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Regulatory and Technical News Stories

TGA discusses Sunscreens: information for consumers

January 29

  • primary sunscreens - sunscreens used for protection from UV radiation that have a rated sun protection factor (SPF) of 4 or more
  • secondary sunscreens - insect repellents with sunscreen with an SPF of 4 or more and moisturisers with sunscreen and an SPF greater than 15. These products are referred to as therapeutic sunscreens and are distinguishable from cosmetic sunscreens because they have an AUST L number on the label.All sunscreens regulated by us are entered in the Australian Register of Therapeutic Goods (ARTG) and you can search for them on the TGA website.



The Australian Competition and Consumer Commission is warning consumers to beware of weight loss shams when looking to fulfil a new year’s resolution.

January 10

"Scammers are experts at preying upon people's vulnerabilities and try to take advantage of people's good intentions to improve their health in the New Year. Unfortunately if you fall for this scam, the only place you will feel lighter is your wallet.

"These scams promise dramatic weight loss for little or no effort. They typically involve an unusual or restrictive diet, revolutionary exercise, a 'fat-busting' device or breakthrough pills, patches or creams. They're advertised online or via mail order with enticing claims such as 'lose 30 kilos in 30 days' or 'lose weight while you sleep', usually accompanied by bogus before and after pictures". ACCC Deputy Chair Dr Michael Schaper said.

Last year, the ACCC received 173 contacts about weight loss scams – a 50 per cent increase on the previous year. Total reported losses in 2013 were over $20,000, a 70 per cent increase on 2012. Over 70 per cent of people who have come into contact with this scam have lost money and the average individual loss is $165. If you have resolved to lose weight in 2014, discuss your options with a health care professional. If you think you have fallen victim to a scam, contact your bank or financial institution immediately.

For further information, visit:


TGA seeks comments regarding (Euphausia superba oil) Krill oil

January 10
The TGA is seeking comments from interested parties on a proposed revision of the draft compositional guideline for Euphausia superba oil.
Document released for consultation on 10 January 2014
Interested parties should respond by close of business Friday, 21 February 2014


TGA sponsored workshop “Evidence supporting indications: Benefits for consumers and industry”


Presented by Kaylene Raynes, Dir. Listing Compliance Section, Office of Complementary Medicines at Department of Health Offices in Sydney on 11/12/13

Presentation summary: This presentation of evidence of traditional use for listed complementary medicines and evidence review case studies was given during a TGA workshop and meeting with the Chinese Medicine Industry Council.



Australian regulatory guidelines for complementary medicines (ARGCM) consultations: Submissions received

December 16

All submissions that were not marked as confidential are now available in PDF format. A total of 27 submissions were received, which included 22 non-confidential submissions; four partially confidential submissions and one confidential submission. 

Source -

Submissions received: ARGCM Part A: General guidance


TGA responds to Australian regulatory guidelines for complementary medicines (ARGCM)

December 16

Full details can be read at each of these links:

"Antibacterial soaps are not more effective and may be dangerous", says FDA

December 16

Read more from Fairfax press story here:

In Response to FDA's Proposed Rule on Antibacterial Soaps and Washes,  American Cleaning Institute and Personal Care Products Council issues the Following Statement


Therapeutic Goods Administration Complaints Resolution Panel (TGACRP) has issued a list of highlighted points from recent panel determinations


At the request of a number of different parties, the Panel has decided to publish excerpts of significant decisions. These excerpts are intended to aid advertisers and consumers in understanding the Code and other relevant regulatory requirements. Ultimately, decisions of the Panel are made on a case-by-case basis. For this reason, the excerpts cannot be relied upon by parties to predict the outcome of complaints. Example points include the following:

  • The use of the words "clinically proven" should be carefully considered
  • Information on retailer websites is the responsibility of the website publisher
  • Claims that a product is "TGA approved" are not permitted

Full details can be read at TGA website:


TGA – Safety Advisories

Acai Berry Living-XS Diet capsules

Erec-Bull tablets

Super Hard tablets

Apple's Quick-Impact Weight Loss capsules

The Therapeutic Goods Administration (TGA) has tested Acai Berry Living-XS Diet capsules and Apple's Quick-Impact Weight Loss capsules and found that they contain the undeclared prescription substance 'sibutramine' - despite the products' label claims that they are natural and contain no medicines.

Consumers are advised that sibutramine is a prescription-only substance (which was the active ingredient in the medicine Reductil). It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events. The products also contain the undeclared substance phenolphthalein which was previously used as an oral laxative, but is no longer available in Australia due to serious safety concerns associated with its long term use.

The TGA tested 'Erec-Bull' tablets and found that they contain the undeclared prescription substance yohimbine. Consumers are advised that yohimbine is a prescription-only substance in Australia; however it is not approved for supply in any registered medicine within Australia. The supply of Erec-Bull tablets is illegal.

The TGA has also tested Super Hard tablets and found that they contain the undeclared prescription substance sildenafil despite the information leaflet claiming the ingredients are animal and plant extracts. Consumers are advised that sildenafil is a prescription-only medicine (which is the active ingredient in Viagra).

Super Hard tablets have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

The supply of all the above products in Australia is illegal.


NSW Food Authority – Alert (Vodka Cruisers: product recall)

December 13

Asahi Premium Beverages Pty Ltd is recalling all batches of its Sugar Free Pomegranate & Guava flavour of Vodka Cruisers sold at Dan Murphy's, Liquorland, First Choice Liquor, Vintage Cellars and other independent liquor stores in NSW and interstate. The recall is due to the ingredient phenylalanine not declared on the label. The recalled product details are: Vodka Cruiser Sugar Free Pomegranate & Guava, 275 ml bottles in 4 packs, cartons, mixed 6 packs and mixed cartons, all 'best before' dates.

Consumers with Phenylketonuria or PKU--which is an inability to break down phenylalanine--should take care to not consume the product.



RFA News items and Conferences

Natural Products Expo West 2014 Anaheim, California USA 6-9 March 2014. “Where doing business just comes naturally”

This is the world's largest trade show in the natural, organic and healthy products industry!

RFA Regulatory Affairs will be present and represented by Robert Forbes (Managing director), Michelle Palmer (International business manager), and Louis Droulers; all of whom will be available for face-to-face meetings. Please contact us if you wish to arrange a business meeting: This email address is being protected from spambots. You need JavaScript enabled to view it.  or This email address is being protected from spambots. You need JavaScript enabled to view it.

Natural Products New Zealand Industry Summit 2014 The Rutherford, Nelson NZ 19-21 March 2014

"Join us for an inspiring conference in Nelson with great speakers who will set the scene and provide you with practical examples of how they achieved success and what you can do in your businesses to do the same. As always, the annual Summit is also an opportunity for you to connect with industry colleagues, learn from each other and soak up the vibrancy that is the natural products industry".

As usual, RFA Regulatory Affairs will be attending this conference and we hope to see you there. If you would like to take this opportunity to arrange a personal appointment with either Robert Forbes (Managing Director), or our new team members, Petra Henniger (Regulatory Affairs Manager) & Michelle Palmer (International Business Manager), then please contact our office and we can set this up for you.

Summit details:


Another new member of the RFA team – Michelle Palmer, International Business Manager

This year we have seen Petra Henniger commence as our new Regulatory Affairs Manager. We are now excited to announce that Michelle Palmer has commenced with us as RFA's International Business Manager. Michelle was Executive Director of Natural Product New Zealand for some years, and has extensive contacts throughout the industry in New Zealand, Australia and the rest of the world.


Business to business service opportunities

RFA's newsletter Current Affairs is providing a new and free service to all our readers. If you have a business request, or any issue that might be of interest to our discerning readership, then please contact This email address is being protected from spambots. You need JavaScript enabled to view it.  and for one issue we will publish a short notice at no charge.


Product label design

Justin Heffernan, designer of RFA website and logos, specialises in packaging and website design. Contact Justin at This email address is being protected from spambots. You need JavaScript enabled to view it.  and visit the site to view examples.


Managing your contract manufacturers

Complementary Medicines Group (CMG) manages contract manufacturing services for the complementary medicine, food and over-the-counter pharmaceuticals industries. Contact Craig Fallshaw This email address is being protected from spambots. You need JavaScript enabled to view it.  or +61 2 9091 0264

Japan product opportunity

A Japanese based company is looking for new natural products that have potential for success in Japan. Contact Brent Winston by email at This email address is being protected from spambots. You need JavaScript enabled to view it.


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