Tag Archives | TGA

TGA initiates court proceedings against Oxymed Australia and director Malcolm Hooper for alleged unlawful advertising

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Posted 08 September 2020

In March 2019, Natasha Bolognesi wrote an article for GroundUp, making the point: “But practitioners of so-called mild hyperbaric oxygen therapy (mHBOT) are fraudulently cashing in on the science that supports medically-approved HBOT”.

She also wrote: “Former chiropractor Malcolm Hooper, who owned the hyperbaric treatment clinic Oxymed Australia, is to stand trial for unsafe practice following the death of a former client who was undergoing treatment for multiple sclerosis at Hooper’s facility.”

TGA initiates court proceedings against Oxymed Australia and director Malcolm Hooper

3 September 2020

The Therapeutic Goods Administration (TGA), part of the Department of Health, has initiated proceedings in the Federal Court of Australia (Federal Court) in response to Oxymed Australia Pty Ltd and its sole director, Mr Malcolm Hooper’s alleged unlawful advertising of hyperbaric oxygen therapy chambers.

The TGA alleges the advertising promoted the devices for the treatment of serious diseases Read the rest

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Consumers face health risks buying erectile dysfunction medicines online

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Posted 06 August 2018

Although this is specifically applicable to Australia, South African consumers are similarly at risk.

The Australian Therapeutic Goods Administration (TGA) is asking consumers to consult with their doctor prior to purchasing medicines for erectile dysfunction from overseas websites. There are no safety, quality or efficacy guarantees for the medicines you purchase from overseas.

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Advertising cosmetic services that include schedule 4 substances

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Posted 15 May 2017

A media release from the Australian TGA:

The following advice is for health professionals and cosmetic/beauty clinics who advertise cosmetic services that involve therapeutic goods containing Schedule 4 (prescription-only) substances.

These groups are reminded that advertising of prescription-only products to consumers is illegal. Generally, it is an offence under section 42DL(1)(f) of the Therapeutic Goods Act 1989 (the Act) for a person to publish or broadcast an advertisement about therapeutic goods that contains a statement referring to goods, or substances or preparations containing goods, included in Schedules 3, 4 or 8 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) (the Poisons Standard). This offence attracts a maximum penalty of $10,800 for an individual and $54,000 for a body corporate[1].

http://www.tga.gov.au/advertising-cosmetic-services-include-schedule-4-substances

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Warning about weight loss products on the web

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Posted 30 August 2016

Australia’s medicines regulator, the Therapeutic Goods Administration (TGA) has warned of the dangers of buying weight loss medicines online, particularly from unknown overseas websites.

The TGA’s Principal Medical Adviser, A/Professor Tim Greenaway, said today the TGA had received many reports about overseas based websites offering ‘herbal’ or ‘drug free’ weight loss products.

“Far from being ‘natural’, many of these products contain ingredients which may be harmful and are not disclosed on the product label,” Professor Greenaway said.

“In Australia, many weight loss products are considered medicines. Because of this they are regulated by the TGA and have to meet quality and safety standards but we have no control over medicines and supplements purchased from overseas by consumers on the web.”

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Warning on buying unregulated slimming preparations

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Posted 11 April 2016

In terms of Regulation 48C published in November 2013, “complementary medicines falling in Category D and in the pharmacological classification 32.3 (Slimming preparations) and pharmacological classifications 7.1, 21.7 (Male sex hormones), pharmacological classification 21.8 (Female sex hormones) and pharmacological classification 21.9 (androgen-oestrogen combinations) claiming sexual stimulation and sexual dysfunction available for sale in the Republic on the date on which it comes into operation shall be subjected to registration within 24 months of the date of this publication.” That deadline therefore expired in November 2015. Those products for which a complete application for registration has not been submitted should now be removed from the market.

The Australian Therapeutic Goods Association (TGA) has issued a warning which applies everywhere, not just in Australia.

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