Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary Medicines (“Dietary supplements”):
Very Important Information for All Sponsors of Listed Complementary Medicines
Details of all products listed on the Australian Register of Therapeutic Goods (ARTG) must now be changed to ensure that:
- Previously permitted ‘free text’ indications are removed.
- All indications must be selected from the revised list of permitted indications https://www.legislation.gov.au/Details/F2018L00215
- These changes are mandatory. Updates to change indications will not incur a TGA fee until 6th September 2019. Each product not revised before 6th September 2019 will incur a TGA fee for the change.
- The transition period to relist ALL products with permitted indications expires on 6th March 2021. Listed medicines not transitioned by 6th March 2021 will be cancelled!
Updated Therapeutic Goods Act is Now Law
As detailed in the last two recent editions of this newsletter, the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed by both houses of Parliament on 15th February 2018. The compilation of the Therapeutic Goods Act 1989 (‘the Act’), which now incorporates the amendments from the Therapeutic Goods Amendment Bill No. 1 of 2017 legally effective from 6 March 2018, has now been uploaded onto the Federal Register of Legislation (FRL). The new Act incorporates significant amendments to the regulatory framework for complementary medicines, including introduction of the permitted indications, relevant changes to sponsor certifications under the Act, the introduction of the new pathway for complementary medicines, and a new advertising framework. Source: TGAact 1989
TGA Announces Updates to the Permissible Ingredients Determination For Listed Medicines
An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in March 2018. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018. A total of 64 changes have been made in the updated Determination. These changes include: The addition of 4 new ingredients; changes to 56 existing ingredient entries (including, making requirements for ingredients less restrictive, such as broadening the use to allow oral use when previously only for topical use; making requirements for ingredients more restrictive, such as the inclusion of additional warning messages; and making minor changes to make a number of entries clearer); and, the removal of 4 ingredients that have been determined not to be suitable for inclusion in listed medicines or were synonymous with other existing ingredients to avoid duplication. A complete list of changes to ingredient availability can be read here: Permissible ingredients update
TGA Releases Assessed Listed Medicines Evidence Guidelines
The assessed listed medicines pathway provides sponsors with a new method of listing a product in the Australian Register of Therapeutic Goods (ARTG). The new pathway sits between the current listed (lower risk) and the registered (higher risk) pathways. It enables sponsors to list products with higher level indications than permitted in standard listed medicines without having to meet the extensive requirements for full registration. This is provided that assessed listed medicines have robust scientific evidence to support the efficacy of the product, and this evidence is pre-market assessed by the TGA. This guidance applies to 'assessed listed medicines' that are eligible for evaluation by the TGA's Complementary and Over-the-counter Medicines Branch (COMB). Sources: ALM guidelines & ALM pathway
(Editor’s note: These are the most significant changes to complementary medicine legislation in a generation. If you think that your product may be better marketed as an ‘assessed listed medicine’ then please feel free to contact RFA Regulatory Affairs for more detailed and confidential advice).
Country of Origin Labelling for Complementary Healthcare Products - A Guide For Business
The Australian Competition & Consumer Commission has prepared this guide to assist the complementary healthcare industry to understand how the safe harbour defences set out in section 255 of the Australian Consumer Law apply to their products. It is intended to supplement the information in the ACCC’s Country of origin claims and the Australian Consumer Law publication. (Please note this document does not constitute legal advice. The ACCC always recommends that businesses seek independent advice when deciding which origin claims to make about their products). This guide will assist businesses to understand the application of the Australian Consumer Law (ACL) in relation to country of origin claims and in particular, when businesses can safely make a ‘made in’ claim about their products. In contrast to origin labelling requirements for food products, neither the ACL or the Therapeutic Goods Act 1989 require complementary medicine products to carry country of origin labelling. However, if companies choose to make such claims they must be aware of the laws against false, misleading or deceptive claims. Sources: CoOL CMeds.pdf & CoOL ACL (Editor’s note: Please see related story under 'Foods', in this newsletter)
TGA Safety Advisories—
LIPRO Dietary capsules – the capsules contain the undeclared substances sibutramine and diphenhydramine Source: LIPRO caps
Gold Viagra 9800mg capsules - the capsules contain the undeclared substance sildenafil. Source: Gold viagra caps
ViaGro 500mg Male Enhancement capsules - the capsules contain the undeclared substances theophylline and caffeine. Source: ViaGro 500 caps
Black Ant King tablets - The Therapeutic Goods Administration has tested a product labelled Black Ant King tablets and found that the tablets contain the undeclared prescription only substances sildenafil and chloramphenicol. Source: Black ant tabs
Vegetal Vigra capsules - the capsules contain sildenafil. Source: Vegetal vigra caps
Stree Overlord Strong tablets - the tablets also contain sildenafil. Source: Stree tabs
Complementary Medicines (“Dietary supplements”):
Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 Summary of Changes
As reported in February 2018 Newsletter, The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed by both houses of Parliament on 15th February 2018. These are the most significant changes to the legislation affecting complementary medicines in Australia since the Therapeutic Goods Act was introduced in 1989. The Bill establishes a new ‘intermediate’ pathway for complementary medicines, sitting between Aust-Listed and Aust-Registered. As well as this new registration pathway, there are changes to the permitted indications (see following story); improved access to new ingredients (there has been a fivefold growth in TGA approved new ingredients in the last few years!); market exclusivity for new ingredients & better IP Protection; closer alignment with overseas regulators; reforms to advertising; and, axing of the Complaints Resolution Panel. Please feel free to contact RFA Regulatory Affiars for more detailed information. Source: Legislation passed (Editor’s note: Key dates to note—8 March 2018 - Permitted indications introduced; market exclusivity for new ingredients introduced. 30 June 2019 - Indications change fee $1,000 waiver expires. 5 March 2021 - transition period to relist ALL products with permitted indications. 6 March 2021 - listed medicines not transitioned will be cancelled.)
TGA Details “Assessed Listed Medicines” Pathway
The Therapeutic Goods Administration has implemented a new ‘assessed listed medicines’ pathway for sponsors to enter their products in the Australia Register of Therapeutic Goods (ARTG). Medicines listed through the assessed listed medicines pathway will be included in the ARTG following self-certification of the safety and quality of the product, and TGA pre-market assessment of efficacy evidence supporting the proposed indications. An interactive decision tree has been developed to assist sponsors in determining which pathway is most suitable for their product. Source: Assessed listed medicines (See also: Pathways for Complementary Medicine Products. This tool will assist potential sponsors of complementary medicines to determine the most suitable pathway to enter their product in the ARTG. CM pathways tool)
Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018 Gets Tabled
The Permissible Ingredient Determination No. 1 of 2018 has been registered on the Federal Register of Legislation. The determination provides for a number of changes and additions of ingredients, their names, content limits and required warning statements. The TGA will be providing industry with a minimum 18 months transition period. Sources: Permissible ingredient legislation; &, LM Guidance doc
'Indications' are statements that describe the specific therapeutic use for a medicine. They describe a medicine's claimed purpose or health benefit. Indications available for use for listed medicines are now contained in a 'list of permitted indications'. The new permitted indications requirements apply to all complementary medicines and sunscreens. However, medicines that are listed for ‘export only’ and medicine kits are not affected by this change. The four main changes in the new legislation are: There is no 'free-text field'; sponsors who apply to list a new medicine will be required to select the indications for their medicine from the list of permitted indications; there is a 3 year transition period for sponsors of existing listed medicines to re-list their products using permitted indications; and, sponsors can apply to have new indications considered for inclusion in the Permissible Indication Determination. The permitted indications reform came into effect on 6th March 2018. Sources: Permitted indications reform & Legislation
Health Canada Issues Warning About Products Containing Yohimbe
Health Canada had extended a warning on dietary supplement products being sold in Canada with Natural Products Numbers and containing illegal ingredients such as yohimbine and sildenafil analogues. Source: Hank Schulz, Nutraingredients-USA Yohimbe warning. Editor’s note: In Australia, the TGA has ruled Yohimbe (an evergreen tree, the bark of which contains yohimbine) is a prescription only substance. Consumers are also advised that yohimbine is a substance included in the Customs (Prohibited Imports) Regulations 1956.
TGA Safety Advisories—
Lida (Plus) capsules: the capsules contain the undeclared substances sibutramine and phenolphthalein. Source: Lida-plus capsules
Slim Trim Gold capsules: the capsules contain the undeclared substances sibutramine and phenolphthalein. Source: Slim trim gold
Nutra Organics Green Tea Extract capsules: the capsules contain the undeclared substance sibutramine. Consumers are advised that sibutramine is a prescription-only medicine (which was the active ingredient in Reductil). It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events. Source: Green tea caps
Arthrem capsules: Arthrem capsules contain the herbal ingredient Artemisia annua extract as the only active ingredient. The New Zealand therapeutic goods regulator, MedSafe, has received 14 reports of liver toxicity associated with the use of Arthrem. Source: Arthrem
Ja Dera Max+ capsules: The capsules contain the undeclared substance lignocaine, also known as lidocaine. Lignocaine is a prescription-only medicine and is widely used as an anaesthetic and antiarrhythmic drug. Source: Ja Dera Max
Cosmetics (& Household cleaning products):
NICNAS Invites Feedback on General Rules, Categorisation Guidelines and Transitional Rules
In Australia, all cosmetics and personal care products are regulated by The National Industrial Chemicals Notification and Assessment Scheme. As part of the Australian Government's reforms to NICNAS, all relevant stakeholders are invited to submit comment before the reforms are finalised. The new scheme is expected to be implemented by 1st July 2019. Sources: NICNAS reform process; &, NICNAS legislation\
Department of Agriculture and Water Resources Amends Food Surveillance Protocols
This Australian authority has completed a review of the surveillance tests applied to many imported food products. Fresh and frozen meat (to start screening for certain antibiotic residues identified as being of high importance to human medicine.); fruit, vegetables and dried herbs that are minimally processed and are ready to eat (to screen for presence of E. coli and Salmonella). As well, hemp seed and hemp seed products, which have been permitted for sale since 12 November 2017, will now have their own screening protocols. From 24 April 2018 the department will introduce testing to verify that imports are derived from low THC cannabis sativa seed and comply with the permitted levels for total THC and cannabidiol. Hemp seed and hemp seed protein powders/flour referred for inspection will be cleared where total THC is not more than 5 mg/kg, cannabidiol is not more than 75 mg/kg, &, hemp oil has a total THC not more than 10 mg/kg and cannabidiol is not more than 75 mg/kg. Source: Food surveillance
Australia’s New Country of Origin Information Standard: A Competitive Advantage for New Zealand?
The new Country of Origin (Food Labelling) Information Standard 2016 is mandatory from 1 July 2018. The effect of this Information Standard in combination with the Trans-Tasman Mutual Recognition Agreement could enhance a competitive trade advantage for New Zealand food companies over Australian companies globally. Under New Zealand law, any New Zealand country of origin claims are permitted but are voluntary. New Zealand has never made country of origin labelling mandatory. If a New Zealand company chooses to emphasize the New Zealand origin of its product, this is because of a belief in the marketplace that the claim can attract a price premium. New Zealand companies know that they can trade off the “clean, green” reputation of New Zealand food products without having to meet the technical burdens that are imposed on Australian companies by the CoOL Information Standard applicable to products that are manufactured in Australia. Source: Lederman & Fisher, Food Legal NZ CoOL (Editor’s note: This information is relevant to ‘foods’, but not to ‘complementary medicines’, which although classifed as ‘food supplements’ in some countries, are categorised as medicines in Australia. The Australian Competition and Consumer Commission is very shortly about to release new guidelines for complementary medicines’ country of origin claims and this will be detailed in our next newsletter. Stay tuned!)
Food Standards Australia & New Zealand has released a survey looking at the levels of seven plasticisers which may be used in food packaging materials. The plasticisers were inspected in a broad range of Australian foods. It found that migration of packaging chemicals into Australian foods is very low and presents a negligible risk for Australian consumers. Source: Plasticisers in food survey
NSW Food Authority Recalls – Source: Current recalls
Macro Chinese Honey Soy Flavoured Tofu: Woolworths has recalled Macro Chinese Honey Soy Flavoured Tofu due to the presence of an undeclared allergen (peanut).
Washed Rind Cheeses: Washed Rind Pty Ltd has recalled a variety of cheeses made in France due to potential Listeria monocytogenes contamination.
Home Ice Cream Coconutters Mango Vanilla: Home Ice Cream Pty Ltd has recalled Home Ice Cream Coconutters Mango Vanilla due to the presence of an undeclared allergen (milk).
The Whole Foodies SEA VEGETABLES Mixed Seaweed: Unique Health Products Pty Ltd has recalled The Whole Foodies SEA VEGETABLES Mixed Seaweed due to high level of Arsenic.
Macro Natural Sunflower Kernels: Woolworths has recalled Macro Natural Sunflower Kernels 500g due to the presence of an undeclared allergen (tree nut - walnut).
Planet Food Organic Hemp Vegan Protein - Rich Chocolate Flavour: Healthy Warrior Pty Ltd has recalled Planet Food Organic Hemp Vegan Protein - Rich Chocolate Flavour due to non compliant labelling (soy free claim made on the front of packaging but soy is included as an ingredient).
FSANZ Food Recall Statistics
FSANZ has collected data on Australian food recalls since 1990, including the causes of all recalls and their domestic or overseas origins. This data can be used to identify trends and common problems occurring in the food industry, so that steps can be taken to prevent future issues. These statistics are updated each year. Source: Food recall stats
Application A1142 – Addition of Prescribed Method of Analysis for Resistant Starch: The purpose of the Application is to add a method of analysis for dietary fibre and other fibre content for specifically named fibre content of food (resistant starch). Source: Resistant starch
Application A1147 – Food derived from Herbicide-tolerant Cotton Line GHB811: The purpose of the Application is to seek approval for food derived from cotton line GHB811, genetically modified to provide resistance to isoxaflutole and glyphosate. Source: Herbicide tolerant cotton
Application A1151–Beta-Galactosidase from Papiliotrema terrestris as a Processing Aid (Enzyme): The purpose of the Application is to amend Schedule 18 of the Australia New Zealand Food Standards Code to include ß-Galactosidase from Papiliotrema terrestris as a Processing Aid. Source: Pap enzyme
Proposal P1044 – Plain English Allergen Labelling: FSANZ is working on a proposal to make allergen labelling requirements clearer, which will help food allergen-sensitive consumers and food businesses. The Food Standards Code already contains a mandatory requirement to label 10 allergens; however it does not include requirements for the terminology that should be used. The proposal aims to make allergen labelling clearer so that food allergen-sensitive consumers have the information they need to make informed and safe food choices. The first consultation paper for the proposal was released in February 2018. Source: Allergen labelling
ACCC Publication: “Advertising and Selling—A Guide for Business”
The Australian Competition & Consumer Commission has released this very helpful and comprehensive document outlining all of the important consumer related issues that need to be considered when advertising or promoting products in Australia. While there is the usual advice to avoid misleading or deceptive claims or conduct, there are particular issues that will be of special interest to our readers. (See especially pages 17+ “Marketing claims that require extra care—premium and credence claims”). Health claims, Premium claims, Animal welfare claims, ‘Not tested on animals’, Environmental and organic claims, and, Country and place of origin claims are among the many topics covered. Using detailed examples and case studies, the ACCC takes the guesswork out of just what is and what isn’t acceptable as a marketing claim for your product. Source: ACCC marketing guide
Quote for the month:
“Let us prove to the world that good taste, good art, and good writing can be good selling” William Bernbach
Business Name for Sale
‘Australian Health Products Pty Ltd’ is available for sale as a company name. Please address any and all inquiries to Rob Haines at New Zealand Health Food Company
RFA Looks Forward to Naturally Good Trade Expo 2018 in Sydney
Far more than just a tradeshow, Naturally Good Expo is a total business event (‘trade-only’) that’s 100% devoted to all things healthy, organic and natural. As the largest event for healthy retailers, brands and practitioners in the Southern Hemisphere, it’s the place where serious buyers meet with suppliers for two days of business, networking, education and to celebrate the latest exciting opportunities within the health and wellness retail market. To be held in the Sydney Convention Centre, Darling Harbour on April 29th and 30th, RFA Regulatory Affairs will have our own booth C 43 and we hope to see you there.
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 (AUST L) 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.