Case study: Homeopathic melatonin

Melatonin is generally known as a medicine for use in connection with jetlag, sleeplessness and insomnia. However, the presentation of melatonin as a homeopathic remedy for these conditions does not align with the traditionally accepted principles of homeopathy, namely that the substance (in this case, melatonin) can produce in a healthy person the symptoms which it is purported to alleviate (the 'Law of Similars').

Additionally, the term 'homeopathic melatonin' suggests that the medicine contains a sufficient quantity of melatonin to have a similar effect and mode of action as non-homeopathic melatonin medicines. In this way, describing these medicines as homeopathic melatonin could be misleading.

About the advertising

On 12 July 2018, the TGA received a complaint regarding the advertising of homeopathic melatonin products by several sponsors and retailers.

Advertising for these products appeared on each company's branded websites (along with the labelling and packaging elements) and there were many online retailers of the products. Various claims regarding melatonin were used, including its ability to provide relief or treatment of insomnia, sleeplessness, mild anxiety, symptoms from jetlag/travel or stress, help regulate normal healthy sleep and provide stamina and endurance.

The TGA assessed the evidence provided by each sponsor in connection with their product against homeopathic evidence standards. We determined that the evidence provided by each sponsor was not sufficient to substantiate the disputed claims. Slight differences existed between each sponsor's evidence, however all had deficiencies relating to the:

• proving substance description and detailed symptom information
• qualifications and experience of investigative personnel, and
• relevance and strength of the evidence to support indications/claims.

Further, the TGA determined that claims regarding the 'traditional use' of melatonin as a homeopathic medicine could not be substantiated. The assessment also identified that the products did not appear to be homeopathic products because they were not prepared in accordance with homeopathic principles such as 'like cures like'.

Details of non-compliance

Since the evidence provided by each sponsor was not satisfactory, none of the therapeutic claims made could be substantiated. These claims were therefore found to be inaccurate, misleading and exaggerating product efficacy, breaching sections 9(a), 9(b) and 10(a)(ii) of the Code.

In an attempt to achieve compliance, each sponsor sought to amend advertising to remove therapeutic claims being made about its products. However, the Code provides that at least one indication must be included in an advertisement for therapeutic goods. Because the goods were available for purchase directly from websites without physical inspection of the label this allegedly contravened section 12(3)(d) of the Code.

Advertising for each product also included references to the treatment of 'insomnia', which as a serious form of a disease, condition, ailment or defect, is a restricted representation. As the TGA had not authorised the use of such restricted representations in the advertising any of these products, this was a breach of sections 42DL(7) and 42DLB(4) of the Act.

Actions taken

The TGA issued correspondence to each sponsor, together with copies of the evidence reviews, alerting them to the alleged legislative breaches identified and the corrective actions needed. These actions included ceasing the use of therapeutic use claims without supporting evidence, advertising with non-compliant product labels, referring to insomnia (restricted representation) and advertising without a relevant indication.

All sponsor advertisers took action to cease the non-compliant advertising of their products. Each company also undertook to contact any Australian online retailers that continued to advertise their products in a non-compliant manner.

The TGA is aware of other sponsors and retailers of homeopathic melatonin products making similar claims and work in this sector is ongoing.