Latest Regulatory News
This news is posted on our website on a regular basis. Visit us often to keep informed. www.robert-forbes.com
Therapeutic Goods Administration Complaints Resolution Panel (TGACRP) issues Highlighted Points From Recent Panel Determinations
The Panel publishes 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.
Key findings include:
- 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 here: http://www.tgacrp.com.au/index.cfm?pageID=21
Access the Complaints Register here http://www.tgacrp.com.au/index.cfm?pageID=13 for a complete list of all product complaints, the TGACARP determinations and the response by the product sponsor.
TGA issues technical guidance on the interpretation of manufacturing standards for non-sterile medicines & complementary medicines
The TGA, in consultation with industry, has published a number of guidance documents on how to interpret manufacturing standards. However it is important to note this statement that appears with each guidance document: “This Guidance is not mandatory or enforceable under law. It is not intended to be restrictive. It describes a way that a manufacturer may operate to demonstrate compliance with the relevant Code of Good Manufacturing Practice (Medicinal Products).”
The guidelines contain useful information. The topics covered by the various guidelines that would be of interest to suppliers of nonprescription medicines include:
American Cleaning Institute and Personal Care Products Council Issues the Following Statement in Response to FDA’s proposed Rule on Antibacterial Soaps and Washes
The American Cleaning Institute www.cleaninginstitute.organd the Personal Care Products Council www.personalcarecouncil.orgissued the following statement in response to the U.S. Food and Drug Administration’s (FDA) proposed rule governing antibacterial soaps and washes. “These products are over-the-counter drugs (OTC) and as such, go through rigorous review by FDA, including review of data and information submitted by industry and health care providers in the U.S. and worldwide”.
Debate flares regarding value of antibacterial soaps.
Antibacterial soaps and washes are no more effective than regular soap and water and may even pose a threat to human health, the US drug regulator (FDA) has warned.The regulator is proposing a new rule that will force the makers of such products to prove that they are both safe for long-term daily use, and effective, if they want to continue selling them.
A spokeswoman for Australia's Therapeutic Goods Administration said it was aware of the US review, and would monitor any developments. Source SMH: http://tinyurl.com/lx3vwch
TGA response: Australian regulatory guidelines for complementary medicines (ARGCM)
The interested parties have made their thoughts known regarding the proposed changes to ARGCM.
All submissions that were not marked as confidential are now available in PDF format. A total of 27 submissions were received. These can be read here: http://tinyurl.com/mea9sej
The TGA has now published their own point-by-point responses to each of these submissions which can be read here: http://tinyurl.com/kdey6ka
ACCC takes action against alleged laundry detergent cartel
12 December 2013
The Australian Competition and Consumer Commission has filed civil proceedings, in the Sydney registry of the Federal Court of Australia, in relation to an alleged cartel that the ACCC alleges denied Australian consumers the benefits of lower prices for laundry detergent products.
The ACCC alleges that Colgate-Palmolive Pty Ltd (Colgate) and PZ Cussons Australia Pty Ltd (Cussons) made and gave effect to cartel and other anti-competitive arrangements. The ACCC alleges that these arrangements applied across the range of laundry products sold by Colgate, Cussons and Unilever, including popular brands like Cold Power, Radiant and Omo, and had a significant effect on competition in an industry valued at almost $500 million per annum.
The ACCC alleges that, in early 2008, Colgate made a proposal that aimed to achieve an industry-wide transition to ultra concentrates. The transition was executed in the first quarter of 2009. The ACCC alleges that Colgate, Unilever and Cussons simultaneously moved to supply ultra concentrates to the major supermarkets and cease the supply of standard concentrated laundry detergents. The products introduced were twice as concentrated as standard concentrate products.
The ACCC also alleges that Colgate and Unilever shared market sensitive information, including information about when they would increase the price of their laundry detergents. The ACCC alleges this information sharing had the purpose, effect or likely effect of substantially lessening competition and controlling or maintaining prices.
Read the full ACCC report here: http://tinyurl.com/mffb6rk
Herbal Regulation in the United Kingdom: The Stop-Start Process
As all those practicing herbal medicine in the United Kingdom will know,for the last 20 years the herbal profession has been negotiating with the UK government for a more secure legislative basis for herbal practice. In 2000, the prestigious House of Lords’ Select Committee on Science and Technology called for the statutory regulation of herbal practitioners. Since then, two Department of Health Working Groups have called for the same thing, and two public consultations have demonstrated huge public support for this initiative. In 2011, the British Health Secretary publicly backed statutory regulation that he described as a “significant milestone.”
Read a detailed report here: http://tinyurl.com/q9unxhb
TGA Safety Advisory: LOVher capsules
LOVher capsules pose a serious risk to your health and should not be taken.
The Therapeutic Goods Administration (TGA) has tested LOVher capsules and found that they contain the undisclosed substance tadalafil (which is the active ingredient in approved medicine Cialis), the undisclosed substance sildenafil (which is the active ingredient in the approved medicine Viagra) and also contains diclofenac, a non steroidal anti-inflammatory, which is an active ingredient in pharmacy only and prescription only medicines used in treatment of pain and inflammation associated with arthritis. The supply of LOVher capsules is illegal.
Read more at: http://tinyurl.com/mq2shf6
ACCC institutes proceedings against free range egg producers
The Australian Competition and Consumer Commission has filed separate proceedings in the Federal Court against egg producers in WA and NSW alleging that each of the producer’s use of “free range” was misleading.
The ACCC alleges that Snowdale Holdings Pty Ltd (Snowdale) in WA and Pirovic Enterprises Pty Ltd (Pirovic) in NSW, through the use of words and images, made false, misleading or deceptive representations by the images and wording on their egg cartons and websites. The ACCC alleges that the eggs were produced by hens most of which did not move about freely on an open range on most days.
“The ACCC does not have a role in determining whether particular farming practices are appropriate and the ACCC is not debating the merits of cage, barn or free range systems,” ACCC Chairman Rod Sims said.
“The ACCC’s concern is simply to ensure that the labelling of eggs accurately reflect the particular farming practices of the producer and the expectations of a consumer making purchasing choices based on those representations.Credence claims such as free range, organic, place of origin or country of origin are all powerful tools for businesses to distinguish their products, but misleading consumers who may pay a premium to purchase such products damages the market and is unfair to competitors”, Mr Sims said.
The ACCC is seeking declarations, injunctions, pecuniary penalties, implementation of compliance programs, corrective notices and costs against each producer.
The full ACCC report can be read here: http://tinyurl.com/km8rmgy
The TGA is seeking comments from interested parties on the 'Draft compositional guideline for alanylglutamine'.
As part of the evaluation of 'alanylglutamine' as a new complementary medicine substance available for use as an active ingredient in listed medicines, the TGA has drafted a compositional guideline to describe, identify and set limits that define the composition and characteristics of alanylglutamine. The TGA now seeks comments from stakeholders on the draft guideline.
Document released for consultation on 6 December 2013
Interested parties should respond by close of business Friday, 17 January 2014
NSW Food Authority - product recall: Vodka Cruisers
3 December 2013
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.
TGA recall notice: Slimming Factor (also known as Easy Trim, Que She and Chinese Herbal Diet Pills)
These products have been marketed as herbal weight-loss supplements. The products have been distributed via the Melanotan 2 Facebook page
Testing by the Therapeutic Goods Administration has found that these products contain medicines not referenced on the product labels.
TGA laboratory analyses have confirmed the presence of the potentially dangerous substances sibutramine, fenfluramine and phenolphthalein in addition to paracetamol, lignocaine and propranolol in this product.
Slimming Factor pills have been illegally supplied in Australia, as they are not listed on the Australian Register of Therapeutic Goods (ARTG) and, as such, have not been assessed by the TGA for quality, safety or efficacy, as required under Australian law. Also, the place of manufacture is not approved by the TGA.
American Botanical Council Publishes 100th Issue of HerbalGram
The 100th issue of the acclaimed magazine HerbalGram hits mailboxes and select retailers around the world this month, and debuts online. Thirty years in the making, the magazine has grown in tandem with the herbal community and the American Botanical Council (ABC), which was created to support the publication and thereby further herbal education.
RFA is a long time supporter of both the American Botanical Council and the magazine HerbalGram. We are proud to be associated with both of these ventures and encourage all our clients with an interest with all things herbal to check them out: http://tinyurl.com/lvw9x3k
TGA invites feedback on DHA/EPA rich Schizochytrium algal oil, & calcium L-threonate.
The TGA is seeking comments from interested parties.
As part of the evaluation of both 'DHA/EPA rich Schizochytrium algal oil' and, ‘calcium L-threonate' as new complementary medicine substances, available for use as active ingredients in listed medicines, the TGA has drafted a compositional guideline to describe, identify and set limits that define the composition and characteristics of these two ingredients. The TGA now seeks comments from stakeholders on the draft guideline.
Document released for consultation on 22 November 2013
Interested parties should respond by close of business Friday, 3 January 2014
Read more on TGA website :http://tinyurl.com/lfvack7 & http://tinyurl.com/n5su8z4
Cancellations from the ARTG following compliance review of Complementary medicines:
There were two cancellations in November:
Aust L # 197703 “Ethical Nutrients Hi-Strength Q10 Absorb 6X 150 MG” (Health World Ltd)
Aust L # 197860 “Ethical Nutrients Hi-Strength Q10 Absorb 6X 100MG” (Health World Ltd)
The TGA found that there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s26A(2)(c) and (j) were incorrect. The goods were deemed not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act.
Read a full list of ARTG cancellations since January 1st, 2013 here: http://tinyurl.com/pocr8wo
Berocca Performance - Bayer Australia Limited - Complaint No. 2010-10-017: Update
Update following compliance with decision:
Bayer Australia Limited has advised the TGA that they have complied with and will continue to comply with the regulation 48 decision made by the delegate of the Minister for Health on 15 July 2013. This includes withdrawal of any representations, including implied representations, that "Berocca Performance" has been clinically trialled and demonstrated to improve concentration and reduce tiredness, and that they will not use these representations in any other advertisement.
TGA website update can be read here: http://tinyurl.com/m2xgslr
American Botanical Council (ABC) refutesUSA TODAY Letter to Editor on Herbal Supplements Opinion Piece
ABC Founder and Executive Director, Mark Blumenthal sent the following letter to USA TODAY in response to an opinion column written by Kevin Pho, MD, and published online Wednesday, Nov. 20, 2013. The piece, titled "Avoid Herbal Supplements: Column," retreads familiar ground in the realm of misinformation about herbal and dietary supplement safety, interweaving citations of more recent studies such as BMC Medicine's error-riddled article on the DNA barcode analysis of a sample of herbal supplements from Canada and the United States.
Read Mark Blumenthal’s rebuttal here: http://tinyurl.com/l4bxdw3
CHINA - Change in “Health Food” Regulations
Those of you exporting tablets and capsules to China under the “health food” category should be aware by now of the sudden change in regulations due to come in on 1 January 2014. Our understanding is that from that date onwards any tablets or capsules will require “blue hat” or medical registration; although it appears that stock already in China will be able to be sold through until the use by date. We urge you to check this out if you sell product in China.
Source: Natural Products New Zealand (NPNZ) – News Update
PS: There has been some misinformation circulating re the importation of products into Australia & NZ from 1st January, 2014. No one we know of has heard of a deadline of Jan 1, 2014 for import of goods into Australia from New Zealand, so we are unsure where this information is coming from. However there is a change of regulation for goods entering CHINA from 1 January 2014, which includes the stipulation that any product that has a limited dosage per day in the form of tablet, soft gel, liquid in bottle, powder or pill cannot be imported as general food, and must have CFDA “blue hat” registration.
Lessons for all in Fonterra debacle
Fonterra's botulism scare has damaged New Zealand's reputation as a quality producer of dairy products, but for companies of all kinds the dairy giant's false alarm could prove salutary.
Read the whole Fairfax-NZ story here: http://tinyurl.com/kkw6u53
The National Institute of Complementary Medicine (NICM) director welcomes new Federal Government
“As the new Federal Government comes into office, NICM continues to lobby for a stronger commitment to the complementary medicine sector. Prime Minister Tony Abbott launched NICM in his role as Health Minister in the Howard Government in 2007, and we are seeking a recommitment of his original support.
The key message is this. Translating complementary medicine research into better health outcomes for all Australians is essential in an ageing population with chronic medical conditions and increasing health costs. In many cases complementary medicine interventions have been shown to be clinically effective, some with better safety profiles and greater cost effectiveness than conventional care while some are of doubtful merit. There is significant untapped potential to improve health outcomes through well developed and evidenced complementary medicines, and there has not been a better time to invest in the sector.”
Read the full address by Professor Alan Bensoussan at: http://tinyurl.com/p5ecjub
FSANZ issues guidance on establishing food-health relationships for general level health claims
This guidance document is provided to assist food businesses wishing to establish a relationship between a food or property of food and a health effect (food-health relationship) by a process of systematic review for the purpose of making a general level health claim.
This guidance outlines scientific best practice for undertaking a systematic review. For the purposes of this guidance document, substantiation is the process of evaluating the evidence for a food-health relationship to underpin a general level health claim.
For the purposes of this guidance document, an established food-health relationship is one for which evidence has been examined using the substantiation process and a reasonable conclusion drawn from the evidence that the relationship is causal.
Examination of the evidence might reveal that the relationship cannot be established in many instances, and thus a health claim cannot be based on this relationship. Download the Guidance on establishing food-health relationships for general level health claims (pdf 901kb)
Alert — US investigation into dietary supplements
Food Standards Australia New Zealand (FSANZ) today alerted consumers to a United States Food and Drug Administration (FDA) investigation into dietary supplements labelled OxyELITE Pro.
FSANZ Chief Executive Officer Steve McCutcheon said the FDA has advised consumers not to use OxyELITE Pro supplements because they are potentially linked to an outbreak of acute non-viral hepatitis in Hawaii.
Australian health authorities have been alerted to be on the lookout for acute cases of non-viral hepatitis.
Link to this story: http://tinyurl.com/p4a6ork
Recent staff changes at RFA Regulatory Affairs:
Our much loved and widely respected Regulatory Affairs Manager, Samantha King, stepped down from her role on Tuesday 3rd December. Sam has done a fantastic job managing the technical team and liaising with clients. However, ongoing health issues mean that Sam must take time off to look after herself. Sam will still be working at RFA, but will be a part time Senior Associate.
This means we now have three, very experienced, Senior Associates who have been working for RFA for many years. You may remember Kate Durey, a previous Regulatory Affairs Manager. Kate returned from maternity leave in July and now works part time from Hobart. The other Senior Associate, Kerry Martin, also now works part time, and at the moment she works from Russia, peer reviewing work prepared by our associates. This works well as Kerry currently peer reviews work in the evening so our regulatory advice lead time to clients is shortened.
We have appointed a new, full-time Regulatory Affairs Manager, Petra Henniger. Petra currently was previously managing a technical and regulatory team at a major Australian company. Petra commences her new role at RFA Regulatory Affairs at the beginning of January 2014. RFA’s technical team now consists of eight regulatory affairs associates and is enhanced by our external specialist consultants who have been affiliated with RFA for many years.