You have a health and wellness product and you’re wondering whether FDA will likely regulate it as a dietary supplement, a cosmetic, or a prescription drug.  So many products out there seem to blur the lines and by the way, they’re sold online with outrageous claims.

Hi, I’m Michael H Cohen, founding attorney at Cohen Healthcare Law Group; we help healthcare companies just like you navigate legal challenges so you can grow or scale your healthcare venture.

Here are three legal tips from us about these FDA issues:

Number One: don’t rely on the manufacturer, they could be making claims that get you in trouble if you make them and your business is on the line, online as a distributor. You are accountable to FDA.

Second, the key to regulatory classification is the intended use of the product, which can be shown by the claims the distributor makes.  Is the product intended or claimed to diagnose or treat or cure a disease or condition?  In that case it’s probably going to be regulated as a drug. It does depend on what you say about it.

On the other hand, does the product merely claim to support general wellness and overall health?  If it does, it’s probably a cosmetic or dietary supplement.

Basically, dietary supplements are consumed orally (by mouth) whereas cosmetics are placed on the skin topically.  Also, the law allows more restrictive claims for cosmetics, and we have more information about that on our blog.

Third point is this, even if you have the right FDA regulatory classification for your product, your claims have to be supported by what FDA and FTC, the Federal Trade Commission, call “competent and reliable scientific evidence.”

Thanks for watching.  Please come to us with your questions, we look forward to talking to you, and we look forward to working with you soon.