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Why We’re Not Allowed to Say That LadyBalance Works

- even though we have experience and documentation

From Certified Medical Device to New Legislation

In 2008, the Danish authorities decided that if a product claims to help with vaginal health issues, it falls under medical device legislation - specifically class 2a. This requires approval of manufacturing, labeling, and documentation by an independent notified body. LadyBalance was approved in 2009 and held certification until 2021. However, a new law came into force in May 2021 with significantly stricter requirements. Many certifying bodies withdrew - including the Danish company Presafe, which had certified LadyBalance until then. A transition to their Norwegian parent company DNV was attempted, but the Norwegian authorities concluded that the product no longer fell under the medical device regulations - making certification transfer impossible.

A Collapsing System - and No Certification to Obtain

At that point, we tried to be re-approved under the former legislation, which we had already fulfilled. But we encountered new, rigid demands - and extremely high fees. Therefore, we chose to abandon the attempt. And without certification, we are no longer allowed to state that the product has any effect. Companies that were approved before the law change were granted a temporary continuation. This transitional arrangement was recently extended by the EU until 2027 - but unfortunately, we fell through the cracks.

Legal Product - But Not Allowed to Mention Symptoms

After dialogue with the authorities, it became clear that LadyBalance may still be marketed - as long as we do not claim it helps against diseases. Otherwise, it would fall under a different regulation - for chemical products – which has no official certification system. That means it’s not possible to obtain a certificate confirming compliance with the requirements. It is the company’s own responsibility to ensure the rules are followed – and we have received expert guidance on this. Still, it’s a strange situation because we cannot rewrite history. Our earlier newsletters - from the time when the product was certified - still exist. But today, we’re not allowed to mention diseases in our product descriptions. Not even if supported by scientific studies.

Gardnerella and Symptoms - What We Know But May Not Say

It’s important to stress that the lack of certification is not due to any issues with the product. Over a million packs have been used - without any reported serious incidents. One point of criticism has been that we haven’t conducted toxicological testing with the active ingredient - lactose. But milk sugar is a well-known substance, also familiar to the female body, and is on the EU’s list of substances so well tested and harmless that they are exempt from standard test requirements. We have user experience - and a clinical study in which the former 0.8 g tablet was examined. The study showed a significant reduction of Gardnerella vaginalis, the bacteria typically associated with bacterial vaginosis and Gardnerella symptoms such as unpleasant odor, discharge, and irritation. However, because the study was conducted with the 0.8 g tablet and not the current 1.2 g version, the result is not permitted to be used as documentation under current rules. That’s why we highlight that the 0.8 g tablet - the one that was tested and documented - is still available in our product range.

We’re Not Allowed to Say It Works - Even If We Have Indications

Even though we have experience, customer satisfaction, and documentation, we are no longer allowed to claim that LadyBalance works. Without certification, it is prohibited - no matter how much knowledge supports it. So we’re back to word-of-mouth: The good story about how to maintain intimate balance must now be shared personally - as in the old days. If you know someone who might benefit from LadyBalance intimate tablets, feel free to tell her about the product. You’re also welcome to share this link: www.ladybalance.dk