In today’s video, we discuss what’s involved in an FDA label review

Hi, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you navigate healthcare and FDA legal issues and launch, or continue to scale, their health and wellness product success.

Typically, a client comes to us with a proposed dietary supplement product and asks us something like, “can you please tell me what it would take to review our labels?”

There is one important thing you need to know about this kind of question and about FDA law concerning dietary supplement labels and it’s this: FDA law considers not only the label itself that you stick on the bottle, but also everything you say in your marketing, everything, as part of the “labeling.” Labeling is a legal term.

FDA law allows you to make “structure/function” claims for your dietary supplement product on your labeling.  For example, “supports a healthy immune system.”  FDA does not allow you to make a disease claim, also known as a therapeutic claim for a supplement.  For example, “prevents viruses,” that would be a disease claim. Disease claims are only allowed for drugs.  And if you label your supplement like a drug -I don’t recommend it, because you’ll get a warning from FDA, or possibly much worse.

Another issue, a lot of times, people ask for a quote. “Can you quote me what a label review would be?” A quote really don’t mean anything. If you ask me for a quote for a new house, sure I can give you a quote – but it depends on a lot of variables, which is something that the buyer, controls: for example, what is the neighborhood, is it a new house or an old house, what’s the house going to be made of, what is the lot size, and so on. If you bought a house, you know what I’m talking about.

So when people ask for a “label review,” they’re asking for a house, really. And what they don’t understand is that there are many different parts to reviewing the labeling, which as we said is more than the label itself.

Of course, first and foremost, you have the review of the label to make sure it complies with very specific and technical FDA rules regarding what can and cannot go on that sticky thing on the bottle.  But that’s just the first layer of the review, the sticky thing on the package.

Second, you have to review the claims being made for the product.  Going back to our earlier example, is the dietary supplement being marketed and promoted for immune support, or, as an anti-viral, in which case it would be regulated as a drug?  So again, no disease claims are allowed for dietary supplements; and, remember that labeling is broader than the label itself—so you have to review the website, social media claims, anything that really is said by the dietary supplement manufacturer or distributor who’s putting the product out to market.

Next you want to check that there are no new dietary ingredients.  Typically, clients aren’t coming to us with new dietary ingredients which requires an NDI submission to FDA, but every once in a while, there is an issue.  And that is something that’s often gets batted to a regulatory consultant because it doesn’t consume a lot of attorney time, it’s mostly very technical.

And then, a dietary supplement manufacturer is responsible for ensuring that the claims are substantiated.  This means the claim has to be supported by competent and reliable scientific evidence, as otherwise the FTC, the Federal Trade Commission, can deem the claims to be false and misleading. We have a lot of other videos about FTC exposure.

Thanks for watching, it’s been a quick dip. If you have questions, click on the link below, cohenhealthcarelaw.com/contact, to send us a message or book an appointment. We have a lot more content on our site, please avail yourselves. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.