Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary medicines ('Dietary supplements')
Safety Review of Coumarin in Topical Listed Medicines and Sunscreens
Coumarin is a naturally occurring chemical found in several food products such as cinnamon. Coumarin is currently permitted for use in listed medicine as an active homoeopathic ingredient (with a maximum concentration of 0.001%) and as an excipient in topical medicines for dermal application. The safety review has established that the appropriate tolerable daily limit for coumarin exposure from all sources (including diet, cosmetic products and sunscreens) is 0.1 mg/kg bodyweight. In the absence of a reliable estimation of Australian intake of coumarin from dietary and cosmetic sources, the requirements for listed medicines will specify that topical products may not exceed a concentration of 0.001% coumarin. Sponsors of existing listed medicines and sunscreens will have until 2 March 2021 to bring their products into compliance. This transition time will align with the March 2020 low-negligible risk changes to the Permissible Ingredients Determination. Source: Coumarin safety review
Changes to the Label Warning Statement Requirements for Menthol and Methyl Salicylate
The Therapeutic Goods Administration (TGA) will be amending the requirements for menthol and methyl salicylate, to be less restrictive, in the Therapeutic Goods (Permissible Ingredients) Determination ('the Determination'). The amendments will mean that some of the existing label warning statements will not be required when these ingredients are present at very low amounts such as when included in topical proprietary ingredient (PI) formulations. Sources: Menthol & salicylate changes and LM's ingredients update
High-Moderate Risk Changes to Permissible Ingredient - Andrographis Paniculata
Andrographis paniculata (also known as ‘green chireta’) is a herb that is currently permitted for use in listed medicines as an active or homeopathic ingredient. Andrographis paniculata is typically used in relation to immune support and immune stimulating effects, such managing colds. The TGA published a safety review in 2015 that suggested an association between Andrographis paniculata and anaphylactic/allergic reactions and also published a safety alert. Since the review in 2015, the TGA has continued to receive adverse event reports concerning anaphylactic/allergic reactions associated with medicines that containing this herb. This further supports a causal association between this ingredient and anaphylactic/allergic reactions. Given the nature of the risk to some consumers, all listed medicines containing Andrographis paniculata, released for supply from 2 May 2020, will need to show the following label warning statement: 'Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention' (or words to that effect). Source: Andrographis warning statement
Outcomes: Changes to Permissible ingredients that are Classified as Low-Negligible Risk
On 30 August 2019, the TGA sought comments on proposed changes to the permissible ingredients: Boron, Withania somnifera, Vitex agnus-castus (VAC), Hydroxyisohexyl-3-cyclohexene carboxaldehyde ('HICC'), as well as a number of permissible ingredients relating to Ispaghula, Plantago, Psyllium, Cymbopogon and Malus species. A total of 4 consultation submissions were received in response, from: Accord Australasia, Complementary Medicines Australia, Consumer Healthcare Products Australia, and Naturopaths and Herbalists of Australia. All comments received for this consultation have now been considered and the changes will commence on 2 March 2020. Sources: Permissible ingredients changes & Permissible ingredients determination
Comparable Overseas Bodies (COBs) for Complementary Medicines
The TGA makes use of assessments from comparable overseas bodies (COBs), where possible, in evaluations for complementary medicines and listed OTC medicines (e.g. sunscreens). In response to the Medicines and Medical Devices Review (MMDR) the TGA has implemented transparent criteria for identifying comparable overseas bodies (COBs), as well as a process for using reports from nominated COBs. The TGA can use evaluation reports from comparable overseas bodies (COBs) to evaluate registered complementary medicines assessed listed medicines and substances for use as ingredients in listed medicines. Source: COBs for CMs
TGA Training Course - Evidence Requirements for Listed Medicines
This online training resource is designed for sponsors of listed medicines and aims to supplement the information in the Evidence Guidelines for Listed Medicines. It also seeks to provide additional information in response to common questions and issues encountered by sponsors. It is helpful to have a copy of the Evidence Guidelines for Listed Medicines available to you for reference when completing this 30 minute module. Source: Evidence training module [For more comprehensive training for complementary medicine regulations please see courses listed on our website: RFA Training Courses ]
Technical Guidance on Medicinal Cannabis Manufacture
In 2016 the Australian Government amended the Narcotic Drugs Act 1967 to allow the cultivation and production of cannabis for medicinal purposes. This guidance is for manufacturers of medicinal cannabis products. It outlines and provides information on manufacturing license and certification requirements; differences between the TGA and the Office of Drug Control (ODC) requirements; and TGA interpretation and expectations for compliance with specific sections of the current PIC/S Guide to Good Manufacturing Practice (GMP) for Medicinal Products (PIC/S Guide to GMP). Source: Medicinal cannabis manufacture
TGA Safety Advisories- Source: TGA current year alerts
Kulchaya Sheaya Lender capsules: The capsules contain the undeclared substance fluoxetine.
Black Storm tablets: The tablets contain the undeclared substance sildenafil.
Brauer Teething Gel 20g: One batch of Brauer Teething Gel 20 g due to bacterial contamination.
NZ Assesses Impact of Medicinal Cannabis Scheme
New Zealand’s Ministry of Health has issued a paper detailing the regulatory impact of the Medicinal Cannabis Scheme which enables domestic cultivation and manufacture of medicinal cannabis, and the import of overseas products. Regulations specific to medicinal cannabis are required to establish the scheme. These will set minimum quality standards for products and set medicinal cannabis licensing requirements. The impact assessment provides supporting analysis for the Cabinet paper seeking approval for policy decisions required to draft the medicinal cannabis regulations. Source: NZ medicinal cannabis
Conflict of Interest: Top Medical Journal takes on Big Pharma
A leading medical journal (The BMJ) is launching a global campaign to separate medicine from big pharma, linking industry influence to the pelvic mesh scandal that injured hundreds of women in Australia. The BMJ says doctors are being unduly influenced by industry-sponsored education events and industry-funded trials for major drugs. Those trials cannot be trusted, the journal's editor and a team of global healthcare leaders write in an editorial published earlier this month. Sources: Liam Mannix, SMH Big pharma & Cochrane study
Potential Herb-Drug Interactions for Commonly Used Herbs
While many useful databases are commonly held behind expensive paywalls, this publicly available chart from Mediherb is easy to read, simple to print and acts as a helpful reminder of what can happen when herbal medicines and prescribed drugs interact in the human body. Source: Herb-drug interactions
ABC-AHP-NCNPR Botanical Adulterants Prevention Program Examines Saw Palmetto and Oregano
The American Botanical Council – American Herbal Pharmacopoeia - National Center for Natural Products Research collaboration has recently published two papers examining product substitution of saw-palmetto (Serenoa repens) and oregano (Origanum vulgare subsp. hirtum, or O. onites). This is the 19th in the series of the Botanical Adulterants Prevention Bulletin (BAPB) and underlines the widespread dilution and/or substitution of herbal ingredients in the supply chain. Sources: Saw palmetto lab guidance & Oregano substitution
FSANZ Final Report - Review of Food Derived Using New Breeding Techniques
Food Standards Australia New Zealand today released the Final Report on its review of food derived using new breeding techniques (NBTs). FSANZ CEO Mark Booth said the Final Report is the result of a significant amount of work by FSANZ, including extensive consultation with stakeholders and the community on whether the current definitions in the Code for genetically modified foods are fit for purpose given recent advancements in genetic technologies. “The Review found that while there are diverse views in the community about the safety and regulation of food derived from NBTs, many agreed the current definitions are no longer fit for purpose and lack clarity," Mr Booth said. “Based on these findings, FSANZ will prepare a proposal to amend the definitions in the Code in the New Year”. Source: NBT report
Order Amendment to Classify Pure and Highly Concentrated Caffeine Products as Risk Food
Importers and brokers are advised that the Imported Food Control Order 2019 (the Order) was amended to classify pure and highly concentrated caffeine products as risk food, on 12 December 2019. A pure and highly concentrated caffeine product is a food in which caffeine is present at a concentration of 5% or greater, if the food is a solid or semi-solid food (non-liquid); or 1% or greater, if the food is a liquid food. This change enables the department to enforce the prohibition in Standard 1.1.1 of the Australia New Zealand Food Standards Code (the Code) on imports of pure and highly concentrated caffeine products intended for retail sale. Source: Pure caffeine regulation
October 2019 Failing Food Report
This latest report details food that was found to fail under the Imported Food Inspection Scheme during the month of October. Among the usual pathogenic organisms detected in these imported foods are such organisms as Vibrio cholerae, Listeria, and E. coli and assorted toxins such as histamine, aflatoxin and others. Of particular note are the number of foods ‘failing’ due to the illegal presence of added vitamins and or minerals. There are also failed ‘blended honeys’, as well as a smorgasbord of residual agricultural chemicals. Source: October 2019 food fails
Proposal M1017 – Maximum Residue Limits (2019): The purpose of this proposal is to consider varying certain maximum residue limits (MRLs) for residues of specified agricultural and veterinary chemicals that may occur in food commodities. Source: MRLs 2019
Proposal P1054 – Pure and highly concentrated caffeine products: Urgent Proposal P1054 was prepared to amend the Australia New Zealand Food Standards Code to prohibit the retail sale of pure and highly concentrated caffeine food products. Source: Caffeine restriction
Application A1161 – Potassium Polyasparatate as a food additive in wine: The purpose of the Application is to permit the use of Potassium Polyaspartate as a food additive in wine at a maximum permitted limit of 100mg/L. Source: Wine additive
Application A1164 – Pullulanase from Bacillus licheniformis as a processing aid (enzyme): The purpose of this Application is to seek approval to permit the use of the enzyme Pullulanase from Bacillus licheniformis as a processing aid in brewing and starch processing. Source: Brewing enzyme
Application A1166 - Reduction in minimum alcohol for Tequila: The purpose of this application is to lower the minimum alcohol percentage by volume specified in Standard 2.7.5 of the Australia New Zealand Food Standards Code for spirits using the Tequila geographical indication (GI) from 37% to 35%. Source: Tequila alcohol minimum
Application A1173 – Minimum protein in follow-on formula: The purpose of the application is to seek approval to vary the minimum protein requirement in follow-on formula. Source: Baby formula protein
Call for comment on a new steviol glycoside: the application is seeking permission for the use of rebaudioside E, produced using enzymes derived from a genetically modified strain of the yeast, Pichia pastoris. Source: Steviol glycoside
Second call for comment - Plain English Allergen Labelling: The purpose of this proposal to make allergen information clearer, more consistent and prominent on food labels. Source: Food allergen labelling
Training: RFA Provides Comprehensive Training in Regulatory Affairs
Quote for the month:
“One of the most glorious messes in the world is the mess created in the living room on Christmas Day. Don’t clean it up too quickly”. Andy Rooney
Cosmetics and TGA Listed Sunscreens
NICNAS Requests Information on Industrial Uses of Certain Chemicals on the Inventory
The new scheme called the Australian Industrial Chemicals Introduction Scheme (AICIS) commences on 1 July 2020 and replaces the Australian Inventory of Chemical Substances (AICS, which is the current Inventory). Only industrial chemicals will be retained on the AICIS. NICNAS proposes that over 1600 chemicals that are not considered industrial chemicals should be removed e.g. medicines, agricultural or veterinary chemicals and foods. These substances are classified as “excluded use” chemicals. Source: Rationalising the chemical inventory (Please see also: AICIS guidance )
For an introduction to cosmetic regulations please view: RFA Regulatory Affairs You Tube Video (Cosmetics Regulation)
Complementary medicines ('Dietary supplements')
When Does Disease Education Stray Into Product Promotion?
This TGA guidance is to assist providers of disease education activities (including sponsors, health professionals, pharmacies, peak organisations and community educators) to ensure that disease education activities do not inadvertently become advertisements for therapeutic goods. While a disease education activity may legally make reference to a range of treatment options, if the information provided is likely to encourage consumers to seek to obtain a particular good, or seek a prescription for a particular medicine, then it will be considered an advertisement. Source: Education V Promotion
Are You A Business Involved with Medicinal Cannabis Products but Unsure How to Advertise?
This TGA guidance aims to assist providers of medicinal cannabis products and therapies (including sponsors, manufacturers, importers, pharmacists, health professionals and marketers) to comply with the therapeutic goods advertising restrictions. The focus of this guidance is to help providers understand how to promote their business or service without advertising medicinal cannabis products to the public, which is prohibited. Source: Medicinal cannabis advertising
TGA Provides Consent to Supply Therapeutic Goods that Don’t Comply With New Label Laws
The TGA has established a process for sponsors of non-prescription medicines (which include complementary and OTC medicines) to request consent for non-compliance with the new TGO No. 92 - Standard for labels of non-prescription medicine, relating to the presentation of the name of the medicine on product labels. This is an interim measure to assist industry to transition to the requirements for TGO 92. This new order includes requirements to ensure easy readability and identification of key health information such as active ingredients. Source: TGO 92 consent for non-compliance
Advertising of Complementary Medicines: Update
The Complementary Healthcare Council of Australia (CHC) is no longer accepting any new applications for advertising pre-approvals of complementary medicines (CMs). Applications received by CHC before 14 November 2019 will continue to be processed and decided, with final decisions for all these applications to be made by 27 January 2020. From 19 November 2019, all new applications for approval of medicines advertising in any specified media (broadcast, print, cinema or public display) should be lodged with Consumer Healthcare Products Australia (CHP Australia), which was previously known as the Australian Self Medication Industry. These new arrangements will apply until the pre-approval process is disbanded on 30 June 2020. Application fees will not change from those already published on the website. Source: CM advertising update
Summary: Therapeutic Goods Determinations
Therapeutic Goods (Complementary Medicines - Information that Must Accompany Application for Registration) Determination 2018: (Sets out the kind of information which must accompany an application for the registration of a complementary medicine, and the form in which the application must be submitted).
Therapeutic Goods (Complementary Medicines - Information that Must Accompany Application for Section 26AE Listing) Determination 2018: (Sets out the kind of information which must accompany an application for the listing of a complementary medicine under section 26AE of the Therapeutic Goods Act 1989 and the form in which the application must be submitted).
Therapeutic Goods (Permissible Indications) Determination (No.2) 2019: (Specifies the indications that are permitted for use in a medicine listed in the Australian Register of Therapeutic Goods under subsection 26BF of the Therapeutic Goods Act 1989 and any requirements associated with their use in such medicines).
Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019: (Determines those ingredients that may be contained in a medicine that is listed in the Australian Register of Therapeutic Goods ("the Register") under section 26A or 26AE of the Therapeutic Goods Act 1989, and requirements in relation to the inclusion of those ingredients in such medicines).
Update to Listed Medicine Ingredients
Therapeutic Goods (Permissible Ingredients) Determination (No. 3) has recently been registered on the Federal Register of Legislation. A total of 40 changes have been made in the updated Determination. These changes include: Addition of 6 new ingredient entries; and changes to 34 existing ingredient entries to make requirements clearer and less restrictive. Source: TGA updates LM ingredients
Consultation: Are Sports Supplements Foods or Therapeutic Goods? CMA Responds
In the October 2019 edition of this newsletter we ran a story with the heading ‘Consultation: Are Sports Supplements Foods or Therapeutic Goods?’. Complementary Medicines Australia has released a major Position Statement regarding this proposed change to legislation, highlighting concerns that may force some current ‘foods’ to be reclassified as ‘medicines’. CMA believes that probably 40% of ‘foods’ in the specialty sports supplement sector may be affected, with a possible cascading or “domino” effect of around 60-80% of products due to other factors such as inability to access manufacturing lines that are licensed under the TGA requirements. Sources: TGA sports food consultation; & CMA position statement; & Media comment
Communique: Therapeutic Goods Advertising Consultative Committee
The fourth meeting of the Therapeutic Goods Advertising Consultative Committee (TGACC) was held in Canberra on 17 October 2019. TGACC members represent a diverse range of stakeholders with an interest in the advertising of therapeutic goods, including consumer, industry and health professional bodies. Topics covered included: work on improving granularity of complaints data against Key Performance Indicators; guidance documents on advertising requirements (specifically for providers of medicinal cannabis products), human cell and tissue products and disease education activities; testimonials and endorsements (including the role of social media influencers); and the role product samples. Source: TGACC communique
The Importance of Approved Terminology for Therapeutic Goods
The TGA develops and maintains approved terminology to ensure the accuracy and consistency of information on the Australian Register of Therapeutic Goods (ARTG). This provides a consistent and standardised method for naming of: ingredients; components; routes of administration; dosage forms; container types; units of expression; and proportion. Source: Approved terminology
TGA Rules on Products Containing Folate
Clarity has been provided that certain goods containing folate, which are represented as being foods for "special medical purposes" or dietary management, are considered to be therapeutic goods. This is due to the high likelihood that these goods may be used for a therapeutic purpose, i.e. to prevent, cure or alleviate folate deficiency or depression, or an inborn error of folate metabolism. This means they must be registered or listed on the Australian Register of Therapeutic Goods (ARTG) and regulated accordingly. Source: Folate substances
Changes Made to Propolis and Royal Jelly in Listed Medicine Applications
The TGA has changed the listed medicine application system to allow equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the Australian Registry of Therapeutic Goods (ARTG). Sponsors can now enter propolis and royal jelly preparations with equivalent starting material in a way that accurately reflects the active ingredient contained in their medicine. This guidance does not apply to ‘Export Only’ medicines. Sponsors of existing listed medicines should review this information before 31 March 2020 to check if they are eligible for a free correction to their ARTG entry. Source: Propolis & royal jelly
Beware the ‘Barbie Drug’: The Dangers of Using Melanotan
The TGA urges consumers to steer clear of products containing 'melanotan'. These products are usually marketed as injectable tanning products. They are not included on the Australian Register of Therapeutic Goods (ARTG) and have not been assessed for quality, safety or efficacy by the TGA. It is illegal to advertise and supply these products, and their use has proven serious side effects that can be very damaging to one's health (darkened skin, increased moles and freckles, nausea, vomiting, loss of appetite, flushing of the face, involuntary stretching and yawning, and spontaneous erections!). Melanotan and melatonin (which is commonly used as a sleep aid) are different substances, and the above warnings do not apply to melatonin. Sources: TGA melanotan warning & Lauren Golman, A Current Affair: ACA melanotan story
TGA Safety Advisories- Source: TGA current year alerts
Grakcu capsules: The capsules contain the undeclared substances Sildenafil and Tadalafil
Me2Shape capsules: The capsules contain the undeclared substance Fluoxetine
De2Xy capsules: The capsules contain the undeclared pharmaceutical substance Bisacodyl.
Ying Da Wang tablets: The tablets contain the undeclared substance Sildenafil.