates a vacuum that removes wax and that it can also relieve ear ache, glue ear, tinnitus, sinus problems, chronic headache, migraine, sore throat, allergies and many more conditions.

In fact, ear candles and candling are ineffective and dangerous. They do not remove wax from the ear and they have no effect (apart from acting as a placebo) on the numerous conditions they claim to treat. They have caused injury from burns, ear canal occlusions, ear drum perforations and secondary ear canal infections with temporary hearing loss.

The Complaint Resolution Panel (CRP) upheld 20 complaints about misleading claims made for ear candles and referred more to the TGA on the grounds that regulatory action was required.

Friends of Science in Medicine also raised this matter with the TGA. They have pointed out that other regulators, such as the U.S. FDA and Health Canada, have provided public warnings, import alerts, seizures, injunctions, and warning letters about these matters. However, the TGA refused to act.

Instead, the TGA advised the government to exclude ear candles from the Therapeutic Goods framework, thus abdicating their responsibilities in this regard and transferring the regulatory responsibility to the ACCC. This disregarded the majority of public submissions about this proposal, including one from the ACCC, that opposed this change.

From 1 July 2018, the CRP was abolished and the TGA became responsible for all complaints about the advertising of therapeutic goods. At that time ear candles had not yet been added to the Therapeutic Goods (Excluded Goods) Order No 1 of 2011.

On 24 July 2018 a portfolio of 104 complaints about the promotion of ear candles was submitted to the TGA. On 21 September 2018 the TGA finalised this complaint by stating they had sent an educational letter to all the identified advertisers. They also said that the outcome of this complaint would not be published on the Advertising Complaints Outcomes. The reason given was that ear candles were expected to be excluded from the therapeutic goods regulatory framework before the end of 2018.

On 1 October 2018 the TGA made a new determination under section 7AA of the Therapeutic Goods Act 1989  excluding ear candles from the TGA’s jurisdiction. These products are now the responsibility of the ACCC.

I have now assessed the impact of the TGA’s “educational letter”. Almost 6 months after making my complaint, 51 (49%) of 104 advertiser web sites are unchanged; 12 (12%) have removed some claims and 41 (39%) had removed all the claims I alleged breached the Therapeutic Goods Advertising Code.

Thus, 61% of the web sites complained about continue to make misleading and deceptive claims which I allege breach both the Therapeutic Goods Advertising Code and Australian Consumer Law.

The critique by Commissioner Haynes on the regulators of the financial services industry is equally applicable to the TGA and the ACCC. A failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that. It also encourages others to break the law, leading to a race to the bottom.

Further action is required. Given the TGA’s abdication of their responsibilities, I have now written to the ACCC requesting that they publish a warning to consumers about misleading and deceptive therapeutic claims made about ear candles on their Scamwatch web site. I have also suggested they send this information to those organisations who members are mainly responsible for these advertisements. In addition, the ACCC should consider pursuing an illustrative court case against a large company such as Chemist Warehouse (see below) who continue to make misleading claims about ear candles despite having received the TGA’s “educational letter”.

Screen shot from Chemist Warehouse web site captured 06/01/2019

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Advertising, Complementary medicine, Medical Devices, Natural Therapies and tagged , , , , , , , . Bookmark the permalink.

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