An Open Letter to the Therapeutic Goods Administration

As a stakeholder in the cosmetic, aesthetic, and intimate health industries, I would like to respectfully bring to your attention the significant challenges your recent regulatory changes have created for both businesses like mine and the consumers we serve.

We fully support the importance of ensuring safety and transparency within the industry. We always have. My business has never used the brand names of the prescription products that we use and we have always only made mention of the results achieved by these products.

I do however, find the current restrictions — particularly around advertising and patient education — have caused unintended consequences that are harming small businesses and leaving consumers without the guidance they need to make informed decisions.

The Impact on Consumers

Your advertising restrictions have created confusion and limited access to critical information for patients. Many individuals are left unaware of safe and effective treatment options, forcing them to rely on incomplete or misleading information from less regulated providers.

For instance, at any point you pick up your device today, I implore you to keyword search “b*tox” and “groupon” and you’ll find list upon list of businesses who aren’t concerned with your regulations and aren’t concerned with safety, offering below the cost price of safe prescription products. There is no way anyone could achieve the safe delivery of a safe product at that price.

It’s this type of behaviour that risks a dark market quickly becoming a black market.

It’s worth adding that the complications of these regulations disproportionally affect young women from low socioeconomic backgrounds, who are vulnerable to underpricing and unsafe practices with no after-care support.

When these “GroupOn” procedures go wrong, there is no one to assist these young women with serious complications such as vascular occlusion, which has the potential to cause tissue ischemia, necrosis and in severe cases, loss of eyesight.

Consumers of every economic level deserve clarity and transparency when it comes to their health and wellbeing. Without this, they may turn to unqualified providers, increasing the risk of unsafe outcomes and undermining the credibility of our industry.

Unseen Enforcement of Regulations

A significant concern for small businesses is the lack of consistent enforcement of TGA regulations across the industry. While many businesses, like mine, dedicate time, resources, and financial investment to ensure compliance, others continue to operate outside the rules without

facing consequences.

I have recently invested considerable money in a trying economic environment to have marketing consultants, who are familiar with your regulations, rewrite and relaunch my website as well as all of my marketing materials, so they are consistent and compliant with the standards outlined by your organisation.

Meanwhile, I watch my competitors continue to blaze on, marketing their before and after photos, communicating their prescription treatments in non-compliant detail and advertising under-cost treatments on discredited discount websites.

This uneven enforcement undermines the credibility of the system and creates an unfair playing field within the industry, where those that do are financially restricted, and those that don’t go unimpeded.

For businesses that do invest in TGA regulations, the lack of penalties for non-compliance leads to:

• Competitive Disadvantage: Non-compliant businesses are able to advertise freely, attracting customers, without bearing the same compliance costs.
• Erosion of Trust: Clients lose confidence in the system and the treatments when they see discrepancies in how rules are applied across different providers.
• Reduced Incentive to Comply: The absence of enforcement discourages businesses from adhering to the guidelines if there are no visible consequences for those who ignore them.

Enforcement is a critical aspect of any regulatory framework. Without consistent monitoring and action against violators, the integrity of the rules is compromised, and businesses that strive to comply are penalised for their efforts.

We urge the TGA to implement a clear, transparent enforcement strategy that ensures all businesses are held accountable to the same standards. This would protect consumers, foster trust in the industry, and create a fair and equitable environment for all providers.

The Disproportionate Burden on Small Businesses

Small Australian businesses, which form the backbone and bedrock of this industry are disproportionately affected by these changes. The high costs of compliance, including updating marketing practices and training staff within the time period we’ve been offered as stakeholders with little consultation, places immense financial strain on businesses that already operate on tight margins in an extreme challenging financial environment.

New Restrictions on Vaginal Laser Therapy

We are particularly concerned about the recent restrictions placed on advertising vaginal laser therapy. There is an extensive body of evidence supporting the safety and efficacy of Erbium lasers in treating various intimate health concerns, including symptoms associated with menopause.

To date, there are over 50 international studies, many of which are randomised controlled trials (RCTs), that demonstrate both the safety and statistically significant efficacy of Erbium laser treatments. These studies underscore the important role that Erbium lasers can play in improving quality of life for women experiencing intimate health issues, including vaginal dryness, reduced elasticity, and discomfort.

In contrast, the recent study by Professor Jason Abbott, which appears to have contributed to the TGA’s decision to restrict vaginal laser treatments, focuses exclusively on the use of CO2 lasers, not Erbium lasers. The study, which involved only 80 women, has drawn criticism for its limited sample size and its findings being applied broadly to all vaginal laser technologies despite clear differences in laser modalities.

The Erbium laser has a distinct mechanism of action that is gentler than CO2 lasers, targeting the tissue with precision while minimising thermal damage. This difference is crucial, as the positive outcomes seen in numerous Erbium laser studies highlight its value as a safe and effective treatment option for women.

It is important to consider these distinctions and the wealth of evidence supporting Erbium lasers when evaluating their use and potential regulatory changes.

The recent introduction of these regulations limit women’s access to valuable information about treatments that could significantly improve their quality of life. Restricting the ability to educate patients about these safe, effective options feels like a step backward for women’s health.

A Call for Collaboration

We urge the TGA to take the following steps:

1. Engage with Small Businesses: Include small business owners in the decision-making process to ensure future regulations reflect the realities of those directly impacted.
2. Ensure Fair Enforcement: Monitor and enforce compliance consistently to create a level playing field and maintain industry credibility.
3. Allow Responsible Advertising: Develop clearer guidelines that allow businesses to responsibly educate consumers about evidence-based treatments.
4. Provide Transitional Support: Offer grants, workshops, or resources to help businesses adapt to new regulations without facing undue financial strain.
5. Reconsider Evidence-Based Treatments: Reassess the restrictions on vaginal laser therapy and similar treatments, allowing appropriate education and advertising to ensure patients have access to the care they need. Not all lasers are the same. We urge you to find nuanced differences between CO2 and erbium lasers, which have far different clinical results.

The industry stands ready to collaborate with the TGA to create a regulatory framework that prioritises both safety and accessibility while supporting the sustainability of small businesses. We believe that together, we can find a balance that benefits all stakeholders.

We hope you will consider the concerns raised in this letter and welcome the opportunity to engage in meaningful dialogue to address these issues.

Sincerely,

Dr Kelly Needham

Owner & Founder

Coastal Goddess & The M Clinic