In today’s video, we help you further understand some of the important FDA rules around labeling your product.

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 and regulatory issues every day, so you can continue to scale, or launch your health and wellness product.

In recent video, we talked about how FDA looks not just at the label that you peel on your product, but everything, everything you say in your marketing about your product.  FDA calls all of this your labeling— not just one label.

What FDA is looking for is whether you are sticking to structure/function claims, which you’re allowed to make for supplements if you dealing with dietary supplement, or, whether you are making disease claims which we also call them drug claims, which are unlawful and will cause your dietary supplement or cosmetic product to be regulated as a drug.

As the manufacturer or distributor of a dietary supplement, you can’t afford to have your product regulated as a drug, because you don’t want to spend years and years and millions of dollars on clinical trials establishing safety and efficacy.  You simply want to say, “supports” this or “boost” that, and the overall context have to be a safe claim, get the product on the shelves and get it sold.

But, sometimes it helps your marketing – it boosts your marketing, it supports your marketing – to be a little more aggressive in your claims.

That in itself is not a bad thing, but that’s where it can be worth a lot of money to have a lawyer who is proactive, who understands the nuances, who knows where you can push the marketing, probably. And when you can be assertive but when your claims are so aggressive that they’re likely going to tip the balance into drug claim territory. And I say probably, because there’s always a judgment call, and you always make a business judgment.

Now, large companies, you can’t make a move without going to the lawyers, you cannot put a claim on the website, without the legal department coming down, a lot of times coming down heavy, because if you get it wrong, the company gets slammed by FDA and, you’ll also have headline news. So you don’t want to be on the news.

Smaller companies sometimes don’t realize this, and they typically tip-toe around trying to get the cheapest quote for a label review.

Sure, you can train a paralegal to review a label for technical compliance, but, that’s not the same as having good sense and experience and judgment as to the nuances of product labeling (including the claim) and understanding FDA’s tolerance—or not—for a little marketing flair.  The difference between a claim that draws FDA fire and one that does not can be very subtle; and, so can effective marketing campaign – a good campaign vs. one that is dull, dry, plain vanilla boring, just because the lawyer always says no.

Please note, the phrase “plain vanilla” has not been approved by FDA.  I’m just kidding, I’m giving you a metaphor.

FDA doesn’t have to approve everything, certainly not plain vanilla; but, they can do something very simple: go into the search bar of Google and they look for terms and in this way FDA can very easily catch you if your marketing terms make claims that FDA considers unlawful for dietary supplements or cosmetics.

One last tip, don’t rely on other companies to do the work for you, even if they are big manufacturers or redistributors and assure you that all is well and done well.  Don’t rely on them vetting the claims, get your own legal counsel. I used to say “Don’t roll the dice, get legal advice.”

Thanks for watching. If you still have questions, please click on the link below, cohenhealthcarelaw.com/contact, to send us a message or book an appointment. We’d love to hear from you, we look forward to speaking with you soon.