Is Your OTC Brand Actually FDA Compliant?

Most OTC drug brands don’t realize they’re out of compliance until FDA shows up — and by then, it’s too late.

Hi, I’m Lisa Capote, FDA regulatory attorney and founder of Capote Law Firm. In this video, I want to walk you through what it actually means for your OTC brand to be FDA compliant — and what most brands get wrong.

There are three core requirements every OTC drug brand must meet.

First: labeling. Your label must include the Drug Facts panel with the correct format, required information, and approved language. Missing, incomplete, or unapproved claims on your label are one of the fastest ways to get an FDA warning letter.

Second: registration. If you’re manufacturing or distributing an OTC drug in the US, your facility must be registered with FDA and your product must have an NDC — a National Drug Code. If you don’t have one, you shouldn’t be selling.

Third: GMPs — Good Manufacturing Practices. FDA requires that OTC drug products be manufactured under quality standards designed to ensure consistency, safety, and identity. If your manufacturer isn’t GMP-compliant, your product isn’t compliant.

Being sold without a prescription doesn’t mean you’re exempt from FDA oversight. OTC products are still drugs, and FDA treats them that way.

At Capote Law Firm, we help OTC brands build defensible compliance programs — before FDA comes knocking.

If you’re not sure where you stand, reach out. A compliance review now is far less costly than a warning letter or recall later.