At Cholrem, our mission has always been to help people improve their cardiovascular health. Since our founding in 2018, we've grown from a small, innovative healthcare company to supporting thousands of people worldwide. The recent surge in demand for Cavadex has been both heartening and challenging – heartening because it shows we're making a difference, but challenging because it's led to faster depletion of our inventory than anticipated.
The FDA Situation
We've been diligently working to engage with the FDA regarding our products. Our legal team has made multiple attempts to contact the relevant departments, providing extensive documentation and seeking to initiate a productive conversation at various levels within the agency. However, despite our persistent efforts, we have not received any response from the FDA.
First Letter: https://www.cholrem.com/Letter_to_FDA.pdf
Second Letter: https://www.cholrem.com/Letter_to_FDA_2.pdf
We acknowledge that the FDA has numerous pressing matters to address, but we will continue to reach out and emphasize the significance of Cavadex in supporting the health journeys of many individuals. It's important to note that our products are still being released after a holding period of 6 to 8 weeks. We are facing challenges, but the FDA has not placed an embargo on our products or taken any direct action against us.
We remain committed to working with the FDA to ensure compliance and maintain open lines of communication, as we believe in the value and safety of our products for our customers.
A Ray of Hope
Despite the challenges we've faced in engaging with the FDA, there is a glimmer of hope on the horizon. An increasing number of healthcare professionals are coming forward to share their positive experiences and observations regarding Cavadex. In the upcoming weeks, highly respected medical practitioners in the United States, such as Dr. James Roberts, will be documenting and presenting their findings and insights about the product.
https://www.youtube.com/watch?v=sNka3qePgWk&t=740s
This growing support from the medical community serves as a powerful reinforcement of what we have known all along – that Cavadex plays a significant role in improving people's lives. Dr. Roberts' upcoming statements carry particular weight, as he will be speaking publicly for the first time after his patients have been using Cavadex for approximately three years. His long-term observations and the experiences of his patients will provide valuable evidence of the product's efficacy and impact on individuals' health journeys.
As more healthcare professionals lend their voices to the discussion, we believe that their collective insights will help to further validate the importance of Cavadex and its potential to positively affect the lives of those who rely on it.
Taking Care of Our Community
To ensure everyone has fair access during this period, we've implemented a pre-order system on our website. This isn't about limiting access – it's about being transparent and fair. Many pre-orders will ship ahead of schedule, and we're working hard to maintain a reliable supply.
Key points about our supply status and pre-order system:
- Pre-orders are being processed and fulfilled
- Many orders are shipping ahead of schedule
- Global distribution continues
- Full customer support remains available
To secure future access, we recommend:
- Placing pre-orders for immediate needs
- Staying informed about developments
- Considering alternative options if needed
- Keeping your contact information current
We value your trust and are working diligently to navigate the challenges while continuing to provide you with the products you rely on.
Your Stories Matter We've been deeply moved by the stories you've shared about how Cavadex has impacted your lives. These stories, along with growing support from medical professionals, strengthen our resolve to keep working through these challenges.
Looking Forward While we can't predict the outcome of the regulatory process, we're optimistic about potential changes after the administrative transition on January 20th, 2025. Until then, we'll keep working through every available channel to maintain availability for our community.
We promise to keep you informed of any developments, good or challenging, as they happen. Thank you for your continued support and trust in Cholrem and Cavadex.
