Reasons To Avoid FDA/FTC Warning Letters

This video helps company staff, executives, and investors understand why FDA/FTC warning letters should be avoided. This is a useful tool to help build a culture of compliance within the company. If top executives are not on board with marketing and manufacturing compliance this is a difficult tide to row against. I have found helping them understand ramifications such as scaring away investors or alerting class action attorneys usually is the big "oh yeah" lightbulb moment. What are your thoughts or advice on how to build a culture of compliance? I love making these videos, please let me know what you think. Kind regards, Asa Waldstein Asa's LinkedIn:   / asa-waldstein-989360b   https://www.AsaWaldstein.com -These comments are considered educational only and are not intended as legal or regulatory advice. What are the reasons why we want to avoid an FDA warning letter? I find this to be really useful. You can share this with your company officers, your CEO, your marketing team, your investors, whomever. You can share it with them as a way to help build this culture of compliance within the company. One, it requires legal resources to respond to. You should hire an attorney. You have to respond within 15 days, unless it's a COVID related warning letter, then you only have 48 hours to respond. It also takes your eyes off the price. Imagine the mental bandwidth it takes to think about responding to an FDA warning letter. It really takes your attention away from growing your company. It's also super embarrassing, it's a matter of public record. Can you imagine your name or your company's name memorialized forever in a FDA warning letter history, and it does rank really high on the search engines. Your name or company name will show up forever and ever. Also, repeat warning letters, they could lead to injunction, seizure, really, really serious ramifications. Also, this is really important. In this day and age, there's so much mergers and acquisition happening in our industry and the easiest way to scare away investors is by getting a warning letter. This includes acquisitions, this includes strategic partnerships. Again, this is really, really important. As I've talked to people, I've been in the conference room or the boardroom and I've brought up reasons why you want to avoid a warning letter, this is really the big light bulb moment here that people think of and say, "Oh yeah, that makes sense. I don't want to lose the opportunity to raise outside capital, for example, by getting a warning letter." Last but not least, class action attorneys. Plaintiff attorneys oftentimes use warning letters as the basis of wrongdoing in their class action lawsuits. We'll see a bunch of warning letters come out and then class action lawsuits will certainly follow.