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HPRA Reminds Public of the Serious Health Risks of Using ‘Melanotan 2’ Self Tan Products

Data shows large increase in online listings of dangerous and illegal substance targeting younger people

The Health Products Regulatory Authority (HPRA) today reminds the public that the unregulated substance Melanotan 2 is not safe for use and may cause serious, long-term damage to your health. Often described as a self-tanning aid, the product is also referred to as Melanotan, Melanotan II or MT2. It is commonly sold as an injectable powder or in the form of drops and nasal sprays.

The HPRA is also concerned that products containing Melanotan 2 are increasingly being targeted towards young people by using bright colours, flavours, and branding. The HPRA will take action against individuals using social media and e-commerce to advertise and supply Melanotan 2 containing products, including the removal of content and accounts, and prosecution activity when there is significant risk to public health. In this regard, the HPRA continues to engage with e-commerce and social media platforms with the goal of limiting the sale and promotion of these untested products.

According to Grainne Power, Director of Compliance with the HPRA, this substance continues to be advertised for cosmetic purposes online despite known side effects. To protect the public, the HPRA works to remove these advertisements with a focus on stemming the supply of Melanotan 2. It is also important to raise awareness and inform people of the dangers of using this product.

“A substance like Melanotan 2 poses a threat to someone’s health. There is no safety data to support its use, with no guarantees as to its quality, safety or effectiveness. If products advertised online seem too good to be true, it is likely that they are. Serious side effects of taking Melanotan 2 include the development of new moles, darkening of existing moles and freckles, potential loss of vision, muscle tremors, stroke and anaphylaxis.” Ms Power said.

Consumers should be aware that Melanotan 2 is not authorised by the HPRA or any medicines regulator to treat any condition. Despite how it may be presented, it is not a cosmetic product. The HPRA advises anyone using Melanotan 2 to stop using it immediately and to contact medical professionals regarding potential health concerns.

Ms. Power continued,

“As it is intended to be inhaled or injected, it cannot be classified as a cosmetic because it results in an action within your body. We urge consumers to carefully consider and question both what they are seeing online and the motivation of the individuals who profit from the sale and promotion of this substance. There are no legitimate suppliers of Melanotan 2 and those that do so illegally do not have your best interests or your health in mind. Taking this product simply puts your health at risk.”

The HPRA has noted a marked increase in activity on social media illegally advertising the sale and promotion of Melanotan 2 products. Between July 2022 and June 2023, the HPRA has removed over 500 social media or e-commerce listings relating to Melanotan 2. This is a noticeable escalation in activity when compared to a combined total of less than 500 listings removed across the previous two years.

Members of the public can report suspicious activities around the supply of Melanotan 2 and other health products to the HPRA, in confidence, by emailing reportacase@hpra.ie or by calling 01 634 3871 or 01 634 3431. Further information for consumers on the dangers of purchasing medicines online is available here: Dangers of buying prescription medicines online

Additional information relating to the dangers of using Melanotan 2 is available in the corresponding HPRA safety notice.

The HPRA’s advice to anyone using Melanotan 2 is to stop immediately. If you are concerned that you have experienced ill effects from using Melanotan 2, we recommend you speak to a medical professional. You can also use our online form to report such effects to the HPRA.

IBM Publishes 2023 Cost of a Data Breach Report

IBM Security has released its annual Cost of a Data Breach Report,1 showing the global average cost of a data breach reached $4.45 million in 2023 – an all-time high for the report and a 15% increase over the last 3 years. Detection and escalation costs jumped 42% over this same time frame, representing the highest portion of breach costs, and indicating a shift towards more complex breach investigations.

 

According to the 2023 IBM report, businesses are divided in how they plan to handle the increasing cost and frequency of data breaches. The study found that while 95% of studied organizations have experienced more than one breach, breached organizations were more likely to pass incident costs onto consumers (57%) than to increase security investments (51%).

 

The 2023 Cost of a Data Breach Report is based on in-depth analysis of real-world data breaches experienced by 553 organizations globally between March 2022 and March 2023. The research, sponsored and analyzed by IBM Security, was conducted by Ponemon Institute and has been published for 18 consecutive years. Some key findings in the 2023 IBM report include:

 

  • AI Picks Up Speed – AI and automation had the biggest impact on speed of breach identification and containment for studied organizations. Organizations with extensive use of both AI and automation experienced a data breach lifecycle that was 108 days shorter compared to studied organizations that have not deployed these technologies (214 days versus 322 days).
  • The Cost of Silence – Ransomware victims in the study that involved law enforcement saved $470,000 in average costs of a breach compared to those that chose not to involve law enforcement. Despite these potential savings, 37% of ransomware victims studied did not involve law enforcement in a ransomware attack.
  • Detection Gaps – Only one third of studied breaches were detected by an organization’s own security team, compared to 27% that were disclosed by an attacker. Data breaches disclosed by the attacker cost nearly $1 million more on average compared to studied organizations that identified the breach themselves.

 

Speaking on the findings of the report, Elaine Hanley of IBM Security Services Ireland said: “Across the globe, and very similar to the UK, this report confirms what we are seeing as ordinary citizens in Ireland. Across all industries studied customer personally identifiable information was the most commonly breached record type and the costliest. In Ireland we are seeing a surge in phishing emails and texts in recent months.

 

Globally, we are seeing that firms with a smaller number of employees were disproportionally affected by higher breach costs, which in the context of Ireland means that most of the indigent industries operating here need to pay attention to cybersecurity. Globally, we saw that only about half of those who suffered a breach actually plan to invest more in their cybersecurity programme, post breach.

 

The pandemic has accelerated digital transformation in Ireland and although this can be seen as generally positive it does incur additional cyber security risks. However, AI and automation had the biggest impact on speed of breach identification and containment for studied organisations. So now is the time to understand to the technologies and strategies that best protect your data.”

 

Additional Sources

Irish stars join more than 4,000 visitors at Barretstown for the annual Big Picnic

Well-known Irish personalities joined thousands of visitors at Barretstown yesterday for a magical day of adventure at the annual Barretstown Big Picnic. Barretstown is Ireland’s largest children’s charity providing life-changing therapeutic programmes to children affected by cancer and other serious illnesses. This special event in association with Brady Family aims to raise vital funds for the charity while allowing visitors to experience the unique magic of the residential camp.

 

The Castle gates opened for an action-packed day of summer fun with visitors enjoying a host of exciting events and activities including the spectacular Fossett’s Circus, magicians, trapeze artists, face-painting, music, dance and much more!

 

Well-known personalities spotted enjoying the festivities with their families included TV personalities Brian Dowling and Arthur Gourounlian; model and broadcaster Glenda Gilson; 2FM presenter and Dancing with the Stars winner Carl Mullan; Rugby star Gordon D’Arcy; GAA legends Lee Keegan, Padraig O’Hora, Bríd Stack and Lindsay Peat; as well as model Sarah Morrissey and her ex-footballer husband Pat Jennings Jr.

 

Visitors were also given the opportunity to tour the Barretstown facilities and meet staff and volunteers to witness first-hand the life-changing work carried out by the specialised on-site teams.

 

Commenting, Barretstown CEO Dee Ahearn said:

 

“On behalf of all the team at Barretstown, I would like to sincerely thank all those who attended our annual Big Picnic. Special events such as this provide a unique opportunity to highlight the vital work carried out by Barretstown to support children affected by cancer and other serious illnesses, while demonstrating why continued support is so important to underpin the delivery of our life-changing therapeutic programmes.

 

“This year, we will serve over 17,000 campers through our Residential Programmes at Barretstown and Outreach Programmes in hospitals across Ireland. Hospitals treat the illness, Barretstown treats the child and plays a key role in helping each child suffering from a serious illness to rebuild emotionally, mentally, and physically”.

 

For more information or to learn how you can support Barretstown visit www.barretstown.org

Insurtech Startup MedoSync Raises €1.1 Million

  • Funding to be used to accelerate MedoSync’s growth trajectory and continued expansion of its suite of user-friendly solutions that automate the medical claims process for healthcare providers, clinicians and insurers with a key focus on European markets.
  • MedoSync aims to raise a further €1 million in a second round in Q4 2023 under the Employment Investment Incentive (EIIS) Scheme, allowing investors to claim up to 40% back in tax relief.
  • This further round will be aimed at investors with industry expertise such as medical consultants who understand the problem to which MedoSync offers a suite of solutions.

 

Irish insurtech startup MedoSync today announced that it has successfully closed a bridging follow-on funding round of €1.1 million following a successful initial round of funding in late 2021. Contributors included returning investors Enrique Curran and JP Sisk. This is the first part of a 2023 funding round, with the next stage set to open in late 2023 to a select pool of potential industry investors, chiefly medical consultants.

A key focus and use of the latest secured funding will be on market preparation in order to expand on existing proven bespoke product solutions currently in operation, however a primary target being the €400 billion German healthcare market. This focus will leverage MedoSync’s access to the German market after its success in the country’s GKV:implulse Accelerator hosted by BITMARCK in late 2022.

MedoSync aims to eliminate waste from medical claims in order to free up capacity across the healthcare ecosystem. By integrating with existing hospital and insurer systems, MedoSync’s suite of user-friendly solutions automates the medical claims process for healthcare providers, clinicians and insurers, providing a single source of verified information for medical billing.

Commenting, MedoSync CEO and co-founder Dr. Martin Rochford said that the funds raised are testament to MedoSync’s proven suite of solutions, with a new focus on European expansion, in addition to the potential for further fundraising later this year.

“We are pleased to have closed this first part of our 2023 funding round, with a mix of new and returning investors. A key focus of this funding will be used for European market preparation while continuing to expand our services in Ireland. This strategic approach will enable us to reopen the funding round later in 2023 to investors with industry expertise such as medical consultants, a key target audience affected by issues related to outdated, paper-based billing. Under the Employment Investment Incentive Scheme (EIIS), these potential investors will have a great opportunity to claim up to 40% back in tax relief.

“Our proven suite of solutions bring clarity to the healthcare claims process for providers, clinicians and insurers, overall freeing up capacity across the ecosystem. Efficient and adaptable, our system flexes to the needs of each partner organisation. By integrating with provider and insurers systems, we are able to automate a number of tasks creating efficiencies for claims teams. Bottle necks and stoppages are quickly identified to reduce payment delays which unlocks capacity, giving administrative teams the space and opportunity to focus on higher value work.”

For more information, see www.medosync.com

Sisters prove the future of farming is definitely female

The European Milk Forum (EMF) is a non-profit organisation which plays a vital role in driving the strategic development, management and exchange of integrated information initiatives on milk and dairy across Europe. Working in partnership with the National Dairy Council, the Irish campaign seeks to highlight the important work of dairy farmers across the country as they embed the latest in sustainable practices into their dairy farms. On International Women’s Day, the Irish Independent’s Western Correspondent Evan Murray profiled one such family when she spoke to Yvonne Connelly and her four daughters – Ava, Anna, Jane and Kate – about their award-winning dairy farm in Tuam, Co. Galway.

Early mornings milking cows, late nights birthing calves and the day in between spreading slurry, measuring grass and sowing clover – it’s all in a day’s work for the four Connelly sisters.

Pictured are Yvonne Connelly (centre) with her daughters Jane, Kate, Anna and Ava at their farm in Tuam.

Read the full article on Independent.ie (link) and join the European Milk Forum on social media via: #SustainableDairyEU and @EuDairyIRE on Twitter (link)

HPRA announces recall of ToothFaerie Toothpaste Range

Public urged not to use products, which may be unsafe

The Health Products Regulatory Authority (HPRA) and the Health Service Executive (HSE) today advised members of the public of a recall of the ToothFaerie brand of toothpaste products. These toothpastes are considered unsafe, and consumers are advised to stop using these products immediately.

The products are not believed to have been made widely available. However, the HPRA understands that some of the recalled products may still be available to Irish consumers, including via online supply or at local markets.

The HPRA previously requested retailers to stop selling these toothpastes as they do not meet the requirements of the European Cosmetics Regulations. For this reason, they are considered unsafe. For example;

  • The products listed an ingredient which is prohibited from use in cosmetic products. This ingredient, sodium tetraborate (borax), may cause damage to the reproductive system which may affect

fertility.

  • One batch was tested and found to contain lead which should also not be used in cosmetics as it can damage fertility or the unborn child and can cause damage to organs through prolonged or repeated exposure.
  • Some batches of product were tested and found to have microbial contamination at levels which may cause infection or irritation.
  • No assurance was received that a Cosmetic Product Safety Report had been carried out for the products in question. Such safety reports are a legal requirement for all cosmetics on the Irish market in order to protect public health.
  • Unfounded medical claims are made in the product advertising material.  

To date, the company has not addressed these safety concerns.  Therefore, these products are still considered non-compliant and unsafe, and are being recalled to consumer level. Any retailers who may have stock of these products are requested to remove the products from sale and contact the HPRA at cosmetics@hpra.ie.

Aoife Farrell, HPRA, advised the public not to continue to use these products.

“Unfortunately, these products do not meet the quality and safety requirements that the European legislation requires. These laws are in place to protect the public from unsafe products. It is concerning that the products contain a banned ingredient, and also bacteria, at levels that could cause infection. Our advice is for consumers to immediately stop using these products. These products were possibly purchased at small local retailers, or ordered online, and were available in six different flavours. If you are concerned about any medical issues, please contact your GP. Shoppers are also advised not to purchase any of these products, even if they find them available for sale.”

The HPRA also reminds consumers to always check that any cosmetic product they buy, whether in a shop or ordered online, has a name and address within the EU on the label. This is a legal requirement, and its absence may indicate the safety standards have not been met.

Cosmetic products on the market must meet the requirements of Regulation (EC) No. 1223/2009. In Ireland, the market surveillance of cosmetic products is carried out by the HPRA and the Environmental Health Service and Public Analysts’ Laboratories of the HSE. Neither the HPRA nor the HSE has any role in refunds of recalled cosmetic products.

The HPRA product recall notice can be found at Product Recall – ToothFaerie Toothpaste Range (hpra.ie)