Product Regulations
In Europe, some ear candles bear the CE mark (93/42/EEC) though they are mostly self-issued by the manufacturer. This mark indicates that the device is designed and manufactured so as to not compromise the safety of patients, but no independent testing is required as proof.
In Australia, Biosun Ear Candles are certified as a Class IIB Medical Device and are registered on the Australian Register of Therapeutic Goods (Registration Number 142411).
While ear candles are widely available in the U.S., selling or importing them with medical claims is illegal. This means that one cannot market ear candles as products that "Diagnose, cure, treat, or prevent any disease".
In a report, Health Canada states "There is no scientific proof to support claims that ear candling provides medical benefits. ... However, there is plenty of proof that ear candling is dangerous." It says that while some people claim to be selling the candles "for entertainment purposes only", the Canadian government consider that there is no reasonable non-medical use, and hence any sale of the devices is illegal in Canada.
Read more about this topic: Ear Candling
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