3 ms·

I've worked with people who have started companies in this space and raised a lot of money, and also with lawyers who have represented some of the most prominen

I've worked with people who have started companies in this space and raised a lot of money, and also with lawyers who have represented some of the most prominent companies in this space. I'd be cautious around even "anecdotal" statements around decreasing base heart rate and aortic stiffness. FDA takes these kinds of claims very seriously, and it costs a LOT of money to get the kind of data FDA requires to back these claims up. Essentially every company that has tried marketing "non drugs" to improve clinical outcomes without complying with regulations and generating rigorous data has been shut down, either temporarily or permanently

vancanwin 9y ago
Greatly appreciate the caution. Yes, we are working doctors who are making these claims with supplements and their device. However, I will tread carefully on my anecdotal statements as well.
- aaavl2821 9y ago
  In the US there is a very big difference between a doctor making a recommendation to a patient and a company marketing a product, even if the company is run by doctors. As you know doctors can make suggestions based on their medical expertise, even for non FDA approved drugs, and in many cases malpractice is the mechanism by which "bad advice" is regulated Companies are not doctors and do not have that same sort of leeway when giving medical advice. If patients complain, or if your company gets to the point where it is marketing drugs (even if you call them supplements) based on unfounded claims and it seems like it can cause reasonable public health concern, FDA can shut you down overnight plus if you get some visibility and doctors get the sense you are marketing overly aggressively and making unsubstantiated claims that could hurt patients, they can be quite vocal you probably know this but based on your answer i couldnt tell. dont mean to be overly critical, but ive seen many companies fail because they are glib re this issue, and when this happens it reflects poorly on the whole sector not a lawyer or doctor, just an observer
  - minfitzgerald 9y ago
    Thanks for the feedback, yes, we've taken the feedback on this and are careful about claims and marketing.

vancanwin 9y ago

Greatly appreciate the caution. Yes, we are working doctors who are making these claims with supplements and their device. However, I will tread carefully on my anecdotal statements as well.

aaavl2821 9y ago
In the US there is a very big difference between a doctor making a recommendation to a patient and a company marketing a product, even if the company is run by doctors. As you know doctors can make suggestions based on their medical expertise, even for non FDA approved drugs, and in many cases malpractice is the mechanism by which "bad advice" is regulated Companies are not doctors and do not have that same sort of leeway when giving medical advice. If patients complain, or if your company gets to the point where it is marketing drugs (even if you call them supplements) based on unfounded claims and it seems like it can cause reasonable public health concern, FDA can shut you down overnight plus if you get some visibility and doctors get the sense you are marketing overly aggressively and making unsubstantiated claims that could hurt patients, they can be quite vocal you probably know this but based on your answer i couldnt tell. dont mean to be overly critical, but ive seen many companies fail because they are glib re this issue, and when this happens it reflects poorly on the whole sector not a lawyer or doctor, just an observer
- minfitzgerald 9y ago
  Thanks for the feedback, yes, we've taken the feedback on this and are careful about claims and marketing.