Best wishes for a happy and peaceful 2026. Welcome to our first newsletter of 2026. The next newsletter will be at the end of February.

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CONTENTS

Training news
Complementary medicines and medical devices
Foods
Cosmetics and sunscreens
ACCC and other news

Regulatory Training Direct is an online training organisation with a focus on regulatory compliance and related topics.

Medical devices. We have three courses, and each of them is available either “live” with a face-to-face Zoom session, or they are also pre-recorded so you can do them at your own leisure. Here are the links to the agenda:

Medical Device Regulation Fundamentals

Medical Device Classification

Interacting with the TGA for Medical Devices

These courses have been written and are presented by Gary Burgess who spent 9 years with the TGA in the medical device section.

Advertising and Social Media – this course was updated in December. Designed for people involved in advertising personal care products on social media and through influencers. See the agenda and book here.

Cosmetics in Australia. this course has been revised, book it here.

Cosmetics in New Zealand course is available here.

View the agenda for all 40 courses and book online here. Some courses are available as live tuition, others are eLearning (pre-recorded), and some are available in both formats. When you purchase an eLearning course your password lasts for 60 days, so you can access the course as often as you want before the password expires

Update to ingredients permitted in listed medicines. 19 changed ingredients. There are 4 added ingredients and 15 ingredients have had their conditions changed. TGA summary of the changes is here.  Read the updated ingredients list here.

Guidelines for listed medicines. Updated on 13 January 2026. Includes sunscreens as well as complementary medicines, with issues covered including applications, safety and efficacy, ingredients, manufacturing, labelling and advertising and more. Published here.

Guidelines for registered non-prescription OTC medicines. Updated 7th January and published here.

Understanding listed and registered complementary medicine regulation. Updated 16th December: Here.

Understanding rules for boundary and combination products updated 16th December. Guidance to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices. Find it here.

Valeriana officinalis – warning statement “In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.”  Targeted reviews of 30 listed medicines were undertaken in 2025. 26 medicines (86%) were found to comply with the required warning statement. The compliance status of two medicines (7%) could not be determined as they were never manufactured. Two medicines (7%) were identified as missing the required warning statement. Read more here.

Guidelines for new sponsors of listed medicines. Provides introductory level information about becoming a sponsor, and the regulations you must comply with. Source:TGA. NOTE: We have a comprehensive course designed for new sponsors, read about Compliance Obligations for Listed Complementary Medicines here.

Interim decisions to amend the Poisons Standard – medium and long chain alkyl sulfates, sodium hydroxide and potassium hydroxide, methyl ethyl ketone oxime (MEKO), acrylates and methacrylates based on bisphenol A (BPA), cyanoacrylate esters, and chromium-DL methionine (Chromium organic chelates). Published here. Also adrenaline, published here.

Public and stakeholder consultations:

– Proposed changes to labelling of medicines. Consultation closes 10th March. Summary information is here, and the latest version of the consultation paper is here.

– Pre-meeting public notice and public consultation on proposed amendments to the Poisons Standard, submissions sought for first-generation sedating antihistamines, melatonin, flufenoximacil, oxalic acid and methylene blue. Information published here and also on the TGA Consultation Hub.

– Proposed changes to improve transparency about disruptions to the supply of medical devices. Consultation closes 20th February. Overview is here

– Conformity Assessment Procedures for Medical Devices – Proposed Amendments. Consultation closes 27th February. Read more here.

– Adoption of 23 international scientific guidelines. Too many to list in this newsletter, and many would be of interest to our subscribers, particularly EU Guideline on quality of herbal medicinal products.  Closes 10th February, information here.

– Survey on digital mental health tools – software and artificial intelligence (AI) in healthcare settings, including where it is used to support people with mental health conditions. Closes 11th February. Read about it here.

– Improved sharing of information about medical devices – relating to transparency of disruptions to supply of a medical device to help in monitoring, assessing and responding to potential and actual supply disruptions. Closes 20th February. More info here.

– Conformity Assessment Procedures for medical devices – Proposed amendments. Closes 27th February. Read about it here.

Application to amend the Poisons Standard – application form updated 11th December, includes when to use the form and how to submit. Information here.

GMP clearance of overseas manufacturers: Sponsor Information Dashboard has just been updated here.

Do you require GMP licencing or certification? This new decision tree may assist.

TGA stakeholder survey report 2025. Annual survey – read the key survey findings here.

Importing and supplying medical devices. This web page is for health professionals who import medical devices for use in their clinic. Examples of importing medical devices include: purchasing from overseas through the internet; from mail order catalogues;  or obtaining from international conferences and trade exhibits. Health professionals can import medical devices under the personal importation provisions for personal use or for their immediate family, but this does not extend to use in their clinical practice. Source: TGA

Advertising personalised medical devices – what can and what can’t be advertised. Source: TGA

AI-enabled medical devices – updated 16th December, a list of devices included in the ARTG is here.

Medical devices: Australian Unique Device Identification Database (UDID)

– information for sponsors and manufacturer here.

– UDI consent to supply consultation – Mandatory compliance begins 1 July 2026 for Class III and IIb devices, with lower classes phased in over later years. TGA is proposing a streamlined consent to supply process with reduced fees, allowing continued supply while organisations work toward compliance. Closes 23rd January – review consultation here.

– UDI news and updates – a summary of actions to date, source: TGA

– regulatory engagement meetings with the TGA – for sponsors and manufacturers of medical devices, who intend to apply to include a device in the Australian Register of Therapeutic Goods, or for a TGA Conformity Assessment Certificate, or for priority applicant determination. Read more here.

– Overview of UDI traceability of medical devices. Source: TGA

– Healthcare executive summary is here

– Information for healthcare providers – how UDI can be used in healthcare settings – is here.

Approved COVID-19 self-tests (home use tests) – list updated 16th December, published here.

Transvaginal surgical mesh

– Resources for health professionals here.

– Support for patients – State-based and non-government support services are available to women, read here.

Medical device recall: The company which has supplied the CellAED Non-rechargeable public automated external defibrillator, RRR Manufacturing Pty Ltd, has gone into liquidation. There is a critical recall of the device as without ongoing service and technical support, the device may not work as intended to treat sudden cardiac arrest. Read more here

Medical device post-market reviews: updated 16th December. A list of current and completed reviews is here.

Additional medical device news can be viewed on the January 2026 edition of TGA Medical Device Resources published on LinkedIn by Gary Burgess, Hill Valley Regulatory Consulting.

TGA’s freedom of disclosure (FOI) log – last updated 14th January 2026, is here.

Good Clinical Practice Guidelines – International Scientific Guideline – ICH E6(R3) has been adopted on 16th January. More information here.

Medicines and medical devices that have been cancelled or suspended by the sponsor – a large number of products – listed here

Listed medicine compliance reports. Updated 4th December. Results of compliance reviews covering 19 listed medicines. Source: TGA

Compliance activity

– Infringement notices – published on 12 January 2026, a list of infringement notices issued in response to breaches – (this list goes back years!) – published here.

– Booty N Buff Nutrition has been issued infringement notices totalling $37,560 for the alleged unlawful advertising of sports supplements which were not included on the Australian register and which contained prescription-only ingredients. Source: TGA.

– Illicit vaping goods worth more than $1 million seized in Bendigo. A warning letter was issued by the TGA earlier in 2025 but non-compliance continued, read more here.

– NSW-based individual issued infringement notices totalling $19,800 for allegedly importing cosmetic injectables Source: TGA

– Queensland individual issued 2 infringement notices totalling $7,716 for the alleged unlawful importation of counterfeit botulinum toxin type A and the unlawful advertising of cosmetic injectables Read more

– Perdays Health Functional Food has been issued an infringement notice for $19,800 for unlawful advertising of a listed medicine with unapproved claims (the fine has been paid). Read more here.

Safety advisories

– Brahmi Vati tablets (Ayurvedic) – TGA has tested these products manufactured by Unjha Ayurvedic Pharmacy and found that the tablets contain extremely high concentrations of heavy metals, including mercury, lead, arsenic, and cadmium. The product is not listed on the ARTG and is only available via import. Source: TGA

– Kumar Kalyan Rasa tablets (Ayurvedic) – manufactured by Unjha Ayurvedic Pharmacy,  testing has found extremely high concentrations of heavy metals, including mercury, lead, arsenic, and cadmium. Read more here.

– Manasamitra Vadakam tablets (Ayurvedic) manufactured by SKM Siddha and Ayurvedha, the tablets contain extremely high concentrations of heavy metals, including mercury, lead, arsenic, and cadmium. Read more here.

Recalls

– Kmart Australia Ltd is recalling their Anko Small Gel Pak and Anko Large Gel Pakbecause they contain ethylene glycol, a toxic substance. Source: TGA.

– Key Sun Laboratories is recalling one batch of Key Sun Kids Travel Sickness Homeopathic Product, due to the risk of a small metal wire being present in the lozenge. Source: TGA

Permission to use a restricted representation: For hypertensin software – a representation to the effect that the specified goods may identify patterns suggestive of hypertension. Restrictions and conditions apply. Read more here.

Vaping

Update to the rules for lawfully handling vaping products make it clearer for businesses that need to lawfully possess and supply vaping goods as part of their operations, here.

Membership of the Advisory Committee on Complementary Medicines (ACCM) – list updated 22nd December, here. Information on the role of the committee is here.

Membership of the Advisory Committee on Medical Devices (ACMD) – here.

Advisory Committee on Complementary Medicines – meeting statement from 31st July published 3rd December, here.

TGA modernising its digital platform:

– information here

– Learn about TGA digital platform by watching videos and accessing resources that explain the refreshed portal and case management system here

Women’s Health Products Worklng Group – Communique from the 11th meeting on 30th October 2025, published 15th December here.

TGA contact details – email, phone, fax, post, social media channels – have been updated again on 2nd January here. .

The New Active Substance Work-Sharing Initiative includes Australia, Canada, Singapore, Switzerland and the UK – agencies are able to co-ordinate regulatory review procedures, and increase each agency’s capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products. Source: TGA

Botanical Adulterants Prevention Programme (BAPP) articles supplied by Michael D. Levin of Health Business Strategies LLC and the Botanical Adulterants Prevention Program:

Upcoming Publication on Turmeric Adulteration.

BAPP is pleased to announce that our article, “A scoping review of turmeric adulteration based on data from six continents,” has been accepted for publication in Pharmaceutical Biology.   Estimated adulteration rate: ~20%. Most comomon adulterants:  dyes, corn starch, synthetic curcumin. Our review, which includes 48 publications covering 2,235 commercial turmeric samples worldwide, demonstrates that turmeric adulteration is a persistent global concern, underscoring the need for robust quality control, fit-for-purpose analytical methods, and transparency across the supply chain. (Advance notice published by BAPP on LinkedIn, December, 2025)

Adulteration Alert: FSDA Expands Safety Warning on Supplements Containing Toxic Yellow Oleander (November 2025)

The latest update follows expanded analytical testing and added several new products to the FDA’s watchlist. Some companies have initiated recalls, and certain listings have been removed from online marketplaces. Concerns about tejocote root adulteration surfaced in 2023 after a CDC report revealed multiple products substituted with yellow oleander. Since then, the FDA has conducted targeted sampling, issued multiple warnings in 2024, and confirmed ongoing adverse event reports linked to these products. To date, more than 20 brands sold online or via independent distributors have tested positive for the toxic plant. Source: US FDA 

BAPP Science Update: Laboratory Strategies to Reduce Dietary Supplement Adulteration Risks

A newer (July, 2025) publication by scientists from the US Pharmacopeia* provides an overview of the quality control tools, analytical approaches, and regulatory expectations that can help reduce adulteration risks in the dietary supplement industry. Adulteration remains a persistent challenge and has been influenced by supply chain disruptions, increased global demand, and variability in raw material sourcing in recent years. Free access here.

LC-MS-based metabolomics for detecting adulteration in Tribulus terrestris-derived dietary supplements. Published here.

Ginseng Adulteration Across Global Markets and Evaluation of Commercial Product Authenticity. The high demand, morphological similarities, and common name confusion contribute to both unintentional and economically motivated adulteration. Source: Natural Product Communications.

For regular news on US dietary supplement and food regulation, go to AWG Regulatory Roundup.

IN THE PRESS

Concerns medical weight-loss treatments are being advertised to vulnerable eating disorder patients. Peak eating disorder bodies are raising concerns about the rapid rollout of GLP-1 weight-loss treatments through telehealth. In one case, a company referred to “pesky Aussie laws” as having prevented it from providing more information about the medication to potential customers. Published by Australian Broadcasting Corporation.

Food Standards Code Compilation PDF has been updated 23rd December. View it here.

FSANZ Food Standards News December 2025

Contains CEO’s report “Year in review”, along with news about a stakeholder forum to be held in Brisbane min-June 2026, and the FSANZ Work Program Dashboard. Read the newsletter here.

FSANZ Board Communique: 9 & 10 December Meeting – details published here.

Amendments to Food Standards Code

– Amendment No. 246 to the Australia New Zealand Food Standards Code was published by FSANZ on 4 December 2025 (FSC 186). It included amendments resulting from the following application and proposal:

A1288 – Thermolysin from Anoxybacillus caldiproteolyticus Rokko as a processing aid
P1060 – Egg Food Safety and Primary Production Requirements
Further information is available on the FSANZ Gazette web page.

Approval

FSANZ has approved variations arising from the following applications on 9 & 10 December 2025. FSANZ has notified this approval to the Food Ministers’ Meeting:

– A1292 – Phospholipase C from Bacillus licheniformis as a processing aid
– A1293 – Phosphoinositide PLC from Bacillus licheniformis as a processing aid
– A1328 – Aminopeptidase from Trichoderma reesei as a processing aid

Rejected application

FSANZ began the assessment of A1294 Moringa oleifera as a novel food in February 2025 but has decided to reject this application – Rejection report is here.

New applications and proposals 

– A1344 – Milk fat globule membrane enriched whey protein concentrate for use as a nutritive substance in formulated supplementary foods for young children. Opportunity to comment will be provided. Read more here.

– Commencement of assessment: A1338 – Triacylglycerol lipase from Komagataella phaffiiexpressing a triacylglycerol lipase from Yarrowia lipolytica as a processing aid. More information here.

– A1345 Dextransucrase from Bacillus subtilis as a processing aid. Read more here.

Public consultations and calls for submissions/comments

– A1340 – 2′-FL from GM Escherichia coli BL21 (gene donor: Akkermansia muciniphila)for use as a nutritive substance in infant formula products – FSANZ invites written submissions on the assessment of the following application via the FSANZ Consultation Hub by 11:59pm (Canberra time) Thursday 12 February 2026 . More Information here.

– A1332 – Cross-linked polyester resins as an adsorbent processing aid in wine – closing date fr submissions 24th February. More information here.

– A1305 – Alpha-amylase from Bacillus licheniformis (containing the gene for alpha-amylase from the gene variant ANZ105) as a processing aid. Closing date for submissions 19th February. Read more here.

– Consultation Paper – 2026-27 Cost Recovery Arrangements. For the 2026–27 period, FSANZ is proposing no changes to application fees. However, they are undertaking a consultation to seek feedback on the broader cost recovery arrangements. Consultation closes 15 February 2026. This link summarises this and includes links to other relevant information.

Plant-based milk manufacturer Inside Out fined $120,000 for providing incorrect storage instructions on some of its products. 198,550 bottles of oat and almond milk products were sold which, despite requiring refrigeration for safety, were incorrectly labelled with the directions “Once opened, keep refrigerated and consume within 5 days”. A man fell seriously ill after consuming the mislabelled Inside Out almond milk, which had been stored in a cupboard. He was hospitalised for 188 days, including 147 in intensive care. He was later diagnosed with botulism and the milk he drank tested positive for Clostridium botulinum. Source: NSW Food Authority.

Novel foods determinations – none since last publication

Recalls 

– Loophole Brewing Co – Pacific Ale 5 Litre Party Keg – due to secondary fermentation. Source: NSW Food Authority.

– Metcash Food & Grocery – Community Co Diced Beetroot – due to a packaging fault resulting in potential presence of rust inside of the can. Source: NSW Food Authority

– Nestlé Australia – Nestlé Alfamino Infant Formula (certain batches) – due to potential presence of toxin (cereulide) contamination, a substance produced by the Bacillus cereus microorganism. Source: NSW Food Authority

– McCain Foods – McCain Cheese & Bacon Pizza Pockets – due to the presence of foreign matter (plastic, metal). Source: NSW Food Authority

– Leo’s Imports & Distributors – Sapori Soft Almond Amaretti Biscuits – due to a biotoxin – higher than usual levels of naturally occurring hydrocyanic acid. Source: NSW Food Authority

– Warwick Meats – Premium 4 Star Mince Beef – due to the presence of foreign matter (plastic). NSW Food Authority

– Smartfoods Limited – Tom & Luke Low Carb Hazelnut Snackaballs and Low Carb Raspberry Snackaballs – due to the presence of foreign matter (plastic) NSW Food Authority

– PBLNT – Tasty Juicy Cheesey Filipino Hot Dogs – due to presence of an undeclared allergen (milk). NSW Food Authority

Additional food news supplied by Gary Kennedy, Correct Food Systems

Red meat allergy claims first fatality.
A U.S. man who died earlier this year after eating a beef burger is thought to be the first person to have succumbed to red meat allergy triggered by a tick bite. The diagnosis was recently confirmed through post mortem blood testing, which revealed extremely high levels of antibodies to alpha-gal, a sugar molecule found in mammalian meat and transmitted to humans via tick saliva. The clinical case was published in the Journal of Allergy and Clinical Immunology – In Practice. Additional reporting can be found on the NBC news website. In 2007, Australian researchers were among the first to identify the link between tick bites and delayed allergic reactions to red meat. Information about mammalian meat allergy in Australia can be found on the Allergy Facts website

Stay up to date with Food News by subscribing to The Correct News, published by Correct Food Systems.

The Worst and Weirdest Food Frauds of 2025.

For some light reading, go to The Rotten Apple and read the list of food frauds compiled by Karen Constable. Karen is a leading global food fraud prevention expert based in Sydney and owner of The Rotten Apple newsletter, which provides a unique weekly perspective on food safety and food fraud issues from around the world. You can subscribe to the newsletter here.

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

These bulletins contain news from all over the world. Latest issue: 8th December.

New Zealand food recalls

– Nestlé – Alfamino Infant Formula (0-12 months) – due to the possible presence of the toxin cereulide. Source: NZ MPI

– Charcuterie du Pacifique Sud – L’Authentique Chicken & Duck Parfait – due to a failure of food safety controls. NZ MPI

– Tom & Luke Low Carb Snackaballs – may contain foreign matter (hard plastic) NZ MPI

– Akaroa King Salmon – Mānuka Cold Smoked Slices and Trim – due to the possible presence of Listeria monocytogenes NZ MPI

For regular news on US dietary supplement and food regulation, go to Regulatory Roundup.

IN THE PRESS

– Square juice bottles, canned wine: Why your food packaging is getting smarter. Juice bottles that are square instead of round and wine in lighter bottles or slim cans will become a more common sight on supermarket shelves as food and drink manufacturers prepare to make packaging lighter, cleaner and easier to recycle. Published in The Sydney Morning Herald.

– Are those prawns really 100 per cent Australian? The mission to fight food fraud. Sydney’s new fish market, the biggest in the southern hemisphere, will be a major tourist attraction. Issues discussed in this article include fake honey and wine, and even fake Kakadu plum. A University of Melbourne academic states “there are seven types of food fraud: adulteration, mislabelling, counterfeiting, unapproved enhancement, theft, diversion, and document forgery.” Read the article published by The Australian Broadcasting Corporation.

– How much do you know about the meat pie? Test yourself (or treat yourself). A fun quiz published by Australian Broadcasting Corporation.

Primary (TGA) sunscreens – see item above re updated guidelines.

– How to choose a sunscreen updated 19th December, published here.

– How to use a sunscreen updated 19th December is here.

– Reading sunscreen labels 19th December, here

– Sunscreen ingredients includes what ingredients can be used in therapeutic (“primary”) sunscreens, which ones the TGA has reviewed, the difference between mineral and chemical sunscreen ingredients and the safety of nanoparticles. 19th December, here

– Sunscreen regulation – which ones are regulated by the TGA and which sunscreens are excluded from therapeutic goods legislation. Summarised here.

– Sunscreens using the same base formulation as Ultra Violette Lean Screen SPF 50+ sunscreen – updated 17th December, listed here.

Recalls

– Vitality Brands Worldwide is recalling three batches of Cancer Council Sunscreen Clear Zinc Kids SPF50+  due to the potential for the product to become separated. Source: TGA

– Naked Sundays Collagen Glow 100% Mineral Sunscreen SPF50+ is being recalled as testing evidence indicates that the SPF levels of the sunscreen may be lower than what is claimed on the label. The updated list of recalled sunscreens is here.

– Dr Schwartz Hand Sanitiser – 60ml Bottle – supplied to guests as a complimentary hand sanitiser at the Paradise Resort, Gold Coast – the product contains methanol which is highly toxic if ingested. Source: ACCC

Completed evaluations

As at 16th December 2025: eight chemicals, listed here.

Extension of the timeframe for the completion (end date) of the evaluation ‘phenol, 4,4′-thiobis[2-(1,1-dimethylethyl)-5-methyl-‘ (EVA00176) – the updated end date is 30 June 2026. AICIS

Chemical added to the Inventory following issue of assessment certificate (early listing) as at 9th December: CAS 98969-19-8

The latest inventory snapshot August 2025 available for download here. the most recent industrial chemicals inventory is here.

Variation of Inventory listing following revocation of CBI approval – as at 9th January, two chemicals here.

Variation of Inventory listing following revocation of CBI approval and variation of Inventory terms of listing: more information on SIRs – 9 January 2026: CAS 1236307-83-7, and CAS 3103256-19-2. Information here.

List of new chemical assessment statements – none this month

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

– as at 2nd December 2025: one chemical: CAS 173904-11-5

– as of 9th December 2025: one chemical, CAS 900151-37-3

Correction of chemical names: 15th December – the list is here.

Are you registered with AICIS as an importer of chemicals? Have you responded to the PFAS questionnaire? If you were registered in the 2023–24 or 2024–25 AICIS registration years and have not yet responded to the PFAS email notice, you must respond, even if you never introduced PFAS.  More information here.

Industrial Chemicals Regulatory News – published regularly by AICIS. Subscribe hereto receive newsletter by email.

More cosmetic news supplied by Rita Sellars from pH Factor

– The Fragrance Shifts That Shaped the Year and the Sensory Evolution Ahead for 2026. Read article on LinkedIn here.

– Exosomes in skin care: Although it has become a major trend, understanding regulatory boundaries has never been more important. This white paper breaks down the differences between plant-based and human-derived exosomes, explains current cosmetic regulations, and provides guidance on which technologies are suitable for compliant cosmetic development. Available either free (Executive summary) or full white paper (paid). Information here.

– HPC Magazine, is a digital publication created for professionals across the Home and Personal Care industry. Subscribe here.

Cosmetics in Europe: Cosmetics Consultants Europe – Cosmetics Product Safety Assessment Online Training restarts on 3rd February 2026. Module 4: ‘Exposure Criteria, Safety Margins’. Begins: Tues., 3. Feb. 2026 | 12EST 17GMT 18-19.30CET
– Fee: €1.400-/Module (purchase all 6 modules, get 1 Free!)
– Discounts to Members of: IBA, SCC, SCS, CCE, CE, RTD-Australia (i.e. subscribers to this newsletter).
– Preferred academic requirement; University degree in Biology, Chemistry, engineering
Register: https://www.ccecosmetic.org/cce-training-courses/
Contact: Steven L. Hanft, M.A., Business Communications, CCE steven.hanft@cpsr-education.com

IN THE PRESS

– More than 30 zinc sunscreen brands using formula that failed preliminary SPF testing. Australian Broadcasting Corporation news.

– Dozens of sunscreens have been recalled, most of them mineral. What does this mean? Australian Broadcasting Corporation.

Nothing relevant to personal care/health products in the last month.

Published by Regulatory Training Direct  www.regulatorytrainingdirect.com

Providing regulatory training courses for complementary medicines, medical devices, GMP, foods, cosmetics, dietary supplements.

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