Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Makers of Nurofen Ran 'Misleading and Deceptive' Campaign Against Panadol

"Nurofen is better than paracetamol for common headaches," declared the advertisements in women's lifestyle magazines. The Federal Court has found that claim to be misleading and deceptive, after two pharmaceutical giants went head-to-head in a two-year legal battle. GlaxoSmithKline, the makers of Panadol​, alleged Nurofen's manufacturer, Reckitt Benckiser​, ran an advertising campaign saying Nurofen was faster and more effective than Panadol, or paracetamol, despite there being no scientific evidence to support it. The judge granted a permanent injunction, barring Reckitt Benckiser from making those or similar claims, and for the company to pay GlaxoSmithKline's legal costs.    Source: Pain for Nurofen

Editor’s note: Regular readers of our newsletter will remember that we reported in April 2017 that the makers of Nurofen, Reckitt Benckiser, were ordered to pay $6 million penalty for false and deceptive advertising   Nurofen penalty

ABC-AHP-NCNPR Announces Botanical Adulterants Program Name Change

The American Botanical Council (ABC) announces a change in the name of the Botanical Adulterants Program, updated to the Botanical Adulterants Prevention Program. ABC and its partners at the American Herbal Pharmacopoeia (AHP) and the National Center for Natural Products Research (NCNPR) at the University of Mississippi decided to add “Prevention” to the name in order to emphasize the purpose and intent of the program. “The program’s goal has always focused on prevention,” said Mark Blumenthal, founder and executive director of ABC and founder and director of BAPP. “What we’ve been trying to do is alert industry members about specific botanical materials that we have confirmed as being adulterated, and counsel industry on the optimum laboratory analytical methods to help determine authenticity of botanical ingredients. By adding the word ‘Prevention’ to the name, we are making our intention clearer to all stakeholders.”    Source: ABC prevention

ABC-AHP-NCNPR Botanical Adulterants Prevention Program Publishes Ginkgo Leaf Extract Adulteration Bulletin

The ABC-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program is an international consortium of non-profit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. Ginkgo is one of the most important medicinal plants worldwide. Ginkgo leaf extract dietary supplements have been consistently among the 25 top-selling herbal supplements in the United States for more than a decade. Reports on ginkgo extract adulteration date back to 2003, when researchers observed uncharacteristically high amounts of the flavonoid rutin in a sample of bulk material. The addition of flavonoids from extraneous sources, which attempts to bring these “ginkgo” extracts in compliance with the 24% flavonol glycoside content standardization required by various pharmacopeial standards, has been confirmed in numerous subsequent papers.    Source: Adulterated ginkgo

TGA Announces Implementation of the NEW Uniform Recall Procedure for Therapeutic Goods (URPTG)

Sponsors of therapeutic goods needing to initiate a product recall are reminded that the new URPTG takes effect on Monday, 15 January 2018. From this date, sponsors must follow the provisions of the new URPTG and the former (2004) version will be archived.    Source: Recall protocol

TGA 2017 List of Complementary Medicines Cancelled from the ARTG

Following a review by the Therapeutic Goods Administration, complementary medicines can be cancelled from the Australian Register of Therapeutic Goods. There were 10 cancellations of complementary medicines in 2017. They are listed here along with the reason for cancellation: CM cancellations

TGA Warns Against Human Placenta Ingestion

The TGA is aware of several websites offering expectant mothers services for the preparation of the placenta for consumption; a practice known as placentophagy. They are advising expectant mothers to be aware of the potential risks associated with placenta consumption. Human placenta is a biological material and is capable of containing and transmitting infectious agents, including bacteria and viruses. In addition, preparation may inadvertently introduce infectious agents. The risk of transmission may be even greater if the placenta is ingested by another person or you ingest another person's placenta. Prepared placenta products, including in capsule or tablet form, are often associated with claims that consumption will have some therapeutic benefit for mothers and/or children, for example, improving mood, energy levels and milk production. Under the Therapeutic Goods Act 1989, it is an offence to make therapeutic biological products without holding the appropriate licence. Depending on the circumstances and the claims made in relation to the product, these laws could also apply to the midwife, doula or even the mother involved.    Source: Placenta ingestion

Business Process Improvements Supporting Complementary Medicines Assessment Pathways for TGA

The TGA acknowledged all respondents who provided submissions in response to the September 2017 public consultation paper Consultation: Business process improvements supporting complementary medicines assessment pathways. A total of 14 submissions were received. All submissions that gave permission are published here: Submissions & feedback

TGA Safety Advisories –    Source: 2018 alerts

Yunnan Feng Shi Ling capsules: the capsules contain the undeclared substance paracetamol (also known as acetaminophen).

Makers of Nurofen Ran 'Misleading and Deceptive' Campaign Against Panadol

"Nurofen is better than paracetamol for common headaches," declared the advertisements in women's lifestyle magazines. The Federal Court has found that claim to be misleading and deceptive, after two pharmaceutical giants went head-to-head in a two-year legal battle. GlaxoSmithKline, the makers of Panadol​, alleged Nurofen's manufacturer, Reckitt Benckiser​, ran an advertising campaign saying Nurofen was faster and more effective than Panadol, or paracetamol, despite there being no scientific evidence to support it. The judge granted a permanent injunction, barring Reckitt Benckiser from making those or similar claims, and for the company to pay GlaxoSmithKline's legal costs.    Source: Pain for Nurofen

Editor’s note: Regular readers of our newsletter will remember that we reported in April 2017 that the makers of Nurofen, Reckitt Benckiser, were ordered to pay $6 million penalty for false and deceptive advertising   Nurofen penalty

ABC-AHP-NCNPR Announces Botanical Adulterants Program Name Change

The American Botanical Council (ABC) announces a change in the name of the Botanical Adulterants Program, updated to the Botanical Adulterants Prevention Program. ABC and its partners at the American Herbal Pharmacopoeia (AHP) and the National Center for Natural Products Research (NCNPR) at the University of Mississippi decided to add “Prevention” to the name in order to emphasize the purpose and intent of the program. “The program’s goal has always focused on prevention,” said Mark Blumenthal, founder and executive director of ABC and founder and director of BAPP. “What we’ve been trying to do is alert industry members about specific botanical materials that we have confirmed as being adulterated, and counsel industry on the optimum laboratory analytical methods to help determine authenticity of botanical ingredients. By adding the word ‘Prevention’ to the name, we are making our intention clearer to all stakeholders.”    Source: ABC prevention

ABC-AHP-NCNPR Botanical Adulterants Prevention Program Publishes Ginkgo Leaf Extract Adulteration Bulletin

The ABC-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program is an international consortium of non-profit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. Ginkgo is one of the most important medicinal plants worldwide. Ginkgo leaf extract dietary supplements have been consistently among the 25 top-selling herbal supplements in the United States for more than a decade. Reports on ginkgo extract adulteration date back to 2003, when researchers observed uncharacteristically high amounts of the flavonoid rutin in a sample of bulk material. The addition of flavonoids from extraneous sources, which attempts to bring these “ginkgo” extracts in compliance with the 24% flavonol glycoside content standardization required by various pharmacopeial standards, has been confirmed in numerous subsequent papers.    Source: Adulterated ginkgo

TGA Announces Implementation of the NEW Uniform Recall Procedure for Therapeutic Goods (URPTG)

Sponsors of therapeutic goods needing to initiate a product recall are reminded that the new URPTG takes effect on Monday, 15 January 2018. From this date, sponsors must follow the provisions of the new URPTG and the former (2004) version will be archived.    Source: Recall protocol

TGA 2017 List of Complementary Medicines Cancelled from the ARTG

Following a review by the Therapeutic Goods Administration, complementary medicines can be cancelled from the Australian Register of Therapeutic Goods. There were 10 cancellations of complementary medicines in 2017. They are listed here along with the reason for cancellation: CM cancellations

TGA Warns Against Human Placenta Ingestion

The TGA is aware of several websites offering expectant mothers services for the preparation of the placenta for consumption; a practice known as placentophagy. They are advising expectant mothers to be aware of the potential risks associated with placenta consumption. Human placenta is a biological material and is capable of containing and transmitting infectious agents, including bacteria and viruses. In addition, preparation may inadvertently introduce infectious agents. The risk of transmission may be even greater if the placenta is ingested by another person or you ingest another person's placenta. Prepared placenta products, including in capsule or tablet form, are often associated with claims that consumption will have some therapeutic benefit for mothers and/or children, for example, improving mood, energy levels and milk production. Under the Therapeutic Goods Act 1989, it is an offence to make therapeutic biological products without holding the appropriate licence. Depending on the circumstances and the claims made in relation to the product, these laws could also apply to the midwife, doula or even the mother involved.    Source: Placenta ingestion

Business Process Improvements Supporting Complementary Medicines Assessment Pathways for TGA

The TGA acknowledged all respondents who provided submissions in response to the September 2017 public consultation paper Consultation: Business process improvements supporting complementary medicines assessment pathways. A total of 14 submissions were received. All submissions that gave permission are published here: Submissions & feedback

TGA Safety Advisories –    Source: 2018 alerts

Yunnan Feng Shi Ling capsules: the capsules contain the undeclared substance paracetamol (also known as acetaminophen).

An Historical View of Ointments, Creams & Lotions

RFA’s regulatory colleagues in Europe have provided a very interesting article on the historical development of topical applications down the ages. From Hippocrates and Galen, all the way to modern global cosmetic regulations, you can read about the fascinating development of cosmetic applications.    Source: CONUSBAT Topical history

FSANZ Apologises to Nanotechnology Experts for Misrepresenting Views About Nanoparticles in Baby Formula

Australia's food regulator had to apologise to its own advisory group of nanotechnology experts after it "misrepresented" the group's views in its public slapdown of a study that found needle-like nanoparticles in baby formula. Tests by an Arizona State University team showed the presence of needle-shaped hydroxyapatite nanoparticles – which the European Union's Scientific Committee on Consumer Safety had concluded was potentially toxic – in two formula products.    Source: Ester Han, SMH Nanoparticles

Australian Government Failing Foods Report

​​​​​​​​​​​​​​​​​The Department of Agriculture and Water Resources Imported Food Inspection Scheme (IFIS) compiles and publishes data from inspections of imported food consignments in its monthly failing food reports. Future consignments of the food from producers of failing foods will be inspected at the rate of 100 per cent of consignments until the food demonstrates compliance with Australian food standards. Failing food reports identify foods that have failed analytical testing or do not meet the compositional requirements of the Australia New Zealand Food Standards Code. The reports do not list foods that have failed for noncompliant labels. The latest report is for December 2017 and details the failings of 36 different foods stopped at Australian borders. Various sea-foods and spices were the main culprits and microbial contamination with salmonella, E. coli and even vibrio cholera being found in the product.    Source: Food fails

NSW Food Authority Recalls —

De Bortoli Woodfired Heathcote Sparkling Shiraz: De Bortoli Wines has recalled Woodfired Heathcote Sparkling Shiraz due to exposure to sustained heat for extended periods which may cause the bottle to shatter.    Source: Hot wine

Coconut Milk Powder Non Organic / Non GMO: Murray River Organics Pty Ltd has recalled Coconut Milk Powder Non Organic / Non GMO from The Source Bulk Foods stores due to the presence of undeclared allergen (milk).    Source: Coconut milk

Tasmanian Smokehouse Australia Sliced Smoked Salmon: Tassal Operations Pty Ltd has recalled Tasmanian Smokehouse Australia Sliced Smoked Salmon for sale in Food Works Summerland Point NSW store only, due to the application of incorrect use by date.    Source: Tassal hassle

Golden North Ice Cream - assorted products: Golden North Pty Ltd has recalled assorted frozen ice cream products (various flavours and sizes) due to the possible presence of small metal pieces in the ice cream.    Source: Metal ice-cream

Mamee Monster Rice Sticks Vegetable Flavour: The recall is due to the presence of an undeclared allergen (gluten).    Source: Gluten allergy

Fruit Mince Tarts: The recall is due to the presence of an undeclared allergen (tree nuts - pistachios).    Source: Nut allergy

Coles Potato Salad: Coles has recalled Coles Potato Salad due to the presence of an undeclared allergen (gluten/wheat).    Source: Potato salad

NZ Sausage Smuggler Sent Packing

A Belgian air passenger has been forced to leave New Zealand after attempting to smuggle 3 sausages into Auckland. Ministry for Primary Industries (MPI) staff intercepted the sausages on Sunday after the passenger attempted to conceal them in a backpack when passing through biosecurity checks at Auckland Airport. "One of our x-ray operators spotted the risk items. They turned out to be pork and salami sausages, both of which could have carried diseases with the potential to cause major harm to New Zealand agriculture," says Craig Hughes, MPI's north passenger manager. The passenger was refused entry to New Zealand after the man admitted he intended to hide the sausages from biosecurity officials.    Source: Silly sausage

Fine for NZ Plant Smuggler

An air passenger has been fined $2250 for following his cousin's advice to smuggle plant cuttings and seeds into New Zealand. Deo Rajan Gounder appeared in the Manukau District Court on Wednesday after pleading guilty of trying to bring 4 plants and 11 seeds into Auckland Airport in July last year. MPI biosecurity officers found the plant material at the bottom of a chilly bin containing food. Two of the cuttings were Neem plants. The others were unidentified.    Source: Plant smuggler

FSANZ Calls for Comment on Changes to Maximum Residue Limits

Food Standards Australia & New Zealand has called for submissions on a proposal to change maximum residue limits for some agricultural and veterinary chemicals. The closing date for submissions is COB 26 February 2018.    Source: MRL comments

FSANZ Notifications —

Application A1130 – Triacylglycerol Lipase as a Processing Aid (Enzyme): The purpose of this Application is to permit the use of triacylglycerol lipase from Candida cylindracea as a processing aid in baking, dairy foods processing and fats and oils processing.    Source: Food enzyme 1

Application A1131 – Aqualysin 1 (Protease) as a Processing Aid (Enzyme): The purpose of the Application is to permit the use of aqualysin 1 sourced from Bacillus subtilis containing the aqualysin 1 gene from Thermus aquaticus for use as a processing aid in the manufacture of bakery products.    Source: Food enzyme 2

Application A1155 – 2’-FL and LNnT as novel foods in infant formula and other products: The purpose of the Application is to permit voluntary use of 2’-O-Fucosyllactose (2’-FL) alone or in combination with Lacto-N-neotetraose (LNnT), produced by similar but independent proprietary fermentation processes, as novel foods in infant formula (IF), follow-on formula (FOF) and formulated supplementary foods for young children (FSFYC) (specifically milk products).    Source: Novel infant food

Codex Committee on Food Additives Convenes in Xiamen, Fujian Province, China

The 50th Session of the Codex Committee on Food Additives will be held from the 26th to the 30th March 2018 in Xiamen, Fujian Province China. The Session will begin at 9:00 on Monday 26 March 2018. The Session will be conducted in English, French, Spanish and Chinese. All participants should provide their information (names and addresses) through the online registration system by 26 February 2018.    Source: Codex conference

Chinese State-Run Sovereign Fund Among Bidders for Australian Supplement Firm Nature's Care

A division of China's state-run investment fund is believed to be among the front runners to snap up Australian vitamin maker Nature's Care, as it embarks on its second sale attempt with a price tag of around $1bn. The Australian supplement company first attempted to find a buyer in 2016.    Source: Garry Scattergood, Food-Navigator, Asia Nature's Care

Food Trends to Watch in 2018

Knowing what’s hot and what’s not can help food and beverage companies to better develop, position and market products. Listed are 10 food trends expected to create buzz at retail and foodservice in 2018. Topics include: Colour Is the New Sugar; Cracked Pepper Is the New Sea Salt; Pistachio Country Transcontinental; &, Vegan and Non-GMO Are the New Green Badges of Food Formulation Courage, amongst others.    Source: Judie Bizzozero, Food Insider Journal 2018 food trends

 

Quote for the month:

“Eating organic isn’t a trend, it’s a return to tradition”    Anon.

 

 

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Business Opportunity

A New Zealander has a “shell” company structure in Australia called Australian Health Products PTY Ltd. (ABN 67 092 335 638).  It is maintained through an accountant and all taxes have been paid etc. but this company has not traded for some time and it never had branded products.  The name/company is for sale as it’s no longer required. Please contact RFA if you are interested and we can link you to the seller. 

 

 

RFA Training Courses for Listed Medicines, Foods, Cosmetics – Now Available

RFA Regulatory Affairs offers Skype training so that you can train at home or from your office at a time that suits, or you and your team can come to our office in Glebe for a group-training session. Our courses cover complementary medicines, cosmetics and food products and a range of topics from labelling to GMP requirements.

All courses are presented in a modular format of either two or three hour’s duration. Training resources are provided and certificates are presented to each participant at the successful conclusion of each module.

You can find more information at RFA Training Courses or email us This email address is being protected from spambots. You need JavaScript enabled to view it.  to discuss your requirements.

 

NEW COURSE NOW AVAILABLE!

Pharmacovigilance Obligations Training

In September 2017, the TGA released guidance on the pharmacovigilance responsibilities of sponsors.  Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines included on the Australian Register of Therapeutic Goods. We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report.  All required documents including SOPs and reporting templates will be provided for your future use.

This one hour training course is available via Skype or in person in our office in Glebe, Sydney. You will receive full course notes, document templates, SOPs and a certificate of attendance.  This is all included in the price.

For more information or to schedule a training time, please email us at This email address is being protected from spambots. You need JavaScript enabled to view it.

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