Dietary Supplement Laws and FDA Regulations

An example of how we integrate ancient knowledge with modern technological progress, and it all centers around the legal regulation, is how we regulate dietary supplements. There’s a company that has an herbal medicine product for weight loss.

The challenge is that the FDA says,

“When you have a dietary supplement, if you make a claim that it helps cure a disease, it gets regulated as a drug.”

And when it’s a drug, you need new drug application, and that’s very expensive to bring a product to market. So you don’t want to do that. You want to make a proper structure function claim such as, “Supports healthy weight loss.”

Now, one of the customers of this company posted on their Facebook page that the product was so good that it helped the client lose an incredible amount of weight, such a huge, staggering amount of weight that it’s simply scientifically untenable and unbelievable. It’s just preposterous. And one of the company’s marketing people got so enthusiastic that they liked this post on their Facebook page. And the FDA said that by doing this, the company was making a disease claim, and therefore, the product had to be regulated as a drug and had to be pulled off the market or they needed a new drug application.

Well, this got the company in really, really deep trouble. I mean, it was a huge expense. So when you bring a dietary supplement to market, you need to be sure to get legal counsel to evaluate all of your marketing materials, not just the little label that says, “This has not been evaluated by the FDA,” but every claim that goes on your website. And you need to have legal counsel rein in your marketing people so that you can bring the product to market responsibly, in a way that is going to satisfy the regulatory system, in a way that’s going to protect you from unnecessary liability, so that your product can be a huge success, bridging that ancient technology with modern wisdom.