Hi, I’m Michael H Cohen, founding attorney of Cohen Healthcare Law Group. In today’s video, we’re going to ask the question: Does properly labeling your dietary supplement product get you out of FDA crosshairs?

We get a lot of requests on labeling, but what people don’t realize is that labeling doesn’t mean just one thing, it’s not just the sticker that you put on the bottle. So, even if you hire a vendor and you pay them a thousand dollars or whatever the money is, to get everything right on that label – you haven’t done your job, and you haven’t gotten the FDA off your back.

So, No, the FDA doesn’t stop at the technical label. Labeling means every piece of literature or graphic that’s connected with your product. It could be a brochure, it could be something else in print, it could be a radio ad, it could be the marketing copy on your website, everything that’s considered part of your labeling. So, everything needs to be reviewed.

Now, there are a couple of things you want to look out for.

The first thing is, obviously with a dietary supplement, it’s meant to supplement your diet. It’s not meant to treat a disease. So, you can’t make a disease claim, but you can make a structure-function claim. So, you could say, “helps overall wellness,” “good for brain health.” There are specific ways that you make a structure function claim. The problem is, the challenges is a lot of wordsmithing because the line between a disease claim which is disallowed, and a structure-function claim which is allowed is very thin.

And it’s kind of like a sliding scale, like if you want to make a lot of money and market this thing, you’re going to be as aggressive as possible pushing it towards the disease claim. But push it too far, your brand is going to be taken off the shelf, and there could be lots of enforcement action. If you make a milk toast claim for your supplement, that’s not going to be good either, nobody wants a milk toast dietary supplement.

So, you want the wordsmithing to be really, really clever. And you need a lawyer who knows the FDA rules up and down, backwards and forwards, and can help you titrate your claim, because that little bit of tweaking could mean hundreds of thousands if not millions of dollars.

How, that’s not the only thing, people assume that because it’s a supplement, we don’t care about safety. I mean supplements are safe, but in fact there are certain supplements where FDA will look at the clinical data or efficacy for certain dosages. They are going to look at the safety. They are going to look at what the trial says. They are going to look at data about adverse effects. And they can get very nitty-gritty into the science of your supplement.

So, if you just assume that you can put something out and have this label and some kind of claim and that’s going to cut it, you’re missing that FDA can go against the ingredients and the overall formulation.

And one more point, there’s this law of unfair advertising which is jointly enforced by both FDA and FTC, and that can land you into regulatory crosshairs. I’ve even seen the case where the DA went against a manufacturer. It actually wasn’t a supplement, it was a medical device but similar – because, again, there’s this broad prohibition and these agencies have enforcement discretion. Discretion meaning, if in their discretion they want to go after you, they will.

So, you want to protect yourself, you want to make an investment into having a good legal counsel that evaluate your language and make sure that you’re within the range, not milk toast, but not so aggressive that you’re going to get milked.

And that’s what we do, we represent lots and lots of people: dietary supplements, cosmetics, medical devices, combination products. FDA regulates a whole slew of products and that’s why we can help people like you.

If you enjoy today’s video and would like to dive deeper into any of the topics, contact us and we’ll arrange for your Legal Strategy Session. In the Legal Strategy Session, we’ll address your specific healthcare legal needs, review your business, and give you concrete recommendations to help you move forward. To get started, click below. We’d love to talk to you.