current affairs

Issue 257, 1st April – 1st May 2025

Training news

Compliance obligations for listed complementary medicines. If you are thinking of launching your complementary medicines into Australia it is important to be aware of your obligations, both prior to and after the launch. This course has just undergone a thorough revision and is now three hours long. View the agenda and book the course here.

We have a story below titled “New guidance on acceptable and unacceptable presentation of listed medicines”. Our courses that are relevant are Advertising and Social Media in Australia and New Zealand, (this course also includes foods and cosmetics), and Advertising medicines and medical devices

The TGA has indicated to industry that Pharmacovigilance Inspections of medicine sponsors will increase 3-fold. Complementary Medicines will be prioritised. If you are a medicine sponsor and don’t have a robust PV system NOW is the time to skill up and implement, and consider doing our course Pharmacovigilance obligations.

We now have 40 regulatory affairs courses, covering regulations in Australia, New Zealand and the USA. You can view them here and book online here

Regulatory affairs news

Complementary Medicines and Medical Devices

New guidance on acceptable and unacceptable presentation of listed medicines. This is an excellent summary just published by the TGA. Important reading for anyone involved in the labelling or advertising of a listed medicine in Australia. In particular, refer to the reference that the ARTG comprises the “presentation” of the goods for supply; and  the paragraph titled “Misleading claims and advertising”. Much of this information is already included in our courses listed above. Read the TGA guidance here.

Indications (“claims”) permitted for listed medicines: updated list commenced on 3rd April. Many minor updates, read the summary here and view the updated list of permitted indications here

Compliance reviews of listed medicines: latest summary published here. The listed medicines covered in this round of updates include medicines containing valerian ingredients, lysine hydrochloride for cold sore management, and Vitamin D for claims relating to bone. This update also includes medicines making non-permitted claims about attention deficit hyperactivity disorder (ADHD), asthma, cardiovascular diseases, diabetes, exercise performance, and urinary frequency.

Nitrosamine impurities – update. Based on recently updated EMA information, the TGA  has updated their own guidelines. This page has several links to documents that would be very useful to suppliers of medicines including complementary medicines.

Reviews of listed medicines with diarrhoea-related indications for use. Permitted indications (“claims”) for listed complementary medicines include: decrease/reduce loose stools, decrease/reduce/relieve diarrhoea, helps decrease/reduce/relieve symptoms of traveller’s diarrhoea, helps reduce occurrence of diarrhoea, helps reduce occurrence of symptoms of traveller’s diarrhoea, Atisara hara/ease diarrhoea. The TGA will be conducting targeted reviews to ensure that products that include these indications also include the mandatory warning on their labels and advertising: ‘Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3 to 6 years or 48 hours in adults and children over 6 years (or words to that effect).’ Source: TGA

TGA advisory committees: vacancies exist for 7 committees, including complementary medicines and medical devices. Read more and see how to apply here.

GMP clearance of overseas manufacturers: the backlog of applications has eased somewhat leading to a reduction in the time taken to process applications. Mid October 2024 there where 2,547 applications in the queue. Source: TGA

* List of TGA licensed manufacturers, updated 9th April is available here.

* List of manufacturers suspended from licensing for manufacture of therapeutic goods, updated 9th April is available here

* List of manufacturers revoked from licensing for manufacture, updated 9th April, available here.

TGA’s performance report for 2023-2024 has been published here.

Poisons standard: consultation is open for proposed changes to the scheduling of adrenaline, psilocybine (psilocybin), 6-Methylnicotine, azelaic acid, and extracts and essential oils primarily composed of methyl salicylate. Consultation period closes 21st May – information is here.

Recalls – now called “Market actions”:

* BlissBaby is recalling all batches of Flatus tube, single-use – Lufti Colic Reliever. BlissBaby did not supply sufficient evidence to the TGA for the safe use of their product. The product has been cancelled from the Australian Register of Therapeutic Goods (ARTG). Source: TGA

* Several vitamin and perinatal (including preconception) products are being recalled due to a lack of or excessive levels of potassium iodine. Source: TGA

* Stryker is conducting an Urgent Recall of certain lots of the HeartSine Samaritan Public Access Defibrillator Pak due to prematurely depleted battery cellsSource: TGA

* For the same product above, some lots are being recalled as a manufacturing related problem may impair device audio prompts and prevent the device from delivering instructional voice prompts to the user during useSource: TGA

Proposed changes to IVD medical device classifications:

* A webinar will be held on 8th May, TGA is seeing feedback. Read about it here.

* TGA is seeking stakeholders’ feedback. The purpose is to align classification rules, principles, and definitions with the European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR) where appropriate. Consultation closes 23 May. Overview of the proposal is here, and this is the form you can use to provide your feedback/.

The TGA has just reminded the industry that NAD, NAD+, NADH and NMN are not currently permitted ingredients. The TGA states “listed medicines that make claims about NAD or NMN through their name, labelling or advertising are at risk of breaching the law, particularly if those claims imply or suggest that the medicine contains NAD or NMN.” Source: TGA

Compliance action

* 4 infringement notices totalling $75,120 were issued to Summit Pharmacy for the alleged unlawful manufacturing of medicinal cannabis products. Summit Pharmacy paid all 4 infringement notices in February 2025. Source: TGA

* A 3 years court enforceable undertaking has been issued to Your Solution Compounding Pharmacy for advertising of prescription-only compounded medicines for weight-lossSource: TGA and more here.

Safety alerts

* New safety warnings for isotretinoin (Roaccutane): a prescription medicine used to treat severe cystic acne: caution needs to be taken if patient shows signs of depression , sexual dysfunction and some other conditions. Read more here.

* Imported product called Magnum XXL, which was previously found to be adulterated, is still being imported and still contains undeclared tadalafilSource: TGA

Counterfeit Ozempic-labelled products have been stopped at the Australian border. Read more

Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories.

* Article regarding therapeutic and safety concerns about Lavandula species – published in European Journal of Pharmaceutical Sciences.

* “Truth in the roots: an investigation into ginseng adulteration, 2015-2025.” – read about a paper presented at the 24th International Congress of the International Society of Ethnopharmacology – LinkedIn post

Why Chemotaxonomy Is Critical for Essential Oils: Beyond the Morphology. Published on LinkedIn.

Botanical Adulterants Monitor – Issue 32 – read it here.

From New Zealand

Medsafe is asking for feedback on the proposed Medicines Amendment Bill. Read more here.

Foods

New – PDF document containing all of the Food Standards Code. This is very useful as it is searchable and contains all the standards and schedules. Access it here.

Amendments to Food Standards Code:

Amendment 237 to vary maximum residue limitsSource: FSANZ

Amendment 236 included three applications

A1299 – Fructosyltransferase from Aspergillus oryzae as a processing aid FSANZ

A1301 – Triacylglycerol lipase from GM Komagataella phaffii as a processing aid FSANZ

A1303 – Food derived from herbicide-tolerant sugar beet line KWS20-1 Source: FSANZ

Approvals: An extraordinary meeting of the FSANZ Board was held on 26th March to notify the decisions:

A1269 – Cultured Quail as a Novel Food (this is the first cell-cultured food approved by FSANZ Board)
P1049 – Carbohydrate and sugar claims on alcoholic beverages
P1059 – Energy labelling on alcoholic beverages

Call for submissions

A1318 – Steviol glycosides produced by enzymatic conversion using enzymes produced by GM Escherichia coli BL21

Nutrition labelling. In Food Standards April newsletter there is a discussion on the work progressing on front- and back-of-pack food labelling through parallel projects covering the Health Star Rating (HSR) system and the nutrition information panel (NIP). 74 submissions were received from stakeholders. A report is expected to go to food ministers for consideration early next year.

Recalls 

* Eskal Salted Caramel Creams – due to the presence of an undeclared allergen (milkNSW Food Authority

* Adora Handmade Chocolates – Easter Egg Milk Chocolate Rocky Road and Easter Egg Dark Chocolate Rocky Road – due to the presence of an undeclared allergen (pistachio)NSW Food Authority

* Uberbrau Ultra Low Alcohol Lager and Henninger Lager Bottle – due to the presence of a chemical on the outer packaging producing an unpleasant odourSource: FSANZ

New Zealand Food safety insights, emerging risks, and current issues bulletins:

These bulletins contain news from all over the world.

2nd April bulletin

10th April bulletin

24th April bulletin

New Zealand Food 2025 food recalls:

* Pendarves – imported whole frozen anchovies due to the possible presence of a marine biotoxin

* New World Ravenswood brand Chicken Cordon Bleu due to the presence of an undeclared allergen (milk)

* Little Island brand Hokey Pokey Coconut Ice Cream due to the presence of an undeclared allergen (milk).

* Lianhua Supermarket brand ready-to-eat Whole Chicken and Pork Head Pieces due to the lack of required food safety controls

* Foodstuffs Own Brands – Pams brand Afghan Oat Baked Bars as the product may contain foreign matter (metal)

* The Lactation Station brand Coconut Cranberry Lactation Cookies due to presence of an undeclared allergen (milk).

* Happy Snacks Limited – Dr Bugs brand Fruit Candy Popcorn as the product may contain foreign matter (metal screw).

* Foodstuffs Own Brands – Gilmours brand Beef Stock & Bouillon due to the presence of an undeclared allergen (gluten).

Food more information on the above recalls click on the links providedNZ MPI food recalls

Food news from USA provided by Rend Al Mondhiry, Partner at Amin Wasserman Gurnani, LLP

New Mexico Becomes the Third U.S. State to Ban PFAS
Following the lead of Maine (2021) and Minnesota (2023), New Mexico is the third U.S. state in prohibit intentionally added PFAS in consumer products. House Bill 212 was signed into law on April 8, 2025, and, among other things, prohibits the sale, offer for sale, distribution, and distribution for sale of the following products if they contain intentionally added PFAS:
– Cookware, food packaging, dental floss, juvenile product, and firefighting foam beginning January 1, 2027;
– Carpets and rugs, cleaning products, cosmetics, fabric treatment, feminine hygiene products, textiles and textile furnishings, ski wax, and upholstered furniture beginning January 1, 2028. Beginning January 1, 2032, the ban will apply to all products containing intentionally added PFAS unless an exemption applies.

Texas Attorney General Investigates “Healthy” Food Labeling. General Ken Paxton announced an investigation into WK Kellogg Co. for potentially violating the state’s consumer protection laws. AG Paxton is targeting Kellogg’s for its alleged “healthy” food labeling on products that contain petroleum-based artificial food colorings linked to disease and other health problems. The April 5, 2025 press release also notes the company has removed these ingredients from foods in other countries, but hasn’t done so in the U.S. Read more here.

US Announces Plans to Phase Out Petroleum-Based Food Dyes

Two articles contributed separately and independently both Rend Al Mondhiry, Partner at from Amin Wasserman Gurnani, and Gary Kennedy, from Correct Food Systems

From Rend Al Mondhiry:

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced measures to phase out the use of petroleum-based synthetic food dyes in the American food supply as part of the administration’s Make America Healthy Again initiative. Specifically, FDA intends to take following actions:
1.    Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
2.    Initiating the process to revoke authorization for two synthetic food colorings—Citrus Red No. 2 and Orange B—within the coming months.
3.    Working with industry to eliminate six remaining synthetic dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—from the food supply by the end of next year.
4.    Authorizing four new natural color additives in the coming weeks, including calcium phosphate, Galdieria extract blue, gardenia blue, butterfly pea flower extract, and other natural alternatives to synthetic food dyes.
5.    Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
6.    Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required.

More information here.

And from Gary Kennedy, an international perspective:

Earlier this week, US Health and Human Services Secretary Robert F. Kennedy Jr and the US Food and Drug Administration (FDA) Commissioner Dr. Marty Makary announced plans to phase out synthetic dyes from American food suppliers by the end of 2026. The initiative targets eight petroleum-based dyes, citing concerns over potential links to health issues such as ADHD and other behavioural problems in children, although to date, the FDA has assessed dozens of human studies and found no causal relationship. Leading food safety authorities, including EFSA, JECFA, FSANZ and others, have reaffirmed food colour safety for years. While not a ban, the FDA will develop a national standard and transition timeline.
The International Association of Color Manufacturers (IACM), representing the global colour industry, has published a statement in response, which you can view here. IACM expressed concern over the announcement, emphasising that colour additives have been rigorously evaluated by global health authorities and deemed safe for consumption. They warned that the proposed reformulation timeline is ambitious and urged the FDA to maintain a science-based approach and provide clear industry guidelines.
Although not a legal mandate, this FDA announcement could have global implications, potentially prompting similar initiatives in other regions. The move reflects growing public scrutiny of synthetic ingredients. While FSANZ has concluded that the estimated dietary exposure to synthetic colours, including those commonly used in beverages, is well within acceptable limits, Australian regulators and producers may be prompted to reevaluate standards.

More information here

In the press

Protein powders in the spotlight – different opinions

Are protein powders a waste of money? Published on abc.net.au

Too much of a good thing? The problem with protein. Published in Sydney Morning Herald.

* Clean Label Project puts Protein Powder under the microscope, critics call the report misleading. Published in NutraIngredients USA.

Cosmetics and TGA listed sunscreens

A very quiet month for regulatory news about cosmetics! As they say: “nothing to see here”.

18 draft evaluations are open to comments, consultations open until 29th May. See the list by clicking on the link here.

Chemicals added to the Inventory 5 years after issue of assessment certificate (obligations to provide information apply)

* As at 28 April: CAS 161074-93-7, and CAS 1857296-89-9. Source: AICIS

Chemicals added to the inventory following issue of assessment certificate as of 15 April: one chemical, CAS 140921-24-0. Not relevant to cosmetics. AICIS

From our colleagues at Cosmetic Consultants Europe:

Safety Assessment of Cosmetic Products online training:
•    Module 1: ‘Regulatory Affairs – Approaching Cosmetic Products & their Safety’
•    Begins: Tues., 27. May 2025 | 12EST  17GMT  18-19.30CET

Contact Steven L. Hanft, M.A., Business Communications, steven.hanft@cpsr-education.com

ACCC and similar

ACCC

The Food and Grocery Code of Conduct is now mandatory for Australia’s largest supermarkets and grocery wholesalers. ACCC news release

Misleading “ocean plastic” claims. The Federal Court has ordered Clorox Australia (manufacturer of GLAD kitchen and garbage bags) to pay a total penalty of $8.25 million for making false or misleading representations that certain GLAD bags were partly made of recycled ‘ocean plastic’. This was false. The products were made from about 50 per cent plastic waste which had been collected from communities in Indonesia with no formal waste management systems, situated up to 50 kilometres from a shoreline, and otherwise from non-recycled plastic, processing aid and dye. ACCC news release

Product safety – toppling furniture. Although a little bit “off-topic” for this newsletter, you may find this interesting. Since 2000 at least 28 people, including 17 children under 5, have died in Australia from toppling furniture and televisions. A mandatory information standard comes into effect on 4th May. More here.

Published by Regulatory Training Direct  www.regulatorytrainingdirect.com

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