Complaint to TGA: Homeopathic Products (Pretorius, Bioglan ...

Complaint to TGA: Homeopathic Products (Pretorius, Bioglan, Healthy Care)

This is a high priority complaint to test the TGA's will to act on recalcitrant sponsors of complementary medicines.

The CRP has upheld more than 15 complaints about homeopathic medicines from 2003 to 2017. In December 2017, the CRP referred the following complaints to the TGA:

? 2017/12/004 Pretorius Homoeopathic Melatonin 6X ? 2017/12/007 Healthy Care Melatonin Homeopathic and ? 2017/12/008 Bioglan Melatonin Homeopathic Tablets and Spray.

To-date, Pretorius have removed the offending insomnia claims, but many other advertisers of this product have not. No action appears to have been taken about the Healthy Care and Bioglan complaints (appended).

In 2003, the Expert committee report: Complementary Medicines in the Australian Health System recommended (2.1.8) that,

"Homoeopathic medicines and related remedies that make therapeutic claims should be regulated to ensure they meet appropriate standards of safety, quality and efficacy".

They also noted that,

"It is evident that a number of substances currently not permitted in Listed medicines are being presented on the market as homoeopathic preparations. It is also possible that some of these products are being formulated with little or no regard to homoeopathic principles or practice. The current definition of `homoeopathic preparation' should be amended to make it clear that only ingredients consistent with homoeopathic principles and practice are considered homoeopathic preparations.

A homoeopathic medicine should be adequately described to ensure that it is clearly differentiated from those medicines not consistent with the homoeopathic or a related paradigm. Any misrepresentation of homoeopathic medicines as other medicines needs to be addressed as a priority".

In 2008, a TGA Consultation on the "Regulation of homoeopathic and anthroposophic medicines in Australia" also made many suggestions about improving the regulation of these products, none of which were implemented.

In 2015, following a thorough review of the evidence, the NHMRC released a statement that concluded that there was no good quality evidence to support the claim that homeopathy is effective in treating health conditions.

In 2017, the TGA held another consultation, "Options for the future regulation of 'low risk' products", which included homeopathic products, without any reference to the previous consultation and submissions. This consultation document failed to document many long-standing concerns about the supply and promotion of homeopathic products and, in my opinion, it failed to provide a viable solution to the well documented problems of previous reviews.

At this consultation, I (and others) advocated that all products making therapeutic claims by invoking the homeopathic tradition should be regulated as listed products with the addition of a mandatory

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Complaint to TGA: Homeopathic Products (Pretorius, Bioglan, Healthy Care)

disclaimer / warning on their ARTG Public Summary documents, product packaging, labelling and promotion like that recently suggested by the U.S. FTC,1 for example,

Warning: This product's traditional claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. There is no scientific evidence that this product works. In June 2018, the TGA reported on the outcome of this consultation and noted that, "The Government is yet to determine what would be an appropriate level of regulation for aromatherapy and homoeopathic products. Further consultation with affected stakeholders may be required". In short, unlike other regulators, the TGA has procrastinated for 15 years about improving the regulation of these products. I've appended a relevant U.S. lawsuit. Meanwhile, in Australia, misleading and deceptive advertising continues. I now attach screen shots of misleading and deceptive advertisements for Pretorius, Healthy Care and Bioglan Melatonin products taken today (12/07/2018) that continue to make claims that I previously alleged breach s.4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d) of the Therapeutic Goods Advertising Code 2015. In addition to concerns previously documented in the appended complaints, Bioglan also states: "Rather than providing a milligram dosage of melatonin into the body, this homeopathic product enhances your body's own melatonin production". I am unaware of any evidence that substantiates this claim.



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Complaint to TGA: Homeopathic Products (Pretorius, Bioglan, Healthy Care)

I submit that these complaints are "high priority" because the sponsor (&/or other advertisers) are recalcitrant, this class of products have had numerous upheld complaints and the sponsor (&/or others) continue to make claims that I allege breach the Therapeutic Goods Advertising Code 2017. This clearly impacts on the consumers ability to appropriately use these goods.

Similar claims can be found at:

? ? ? ?

2.html/ ? ? ?

Homeopathic+Formula%29 ?

Tablets ?

hic+90+Tablets ?

90-tablets/7d1b5df0-c995-4b19-8db3-19449f0c9918 ? ? ? ? Etc.

Finally, I note that the recently enacted Therapeutic Goods Information (Outcomes of Advertising Complaints Investigations) Specification 2018 states that,

"The following specified kinds of therapeutic goods information may be released by the Secretary to the public under subsection 61(5C) of the Act....".

Regardless, I insist on an immediate response to me as to the priority allocated to this complaint, the measures taken by the TGA to achieve compliance and the final outcome.

Sincerely, --Dr Ken Harvey MBBS, FRCPA, AM Associate Professor Department of Epidemiology and Preventive Medicine School of Public Health and Preventive Medicine

Monash University Alfred Campus 553 St Kilda Rd Melbourne VIC 3004 Mobile: +61 419181910 Email: kenneth.harvey@monash.edu WWW: .au 12 July 2018

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