Hi, I’m Michael H. Cohen. I’m founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness.

In today’s video, we’ll talk about dietary supplement labeling, one of my favorite topics. I love it because it’s a language game, and you got to titrate the claim so that it’s aggressive enough, assertive enough, Did he get market share but doesn’t cross the line?

It’s something the FDA is going to flag.

Claims are important. Manufacturing practices are important. Adhere to good current GMP. So we’ve advised clients on how to upgrade their production standards so that they get safer products and they reduce the risk of recalls. The claims, as I mentioned, the claims have to be evidence-based as well as proper claims. They have to be substantiated.

There are FDA standards. You can’t just say anything you want without having a basis for it. Also, you want to have great labels that make, as I said, the titrated claims that are proactively taking advantage of everything you can do in a structure function claim. But they don’t mention insomnia, anxiety all of these disease terms that FDA is just going to flag.

You also want to take a look at the ingredients. Make sure that the ingredients don’t raise any safety issues. Have an ingredients check, it’s not just all about the label and labeling. So you want to really go deep when you’re getting your product out there so that it doesn’t get taken off the shelves and you don’t want a warning letter.

And you know, it’s not rocket science, like you can look at warning letters and you can find claims. We’ve actually had clients come to us making the same claim as something that was flagged by FDA in a warning letter to another company.

So don’t do that at home, don’t do that at business. Get the right legal advice. Get a thorough FDA review of your dietary supplement product before you put it on to market. Then you won’t have problems later.

If you’d like to dive deeper into any of the topics we’ve talked about today, reach out to us. Click below. We’d love to talk to you. We look forward to it.